PART 1:

GENERAL PROVISIONS 1.1 Purpose and Scope.

1.1.1 Authority.

Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1- 108, 25-1.5-101(1)(k), 25-1.5-101(1)(l), and 25-11-104, CRS. 1.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department. 1.1.3 Scope.

This part includes provisions generally applicable throughout all parts of these radiation control regulations.

1.1.4 Applicability Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, own, acquire, use, process, store, transfer, or dispose any source of radiation; provided, however, that nothing in these regulations shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission. 1 1 Attention is directed to the fact that regulation by the State of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the State and the U.S. Nuclear Regulatory Commission and to 10 CFR Part 150 (January 1, 2004) of the Commission's regulations. 1.2 Definitions.

As used in these regulations, these terms have the definitions set forth below. Additional definitions used only in a certain part of these regulations will be found in that part. "A1" means the maximum activity of special form radioactive material permitted in a Type A package. This value is either listed in Appendix 17A, Table 17A1, or may be derived in accordance with the procedures prescribed in Appendix 17A. "A2" means the maximum activity of radioactive material, other than special form, low specific activity (LSA) and surface contaminated object (SCO) material, permitted in a Type A package. This value is either listed in Appendix 17A, Table 17A1, or may be derived in accordance with the procedures prescribed in Appendix 17A.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad. "Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material” means any material made radioactive by a particle accelerator. “Accident” means any unintended event (including an operating error, equipment failure or other mishap) which could (1) result in a dose in excess of regulatory limits on site or for the public or (2) have consequences or potential consequences which cannot be ignored from the point of view of protection or safety (such as an actual or potential substantial degradation of the level of protection or safety of the facility or release of radioactive material in sufficient quantity to warrant consideration of protective actions).

"Act" means Title 25, Article 11, Colorado Revised Statutes (CRS), as amended. "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci). "Adult" means an individual 18 or more years of age.

"Agreement State" means any State with which the U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689). "Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DACs) specified in Appendix 4B, Table 4B1, or (2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC hours. "Air-purifying respirator" means a respirator with an air purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element. "Airline respirator" (see "supplied-air respirator” ).

"Alert" means an event may occur, is in progress, or has occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

"Annual limit on intake" (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Part 4, Appendix 4B, Table 4B1, Columns 1 and 2. “Annually” means either (1) at intervals not to exceed 1 year or (2) once per year, at about the same time each year (plus or minus 1 month).

“ANSI” means the American National Standards Institute. "Assigned protection factor” (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"Atmosphere supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units. "Background radiation" means radiation from: (1) extraterrestrial sources; (2) naturally occurring radioactive material (which has not been technologically enhanced), including radon, except as a decay product of source or special nuclear material; and (3) global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Department. "Becquerel" (Bq) means the SI unit of activity. One becquerel is equal to 1 disintegration per second or transformation per second (dps or s -1 ).

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in-vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term. "Brachytherapy" means a method of radiation therapy in which plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or interstitial application. "Byproduct material" means:

(1) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material; and (2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method used in determining calendar quarters for purposes of these regulations shall not be changed by any licensee or registrant except at the beginning of a year (see also “quarter” and “year” ). "Calibration" means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument or (2) the strength of a source of radiation relative to a standard.

"CFR" means Code of Federal Regulations.

"Chelating agent" means amine polycarboxylic acids, hydroxy carboxylic acids, and polycarboxylic acids.

"Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than 10 days, for class W, weeks, from 10 to 100 days, and for class Y, years, of greater than 100 days. For purposes of these regulations, “lung class” and “inhalation class” are equivalent terms. "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation. "Committed dose equivalent" (H ,50) means the dose equivalent to organs or tissues of T reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

"Committed effective dose equivalent" (H ,50) is the sum of the products of the weighting E factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (H ,50 = S x W x H ,50). E T T "Constraint" (dose constraint) means a value above which specified licensee actions are required. “Continuing education unit” (CEU) means one documentable training or education contact hour. “Cost estimate” means a document containing the total costs that would be incurred if an independent contractor were hired to perform decommissioning of the facility and disposal of radioactive materials at the facility, and associated administrative indirect and legal costs to the Department in conducting decommissioning oversight.

"Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances. "CRS" means the Colorado Revised Statutes.

"Curie" means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7 x 10 10 transformations per second (s -1 ). "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

"Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits: (1) release of the property for unrestricted use and termination of the license or (2) release of the property under restricted conditions and termination of the license.

"Decommissioning funding plan" means a written document that contains a cost estimate for decommissioning and a description of the method for assuring funds for decommissioning, including means of adjusting cost estimates and associated funding levels periodically over the life of the facility.

"Decommissioning plan" means a written document that includes the licensee’s planned procedures and activities for decommissioning of the facility or site. "Deep dose equivalent" (H ), which applies to external whole body exposure, means the dose D equivalent at a tissue depth of 1 centimeter (1000 mg/cm 2 ). "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation. "Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice dentistry. "Department" means the Colorado Department of Public Health and Environment. "Depleted uranium" means the source material uranium in which the isotope uranium 235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

"Derived air concentration" (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these regulations, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Part 4, Appendix 4B, Table 4B1, Column 3.

"Derived air concentration-hour" (DAC-hour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

“Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction to the supervisee throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end of service life renders it unsuitable for use. Examples of this type of respirator are a disposable half mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose equivalent (H )" means the product of the absorbed dose in tissue, quality factor, and all T other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term. "Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

"Drill" means a supervised, hands-on instruction period intended to test, develop or maintain a specific emergency response capability. A drill may be a component of an exercise. "Effective dose equivalent” (H ) means the sum of the products of the dose equivalent to each E organ or tissue (H ) and the weighting factor (W ) applicable to each of the body organs or T T tissues that are irradiated (H = S x W x H ).

E T T "Embryo/fetus" means the developing human organism from conception until the time of birth. "Emergency" means an event requiring prompt action to mitigate a threat to the health and safety of workers and the public or a threat of damage to the environment. "Emergency planning zone" means a geographic area surrounding a specific facility for which special planning and preparedness efforts are carried out to ensure that prompt and effective protective actions can reduce or minimize the impact of releases of radioactive material to public health and safety or to the environment.

"Entrance or access point" means any location through which an individual could gain access to radiation areas or to licensed or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use. "Evacuation" means the urgent removal of people from an area to avoid or reduce high-level, short-term exposure.

"Event" means a situation reasonably discrete in time, location and consequences. "Exercise" means a multi-faceted activity that tests the plans, procedures, adequacy of training, resources, and integrated capability of an emergency response system. "Explosive material" means any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

"Exposure" means being exposed to ionizing radiation or to radioactive material. " Exposure " means the quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). See Section 1.14 units of exposure and dose for the special unit. 2 2 When not underlined as above, or indicated as "exposure" (X), the term "exposure" has a more general meaning in these regulations.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee. “Facility” means the location within one building, or vehicle, or under one roof and under the same administrative control (1) at which the possession, use, processing or storage of radioactive material is or was authorized or (2) at which one or more radiation machines are or were installed, operated and / or located. “Facility” may also mean multiple such locations at a site or part of a site.

"Final radiation survey" means the survey of the facility or site after decommissioning activities have been completed during which the determination is made by the licensee that the facility or site meets the Department’s release criteria.

"Financial surety" or "financial warranty" means the method of assuring that sufficient funds will be available at the time of license termination and decommissioning of the facility to cover all costs associated with the decommissioning.

"Filtering facepiece" (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps. “Fissile material” means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium, that has been irradiated in thermal reactors only, are not included in this definition.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

"Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated. "General supervision" means the procedure is furnished under the supervisor’s overall direction and control but the supervisor’s presence is not required during the performance of the procedure.

"General emergency" means an accident has occurred or is in progress which involves actual or imminent catastrophic reduction of facility safety systems with potential for loss of containment or confinement integrity or release of radioactive material that can be reasonably expected to exceed offsite protective action guides. 3 3 A definition of “general emergency” is provided for reference and completeness. It is unlikely that any Colorado licensee would need to plan for a general emergency.

"Generally applicable environmental radiation standards" means standards issued by the U.S. Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material. "Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed dose resulting from deposition of 1 joule (J) of energy in 1 kilogram of material (100 rad). "Hazardous waste" means those wastes designated as hazardous by Department regulations in 6 CCR 1007-1-3.

"Healing arts" means any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury or unhealthy or abnormal physical or mental condition. "Helmet" (respiratory) means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

“High radiation area” means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates. "Hood" (respiratory) means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso. "Human use" means the internal or external administration of radiation or radioactive material to human beings.

“ICRP” means the International Commission on Radiological Protection.” "Immediate" means within not more than fifteen minutes or as otherwise specified in writing by the licensee and approved by the Department.

"Incident" means any unintended event involving radioactive material for which the public dose is a fraction of regulatory limits and safety provisions are sufficient, but further degradation of safety systems could lead to an accident condition.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent by the use of:

(a) Individual monitoring devices; or (b) Survey data; or (2) Committed effective dose equivalent by:

(a) Bioassay; or (b) Determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition of DAC-hours). “Individual monitoring device” mean a device designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices. “Inhalation class” (see “class” ).

"Inspection" means an official examination or observation including but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, license conditions and other requirements of the Department.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur. "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

“Lens dose equivalent" (LDE) means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm 2 ). "License" means a license issued by the Department in accordance with the regulations adopted by the Department.

"Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department. "Licensee" means any person who is licensed by the Department in accordance with these regulations and the Act. "Licensee" also means any person who is responsible for decommissioning by being registered with the Department, being subject to a record of possession of a radiation source or device under general license (for example, pursuant to 3.6.4.3(13)), or being otherwise legally obligated to conduct decommissioning activities in accordance with these regulations and the Act.

"Licensing State" means any State which has been finally designated as such by the Conference of Radiation Control Program Directors, Inc., based upon having regulations for control of radiation relating to naturally occurring or accelerator produced radioactive material (NARM) and an effective program for the regulatory control of NARM. 4 4 For the purpose of meeting the definition of a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), NARM refers only to discrete sources of NARM. Diffuse sources of NARM are excluded from consideration by the CRCPD for Licensing State designation purposes.

"Limits" (see "dose limits").

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing licensed source of radiation" means licensed or registered source(s) of radiation whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

“Lung class” (see “class” ).

"Mammographer" means a person who operates a machine source of ionizing radiation, commonly known as an "x-ray machine", in the conduct of a mammography exam. "Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in Part 17 of these regulations.

"Management" means the chief executive officer, or other individual having the authority to manage, direct, or administer the licensee's activities, or such person’s delegate(s). "Medical institution" means an organization in which two or more medical disciplines are practiced.

"Medical use” means the intentional internal or external administration of radioactive material or radiation to humans in the practice of the healing arts, including administration of radioactive materials to patients or human research subjects under the supervision of an authorized user and operation of radiation machines.

"Member of the public" means an individual, except when that individual is receiving an occupational dose.

“MeV” means one mega electron volt, or one million electron volts. One MeV is the amount of energy acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. One MeV is equivalent to 1.60 x 10 -16 joules. "Minor" means an individual less than 18 years of age.

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. "NARM" means any naturally occurring or accelerator produced radioactive material. NARM does not include byproduct, source, or special nuclear material. 5 5 For the purpose of meeting the definition of a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), NARM refers only to discrete sources of NARM. Diffuse sources of NARM are excluded from consideration by the CRCPD for Licensing State designation purposes.

"Natural radioactivity" means radioactivity of naturally-occuring nuclides. "Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight per cent thorium 232).

"Natural uranium" means uranium containing a mixture of the uranium isotopes 234, 235 and 238 (approximately 0.7 weight percent uranium-235 and the remainder by weight essentially uranium-238 ) that is neither enriched nor depleted in the isotope uranium 235. “NCRP” means the National Council on Radiation Protection and Measurements. "Negative-pressure respirator" (tight-fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

“Nonstochastic effect” means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these regulations, “deterministic effect” is an equivalent term.

"Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as "special form radioactive material".

"NRC" (see "Nuclear Regulatory Commission").

"Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation whether or not the sources of radiation are in the possession of the licensee, registrant or other person. Occupational dose does not include doses received (1) from background radiation, (2) from any medical administration the individual has received, (3) from exposure to individuals administered radioactive material and released in accordance with Section 7.26 of these regulations, (4) from voluntary participation in medical research programs, or (5) as a member of the public.

“Offsite response organization" means the non-licensee offsite organizations that may be needed to respond to an emergency, including, but not limited to, local fire, police, ambulance and hospital services.

"Package" means the packaging together with its radioactive contents as presented for transport. "Particle accelerator" (see "accelerator").

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing.

“Personal supervision” means the supervisor must be in attendance in the room with the supervisee during the performance of the procedure.

"Personnel monitoring equipment" (see "individual monitoring device"). "Pharmacist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice pharmacy. "Physician" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to dispense drugs in the practice of medicine. “Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

"Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice podiatry. "Principal activity" means an activity authorized by the license which is essential to achieving the purpose(s) for which the license was issued or amended. Not included as principal activities are (1) radioactive material storage while no licensed material is accessed for use or disposal and (2) activity incidental to decontamination or decommissioning. "Positive-pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator. “Powered air-purifying respirator" (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the facepiece. “Pressure-demand respirator” means a positive-pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Projected dose" means a future dose calculated for a specified time period on the basis of estimated or measured initial concentrations of radionuclides or exposure rates and in the absence of protective actions.

"Protective action" means an action taken by members of the public to protect themselves from radiation from an accident involving radioactive material. Protective action may include sheltering, evacuation, relocation, control of access, administration of a radioprotective drug, decontamination of persons, decontamination of land or property, or control of food or water. "Protective action guide" means a projected dose from an accidental release of radioactive material at which protective action is to be considered. "Public dose" means the dose received by a member of the public from exposure to radiation or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with Section 7.26 of these regulations, or from voluntary participation in medical research programs. "Pyrophoric liquid" means any liquid that ignites spontaneously in dry or moist air at or below 130 ° F (54.4 ° C). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water reactive materials. "Qualified expert" means an individual, approved by the Department, having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs. The individual shall receive approval from the department for specific activities and shall:

(1) Be certified in the appropriate field by the American Board of Radiology, the American Board of Health Physics, the American Board of Medical Physics or the American Board of Nuclear Medicine Science; or (2) Hold a master's or doctor's degree in physics, biophysics, radiological physics, health physics, or medical physics and have completed 1 year of documented, full time training in the appropriate field and also 1 year of documented, full-time work experience under the supervision of a qualified expert in the appropriate field. To meet this requirement, the individual shall have performed the tasks required of a qualified expert during the year of work experience.

"Qualitative fit test" (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

"Quality factor" (Q) means the modifying factor, listed in 1.14, Table 1-2 or Table 1-3, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test" (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator. “Quarter” means a period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters (see also “calendar quarter” and “year” ).

"Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, X rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates. "Radiation dose" (see "dose").

"Radiation machine" means any device capable of producing radiation except, those devices with radioactive material as the only source of radiation.

"Radiation safety officer" (RSO) means an individual who has demonstrated sufficient knowledge to apply radiation protection regulations appropriately and who has been assigned such responsibility by the licensee or registrant.

"Radioactive material" means any solid, liquid, or gas which emits radiation spontaneously. "Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation. "Radiobioassay" (see "bioassay").

“Reference man” means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base. A description of the reference man is contained in International Commission On Radiological Protection (ICRP) Publication 23, “Report Of The Task Group On Reference Man,” 1975.

"Registrant" means any person who is registered with the Department and is legally obligated to register with the Department pursuant to these regulations and the Act. "Registration" means registration with the Department in accordance with the regulations adopted by the Department.

"Regulations of the U.S. Department of Transportation" means the regulations in 49 CFR Parts 100-189 and Parts 390-397 (October 1, 2003).

"Relocation" means the removal or, after a plume has passed, continued exclusion of people from contaminated areas to avoid chronic radiation dose.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert).

"Research and development" means (1) theoretical analysis, exploration, or experimentation or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

“Residual radioactivity” means radioactivity in structures, materiel, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part 4 of these regulations. "Respiratory protective equipment" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. "Restricted use" means that a limit or control has been placed on future use of the facility and the facility is no longer under the control of the licensee, registrant, of holder of the record of possession.

"Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58 x 10 -4 coulombs/kilogram of air (see "Exposure").

“Sanitary sewerage” means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.

"Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling. “Sealed source and device registry” (SSD) means the national registry, maintained by the U.S. Nuclear Regulatory Commission (NRC), which contains the registration certificates that summarize the radiation safety information for sealed sources and devices and describe the licensing and use conditions approved for the product.

"Self-contained breathing apparatus" (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user. "Shallow dose equivalent" (H ), which applies to the external exposure of the skin of the whole S body or the skin of an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm 2 ).

“Sheltering" means the use of a structure for radiation protection from an airborne plume containing radioactive material.

"SI" means the abbreviation for the international system of units. "Sievert" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

"Site" means the area within the boundary of a location under the control of persons generating or storing radioactive materials.

"Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

"Site area emergency" means an event may occur, is in progress, or has occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

"Source material" means material, in any physical or chemical form, including ores, that contain by weight one-twentieth of 1 percent (0.05 percent) or more of uranium, thorium or any combination thereof. Source material does not include special nuclear material. "Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and (3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on March 31, 1996, and constructed prior to April 1, 1998, may continue to be used. A special form encapsulation either designed or constructed after April 1, 1998, must meet requirements of this definition applicable at the time of its design or construction. "Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the U.S. Nuclear Regulatory Commission, pursuant to the provisions of Section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or (2) Any material artificially enriched by any of the foregoing but does not include source material. "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope 235 U in quantities not exceeding 350 grams of contained 235 U; 233 U in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula: "Specific activity of a radionuclide" means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material. “Spent nuclear fuel” or “spent fuel” means fuel that has been withdrawn from a nuclear reactor following irradiation, has undergone at least 1 year's decay since being used as a source of energy in a power reactor, and has not been chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies. “Stochastic effect” means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these regulations, “probabilistic effect” is an equivalent term. "Supplied-air respirator" (SAR) or airline respirator means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user. "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present. "Test" means the process of verifying compliance with an applicable regulation. "These regulations" mean all parts of the State of Colorado “Rules and Regulations Pertaining to Radiation Control,” 6 CCR 1007-1.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures. "Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose. "U.S. Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to Sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93 438, October 11, 1974, 88 Stat. 1233 at 1237 42 U.S.C. 5814, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to Section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977). "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"Unrestricted use" means that the facility or area may be used by individuals for any purpose without limits or controls. The facility or area is no longer under the control of the licensee, registrant, or holder of the record of possession.

"Uranium - depleted, enriched"

(1) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(2) "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

"User seal check" (fit check) means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamylacetate check. "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates. 6 6 At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

"Waste" means those low level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low level waste has the same meaning as in the Low Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act (uranium or thorium tailings and waste) and (b) classified as low level radioactive waste consistent with existing law and in accordance with (a) by the U.S. Nuclear Regulatory Commission.

"Waste handling licensees" means persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste. "Week" means 7 consecutive days starting on Sunday.

“Weighting factor” (w ) for an organ or tissue (T) means the proportion of the risk of stochastic T effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of w are:

T TABLE 1-1: ORGAN DOSE WEIGHTING FACTORS Organ Or Tissue W T Gonads 0.25 Breast 0.15 Red Bone Marrow 0.12 Lung 0.12 Thyroid 0.03 Bone Surfaces 0.03 7 0.30 Remainder 8 1.00 Whole Body 7 0.30 results from 0.06 for each of 5 “remainder” organs, excluding the skin and the lens of the eye, that receive the highest doses.

8 For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, w = 1.0, T has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Worker" means an individual engaged in work under a license or registration issued by the Department and controlled by a licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 10 5 MeV of potential alpha particle energy. The short-lived radon daughters are: for radon-222: polonium-218, lead-214, bismuth-214, and polonium 214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212. "Working level month" (WLM) means an exposure to 1 working level for 170 hours -- 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a transition from one licensee or registrant to another occurs during a year, each licensee or registrant shall assure that no day is omitted or duplicated in consecutive years (see also “calendar quarter” and “quarter” ).

COMMUNICATIONS AND REFERENCED MATERIALS 1.3 Communications.

All communications and reports concerning parts of these regulations, and applications filed thereunder, should be addressed to the Department.

1.4 Referenced Materials.

1.4.1 Parts of these regulations incorporate by reference (as identified within a particular section) materials originally published elsewhere. These regulations do not include amendments to or editions of incorporated materials published later than the effective date of the particular section. 1.4.2 The Department of Public Health and Environment maintains copies of the complete text of the incorporated materials for public inspection during regular business hours. 1.4.3 The Hazardous Materials And Waste Management Division will provide certified copies of any non- copyrighted referenced material at cost upon request. Information regarding how the incorporated material may be obtained or examined is available from: Director, Hazardous Materials And Waste Management Division Colorado Department of Public Health and Environment 4300 Cherry Creek Drive South Denver, CO 80246-1530 1.4.4 In accordance with 24 4 103(12.5)(c)(II)(C), CRS, copies of any material that has been incorporated by reference have been provided to the State Publications Depository Library and Distribution Center and are available for interlibrary loan. The incorporated materials may be examined at any state publications depository library.

EXEMPTIONS FROM THE REGULATORY REQUIREMENTS 1.5 Exemptions.

1.5.1 General Provision.

The Department may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of these regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property. 1.5.2 U.S. Department of Energy Contractors and U.S. Nuclear Regulatory Commission Contractors. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from these regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers or acquires sources of radiation: 1.5.2.1 Prime contractors performing work for the U.S. Department of Energy at U.S. Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

1.5.2.2 Prime contractors of the U.S. Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;

1.5.2.3 Prime contractors of the U.S. Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and 1.5.2.4 Any other prime contractor or subcontractor of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission when the State and the U.S. Nuclear Regulatory Commission jointly determine that:

(1) The exemption of the prime contractor or subcontractor is authorized by law; and (2) Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

GENERAL REGULATORY REQUIREMENTS 1.6 Records.

Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in these regulations.

1.7 Inspections.

1.7.1 Each licensee and registrant shall afford the Department at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

1.7.2 Each licensee and registrant shall make available to the Department for inspection, at all reasonable times, records maintained pursuant to these regulations. 1.8 Tests.

Each licensee and registrant shall perform upon instructions from the Department, or shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary including, but not limited to, tests of:

1.8.1 Sources of radiation;

1.8.2 Facilities wherein sources of radiation are used or stored; 1.8.3 Radiation detection and monitoring instruments; and 1.8.4 Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

ADDITIONAL REGULATORY REQUIREMENTS 1.9 Additional Requirements.

The Department may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in these regulations as it deems appropriate or necessary to minimize danger to public health and safety or property. ENFORCEMENT REQUIREMENTS 1.10 Violations.

An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any regulation or order issued thereunder. Any person who willfully violates any provision of the Act or any regulation or order issued thereunder may be guilty of a misdemeanor and, upon conviction, may be punished by fine or imprisonment or both, as provided by law. Additionally, any person who violates any provision of the Act or any regulation may be subject to a civil penalty as provided for in Part 13 or these regulations.

1.11 Impounding.

Sources of radiation shall be subject to impounding pursuant to the Act. 1.12 Prohibited Uses.

1.12.1 A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been listed in the registry of sealed source and devices or accepted for certification by the U.S. Food and Drug Administration, Center for Devices and Radiological Health. 1.12.2 A shoe-fitting fluoroscopic device shall not be used. SEVERABILITY 1.13 Severability.

The provisions of parts of these regulations are severable, and if any provisions or the application of the provisions to any circumstances is held invalid, the application of such provision to other circumstances, and the remainder of this regulation shall not be affected thereby. INFORMATIONAL PROVISIONS 1.14 The International System of Units (SI).

For purposes of these regulations:

1.14.1 The unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58 x 10 -4 coulomb per kilogram.

1.14.2 The units of dose are:

1.14.2.1 gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

1.14.2.2 rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 Gy).

1.14.2.3 rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

1.14.2.4 sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

1.14.3 The quality factors for converting absorbed dose to dose equivalent are shown in Table 1-2 TABLE 1-2: QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES Type of radiation Quality factor (Q) Absorbed dose equal to a 9 unit dose equivalent X, gamma, or beta 1 1 radiation and high-speed electrons Alpha particles, multiple- 20 0.05 charged particles, fission fragments and heavy particles of unknown charge Neutrons of unknown 10 0.1 energy High-energy protons 10 0.1 9 Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem. 1.14.4 If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in 1.14.3, 0.01 Sv (1 rem) of neutron radiation of unknown energies may be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table 1-3 to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem. TABLE 1-3: MEAN QUALITY FACTORS (Q) AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS Neutron energy (MeV) 10 Fluence per unit dose Fluence per unit dose Quality factor (Q)

11 11 equivalent (neutrons equivalent (neutrons -2 -1 -2 -1 cm rem ) cm Sv )

-8 2 6 8 2.5 x 10 980 x 10 980 x 10 (thermal)

-7 2 6 8 1 x 10 980 x 10 980 x 10 -6 2 6 8 1 x 10 810 x 10 810 x 10 -5 2 6 8 1 x 10 810 x 10 810 x 10 -4 2 6 8 1 x 10 840 x 10 840 x 10 -3 2 6 8 1 x 10 980 x 10 980 x 10 -2 2.5 6 8 1 x 10 1010 x 10 1010 x 10 -1 7.5 6 8 1 x 10 170 x 10 170 x 10 -1 11 6 8 5 x 10 39 x 10 39 x 10 1 11 6 8 27 x 10 27 x 10 2.5 9 6 8 29 x 10 29 x 10 5 8 6 8 23 x 10 23 x 10 7 7 6 8 24 x 10 24 x 10 10 6.5 6 8 24 x 10 24 x 10 14 7.5 6 8 17 x 10 17 x 10 20 8 6 8 16 x 10 16 x 10 40 7 6 8 14 x 10 14 x 10 60 5.5 6 8 16 x 10 16 x 10 100 4 6 8 20 x 10 20 x 10 200 3.5 6 8 19 x 10 19 x 10 300 3.5 6 8 16 x 10 16 x 10 400 3.5 6 8 14 x 10 14 x 10 10 Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue- equivalent phantom.

11 Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom. 1.14.5 Units of activity.

For purposes of these regulations, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time. 1.14.5.1 One becquerel (Bq) = 1 disintegration per second or transformation per second (dps or s -1 ).

1.14.5.2 One curie (Ci) = 3.7 x 10 10 disintegrations per second or transformations per second (dps or s -1 ) = 3.7 x 10 10 becquerel (Bq) = 2.22 x 10 12 disintegrations per minute (dpm).

PART 2:

REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES 2.1 Purpose and Scope.

2.1.1 Authority Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1- 108, 25-1.5-101(1)(l), and 25-11-104, CRS.

2.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department. 2.1.3 Scope.

This part provides for the registration of facilities, for the certification of radiation machines, for the registration of persons providing radiation machine installation, servicing, and/or services, for the registration of qualified inspectors, and for approval of mammographers and operators. 2.1.4 Applicability.

In addition to the requirements of this part, all registrants are subject to the applicable provisions of Parts 1, 4, 5, 6, 7, 8, 9, 10 and 20 of these regulations. 2.2 Definitions.

As used in this part:

“Air kerma” means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the gray (Gy). For x-rays with energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad = 114 roentgen (R) of exposure.

“ARRT” means the American Registry of Radiologic Technologists. “ARRT(R)” , see “radiologic technologist” .

“ASRT” means American Society of Radiologic Technologists. “Assembler” means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or the owner’s employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services. “Calibration” means to adjust and/or determine: (1) the response or reading of an instrument relative to a series of conventionally true values; or (2) the strength of a radiation source relative to a standard or conventionally true value. This does not include the adjustments made to an x- ray system done as part of its installation or repair.

“Certification Evaluation” (CE) means the evaluation of a radiation machine and/or facility by the Department, or by a qualified inspector, for the purpose of evaluating the performance of the radiation machine system and/or facility against these regulations. “Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction to the supervisee throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed. Direct supervision during the performance of a mammography examination or certification evaluation of the facility's equipment and quality assurance program means that the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the certification evaluation. “Equipment/machine performance adjustments” means the adjustment/repair of one or more functions of an x-ray machine that are required to bring the machine into compliance with these regulations and the manufacturer's specifications. These adjustments do not include the setting(s) of operator-selectable functions, such as time, mA, kVp, etc. for individual exposures. “Facility” means the location, under the same administrative control within one building, or vehicle, or under one roof, at which one or more radiation machines are installed, operated and/or stored.

“FDA” means the United States Food and Drug Administration. “Intercomparison” means the direct comparison, in accord with 2.4.3.3, of two instruments designed to measure the same physical quantity.

“Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.

“Limited-scope operator” means an individual who has taken and passed a required test and has approval by the Department pursuant to 2.6.1 to operate x-ray systems and to conduct radiographic examinations of the chest, extremities, skull and spine. “LSO” means limited-scope x-ray machine operator, abbreviated by the ASRT as LXMO, limited x-ray machine operator.

“Mammographer” means a radiologic technologist who has specialized training in performing mammography examinations and has a current registration in mammography with the ARRT. “Medical physicist” means an individual who is approved by the MQSA program to conduct surveys of mammography facilities and machines and to provide oversight of the facility quality assurance program.

“MQSA” means Mammography Quality Standards Act.

“NIST” means National Institute of Standards and Technology. “Provisional mammographer” means an individual radiologic technologist who is currently in or has completed a structured training program in mammography, has a current registration with the ARRT, and is currently approved by the Department.

“Qualified inspector” means an individual who is approved and designated by the Department to perform inspections and evaluate radiation machines, facilities and operators and meets the criteria in Appendix 2B.

“Qualified trainer” means an individual whose training and experience adequately prepares the individual to carry out specified training assignments. (1) An interpreting physician, radiologic technologist or medical physicist who is approved under MQSA program requirements is considered a qualified trainer for the respective competency.

(2) A physician, radiologic technologist, or operator who is approved pursuant to 2.6.1 is considered a qualified trainer for the respective competency. (3) Other examples of an individual who might be considered by the Department to be a qualified trainer for the purpose of providing training to meet the requirements of this part include, but are not limited to, an trainer in a post-high-school training institution or a manufacturer's representative.

“Qualified mammographer” means a mammographer who has successfully maintained continuing education and experience requirements and is approved by the Department. “Radiologic technologist” means an individual who is currently registered in radiologic technology with the American Registry of Radiologic Technologists, i.e. ARRT(R). “Storage” means that a radiation machine is in a condition of not being used for an extended period of time and has been made inoperable.

“X-ray system” means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and necessary supporting structures. Additional components that function with the system are considered integral parts of the system. EXEMPTIONS FROM THE REGULATORY REQUIREMENTS 2.3 Exemptions.

2.3.1 Electronic equipment that produces radiation incidental to operation for other purposes is exempt from the registration and notification requirements of this part, provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 microsievert (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. Electronic equipment that fails to meet the dose equivalent rate limit specified in 2.3.1 shall be registered with the Department and inspected in accordance with 2.5.1. The production, testing, or factory servicing of such equipment shall not be exempt.

2.3.2 Radiation machines while in transit or storage incident thereto are exempt from the requirements of this part.

2.3.3 Domestic television receivers, computer monitors, and similar devices are exempt from the requirement of this part.

2.3.4 Radiation machines that are in storage are exempt provided that the electrical circuitry is inactivated, dismantled, and made physically inoperable so that the radiation machine is not capable of producing radiation.

2.3.5 Electron microscopes are exempt from this part provided that they have been initially surveyed to show compliance with 2.3.1.

2.3.6 The legal owner of electronic equipment which meets the requirements of 2.3.1 but which is not specifically exempted under 2.3.2, 2.3.3 and 2.3.4, shall maintain for the lifetime of the equipment radiation measurement results or certification from the manufacturer or a qualified inspector indicating that the equipment complies with the exposure rates specified in 2.3.1. 2.3.7 Electron microscopes and electron microprobes manufactured after September 30, 1999, are exempt from this part provided that the instrument is not capable of exceeding an operating voltage of 50,000 electron volts. Instruments capable of operating at voltages in excess of 50,000 electron volts shall be registered with the Department and inspected in accordance with 2.5.1.

REGISTRATION 2.4 Application for Registration.

2.4.1 Application for Registration of Radiation Machine Facilities. Each person possessing or in the process of coming into the possession of a radiation machine facility shall:

2.4.1.1 Be registered with the Department;

2.4.1.2 Apply for registration of such facility with the Department prior to the operation of a radiation machine facility;

2.4.1.3 Complete an application for registration on forms furnished by the Department and include all the information required by the form and any accompanying instructions; and 2.4.1.4 Designate on the application form the individual(s) to be responsible for radiation safety of the radiation machine(s) and radiation protection for the facility. 2.4.2 Application for Registration of Servicing and Services. 2.4.2.1 Each person who is engaged in the business of installing or offering to install radiation machines and their related components, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State, shall be registered with the Department prior to furnishing or offering to furnish any such services. 2.4.2.2 Application for registration shall be completed on forms furnished by the Department and shall contain all information required by the Department as indicated on the forms and accompanying instructions.

(1) Each registration shall be for a period of two (2) years. (2) Application fee(s) pursuant to Appendix 2A must accompany the application when it is filed. The Department shall not review or otherwise process applications for which no remittance is received. These applications may be returned to the applicant.

(3) The Department shall audit proficiency of each qualified service company engineer. 2.4.2.3 In any case in which a service company, not less than thirty (30) days prior to the expiration of an existing authorization to perform servicing/services, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department. 2.4.2.4 Each person applying for registration under this part shall specify: (1) That each individual who is applying has read and understands the requirements of these regulations; including the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2004); and (2) The services for which registration is being requested (see 2.4.2.1); and (3) The training and experience that qualify the person to provide the services for which registration is being requested; and (4) The type of measurement instruments that will be used to determine compliance with these regulations, including:

(a) The frequency of calibration; and (b) The provider of calibration services; and (5) A written commitment by each service company to meet the instrument calibration requirements specified in 2.4.3.3.

(6) The type of personnel monitoring supplied, frequency of reading, and replacement or exchange schedule as appropriate. (See 4.17 and 4.18)

2.4.2.5 For purposes of this part, services may include but shall not be limited to: (1) Installation of radiation machines and associated radiation machine components; and (2) Servicing of radiation machines and associated radiation machine components; and (3) Performance adjustments to radiation machines, radiation measurement instruments, and devices; and (4) Radiation protection, health physics consultations or surveys performed by a qualified expert.

2.4.2.6 No person shall perform on radiation machine system or facility any service that is not specifically stated for that person on the Notice of Registration issued by the Department. 2.4.2.7 Assemblers and services and servicing personnel shall provide to the registrant, as required by the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2004) and these regulations, instruction manuals, manufacturer specifications and other information notices which are applicable to the newly installed x-ray machine systems or components.

2.4.2.8 A “Notice of Registrant's Rights” Department Form R-65 shall be furnished to the registrant prior to beginning the service or evaluation, whenever a business relationship exists between the qualified inspector and services and servicing provider. This includes when a qualified inspector is also authorized to perform services and servicing, when a qualified inspector is also a qualified expert, and when a qualified inspector, a qualified expert and/or a services and servicing provider is a member of the same corporation, partnership or other formal business relationship.

2.4.2.9 Audits.

(1) The Department shall audit the servicing and services of each registrant and the proficiency of each service company engineer.

(2) Service companies who fail to adequately comply with the provisions of these regulations shall be subject to 2.4.8.

2.4.3 Application for Registration of Qualified Inspectors. A qualified inspector shall meet the criteria established in Appendix 2B. 2.4.3.1 Non-Department individuals requesting Department approval to perform certification evaluations of radiation machines and facilities shall submit to the Department an application for authorization to perform such evaluations. The application shall be submitted on Department Form R-53, “Application for Registration of a Qualified Inspector,” together with the required fee prescribed in Appendix 2A. 2.4.3.2 Authorization to perform certification evaluations in accordance with the requirements of these regulations shall be for a period of two (2) years. The Department shall provide written notification of the authorization to the qualified inspector. (1) The Department may withdraw, limit or qualify its approval of individuals to perform certification evaluations upon determining that such action is necessary in order to prevent undue hazard to public health and safety.

(2) In any case in which a qualified inspector, not less than thirty (30) days prior to the expiration of the qualified inspector’s authorization to perform certification evaluations, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department.

(3) No qualified inspector shall perform certification evaluations on radiation machine systems or facilities that are not specifically stated for that qualified inspector on the Notice of Registration issued by the Department.

(4) Audits.

The Department shall audit the evaluation findings and inspection procedures of qualified inspectors. A qualified inspector who fails to adequately evaluate radiation machine systems and facilities, or who fails to provide complete and accurate certification reports, or who fails to comply with the provisions of these regulations, shall be subject to the withdrawal of Departmental approval. 2.4.3.3 Instrumentation.

Measurements shall be made with instruments that are sufficiently sensitive to determine compliance with these regulations.

(1) The instruments must be maintained and used in good working order. (2) Not withstanding the requirement of 4.17.2, such equipment shall be calibrated every two (2) years, or in accordance with the manufacturer's recommendations, whichever is more frequent, or after any repair that could affect the calibration. (3) Calibrations shall be NIST-traceable where such traceability is feasible. (4) In lieu of calibration, instrument accuracy may, with Department approval, be determined by intercomparison with a suitable and appropriately calibrated instrument.

(5) Each intercomparison protocol shall be submitted to the Department for review and approval.

(a) The comparison shall be between an instrument that has a current calibration traceable to the National Institute of Standards and Technology (NIST) and an instrument for which a calibration factor is to be determined. (b) The comparison shall be made using the actual physical quantity to be routinely measured (radiation energy/quality, visible light spectrum, etc.) and shall be compared in the same physical geometry.

(c) Intercomparisons shall be NIST-traceable.

2.4.3.4 Instrumentation for Mammography.

Instruments used for the certification evaluation report to measure the air kerma or air kerma rate of mammography machines shall be calibrated at least once every two (2) years and each time the instrument is repaired. The instrument calibration shall be NIST- traceable and shall be calibrated with an accuracy of + or - six (6) percent (95 percent confidence level) in the mammography energy range.

2.4.4 Approval of Mammographers and Provisional Mammographers. 2.4.4.1 Mammographers as defined in 2.4 are approved by the Department to perform mammography examinations. In addition, mammographers shall meet the requirements of 21 CFR Part 900, Section 900.12(a)(2), April 1, 2004. 2.4.4.2 Radiologic technologists in training who are not registered in mammography by the American Registry of Radiologic Technologists (ARRT) shall apply to the Department for approval as a provisional mammographer.

(1) A provisional mammographer certificate shall be issued for one year as part of a structured training program in mammography. During the one year structured training program, the provisional mammographer shall at all times be under the direct supervision of a qualified mammographer who shall be present on the premises and available for prompt consultation. The provisional certificate for training under this section, 2.4.4.2(1), may not be renewed. (2) The structured training program shall include, at a minimum, 40 contact hours of documented training specific to mammography under the direct supervision of a qualified mammographer. The hours of documented training shall include, but not necessarily be limited to:

(a) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants;

(b) The performance of a minimum of 25 examinations under the direct supervision of a qualified mammographer; and (c) At least eight (8) hours of training in each mammography modality to be used by the technologist in performing mammography examinations. (3) A fully trained and experienced technologist may apply for a six (6) months operator's provisional certificate subsequent to such training as described in 2.4.4.1 while waiting for the mammography certification test to be given by the ARRT and for the test results to be released. The six (6) month provisional certificate may be renewed only once.

(4) A student radiologic technologist, enrolled in an ARRT-recognized two-(2)-year program, shall be exempt from the requirement of 2.4.4.1, so long as the student remains under the direct supervision of a qualified mammographer during the two-(2)-year program.

2.4.4.3 Application for registration for a provisional certificate shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions.

(1) The application shall be submitted to the Department together with the applicable fee specified in Appendix 2A.

(2) The provisional certificate shall be displayed in the room/area where patient examinations are performed.

2.4.5 Registration by the Department.

This section applies to facility registrants, qualified inspectors, and servicing and services. 2.4.5.1 Upon a determination that an applicant meets the requirements of the regulations, the Department shall issue a Notice of Registration.

2.4.5.2 The Department may incorporate in the Notice of Registration at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's activities as the Department deems appropriate or necessary.

2.4.6 Report of Changes.

The registrant shall notify the Department in writing within thirty (30) days of making any change which would render inaccurate the information contained in the application for registration and/or, as appropriate, the Notice of Registration.

2.4.7 Approval Not Implied.

No person, in any advertisement, shall refer to the fact that the facility is registered with the Department pursuant to the provisions of 2.4.1, 2.4.2, and 2.4.3, and no person shall state or imply that any activity under such registration has been approved by the Department. REVOCATION OF REGISTRATIONS 2.4.8 Modification and Revocation of Registration.

The terms and conditions of all registrations/certificates shall be subject to amendment, revision, or modification or the registration/certificate may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the Department. CERTIFICATION EVALUATIONS 2.5 Certification Evaluations.

2.5.1 Frequency of Certification Evaluations.

Each radiation machine registrant shall have its radiation machine(s) and facility evaluated by a Department-approved qualified inspector in accordance with the frequency established in 2.5.1.1 through 2.5.1.2. Such evaluations shall be capable of determining if the machine is safe for the intended uses and in compliance with the specifications of the State Board of Health and the equipment manufacturer. However, these evaluations are in addition to and not intended to replace the recommended equipment service procedures or facility quality assurance programs for purposes of manufacturer(s) equipment repair or quality assurance. 2.5.1.1 Frequency of Inspection by Type Type Frequency General Purpose Every year Stationary and Mobile Radiographic, Fluoroscopic and Chiropractic Mobile Industrial Every year Radiography, Excluding Airport Inspection, Analytical and Cabinet X-ray Systems Computed Tomography Every year Veterinary, Podiatric, and Every 3 years Dental Out-of-State Radiation Within 1 year prior to Machines (see 2.8, entering State Reciprocity)

Fixed Industrial, i.e., Every 2 years Fixed Radiography Airport Inspection, Every 2 years Analytical and Cabinet X-ray Systems Machines Specifically Every 3 years Designed for and Limited to Bone Densitometry All Other (for example, Every year, unless cone beam systems of otherwise authorized by types specified by the the Department Department)

(1) Podiatry and dental radiation machine facilities that operate radiographic x-ray machine(s) or tomographic or computed tomographic systems that have variable kilovoltage peak (kVp), and variable milliamperage (mA), and variable collimation, shall have these systems evaluated on an annual (every year) frequency.

(2) Podiatry machines that operate at less than or equal to 30 mA shall be evaluated every three years.

(3) Each certification evaluation subsequent to the initial certification evaluation shall be completed in the same month as the previous certification evaluation. (4) Not withstanding the requirements of 2.5.1.1(3), the registrant may have a certification evaluation of a machine in a month prior to the month in which it is due, which shall become the new month in which the certification is due. (5) A certification evaluation conducted after the month in which it was due shall not alter or change the month in which subsequent certification evaluations are due. (6) Each computed tomography inspection shall be by a qualified inspector who is also a qualified expert.

(7) For types of systems specified by the Department pursuant to 2.5.1.1, “All Other” , each initial and subsequent certification evaluation shall be by a qualified inspector who is also a qualified expert, unless otherwise authorized by the Department.

2.5.1.2 New Installations.

All new installations of radiation machine systems or replacement components which affect or could potentially affect a change in the radiation output shall be evaluated within three (3) months of installation except that new installations of mammography systems shall be evaluated by a qualified inspector authorized in mammography prior to being used to perform human examinations.

2.5.1.3 State Inspections.

Any radiation machine and/or facility not inspected in accordance with 2.5.1.1 through 2.5.1.2, or otherwise determined to be out of compliance with these regulations, shall be subject to a Department enforcement inspection and subject to the fees specified in Appendix 2A.

2.5.2 Procedures for Certification Evaluations.

2.5.2.1 Inspection Procedures.

(1) For evaluation of radiation machines and facilities, each qualified inspector shall use procedures, which are adequate for determining compliance with the regulations. (2) Each qualified inspector shall perform radiation machine system and facility evaluations within the category or categories authorized by the Department. 2.5.2.2 Reporting and Labeling Procedures.

(1) Each qualified inspector shall certify and be responsible to provide accurate and complete Certification Evaluation Reports to the registrant/facility and to the Department on Department Form R-59-1, “X-Ray Facility Certification Evaluation Report,” in accordance with the instructions contained in that form. (a) A clear and legible report may be substituted for the Department Form R-59- 1, provided that it is in the same format and provides all of the information required by Department Form R-59-1.

(b) Violations of the regulations not specifically related to the performance of the x-ray machine(s) shall be reported to the Department using Department Form R-59-2, “X-Ray Facility Noncompliance Certification Evaluation Report.”

(2) A qualified inspector shall provide to the registrant and Department a copy of the Certification Evaluation Report. The Report shall indicate compliance or specific violations with these regulations. Recommendations for corrective actions should be provided to the registrant (if applicable) to assist in achieving full compliance and/or improving the quality of the imaging process, and improving radiation safety.

(3) When it is determined that the requirements of these regulations or manufacturer's required specifications are met, the qualified inspector shall affix a certification label issued by the Department in a location clearly visible to the machine operator and/or patient.

(4) If the radiation machine fails to meet the requirements specified by these regulations or manufacturer's required specifications, the qualified inspector shall notify the registrant/owner immediately and shall notify the Department within three (3) business days after identifying that the facility is in noncompliance. (5) If the radiation machine fails to meet the requirements specified by these regulations or required manufacturer specifications and is determined to be unsafe for human use, as described in Appendix 2C, the qualified inspector shall: (a) Affix to such radiation machine system an “Unsafe for Human Use” label issued by the Department indicating such machine is not authorized for human use. The label shall be affixed in a location clearly visible to the patient.

(b) Notify the registrant/owner immediately and shall notify the Department within three (3) business days after identifying that the facility is in noncompliance.

(6) Concealing, defacing or altering of Department issued labels is prohibited. (7) Labels shall only be affixed by a qualified inspector on the basis of the certification evaluation.

2.5.2.3 Department Actions.

(1) The Department shall notify the registrant regarding inaction on any item of violation. The Department shall specify a date by which compliance must be achieved. (2) The Department shall confirm and, if appropriate, verify by inspection, a registrant’s corrective actions to assure compliance of these regulations. (3) The Department shall charge an inspection fee for the inspection of a radiation machine system or facility if the registrant fails the requirements stated in 2.5.1, or if any item of violation has not been corrected in accordance with the compliance schedule established in 2.5.2.3.1. The Department inspection and fee schedule payment shall be in accordance with Appendix 2A. 2.6 Facility Registrant Responsibilities.

2.6.1 The registrant shall be responsible to ensure that the requirements of these regulations are being complied with for the operation of the radiation machine facility. 2.6.1.1 In any facility regulated by or requiring registration under these regulations, the registrant shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine. 2.6.1.2 At least annually, the registrant shall make a written evaluation of the qualifications of all persons permitted to operate any or all radiation machines at the facility. Records of such evaluations shall be maintained by the facility and produced for examination upon request during any inspection conducted under the requirements of these regulations. 2.6.1.3 Any physician, licensed by the appropriate licensing board, may operate radiation machines as part of the physician’s medical practice and shall be exempt from the provisions of 2.6.1.1 regarding adequate training.

2.6.1.4 A student, enrolled in an ARRT-recognized two-year program, shall be exempt from the requirement 2.6.1 for the duration of the two-year program, so long as the student works under the direct supervision of a qualified radiologic technologist and has documentation from the program that the student has completed education and experience equal to that specified in the adequate training appendices of this part as appropriate for the assigned use of x-ray systems or any radiation machine.

2.6.1.5 Department approval of training as adequate pursuant to 2.6.1.6, 2.6.1.7, 2.6.1.8 and / or 2.6.1.9 shall pertain only to the areas of training and experience specifically named in the Department approval.

(1) Limited-scope x-ray machine operator approval is limited to imaging procedures for x- ray examination of the skull, chest, spine, upper extremities and lower extremities. A limited-scope x-ray machine operator shall not perform radiologic procedures involving the administration or utilization of contrast media, fluoroscopic equipment, mammography, computed tomography, or radiation therapy procedures.

(2) The application for training review and approval or for an examination administered by the Department shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions. The application fee(s) specified in Appendix 2A shall accompany the application.

(3) The Department may, upon application or upon its own initiative, accept as being adequate:

(a) Documented combinations of radiation safety training and experience; (b) Equivalent approval by another state or agency;

(c) For an individual in practice for a minimum of three of the immediately preceding past five years prior to July 1, 2005, a signed written attestation by the operator and supervisor(s) that the applicable requirements have been met sufficiently to qualify the individual by virtue of prior training and experience.

2.6.1.6 For radiographic x-ray systems used on living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2D by: (1) Being an ARRT-registered radiologic technologist, or having at least equivalent training, certification and/or registration; or (2) Having been approved as a limited-scope x-ray machine operator by passing the Department-required examination.

2.6.1.7 For computed tomography systems used on living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2E by: (1) Being an ARRT-registered radiologic technologist who is also either ARRT-registered in computed tomography or has met the requirements of Section 2E.2.2 in Appendix 2E; or (2) Being certified in computed tomography by a specialty board recognized by the Department, including or in combination with training accepted by the Department.

2.6.1.8 For bone densitometry equipment used in examination of living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2F by: (1) Being an ARRT-registered radiologic technologist or equivalent for bone densitometry; or (2) Being certified in bone densitometry by a specialty board recognized by the Department, including or in combination with training accepted by the Department; or (3) Having been approved as a bone densitometry equipment operator by passing the Department-required examination.

2.6.1.9 For fluoroscopy equipment used in examination of living humans, “adequately trained” shall mean that the individual is an ARRT-registered radiologic technologist, or has at least equivalent certification and/or registration or licensure, including or in combination with training for fluoroscopy accepted by the Department. 2.6.2 If a radiation machine or facility fails to meet the requirements of these regulations or required manufacturer specifications the facility registrant shall: 2.6.2.1 If a radiation machine has been determined to be unsafe for human use (1) Not use the radiation machine thereafter for human use until subsequent certification by a Department-approved qualified inspector; and (2) Notify the Department of the appropriate corrective action plan within fifteen (15) calendar days of the inspection.

2.6.2.2 Correct any items of violation within the time specified by the Department. 2.6.2.3 Provide documentation to the qualified inspector upon correction of any radiation machine items of violation to confirm that indicated violations and repairs have been completed to bring the radiation machine system and/or facility into compliance. Copies of service reports may be acceptable evidence of completed corrective actions. 2.6.2.4 Provide documentation to the Department upon correction of any facility items of violation to confirm that indicated violations have been addressed to bring the facility into compliance.

2.6.2.5 The facility registrant shall pay the required fee of $50 for each certification label issued to the registrant by the qualified inspector.

2.6.3 Record Retention.

2.6.3.1 The registrant shall maintain for a period of three years (six years for a facility or machine inspected only every three years) copies of personnel qualifications, facility and machine certification evaluations, notice of violations, complaints, investigations, and service records for the x-ray machines and processors for review by the Department. 2.6.3.2 The registrant shall maintain for the duration of the registration, records of shielding evaluations performed for the facility; and until a machine is retired from service, the operator's and service manual provided by the manufacturer, if available. (1) If the operator's manual is not obtainable from the manufacturer, one must be developed and maintained by the registrant. This shall contain written operating procedures to be followed, including:

(a) A description, including purpose and function, of each control panel knob, button, and meter;

(b) Techniques for collimation and centering of the beam to the image receptor; (c) The function of all locks and detents; and (d) Emergency shutdown instructions.

The registrant shall permit radiation machine servicing or services as described in 2.4.2.4 only by a person that provides evidence of current registration with the Department as a provider of services in accordance with these regulations.

2.7 Assembler and/or Transfer Obligation.

2.7.1 Any person who sells, leases, transfers, lends, disposes, assembles, trades out or installs radiation machines, or components, which affect radiation output in this State shall notify the Department in writing within fifteen (15) days of installation with the following information: 2.7.1.1 The full name and address of each person who has received the radiation machines or components and the specific location within the facility; and 2.7.1.2 Specific information of the x-ray system or sub-system, including the manufacturer, model, and serial number of each radiation machine or component transferred; and 2.7.1.3 The date of transfer, assembly, or installation of each radiation machine or component; and 2.7.1.4 An affirmation that all instruction manuals and other information as required by the Federal Performance Standard (21 CFR 1020.30(d), April 1, 2004) and a copy of these regulations applicable to the newly installed x-ray machine system or components have been delivered to the registrant.

2.7.2 A report of assembly of a diagnostic x-ray system (Form FDA 2579 or equivalent) submitted in compliance with requirements of the Federal Performance Standard (21 CFR 1020.30(d), April 1, 2004) shall be submitted to the Department within fifteen (15) days following completion of the assembly. Such report shall suffice in lieu of any reports required in 2.7.1. 2.7.3 The assembly is considered completed and operational when the unit is ready for its intended use. 2.7.4 No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines, components or the supplies used in connection with such machines unless such supplies and equipment when property placed in operation and used shall meet the manufacturer's specifications and the requirements of these regulations. RECIPROCITY 2.8 Out-of-State Radiation Machines.

2.8.1 Subject to these regulations, any person who desires to bring radiation machines into this state for temporary use is hereby granted authorization to conduct activities using these machines for a period not to exceed 180 days in any calendar year, provided that: 2.8.1.1 The out-of-state registration, and/or other documents authorizing the use of radiation machines issued by the agency having jurisdiction where the out-of-state registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, does not limit the activity authorized by such document to specified installations or locations; and 2.8.1.2 The person proposing to bring such machines into Colorado shall give written notice to the Department at least three (3) working days before such machine is to be used in the state. The notice shall be made using the Department's “X-ray Reciprocity Request” Form R-200 and shall include all information required by that form. (1) As part of this notice, the person requesting reciprocity shall certify that (1) a copy of all applicable parts of these regulations shall be available at each use location in Colorado; (2) each machine has been evaluated and determined to be in compliance with these, or equivalent, regulations; and (3) that the operation of each radiation machine shall be in accordance with the applicable requirements of these regulations.

(2) In the case of requests to perform a healing arts screening program within this state, the information required in Part 6, Appendix 6C, must be included with the reciprocity request.

(3) In the case of requests to perform mammography screenings within this state, a copy of the person's mammography certificate issued by the FDA (21 CFR 900.11(a), April 1, 2004) must be included with the reciprocity request. (4) The person requesting reciprocity shall also supply such other information as the Department may request.

2.8.1.3 The out-of-state registrant complies with all applicable regulations of the Department; and 2.8.1.4 The out-of-state registrant shall at all times during work at any work location within Colorado have available the pertinent documentation as required by these regulations, including:

(1) Pertinent registration documentation;

(2) Written authorization from the Department for in-state activities; (3) Applicable sections of these regulations;

(4) Documentation that each radiation machine has been evaluated in accordance with these regulations, or other state regulations which are equivalent and that the machines comply with the manufacturer's recommended specifications. Evaluations shall have been performed within one year prior to entry into the State as required in 2.5; and (5) In the case of mammography related functions, a copy of the mammography certificate, quality control records, personnel records, and the most recent medical physicist survey.

2.8.2 Based upon an application that includes documentation of why it is not possible or is an undue hardship to provide three (3) days notice, the Department may grant permission to proceed sooner. The Department may also waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities pursuant to 2.8.1.

2.8.3 While in the State of Colorado, all radiation machines may be required to be inspected and/or certified by a qualified inspector who is registered with this Department. 2.8.4 The out-of-state registrant shall notify the Department within one hour after arrival at the actual work location within Colorado and shall notify the Department within one hour after any change of work location within Colorado.

2.8.5 If multiple individuals work concurrently at more than one work location under an approval granted pursuant to this 2.8.1, each day worked per location shall be counted separately toward the limit of 180 days per calendar year.

2.8.6 The Department may revoke, limit, or qualify its approval for the use of radiation machines in Colorado upon determining that the approval was based on false or misleading information submitted to the Department or that such action is necessary in order to prevent undue hazard to public health and safety or property.

2.8.7 Each person operating a radiation machine within Colorado under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable federal requirements. PART 2, APPENDIX 2A:

SCHEDULE OF FEES FOR RADIATION MACHINE SERVICES 4 Category of Radiation Type of fee Maximum Fee Maximum Frequency Machine Services 5 . $129 Per Hour 1. Hourly Rate 6 Certification 7 Each Enforcement Action 2. Enforcement Action $1,157 3. Qualified Inspector or Registration 9 Every 2 Years $160 8 Servicing and Services 4. Provisional Certification $50 Each Review Mammography 5. Adequate Training Acceptance $50 Each Review 4 Fees listed in Appendix 2A “Schedule of Fees for Radiation Machine Services” are maximum amounts that may be billed for these categories. In no event will the fee exceed that shown in this schedule. 5 Hourly rate. All services rendered by the Department will be based on actual cost and the hourly fee for services will be adjusted every six months from the effective date of these regulations, and an updated version of the fee schedule shall be available upon request. The adjustment will be based on the Denver Consumer Price Index for all urban consumers. Every two (2) years from the effective date of these regulations, the Department will review the fees and the Department's costs. If the adjusted fees and costs for any categories differ by more than ten (10) percent, the Department will propose a revised fee to the State Board of Health for those categories. For each hourly-rate service rendered by the Department, records will be maintained of time spent, by at least fifteen (15) minute intervals, using reasonable accounting procedures. A statement will be sent to the registrant indicating the actual costs incurred.

6 Any registrant that fails the requirements of 2.5.1, or does not correct any violation in accordance with the compliance schedule established in 2.5.2.3, shall be subject to a Department enforcement action at the current hourly rate and/or maximum fee. The Department shall charge enforcement fees, which may include inspection fees for the inspection of radiation machines and facilities that have been determined, by either a qualified inspector or by the Department, to be in noncompliance with these regulations and with the certification frequency. These fees do not include penalties imposed under Part 13. 7 This represents the maximum fee that may be incurred for the Department enforcement actions of each radiation machine and/or facility determined to be in violation with these regulations by either a qualified inspector or by the Department. 8 Qualified inspector registration fee is an individual fee. Servicing and services registration fee is a company fee. 9 The annual fee is $80 and is payable every two (2) years in the amount of $160. This fee is non-refundable in the event that the application is not approved by the Department.

PART 2, APPENDIX 2B:

MINIMUM QUALIFICATIONS FOR QUALIFIED INSPECTOR TIER 1 10, 11 Tier 1 includes individuals who are considered by the Department to be fully qualified by virtue of both education and experience.

Tier 2 is a preparatory program for individuals who do not meet the minimum experience requirements for qualified inspector status.

Tier 1 10, 11 The established minimum education and experience criteria for individuals are listed for Tier 1 qualified inspector status. The following are representative but not all inclusive lists of the qualifications of individuals who may have sufficient experience and or training to be given the status of qualified inspector.

10 Tier 1 inspectors are required to meet more stringent qualifications and assume the primary responsibility for all inspections. Tier 2 inspectors are defined as less qualified individuals who are required to work under the direction of Tier 1 inspector(s). This system provides for a mechanism whereby individuals could gain the experience to qualify as Tier 1 inspectors. 11 Receiving approval in one category does not automatically permit inspectors to perform inspections in other categories. 1. Education and Experience a. General Requirements:

GENERAL REQUIREMENTS FOR QUALIFIED INSPECTOR EDUCATION AND EXPERIENCE Education / Experience Certification Board-certified in Not Applicable Diagnostic Radiologic Physics or Radiologic Physics by the American Board of Radiology; or board-certified in Diagnostic Imaging Physics by the American Board of Medical Physics; or Other board certifications 6 months by the American Board of Radiology or comprehensive certification by the American Board of Health Physics; or Doctorate or Masters; or 1 year B.A./B.S.; or 2 years Associate Degree; or 3 years Registered Radiologic 4 years Technologist (Radiography)

b. Educational/Experience Requirements:

(1) The formal education shall be in a related discipline, such as medical physics, health physics, physics, biophysics, biomedical engineering, or equivalent. (2) For each category of radiation machine for which approval is requested, the experience shall include but not be limited to: measuring ionizing radiation; evaluating radiation machines and components; film processing; and familiarity with the appropriate requirements stated in these regulations. c. Specific Qualifications for a Qualified Inspector to Inspect Mammography Facilities: Prior to authorization as a qualified inspector for mammography facilities, an applicant shall:

(1) Be board-certified in diagnostic radiologic physics or radiologic physics by the American Board of Radiology; or board-certified in diagnostic imaging physics by the American Board of Medical Physics; or board-certified in an equivalent specialty area by another certifying body recognized by the American College of Radiology; or (2) Hold a master of science, master of arts, or higher degree in the field of physics, applied physics, radiologic physics, biophysics or health physics; have at least two (2) years of training in medical physics in the area of clinical diagnostic radiologic physics; and have had at least three (3) years of experience in conducting mammography equipment performance evaluations; and (3) Have twenty (20) contact hours of documented specialized training in conducting surveys of mammography facilities; and (4) Have the experience of conducting surveys of at least one mammography facility and a total of at least ten (10) mammography units. No more than one survey of a specific unit within a period of sixty (60) days can be counted towards the total mammography unit survey requirement. This experience must be accomplished under the direct supervision of a currently registered qualified inspector in mammography; and (5) Have documented a minimum of fifteen (15) hours of continuing education in mammography which are no more than thirty-six months old; and (6) Have surveyed at least two (2) mammography facilities and a total of at least six (6) mammography units. This experience shall not be more than twenty-four (24) months old; and (7) If performing a certification evaluation including a new modality of mammography imaging, have a minimum of eight (8) hours of training in the new modality prior to performing such a certification evaluation independently; and (8) If the applicant fails to meet the continuing education requirement, obtain the additional continuing education hours, prior to performing any certification evaluation; and (9) If the applicant fails to meet the continuing experience requirement, complete a sufficient number of certification evaluations under the supervision of a currently registered qualified inspector in mammography or a MQSA approved medical physicist to bring the applicant’s total certification evaluations up to the required two (2) facilities and six (6) units in the previous twenty-four (24) months. 2. Proficiency testing for all applicants The Department shall audit proficiency of each qualified inspector. In addition, each applicant shall demonstrate to the Department a satisfactory knowledge of the applicable provisions of the State of Colorado Rules and Regulations Pertaining to Radiation Control . 3. Calibration Records Applicable measuring instruments and devices shall be sufficiently sensitive and calibrated in accordance with 2.4.3.3 to determine compliance with the applicable provisions of the State of Colorado Rules and Regulations Pertaining to Radiation Control . Current calibration records shall be submitted upon initial application and each subsequent renewal application. These records shall be readily available for the Department's review upon reasonable request. Tier 2 An individual who meets the educational but not the experience qualifications listed for a Tier 1 inspector can apply for Department approval to perform evaluations under the tutelage and supervision of a Tier 1 inspector. Before an individual can apply for Tier 2 status, the individual must have worked directly with a Tier 1 inspector for three (3) months. The Tier 1 sponsor shall provide the Department adequate documentation that these requirements are met.

Each individual in this category must submit an application to the Department prior to performing any certification evaluations. The application shall include the name and signature of each Tier 1 individual with whom the applicant will be working.

Each submitted Certification Evaluation Report shall be signed by the Tier 2 inspector and the Tier 1 sponsor. The final responsibility for the content of the report belongs to the Tier 1 inspector who sponsors the Tier 2 inspector.

PART 2, APPENDIX 2C:

CRITERIA FOR CLASSIFYING A MACHINE UNSAFE FOR ROUTINE HUMAN USE The operating condition of an x-ray machine and related equipment may be such that the continued operation of that machine endangers the public health and safety. An x-ray machine shall be considered unsafe for human use if:

1. The x-ray machine system has a malfunctioning component or components that could result in an inadvertent exposure to members of the public, the operator, or the patient. Examples include but are not limited to: a timer which fails to terminate the exposure, an exposure switch when activated once produces multiple exposures, a system which produces x-rays without activation of the exposure switch.

2. The x-ray machine is not equipped with a means of determining when x-rays are in production. 3. The x-ray machine is equipped with variable technique factors and the selectors and/or indicators of these technique factors do not permit the operator to determine the factors in use or if the indicated versus the technique factor(s) are in error by fifty (50) percent or more, except for exposure times selected less than 50 millisecond.

4. The collimation of the x-ray beam of a fluoroscopic/spot film system is such that either the length or width of the x-ray field in the plane of the image receptor differs (in excess) from the corresponding image receptor dimensions by more than 25 percent of the source to image distance (SID).

5. The half-value layer of aluminum (or equivalent) filtration in the useful beam is more than fifty (50) percent below the values specified in 6.4.5.1.

6. In addition to the above items a fluoroscopic x-ray system will be considered unsafe if: a. No operational image intensifier is provided.

b. Except for radiation oncology simulators, the primary protective barrier does not intercept 100 percent of the x-ray beam of a fluoroscopic x-ray system. c. Except for radiation oncology simulators, the fluoroscopic x-ray system is capable of producing x-rays when the primary protective barrier is not in position to intercept the beam. d. The fluoroscopic x-ray system has a tabletop entrance exposure rate equal to or greater than 25 R/min at the point where the useful beam enters the patient, except: (1) During the recording of fluoroscopic images, or (2) When an optional high-level control is activated.

Note that this is normal fluoroscopic mode, and the FDA's regulations (21 CFR 1020.32(e)(2)(II), April 1, 2004) allow up to 20 R/min when recording or using high- level control.

7. An electro-mechanical defect exists which endangers human life when a radiograph is made or fluoroscopy is performed.

PART 2, APPENDIX 2D:

X-RAY SYSTEM OPERATOR ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE, INCLUDING LIMITED-SCOPE X-RAY MACHINE OPERATOR (LSO)

The registrant shall require each x-ray system operator to be an individual at least 18 years of age who: 2D1 Is certified or registered by:

2D1.1 The American Registry of Radiologic Technologists; or 2D1.2 A specialty board that has been recognized by the Department, including or in combination with documentation accepted by the Department of the training required by 2D4A through 2D4F; or 2D2 Is accepted in accordance with 2.6.1.5(3) by the Department as having met, prior to July 1, 2005, the requirements of Rule 700 of the Colorado Board Of Medical Examiners; or 2D3 Is accepted by the Department as having:

2D3.1 Been enrolled, prior to July 1, 2005, in a limited-scope x-ray machine operator radiologic technology program that is accredited by a national accrediting institution recognized by the U.S. Department of Education;

2D3.2 Completed that program prior to July 1, 2007; and 2D3.3 Passed the LSO test with a score of 75% or higher on each portion of the test; or 2D4 Is accepted by the Department as a limited-scope x-ray machine operator, having satisfactorily completed:

[Elements of the following are from the 20015 Content Specifications For The Examination For The Limited Scope Of Practice In Radiology and used with ARRT permission.] 2D4.1 At least 80 hours of didactic training providing the minimum hours of instruction in the specific subjects listed in 2D4A through 2D4F:

RADIATION SAFETY (passing score on written test of 75% or higher on the radiation safety module)

2D4A Basic X-Ray Physics—20 hours 1. Structure of matter and the atom 2. General description of production of x rays 3. X-ray emission, quantity and quality 4. Function of filtration and effects it has on x-ray beam collimation 5. Types of function of beam limiting devices 6. Design, features and functions of x-ray tubes 7. Circuitry of the x-ray machine 2D4B Radiobiology—3 hours 1. Effects of ionizing radiation to the human body 2. Molecular and cellular radiobiology 3. Factors that cause somatic and genetic damage 2D4C Radiation Protection—6 hours 1. ALARA 2. Shielding materials 3. Radiation quantity and units of measurement 4. Basic interactions of x-rays with matter 5. Primary and secondary scatter 6. Importance of time, distance, shielding 7. Maximum permissible doses: occupational and public 8. Patient protection RADIOGRAPHIC PROCEDURES (passing score on written test of 75% or higher on radiographic procedures module 2D4D Principles of Exposure—15 hours 1. Factors that control and influence radiographic quality 2. Properties of x-rays 3. Size distortion 4. Shape distortion 5. kVp, mAs, time 6. AEC and manual 7. Grids 8. Collimation 9. Intensifying screens 10. X-ray films and holders 11. Artifacts 12. Inverse square law 2D4E Procedures and Processing—4 hours 1. Film storage and handling 2. Manual, automatic processing film processing and troubleshooting 3. Computed Radiography (CR)

4. Digital Radiography (DR)

5. PACs 6. Quality assurance / quality control 2D4F Anatomy and Positioning—32 hours 1. Chest—4 hours 2. Extremity—12 hours 3. Spine—8 hours 4. Skull—8 hours; and 2D4.2 At least 480 hours of clinical training during which time the individual may perform x-ray examinations only under personal (in attendance during the procedure) supervision of a qualified trainer, including:

2D4.2.1 At least 320 hours experiential training at a clinic; and 2D4.2.2 No more than 160 hours of laboratory training (exclusive of the didactic hours required by 2D4A through 2D4F); and 2D4.3 Performance of the following imaging procedures ( at least 80 examinations in total, with record of each examination kept on file):

2D4.3.1 Ribs—4 examinations 2D4.3.2 Hand—4 examinations 2D4.3.3 Wrist—4 examinations 2D4.3.4 Forearm—4 examinations 2D4.3.5 Elbow—4 examinations 2D4.3.6 Humerus—4 examinations 2D4.3.7 Shoulder—4 examinations 2D4.3.8 Clavicle—4 examinations 2D4.3.9 Femur—4 examinations 2D4.3.10 Tibia - Fibula—4 examinations 2D4.3.11 Ankle—4 examinations 2D4.3.12 Foot—4 examinations 2D4.3.13 Sinuses—4 examinations 2D4.3.14 Skull—4 examinations 2D4.3.15 Facial Bones—4 examinations 2D4.3.16 C-Spine—4 examinations 2D4.3.17 Thoracic Spine—4 examinations 2D4.3.18 Lumbar Spine—4 examinations 2D4.3.19 Chest—4 examinations 2D4.3.20 Hip / Pelvis—4 examinations 2D5 Has maintained a minimum of twenty-four (24) hours of continuing education every two years in the areas of radiology, radiation safety, radiography and similar fields. This education shall: 2D5.1 Conform to guidelines equivalent to the July 1, 2004 ARRT Continuing Education Requirements For Renewal Of Registration ; and 2D5.2 Be documented by certificate(s) or other attestation(s) of satisfactory completion. PART 2, APPENDIX 2E:

COMPUTED TOMOGRAPHY (CT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The registrant shall require each computed tomography operator to be an individual at least 18 years of age who:

2E1 Is certified:

2E1.1 As ARRT(R) and also certified in computed tomography by ARRT; or 2E1.2 As ARRT(N) or ARRT(T); or 2E1.3 As CNMT by the Nuclear Medicine Technologist Certification Board; or 2E1.4 By a specialty board that has been recognized by the Department, including or in combination with documentation accepted by the Department for the training required by 2E2A through 2E2L; or 2E2 Is ARRT(R) and also has satisfactorily completed:

[Elements of the following are from the July 2004 Content Specifications For The Examination In Computed Tomography and used with ARRT permission.] 2E2.1 At least 60 hours of didactic training providing the minimum hours of instruction in the specific subjects listed in 2E2A through 2E2L:

2E2A IV Procedures—2 hours 1. Venipuncture a. Site selection b. Aseptic and sterile techniques 2. Injection techniques a. Manual b. Automatic (1) Single phase (2) Multi-phase (3) Flow rate 2E2B Contrast Agent—6 hours 1. Types a. Ionic b. Non-ionic c. Water soluble d. Air e. Water 2. Administration route and dose calculations a. IV (angiocatheter or butterfly)

b. Oral c. Rectal d. Intrathecal e. Catheters 3. Special considerations a. Allergy preparation b. Pathologic processes c. Contraindications d. Indicators 4. Adverse reactions a. Recognition and assessment of symptoms b. Treatment (e.g., compresses, medications)

c. Documentations 2E2C Radiation Safety and Dosimetry—6 hours 1. Technical factors affecting patient dose 2. Radiation protection 3. CT Dose Index (CTDI) / Multiple Scan Average Dose (MSAD) 4. Pediatric dose reduction 2E2D Type of Study (24 hours; 1 hour for each topic—2E2E, 2E2F, 2E2G and 2E2H—for each type of study)

1. Head 2. Neck 3. Chest 4. Abdomen 5. Pelvis 6. Musculo-skeletal 2E2E Sectional Anatomy (for each type of study)

1. Sagittal plane 2. Transverse plane (axial)

3. Coronal plane 4. Off-axis (oblique)

5. Landmarks 6. Pathology recognition 2E2F Contrast Media (for each type of study)

1. Types of agents 2. Indications 3. Contraindications 4. Dose calculation 5. Administration route 6. Scan/prep delay 2E2G Scanning Procedures (for each type of study)

1. Positioning 2. Scout 3. Acquisition methods (e.g., spiral, non spiral, dynamic, multi-row detector) 4. Parameter selection (e.g., slice thickness, mA, time, algorithm, pitch) 5. Protocol modification for pathology or trauma 2E2H Special Procedures (for each type of study)

1. 3-D studies 2. Biopsies 3. Radiation therapy planning 4. Drainage and aspiration 5. Post-myelography 6. CT arthrography and angiography 7. Cardiac gating 2E2I Systems Operation and Components—4 hours 1. Tube 2. Detector (single row and multi row)

3. Collimation 4. Computer and array processor 5. Equipment maintenance 2E2J Image Processing & Display—10 hours 1. Image reconstruction a. Filtered back projection reconstruction b. Reconstruction filters (algorithms)

c. Raw data vs. image data d. Prospective / retrospective reconstruction (single and multi-row) e. Effective slice thickness f. Reconstruction interval 2. Image display a. Pixel, voxel b. Matrix c. Image magnification d. Field of view (scan, reconstruction and display)

e. Attenuation coefficient f. CT number g. Window level, window width h. Plane specification (X, Y, Z coordinates)

i. ROI (single and multiple image)

3. Post-processing a. Multiplanar reformation b. 3 D rendering (MIP, SSD, VR)

c. Quantitative measurements (volume, distance, diameter) 4. Data management a. Hard copy b. Storage / archive c. Electronic transmission 2E2K Image Quality—4 hours 1. Spatial resolution 2. Contrast resolution 3. Noise 4. Quality assurance procedures 2E2L Artifact Recognition and Reduction—4 hours 1. Beam hardening 2. Partial volume averaging 3. Motion 4. Metallic 5. Edge gradient 6. Patient positioning 7. Equipment-induced a. Rings b. Streaks c. Tube arcing d. Cone beam; and 2E2.2 At least 480 hours of clinical training during which time computed tomography examinations are performed only under direct supervision of an ARRT(N), ARRT(R), ARRT(T) or CNMT computed tomography operator or other qualified trainer: 2E2.2.1 “Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed.

2E2.2.2 A signed statement by the individual(s) who provided supervision and evaluation shall be kept on file to document dates and locations of clinical training; and 2E2.3 Documented performance of the following imaging procedures ( at least 60 examinations in total, with record of each examination kept on file): 2E2.3.1 Head—10 examinations 2E2.3.2 Neck—10 examinations 2E2.3.3 Chest—10 examinations 2E2.3.4 Abdomen—10 examinations 2E2.3.5 Pelvis—10 examinations 2E2.3.6 Musculo-skeletal—10 examinations PART 2, APPENDIX 2F:

BONE DENSITOMETRY (BD) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The registrant shall require each bone densitometry equipment operator (BDEO) to be an individual at least 18 years of age who:

2F1 Is certified or registered by:

2F1.1 ARRT(R), ARRT(M), ARRT(N), ARRT(T), or CNMT; or 2F1.2 The International Society for Clinical Densitometry (ISCD), combined with or including the didactic radiation safety training in 2F2A, 2F2B and 2F2C; or 2F1.3 A specialty board that has been recognized by the Department, in combination with documentation accepted by the Department for the training required by 2F2A through 2F2I; or 2F2 Is accepted by the Department as having satisfactorily completed: [Elements of the following are from the 2002 Content Specifications for the Bone Densitometry Equipment Operators Examination and used with ARRT permission.] 2F2.1 At least 30 hours of didactic training recognized by the Department that provided the minimum hours of instruction (as part of, or in addition to, specialty certificate and equipment operation training) in the specific subjects listed in 2F2A through 2F2I; RADIATION SAFETY:

2F2A Basic X-Ray Physics—2 hours 1. Structure of matter and the atom 2. General description of production of x rays 3. X-ray emission, quantity and quality 4. Function of filtration and effects it has on x-ray beam collimation 5. Types of function of beam limiting devices 6. Design, features and functions of x-ray tubes 7. Circuitry of the x-ray machine 2F2B Radiobiology—2 hours 1. Effects of ionizing radiation to the human body 2. Molecular and cellular radiobiology 3. Factors that cause somatic and genetic damage 2F2C Radiation Protection—5 hours 1. ALARA 2. Shielding materials 3. Radiation quantity and units of measurement 4. Basic interactions of x-ray with matter 5. Primary and secondary scatter 6. Importance of time, distance, shielding 7. Maximum permissible dose: occupational and public 8. Patient protection a. Patient instruction b. Comparison levels of radiation (1) Natural background radiation (2) Central DXA (3) Peripheral DXA BONE DENSITOMETRY PROCEDURES 2F2D Basic Concepts—8 hours 1. Osteoporosis a. World Health Organization definition and diagnostic criteria b. Primary vs. secondary c. Type I (postmenopausal) vs. Type II (senile)

d. Risk factors (1) Controllable (smoking, calcium intake, estrogen, medications)

(2) Uncontrollable (heredity, race, gender, age, medical conditions)

e. Radiographic Absorptiometry (RA)

2. Bone physiology a. Functions of bone (1) Structural support and protection (2) Storage of essential minerals b. Types of bone (1) Cortical (2) Trabecular c. Bone remodeling cycle (1) Resorption / formation (2) Osteoblasts/osteoclasts d. Bone health (1) Nutrition (2) Exercise 3. BMD testing methods (anatomical sites scanned, key advantages and disadvantages)

a. Dual-energy X-Ray Absorptiometry (DXA)

b. Single X-ray Absorptiometry (SXA)

c. Quantitative Ultrasound (QUS)

4. Measuring BMD a. Basic statistical concepts (1) Mean (2) Standard deviation (3) Coefficient of variation b. Reporting patient results (1) BMD formula (2) Z–score (3) T–score 2F2E Equipment Operation & Quality Control—6 hours 1. Computer console a. Major components b. File management 2. X-ray energy production a. Single b. Dual 3. Types of DXA systems a. Pencil beam systems b. Fan beam systems c. Cone beam systems 4. Quality control a. Equipment safety (electrical, pinch points, emergency stop) b. Use of phantoms and/or calibration c. Troubleshooting (1) Shift or drift (2) Pass / fail d. Record maintenance 5. Determining quality in BMD a. Precision (definition)

b. Accuracy (definition)

c. Factors affecting accuracy and precision (1) Scanner (2) Operator (3) Patient 2F2F DXA Scanning of Finger and Heel (OS CALCIS)—1 hour 1. Anatomy a. Regions of interest b. Bony landmarks c. Radiographic appearance 2. Scan acquisition a. Patient instructions b. Patient positioning c. Evaluating pre-set scan parameters 3. Scan analysis: BMD, T score, Z score 4. Common problems a. Nonremovable artifacts b. Fractures or pathology 2F2G DXA Scanning of Forearm—2 hours 1. Anatomy a. Regions of interest b. Bony landmarks c. Radiographic appearance d. Adjacent structures 2. Scan acquisition a. Patient instructions b. Patient positioning c. Evaluating pre-set scan parameters 3. Scan analysis a. Accurate ROI placement b. BMC, area, and BMD c. T-score, Z-score 4. Common problems a. Poor bone edge detection b. Nonremovable artifacts c. Variant anatomy d. Fractures or pathology 5. Follow-up scans a. Unit of comparison: BMD, T-score b. Reproduce baseline study 2F2H DXA Scanning of Lumbar Spine—2 hours 1. Anatomy a. Regions of interest b. Bony landmarks c. Radiographic appearance d. Adjacent structures 2. Scan acquisition a. Patient instructions b. Patient positioning c. Evaluating pre-set scan parameters 3. Scan analysis a. Accurate ROI placement b. BMC, area, and BMD c. T-score, Z-score 4. Common problems a. Poor bone edge detection b. Nonremovable artifacts c. Variant anatomy d. Fractures or pathology 5. Follow-up scans a. Unit of comparison: BMD, T score b. Reproduce baseline study 2F2I DXA Scanning of Proximal Femur—2 hours 1. Anatomy a. Regions of interest b. Bony landmarks c. Radiographic appearance d. Adjacent structures 2. Scan acquisition a. Patient instructions b. Patient positioning c. Evaluating pre-set scan parameters 3. Scan analysis a. Accurate ROI placement b. BMC, area, and BMD c. T-score, Z-score 4. Common problems a. Poor bone edge detection b. Nonremovable artifacts c. Variant anatomy d. Fractures or pathology 5. Follow-up scans a. Unit of comparison: BMD, T-score b. Reproduce baseline study; and 2F2.2 At least 480 hours of clinical training during which time DXA examinations are performed only under direct supervision of a Colorado qualified bone densitometry equipment operator or other qualified trainer:

2F2.2.1 “Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed.

2F2.2.2 A signed statement by the individual(s) who provided supervision and evaluation shall be kept on file to document dates and locations of clinical training; and 2F2.3 Performance of the following imaging procedures (at least 30 examinations in total, with record of each examination kept on file):

2F2.3.1 DXA scanning of the forearm—10 examinations 2F2.3.2 DXA scanning of the lumbar spine—10 examinations 2F2.3.3 DXA scanning of the proximal femur—10 examinations 2F3 Has maintained a minimum of eighteen (18) hours continuing education every three years, documented by certificate(s) or other attestation(s) of satisfactory completion. PART 3 LICENSING OF RADIOACTIVE MATERIAL RH 3.1 Purpose and Scope.

3.1.1 This part, and Parts 5, 7, 14, 16, 17, and 18 of these regulations, provide for the licensing of radioactive material. No person shall receive, possess, process, use, own, transfer, or acquire radioactive material except as authorized pursuant to this part or Parts 7, 14, 17, or 18 of these regulations, or as otherwise provided in these parts.

3.1.2 In addition to the requirements of this part, all licensees are subject to the requirements of Parts 1, 4, 10, 12 and 17 of these regulations. Furthermore, licensees engaged in industrial radiographic operations are subject to the requirements of Part 5 of these regulations, licensees using radionuclides in the healing arts are subject to the requirements of Part 7 of these regulations, licensees engaged in land disposal of radioactive material are subject to the requirements of either Part 14 or Part 18 of these regulations, as appropriate. Licensees engaged in source material milling are subject to the requirements of Part 18 of these regulations, and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of Part 16 of these regulations.

3.1.3 The department may engage the services of qualified persons in order to assist the department in meeting the requirements of these regulations, including, but not limited to, evaluating information that may be required under RH 3.8.8. Fees for these services may be charged by the department as a part of fees charged for radiation control services under Part 12 of these regulations Exemptions From The Regulatory Requirements RH 3.2 Source Material.

3.2.1 Any person is exempt from this part to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1 percent (0.05 percent) of the mixture, compound, solution, or alloy.

3.2.2 Any person is exempt from this part to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. 3.2.3 Any person is exempt from this part to the extent that such person receives, possesses, uses, or transfers:

3.2.3.1 any quantities of thorium contained in 3.2.3.1.1 incandescent gas mantles, 3.2.3.1.2 vacuum tubes, 3.2.3.1.3 welding rods, 3.2.3.1.4 electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium, 3.2.3.1.5 germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium, 3.2.3.1.6 rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or 3.2.3.1.7 personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;

3.2.3.2 source material contained in the following products: 3.2.3.2.1 glazed ceramic tableware, provided that the glaze contains not more than 20 percent by weight source material, 3.2.3.2.2 glassware containing not more than 10 percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass or ceramic used in construction, 3.2.3.2.3 glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983, or 3.2.3.2.4 piezoelectric ceramic containing not more than 2 percent by weight source material;

3.2.3.3 photographic film, negatives, and prints containing uranium or thorium; 3.2.3.4 any finished product or part fabricated of, or containing, tungsten-thorium or magnesium- thorium alloys, provided that the thorium content of the alloy does not exceed 4 percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part; 3.2.3.5 uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that 3.2.3.5.1 the counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, authorizing distribution by the licensee pursuant to 10 CFR Part 40, 3.2.3.5.2 each counterweight has been impressed with the following legend clearly legible through any plating or other covering: “DEPLETED URANIUM”,1 1The requirements specified in RH 3.2.3.5.2 and RH 3.2.3.5.3 need not be met by counterweights manufactured prior to December 31, 1969; provided, that such counterweights are impressed with the legend, “CAUTION - RADIOACTIVE MATERIAL - URANIUM”, as previously required by the regulations.

3.2.3.5.3 each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: “UNAUTHORIZED ALTERATIONS PROHIBITED”,1and 1The requirements specified in RH 3.2.3.5.2 and RH 3.2.3.5.3 need not be met by counterweights manufactured prior to December 31, 1969; provided, that such counterweights are impressed with the legend, “CAUTION - RADIOACTIVE MATERIAL - URANIUM”, as previously required by the regulations.

3.2.3.5.4 this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering; 3.2.3.6 natural or depleted uranium used as shielding constituting part of any shipping container, provided that:

3.2.3.6.1 the shipping container is conspicuously and legibly impressed with the legend “CAUTION - RADIOACTIVE SHIELDING - URANIUM” and 3.2.3.6.2 the uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 1/8 inch (3.2 mm).

3.2.3.7 thorium contained in finished optical lenses, provided that each lens does not contain more than 30 percent by weight of thorium, and that this exemption shall not be deemed to authorize either 3.2.3.7.1 the shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or 3.2.3.7.2 the receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments; 3.2.3.8 uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 185 Bq (0.005 µCi) of uranium; or 3.2.3.9 thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that 3.2.3.9.1 the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and 3.2.3.9.2 the thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.

3.2.4 The exemptions in RH 3.2.3 do not authorize the manufacture of any of the products described. RH 3.3 Radioactive Material Other Than Source Material. 3.3.1 Exempt Concentrations.

3.3.1.1 Except as provided in RH 3.3.1.2, any person is exempt from this part to the extent that such person receives, possesses, uses, transfers, or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Schedule A of this part. 3.3.1.2 No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under RH 3.3.1.1 or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State, except in accordance with a specific license issued pursuant to RH 3.12.1 or the general license provided in RH 3.24.

3.3.2 Exempt Quantities.

3.3.2.1 Except as provided in RH 3.3.2.3 and RH 3.3.2.4, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Schedule B of this part.

3.3.2.2 Any person who possesses radioactive material received or acquired under the general license formerly provided in RH 3.6.2 is exempt from the requirements for a license set forth in this part to the extent that such person possesses, uses, transfers or owns such radioactive material. Such exemption does not apply for radium-226.

3.3.2.3 This paragraph (RH 3.3.2) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution. 3.3.2.4 No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Appendix B of this part, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under RH 3.3.2 or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR Part 32 or by the Department pursuant to RH 3.12.2 which license states that the radioactive material may be transferred by the licensee to persons exempt under RH 3.3.2 or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or Licensing State.2 2Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.3.3 Exempt Items.

3.3.3.1 Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from these regulations to the extent that the person receives, possesses, uses, transfers, owns, or acquires the following products:2 2Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.3.3.1.1 Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate: 3.3.3.1.1.1 925 MBq (25 mCi) of tritium per timepiece.

3.3.3.1.1.2 185 MBq (5mCi) of tritium per hand.

3.3.3.1.1.3 555 MBq (15 mCi) of tritium per dial (bezels when used shall be considered as part of the dial).

3.3.3.1.1.4 3.7 MBq (100 µCi) of promethium-147 per watch or 7.4 MBq (200 µCi) of promethium-147 per any other timepiece.

3.3.3.1.1.5 0.74 MBq (20 µCi) of promethium-147 per watch hand or 1.48 MBq (40 µCi) of promethium-147 per other timepiece hand.

3.3.3.1.1.6 2.22 MBq (60 µCi) of promethium-147 per watch dial or 4.44 MBq (120 µCi) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).

3.3.3.1.1.7 The radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

3.3.3.1.1.7.1 For wrist watches, 1 uGy (0.1 mrad) per hour at 10 centimeters from any surface.

3.3.3.1.1.7.2 For pocket watches, 1 uGy (0.1 mrad) per hour at 1 centimeter from any surface.

3.3.3.1.1.7.3 For any other timepiece, 2 uGy (0.2 mrad) per hour at 10 centimeters from any surface.

3.3.3.1.1.8 37 kBq (1 µCi) of radium-226 per timepiece in timepieces acquired prior to the effective date of this regulation.

3.3.3.1.2 Lock illuminators containing not more than 555 MBq (15 mCi)of tritium or not more than 74 MBq (2 mCi) of promethium-147 installed in automobile locks. The radiation dose rate from each lock illuminator containing promethium-147 will not exceed 10 uGy (1 mrad) per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.

3.3.3.1.3 Precision balances containing not more than 37 MBq (1 mCi) of tritium per balance or not more than 18.5 MBq (0.5 mCi) of tritium per balance part. 3.3.3.1.4 Automobile shift quadrants containing not more than 925 MBq (25 mCi) of tritium. 3.3.3.1.5 Marine compasses containing not more than 27.8 GBq (750 mCi) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 mCi) of tritium gas.

3.3.3.1.6 Thermostat dials and pointers containing not more than 925 MBq (25 mCi) of tritium per thermostat.

3.3.3.1.7 Electron tubes; provided, that each tube does not contain more than one of the following specified quantities of radioactive material: 3.3.3.1.7.1 5.55 GBq (150 mCi) of tritium per microwave receiver protector tube or 370 MBq (10 mCi) of tritium per any other electron tube.

3.3.3.1.7.2 37 kBq (1 µCi) of cobalt-60.

3.3.3.1.7.3 185 kBq (5 µCi) of nickel-63.

3.3.3.1.7.4 1.11 MBq (30 µCi) of krypton-85.

3.3.3.1.7.5 185 kBq (5 µCi) of cesium-137.

3.3.3.1.7.6 1.11 MBq (30 µCi) of promethium-147.

And provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed 10 uGy (1 mrad) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.3 3For purposes of RH 3.3.3.1.7, “electron tubes” include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

3.3.3.1.8 Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that: 3.3.3.1.8.1 Each source contains no more than one exempt quantity set forth in Schedule B of this part, and 3.3.3.1.8.2 Each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Schedule B of this part, provided that the sum of such fractions shall not exceed unity. 3.3.3.1.8.3 For americium-241, 1.85 kBq (0.05 µCi) is considered an exempt quantity under RH 3.3.3.1.8.

3.3.3.1.9 Spark gap irradiators containing not more than 37 kBq (1 µCi) of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons (11.4 I) per hour.

3.3.3.2 Self-Luminous Products Containing Radioactive Material. 3.3.3.2.1 Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in RH 3.3.3.2 does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.

3.3.3.2.2 Radium-226. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 3.7 kBq (0.1 µCi) of radium-226 which were acquired prior to the effective date of this regulation.

3.3.3.3 Gas and Aerosol Detectors Containing Radioactive Material. 3.3.3.3.1 Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission2 pursuant to Section 32.26 of 10 CFR Part 32; or a Licensing State pursuant to RH 3.12.3, which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. 2Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.3.3.3.2 Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State shall be considered exempt under RH 3.3.3.3.1, provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of RH 3.12.3. 3.3.3.3.3 Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a Licensing State shall be considered exempt under RH 3.3.3.3.1, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of RH 3.12.3.

3.3.3.4 Resins Containing Scandium-46 and Designed for Sand Consolidation in Oil Wells. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer of such resins pursuant to licensing requirements equivalent to those in Sections 32.16 and 32.17 of 10 CFR Part 32 of the regulations of the U. S. Nuclear Regulatory Commission. This exemption does not authorize the manufacture of any resins containing scandium-46. 3.3.3.5 Radioactive Drug: Capsules Containing Carbon-14 urea for “in vivo” Diagnostic Use for Humans. 3.3.3.5.1 Except as provided in paragraphs RH 3.3.3.5.2 and 3.3.3.5.3 of this section, any person is exempt from the regulations in this part provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for “in vivo” diagnostic use for humans. 3.3.3.5.2 Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part 7 of these regulations. 3.3.3.5.3 Nothing in this section relieves persons from complying with applicable FDA, Federal, and state requirements governing receipt, administration, and use of drugs. Licenses RH 3.4 Types of Licenses.

Licenses for radioactive materials are of two types: general and specific. 3.4.1 General licenses provided in this part are effective without the filing of applications with the Department or the issuance of licensing documents to the particular persons, although the filing of a certificate with the Department may be required by the particular general license. The general licensee is subject to all other applicable portions of these regulations and any limitations of the general license.

3.4.2 Specific licenses require the submission of an application to the Department and the issuance of a licensing document by the Department. The licensee is subject to all applicable portions of these regulations as well as any limitations specified in the licensing document. General Licenses RH 3.5 General Licenses - Source Material.

3.5.1 A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and State and local government agencies to use and transfer not more than 15 pounds (6.82 kg) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, pursuant to this general license, may not receive more than a total of 150 pounds (68.2 kg) of source material in any one calendar year. 3.5.1.1 Persons who receive, possess, use or transfer source material pursuant to the general license in RH 3.5.1 are prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized in a specific license.

3.5.2 Persons who receive, possess, use, or transfer source material pursuant to the general license issued in RH 3.5.1 are exempt from the provisions of Parts 4 and 10 of these regulations to the extent that such receipt, possession, use, or transfer is within the terms of such general license; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to this part. 3.5.3 A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material.

3.5.4 A general license is hereby issued authorizing the possession of source material involved in mining operations provided such operations meet the regulatory requirements of the Division of Mines, Colorado Department of Natural Resources, or any successor thereto, and except as authorized in a specific license, such mining operations shall not refine or process such ore. 3.5.5 Depleted Uranium in Industrial Products and Devices. 3.5.5.1 A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of RH 3.5.5.2, RH 3.5.5.3, RH 3.5.5.4, and RH 3.5.5.5, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device. 3.5.5.2 The general license in RH 3.5.5.1 applies only to industrial products or devices which have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices pursuant to RH 3.12.13 or in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.

3.5.5.3.1 Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by RH 3.5.5.1 shall file Department Form OR- RH-52 “Registration Certificate - Use of Depleted Uranium Under General License”, with the Department. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The general licensee shall furnish on Department Form OR-RH-52 the following information and such other information as may be required by that form:

3.5.5.3.1.1 name and address of the general licensee;

3.5.5.3.1.2 a statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium described in RH 3.5.5.1 and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and 3.5.5.3.1.3 name and title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in RH 3.5.5.3.1.2.

3.5.5.3.2 The general licensee possessing or using depleted uranium under the general license established by RH 3.5.5.1 shall report in writing to the Department any changes in information furnished by him in Department Form OR-RH-52 “Registration Certificate - Use of Depleted Uranium Under General License”. The report shall be submitted within 30 days after the effective date of such change. 3.5.5.4 A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by RH 3.5.5.1:

3.5.5.4.1 shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium; 3.5.5.4.2 shall not abandon such depleted uranium;

3.5.5.4.3 shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of RH 3.22. In the case where the transferee receives the depleted uranium pursuant to the general license established by RH 3.5.5.1, the transferor shall furnish the transferee a copy of this regulation and a copy of Department Form OR-RH-52. In the case where the transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to RH 3.5.5.1, the transferor shall furnish the transferee a copy of this regulation and a copy of Department Form OR-RH-52 accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or Agreement State under requirements substantially the same as those in this regulation;

3.5.5.4.4 within 30 days of any transfer, shall report in writing to the Department the name and address of the person receiving the depleted uranium pursuant to such transfer, and 3.5.5.4.5 shall not export such depleted uranium except in accordance with a license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 110. 3.5.5.5 Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by RH 3.5.5.1 is exempt from the requirements of Parts 4 and 10 of these regulations with respect to the depleted uranium covered by that general license.

* RH 3.6 General Licenses Radioactive Material Other Than Source Material. *Note: Different general licenses are issued in this section, each of which has its own specific conditions and requirements. 3.6.1 Certain Devices and Equipment.

A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission for use pursuant to Section 31.3 of 10 CFR Part 31. This general license is subject to the provisions of RH 1.4 through 1.9, RH 3.3.1.2, 3.15, 3.22, 3.23 and 3.25, Part 4,4 Part 10 and Part 17 of these regulations.

4Attention is directed particularly to the provisions of Part 4 of these regulations which relate to the labeling of containers. 3.6.1.1 Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device.

3.6.1.2 Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device or a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

3.6.2 Reserved.

3.6.3 Reserved.

3.6.4 Certain Measuring, Gauging or Controlling Devices. 3.6.4.1 A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and State or local government agencies to receive, acquire, possess, use or transfer in accordance with the provisions of RH 3.6.4.2, RH 3.6.4.3, and RH 3.6.4.4, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

3.6.4.2 The general license in RH 3.6.4.1 applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the Department pursuant to RH 3.12.4 or in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, which authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.5 5Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in 21 CFR 179.21. 3.6.4.3 Any person who owns, receives, acquires, possesses, uses, owns, or transfers radioactive material in a device pursuant to the general license in RH 3.6.4.1: 3.6.4.3.1 shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels; 3.6.4.3.2 shall assure that the device is tested for leakage of radioactive material and proper operation of the “on-off” mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, however, 3.6.4.3.2.1 devices containing only krypton need not be tested for leakage of radioactive material, and 3.6.4.3.2.2 devices containing only tritium or not more than 3.7 MBq (100 µCi) of other beta-and/or gamma-emitting material or 0.37 MBq (10 µCi) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose; 3.6.4.3.3 shall assure that other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed: 3.6.4.3.3.1 in accordance with the instructions provided by the labels, or 3.6.4.3.3.2 by a person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such activities;

3.6.4.3.4 shall maintain records showing compliance with the requirements of RH 3.6.4.3.2 and RH 3.6.4.3.3. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by RH 3.6.4.3.2 shall be maintained for 1 year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the “on-off” mechanism and indicator required by RH 3.6.4.3.2 shall be maintained for 1 year after the next required test of the “on-off” mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by RH 3.6.4.3.3 shall be maintained for a period of 2 years from the date of the recorded event or until the device is transferred or disposed of;

3.6.4.3.5 upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the “on-off” mechanism or indicator, or upon the detection of 185 Bq (0.005 µCi) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the Department a report containing a brief description of the event and the remedial action taken; 3.6.4.3.6 shall not abandon the device containing radioactive material; 3.6.4.3.7 except as provided in RH 3.6.4.3.8, shall transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State whose specific license authorizes him to receive the device and within 30 days after transfer of a device to a specific licensee shall furnish to the Department a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific licensee in order to obtain a replacement device; 3.6.4.3.8 shall transfer the device to another general licensee only: 3.6.4.3.8.1 where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this regulation and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Department the manufacturer's name and model number of device transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the Department and the transferee; or 3.6.4.3.8.2 where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee; and 3.6.4.3.9 shall comply with the provisions of RH 4.51 and 4.52 of these regulations for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Parts 4 and 10 of these regulations.

3.6.4.4 The general license in RH 3.6.4.1 does not authorize the manufacture of devices containing radioactive material.

3.6.4.5 The general license provided in RH 3.6.4.1 is subject to the provisions of RH 1.4 through 1.9, 3.15, 3.22, 3.23 and Part 17 of these regulations.

3.6.5 Luminous Safety Devices for Aircraft.

3.6.5.1 A general license is hereby issued to receive, acquire, possess, and use tritium or promethium- 147 contained in luminous safety devices for use in aircraft, provided: 3.6.5.1.1 each device contains not more than 370 GBq (10 Ci) of tritium or 11.1 GBq (300 mCi) of promethium-147; and 3.6.5.1.2 each device has been manufactured, assembled or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR Part 32.

3.6.5.2 Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in RH 3.6.5.1 are exempt from the requirements of Parts 4 and 10 of these regulations except that they shall comply with the provisions of RH 4.51 and 4.52. 3.6.5.3 This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147.

3.6.5.4 This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

3.6.5.5 This general license is subject to the provisions of RH 1.4 through 1.9, 3.15, 3.22, 3.23, and Part 17 of these regulations.

3.6.6 Ownership of Radioactive Material.

A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this part, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material. 3.6.7 Calibration and Reference Sources.

3.6.7.1 A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of RH 3.6.7.4 and RH 3.6.7.5, americium-241 in the form of calibration or reference sources: 3.6.7.1.1 any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material; and 3.6.7.1.2 any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear material.

3.6.7.2 A general license is hereby issued to receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of RH 3.6.7.4 and RH 3.6.7.5 to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material. 3.6.7.3 A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of RH 3.6.7.4 and RH 3.6.7.5 to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material. 3.6.7.4 The general licenses in RH 3.6.7.1, RH 3.6.7.2, and RH 3.6.7.3 apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Department, any Agreement State or Licensing State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70. 3.6.7.5 The general licenses provided in RH 3.6.7.1, RH 3.6.7.2, and RH 3.6.7.3 are subject to the provisions of RH 1.4 through 1.9, 3.15, 3.22, 3.23 and 3.25, and Parts 4 and 10 of these regulations. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses: 3.6.7.5.1 shall not possess at any one time, at any one location of storage or use, more than 185 kBq (5 µCi) of americium-241, 185 kBq (5 µCi) of plutonium, or 185 kBq (5 µCi) of radium-226 in such sources;

3.6.7.5.2 shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:

3.6.7.5.2.1 The receipt, possession, use and transfer of this source, Model ___, Serial No.__ are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (AMERICIUM-241). (PLUTONIUM)6DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. 6Showing only the name of the appropriate material.

______________________________________ Name of manufacturer or importer 3.6.7.5.2.2 The receipt, possession, use and transfer of this source, Model ___, Serial No.__ are subject to a general license and the regulations of a Licensing State. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

______________________________________ Name of manufacturer or importer 3.6.7.5.3 shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to receive the source; 3.6.7.5.4 shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium- 226 which might otherwise escape during storage; and 3.6.7.5.5 shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

3.6.7.6 These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium or radium-226.

3.6.8 Reserved.

3.6.9 General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory 7 Testing.

7The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.

3.6.9.1 A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of RH 3.6.9.2, RH 3.6.9.3, RH 3.6.9.4, RH 3.6.9.5, and RH 3.6.9.6, the following radioactive materials in prepackaged units for use in in Vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:

3.6.9.1.1 Carbon-14, in units not exceeding 370 kBq (10 µCi) each. 3.6.9.1.2 Cobalt-57, in units not exceeding 370 kBq (10 µCi) each. 3.6.9.1.3 Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 µCi) each. 3.6.9.1.4 Iodine-125, in units not exceeding 370 kBq (10 µCi) each. 3.6.9.1.5 Mock Iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 1.85 Bq (0.005 µCi) of americium-241 each. 3.6.9.1.6 Iodine-131, in units not exceeding 370 kBq (10 µCi) each. 3.6.9.1.7 Iron-59, in units not exceeding 740 kBq (20 µCi) each. 3.6.9.1.8 Selenium-75, in units not exceeding 370 kBq (10 µCi) each. 3.6.9.2 No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by RH 3.6.9.1 until the person has filed Department Form OR-RH-27, “Certificate - In Vitro Testing with Radioactive Material Under General License”, with the Department and received from the Department a validated copy of Department Form OR-RH-27 with certification number assigned. The physician, veterinarian, clinical laboratory or hospital shall furnish on Department Form OR-RH-27 the following information and such other information as may be required by that form:

3.6.9.2.1 Name and address of the physician, veterinarian, clinical laboratory or hospital; 3.6.9.2.2 the location of use; and 3.6.9.2.3 a statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in Vitro clinical or laboratory tests with radioactive material as authorized under the general license in RH 3.6.9.1 and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material. 3.6.9.3 A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by RH 3.6.9.1 shall comply with the following: 3.6.9.3.1 The general licensee shall not possess at any one time, pursuant to the general license in RH 3.6.9.1, at any one location of storage or use, a total amount of iodine-125, iodine- 131, selenium-75, iron-59, and/or cobalt-57 in excess of 7.4 MBq (200 µCi). 3.6.9.3.2 The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection. 3.6.9.3.3 The general licensee shall use the radioactive material only for the uses authorized by RH 3.6.9.1.

3.6.9.3.4 The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Department, the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

3.6.9.3.5 The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in RH 3.6.9.1.5 as required by RH 4.33 of these regulations. 3.6.9.4 The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to RH 3.6.9.1:

3.6.9.4.1 Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to RH 3.12.8 or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under RH 3.6.9 or its equivalent, and 3.6.9.4.2 unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

3.6.9.4.2.1 This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in Vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

______________________________________ Name of manufacturer 3.6.9.4.2.2 This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in Vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

________________________________________ Name of manufacturer 3.6.9.5 The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of RH 3.6.9.1 shall report in writing to the Department, any changes in the information furnished by him in the “Certificate - In Vitro Testing with Radioactive Material Under General License”, Department Form OR-RH-27. The report shall be furnished within 30 days after the effective date of such change.

3.6.9.6 Any person using radioactive material pursuant to the general license of RH 3.6.9.1 is exempt from the requirements of Parts 4 and 10 of these regulations with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in RH 3.6.9.1.5 shall comply with the provisions of RH 4.33, 4.51 and 4.52 of these regulations. 3.6.10 Ice Detection Devices.

3.6.10.1 A general license is hereby issued to receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 1.85 MBq (50 µCi) of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the Department or an Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32. 3.6.10.2 Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in RH 3.6.10.1, 3.6.10.2.1 shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of RH 4.33 of these regulations;

3.6.10.2.2 shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and 3.6.10.2.3 are exempt from the requirements of Parts 4 and 10 of these regulations except that such persons shall comply with the provisions of RH 4.33, 4.51, and 4.52. 3.6.10.3 This general license does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.

3.6.10.4 This general license is subject to the provisions of RH 1.4 through 1.9; 3.15, 3.22, 3.23 and Part 17 of these regulations.

RH 3.7 Reserved.

Specific Licenses RH 3.8 Filing Application for Specific Licenses.

3.8.1 Applications for specific licenses shall be filed in duplicate on a form prescribed by the Department. 3.8.2 The Department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Department to determine whether the application should be granted or denied or whether a license should be modified or revoked. 3.8.3 Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on the applicant's or licensee's behalf.

3.8.4 An application for a license may include a request for a license authorizing one or more activities. 3.8.5 In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Department provided such references are clear and specific.

3.8.6 Applications and documents submitted to the Department may be made available for public inspection except that the Department may withhold any document or part thereof from public inspection pursuant to 24-72-204 C.R.S., 1988.

3.8.7 Pre-licensing Construction 3.8.7.1 An application for a license, or to amend or renew an existing license, for (1) source material milling, (2) commercial waste storage, treatment or disposal by incineration, (3) transfer for disposal of wastes from treatment or incineration, (4) commercial waste disposal by land burial or by underground injection, or the (5) conduct of any other activity within the licensing authority of the Department which the Department determines will significantly affect the radiological quality of the human environment, shall be filed with the Department at least nine (9) months prior to the anticipated commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by the environmental report required by RH 3.8.8 of these regulations, unless an exemption from the requirement of furnishing such a report has been obtained from the Department No construction shall be commenced until the license has been issued. For the purpose of RH 3.8.7 the term “commencement of construction” means any clearing of land, excavation or other substantial action related to a proposed activity for specific licensing that would adversely affect the natural environment of a site; this term does not include changes desirable for the temporary use of the land for public recreational uses, limited borings to determine site characteristics as necessary for environmental assessment of other pre-construction monitoring to establish background information related to the suitability of a site, or to the protection of environmental values. 3.8.8 Environmental Impact Assessment.

3.8.8.1 In the case of an application for a license, or to amend or renew an existing license, for (1) source material milling, (2) commercial waste storage, treatment or disposal by incineration, (3) transfer for disposal of waste from incineration, (4) commercial waste disposal by land burial or by underground injection, or for (5) the conduct of any other activity which will affect the quality of the human environment by reason of exposure to radiation, before “commencement of construction”, as defined in RH 3.8.7.1, of the plant or facility in or at which the activity will be conducted, or in case of a renewal of such a license, the applicant shall submit all information required under these regulations and such other material as the Department may deem necessary. Such information shall include the environmental report and other information required by RH 3.8.8.2 to be submitted to assist the Department in the evaluation of the short-term and long-range environmental impact of the project and activity so that the Department may weigh environmental, economic, technical, and other benefits against environmental costs, while considering available alternatives.

3.8.8.1.1 In the event that an environmental report acceptable to the Department is on file with the Department in regard to the specific licensed activity authorized under an existing license, and upon request of the applicant to amend or renew an existing license or at the initiation of the Department, the Department may grant an exemption of the requirement to submit an additional environmental report or require such amendment of the existing environmental report as will demonstrate the environmental impact to result from the proposed activity. The request for exemption shall provide the Department with such information as the Department requires of the applicant to demonstrate that no significant environmental impact will result from the licensed activity. 3.8.8.2 An environmental report shall be required of the applicant and shall contain all information deemed necessary by the Department as authorized by the Act. Upon receipt of the environmental report or any amendment thereto, and of any other documents required, the Department shall determine the necessity to transmit and, if appropriate, shall transmit the same for review and comment to Federal, State, and local agencies having expertise in and jurisdiction over the proposed project and activity. Written comments and reports of reviewing agencies shall be considered by the Department in its decision-making review process on the license application request. 3.8.8.2.1 If an environmental impact statement (EIS) is required of a Federal agency pursuant to the National Environment Policy Act of 1969 (NEPA) and is provided by such Federal agency, it shall be used by the Department in its decision- making review process on the license application request. 3.8.8.2.2 The Department shall consider applicable regulations of Federal, State, and local regulatory agencies and permit requirements thereof. RH 3.9 General Reguirements for the Issuance of Specific Licenses. A license application will be approved if the Department determines that: 3.9.1 The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these regulations in such a manner as to minimize danger to public health and safety or property;

3.9.2 The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

3.9.3 The issuance of the license will not be inimical to the health and safety of the public; 3.9.4 The applicant satisfies any applicable special requirements in RH 3.10, 3.11, 3.12, or 3.13; and 3.9.5 The applicant has established Department-approved financial assurance warranties in accordance with the following requirements.

3.9.5.1 A signed executed original copy of each warranty required by this part shall be furnished to and approved by the Department prior to the issuance of a new license, or any amendment or renewal of an existing license.

3.9.5.2 The Department may require any licensee to furnish a decommissioning warranty to ensure decontamination and decommissioning of a facility and disposal of radioactive materials in the event of abandonment, default or inability of the licensee to meet the requirements of the Act, these regulations, or the license. 3.9.5.3 The following specific licensees are required to furnish decommissioning warranties: 3.9.5.3.1 Radioactive waste disposal licensees;

3.9.5.3.2 Commercial radioactive waste handling and/or packaging licensees; 3.9.5.3.3 Source material milling licensees;

3.9.5.3.4 Each licensee authorized to possess and use greater than 370 MBq (10 mCi) of source material in a readily dispersable form; and 3.9.5.3.5 Each licensee authorized to possess and use radioactive material with a half life greater than 120 days, in quantities:

3.9.5.3.5.1 Greater than 103 times the applicable quantity of Schedule B of part 3 in unsealed form. For a combination of isotopes if R divided by 103 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Schedule B.

3.9.5.3.5.2 Greater than 1010 times the applicable quantity of Schedule B of Part 3 in sealed sources or plated foils. For a combination of isotopes if R divided by 1010 is greater than 1 (unity rule), where R is defined in RH 3.9.5.3.5.1.

3.9.5.3.5.3 For the purpose of determining if the quantity of licensed radioactive material requires a decommissioning warranty or a decommissioning funding plan as defined in RH 3.9.6, a value of 370 Bq (0.01 µCi) shall be used as the Schedule B quantity for any alpha emitting radionuclide not listed in Schedule B of Part 3, or mixtures of alpha emitters of unknown composition.

3.9.5.4 Financial assurance warranties shall contain provisions which are acceptable to the Department for: (a) defining the amount and term of the warranty, (b) providing written notification to the Department by the warrantor at least ninety (90) days prior to cancellation, termination, or revocation of the warranty, and © converting the warranty into cash upon forfeiture of the warranty, and shall be in a form as described below: 3.9.5.4.1 A bond issued by a fidelity or surety company consistent with the provisions of Section 25-11-110(6)(b)(l) CRS 1997, as amended;

3.9.5.4.2 An irrevocable “letter of credit” or “line of credit” issued by a recognized financial institution whose financial condition and commitment are established to the satisfaction of the Department;

3.9.5.4.3 A cash deposit, certificate of deposit, or deposit of government securities posted by the licensee;

3.9.5.4.4 For a decommissioning warranty, a guarantee of funds by the applicant, licensee, or parent company which satisfies the requirements listed below. However, this self guarantee shall not apply to uranium or thorium milling licensees.

3.9.5.4.4.1 The Department may accept a parent company guarantee of funds for decommissioning costs based upon a financial test of the parent company and a written guarantee as contained in Appendix A of Part 3. 3.9.5.4.4.2 The Department may accept an applicant or licensee guarantee of funds for decommissioning costs based upon a financial test of the applicant or licensee and a written guarantee as contained in Appendix B of Part 3.

3.9.5.4.4.3 A guarantee by the applicant, licensee, or parent company may not be used in combination with other financial methods to satisfy the requirements of this section. A guarantee by the applicant or licensee may not be used in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

3.9.5.4.5 Financial assurance warranties previously provided to any State, Federal and/or local governing bodies concerning activities subject to license under these regulations, where the amount, terms, and conditions of such financial assurance warranties have been established to the satisfaction of the Department and in accordance with the requirements of RH 3.9.5.

3.9.5.4.6 Except for the guarantee of funds noted in RH 3.9.5.4.4, combinations of the above may be used to establish an acceptable financial assurance warranty. 3.9.5.4.7 The term of the financial assurance warranty shall be open-ended or shall have provisions for automatic renewal until termination of the license by the Department, unless it can be demonstrated that another arrangement would provide an equivalent level of assurance.

3.9.5.4.8 The value of the financial assurance warranty must not be dependent upon the success, profitability, or continued operation of the licensed business or operation.

3.9.5.5 The amount of funds to be provided by such decommissioning warranties shall be based on Department-approved cost estimates for (1) the disposal of radioactive materials, (2) decontamination and decommissioning of buildings, facilities and the site to levels which would allow unrestricted use of these areas upon decommissioning, and (3) for the reclamation of tailings and/or waste disposal areas in accordance with technical criteria delineated in Parts 3, 14, and/or 18 as appropriate.

3.9.5.5.1 Cost estimates used to determine the amount of a decommissioning warranty shall take into account total costs that would be incurred if an independent contractor were hired to dispose of radioactive materials and perform decontamination, decommissioning, and reclamation work. The cost estimates shall include reasonable administrative costs, including indirect costs, incurred by the Department in conducting or overseeing the decontamination, decommissioning, and disposal activities, and to cover the Department's reasonable attorney costs that may be incurred in successfully revoking, foreclosing, or realizing the decommissioning warranties established by the licensee in accordance with Part 3.

3.9.5.6 The licensee shall provide in writing to the Department, no later than June 30th of each calendar year, any licensee-proposed changes to the financial assurance warranties, including updated decommissioning funding plans, cost estimates, or the type of warranty.

3.9.5.7 Each licensee's financial assurance warranties will be reviewed annually by the Department to assure the continued adequacy of each warranty. 3.9.5.8 The Department will determine if the licensee must adjust the amount of the warranty to account for increases or decreases in cost estimates resulting from inflation or deflation; changes in engineering plans, activities performed, authorized quantities of radioactive material; or changes in any other conditions affecting disposal, decontamination, and decommissioning costs. With the approval of the Department, a licensee may reduce the amount of a decommissioning warranty as decommissioning activities are completed in accordance with an approved decommissioning plan and/or to reflect current site conditions and license authorizations.

3.9.5.9 Regardless of whether the disposal, decontamination and decommissioning work is phased through the life of the licensed operations or takes place at the end of the operation, an appropriate and adequate decommissioning warranty shall be maintained in good standing by the licensee until termination of the license or as otherwise authorized by the Department.

3.9.5.10 In addition to the decommissioning warranty required by RH 3.9.5.2, the Department may require any licensee to provide a long-term care warranty if the licensed facility will remain a disposal site for radioactive materials subsequent to the termination of the license, or the license will be terminated using criteria in RH 4.61.3 or 4.61.4. 3.9.5.10.1 Except as provided in RH 3.9.5.10.2, the following specific licensees are required to provide long-term care warranties:

3.9.5.10.1.1 Radioactive waste disposal licensees;

3.9.5.10.1.2 Commercial radioactive waste handling and/or packaging licensees; 3.9.5.10.1.3 Source material milling licensees; and 3.9.5.10.1.4 Formerly U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission-licensed facilities;

3.9.5.10.2 A long-term care warranty is not required for a licensee identified in RH 3.9.5.10.1 if the disposition of radioactive materials by the licensee is made in such a manner as the Department determines does not require long-term monitoring and maintenance of the site.

3.9.5.10.3 The long-term care warranty shall be in a form as described in RH 3.9.5.4. 3.9.5.10.4 The amount of funds to be provided by such long-term care warranties shall be based on Department-approved cost estimates and shall be enough that with an assumed six percent annual real interest rate, the annual interest earnings will be sufficient to cover to the annual costs of site surveillance by the Department, including reasonable administrative costs incurred by the Department, in perpetuity, subsequent to the termination of the license. 3.9.5.10.4.1 For each source material mill licensee, the long-term care warranty must have a minimum value equivalent to $250,000 in 1978 dollars. The value of the long-term care warranty shall be adjusted annually to recognize inflation. The inflation rate to be used for this adjustment is that indicated by the change in the consumer price index published by the U.S. Department of Labor, Bureau of Labor Statistics. The Department may use other indicators of the inflation rate if reasonable; provided, however, that the license shall not terminate unless the amount of the long-term care warranty is acceptable to the licensing agency and site caretaker.

3.9.5.10.4.2 Cost estimates for facilities and sites requiring long-term care subsequent to license termination are to be based on the final disposition of wastes such that ongoing active maintenance is not necessary to preserve isolation. It is expected that, as a minimum, annual site inspections shall be conducted to confirm the integrity of the stabilized waste systems and to determine the need, if any, for maintenance and/or monitoring. Cost estimates shall be adjusted if more frequent site inspections are required based on an evaluation of a particular site. 3.9.5.10.4.3 For sites decommissioned in accordance with the provisions of RH 4.61.3 or 4.61.4, cost estimates for long-term care subsequent to license termination must be sufficient to enable the Department, a responsible government agency, or an independent third party to: (1) perform periodic site inspections no less frequently than each five years, (2) assure the continuation of institutional controls, and (3) assume responsibilities and carry out any necessary control and maintenance of the site. Cost estimates shall be adjusted if more frequent site inspections are required based on an evaluation of a particular site and the institutional controls established for that site.

3.9.5.10.5 Whenever the Department determines that a licensee's disposal, decommissioning and decontamination requirements have been satisfied, provisions shall be made for transferring custody of the site and the long-term care warranty funds for that license in accordance with the act. If the value of the long-term care warranty funds exceeds the amount required by the government agency overseeing the long-term care of the site, then all such excess amounts shall be returned to the licensee.

3.9.6 Licensees authorized to possess and use unsealed radioactive materials with half-life greater than 120 days and in quantities greater than 105 times the applicable quantity of Schedule B of Part 3, shall establish a Department-approved decommissioning funding plan to assure the availability of funds for decommissioning activities conducted over the life of the licensed facility. This plan shall contain a cost estimate for decommissioning, as required in this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. The decommissioning funding plan must also include a certification by the licensee that funding for decommissioning activities has been provided for in the amount of the cost estimate for decommissioning. A decommissioning funding plan is also required for licensees authorized a combination of isotopes if R divided by 105 is greater than 1 (unity rule), where R is defined RH 3.9.5.3.5.1.

3.9.7 In the case of an application for a license for (1) source material milling, (2) commercial waste storage, treatment or disposal by incineration, (3) transfer for disposal of waste from incineration, (4) commercial waste disposal by land burial or by underground injection, or for (5) the conduct of any other activity which the Department determines will significantly affect the quality of the human environment, the Department has concluded that the action called for is the issuance of the proposed license with any appropriate conditions to protect environmental values. Such determination shall be made before commencement of construction of the plant or facility in which the activity will be conducted and based on information filed and evaluation made pursuant to RH 3.8.8.

3.9.8 Commencement of construction prior to the issuance of a license, or of an amendment or renewal thereof, or of an exemption under the requirements of RH 3.8.7, may be grounds for denial of such license, amendment or renewal; and 3.9.9 The applicant shall satisfy any applicable special requirements of RH 3.10, 3.11, and 3.12. 3.9.10 License Hearings.

3.9.10.1 There shall be an opportunity for public hearings to be held in the following circumstances in accordance with the procedures in 24-4-104 and -105, C.R.S. and this paragraph:

3.9.10.1.1 prior to the licensing or leasing of state-owned property for the concentration, storage or permanent disposal of radioactive materials. 3.9.11 Emergency Plans 3.9.11.1 Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in Schedule E of Part 3 - “Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release”, must contain either: 3.9.11.1.1 An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 Sv (1 rem) effective dose equivalent or 0.05 Sv (5 rems) to the thyroid; or 3.9.11.1.2 An emergency plan for responding to a release of radioactive material. 3.9.11.2 One or more of the following factors may be used to support an evaluation submitted under RH 3.9.11.1.1 of this section:

3.9.11.2.1 The radioactive material is physically separated so that only a portion could be involved in an accident;

3.9.11.2.2 All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

3.9.11.2.3 The release fraction in the respirable size range would be lower than the release fraction shown in Schedule E of Part 3 due to the chemical or physical form of the material;

3.9.11.2.4 The solubility of the radioactive material would reduce the dose received; 3.9.11.2.5 Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Schedule E of Part 3. 3.9.11.2.6 Operating restrictions or procedures would prevent a release fraction as large as that shown in Schedule E of Part 3; or 3.9.11.2.7 Other factors appropriate for the specific facility. 3.9.11.3 An emergency plan for responding to a release of radioactive material submitted under RH 3.9.11.1.2 of this section must include the following information: 3.9.11.3.1 Facility description. A brief description of the licensee's facility and area near the site.

3.9.11.3.2 Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.

3.9.11.3.3 Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

3.9.11.3.4 Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

3.9.11.3.5 Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

3.9.11.3.6 Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

3.9.11.3.7 Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department; also responsibilities for developing, maintaining, and updating the plan.

3.9.11.3.8 Notification and coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

3.9.11.3.9 Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the Department. 3.9.11.3.10 Training. A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

3.9.11.3.11 Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

3.9.11.3.12 Exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

3.9.11.3.13 Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-To-Know Act of 1986, Title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.

3.9.11.4 The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Department. The licensee shall provide any comments received within 60 days to the Department with the emergency plan.

RH 3.10 Additional Reguirements for Issuance of Certain Specific Licenses for Radioactive Material.

3.10.1 Use of Unsealed Radioactive Materials.

In addition to the requirements set forth in RH 3.9, applicants for licenses authorizing the possession and use of unsealed radioactive materials shall include in the application a description of the facility and procedures for operation which (1) minimize to the extent practicable, contamination of the facility and environment, and the generation of radioactive waste; and (2) facilitate eventual decommissioning. 3.10.2 Reserved.

3.10.3 Reserved.

3.10.4 Reserved.

3.10.5 Reserved.

3.10.6 Reserved.

RH 3.11 Special Requirements for Specific Licenses of Broad Scope. This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of such licenses.8 8Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.11.1 The different types of broad scope licenses are set forth below: 3.11.1.1 A “Type A specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

3.11.1.2 A “Type B specific license of broad scope” is a specific license authorizing receipt, acquisition, possession, use and transfer of any chemical or physical form of radioactive material specified in Schedule D of this part, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule D, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3.11.1.3 A “Type C specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in Schedule D of this part, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule D, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3.11.2 An application for a Type A specific license of broad scope will be approved if: 3.11.2.1 the applicant satisfies the general requirements specified in RH 3.9; 3.11.2.2 the applicant has engaged in a reasonable number of activities involving the use of radioactive material; and 3.11.2.3 the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

3.11.2.3.1 the establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material; 3.11.2.3.2 the appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and 3.11.2.3.3 the establishment of appropriate administrative procedures to assure: 3.11.2.3.3.1 control of procurement and use of radioactive material; 3.11.2.3.3.2 completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, the operating or handling procedures; and 3.11.2.3.3.3 review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with RH 3.11.2.3.3.2 prior to use of the radioactive material.

3.11.3 An application for a Type B specific license of broad scope will be approved if: 3.11.3.1 the applicant satisfies the general requirements specified in RH 3.9; and 3.11.3.2 the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

3.11.3.2.1 the appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and 3.11.3.2.2 the establishment of appropriate administrative procedures to assure, 3.11.3.2.2.1 control of procurement and use of radioactive material, 3.11.3.2.2.2 completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures, and 3.11.3.2.2.3 review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with RH 3.11.3.2.2.2 prior to use of the radioactive material.

3.11.4 An application for a Type C specific license of broad scope will be approved if: 3.11.4.1 the applicant satisfies the general requirements specified in RH 3.9; 3.11.4.2 the applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received: 3.11.4.2.1 a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and 3.11.4.2.2 at least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and 3.11.4.3 the applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations. 3.11.5 Specific licenses of broad scope are subject to the following conditions: 3.11.5.1 Unless specifically authorized, persons licensed pursuant to RH 3.11 shall not: 3.11.5.1.1 conduct tracer studies in the environment involving direct release of radioactive material;

3.11.5.1.2 receive, acquire, own, possess, use; or transfer devices containing 3.7 PBq (100 kCi) or more of radioactive material in sealed sources used for irradiation of materials;

3.11.5.1.3 conduct activities for which a specific license issued by the Department under RH 3.10, RH 3.12, or Parts 7, 14, and 18 of these regulations is required; or 3.11.5.1.4 add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

3.11.5.2 Each Type A specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

3.11.5.3 Each Type B specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

3.11.5.4 Each Type C specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of RH 3.11.4. RH 3.12 Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material. 3.12.1 Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations. 3.12.1.1 In addition to the requirements set forth in RH 3.9, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under RH 3.3.1.1 will be issued if:

3.12.1.1.1 the applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer, and 3.12.1.1.2 the applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Schedule A of this part, that reconcentration of the radioactive material in concentrations exceeding those in Schedule A is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being. 3.12.1.2 Each person licensed under RH 3.12.1 shall file an annual report with the Department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to RH 3.12.1 during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter. 3.12.2 Licensing the Distribution of Radioactive Material in Exempt Quantities.8 8Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

3.12.2.1 An application for a specific license to distribute NARM to persons exempted from these regulations pursuant to RH 3.3.2 will be approved if:

3.12.2.1.1 the radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

3.12.2.1.2 the radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and 3.12.2.1.3 the applicant submits copies of prototype labels and brochures and the Department approves such labels and brochures.

3.12.2.2 The license issued under RH 3.12.2.1 is subject to the following conditions: 3.12.2.2.1 No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

3.12.2.2.2 Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to RH 3.3.2. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 uSv) per hour.

3.12.2.2.3 The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which: 3.12.2.2.3.1 identifies the radionuclide and the quantity of radioactivity, and 3.12.2.2.3.2 bears the words “Radioactive Material”.

3.12.2.2.4 In addition to the labeling information required by RH 3.12.2.2.3, the label affixed to the immediate container, or an accompanying brochure, shall: 3.12.2.2.4.1 state that the contents are exempt from Licensing State requirements, 3.12.2.2.4.2 bear the words “Radioactive Material-Not for Human Use- Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited- Exempt Quantities Should Not Be Combined”, and 3.12.2.2.4.3 set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

3.12.2.3 Each person licensed under RH 3.12.2 shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under RH 3.3.2 or the equivalent regulations of a Licensing State, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Department. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to RH 3.12.2 during the reporting period, the report shall so indicate. 3.12.3 Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under RH 3.3.3.3 will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32. The maximum quantity of radium-226 in each device shall not exceed 3.7 kBq (0.1 µCi).

3.12.4 Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under RH 3.6.4.

3.12.4.1 An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under RH 3.6.4 or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State will be approved if: 3.12.4.1.1 the applicant satisfies the general requirements of RH 3.9; 3.12.4.1.2 the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: 3.12.4.1.2.1 the device can be safely operated by persons not having training in radiological protection, 3.12.4.1.2.2 under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of 1 calender quarter a dose in excess of 10 percent of the limits specified in RH 4.6.1, and 3.12.4.1.2.3 under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

Whole body; head and 150 mSv (15 rem)

trunk; active blood- forming organs; gonads;

or lens of eye Hands and forearms; feet 2 Sv (200 rem)

and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter Other organs 500 mSv (50 rem); and 3.12.4.1.3 each device bears a durable, legible, clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement: 3.12.4.1.3.1 instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information, 3.12.4.1.3.2 the requirement, or lack of requirement, for leak testing, or for testing any “on-off” mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and 3.12.4.1.3.3 the information called for in one of the following statements, as appropriate, in the same or substantially similar form: 3.12.4.1.3.3.1 The receipt, possession, use, and transfer of this device, Model ___, Serial No. ___,9 are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

9The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

CAUTION - RADIOACTIVE MATERIAL ________________________________ Name of manufacturer or distributor 3.12.4.1.3.3.2 The receipt, possession, use, and transfer of this device, Model___, Serial No. ___,9 are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

9The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

CAUTION - RADIOACTIVE MATERIAL ________________________________ Name of manufacturer or distributor 3.12.4.2 In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the “on-off” mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the “on-off” mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider information which includes, but is not limited to: 3.12.4.2.1 primary containment or source capsule;

3.12.4.2.2 protection of primary containment;

3.12.4.2.3 method of sealing containment;

3.12.4.2.4 containment construction materials;

3.12.4.2.5 form of contained radioactive material;

3.12.4.2.6 maximum temperature withstood during prototype tests; 3.12.4.2.7 maximum pressure withstood during prototype tests; 3.12.4.2.8 maximum quantity of contained radioactive material; 3.12.4.2.9 radiotoxicity of contained radioactive material; and 3.12.4.2.10 operating experience with identical devices or similarly designed and constructed devices.

3.12.4.3 In the event the applicant desires that the general licensee under RH 3.6.4, or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the “on- off” mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the limits specified in RH 4.6.1 of these regulations.

3.12.4.4 Each person licensed under RH 3.12.4 to distribute devices to generally licensed persons shall:

3.12.4.4.1 furnish a copy of the general license contained in RH 3.6.4 to each person to whom the licensee directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in RH 3.6.4;

3.12.4.4.2 furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's, Agreement State's, or Licensing State's regulation equivalent to RH 3.6.4, or alternatively, furnish a copy of the general license contained in RH 3.6.4 to each person to whom the licensee directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the Agreement State, or the Licensing State. If a copy of the general license in RH 3.6.4 is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State under requirements substantially the same as those in RH 3.6.4; 3.12.4.4.3 report to the Department all transfers of such devices to persons for use under the general license in RH 3.6.4. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under RH 3.6.4 during the reporting period, the report shall so indicate. The report shall cover each calender quarter and shall be filed within 30 days thereafter, 3.12.4.4.4 furnish reports to other agencies.

3.12.4.4.4.1 Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31. 3.12.4.4.4.2 Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to RH 3.12.4 for use under a general license in that State's regulations equivalent to RH 3.6.4. 3.12.4.4.4.3 Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

3.12.4.4.4.4 If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission.

3.12.4.4.4.5 If no transfers have been made to general licensees within a particular State during the reporting period, this information shall be reported to the responsible State agency upon request of that agency; and 3.12.4.4.5 Keep records showing the name, address, and the point of contact for each general licensee to whom the transferor directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in RH 3.6.4, or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of RH 3.12.4.4. 3.12.5 Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under RH 3.6.5 will be approved if:

3.12.5.1 the applicant satisfies the general requirements specified in RH 3.9; and 3.12.5.2 the applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32, or their equivalent.

3.12.6 Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Licensed Under RH 3.6.7. An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under RH 3.6.7 will be approved if:

3.12.6.1 the applicant satisfies the general requirement of RH 3.9; and 3.12.6.2 the applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent. 3.12.7 Reserved.

3.12.8 Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of RH 3.6.9 will be approved if: 3.12.8.1 the applicant satisfies the general requirements specified in RH 3.9. 3.12.8.2 the radioactive material is to be prepared for distribution in prepackaged units of: 3.12.8.2.1 carbon-14 in units not exceeding 370 kBq (10 µCi) each. 3.12.8.2.2 cobalt-57 in units not exceeding 370 kBq (10 µCi) each. 3.12.8.2.3 hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 µCi) each. 3.12.8.2.4 iodine-125 in units not exceeding 370 kBq (10 µCi) each. 3.12.8.2.5 Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 185 Bq (0.05 µCi) of americium-241 each.

3.12.8.2.6 iodine-131 in units not exceeding 370 kBq (10 µCi) each. 3.12.8.2.7 iron-59 in units not exceeding 740 kBq (20 µCi) each. 3.12.8.2.8 selenium-75 in units not exceeding 370 kBq (10 µCi) each. 3.12.8.3 each prepackaged unit bears a durable, clearly visible label: 3.12.8.3.1 identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kBq (10 µCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 µCi) of hydrogen-3 (tritium); 740 kBq (20 µCi) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 µCi) of iodine-129 and 185 Bq (0.005 µCi) of americium-241 each; and 3.12.8.3.2 displaying the radiation caution symbol described in RH 4.27.1 and the words, “CAUTION, RADIOACTIVE MATERIAL”, and “Not for Internal or External Use in Humans or Animals”.

3.12.8.4 one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

3.12.8.4.1 This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

___________________________________ Name of manufacturer 3.12.8.4.2 This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a Licensing State.

___________________________________ Name of manufacturer 3.12.8.5 the label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in RH 4.33 of these regulations.

3.12.9 Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under RH 3.6.10 will be approved if:

3.12.9.1 the applicant satisfies the general requirements of RH 3.9; and 3.12.9.2 the criteria of Sections 32.61, 32.62, and 32.103 of 10 CFR Part 32 are met. 3.12.10 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs for Medical Use.

3.12.10.1 An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs for medical use will be approved if: 3.12.10.1.1 the applicant satisfies the general requirements specified in RH 3.9 of this part;

3.12.10.1.2 the applicant submits evidence that the applicant is at least one of the following:

3.12.10.1.2.1 registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;

3.12.10.1.2.2 registered or licensed with the State Board of Pharmacy as a drug manufacturer;

3.12.10.1.2.3 licensed as a pharmacy by the State Board of Pharmacy; 3.12.10.1.3 the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radioactive drugs by medical use licensees; and 3.12.10.1.4 the applicant has procedures to assure the following labeling requirements: 3.12.10.1.4.1 a label shall be affixed to each transport radiation shield (whether it is constructed of lead, glass, plastic, or other material) of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.

3.12.10.1.4.2 A label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL” and an identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label.

3.12.10.2 A radioactive materials licensee who is also licensed by the State Board of Pharmacy: 3.12.10.2.1 May prepare radioactive drugs for medical use, as defined in RH 1.4, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in RH 3.12.10.2.2 of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in RH 7.10; 3.12.10.2.2 May allow a pharmacist to work as an authorized nuclear pharmacist if: 3.12.10.2.2.1 This individual qualifies as an authorized nuclear pharmacist as defined in RH 1.4;

3.12.10.2.2.2 This individual meets the requirements specified in RH 7.74, 7.76, and 7.78 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or 3.12.10.2.2.3 This individual is identified on July 1, 1998 as an “authorized user” on a nuclear pharmacy license issued by the Department under this part, or by the NRC, an Agreement State or a Licensing State under regulations similar to this part.

3.12.10.2.3 Shall, within 30 days after the date the licensee allows an individual to work as an authorized nuclear pharmacist pursuant to RH 3.12.10.2.2.1 and RH 3.12.10.2.2.3 provide to the Department:

3.12.10.2.3.1 A copy of each individual's certification by the Board of Pharmaceutical Specialties; or 3.12.10.2.3.2 The Department, the NRC or Agreement State license, or the permit issued by a licensee of broad scope; and 3.12.10.2.3.3 A copy of the State Pharmacy licensure or registration. 3.12.10.3 A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta- or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

3.12.10.3.1 Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and 3.12.10.3.2 Check each instrument for constancy and proper operation at the beginning of each day of use.

3.12.10.4 Nothing in this section relieves the licensee from complying with applicable FDA, Federal, and state requirements governing radioactive drugs. 3.12.12 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part 7 for use as a calibration or reference source or for the uses listed in RH 7.40 and RH 7.42 of these regulations will be approved if:

3.12.12.1 the applicant satisfies the general requirements in RH 3.9 of this part; 3.12.12.2 the applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: 3.12.12.2.1 the radioactive material contained, its chemical and physical form, and amount, 3.12.12.2.2 details of design and construction of the source or device, 3.12.12.2.3 procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents, 3.12.12.2.4 for devices containing radioactive material, the radiation profile of a prototype device, 3.12.12.2.5 details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests, 3.12.12.2.6 procedures and standards for calibrating sources and devices, 3.12.12.2.7 legend and methods for labeling sources and devices as to their radioactive content, and 3.12.12.2.8 instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

3.12.12.3 the label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the Department for distribution to persons licensed pursuant to RH 7.40 and RH 7.42 of these regulations or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, provided that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source; 3.12.12.4 in the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and 3.12.12.5 in determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to: 3.12.12.5.1 primary containment or source capsule, 3.12.12.5.2 protection of primary containment, 3.12.12.5.3 method of sealing containment, 3.12.12.5.4 containment construction materials, 3.12.12.5.5 form of contained radioactive material, 3.12.12.5.6 maximum temperature withstood during prototype tests, 3.12.12.5.7 maximum pressure withstood during prototype tests, 3.12.12.5.8 maximum quantity of contained radioactive material, 3.12.12.5.9 radiotoxicity of contained radioactive material, and 3.12.12.5.10 operating experience with identical sources or devices or similarly designed and constructed sources or devices.

3.12.13 Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications.

3.12.13.1 An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to RH 3.5.5 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if: 3.12.13.1.1 the applicant satisfies the general requirements specified in RH 3.9; 3.12.13.1.2 the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of 1 calender quarter a radiation dose in excess of 10 percent of the limits specified in RH 4.6.1 of these regulations; and 3.12.13.1.3 the applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device. 3.12.13.2 In the case of an industrial product or device whose unique benefits are questionable, the Department will approve an application for a specific license under RH 3.12.13 only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

3.12.13.3 The Department may deny any application for a specific license under RH 3.12.13 if the end use(s) of the industrial product or device cannot be reasonably foreseen. 3.12.13.4 Each person licensed pursuant to RH 3.12.13.1 shall: 3.12.13.4.1 maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

3.12.13.4.2 label or mark each unit to:

3.12.13.4.2.1 identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and 3.12.13.4.2.2 state that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State;

3.12.13.4.3 assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: “Depleted Uranium”;

3.12.13.4.4.1 furnish a copy of the general license contained in RH 3.5.5 and a copy of Department Form OR-RH-52 to each person to whom the specific licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in RH 3.5.5, or 3.12.13.4.4.2 furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to RH 3.5.5 and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in RH 3.5.5 and a copy of Department Form OR-RH-52 to each person to whom the specific licensee transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in RH 3.5.5; 3.12.13.4.5 report to the Department all transfers of industrial products or devices to persons for use under the general license in RH 3.5.5. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under RH 3.5.5 during the reporting period, the report shall so indicate;

3.12.13.4.6.1 report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 40.25 of 10 CFR Part 40, 3.12.13.4.6.2 report to the responsible State agency all transfers of devices manufactured and distributed pursuant to RH 3.12.13 for use under a general license in that State's regulations equivalent to RH 3.5.5, 3.12.13.4.6.3 such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person, 3.12.13.4.6.4 if no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission, and 3.12.13.4.6.5 if no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon the request of that agency; and 3.12.13.4.7 keep records showing the name, address, and point of contact for each general licensee to whom the specific licensee transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in RH 3.5.5 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.

RH 3.12.14 Registration of Product Information.

3.12.14.1 Any manufacturer or initial distributor of a sealed source, or of a device containing a sealed source, whose product is intended for use under a specific license may submit a request to the Department for evaluation of radiation safety information about the product and for the product registration.

3.12.14.2 The request for review must be made in duplicate and sent to the Director, Laboratory and Radiation Services Division, Colorado Department of Public Health and Environment, 8100 Lowry Boulevard, Denver, Colorado 80220-6928.

3.12.14.3 The request for review of a sealed source or device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

3.12.14.4 The Department normally evaluates a sealed source or device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Department formulates reasonable standards and criteria with the help of the manufacturer or distributor. The Department shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. 3.12.14.5 After completion of the evaluation, the Department issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for specific license proposing use of the product.

3.12.14.6 The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with: 3.12.14.6.1 The statements and representations, including quality control program, contained in the request; and 3.12.14.6.2 The provisions of the certificate of registration. RH 3.13 Third Party Method.

If the applicant consents, the Department may enter into third party agreements for the applicant to engage and pay for the services of a third party contractor to prepare the environmental impact analysis required under RH 18.4 and/or to furnish an opinion of independent experts, satisfactory to the Department, in respect to the completeness and adequacy of any information or data furnished by the applicant and on any aspect of the applicant's project or effects thereof. 3.13.1 When the license applicant pays for a third party agreement, the monies paid for the consultant shall not be charged as part of the fees required under Part 12 of these regulations. 3.13.2 In proceeding under the third party agreement, the Department shall carry out the following practices:

3.13.2.1 Such contractor shall be chosen solely by the Department. 3.13.2.2 The Department shall manage the contract.

3.13.2.3 The consultant shall be selected based on the consultant's ability relevant and applicable work experience and an absence of conflict of interest. Third party contractors will be required to execute a disclosure statement signifying they have no financial or other conflicting interest in the outcome of the project. 3.13.2.4 The Department shall specify the information to be developed and supervise the gathering, analysis and presentation of the information. The Department shall have sole authority for approval and modification of the statement, analysis, and conclusions included in third party's report.

RH 3.14 Issuance of Specific Licenses.

3.14.1 Upon a determination that an application meets the requirements of the Act and the regulations of the Department, the Department will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. 3.14.2 The Department may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this part as it deems appropriate or necessary in order to:

3.14.2.1 minimize danger to public health and safety or property; 3.14.2.2 require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and 3.14.2.3 prevent loss or theft of material subject to this part. 3.14.3 Whenever the Department denies an application for a new license or a license renewal, the Department will notify the applicant in writing stating the grounds for denial. Upon denial, the applicant may request a hearing pursuant to sections 24-4-104 and 24-4-105, C.R.S. RH 3.15 Specific Terms and Conditions of License.

3.15.1 Each license issued pursuant to this part shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the Department. 3.15.2 No license issued or granted under this part and no right to possess or utilize radioactive material granted by any license issued pursuant to this part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the Department shall, after securing full information find that the transfer is in accordance with the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations, and orders of the Department, and shall give its consent in writing. 3.15.3 Each person licensed by the Department pursuant to this part shall confine use and possession of the material licensed to the locations and purposes authorized in the license. 3.15.4 Notice and Disposition of Records Prior to License Termination. Each licensee shall notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. 3.15.4.1 Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Department.

3.15.4.1.1 Records of disposal of licensed material made under RH 4.34, 4.35, 4.36, 4.37; and 3.15.4.1.2 Records required by RH 4.42.

3.15.4.2 If licensed activities are transferred or assigned in accordance with RH 3.15.2, each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the records required in RH 3.15.4.1 to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated.

3.15.4.3 Prior to license termination, each licensee shall forward the records required by RH 3.16.6.8 to the Department.

3.15.5 Each licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

3.15.5.1 the licensee;

3.15.5.2 an entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or 3.15.5.3 an affiliate (as that term is defined in 11 U.S.C. 101 (2)) of the licensee. 3.15.6 The notification specified in RH 3.15.5 shall include the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition. RH 3.16 Expiration, Decommissioning and Termination of Licenses. 3.16.1 Definition:

As used in this regulation, “principal activities” means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities. 3.16.2 Expiration.

3.16.2.1 Except as provided in RH 3.17.2, each specific license shall expire at the end of the specified day in the month and year stated therein.

3.16.2.2 Each specific license revoked by the Department expires at the end of the day on the date of final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by order.

3.16.2.3 With respect to possession of radioactive materials and residual radioactive contamination, each specific license continues in effect beyond the expiration date until the Department notifies the licensee in writing that the license is terminated. 3.16.2.4 No less than 30 days before the expiration date specified in the license, the licensee shall either:

3.16.2.4.1 Submit an application for license renewal under RH 3.17; or 3.16.2.4.2 Notify the Department, in writing, that the licensee has decided not to renew the license.

3.16.2.5 If a licensee does not submit an application for license renewal under RH 3.17, the licensee shall, on or before the expiration date specified in the license: 3.16.2.5.1 Terminate use of radioactive material;

3.16.2.5.2 Reduce residual radioactive contamination to levels which are as low as reasonably achievable (ALARA);

3.16.2.5.3 Transfer radioactive materials to an authorized recipient and/or properly dispose of radioactive material; and 3.16.2.5.4 Submit a completed Department form AOR-RH-23 or equivalent information requesting license termination, including survey results, leak tests, disposal records, and/or other documentation which demonstrates acceptable conditions for license termination as specified in RH 3.16.6.

3.16.2.6 Each licensee who possesses radioactive material, including residual radioactive material attributable to licensed activities, following the expiration date specified in the license shall:

3.16.2.6.1 Limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and 3.16.2.6.2 Continue to control entry to restricted areas until they are suitable for release for unrestricted use or the Department notifies the licensee in writing that the license is terminated.

3.16.3 Timely Decommissioning.

3.16.3.1 Each licensee shall notify the Department immediately, in writing, when the licensee decides to terminate all activities involving radioactive material authorized under the license.

3.16.3.2 The licensee shall notify the division in writing within 60 days of the occurrence of any of the following:

3.16.3.2.1 The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for unrestricted use in accordance with of these regulations; or 3.16.3.2.2 No principal activities under the license have been conducted for a period of 24 months; or 3.16.3.2.3 No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for unrestricted use in accordance with these regulations.

3.16.3.3 Concurrent with the notification of the Department required in RH 3.16.3.1 and 3.16.3.2, the licensee shall either begin decommissioning activities; or within 12 months of notification: submit a decommissioning plan if required by RH 3.16.4, and begin decommissioning upon approval of that plan.

3.16.3.4 Licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning, unless an alternate schedule addressing the factors in RH 3.16.4.4 is requested and approved by the Department.

3.16.3.5 When decommissioning involves the entire site, the licensee shall request license termination upon completion of decommissioning activities. 3.16.3.6 The Department may approve alternate schedules for the submission of plans and for the completion of decommissioning as required pursuant to RH 3.16.3.3 and 3.16.3.4 if the Department determines that the alternate schedule (1) is necessary to effectively conduct decommissioning, (2) presents no undue risks to public health and safety, and (3) is otherwise in the public interest.

3.16.4 Decommissioning Plan.

3.16.4.1 A licensee must submit a decommissioning plan: if the licensee intends to terminate the license using radiological criteria specified in RH 4.61.3 or 4.61.4 (the exemption of RH 4.61.1.1 applies); if required otherwise by these regulations; if required by license condition; if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Department and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases: 3.16.4.1.1 Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

3.16.4.1.2 Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

3.16.4.1.3 Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or 3.16.4.1.4 Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation. 3.16.4.2 Procedures such as those listed in RH 3.16.4.1 of this section with potential health and safety impacts may not be carried out prior to Department approval of the decommissioning plan.

3.16.4.3 The decommissioning plan for the site or separate building or outdoor area must include:

3.16.4.3.1 A description of the conditions of the site, separate buildings, and/or outdoor areas sufficient to evaluate the acceptability of the plan; 3.16.4.3.2 A description of planned decommissioning activities and a schedule for completion;

3.16.4.3.3 A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning; 3.16.4.3.4 A description of the planned final radiation survey; 3.16.4.3.5 A current detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and 3.16.4.3.6 A description of the intended final condition of the site, separate buildings, and/or outdoor areas upon completion of decommissioning activities. 3.16.4.3.7 Decommissioning plans proposing the use of radiological criteria specified in RH 4.61.3 or 4.61.4, must also include:

3.16.4.3.7.1 An analysis demonstrating that reductions in residual radioactivity necessary to comply with the provisions of RH 4.61.2 would result in net public or environmental harm or were not being made because the residual levels of contamination associated with restricted conditions are ALARA. Determination of dose and residual radioactivity levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

3.16.4.3.7.2 A description of the institutional controls necessary to satisfy the requirements of RH 4.61.3.2, including a description of how the controls will be enforced and an analysis showing that the controls will not impose undue burdens on the local community or other affected parties; 3.16.4.3.7.3 An analysis demonstrating that if institutional controls were no longer in effect then the dose criteria of RH 4.61.3.3 will be met. 3.16.4.3.7.4 A detailed cost estimate for a long-term care warranty, and a plan for establishing a Department approved warranty prior to completion of decommissioning activities;

3.16.4.3.7.5 A description of how the licensee will seek advice from representatives of a broad cross section of community interests who may be affected by the decommissioning and how the licensee will provide participants an opportunity for a comprehensive, collective discussion on key decommissioning issues, including: the adequacy and enforceability of institutional controls, burdens/impacts to local communities and affected parties, and the adequacy of financial assurance; and 3.16.4.3.7.6 A description of how the licensee will make publicly available a summary of the results of all such discussions, including: a description of the individual viewpoints of the participants on the issues, the extent of agreement and disagreement among the participants on the issues, and a description of how key issues in disagreement will be addressed during decommissioning.

3.16.4.4 For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the decommissioning schedule which addresses the following:

3.16.4.4.1 Whether it is technically feasible to complete decommissioning within a 24- month period;

3.16.4.4.2 Whether sufficient waste disposal capacity is available to allow completion of decommissioning with a 24-month period;

3.16.4.4.3 Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay; 3.16.4.4.4 Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and 3.16.4.4.5 Other site-specific factors which the Department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground- water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee. 3.16.4.5 Upon the receipt of a decommissioning plan or proposal by the licensee for release of a site pursuant to RH 4.61.3 or 4.61.4, or whenever the Department deems such notice to be in the public interest, the Department shall:

3.16.4.5.1 Notify and solicit comments from: (1) local and state governments in the vicinity of the site and any Indian nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and (2) the environmental protection agency for cases where the licensee proposes to release a site pursuant to RH 4.61.4.

3.16.4.5.2 Publish a notice in a forum, such as local newspapers, letters to state or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties. 3.16.4.6 The proposed decommissioning plan will be approved by the Department if the information therein demonstrates that the decommissioning will be in accordance with the requirements of RH 3.9.5.10, 3.16, and 4.61 of the regulations (the exemption of RH 4.61.1.1 applies), completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

3.16.5 Decommissioning Record Keeping.

The licensee shall keep records of information important to the decommissioning of a facility in an identified location until authorized by the Department. Before licensed activities are transferred or assigned in accordance with RH 3.15.2, licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information considered important to decommissioning includes: 3.16.5.1 Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms and concentrations.

3.16.5.2 As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document needs to be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations. 3.16.5.3 Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak), radioactive materials having only half-lives of less than 65 days, or areas containing depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every 2 years, of the following:

3.16.5.3.1 All areas designated and formerly designated restricted areas as defined in RH 1.4;

3.16.5.3.2 All areas outside of restricted areas that require documentation under RH 3.16.5.1;

3.16.5.3.3 All areas outside of restricted areas where current and previous wastes have been buried as documented under RH 4.48; and 3.16.5.3.4 All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under RH 4.34. 3.16.5.3.5 A list containing the location and description of all equipment to remain onsite after license termination that was contaminated when final decommissioning was initiated; and 3.16.5.3.6 Any other information not required by RH 3.16.5.3 that is considered necessary to support the adequacy of the decommissioning plan for approval. 3.16.5.4 Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used. 3.16.5.5 For licenses decommissioned in accordance with the requirements of RH 4.61.3 or 4.61.4, the licensee shall maintain documentation of public meetings held to discuss decommissioning activities. This documentation is to include: the dates and locations of the meetings, participants, topics of discussion, a description of the individual viewpoints of the participants on the issues, the extent of agreement and disagreement among the participants on the issues, and a description of how key issues in disagreement were addressed during decommissioning.

3.16.6 Demonstrating Acceptable Conditions for License Termination. 3.16.6.1 The Department will address comments provided by the U.S. Environmental Protection Agency and public comments submitted pursuant to RH 3.16.4.5 prior to the use of the alternate criteria, authorized in RH 4.61.4, to terminate a license. 3.16.6.2 The licensee shall conduct a radiation survey of the licensee's site to confirm the absence of radioactive material and/or to establish levels of residual radioactive contamination, unless the licensee can demonstrate that the site is suitable for release in some other manner. As appropriate, the licensee shall also conduct radiation surveys in any separate building or outdoor area that contains residual radioactivity resulting from the licensee's activities.

3.16.6.3 The licensee shall submit a report of the results of this survey and/or other documentation to the Department which demonstrates compliance with the radiological criteria for license termination specified in Part 4 of the regulations. The licensee shall, as appropriate:

3.16.6.3.1 Report levels of gamma radiation in units of microsievert per hour (µSv/hr or µrem/hr) at one meter from surfaces;

3.16.6.3.2 Report levels of radioactive surface contamination, including alpha and beta emitting radioactive materials, in units of disintegrations per minute per 100 square centimeters (dpm/100cm2 or Bq/100cm2), specifying levels for both removable and fixed contamination;

3.16.6.3.3 Report levels of radioactivity in units of becquerels per liter (Bq/l or pCi/l) for water, and becquerels per gram (Bq/g or pCi/g) for solids such as soils or concrete; and 3.16.6.3.4 Specify the survey instrument(s) and certify that each instrument is properly calibrated and tested.

3.16.7 License Termination.

Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Department determines that:

3.16.7.1 Radioactive materials have been properly disposed; 3.16.7.2 The licensee has demonstrated, by radiation survey results and/or other appropriate methods, that the license termination will be in compliance with these regulations; 3.16.7.3 The licensee has established a Department approved long term care warranty, if required; and 3.16.7.4 Department approved institutional controls have been implemented to limit public doses, if required.

3.16.8 Additional Cleanup.

Except for facilities exempted under RH 4.61.1.1, after a site has been decommissioned and the license terminated in accordance with RH 3.16 and RH 4.61 of these regulations, the Department may reinstate the terminated license or issue a new license and require additional cleanup only if, based on new or previously unknown information, it determines that the criteria of RH 4.61 were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.

RH 3.17 Renewal of Licenses.

3.17.1 Applications for renewal of specific licenses shall be filed in accordance with RH 3.8. 3.17.2 In any case in which a licensee, not less than 30 days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until final action by the Department. RH 3.18 Amendment of Licenses at Reguest of Licensee.

Applications for amendment of a license shall be filed in accordance with RH 3.8 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment. RH 3.19 Agency Action on Applications to Renew and Amend. In considering an application by a licensee to renew or amend the license, the Department will apply the criteria set forth in RH 3.9 and RH 3.10, RH 3.11, RH 3.12, and in Parts 5, 7, 14, 16 and 18 of these regulations, as applicable.

Licenses Held at the Time of the Effective Date of These Regulations RH 3.20 Reserved.

RH 3.21 Reserved.

Transfer of Materials RH 3.22 Transfer of Material.

3.22.1 No licensee shall transfer radioactive material except as authorized pursuant to RH 3.22. 3.22.2 Except as otherwise provided in his license and subject to the provisions of RH 3.22.3 and RH 3.22.4, any licensee may transfer radioactive material: 3.22.2.1 to the Department;11 11A licensee may transfer material to the Department only after receiving prior approval from the Department. 3.22.2.2 to the U.S. Department of Energy;

3.22.2.3 to any person exempt from the regulations in this part to the extent permitted under such exemption;

3.22.2.4 to any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Department, the U.S. Nuclear Regulatory Commission, any Agreement State or any Licensing State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Department, an Agreement State, or a Licensing State; or 3.22.2.5 as otherwise authorized by the Department in writing. 3.22.3 Before transferring radioactive material to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, or to a general licensee who is required to register with the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

3.22.4 Any of the following methods for the verification required by RH 3.22.3 is acceptable: 3.22.4.1 The transferor may possess and read a current copy of the transferee's specific license or registration certificate.

3.22.4.2 The transferor may possess a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date.

3.22.4.3 For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided, that the oral certification is confirmed in writing within 10 days.

3.22.4.4 The transferor may obtain other information compiled by a reporting service from official records of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State regarding the identity of licensees and the scope and expiration dates of licenses and registration.

3.22.4.5 When none of the methods of verification described in RH 3.22.4.1 through RH 3.22.4.4 are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State, or a Licensing State that the transferee is licensed to receive the radioactive material.

3.22.5 Shipment and transport of radioactive material shall be in accordance with the provisions of Part 17 of these regulations.

Modification and Revocation of Licenses RH 3.23 Modification and Revocation of Licenses.

3.23.1 The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the Department. 3.23.2 Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Department to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the Department. 3.23.3 Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements. Reciprocity RH 3.24 Reciprocal Recognition of Licenses.

3.24.1 Radioactive Material in Quantities Not Sufficient to Form a Critical Mass. 3.24.1.1 Subject to these regulations, any person who holds a specific license from the U. S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State for a period not in excess of 180 days in any calendar year, provided that:

3.24.1.1.1 The licensing document does not limit the activity authorized by such document to specified installations or locations;

3.24.1.1.2 The out-of-state licensee notifies the Department in writing at least 3 days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the State, and shall be accompanied by a copy of the pertinent licensing document. Based upon an application which includes documentation of why it is not possible or is an undue hardship to provide 3 days notice, the Department may grant permission to proceed sooner. The Department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in RH 3.24.1.1;

3.24.1.1.3 The out-of-state licensee complies with all applicable regulations of the Department and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the Department;

3.24.1.1.4 The out-of-state licensee supplies such other information as the Department may request; and 3.24.1.1.5 The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in RH 3.24.1.1 except by transfer to a person:

3.24.1.1.5.1 Specifically licensed by the Department, or by the U. S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, to receive such material, or 3.24.1.1.5.2 Exempt from the requirements for a license for such material under RH 3.3.1.

3.24.1.1.6 The out-of-state licensee shall at all times during work at any work location within the state have available the pertinent licensing document, the applicable sections of the state radiation regulations, a complete source inventory, pertinent U.S. Department of Transportation documentation, leak test records, instrument calibration records, personnel training records, and necessary documentation required by applicable special requirements of these regulations. 3.24.1.1.7 While working in Colorado, the out-of-state licensee shall notify the Department (in writing, indicating date and court) immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title II (bankruptcy) of the United States code by or against:

A. The licensee;

B. An entity (as that term is defined in II U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or C. An affiliate (as that term is defined in II U.S.C. 101(2)) of the license. 3.24.1.1.8 The out-of-state licensee shall notify the Department within 1 hour after arrival at the actual work location within the state and notification within 1 hour after any change of work location within the state.

3.24.1.1.9 If multiple persons work concurrently at more than one work location under a general license granted pursuant to this RH 3.24.1, each day worked per location shall be counted separately toward the limit of 180 days per calendar year. 3.24.1.2 Notwithstanding the provisions of RH 3.24.1.1, any person who holds a specific license issued by the U. S. Nuclear Regulatory Commission, an Agreement State or a Licensing State authorizing the holder to manufacture, transfer, install, or service a device described in RH 3.6.4.1 within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this State provided that:

3.24.1.2.1 Such person shall file a report with the Department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device; 3.24.1.2.2 The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U. S. Nuclear Regulatory Commission, an Agreement State or a Licensing State;

3.24.1.2.3 Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that “Removal of this label is prohibited”; and 3.24.1.2.4 The holder of the specific license shall furnish to each general licensee to whom the specific licensee transfers such device or on whose premises the specific licensee installs such device a copy of the general license contained in RH 3.6.4 or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device.

3.24.1.3 The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by the U. S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

3.24.2 Each general licensee granted authorization to conduct activities within this state pursuant to RH 3.24.1 based upon an acceptable licensing document will receive acknowledgment from the Department. This acknowledgment shall be kept at the site of use. 3.24.3 Each general licensee granted authorization to conduct activities within this state pursuant to RH 3.24.1 based upon an acceptable licensing document may be inspected by the Department and subject to a fee for the inspection. The fee for a routine inspection shall: 3.24.3.1 Be as provided by Part 12 of these regulations; and 3.24.3.2 Shall not be charged more often than once during each calendar year, except that for a licensee authorizing use of material at more than one address, a separate fee will be assessed for inspection of each location. If multiple installations are inspected during a single visit, a single inspection fee will be assessed. 3.24.4 Each general licensee operating within the state under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable provisions of 10 CFR 150.20. Transportation RH 3.25 Reserved.

RH 3.26 Reserved.

RH 3.27 Reserved.

RH 3.28 Reserved.

RH 3.29 Reserved.

PART 3 SCHEDULE A EXEMPT CONCENTRATIONS Element (atomic number) Isotope Column I Gas Column II Liquid and 1 Solid Concentration Concentration uCi/ml 2 uCi/ml 1 Values are given in Column I only for those materials normally used as gases. 2 uCi/g for solids.

Antimony (51) Sb-122 -4 3×10 Sb-124 -4 2×10 Sb-125 -3 1×10 Argon (18) Ar-37 -3 1×10 Ar-41 -7 4×10 Arsenic (33) As-73 -3 5×10 As-74 -4 5×10 As-76 -4 2×10 As-77 -4 8×10 Barium (56) Ba-131 -3 2×10 Ba-140 -4 3×10 Beryllium (4) Be-7 -2 2×10 Bismuth (83) Bi-206 -4 4×10 Bromine (35) Br-82 -7 -3 4×10 3×10 Cadmium (48) Cd-109 -3 2×10 Cd-115m -4 3×10 Cd-115 -4 3×10 Calcium (20) Ca-45 -5 9×10 Ca-47 -4 5×10 Carbon (6) C-14 -6 -3 1×10 8×10 Cerium (58) Ce-141 -4 9×10 Ce-143 -4 4×10 Ce-144 -4 1×10 Cesium (55) Cs-131 -2 2×10 Cs-134m -2 6×10 Cs-134 -5 9×10 Chlorine (17) Cl-38 -7 -3 9×10 4×10 Chromium (24) Cr-51 -2 2×10 Cobalt (27) Co-57 -3 5×10 Co-58 -3 1×10 Co-60 -4 5×10 Copper (29) Cu-64 -3 3×10 Dysprosium (66) Dy-165 -3 4×10 Dy-166 -4 4×10 Erbium (68) Er-169 -4 9×10 Er-171 -3 1×10 Europium (63) Eu-152(9.2 h) -4 6×10 Eu-155 -3 2×10 Fluorine (9) F-18 -6 -3 2×10 8×10 Gadolinium (64) Gd-153 -3 2×10 Gd-159 -4 8×10 Gallium (31) Ga-72 -4 4×10 Germanium (32) Ge-71 -2 2×10 Gold (79) Au-196 -3 2×10 Au-198 -4 5×10 Au-199 -3 2×10 Hafnium (72) Hf-181 -4 7×10 Hydrogen (1) H-3 -6 -2 5×10 3×10 Indium (49) In-113m -2 1×10 In-114m -4 2×10 Iodine (53) I-126 -9 -5 3×10 2×10 I-131 -9 -5 3×10 2×10 I-132 -8 -4 8×10 6×10 I-133 -8 -5 1×10 7×10 I-134 -7 -3 2×10 1×10 Iridium (77) Ir-190 -3 2×10 Ir-192 -4 4×10 Ir-194 -4 3×10 iron (26) Fe-55 -3 8×10 Fe-59 -4 6×10 Krypton (36) Kr-85m -6 1×10 Kr-85 -6 3×10 Lanthanum (57) La-140 -4 2×10 Lead (82) Pb-203 -3 4×10 Lutetium (71) Lu-177 -3 1×10 Manganese (25) Mn-52 -4 3×10 Mn-54 -3 1×10 Mn-56 -3 1×10 Mercury (80) Hg-197m -3 2×10 Hg-197 -3 3×10 Hg-203 -4 2×10 Molybdenum (42) Mo-99 -3 2×10 Neodymium (60) Nd-147 -4 6×10 Nd-149 -3 3×10 Nickel (28) Ni-65 -3 1×10 Niobium (Columbium) Nb-95 -3 1×10 (41)

Nb-97 -3 9×10 Osmium (76) Os-185 -4 7×10 Os-191m -2 3×10 Os-191 -3 2×10 Os-193 -4 6×10 Palladium (46) Pd-103 -3 3×10 Phosphorus (15) P-32 -4 2×10 Platinum (78) Pt-191 -3 1×10 Pt-193m -2 1×10 Pt-197m -2 1×10 Pt-197 -3 1×10 Potassium (19) K-42 -3 3×10 Praseodymium (59) Pr-142 -4 3×10 Pr-143 -4 5×10 Promethium (61) Pm-147 -3 2×10 Pm-149 -4 4×10 Rhenium (75) Re-183 -3 6×10 Re-186 -4 9×10 Re-188 -4 6×10 Rhodium (45) Rh-103m -1 1×10 Rh-105 -3 1×10 Rubidium (37) Rb-86 -4 7×10 Ruthenium (44) Ru-97 -3 4×10 Ru-103 -4 8×10 Ru-105 -3 1×10 Ru-106 -4 1×10 Samarium (62) Sm-153 -4 8×10 Scandium (21) Sc-46 -4 4×10 Sc-47 -4 9×10 Sc-48 -4 3×10 Selenium (34) Se-75 -3 3×10 Silicon (14) Si-31 -3 9×10 Silver (47) Ag-105 -3 1×10 Ag-110m -4 3×10 Ag-111 -4 4×10 Sodium (11) Na-24 -3 2×10 Strontium (38) Sr-85 -3 1×10 Sr-89 -4 1×10 Sr-91 -4 7×10 Sr-92 -4 7×10 Sulfur (16) S-35 -8 -4 9×10 6×10 Tantalum (73) Ta-182 -4 4×10 Technetium (43) Tc-96m -1 1×10 Tc-96 -3 1×10 Tellurium (52) Te-125m -3 2×10 Te-127m -4 6×10 Te-127 -3 3×10 Te-129m -4 3×10 Te-131m -4 6×10 Te-132 -4 3×10 Terbium (65) Tb-160 -4 4×10 Thallium (81) Tl-200 -3 4×10 Tl-201 -3 3×10 Tl-202 -3 1×10 Tl-204 -3 1×10 Thulium (69) Tm-170 -4 5×10 Tm-171 -3 5×10 Tin (50) Sn-113 -4 9×10 Sn-125 -4 2×10 Tungsten (Wolfram) (74) W-181 -3 4×10 W-187 -4 7×10 Vanadium (23) V-48 -4 3×10 Xenon (54) Xe-131m -6 4×10 Xe-133 -6 3×10 Xe-135 -6 1×10 Ytterbium (70) Yb-175 -3 1×10 Yttrium (39) Y-90 -4 2×10 Y-91m -2 3×10 Y-91 -4 3×10 Y-92 -4 6×10 Y-93 -4 3×10 Zinc (30) Zn-65 -3 1×10 Zn-69m -4 7×10 Zn-69 -2 2×10 Zirconium (40) Zr-95 -4 6×10 Zr-97 -4 2×10 Beta- and/or -10 -6 1×10 1×10 gammaemitting radioactive material not listed above with half-life of less than 3 years.

Note 1: Many radionuclides transform into other radionuclides. In expressing the concentrations in Schedule A, the activity stated is that of the parent radionuclide and takes into account the radioactive decay products.

Note 2: For purposes of Section RH 3.3 where there is involved a combination of radionuclides, the limit for the combination should be derived as follows: Determine for each radionuclide in the product the ratio between the radioactivity concentration present in the product and the exempt radioactivity concentration established in Schedule A for the specific radionuclide when not in combination. The sum of such ratios may not exceed “1”.

Example: Concentration of + Radionuclide A in Product Exempt concentration of Radionuclide A Concentration of ≤ 1 Radionuclide B in Product Exempt concentration of Radionuclide B Note 3: To convert uCi/ml to SI units of megabecquerels per liter multiply the above values by 37. Example: Zirconium (40) Zr-97 (2×10-4 uCi/ml multiplied by 37 is equivalent to 74 × 10-4 MBq/l) PART 3 SCHEDULE B EXEMPT QUANTITIES Radioactive Material Microcuries Antimony-122 (Sb 122) 100 Antimony-124 (Sb 124) 10 Antimony-125 (Sb 125) 10 Arsenic-73 (As 73) 100 Arsenic-74 (As 74) 10 Arsenic-76 (As 76) 10 Arsenic-77 (As 77) 100 Barium-131 (Ba 131) 10 Barium-133 (Ba 133) 10 Barium-140 (Ba 140) 10 Bismuth-210 (Bi 210) 1 Bromine-82 (Br 82) 10 Cadmium-109 (Cd 109) 10 Cadmium-115m (Cd 10 115m)

Cadmium-115 (Cd 115) 100 Calcium-45 (Ca 45) 10 Calcium-47 (Ca 47) 10 Carbon-14 © 14) 100 Cerium-141 (Ce 141) 100 Cerium-143 (Ce 143) 100 Cerium-144 (Ce 144) 1 Cesium-129 (Cs 129) 100 Cesium-131 (Cs 131) 1,000 Cesium-134m (Cs 134m) 100 Cesium-134 (Cs 134) 1 Cesium-135 (Cs 135) 10 Cesium-136 (Cs 136) 10 Cesium-137 (Cs 137) 10 Chlorine-36 (Cl 36) 10 Chlorine-38 (Cl 38) 10 Chromium-51 (Cr 51) 1,000 Cobalt-57 (Co 57) 100 Cobalt-58m (Co 58m) 10 Cobalt-58 (Co 58) 10 Cobalt-60 (Co 60) 1 Copper-64 (Cu 64) 100 Dysprosium-165 (Dy 10 165)

Dysprosium-166 (Dy 100 166)

Erbium-169 (Er 169) 100 Erbium-171 (Er 171) 100 Europium-152 (Eu 100 152)9.2h Europium-152 (Eu 152) 1 13 yr Europium-154 (Eu 154) 1 Europium-155 (Eu 155) 10 Fluorine-18 (F 18) 1,000 Gadolinium-153 (Gd 153) 10 Gadolinium-159 (Gd 159) 100 Gallium-67 (Ga 67) 100 Gallium-72 (Ga 72) 10 Germanium-68 (Ge 68) 10 Germanium-71 (Ge 71) 100 Gold-195 (Au 195) 10 Gold-198 (Au 198) 100 Gold-199 (Au 199) 100 Hafnium-181 (Hf 181) 10 Holmium-166 (Ho 166) 100 Hydrogen-3 (H 3) 1,000 Indium-111 (In 111) 100 Indium-113m (In 113m) 100 Indium-114m (In 114m) 10 Indium-115m (In 115m) 100 Indium-115 (In 115) 10 Iodine-123 (I 123) 100 Iodine-125 (I 125) 1 Iodine-126 (I 126) 1 Iodine-129 (I 129) 0.1 Iodine-131 (I 131) 1 Iodine-132 (I 132) 10 Iodine-133 (I 133) 1 Iodine-134 (I 134) 10 Iodine-135 (I 135) 10 Iridium-192 (Ir 192) 10 Iridium-194 (Ir 194) 100 Iron-52 (Fe 52) 10 Iron-55 (Fe 55) 100 Iron-59 (Fe 59) 10 Krypton-85 (Kr 85) 100 Krypton-87 (Kr 87) 10 Lanthanum-140 (La 140) 10 Lutetium-177 (Lu 177) 100 Manganese-52 (Mn 52) 10 Manganese-54 (Mn 54) 10 Manganese-56 (Mn 56) 10 Mercury-197m (Hg 100 197m)

Mercury-197 (Hg 197) 100 Mercury-203 (Hg 203) 10 Molybdenum-99 (Mo 99) 100 Neodymium-147 (Nd 100 147)

Neodymium-149 (Nd 100 149)

Nickel-59 (Ni 59) 100 Nickel-63 (Ni 63) 10 Nickel-65 (Ni 65) 100 Niobium-93m (Nb 93m) 10 Niobium-95 (Nb 95) 10 Niobium-97 (Nb 97) 10 Osmium-185 (Os 185) 10 Osmium-191m (Os 100 191m)

Osmium-191 (Os 191) 100 Osmium-193 (Os 193) 100 Palladium-103 (Pd 103) 100 Palladium-109 (Pd 109) 100 Phosphorus-32 (P 32) 10 Platinum-191 (Pt 191) 100 Platinum-193m (Pt 100 193m)

Platinum-193 (Pt 193) 100 Platinum-197m (Pt 100 197m)

Platinum-197 (Pt 197) 100 Polonium-210 (Po 210) 0.1 Potassium-42 (K 42) 10 Potassium-43 (K 43) 10 Praseodymium-142 (Pr 100 142)

Praseodymium-143 (Pr 100 143)

Promethium-147 (Pm 10 147)

Promethium-149 (Pm 10 149)

Rhenium-186 (Re 186) 100 Rhenium-188 (Re 188) 100 Rhodium-103m (Rh 100 103m)

Rhodium-105 (Rh 105) 100 Rubidium-81 (Rb 81) 10 Rubidium-86 (Rb 86) 10 Rubidium-87 (Rb 87) 10 Ruthenium-97 (Ru 97) 100 Ruthenium-103 (Ru 103) 10 Ruthenium-105 (Ru 105) 10 Ruthenium-106 (Ru 106) 1 Samarium-151 (Sm 151) 10 Samarium-153 (Sm 153) 100 Scandium-46 (Sc 46) 10 Scandium-47 (Sc 47) 100 Scandium-48 (Sc 48) 10 Selenium-75 (Se 75) 10 Silicon-31 (Si 31) 100 Silver-105 (Ag 105) 10 Silver-110m (Ag 110m) 1 Silver-111 (Ag 111) 100 Sodium-22 (Na 22) 10 Sodium-24 (Na 24) 10 Strontium-85 (Sr 85) 10 Strontium-89 (Sr 89) 1 Strontium-90 (Sr 90) 0.1 Strontium-91 (Sr 91) 10 Strontium-92 (Sr 92) 10 Sulphur-35 (S 35) 100 Tantalum-182 (Ta 182) 10 Technetium-96 (Tc 96) 10 Technetium-97m (Tc 100 97m)

Technetium-97 (Tc 97) 100 Technetium-99m (Tc 100 99m)

Technetium-99 (Tc 99) 10 Tellurium-125m (Te 10 125m)

Tellurium-127m (Te 10 127m)

Tellurium-127 (Te 127) 100 Tellurium-129m (Te 10 129m)

Tellurium-129 (Te 129) 100 Tellurium-131 m (Te 10 131m)

Tellurium-132 (Te 132) 10 Terbium-160 (Tb 160) 10 Thallium-200 (Tl 200) 100 Thallium-201 (Tl 201) 100 Thallium-202 (Tl 202) 100 Thallium-204 (Tl 204) 10 Thulium-170 (Tm 170) 10 Thulium-171 (Tm 171) 10 Tin-113 (Sn 113) 10 Tin-125 (Sn 125) 10 Tungsten-181 (W 181) 10 Tungsten-185 (W 185) 10 Tungsten-187 (W 187) 100 Vanadium-48 (V 48) 10 Xenon-131m (Xe 131 m) 1,000 Xenon-133 (Xe 133) 100 Xenon-135 (Xe 135) 100 Ytterbium-175 (Yb 175) 100 Yttrium-87 (Y 87) 10 Yttrium-88 (Y 88) 10 Yttrium-90 (Y 90) 10 Yttrium-91 (Y 91) 10 Yttrium-92 (Y 92) 100 Yttrium-93 (Y 93) 100 Zinc-65 (Zn 65) 10 Zinc-69m (Zn 69m) 100 Zinc-69 (Zn 69) 1,000 Zirconium-93 (Zr 93) 10 Zirconium-95 (Zr 95) 10 Zirconium-97 (Zr 97) 10 Any radioactive material 0.1 not listed above other than alpha-emitting radioactive material Note 1: For purposes of RH 3.9.5.1.2.5.1 and 3.9.5.1.2.5.2 where there is involved a combination of radionuclides, the limit for the combination should be derived as follows: Determine the amount of each radionuclide possessed and 1,000 times the amount in Schedule B for each of those radionuclides when not in combination. The sum of the ratios of those quantities may not exceed 1.

Example:

Amt. of Radionuclide A + Amt. of Radionuclide B ≤ 1 possessed possessed 1000 × Schedule B 1000 × Schedule B quantity for Radionuclide quantity for Radionuclide A B Note 2: To convert microcuries (uCi) to SI units of kilobecquerels (kBq), multiply the above values by 37. Example: Zirconium-97 (10 uCi multiplied by 37 is equivalent to 370 kBq). PART 3 SCHEDULE C RESERVED PART 3 SCHEDULE D LIMITS FOR BROAD LICENSES (RH 3.11)

Radioactive Material Col. I curies Col. II curies Antimony-122 1 0.01 Antimony-124 1 0.01 Antimony-125 1 0.01 Arsenic-73 10 0.1 Arsenic-74 1 0.01 Arsenic-76 1 0.01 Arsenic-77 10 0.1 Barium-131 10 0.1 Barium-140 1 0.01 Beryllium-7 10 0.1 Bismuth-210 0.1 0.001 Bromine-82 10 0.1 Cadmium-109 1 0.01 Cadmium-115m 1 0.01 Cadmium-115 10 0.1 Calcium-45 1 0.01 Calcium-47 10 0.1 Carbon-14 100 1.

Cerium-141 10 0.1 Cerium-143 10 0.1 Cerium-144 0.1 0.001 Cesium-131 100 1.

Cesium-134m 100 1.

Cesium-134 0.1 0.001 Cesium-135 1 0.01 Cesium-136 10 0.1 Cesium-137 0.1 0.001 Chlorine-36 1 0.01 Chlorine-38 100 1.

Chromium-51 100 1.

Cobalt-57 10 0.1 Cobalt-58m 100 1.

Cobalt-58 1 0.01 Cobalt-60 0.1 0.001 Copper-64 10 0.1 Dysprosium-165 100 1.

Dysprosium-166 10 0.1 Erbium-169 10 0.1 Erbium-171 10 0.1 Europium-152 (9.2 h) 10 0.1 Europium-152 (13 y) 0.1 0.001 Europium-154 0.1 0.001 Europium-155 1 0.01 Fluorine-18 100 1.

Gadolinium-153 1 0.01 Gadolinium-159 10 0.1 Gallium-72 10 0.1 Germanium-71 100 1.

Gold-198 10 0.1 Gold-199 10 0.1 Hafnium-181 1 0.01 Holmium-166 10 0.1 Hydrogen-3 100 1.

Indium-113m 100 1.

Indium-114m 1 0.01 Indium-115m 100 1.

Indium-115 1 0.01 Iodine-125 0.1 0.001 Iodine-126 0.1 0.001 Iodine-129 0.1 0.001 Iodine-131 0.1 0.001 Iodine-132 10 0.1 Iodine-133 1 0.01 Iodine-134 10 0.1 Iodine-135 1 0.01 Iridium-192 1 0.01 Iridium-194 10 0.1 Iron-55 10 0.1 Iron-59 1 0.01 Krypton-85 100 1.

Krypton-87 10 0.1 Lanthanum-140 1 0.01 Lutetium-177 10 0.1 Manganese-52 1 0.01 Manganese-54 1 0.01 Manganese-56 10 0.1 Mercury-197m 10 0.1 Mercury-197 10 0.1 Mercury-203 1 0.01 Molybdenum-99 10 0.1 Neodymium-147 10 0.1 Neodymium-149 10 0.1 Nickel-59 10 0.1 Nickel-63 1 0.01 Nickel-65 10 0.1 Niobium-93m 1 0.01 Niobium-95 1 0.01 Niobium-97 100 1.

Osmium-185 1 0.01 Osmium-191m 100 1.

Osmium-191 10 0.1 Osmium-193 10 0.1 Palladium-103 10 0.1 Palladium-109 10 0.1 Phosphorus-32 1 0.01 Platinum-191 10 0.1 Platinum-193m 100 1.

Platinum-193 10 0.1 Platinum-197m 100 1.

Platinum-197 10 0.1 Polonium-210 0.01 0.0001 Potassium-42 1 0.01 Praseodymium-142 10 0.1 Praseodymium-143 10 0.1 Promethium-147 1 0.01 Promethium-149 10 0.1 Radium-226 0.01 0.0001 Rhenium-186 10 0.1 Rhenium-188 10 0.1 Rhodium-103m 1,000 10.

Rhodium-105 10 0.1 Rubidium-86 1 0.01 Rubidium-87 1 0.01 Ruthenium-97 100 1.

Ruthenium-103 1 0.01 Ruthenium-105 10 0.1 Ruthenium-106 0.1 0.001 Samarium-151 1 0.01 Samarium-153 10 0.1 Scandium-46 1 0.01 Scandium-47 10 0.1 Scandium-48 1 0.01 Selenium-75 1 0.01 Silicon-31 10 0.1 Silver-105 1 0.01 Silver-110m 0.1 0.001 Silver-111 10 0.1 Sodium-22 0.1 0.001 Sodium-24 1 0.01 Strontium-85m 1,000 10.

Strontium-85 1 0.01 Strontium-89 1 0.01 Strontium-90 0.01 0.0001 Strontium-91 10 0.1 Strontium-92 10 0.1 Sulphur-35 10 0.1 Tantalum-182 1 0.01 Technetium-96 10 0.1 Technetium-97m 10 0.1 Technetium-97 10 0.1 Technetium-99m 100 1.

Technetium-99 1 0.01 Tellurium-125m 1 0.01 Tellurium-127m 1 0.01 Tellurium-127 10 0.1 Tellurium-129m 1 0.01 Tellurium-129 100 1.

Tellurium-131m 10 0.1 Tellurium-132 1 0.01 Terbium-160 1 0.01 Thallium-200 10 0.1 Thallium-201 10 0.1 Thallium-202 10 0.1 Thallium-204 1 0.01 Thulium-170 1 0.01 Thulium-171 1 0.01 Tin-113 1 0.01 Tin-125 1 0.01 Tungsten-181 1 0.01 Tungsten-185 1 0.01 Tungsten-187 10 0.1 Vanadium-48 1 0.01 Xenon-131m 1,000 10.

Xenon-133 100 1.

Xenon-135 100 1.

Ytterbium-175 10 0.1 Yttrium-90 1 0.01 Yttrium-91 1 0.01 Yttrium-92 10 0.1 Yttrium-93 1 0.01 Zinc-65 1 0.01 Zinc-69m 10 0.1 Zinc-69 100 1.

Zirconium-93 1 0.01 Zirconium-95 1 0.01 Zirconium-97 1 0.01 Any radioactive material 0.1 0.001 other than source material, special nuclear material, or alpha emitting radioactive material not listed above.

Note 1: To convert curies (Ci) to SI units of gigabecquerels (GBq), multiply the above values by 37. Example: Zirconium-97 (Col. II) (0.01 Ci multiplied by 37 is equivalent to 0.37 GBq) PART 3 SCHEDULE E QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN FOR RESPONDING TO A RELEASE. 1 Release fraction Quantity Radioactive material TBq Ci 1 For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive materials authorized to the quantity listed for that material in Schedule E exceeds one.

2 Waste packaged in Type B containers does not requires an emergency plan. Actinium-228 0.001 148 (4,000)

Americium-241 .001 0.074 (2)

Americium-242 .001 0.074 (2)

Americium-243 .001 0.074 (2)

Antimony-124 .01 148 (4,000)

Antimony-126 .01 222 (6,000)

Barium-133 .01 370 (10,000)

Barium-140 .01 1,100 (30,000)

Bismuth-207 .01 185 (5,000)

Bismuth-210 .01 22.2 (600)

Cadmium-109 .01 37 (1,000)

Cadmium-113 .01 2.96 (80)

Calcium-45 .01 740 (20,000)

Californium-252 .001 0.333 (9)(20 mg)

Carbon-14 .01 1,850 (50,000)

Non CO Cerium-141 .01 370 (10,000)

Cerium-144 .01 11.1 (300)

Cesium-134 .01 74 (2,000)

Cesium-137 .01 111 (3,000)

Chlorine-36 .5 3.7 (100)

Chromium-51 .01 11,100 (300,000)

Cobalt-60 .001 185 (5,000)

Copper-64 .01 7,400 (200,000)

Curium-242 .001 2.22 (60)

Curium-243 .001 0.111 (3)

Curium-244 .001 0.148 (4)

Curium-245 .001 0.074 (2)

Europium-152 .01 18.5 (500)

Europium-154 .01 14.8 (400)

Europium-155 .01 111 (3,000)

Germanium-68 .01 74 (2,000)

Gadolinium-153 .01 185 (5,000)

Gold-198 .01 1,110 (30,000)

Hafnium-172 .01 14.8 (400)

Hafnium-181 .01 259 (7,000)

Holmium-166m .01 3.7 (100)

Hydrogen-3 .5 740 (20,000)

Iodine-125 .5 0.37 (10)

Iodine-131 .5 0.37 (10)

Indium-114m .01 37 (1,000)

Iridium-192 .001 1,480 (40,000)

Iron-55 .01 1,480 (40,000)

Iron-59 .01 259 (7,000)

Krypton-85 1.0 222,000 (6,000,000)

Lead-210 .01 0.296 (8)

Manganese-56 .01 2,200 (60,000)

Mercury-203 .01 370 (10,000)

Molybdenum-99 .01 1,100 (30,000)

Neptunium-237 .001 0.074 (2)

Nickel-63 .01 740 (20,000)

Niobium-94 .01 11.1 (300)

Phosphorus-32 .5 3.7 (100)

Phosphorus-33 .5 37 (1,000)

Polonium-210 .01 0.37 (10)

Potassium-42 .01 333 (9,000)

Promethium-145 .01 148 (4,000)

Promethium-147 .01 148 (4,000)

Ruthenium-106 .01 7.4 (200)

Samarium-151 .01 148 (4,000)

Scandium-46 .01 111 (3,000)

Selenium-75 .01 370 (10,000)

Silver-110m .01 37 (1,000)

Sodium-22 .01 333 (9,000)

Sodium-24 .01 370 (10,000)

Strontium-89 .01 111 (3,000)

Strontium-90 .01 3.33 (90)

Sulfur-35 .5 33.3 (900)

Technetium-99 .01 370 (10,000)

Technetium-99m .01 14,800 (400,000)

Tellurium-127m .01 185 (5,000)

Tellurium-129m .01 185 (5,000)

Terbium-160 .01 148 (4,000)

Thulium-170 .01 148 (4,000)

Tin-113 .01 370 (10,000)

Tin-123 .01 111 (3,000)

Tin-126 .01 37 (1,000)

Titanium-44 .01 3.7 (100)

Vanadium-48 .01 259 (7,000)

Xenon-133 1.0 33,300 (900,000)

Yttrium-91 .01 74 (2,000)

Zinc-65 .01 185 (5,000)

Zirconium-93 .01 14.8 (400)

Zirconium-95 .01 185 (5,000)

Any other beta-gamma .01 370 (10,000)

emitter Mixed fission products .01 37 (1,000)

Mixed corrosion products .01 370 (10,000)

Contaminated equipment .001 370 (10,000)

beta-gamma Irradiated material, any .01 37 (1,000)

form other than solid noncombustible Irradiated material, solid .001 370 (10,000)

noncombustible Mixed radioactive waste, .01 37 (1,000)

beta-gamma Packaged mixed waste, .001 370 (10,000)

2 beta-gamma Any other alpha emitter .001 0.074 (2)

Contaminated equipment, .0001 0.74 (20)

alpha 2 .0001 0.74 (20)

Packaged waste, alpha Combinations of radioactive materials 1 listed above PART 3 APPENDIX A CRITERIA RELATING TO USE OF FINANCIAL TESTS AND PARENT COMPANY GUARANTEES FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This Appendix establishes criteria for passing the financial test and for obtaining the parent company guarantee.

II. Financial Test A. To pass the financial test, the parent company must meet the criteria of either paragraph A. 1. or A.2. of this Appendix:

1. The parent company must have:

(i) Two of the following three ratios: a ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and ratio of current assets to current liabilities greater than 1.5; and (ii) Net working capital and tangible net worth each at least ten times the current decommissioning cost estimates (or prescribed amount if a certification is used); and (iii) Tangible net worth of at least $10 million; and (iv) Assets located in the United States amounting to at least 90 percent of total assets or at least ten times the current decommissioning cost estimates (or prescribed amount if a certification is used).

2. The parent company must have:

(i) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or AAA, AA, A, or BAA as issued by Moody's; and (ii) Tangible net worth at least ten times the current decommissioning cost estimate (or prescribed amount if a certification is used); and (iii) Tangible net worth of at least $10 million; and (iv) assets located in the United States amounting to at least 90 percent of total assets or at least ten times the current decommissioning cost estimates (or prescribed amount if certification is used).

B. The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from independently audited, year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure the licensee shall inform the Department within 90 days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. C. 1. After the initial financial test, the parent company must repeat the passage of the test within 90 days after the close of each succeeding fiscal year.

2. If the parent company no longer meets the requirements of Paragraph A of this section, the licensee must send notice to the Department of intent to establish alternate financial assurance as specified in the Department's regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year end financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.

III. Parent Company Guarantee The terms of a parent company guarantee which an applicant or licensee obtains must provide that: A. The parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Department, as evidenced by the return receipts. B. If the licensee fails to provide alternate financial assurance as specified in the Department's regulations within 90 days after receipt by the licensee and Department of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee.

C. The parent company guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.

D. If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Department. An acceptable trustee includes the following: an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a state or federal agency. Part 3 APPENDIX B CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF GUARANTEES FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning, based on furnishing its own guarantee that funds will be available for decommissioning costs, and on a demonstration that the company passes the financial test Section II of this Appendix. The terms of this self-guarantee are in Section III of this Appendix. This Appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee. II. Financial Test A. To pass the financial test, a company must meet the all of the following criteria: 1. A tangible net worth of at least ten times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor. 2. Assets located in the United States amounting to at least 90 percent of total assets or at least ten times the current decommissioning cost estimates (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor. 3. A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poor's or AAA, AA, or A as issued by Moody's; and B. To pass the financial test, a company must meet all of the following additional requirements: 1. The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934.

2. The company's independent certified public accountant must have compared the data used by the company in the financial test which is derived from the independently audited, year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

3. After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.

C. If the licensee no longer meets the requirements of Section II.A. of this Appendix, the licensee must send immediate notice to the Department of its intent to establish alternate financial assurance as specified in the Department's regulations within 120 days of such notice. III. Company Self-Guarantee The terms of a self-guarantee which an applicant or licensee furnishes must provide that: A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Department, as evidenced by the return receipt. B. The licensee shall provide alternative financial assurance as specified in the Department's regulations within 90 days following receipt by the Department of a notice of cancellation of the guarantee. C. The guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.

D. The licensee will promptly forward to the Department and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of Section 13 of the Securities and Exchange Act of 1934.

E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of “A” or above by either Standard and Poors and Moodys, the licensee will provide notice in writing of such fact to the Department within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of Section II.A. of this Appendix.

F. The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning. PART 4:

STANDARDS FOR PROTECTION AGAINST RADIATION 4.1 Purpose and Scope 4.1.1 Authority.

Rules and regulations set forth herein are adopted pursuant to the provisions of Sections 25-1- 108, 25-1.5-101(1)(k) and (1)(l), and 25-11-104, CRS.

4.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department. 4.1.3 Scope.

4.1.3.1 This Part 4 establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Department. 4.1.3.2 The requirements of Part 4 are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part 4. However, nothing in Part 4 shall be construed as limiting actions that may be necessary to protect health and safety.

4.1.4 Applicability.

Except as specifically provided in other parts of these regulations, Part 4 applies to persons licensed or registered by the Department to receive, possess, use, transfer, or dispose of sources of radiation. The limits in Part 4 do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with 7.26, or to exposure from voluntary participation in medical research programs.

4.2 Definitions.

Reserved.

4.3 Implementation.

Any existing license or registration condition that is more restrictive than Part 4 remains in force until there is an amendment or renewal of the license or registration. 4.4 Reserved.

RADIATION PROTECTION PROGRAMS 4.5 Radiation Protection Programs.

4.5.1 Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of Part 4. See 4.41 for recordkeeping requirements relating to these programs.

4.5.2 The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). 4.5.3 The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation protection program content and implementation.

4.5.4 To implement the ALARA requirements of 4.5.2 and notwithstanding the requirements in 4.14 of this part, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its decay products, shall be established by licensees, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report such event as provided in 4.53.2 and promptly take appropriate corrective action to ensure against recurrence. OCCUPATIONAL DOSE LIMITS 4.6 Occupational Dose Limits for Adults.

4.6.1 The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to 4.11, to the following dose limits: 4.6.1.1 An annual limit, which is the more limiting of: (1) The total effective dose equivalent being equal to 0.05 Sv (5 rem); or (2) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 Sv (50 rem).

4.6.1.2 The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(1) A lens dose equivalent of 0.15 Sv (15 rem), and (2) A shallow dose equivalent of 0.5 Sv (50 rem) to the skin of the whole body or to the skin of any extremity.

4.6.2 Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See 4.11.5.1 and 4.11.5.2.

4.6.3 Assigned dose equivalent.

4.6.3.1 The assigned deep dose equivalent must be for the part of the body receiving the highest exposure.

4.6.3.2 The assigned shallow dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. 4.6.3.3 The deep-dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

4.6.3.4 In the case of occupational exposures to x-rays with accelerating voltages of less than 145 kVp and where the worker utilizes lead garment protection, the registrant may calculate the assigned dose equivalent using the following methods: (1) Lead apron and no thyroid collar:

assigned deep dose equivalent = 0.06 x (collar dose – waist dose) + waist dose (2) Lead apron and thyroid collar:

assigned deep dose equivalent = 0.02 x (collar dose – waist dose) + waist dose 4.6.4 Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Table 4B1 of Appendix 4B and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See 4.46. 4.6.5 Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote 3 of Appendix 4B.

4.6.6 The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person. See 4.10.3.1 and 4.10.5.

4.7 Compliance with Requirements for Summation of External and Internal Doses. 4.7.1 If the licensee or registrant is required to monitor pursuant to both 4.18.1 and 4.18.2, the licensee or registrant shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only pursuant to 4.18.1 or only pursuant to 4.18.2, then summation is not required to demonstrate compliance with the dose limits. The licensee or registrant may demonstrate compliance with the requirements for summation of external and internal doses pursuant to 4.7.2, 4.7.3 and 4.7.4. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

4.7.2 Intake by Inhalation.

If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity: 4.7.2.1 The sum of the fractions of the inhalation ALI for each radionuclide, or 4.7.2.2 The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or 4.7.2.3 The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W , and the committed dose equivalent, H , per unit T T,50 intake is greater than 10 percent of the maximum weighted value of H , that is, W x 50 T H , per unit intake for any organ or tissue.

T,50 4.7.3 Intake by Oral Ingestion.

If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee or registrant shall account for this intake and include it in demonstrating compliance with the limits. 4.7.4 Intake through Wounds or Absorption through Skin. The licensee or registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated or accounted for pursuant to 4.7.4. 4.8 Determination of External Dose from Airborne Radioactive Material. 4.8.1 Licensees or registrants shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix 4B, footnotes 1 and 2. 4.8.2 Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices. 4.9 Determination of Internal Exposure.

4.9.1 For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee or registrant shall, when required pursuant to 4.18, take suitable and timely measurements of:

4.9.1.1 Concentrations of radioactive materials in air in work areas; or 4.9.1.2 Quantities of radionuclides in the body; or 4.9.1.3 Quantities of radionuclides excreted from the body; or 4.9.1.4 Combinations of 4.9.1.1, 4.9.1.2 and 4.9.1.3.

4.9.2 Unless respiratory protective equipment is used, as provided in 4.24, or the assessment of intake is based on bioassays, the licensee or registrant shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present. 4.9.3 When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee or registrant may:

4.9.3.1 Use that information to calculate the committed effective dose equivalent, and, if used, the licensee or registrant shall document that information in the individual's record; and 4.9.3.2 Upon prior approval of the Department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and 4.9.3.3 Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Appendix 4B. 4.9.4 If the licensee or registrant chooses to assess intakes of Class Y material using the measurements given in 4.9.1.2 or 4.9.1.3, the licensee or registrant may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by 4.52 or 4.53. This delay permits the licensee or registrant to make additional measurements basic to the assessments. 4.9.5 If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either: 4.9.5.1 The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from Appendix 4B for each radionuclide in the mixture; or 4.9.5.2 The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture. 4.9.6 If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.

4.9.7 When a mixture of radionuclides in air exists, a licensee or registrant may disregard certain radionuclides in the mixture if:

4.9.7.1 The licensee or registrant uses the total activity of the mixture in demonstrating compliance with the dose limits in 4.6 and in complying with the monitoring requirements in 4.18.2; and 4.9.7.2 The concentration of any radionuclide disregarded is less than 10 percent of its DAC; and 4.9.7.3 The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.

4.9.8 When determining the committed effective dose equivalent, the following information may be considered:

4.9.8.1 In order to calculate the committed effective dose equivalent, the licensee or registrant may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 0.05 Sv (5 rem) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent. 4.9.8.2 For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 Sv (50 rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 Sv (5 rem), that is, the stochastic ALI, is listed in parentheses in Table 4B1 of Appendix 4B. The licensee or registrant may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee or registrant uses the stochastic ALI, the licensee or registrant shall also demonstrate that the limit in 4.6.1.1.2 is met.

4.10 Determination of Prior Occupational Dose.

4.10.1 For each individual who is likely to receive, in a year, an occupational dose requiring monitoring pursuant to 4.18, the licensee or registrant shall:

4.10.1.1 Determine the occupational radiation dose received during the current year; and 4.10.1.2 Attempt to obtain the records of lifetime cumulative occupational radiation dose. 4.10.2 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

4.10.2.1 The internal and external doses from all previous planned special exposures; and 4.10.2.2 All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and 4.10.2.3 All lifetime cumulative occupational radiation dose. 4.10.3 In complying with the requirements of 4.10.1, a licensee or registrant may: 4.10.3.1 Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and 4.10.3.2 Accept, as the record of lifetime cumulative radiation dose, an up-to-date Department Form R-16, Cumulative Occupational Exposure History, or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and 4.10.3.3 Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established. 4.10.4 Record of Exposure History.

4.10.4.1 The licensee or registrant shall record the exposure history, as required by 4.10.1, on Department Form R-16, or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing Department Form R-16 or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on Department Form R-16 or equivalent indicating the periods of time for which data are not available.

4.10.4.2 Licensees or registrants are not required to reevaluate the separate external dose equivalents and internal committed dose equivalents or intakes of radionuclides assessed pursuant to the Regulations in Part 4 in effect before January 1, 1994. Further, occupational exposure histories obtained and recorded before January 1, 1994 on Department Form R-16 or equivalent, would not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.

4.10.5 If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume: 4.10.5.1 In establishing administrative controls pursuant to 4.6.6 for the current year, that the allowable dose limit for the individual is reduced by 12.5 mSv (1.25 rem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and 4.10.5.2 That the individual is not available for planned special exposures. 4.10.6 The licensee or registrant shall retain the records on Department Form R-16 or equivalent until the Department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Department Form R-16 or equivalent for 3 years after the record is made.

4.11 Planned Special Exposures.

A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in 4.6 provided that each of the following conditions in 4.11.1 through 4.11.7 is satisfied: 4.11.1 The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.

4.11.2 The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs. 4.11.3 Before a planned special exposure, the licensee or registrant ensures that each individual involved is:

4.11.3.1 Informed of the purpose of the planned operation; and 4.11.3.2 Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and 4.11.3.3 Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

4.11.4 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by 4.10.2 during the lifetime of the individual for each individual involved.

4.11.5 Subject to 4.6.2, the licensee or registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

4.11.5.1 The numerical values of any of the dose limits in 4.6.1 in any year; and 4.11.5.2 Five times the annual dose limits in 4.6.1 during the individual's lifetime. 4.11.6 The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with 4.45 and submits a written report in accordance with 4.54. 4.11.7 The licensee or registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to 4.6.1 but shall be included in evaluations required by 4.11.4 and 4.11.5. 4.12 Occupational Dose Limits for Minors.

The annual occupational dose limits for minors are 10 percent of the annual occupational dose limits specified for adult workers in 4.6.

4.13 Dose Equivalent to an Embryo/Fetus.

4.13.1 The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 5 mSv (0.5 rem). See 4.46 for recordkeeping requirements. 4.13.2 The licensee or registrant shall make efforts to avoid substantial variation 1 above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in 4.13.1.

1 The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987) that no more than 0.5 mSv (0.05 rem) to the embryo/fetus be received in any one month.

4.13.3 The dose equivalent to an embryo/fetus is the sum of: 4.13.3.1 The deep dose equivalent to the declared pregnant woman; and 4.13.3.2 The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman. 4.13.4 If the dose equivalent to the embryo/fetus is found to have exceeded 5 mSv (0.5 rem), or is within 0.5 mSv (0.05 rem) of this dose, by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with 4.13.1 if the additional dose equivalent to the embryo/fetus does not exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.

RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC 4.14 Dose Limits for Individual Members of the Public.

4.14.1 Each licensee or registrant shall conduct operations so that: 4.14.1.1 The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 millisievert (0.1 rem) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 7.26, from voluntary participation in medical research programs, and from the dose contribution from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with 4.35, and 4.14.1.2 The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 7.26, does not exceed 0.02 millisievert (0.002 rem) in any one hour. 4.14.2 A licensee may permit visitors to an individual who cannot be released under 7.26 to receive a radiation dose greater than 1 mSv (0.1 rem) if:

4.14.3.1 The radiation dose received does not exceed 5 mSv (0.5 rem); and 4.14.3.1 The authorized user, as defined in Part 7, has determined before the visit that it is appropriate.

4.14.3 A licensee, registrant, or an applicant for a license or registration may apply for prior Department authorization to operate up to an annual dose limit for an individual member of the public of 5 mSv (0.5 rem). This application shall include the following information: 4.14.3.1 Demonstration of the need for and the expected duration of operations in excess of the limit in 4.14.1; and 4.14.3.2 The licensee's or registrant's program to assess and control dose within the 5 mSv (0.5 rem) annual limit; and 4.14.3.3 The procedures to be followed to maintain the dose ALARA. 4.14.4 In addition to the requirements of Part 4, a licensee or registrant subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190 (July 1, 2004) shall comply with those standards. 4.14.5 The Department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee or registrant may release in effluents in order to restrict the collective dose.

4.15 Compliance with Dose Limits for Individual Members of the Public. 4.15.1 The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in 4.14. 4.15.2 A licensee or registrant shall show compliance with the annual dose limit in 4.14 by: 4.15.2.1 Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or 4.15.2.2 Demonstrating that:

(1) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table 4B2 of Appendix 4B; and (2) If an individual were continually present in an unrestricted area, the dose from external sources would not exceed 0.02 mSv (0.002 rem) in an hour and 0.5 mSv (0.05 rem) in a year.

4.15.3 Upon approval from the Department, the licensee or registrant may adjust the effluent concentration values in Appendix 4B, Table 4B2, for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as, aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form. 4.15.4 Rooms or areas in which diagnostic x-ray systems are the only source of radiation shall demonstrate compliance with 4.15.2.1 after construction of a new x-ray facility, after modification or renovation of an existing x-ray facility, or installation or a new x-ray machine in an existing x- ray facility when there is a change in primary beam orientation, or a change in primary shielding due to the modification or renovation of a facility, or where there is a projected increase in the x- ray workload from that which was used for a prior x-ray shielding design. 4.15.5 Facilities using only dental intraoral or panoramic machines in single occupancy rooms are exempt from the requirements of 4.15.2.1.

TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES 4.16 Testing for Leakage or Contamination of Sealed Sources. 4.16.1 The licensee or registrant in possession of any sealed source shall assure that: 4.16.1.1 Each sealed source, except as specified in 4.16.2, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee or registrant has a certificate from the transferor indicating that the sealed source was tested within 6 months before transfer to the licensee or registrant. Sources that indicate contamination in excess of 185 Bq (0.005 microcuries) shall not be put into use.

4.16.1.2 Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 6 months or at alternative intervals approved by the Department, after evaluation of information specified by 3.12.12.4 and 3.12.12.5 of these regulations, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission.

4.16.1.3 Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 3 months or at alternative intervals approved by the Department, after evaluation of information specified by 3.12.12.4 and 3.12.12.5 of these regulations, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission.

4.16.1.4 For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee or registrant shall assure that the sealed source is tested for leakage or contamination before further use.

4.16.1.5 Tests, and evaluations of tests, for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of 185 Bq (0.005 µCi) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the “off” position.

4.16.1.6 The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute le akage rate of 37 Bq (0.001 µCi) of radon-222 in a 24- hour period when the collection efficiency for radon-222 and its decay products has been determined with respect to collection method, volume and time. 4.16.1.7 Tests for contamination from radium decay products shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 µCi) of a radium decay product which has a half-life greater than 4 days.

4.16.2 A licensee or registrant need not perform test for leakage or contamination on the following sealed sources:

4.16.2.1 Sealed sources containing only radioactive material with a half-life of less than 30 days; 4.16.2.2 Sealed sources containing only radioactive material as a gas; 4.16.2.3 Sealed sources containing 3.7 MBq (100 µCi) or less of beta or photon-emitting material or 370 kBq (10 µCi) or less of alpha-emitting material; 4.16.2.4 Sealed sources containing only hydrogen-3;

4.16.2.5 Seeds of iridium-192 encased in nylon ribbon; and 4.16.2.6 Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. The licensee or registrant shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within 6 months before the date of use or transfer.

4.16.3 Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Department, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission to perform such services.

4.16.4 Test results shall be kept in units of becquerel (or microcurie) and maintained for inspection by the Department.

4.16.5 The following shall be considered evidence that a sealed source is leaking: 4.16.5.1 The presence of 185 Bq (0.005 µCi) or more of removable contamination on any test sample.

4.16.5.2 Leakage of 37 Bq (0.001 µCi) of radon-22 2 per 24 hours for brachytherapy sources manufactured to contain radium.

4.16.5.3 The presence of removable contamination resulting from the decay of 185 Bq (0.005 µCi) or more of radium.

4.16.6 The licensee or registrant shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this Part.

4.16.7 Reports of test results for leaking or contaminated sealed sources shall be made pursuant to 4.58. SURVEYS AND MONITORING 4.17 General.

4.17.1 Each licensee or registrant shall make, or cause to be made, surveys that: 4.17.1.1 Are necessary for the licensee or registrant to comply with Part 4; and 4.17.1.2 Are necessary under the circumstances to evaluate: (1) The magnitude and extent of radiation levels; and (2) Concentrations or quantities of radioactive material; and (3) The potential radiological hazards.

4.17.2 The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are calibrated at intervals not to exceed 12 months for the radiation measured unless otherwise noted in these regulations.

4.17.3 All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with 4.6, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor: 4.17.3.1 Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and 4.17.3.2 Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. 4.17.4 The licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.

4.18 Conditions Requiring Individual Monitoring of External and Internal Occupational Dose. Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of Part 4. As a minimum: 4.18.1 Each licensee or registrant shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by:

4.18.1.1 Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in 4.6.1;

4.18.1.2 Minors likely to receive, in 1 year from radiation sources external to the body, a deep dose equivalent in excess of 1mSv (0.1 rem), a lens dose equivalent in excess of 1.5 mSv (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess 5 mSv (0.5 rem);

4.18.1.3 Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 1mSv (0.1 rem) 2 ; and 2 All of the occupational doses in 4.6 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.

4.18.1.4 Individuals entering a high radiation area or a very high radiation area. 4.18.2 Each licensee or registrant shall monitor, to determine compliance with 4.9, the occupational intake of radioactive material by and assess the committed effective dose equivalent to: 4.18.2.1 Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in Table 4B1, Columns 1 and 2, of Appendix 4B;

4.18.2.2 Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 1 mSv (0.1 rem); and 4.18.2.3 Declared pregnant women likely to receive during the entire pregnancy, a committed effective dose equivalent in excess of 1 mSv (0.1 rem). 4.18.3 Upon approval of the Department, an acceptable alternative to the use of continuous individual monitoring devices in order to demonstrate compliance with 4.18.1 and 4.18.2 may be used. 4.18.3.1 Acceptable alternative demonstrations that doses will not exceed 10 percent of the annual limits in 4.6.1, 4.12 and 4.13 include submittal to the Department of: (1) An acceptable application documenting six months of the use of continuous individual monitoring devices; or (2) An acceptable assessment from a qualified expert, as defined in 1.4, that takes into account design configuration, workload, radiation-producing machine output, and survey data.

4.18.3.2 To maintain approval of an acceptable alternative to the use of continuous individual monitoring devices:

(1) Reapplication under 4.18.3.1(1) or reassessment under 4.18.3.1(2) is required for any change in configuration, equipment or workload; and (2) The licensee or registrant shall include assessment of individual monitoring in the review of the radiation protection program required annually by 4.5. CONTROL OF EXPOSURE FROM EXTERNAL SOURCES IN RESTRICTED AREAS 4.19 Control of Access to High Radiation Areas.

4.19.1 The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

4.19.1.1 A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from the source of radiation from any surface that the radiation penetrates; or 4.19.1.2 A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or 4.19.1.3 Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

4.19.2 In place of the controls required by 4.19.1 for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

4.19.3 The licensee or registrant may apply to the Department for approval of alternative methods for controlling access to high radiation areas.

4.19.4 The licensee or registrant shall establish the controls required by 4.19.1 and 4.19.3 in a way that does not prevent individuals from leaving a high radiation area. 4.19.5 The licensee or registrant is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation provided that:

4.19.5.1 The packages do not remain in the area longer than 3 days; and 4.19.5.2 The dose rate at 1 meter from the external surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.

4.19.6 The licensee or registrant is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Part 4 and to operate within the ALARA provisions of the licensee's or registrant's radiation protection program.

4.19.7 The licensee or registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in 4.19 if the licensee or registrant has met all the specific requirements for access and control specified in other applicable parts of these regulations, such as, Part 5 for industrial radiography, Part 6 for x- rays in the healing arts, and Part 9 for particle accelerators. 4.20 Control of Access to Very High Radiation Areas.

4.20.1 In addition to the requirements in 4.19, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 Gy (500 rad) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self-shielded irradiators.

4.20.2 The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in 4.20.1 if the registrant has met all the specific requirements for access and control specified in other applicable parts of these regulations, such as, Part 5 for industrial radiography, Part 6 for x-rays in the healing arts, and Part 9 for particle accelerators. 4.21 Control of Access to Very High Radiation Areas - Irradiators. 4.21.1 Section 4.21 applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. Section 4.21 does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual. 4.21.2 Each area in which there may exist radiation levels in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials shall meet the following requirements:

4.21.2.1 Each entrance or access point shall be equipped with entry control devices which: (1) Function automatically to prevent any individual from inadvertently entering a very high radiation area; and (2) Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (3) Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 1 mSv (0.1 rem) in 1 hour.

4.21.2.2 Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by 4.21.2.1:

(1) The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (2) Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

4.21.2.3 The licensee or registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container: (1) The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (2) Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier. 4.21.2.4 When the shield for stored sealed sources is a liquid, the licensee or registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

4.21.2.5 Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of 4.21.2.3 and 4.21.2.4. 4.21.2.6 Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation. 4.21.2.7 Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.

4.21.2.8 Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour. 4.21.2.9 The entry control devices required in 4.21.2.1 shall be tested for proper functioning. See 4.49 for recordkeeping requirements.

(1) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day; and (2) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and (3) The licensee or registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

4.21.2.10 The licensee or registrant shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.

4.21.2.11 Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and to automatically prevent loose radioactive material from being carried out of the area.

4.21.3 Licensees, registrants, or applicants for licenses or registrations for sources of radiation within the purview of 4.21.2 which will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of 4.21.2, such as those for the automatic control of radiation levels, may apply to the Department for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in 4.21.2. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.

4.21.4 The entry control devices required by 4.21.2 and 4.21.3 shall be established in such a way that no individual will be prevented from leaving the area.

RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE IN RESTRICTED AREAS 4.22 Use of Process or Other Engineering Controls.

The licensee shall use, to the extent practical, process or other engineering controls, such as containment, decontamination or ventilation, to control the concentrations of radioactive material in air.

4.23 Use of Other Controls.

4.23.1 When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means: 4.23.1.1 Control of access; or 4.23.1.2 Limitation of exposure times; or 4.23.1.3 Use of respiratory protection equipment; or 4.23.1.4 Other controls.

4.23.2 If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on workers' industrial health and safety. 4.24 Use of Individual Respiratory Protection Equipment. 4.24.1 If the licensee uses respiratory protection equipment to limit intakes pursuant to 4.23: 4.24.1.1 Except as provided in 4.24.1.2, the licensee shall use only respiratory protection equipment that is tested and certified or had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration.

4.24.1.2 If the licensee wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration, or has not had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration, or for which there is no schedule for testing or certification, the licensee shall submit an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of reliable test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. 4.24.1.3 The licensee shall implement and maintain a respiratory protection program that includes:

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; and (2) Surveys and bioassays, as appropriate, to evaluate actual intakes; and (3) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; and (4) Written procedures regarding selection, fitting, issuance, maintenance, repair, quality assurance, storage and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; limitations on periods of respirator use and relief from respirator use; breathing air quality; monitoring, including air sampling and bioassays; inventory, control and recordkeeping; and (5) Determination by a physician, prior to initial fitting of respirators, before the first field use of non-face-sealing respirators, and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. (6) Fit testing, with fit factor 10 times the assigned protection factor (APF) for negative pressure devices, and a fit factor greater than or equal to 500 for any positive pressure, continuous flow, and pressure demand devices, before the first field use of tight-fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

4.24.1.4 The licensee shall:

(1) Issue a written policy statement on respirator usage covering: (a) The use of process or other engineering controls, instead of respirators; and (b) The routine, nonroutine, and emergency use of respirators; and (c) The length of periods of respirator use and relief from respirator use; and (2) Advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

4.24.1.5 The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator. 4.24.1.6 Standby rescue persons are required whenever one piece atmosphere supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

4.24.1.7 Atmosphere-supplying respirators must be supplied with respirable air of Grade D quality or better as defined by the Compressed Gas Association in Publication G-7.1, “Commodity Specification For Air,” edition 5, published August 27, 2004, and included in the regulations of the Occupational Safety And Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E), July 1, 2004).

Grade D quality air criteria include:

(1) Oxygen content (V/V) between 19.5 per cent and 23.5 per cent; (2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less; (3) Carbon monoxide (CO) content of 10 parts per million or less; (4) Carbon dioxide content of 1,000 parts per million or less; and (5) Lack of noticeable odor.

4.24.1.8 The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face, facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight fitting respirator facepiece. 4.24.1.9 In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used. 4.24.2 When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes pursuant to 4.23, provided that the following conditions, in addition to those in 4.24.1, are satisfied: 4.24.2.1 The licensee selects respiratory protection equipment that provides a protection factor, specified in Appendix 4A, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Appendix 4B, Table 4B1, Column 3. However, if the selection of respiratory protection equipment with a protection factor greater than the multiple defined in the preceding sentence is inconsistent with the goal specified in 4.23 of keeping the total effective dose equivalent ALARA, the licensee may select respiratory protection equipment with a lower protection factor provided that such a selection would result in a total effective dose equivalent that is ALARA. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the average concentration in air, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used; if the exposure is later found to be less than initially estimated, the corrected value may be used.

4.24.2.2 The licensee shall obtain authorization from the Department before assigning respiratory protection factors in excess of those specified in Appendix 4A. The Department may authorize a licensee to use higher protection factors on receipt of an application that:

(1) Describes the situation for which a need exists for higher protection factors, and (2) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use. 4.24.3 In an emergency, the licensee shall use as emergency equipment only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration.

4.24.4 The licensee shall notify the Department in writing at least 30 days before the date that respiratory protection equipment is first used pursuant to either 4.24.1 or 4.24.2. 4.24.5 The Department may impose restrictions in addition to the provisions of 4.23.2, 4.24.1, and Appendix 4A, in order to:

4.24.5.1 Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and 4.24.5.2 Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION 4.25 Security of Stored Sources of Radiation.

4.25.1 The licensee shall secure from unauthorized removal or access licensed or registered sources of radiation that are stored in unrestricted areas.

4.25.2 Security requirements for portable gauges.

Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee. 4.26 Control of Sources of Radiation not in Storage.

4.26.1 The licensee shall control and maintain constant surveillance of licensed or registered radioactive material that is in an unrestricted area and that is not in storage or in a patient. 4.26.2 The registrant shall maintain control of radiation machines that are in an unrestricted area and that are not in storage.

PRECAUTIONARY PROCEDURES 4.27 Caution Signs.

4.27.1 Standard Radiation Symbol. Unless otherwise authorized by the Department, the symbol prescribed by 4.27 shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows: RADIATION SYMBOL 4.27.1.1. Cross-hatched area is to be magenta, or purple, or black, and 4.27.1.2. The background is to be yellow.

4.27.2 Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of 4.27.1, licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

4.27.3 Additional Information on Signs and Labels.

In addition to the contents of signs and labels prescribed in Part 4, the licensee shall provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures. 4.28 Posting Requirements.

4.28.1 Posting of Radiation Areas.

The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol prescribed in 4.27 and the words “CAUTION, RADIATION AREA.” 4.28.2 Posting of High Radiation Areas.

The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol prescribed in 4.27 and the words “CAUTION, HIGH RADIATION AREA” or “DANGER, HIGH RADIATION AREA.”

4.28.3 Posting of Very High Radiation Areas.

The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol prescribed in 4.27 and words “GRAVE DANGER, VERY HIGH RADIATION AREA.”

4.28.4 Posting of Airborne Radioactivity Areas.

The licensee or registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol prescribed in 4.27 and the words “CAUTION, AIRBORNE RADIOACTIVITY AREA” or “DANGER, AIRBORNE RADIOACTIVITY AREA.” 4.28.5 Posting of Areas or Rooms in which Licensed or Registered Material is Used or Stored. The licensee or registrant shall post each area or room in which there is used or stored an amount of licensed or registered material exceeding 10 times the quantity of such material specified in Appendix 4C with a conspicuous sign or signs bearing the radiation symbol prescribed in 4.27 and the words “CAUTION, RADIOACTIVE MATERIAL(S)” or “DANGER, RADIOACTIVE MATERIAL(S).”

4.29 Exceptions to Posting Requirements.

4.29.1 A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met: 4.29.1.1 The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part 4; and 4.29.1.2 The area or room is subject to the licensee's or registrant's control. 4.29.2 Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to 4.28 provided that the total effective dose equivalent to individual members of the public from the patient does not exceed 1 millisievert (0.1 rem) in a year. 4.29.3 A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 0.05 mSv (0.005 rem) per hour. 4.29.4 Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under 4.28 if:

4.29.4.1 Access to the room is controlled pursuant to 7.52; and 4.29.4.2 Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this part.

4.29.5 A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts. 4.30 Labeling Containers and Radiation Machines.

4.30.1 The licensee or registrant shall ensure that each container of licensed or registered material bears a durable, clearly visible label bearing the radiation symbol prescribed in 4.27 and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL.” The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures. 4.30.2 Each licensee or registrant shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials. 4.30.3 Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner, which cautions individuals that radiation is produced when it is energized. 4.31 Exemptions to Labeling Requirements.

A licensee or registrant is not required to label:

4.31.1 Containers holding licensed or registered material in quantities less than the quantities listed in Appendix 4C; or 4.31.2 Containers holding licensed or registered material in concentrations less than those specified in Table 4B3 of Appendix 4B; or 4.31.3 Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by Part 4; or 4.31.4 Containers when they are in transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation 3 or 3 Labeling of packages containing radioactive materials is required by the U.S. Department of Transportation if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by U.S. Department of Transportation regulations 49 CFR 173.403(m) and (w) and 173.421-424, October 1, 2003. 4.31.5 Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or 4.31.6 Installed manufacturing or process equipment, such as piping and tanks. 4.32 Procedures for Receiving and Opening Packages.

4.32.1 Each licensee or registrant who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in 17.2 and Appendix 17A of Part 17 of these regulations, shall make arrangements to receive:

4.32.1.1 The package when the carrier offers it for delivery; or 4.32.1.2 The notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.

4.32.2 Each licensee or registrant shall:

4.32.2.1 Monitor the external surfaces of a labeled 4 package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in 1.4 of these regulations; and 4 Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S. Department of Transportation regulations 49 CFR 172.403 and 172.436-440, October 1, 2003.

4.32.2.2 Monitor the external surfaces of a labeled 5 package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 17.2 and Appendix 17A to Part 17 of these regulations; and 5 Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S. Department of Transportation regulations 49 CFR 172.403 and 172.436-440, October 1, 2003.

4.32.2.3 Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.

4.32.3 The licensee or registrant shall perform the monitoring required by 4.32.2 as soon as practical after receipt of the package, but not later than 3 hours after the package is received at the licensee's or registrant's facility if it is received during the licensee's or registrant's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.

4.32.4 The licensee or registrant shall immediately notify the final delivery carrier and the Department by telephone, when:

4.32.4.1 Removable radioactive surface contamination exceeds the limits of 17.15.8 of these regulations; or 4.32.4.2 External radiation levels exceed the limits of 17.15.9 and 17.15.10 of these regulations. 4.32.5 Each licensee or registrant shall:

4.32.5.1 Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and 4.32.5.2 Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

4.32.6 Licensees or registrants transferring special form sources in vehicles owned or operated by the licensee or registrant to and from a work site are exempt from the contamination monitoring requirements of 4.32.2, but are not exempt from the monitoring requirement in 4.32.2 for measuring radiation levels that ensures that the source is still properly lodged in its shield. WASTE DISPOSAL 4.33 General Requirements.

4.33.1 A licensee or registrant shall dispose of licensed or registered material only: 4.33.1.1 By transfer to an authorized recipient as provided in 4.38 or in Parts 3, 14, or 18 of these regulations, or to the U.S. Department of Energy; or 4.33.1.2 By decay in storage; or 4.33.1.3 By release in effluents within the limits in 4.14; or 4.33.1.4 As authorized pursuant to 4.34, 4.35, 4.36 or 4.37. 4.33.2 A person shall be specifically licensed or registered to receive waste containing licensed or registered material from other persons for:

4.33.2.1 Treatment prior to disposal; or 4.33.2.2 Treatment or disposal by incineration; or 4.33.2.3 Decay in storage; or 4.33.2.4 Disposal at a land disposal facility pursuant to Part 14 of these regulations or as authorized under Parts 3 or 18 of these regulations; or 4.33.2.5 Storage until transferred to a storage or disposal facility authorized to receive the waste. 4.34 Method for Obtaining Approval of Proposed Disposal Procedures. A licensee or registrant or applicant for a license or registration may apply to the Department for approval of proposed procedures, not otherwise authorized in these regulations, to dispose of licensed or registered material generated in the licensee's or registrant's operations. Each application shall include:

4.34.1 A description of the waste containing licensed or registered material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal; and 4.34.2 An analysis and evaluation of pertinent information on the nature of the environment; and 4.34.3 The nature and location of other potentially affected facilities; and 4.34.4 Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in Part 4.

4.35 Disposal by Release into Sanitary Sewerage.

4.35.1 A licensee or registrant may discharge licensed or registered material into sanitary sewerage if each of the following conditions is satisfied:

4.35.1.1 The material is “readily soluble,” or is “readily dispersible biological material,” in water; and 4.35.1.2 The quantity of licensed or registered radioactive material that the licensee or registrant releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee or registrant does not exceed the concentration listed in Table 4B3 of Appendix 4B; and 4.35.1.3 If more than one radionuclide is released, the following conditions must also be satisfied:

(1) The licensee or registrant shall determine the fraction of the limit in Table 4B3 of Appendix 4B represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee or registrant into the sewer by the concentration of that radionuclide listed in Table 4B3 of Appendix 4B; and (2) The sum of the fractions for each radionuclide required by 4.35.1.3.1 does not exceed unity; and 4.35.1.4 The total quantity of licensed or registered radioactive material that the licensee or registrant releases into the sanitary sewerage in a year does not exceed 185 GBq (5 Ci) of hydrogen-3, 37 GBq (1 Ci) of carbon-14, and 37 GBq (1 Ci) of all other radioactive materials combined.

4.35.2 Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in 4.35.1.

4.36 Treatment or Disposal by Incineration.

A licensee or registrant may treat or dispose of licensed or registered material by incineration only in the amounts and forms specified in 4.37 or as specifically approved by the Department pursuant to 4.34.

4.37 Disposal of Specific Wastes.

4.37.1 A licensee or registrant may dispose of the following licensed or registered material as if it were not radioactive:

4.37.1.1 1.85 kBq (0.05 µCi), or less, of hydrogen-3 or carbon-14 per gr am of medium used for liquid scintillation counting; and 4.37.1.2 1.85 kBq (0.05 µCi), or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.

4.37.2 A licensee or registrant shall not dispose of tissue pursuant to 4.37.1.2 in a manner that would permit its use either as food for humans or as animal feed. 4.37.3 The licensee or registrant shall maintain records in accordance with 4.48. 4.38 Transfer for Disposal and Manifests.

4.38.1 The requirements of 4.38 and Appendix 4D are designed to control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this part, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes.

4.38.2 Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility shall document the information required on the uniform low-level radioactive waste manifest and transfer this recorded manifest information to the intended consignee in accordance with Appendix 4D.

4.38.3 Each shipment manifest shall include a certification by the waste generator as specified in Section II of Appendix 4D.

4.38.4 Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Section III of Appendix 4D. 4.39 Compliance with Environmental and Health Protection Regulations. Nothing in 4.33, 4.34, 4.35, 4.37 or 4.38 relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of pursuant to 4.33, 4.34, 4.35, 4.37 or 4.38. RECORDS 4.40 General Provisions.

4.40.1 Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by Part 4. 4.40.2 The licensee or registrant shall make a clear distinction among the quantities entered on the records required by Part 4 (e.g., total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, committed effective dose equivalent).

4.40.3 The licensee or registrant shall be consistent in their use of SI or special units. The licensee or registrant shall not change the units used on records required by Part 4 except at the beginning of the calendar year or with Department approval.

4.41 Records of Radiation Protection Programs.

4.41.1 Each licensee or registrant shall maintain records of the radiation protection program, including: 4.41.1.1 The provisions of the program; and 4.41.1.2 Audits and other reviews of program content and implementation. 4.41.2 The licensee or registrant shall retain the records required by 4.41.1.1 until the Department terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by 4.41.1.2 for 3 years after the record is made. 4.42 Records of Surveys.

4.42.1 Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by 4.17 and 4.32.2. The licensee or registrant shall retain these records for 3 years after the record is made.

4.42.2 The licensee or registrant shall retain each of the following records until the Department terminates each pertinent license or registration requiring the record: 4.42.2.1 Records of the results of surveys to determine the dose from external sources of radiation and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents; and 4.42.2.2 Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; and 4.42.2.3 Records showing the results of air sampling, surveys, and bioassays required pursuant to 4.24.1.3(1) and 4.24.1.3(2); and 4.42.2.4 Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

4.42.3 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Department Form R-16 or equivalent, or shall make provision with the Department for transfer to the Department.

4.43 Records of Tests for Leakage or Contamination of Sealed Sources. Records of tests for leakage or contamination of sealed sources required by 4.16 shall be kept in units of becquerel (or microcurie) and maintained for inspection by the Department for 5 years after the records are made.

4.44 Records of Prior Occupational Dose.

4.44.1 The licensee or registrant shall retain the records of prior occupational dose and exposure history as specified in 4.10 on Department Form R-16 or equivalent until the Department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Department Form R-16 or equivalent for 3 years after the record is made.

4.44.2 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Department Form R-16 or equivalent, or shall make provision with the Department for transfer to the Department.

4.45 Records of Planned Special Exposures.

4.45.1 For each use of the provisions of 4.11 for planned special exposures, the licensee or registrant shall maintain records that describe:

4.45.1.1 The exceptional circumstances requiring the use of a planned special exposure; and 4.45.1.2 The name of the management official who authorized the planned special exposure and a copy of the signed authorization; and 4.45.1.3 What actions were necessary; and 4.45.1.4 Why the actions were necessary; and 4.45.1.5 What precautions were taken to assure that doses were maintained ALARA; and 4.45.1.6 What individual and collective doses were expected to result; and 4.45.1.7 The doses actually received in the planned special exposure. 4.45.2 The licensee or registrant shall retain the records until the Department terminates each pertinent license or registration requiring these records.

4.45.3 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Department Form R-16 or equivalent, or shall make provision with the Department for transfer to the Department.

4.46 Records of Individual Monitoring Results.

4.46.1 Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to 4.18, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before January 1, 1994 need not be changed. These records shall include, when applicable:

4.46.1.1 The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; 4.46.1.2 The estimated intake of radionuclides (see 4.7); 4.46.1.3 The committed effective dose equivalent assigned to the intake of radionuclides; 4.46.1.4 The specific information used to assess and calculate the committed effective dose equivalent pursuant to 4.9.1 and 4.9.3, and when required by 4.18; 4.46.1.5 The total effective dose equivalent when required by 4.7; and 4.46.1.6 The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

4.46.2 Recordkeeping Frequency.

The licensee or registrant shall make entries of the records specified in 4.46.1 at intervals not to exceed 1 year.

4.46.3 Recordkeeping Format.

The licensee or registrant shall maintain the records specified in 4.46.1 on Department Form R- 17, Occupational Exposure Record for a Monitoring Period, in accordance with the instructions for Department Form R-17, or in clear and legible records containing all the information required by Department Form R-17.

4.46.4 The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.

4.46.5 The licensee or registrant shall retain each required form or record until the Department terminates each pertinent license or registration requiring the record. 4.46.6 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Department Form R-16 or equivalent, or shall make provision with the Department for transfer to the Department.

4.47 Records of Dose to Individual Members of the Public. 4.47.1 Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See 4.14. 4.47.2 The licensee or registrant shall retain the records required by 4.47.1 until the Department terminates each pertinent license or registration requiring the record. 4.48 Records of Waste Disposal.

4.48.1 Each licensee or registrant shall maintain records of the disposal of licensed or registered materials made pursuant to 4.34, 4.35, 4.36, 4.37, Part 14 of these regulations, and disposal by burial in soil, including burials authorized before December 30, 1985. 4.48.2 The licensee or registrant shall retain the records required by 4.48.1 in accordance with 3.15.4 until the Department terminates each pertinent license or registration requiring the record. 4.49 Records of Testing Entry Control Devices for Very High Radiation Areas. 4.49.1 Each licensee or registrant shall maintain records of tests made pursuant to 4.21.2.9 on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

4.49.2 The licensee or registrant shall retain the records required by 4.49.1 for 3 years after the record is made.

4.50 Form of Records.

Each record required by Part 4 shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in Department-approved electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. REPORTS 4.51 Reports of Stolen, Lost, or Missing Licensed or Registered Sources of Radiation. 4.51.1 Telephone Reports.

Each licensee or registrant shall report to the Department by telephone as follows: 4.51.1.1 Immediately after its occurrence becomes known to the licensee or registrant, stolen lost, or missing licensed or registered radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix 4C under such circumstances that it appears to the licensee or registrant that an exposure could result to individuals in unrestricted areas; or 4.51.1.2 Within 30 days after its occurrence becomes known to the licensee or registrant, lost, stolen, or missing licensed or registered radioactive material in an aggregate quantity greater than 10 times the quantity specified in Appendix 4C that is still missing. 4.51.1.3 Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine.

4.51.2 Written Reports.

Each licensee or registrant required to make a report pursuant to 4.51.1 shall, within 30 days after making the telephone report, make a written report to the Department setting forth the following information:

4.51.2.1 A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

4.51.2.2 A description of the circumstances under which the loss or theft occurred; and 4.51.2.3 A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved; and 4.51.2.4 Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; and 4.51.2.5 Actions that have been taken, or will be taken, to recover the source of radiation; and 4.51.2.6 Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation. 4.51.3 Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

4.51.4 The licensee or registrant shall prepare any report filed with the Department pursuant to 4.51 so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

4.52 Notification of Incidents.

4.52.1 Immediate Notification.

Notwithstanding other requirements for notification, each licensee or registrant shall notify the Department as soon as possible but not later than 4 hours after the discovery of an event: 4.52.1.1 Involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions: (1) An individual to receive:

(a) A total effective dose equivalent of 0.25 Sv (25 rem) or more; or (b) A lens dose equivalent of 0.75 Sv (75 rem) or more; or (c) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 Gy (250 rad) or more; or (2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.

4.52.1.2 That prevents immediate protective actions necessary to avoid exposures to radiation and/or radioactive materials that could exceed regulatory limits, or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

4.52.2 Twenty-Four Hour Notification.

Each licensee or registrant shall, within 24 hours of discovery of the event, report to the Department:

4.52.2.1 Each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:

(1) An individual to receive, in a period of 24 hours:

(a) A total effective dose equivalent exceeding 0.05 Sv (5 rem); or (b) A lens dose equivalent exceeding 0.15 Sv (15 rem); or (c) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 Sv (50 rem); or (2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

4.52.2.2 An unplanned contamination event that:

(1) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

(2) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix 4B for the material; and (3) Has access to the area restricted for a reason other than to allow isotopes with a half- life of less than 24 hours to decay prior to decontamination. 4.52.2.3 An event in which equipment is disabled or fails to function as designed when: (1) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and/or radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; and (2) The equipment is required to be available and operable when it is disabled or fails to function during the event; and (3) No redundant equipment is available and operable to perform the required safety function.

4.52.2.4 An event that requires unplanned medical treatment at a medical facility of an individual whose body or clothing is contaminated with spreadable radioactive material. 4.52.2.5 An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(1) The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix 4B for the material; and (2) The damage affects the integrity of the licensed material or its container. 4.53 Preparation and Submission of Reports.

4.53.1 Reports made by licensees or registrants in response to the requirements of 4.52, must be made as follows:

4.53.1.1 Licensees or registrants shall make the reports required by 4.52.1 and 4.52.2 to the Department by telephone. To the extent that the information is available at the time of notification, the information provided in these reports must include: (1) The caller's name and call back telephone number;

(2) A description of the event including date and time; (3) The exact location of the event;

(4) The isotopes, quantities, and chemical and physical form of the licensed material involved; and (5) Any personnel radiation exposure data available.

4.53.1.2 Each licensee or registrant who makes a report required by 4.52.1 or 4.52.2 shall submit a written follow-up report to the Department pursuant to 4.53.3 within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made.

4.53.1.3 The provisions of 4.52 do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to 4.54.

4.53.2 Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Constraints or Limits.

In addition to the notification required by 4.52, each licensee or registrant shall submit a written report to the Department within 30 days after learning of any of the following occurrences: 4.53.2.1 Incidents for which notification is required by 4.52; or 4.53.2.2 Doses in excess of any of the following:

(1) The occupational dose limits for adults in 4.6; or (2) The occupational dose limits for a minor in 4.12; or (3) The limits for an embryo/fetus of a declared pregnant woman in 4.13; or (4) The limits for an individual member of the public in 4.14; or (5) Any applicable limit in the license or registration; or (6) The ALARA constraints for air emissions established under 4.5.4. 4.53.2.3 Levels of radiation or concentrations of radioactive material in: (1) A restricted area in excess of applicable limits in the license or registration; or (2) An unrestricted area in excess of 10 times the applicable limit set forth in Part 4 or in the license or registration, whether or not involving exposure of any individual in excess of the limits in 4.14; or 4.53.2.4 For licensees subject to the provisions of U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190, July 1, 2004, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

4.53.3 Contents of Written Reports.

4.53.3.1 Each report required by 4.53.1.2 or 4.53.2 shall include the following, as appropriate: (1) A description of the event, including the possible cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (2) The exact location of the event;

(3) The isotopes, quantities, and chemical and physical form of the licensed material involved;

(4) Date and time of the event;

(5) The results of any evaluations or assessments, including: (a) Estimates of each individual's dose;

(b) The levels of radiation and concentrations of radioactive material involved; (c) The cause of the elevated exposures, dose rates, or concentrations; and (d) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

4.53.3.2 Each report filed pursuant to 4.53 shall include for each occupationally overexposed individual exposed: the name, Social Security account number, and date of birth. With respect to the limit for the embryo/fetus in 4.13, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report and must be clearly labeled “Privacy Act Information: Not for Public Disclosure” .

4.54 Reports of Planned Special Exposures.

The licensee or registrant shall submit a written report to the Department within 30 days following any planned special exposure conducted in accordance with 4.11, informing the Department that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by 4.45.

4.55 Reserved.

4.56 Reports of Individual Monitoring.

4.56.1 This section applies to each person licensed or registered by the Department to: 4.56.1.1 Possess or use sources of radiation for purposes of industrial radiography pursuant to Parts 3 and 5 of these regulations; or 4.56.1.2 Receive radioactive waste from other persons for disposal pursuant to Part 14 of these regulations; or 4.56.1.3 Possess or use at any time, for processing or manufacturing for distribution pursuant to Part 3 or 7 of these regulations, radioactive material in quantities exceeding any one of the following quantities:

Radionuclide 6 6 Activity Activity . Ci GBq Cesium-137 1 37 Cobalt-60 1 37 Gold-198 100 3,700 Iodine-131 1 37 Iridium-192 10 370 Krypton-85 1,000 37,000 Promethium-147 10 370 Technetium- 99m 1,000 37,000 6 The Department may require as a license condition, or by rule, regulation, or order pursuant to 1.9, reports from licensees or registrants who are licensed or registered to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels.

4.56.2 Each licensee or registrant in a category listed in 4.56.1 shall submit an annual report to the Department of the results of individual monitoring carried out by the licensee or registrant for each individual for whom monitoring was required by 4.18 during that year. The licensee or registrant may include additional data for individuals for whom monitoring was provided but not required. The licensee or registrant shall use Department Form R-17 or equivalent or Department- approved electronic media containing all the information required by Department Form R-17. 4.56.3 The licensee or registrant shall file the report required by 4.56.2, covering the preceding year, on or before April 30 of each year.

4.57 Notifications and Reports to Individuals.

4.57.1 Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in 10.4 of these regulations.

4.57.2 When a licensee or registrant is required pursuant to 4.53 to report to the Department any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the Department, and shall comply with the provisions of 10.4.1 of these regulations. 4.58 Reports of Leaking or Contaminated Sealed Sources. The licensee or registrant shall file a report within 5 days with the Department if the test for leakage or contamination indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken. ADDITIONAL REQUIREMENTS 4.59 Vacating Premises.

Each specific licensee or registrant shall, no less than 30 days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of the licensee's or registrant's activities, notify the Department in writing of intent to vacate. When deemed necessary by the Department, the licensee shall decontaminate the premises in such a manner as the Department may specify. 4.60 Permissible Levels of Radioactive Material in Uncontrolled Areas. 4.60.1 Plutonium. Contamination of the soil in excess of 2.0 disintegrations per minute (0.03 Bq) of plutonium per gram of dry soil or square centimeter of surface area (0.01 microcurie [370 Bq] per square meter) presents a sufficient hazard to the public health to require the utilization of special techniques of construction upon property so contaminated. Evaluation of proposed control techniques shall be available from the Department upon request. 4.61 Radiological Criteria For License Termination.

4.61.1 The criteria in this section apply to the decommissioning of facilities licensed under Parts 3, 5, 7, 14, 16, and 19 of these regulations. For low-level waste disposal facilities licensed under Part 14, the criteria apply only to the ancillary surface facilities that support radioactive waste disposal activities.

4.61.1.1 The criteria in this section do not apply to uranium and thorium recovery facilities already subject to Appendix 18A of Part 18; uranium solution extraction facilities; sites which have been decommissioned and the license terminated prior to July 1, 1999; or sites which submitted a decommissioning plan prior to July 1, 2000 and received Department approval of that decommissioning plan prior to July 1, 2001. 4.61.1.2 When calculating the TEDE to the average member of the critical group, the licensee shall determine the peak annual TEDE expected within the first 1000 years after decommissioning. In accordance with 1.5.1, the Department may authorize the licensee to exclude dose contributions from the inhalation of radon and its decay products when calculating TEDE.

4.61.1.3 Determination of dose and residual radioactivity levels which are as low as reasonably achievable (ALARA) must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

4.61.2 Radiological Criteria For Unrestricted Use.

A site will be considered acceptable for license termination under conditions of unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 0.25 mSv per year (25 mrem/y), including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are ALARA.

4.61.3 Radiological Criteria For Restricted Use.

A site will be considered acceptable for license termination under restricted conditions if: 4.61.3.1 The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of 4.61.2 would result in net public or environmental harm or were not being made because the residual levels of contamination associated with restricted conditions are ALARA;

4.61.3.2 The licensee has made provisions for durable, legally enforceable institutional controls which provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 0.25 mSv per year (25 mrem/y); and 4.61.3.3 Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is ALARA and would not exceed either: 1 mSv per year (100 mrem/y); or 5 mSv per year (500 mrem/y), provided the licensee demonstrates that further reductions in residual radioactivity necessary to comply with the 1-mSv-per-year (100 mrem/y) value of this paragraph are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm.

4.61.4 Alternate Criteria For License Termination.

4.61.4.1 The Department may terminate a license using alternate criteria greater than the dose criterion of 4.61.2 or 4.61.3.2, if:

(1) The licensee has performed an analysis for possible sources of exposure to radiation which provides assurance that public health and safety would continue to be protected, and that it is unlikely the TEDE to an average member of the critical group from all radiation that is distinguishable from background radiation, other than medical, would be more than 1 mSv per year (100 mrem/y); (2) The licensee has employed, to the extent practical, restrictions on site use which minimize exposures at the site in accordance with the provisions of 4.61.3; and (3) The licensee has reduced doses to levels which are ALARA. PART 4, APPENDIX 4A:

ASSIGNED PROTECTION FACTORS FOR RESPIRATORS a . Operating Mode Assigned Protection Factors I. Air purifying . .

b respirators [particulate c only] :

Filtering facepiece Negative pressure d ( )

disposable e Negative pressure 10 Facepiece, half Facepiece, full Negative pressure 100 Facepiece, half Powered air-purifying 50 respirators Facepiece, full Powered air-purifying 1000 respirators Helmet/hood Powered air-purifying 1000 respirators Facepiece, loose-fitting Powered air-purifying 25 respirators II. Atmosphere supplying . .

respirators [particulate, f gases and vapors ]:

1. Air-line respirator: . .

Facepiece, half Demand 10 Facepiece, half Continuous flow 50 Facepiece, half Pressure demand 50 Facepiece, full Demand 100 Facepiece, full Continuous flow 1000 Facepiece, full Pressure demand 1000 Helmet/hood Continuous flow 1000 Facepiece, loose-fitting Continuous flow 25 Suit Continuous flow g ( )

2. Self-contained . .

breathing apparatus (SCBA):

Facepiece, full Demand h 100 Facepiece, full Pressure demand i 10,000 Facepiece, full Demand, recirculating h 100 Facepiece, full Positive pressure i 10,000 recirculating III. Combination . .

respirators:

Any combination of air- Assigned protection .

purifying and factor for type and mode atmosphere-supplying of operation as listed respirators above.

a These assigned protection factors apply only in a respiratory protection program that meets the requirements of this part. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with department of labor regulations.

Radioactive contaminants for which the concentration values in Table 4B1, Column 3 of Appendix 4B are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits. b Air-purifying respirators with APF < 100 must be equipped with particulate filters that are at least 95 percent efficient. Air- purifying respirators with APF = 100 must be equipped with particulate filters that are at least 99 percent efficient. Air-purifying respirators with APFs > 100 must be equipped with particulate filters that are at least 99.97 percent efficient. c The licensee may apply to the commission for the use of an APF greater than 1 for sorbent cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine). d Licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device. All other respiratory protection program requirements listed in 4.24.1 apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test.

e Under-chin type only. No distinction is made in this appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 95 percent efficient and all other requirements of this part are met.

f The assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations. g No National Institute of Occupational Safety and Health (NIOSH) approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (that is, 4.24.1). h The licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life or health (IDLH).

I This type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.

PART 4, APPENDIX 4B:

ANNUAL LIMITS ON INTAKE (ALI) AND DERIVED AIR CONCENTRATIONS (DAC) OF RADIONUCLIDES FOR OCCUPATIONAL EXPOSURE; EFFLUENT CONCENTRATIONS; CONCENTRATIONS FOR RELEASE TO SANITARY SEWERAGE Introduction For each radionuclide, Table 4B1 indicates the chemical form which is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 µm, micron, and for three classes (D, W, Y) of radioactive material, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. Table 4B2 provides concentration limits for airborne and liquid effluents released to the general environment. Table 4B3 provides concentration limits for discharges to sanitary sewerage.

Note:

The values in Table 4B1, Table 4B2, and Table 4B3 are presented in the computer “E” notation. In this notation a value of 6E-02 represents a value of 6 x 10 -2 or 0.06, 6E+2 represents 6 x 10 2 or 600, and 6E+0 represents 6 x 10 0 or 6.

Table 1 “Occupational Values”

Note that the columns in Table 4B1 of this appendix captioned “Oral Ingestion ALI,” “Inhalation ALI,” and “DAC,” are applicable to occupational exposure to radioactive material. The ALIs in this appendix are the annual intakes of given radionuclide by “reference man” which would result in either (1) a committed effective dose equivalent of 0.05 Sv (5 rem), stochastic ALI, or (2) a committed dose equivalent of 0.5 Sv (50 rem) to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 0.05 Sv (5 rem). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, w . This weighting T factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of w are listed T under the definition of weighting factor in 4.3. The non-stochastic ALIs were derived to avoid non- stochastic effects, such as prompt damage to tissue or reduction in organ function. A value of w = 0.06 is applicable to each of the five organs or tissues in the “remainder” category T receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the Gl tract — stomach, small intestine, upper large intestine, and lower large intestine — are to be treated as four separate organs. Note that the dose equivalents for an extremity, skin and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used:

LLI wall = lower large intestine wall;

St. wall = stomach wall;

Blad wall = bladder wall; and Bone surf = bone surface.

The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative, the licensee may use the stochastic ALI to determine the committed effective dose equivalent. However, the licensee shall also ensure that the 0.5 Sv (50 rem) dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose equivalent to that organ, not the effective dose. For the case where there is no external dose contribution, this would be demonstrated if the sum of the fractions of the nonstochastic ALIs (ALI ) that contribute to the committed dose equivalent to the organ receiving ns the highest dose does not exceed unity, that is, ∑ (intake (in µCi) of each radionuclide/ALI ) ≤ 1.0. If ns there is an external deep dose equivalent contribution of H , then this sum must be less than 1 - (H / d d 50), instead of ≤ 1.0.

Note that the dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. The derived air concentration (DAC) values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by: DAC = ALI (in µCi)/(2000 hours per working year x 60 minutes/hour x 2 x 10 4 ml per minute) = (ALI/2.4 x 10 9 ) µCi/ml, where 2 x 10 4 ml is the volume of air breathed per minute at work by reference man under working conditions of light work.

The DAC values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately.

The ALI and DAC values include contributions to exposure by the single radionuclide named and any in- growth of decay product radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and decay product radionuclides should be treated by the general method appropriate for mixtures.

The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See 4.7. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as, Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different radionuclides.

It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides.

Table 2 “Effluent Concentrations”

The columns in Table 4B2 of this appendix captioned “Effluents,” “Air” and “Water” are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of 4.15. The concentration values given in Columns 1 and 2 of Table 4B2 are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.5 mSv (0.05 rem).

Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table 4B2. For this reason, the DAC and airborne effluent limits are not always proportional as they were in Appendix A of Part D of the Eighth Edition of Volume I of the Suggested State Regulations for Control of Radiation, April 2004.

The air concentration values listed in Table 4B2, Column 1, were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 10 9 , relating the inhalation ALI to the DAC, as explained above, and then divided by a factor of 300. The factor of 300 includes the following components: a factor of 50 to relate the 0.05 Sv (5 rem) annual occupational dose limit to the 0.1 rem limit for members of the public, a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups.

For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Table 4B1, Column 3 was divided by 219. The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case.

The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 10 7 . The factor of 7.3 x 10 7 (ml) includes the following components: the factors of 50 and 2 described above and a factor of 7.3 x 10 5 (ml) which is the annual water intake of reference man.

Note 2 of this appendix provides groupings of radionuclides which are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements. Table 3 “Releases to Sewerage”

The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in 4.35. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 10 6 (ml). The factor of 7.3 x 10 6 (ml) is composed of a factor of 7.3 x 10 5 (ml), the annual water intake by reference man, and a factor of 10, such that the concentrations, if the sewage released by the licensee were the only source of water ingested by a reference man during a year, would result in a committed effective dose equivalent of 0.5 rem. Table 4B1, Table 4B2, and Table 4B3 are found at http://www.cdphe.state.co.us/op/regs/radiationcontrol/10070104app.pdf LIST OF ELEMENTS Name Atomic Symbol Atomic Number Actinium Ac 89 Aluminum Al 13 Americium Am 95 Antimony Sb 51 Argon Ar 18 Arsenic As 33 Astatine At 85 Barium Ba 56 Berkelium Bk 97 Beryllium Be 4 Bismuth Bi 83 Bromine Br 35 Cadmium Cd 48 Calcium Ca 20 Californium Cf 98 Carbon C 6 Cerium Ce 58 Cesium Cs 55 Chlorine Cl 17 Chromium Cr 24 Cobalt Co 27 Copper Cu 29 Curium Cm 96 Dysprosium Dy 66 Einsteinium Es 99 Erbium Er 68 Europium Eu 63 Fermium Fm 100 Fluorine F 9 Francium Fr 87 Gadolinium Gd 64 Gallium Ga 31 Germanium Ge 32 Gold Au 79 Hafnium Hf 72 Holmium Ho 67 Hydrogen H 1 Indium In 49 Iodine I 53 Iridium Ir 77 Iron Fe 26 Krypton Kr 36 Lanthanum La 57 Lead Pb 82 Lutetium Lu 71 Magnesium Mg 12 Manganese Mn 25 Mendelevium Md 101 Mercury Hg 80 Molybdenum Mo 42 Neodymium Nd 60 Neptunium Np 93 Nickel Ni 28 Niobium Nb 41 Osmium Os 76 Palladium Pd 46 Phosphorus P 15 Platinum Pt 78 Plutonium Pu 94 Polonium Po 84 Potassium K 19 Praseodymium Pr 59 Promethium Pm 61 Protactinium Pa 91 Radium Ra 88 Radon Rn 86 Rhenium Re 75 Rhodium Rh 45 Rubidium Rb 37 Ruthenium Ru 44 Samarium Sm 62 Scandium Sc 21 Selenium Se 34 Silicon Si 14 Silver Ag 47 Sodium Na 11 Strontium Sr 38 Sulfur S 16 Tantalum Ta 73 Technetium Tc 43 Tellurium Te 52 Terbium Tb 65 Thallium Tl 81 Thorium Th 90 Thulium Tm 69 Tin Sn 50 Titanium Ti 22 Tungsten W 74 Uranium U 92 Vanadium V 23 Xenon Xe 54 Ytterbium Yb 70 Yttrium Y 39 Zinc Zn 30 Zirconium Zr 40 PART 4, APPENDIX 4C:

QUANTITIES j OF LICENSED OR REGISTERED MATERIAL REQUIRING LABELING * To convert µCi to kBq, multiply the µCi value by 37.

Note: For purposes of 4.28.5, 4.31.1, and 4.51.1, where there is involved a combination of radionuclides in known amounts, the limit for the combination shall be derived as follows: determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed “1” - that is, unity. j The quantities listed above were derived by taking 1/10th of the most restrictive ALI listed in Table 4B1, Columns 1 and 2, of Appendix 4B, rounding to the nearest factor of 10, and constraining the values listed between 37 Bq and 37 MBq (0.001 and 1,000 µCi). Values of 3.7 MBq (100 µCi) have been assigned for radionuclides having a radioactive half-life in excess of E+9 years, except Rhenium, 37 MBq (1,000 µCi), to take into account their low specific activity. PART 4, APPENDIX 4D:

REQUIREMENTS FOR TRANSFERS OF LOW-LEVEL RADIOACTIVE WASTE FOR DISPOSAL AT LAND DISPOSAL FACILITIES AND MANIFESTS I. Manifest A. A waste generator, collector, or processor who transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility must prepare a manifest reflecting information requested on applicable forms 540, uniform low-level radioactive waste manifest (shipping paper), and 541, Uniform Low-Level Radioactive Waste Manifest (container and waste description), and, if necessary, on an applicable Form 542, Uniform Low-Level Radioactive Waste Manifest (manifest index and regional compact tabulation). Forms 540 and 540a must be completed and must physically accompany the pertinent low-level waste shipment. Upon agreement between the shipper and consignee, Forms 541 and 541a and 542 and 542a may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate and complete records on the respective forms. B. Licensees are not required by this department to comply with manifesting requirements of this part when they ship:

1. Low-level radioactive waste for processing and expect its return (that is, for storage under their license) prior to disposal at a licensed land disposal facility; 2. Low-level radioactive waste that is being returned to the licensee who is the “waste generator” or “generator” as defined in this appendix; or 3. Radioactively contaminated material to a “waste processor” that becomes the processor's “residual waste” .

C. For guidance in completing these forms, refer to the instructions that accompany the forms. Copies of manifests required by this appendix may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.

D. As used in this appendix, the following definitions apply: “Chelating agent” means amine polycarboxylic acids, hydroxy-carboxylic acids, and polycarboxylic acids.

“Chemical description” means a description of the principal chemical characteristics of the low-level radioactive waste.

“Consignee” means the designated receiver of the shipment of low-level radioactive waste.

“Decontamination facility” means a facility operating under a U.S. Nuclear Regulatory Commission or Agreement State license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for the purposes of this Part, is not considered to be a consignee for low- level radioactive waste shipments.

“Disposal container” means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see “high integrity container” ). Note that for some shipments, the disposal container may be the transport package.

“EPA identification number” means the number received by a transporter following application to the administrator of the U.S. Environmental Protection Agency as required by 40 CFR Part 263, July 1, 2004.

Forms 540, 540a, 541, 541a, 542, and 542a are official forms referenced in this appendix. Licensees need not use originals of these forms so long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, Form 541 (and 541a) and Form 542 (and 542a) may be completed, transmitted and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest. “Generator” means a licensee operating under a Nuclear Regulatory Commission or Agreement State license who (1) is a waste generator as defined in this appendix or (2) is a licensee to whom waste can be attributed (for example, waste generated as a result of decontamination or recycle activities).

“High integrity container” (HIC) means a container commonly designed to meet the applicable Nuclear Regulatory Commission structural stability requirements and to meet U.S. Department of Transportation requirements for a Type A package. “Land disposal facility” means the same as in Part 14 of these regulations. “Physical description” means the items called for on Form 541 to describe a low-level radioactive waste.

“Residual waste” means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.

“Shipper” means the licensed entity (that is, the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.

“Shipping paper” means Form 540 and, if required, Form 540a which includes the information required by the U.S. Department of Transportation in 49 CFR Part 172, October 1, 2003.

“Uniform low-level radioactive waste manifest” or “uniform manifest” means the combination of Nuclear Regulatory Commission Forms 540, 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent. “Waste collector” means an entity, operating under a Nuclear Regulatory Commission or Agreement State license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.

“Waste description” means the physical, chemical and radiological description of a low-level radioactive waste as called for in Form 541.

“Waste generator” means an entity, operating under a Nuclear Regulatory Commission or Agreement State license, who (1) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (2) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a “waste generator” if the transfer low-level radioactive waste from the facility is defined as “residual waste” .

“Waste processor” means an entity, operating under a Nuclear Regulatory Commission or Agreement State license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility. “Waste type” means a waste within a disposal container having a unique physical description (that is, a specific waste descriptor code or description, or a waste sorbed on or solidified in a specifically defined media).

II. Information requirements A. General information. The shipper of the radioactive waste shall provide the following information on the uniform manifest:

1. The name, facility address, and telephone number of the licensee shipping the waste; 2. An explicit declaration indicating whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and 3. The name, address, and telephone number or the name and U.S. Environmental Protection Agency hazardous waste identification number for the carrier transporting the waste.

B. Shipment information. The shipper of the radioactive waste shall provide the following information regarding the waste shipment on the uniform manifest: 1. The date of the waste shipment;

2. The total number of packages/disposal containers;

3. The total disposal volume and disposal weight of the shipment; 4. The total radionuclide activity in the shipment;

5. The activity of each of the radionuclides H-3, C-14, Tc-99, and I-129 contained in the shipment; and 6. The total masses of U-233, U-235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material.

C. Disposal container and waste information. The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:

1. An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;

2. A physical description of the disposal container, including the manufacturer and model of any high integrity container;

3. The volume displaced by the disposal container;

4. The gross weight of the disposal container, including the waste; 5. For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;

6. A physical and chemical description of the waste;

7. The total weight percentage of chelating agent for any waste containing more than 0.1 % chelating agents by weight, plus the identity of the principal chelating agent; 8. The approximate volume of waste within the container; 9. The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;

10. The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types (that is, activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides associated with or contained in these waste types within a disposal container shall be reported; 11. The total radioactivity within each container; and 12. For wastes consigned to a disposal facility, the classification as Class A, Class B, or Class C pursuant to Section I of Appendix 4E. Waste not meeting the structural stability requirements of Appendix 4E shall be identified. D. Uncontainerized waste information The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container: 1. The approximate volume and weight of the waste;

2. A physical and chemical description of the waste;

3. The total weight percentage of chelating agent if the chelating agent exceeds 0.1 % by weight, plus the identity of the principal chelating agent; 4. For wastes consigned to a disposal facility, the classification as Class A, Class B, or Class C pursuant to Section I of Appendix 4E; Waste not meeting the structural stability requirements of Appendix 4E shall be identified; 5. The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material;

6. For wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.

E. Multi-generator disposal container information This section applies to disposal containers enclosing mixtures of waste originating from different generators. The origin of the low-level radioactive waste resulting from a processor's activities may be attributable to one or more “generators,” including “waste generators,” as defined in this Part. This section also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators.

1. For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.

2. For heterogenous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (that is, activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification stabilization media), the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container. For each generator, provide the following:

1. The volume of waste within the container 2. A physical and chemical description of the waste, including the solidification agent, if any;

3. The total weight percentage of chelating agent for any disposal container containing more than 0.1% chelating agents by weight, plus the identity of the principal chelating agent;

4. The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in Appendix 4E;

5. Radionuclide identities and activities contained in the waste, the masses of U 233, U- 235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material if contained in the waste.

III. Certification An authorized representative of the waste generator, collector or processor shall certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the Department of Transportation and the Department. A collector in signing the certification is certifying that nothing has been done to the collected waste which would invalidate the waste generator's certification.

IV. Control and tracking A. Any license who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in IV.A.1. through IV.A.9. of this section. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of IV.A.4. through IV.A.9. of this section. A licensee shall:

1. Prepare all wastes so that the waste is classified according to Section I of Appendix 4E and meets the waste characteristics requirements in Section II of Appendix 4E;

2. Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with Section I of Appendix 4E;

3. Conduct a quality assurance program to ensure compliance with Sections I and II of Appendix 4E; the program shall include management evaluation of audits; 4. Prepare the uniform manifest as required by this appendix; 5. Forward a copy or electronically transfer the uniform manifest to the intended consignee so that either:

a. Receipt of the manifest precedes the low-level radioactive waste shipment or b. The manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (a) and (b) is also acceptable;

6. Include Form 540 (and Form 540a, if required) with the shipment regardless of the option chosen in Section IV.A.5.;

7. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of Form 540;

8. Retain a copy of or electronically store the uniform manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 3.22 of these regulations; and 9. For any shipments or any portion of a shipment for which acknowledgment of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with Section V.

B. Any waste collector licensee who handles only prepackaged waste shall: 1. Acknowledge receipt of the waste from the shipper within 1 week of receipt by returning a signed copy of Form 540;

2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this appendix. The waste collector shall ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;

3. Forward a copy or electronically transfer the uniform manifest to the intended consignee so that either: (i) receipt of the manifest precedes the low-level radioactive waste shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;

4. Include Form 540 (and Form 540a, if required) with the shipment regardless of the option chosen in Section IV.B.3.;

5. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of Form 540;

6. Retain a copy of or electronically store the uniform manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 3.22 of these regulations; and 7. For any shipments or any portion of a shipment for which acknowledgment of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with Section V.

8. Notify the shipper and the department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

C. Any licensed waste processor who treats or repackages wastes shall: 1. Acknowledge receipt of the waste from the shipper within 1 week of receipt by returning a signed copy of Form 540;

2. Prepare a new manifest that meet the requirements of this appendix. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and the other information required in Section II.E of this appendix;

3. Prepare all wastes so that the waste is classified according to Appendix 4E and meets the waste characteristics requirements in Section I of Appendix 4E; 4. Label each package of waste to identify whether is Class A waste, Class B waste, or Class C waste in accordance with Appendix 4E;

5. Conduct a quality assurance program to ensure compliance with Sections I and II of Appendix 4E; the program shall include management evaluation of audits; 6. Forward a copy or electronically transfer the uniform manifest to the intended consignee so that either:

a. Receipt of the manifest precedes the low-level radioactive waste shipment or b. The manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (a) and (b) is also acceptable;

7. Include Form 540 (and Form 540a, if required) with the shipment regardless of the option chosen in IV.C.6;

8. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of Form 540;

9. Retain a copy of or electronically store the uniform manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 3.22 of these regulations; and 10. For any shipments or any portion of a shipment for which acknowledgment of receipt has not been received within the times set forth in this appendix, conduct an investigation in accordance with Section V.

11. Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

D. The land disposal facility operator shall:

1. Acknowledge receipt of the waste within 1 week of receipt by returning, as a minimum, a signed copy of Form 540 to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the uniform manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating the discrepancy;

2. Maintain copies of all completed manifests and electronically store the information required by Part 14 of these Regulations until license termination; 3. Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

V. Any shipment or part of a shipment for which acknowledgement is not received within the times set forth in this section shall:

A. Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and B. Be traced and reported. The investigation shall include tracing the shipment and filing a report with the Department. Each licensee who conducts a trace investigation shall file a written report with the Department within 2 weeks of completion of the investigation. C. Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.

APPENDIX E:

CLASSIFICATION AND CHARACTERISTICS OF LOW-LEVEL RADIOACTIVE WASTE I. Classification of Radioactive Waste for Land Disposal A. Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.

B. Classes of waste.

1. Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in Section II.A. If Class A waste also meets the stability requirements set forth in Section II.B. It is not necessary to segregate the waste for disposal.

2. Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in Section II.

3. Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in Section II.

C. Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in Table 4B1, classification shall be determined as follows: 1. If the concentration does not exceed 0.1 times the value in Table 4B1, the waste is Class A.

2. If the concentration exceeds 0.1 times the value in Table 4B1, but does not exceed the value in Table 4B1, the waste is Class C.

3. If the concentration exceeds the value in Table 4B1, the waste is not generally acceptable for land disposal.

4. For wastes containing mixtures of radionuclides listed in Table 4B1, the total concentration shall be determined by the sum of fractions rule described in Section I.G. of this appendix.

TABLE 1 . Concentration Concentration Radionuclide k l curie/cubic meter nanocurie/gram 3 (nCi/g)

(Ci/m )

C-14 in activated metal 80 .

C-14 8 .

Ni-59 in activated metal 220 .

Nb-94 in activated metal 0.2 .

I-129 0.08 .

Tc-99 3 .

Alpha-emitting . 100 transuranic radionuclides with half-life greater than five years Cm-242 . 20,000 Ra-226 100 .

Pu-241 3,500 .

k To convert the Ci/m3 values to gigabecquerel (GBq) per cubic meter, multiply the Ci/m3 value by 37. l To convert the nCi/g values to becquerel (Bq) per gram , multiply the nCi/g value by 37. D. Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in Table 4B1, classification shall be determined based on the concentrations shown in Table 4B2. However, as specified in Section I.F. of this appendix, if radioactive waste does not contain any nuclides listed in either Table 4B1 or Table 4B2, it is Class A. 1. If the concentration does not exceed the value in Column 1, the waste is Class A. 2. If the concentration exceeds the value in Column 1 but does not exceed the value in Column 2, the waste is Class B.

3. If the concentration exceeds the value in Column 2 but does not exceed the value in Column 3, the waste is Class C.

4. If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.

5. For wastes containing mixtures of the radionuclides listed in Table 4B2, the total concentration shall be determined by the sum of fractions rule described in Section I.G.

TABLE 2 Radionuclide Concentration, curie/cubic meter* curie/cubic meter* . Column 1 Column 2 Column 3 Total of all radionuclides 700 * * with less than 5-year half- life Co-60 700 * * Cs-137 1 44 4600 H-3 40 * * Ni-63 3.5 70 700 Ni-63 in activated metal 35 700 7000 Sr-90 0.04 150 7000 *Department Note: To convert the Ci/m3 value to gigabecquerel (GBq) per cubic meter, multiply the Ci/m3 value by 37. There are no limits established for these radionuclides in Class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be Class B unless the concentrations of other radionuclides in Table 4B2 determine the waste to be Class C independent of these radionuclides.

E. Classification determined by both long- and short-lived radionuclides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in Table 4B1 and some of which are listed in Table 4B2, classification shall be determined as follows: 1. If the concentration of a radionuclide listed in Table 4B1 is less than 0.1 times the value listed in Table 4B1, the class shall be that determined by the concentration of radionuclides listed in Table 4B2.

2. If the concentration of a radionuclide listed in Table 4B1 exceeds 0.1 times the value listed in Table 4B1, but does not exceed the value in Table 4B1, the waste shall be Class C, provided the concentration of radionuclides listed in Table 4B2 does not exceed the value shown in Column 3 of Table 4B2.

F. Classification of wastes with radionuclides other than those listed in Table 4B1 and Table 4B2. If the waste does not contain any radionuclides listed in either Table 4B1 or Table 4B2, it is Class A.

G. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 1.85 TBq/m 3 (50 Ci/m 3 ) and Cs-137 in a concentration of 814 GBq/m 3 (22 Ci/m 3 ). Since the concentrations both exceed the values in Column 1, Table 4B2, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.

H. Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as becquerel (microcurie) per gram.

II. Radioactive Waste Characteristics A. The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site. 1. Wastes shall be packaged in conformance with the conditions of the license issued to the site operator to which the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of Part 4, the site license conditions shall govern.

2. Wastes shall not be packaged for disposal in cardboard or fiberboard boxes. 3. Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid.

4. Solid waste containing liquid shall contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1 % of the volume.

5. Waste shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

6. Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with Section II.A.8.

7. Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable.

8. Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20° C. Total activity shall not exceed 3.7 TBq (100 Ci) per container.

9. Wastes containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.

B. The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.

1. Waste shall have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal. 2. Notwithstanding the provisions in Section II.A.3. and II.A.4., liquid wastes, or wastes containing liquid, shall be converted into a form that contains as little free- standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1 % of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.

3. Void spaces within the waste and between the waste and its package shall be reduced to the extent practicable.

III. Labeling.

Each package of waste shall be clearly labeled to identify whether it is Class A, Class B, or Class C waste, in accordance with Section I.

PART 4, APPENDIX 4F:

QUANTITIES FOR USE WITH DECOMMISSIONING Material Microcurie* Americium-241 0.01 Antimony-122 100 Antimony-124 10 Antimony-125 10 Arsenic-73 100 Arsenic-74 10 Arsenic-76 10 Arsenic-77 100 Barium-131 10 Barium-133 10 Barium-140 10 Bismuth-210 1 Bromine-82 10 Cadmium-109 10 Cadmium-115 100 Cadmium-115m 10 Calcium-45 10 Calcium-47 10 Carbon-14 100 Cerium-141 100 Cerium-143 100 Cerium-144 1 Cesium-131 1,000 Cesium-134 1 Cesium-134m 100 Cesium-135 10 Cesium-136 10 Cesium-137 10 Chlorine-36 10 Chlorine-38 10 Chromium-51 1,000 Cobalt-58 10 Cobalt-58m 10 Cobalt-60 1 Copper-64 100 Dysprosium-165 10 Dysprosium-166 100 Erbium-169 100 Erbium-171 100 Europium-152 (13 yr) 1 Europium-152 (9.2 h) 100 Europium-154 1 Europium-155 10 Florine-18 1,000 Gadolinium-153 10 Gadolinium-159 100 Gallium-72 10 Germanium-71 100 Gold-198 100 Gold-199 100 Hafnium-181 10 Holmium-166 100 Hydrogen-3 1,000 Indium-113m 100 Indium-114m 10 Indium-115 10 Indium-115m 100 Iodine-125 1 Iodine-126 1 Iodine-129 0.1 Iodine-131 1 Iodine-132 10 Iodine-133 1 Iodine-134 10 Iodine-135 10 Iridium-192 10 Iridium-194 100 Iron-55 100 Iron-59 10 Krypton-85 100 Krypton-87 10 Lanthanum-140 10 Lutetium-177 100 Manganese-52 10 Manganese-54 10 Manganese-56 10 Mercury-197 100 Mercury-197m 100 Mercury-203 10 Molybdenum-99 100 Neodymium-147 100 Neodymium-149 100 Nickel-59 100 Nickel-63 10 Nickel-65 100 Niobium-93m 10 Niobium-95 10 Niobium-97 10 Osmium-185 10 Osmium-191 100 Osmium-191m 100 Osmium-193 100 Palladium-103 100 Palladium-109 100 Phosphorus-32 10 Platinum-191 100 Platinum-193 100 Platinum-193m 100 Platinum-197 100 Platinum-197m 100 Plutonium-239 0.01 Polonium-210 0.1 Potassium-42 10 Praseodymium-142 100 Praseodymium-143 100 Promethium-147 10 Promethium-149 10 Radium-226 0.01 Rhenium-186 100 Rhenium-188 100 Rhodium-103m 100 Rhodium-105 100 Rubidium-86 10 Rubidium-87 10 Ruthenium-103 10 Ruthenium-105 10 Ruthenium-106 1 Ruthenium-97 100 Samarium-151 10 Samarium-153 100 Scandium-46 10 Scandium-47 100 Scandium-48 10 Selenium-75 10 Silicon-31 100 Silver-105 10 Silver-111 100 Silver-110m 1 Sodium-22 1 Sodium-24 10 Strontium-85 10 Strontium-89 1 Strontium-90 0.1 Strontium-91 10 Strontium-92 10 Sulfur -35 100 Tantalum-182 10 Technetium-96 10 Technetium-97 100 Technetium-97m 100 Technetium-99 10 Technetium-99m 100 Tellurium-125m 10 Tellurium-127 100 Tellurium-127m 10 Tellurium-129 100 Tellurium-129m 10 Tellurium-131m 10 Tellurium-132 10 Terbium-160 10 Thallium-200 100 Thallium-201 100 Thallium-202 100 Thallium-204 10 Thorium (natural)** 100 Thulium-170 10 Thulium-171 10 Tin-113 10 Tin-125 10 Tungsten-181 10 Tungsten-185 10 Tungsten-187 100 Uranium (natural)*** 100 Uranium-233 0.01 Uranium-234 0.01 Uranium-235 0.01 Vanadium-48 10 Xenon-131m 1,000 Xenon-133 100 Xenon-135 100 Ytterbium-175 100 Yttrium-90 10 Yttrium-91 10 Yttrium-92 100 Yttrium-93 100 Zinc-65 10 Zinc-69 1,000 Zinc-69m 100 Zirconium-93 10 Zirconium-95 10 Zirconium-97 10 Any alpha emitting 0.01 radionuclide not listed above or mixtures of alpha emitters of unknown composition Any radionuclide other 0.1 than alpha emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition * .

To convert µCi to kBq, multiply the µCi value by 37.

** .

Based on alpha disintegration rate of Th- 232, Th-230 and their decay products.

*** .

Based on alpha disintegration rate of U- 238, U-234, and U-235.

Note: Where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed “1” — that is, unity.

PART 5:

RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS 5.1 Purpose.

This Part prescribes requirements for the issuance of licenses or registrations for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography.

5.2 Scope.

The provisions and requirements of this Part are in addition to, and not in substitution for, other requirements of these regulations. In particular, the general requirements and provisions of Parts 1, 2, 3, 4, 10, and 17, of these regulations apply to applicants, licensees and registrants subject to this Part. Parts 3 and 17 of these regulations apply to licensing and transportation of radioactive material. Part 2 of these regulations applies to the registration of radiation machines. Except for sections which are applicable only to sealed radioactive sources, radiation machines and sealed radioactive sources are both covered by this Part. This regulation does not apply to medical uses of sources of radiation which are addressed in Parts 6 and 20 of these regulations. 5.3 Definitions.

As used in this Part, the following definitions apply:

“Annual refresher safety training” means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions. “Associated equipment” means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the source (e.g., guide tube, control tube, control (drive) cable, removable source stop, “J” tube and collimator when used as an exposure head).

“Cabinet radiography” means industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for individual members of the public as specified in 4.14 of these regulations.

“Cabinet x-ray system” means an x-ray system with the x-ray tube installed in an enclosure, hereinafter termed a cabinet, that is independent of existing architectural structures except the floor. The cabinet x-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. This definition includes x-ray systems designed primarily for the inspection of carry- on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet x-ray system. “Camera” (see “radiographic exposure device” ).

“Certifiable cabinet x-ray system” means an existing uncertified x-ray system that has been modified to meet the certification requirements specified in 21 CFR 1020.40, April 1, 2004. “Certified cabinet x-ray system” means an x-ray system that has been certified in accordance with 21 CFR 1010.2, April 1, 2004, as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40, April 1, 2004.

“Certifying entity” means an independent certifying organization meeting the requirements in Appendix A of this Part or a state regulatory program meeting the requirements in Appendix A, Sections II and III of this Part.

“Collimator” means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

“Control cable” means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

“Control drive mechanism” means a device that enables the source assembly to be moved into and out of the exposure device.

“Control tube” means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device. “Drive cable” (see “control cable” ).

“Exposure head” means a device that locates the gamma radiography sealed source in the selected working position. An exposure head is also known as a source stop. “Field station” means a facility from which sources of radiation may be stored or used and from which equipment is dispatched.

“Guide tube” means a flexible or rigid tube, or “J” tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

“Hands-on experience” means experience in all of those areas considered to be directly involved in the radiography process, and includes taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records and radiation area surveillance, etc., as applicable. Excessive time spent in only one or two of these areas, such as film development or radiation area surveillance, should not be counted toward the 2000 hours of hands-on experience required for a radiation safety officer in 5.16.1.2 or the hands-on experience for a radiographer as required by 5.17.1. “Independent certifying organization” means an independent organization that meets all of the criteria of Appendix A of this Part.

“Industrial radiography” means an examination of the structure of materials by the nondestructive method of utilizing ionizing radiation to make radiographic images. “Lay-barge radiography” means industrial radiography performed on any water vessel used for laying pipe.

“Offshore platform radiography” means industrial radiography conducted from a platform over a body of water.

“Permanent radiographic installation” means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed. “Pigtail” (see “source assembly” ).

“Pill” (see “sealed source” ).

“Practical examination” means a demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.

“Projection sheath” (see “guide tube” ).

“Projector” (see “radiographic exposure device” ).

“Radiation safety officer for industrial radiography” means an individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of 5.16.

“Radiographer” means any individual who performs or who, in attendance at the site where the sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of the Department's regulations and the conditions of the license or registration. “Radiographer certification” means written approval received from a certifying entity stating that an individual has satisfactorily met the radiation safety, testing, and experience criteria in 5.17. “Radiographer's assistant” means any individual who under the personal supervision of a radiographer, uses radiographic exposure devices, sources of radiation, related handling tools, or radiation survey instruments in industrial radiography. “Radiographic exposure device” means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure. “Radiographic operations” means all activities performed with a radiographic exposure device, or with a radiation-producing machine. Such activities include: using; transporting except by common or contract carriers; storing at a temporary job site; performing surveys to confirm the adequacy of boundaries; setting up equipment; and any activity inside restricted area boundaries. Transporting a radiation machine is not considered a radiographic operation. “Radiography” (see “industrial radiography” ).

“S-tube” means a tube through which the radioactive source travels when inside a radiographic exposure device.

“Shielded position” means the location within the radiographic exposure device, source changer, or storage container that, by manufacturer's design, is the proper location for storage of the sealed source.

“Source assembly” means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may include a ballstop to secure the source in the shielded position.

“Source changer” means a device designed and used for replacement of sealed sources in radiographic exposure devices. They may also be used for transporting and storing sealed sources.

“Storage area” means any location, facility, or vehicle that is used to store and secure a radiographic exposure device, a radiation machine, or a storage container when it is not used for radiographic operations. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the device, machine, or container. “Storage container” means a device in which sealed sources or radiation machines are secured and stored.

“Temporary jobsite” means a location where radiographic operations are performed and where sources of radiation may be stored other than the location(s) of use authorized on the license or registration.

“Underwater radiography” means radiographic operations performed when the radiographic exposure device or radiation machine and/or related equipment are beneath the surface of the water.

5.4 Exemptions.

5.4.1 Uses of certified and certifiable cabinet x-ray systems are exempt from the requirements of this Part except for the following:

5.4.1.1 For certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals:

(1) No registrant shall permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the unit and has demonstrated competence in its use. Records that demonstrate compliance with this subparagraph shall be maintained for Department inspection until disposal is authorized by the Department. (2) Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed six months. Records of these tests shall be maintained for Department inspection until disposal is authorized by the Department. (3) The registrant shall perform an evaluation of the radiation exposure to determine compliance with 4.14.1 and 4.14.3 of these regulations, and 21 CFR 1020.40, April 1, 2004 (Cabinet X-Ray Systems, 39 Federal Register 12986, April 10, 1974), at intervals not to exceed one year. Records of these evaluations shall be maintained for Department inspection for two years after the evaluation. 5.4.1.2 Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40, April 1, 2004 (Cabinet X-Ray Systems, 39 Federal Register 12986, April 10, 1974), and no modification shall be made to the system unless prior Department approval has been granted.

5.4.2 Industrial uses of hand-held light intensified imaging devices are exempt from the requirements of this Part if the dose rate 45 cm (18 inches) from the source of radiation to any individual does not exceed 0.02 millisievert (2 millirem) per hour. When this dose rate limit is exceeded, such devices shall meet the applicable requirements of this Part and the licensing or registration requirements of Part 2 or Part 3 of these regulations, as applicable. 5.5 Licensing and Registration Requirements for Industrial Radiography Operations. The Department will approve an application for a specific license for the use of licensed material or a registration for use of radiation machines if the applicant meets the following requirements, as applicable:

5.5.1 The applicant satisfies the general requirements specified in Part 2 for radiation machine facilities or Part 3 for radioactive material, as applicable, and any special requirements contained in this Part;

5.5.2 The applicant submits documentation demonstrating an adequate program for training radiographers and radiographer's assistants that meets the requirements of 5.17. 5.5.3 The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid;

5.5.4 The applicant submits written operating and emergency procedures as described in 5.18; 5.5.5 The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed 6 months as described in 5.17.5;

5.5.6 The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility;

5.5.7 The applicant submits the qualifications of the individual(s) designated as the radiation safety officer as described in 5.16.1, 5.5.8 If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test. The description must include the:

5.5.8.1 Methods of collecting the samples;

5.5.8.2 Qualifications of the individual who analyzes the samples; 5.5.8.3 Instruments to be used; and 5.5.8.4 Methods of analyzing the samples.

5.5.9 If the applicant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant must describe methods to be used and the experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 5.9 and 5.20.7.4;

5.5.10 The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations;

5.5.11 The applicant identifies the location(s) where all records required by this and other Parts of these regulations will be maintained;

5.5.12 If a license application includes underwater radiography, a description of: 5.5.12.1 Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;

5.5.12.2 Radiographic equipment and radiation safety equipment unique to underwater radiography; and 5.5.12.3 Methods for gas-tight encapsulation of equipment; and 5.5.13 If an application includes offshore platform and/or lay-barge radiography, a description of: 5.5.13.1 Transport procedures for radioactive material to be used in industrial radiographic operations;

5.5.13.2 Storage facilities for radioactive material; and 5.5.13.3 Methods for restricting access to radiation areas. 5.6 Performance Requirements for Industrial Radiography Equipment. Equipment used in industrial radiographic operations must meet the following minimum criteria: 5.6.1 Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standard Institute, N432- 1980, “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography” (published as NBS Handbook 136, issued January 1981); 5.6.2 In addition to the requirements specified in 5.6.1 the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources; 5.6.2.1 The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:

(1) Chemical symbol and mass number of the radionuclide in the device; (2) Activity and the date on which this activity was last measured; (3) Model or product code and serial number of the sealed source; (4) Name of the manufacturer of the sealed source; and (5) Licensee's name, address, and telephone number.

5.6.2.2 Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of Part 17 of these regulations. 5.6.2.3 Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless approved by the Department, another Agreement State, or the NRC.

5.6.3 In addition to the requirements specified in 5.6.1 and 5.6.2, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers: 5.6.3.1 The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. 5.6.3.2 The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device. 5.6.3.3 The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.

5.6.3.4 Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words:

“DANGER - RADIOACTIVE.”

The label may not interfere with the safe operation of the exposure device or associated equipment.

5.6.3.5 The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.

5.6.3.6 Guide tubes must be used when moving the source out of the device. 5.6.3.7 An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.

5.6.3.8 The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980, “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography” , National Bureau of Standards (NBS) Handbook 136 (January 1981).

5.6.3.9 Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

5.6.4 All radiographic exposure devices and associated equipment in use after January 10, 1996 must comply with the requirements of this section; and 5.6.5 As an exception to 5.6.1, equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in ANSI N432-1980, “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography” , National Bureau of Standards (NBS) Handbook 136 (January 1981), if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can reasonably exert on the lever or crankshaft of the drive mechanism. 5.7 Limits on External Radiation Levels From Storage Containers and Source Changers. The maximum exposure rate limits for storage containers and source changers are 2 millisievert (200 mrem) per hour at any exterior surface, and 0.1 millisievert (10 mrem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position. 5.8 Locking of Sources of Radiation, Storage Containers and Source Changers. 5.8.1 Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (if a keyed lock, the key must be removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in 5.22. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

5.8.2 Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (if a keyed lock, the key must be removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant. 5.8.3 The control panel of each radiation machine shall be equipped with a lock that will prevent the unauthorized use of an x-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer or a radiographer's assistant. 5.9 Radiation Survey Instruments.

5.9.1 The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by this Part and by Part 4 of these regulations. Instrumentation required by this section must be capable of measuring a range from 0.02 millisievert (2 mrem) per hour through 0.01 sievert (1 rem) per hour.

5.9.2 The licensee or registrant shall have each radiation survey instrument required under 5.9.1 calibrated:

5.9.2.1 At energies appropriate for use and at intervals not to exceed 6 months and after instrument servicing, except for battery changes;

5.9.2.2 For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at 3 points between 0.02 and 10 millisievert (2 and 1000 mrem) per hour; and 5.9.2.3 So that an accuracy within plus or minus 20 percent of the true radiation dose rate can be demonstrated at each point checked.

5.9.3 The licensee or registrant shall maintain records of the results of the instrument calibrations in accordance with 5.26.

5.10 Leak Testing and Replacement of Sealed Sources.

5.10.1 The replacement of any sealed source fastened to or contained in a radiographic exposure device and the leak testing of any sealed source must be performed by persons authorized to do so by the Department, the Nuclear Regulatory Commission, or another Agreement State. 5.10.2 The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Department, the Nuclear Regulatory Commission, or another Agreement State.

5.10.3 Testing and recordkeeping requirements.

5.10.3.1 Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed 6 months. The leak testing of the source must be performed using a method approved by the Department, the Nuclear Regulatory Commission, or by another Agreement State. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 becquerel (0.005 µCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, the Nuclear Regulatory Commission, or another Agreement State to perform the analysis.

5.10.3.2 The licensee shall maintain records of the leak tests in accordance with 5.27. 5.10.3.3 Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within 6 months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds 6 months.

5.10.4 Any test conducted pursuant to 5.10.2 and 5.10.3 that reveals the presence of 185 becquerel (0.005 µCi) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with Department regulations. A report must be filed with the Department within 5 days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.

5.10.5 Each exposure device using depleted uranium (DU) shielding and an “S” tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 becquerel (0.005 µCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, the Nuclear Regulatory Commission, or another Agreement State to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while not in use and in storage. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak-test must be made in accordance with 5.27.

5.11 Quarterly Inventory.

5.11.1 Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation, and for devices containing depleted uranium received and possessed under the license.

5.11.2 The licensee or registrant shall maintain records of the quarterly inventory in accordance with 5.28.

5.12 Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices. Transport and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments.

5.12.1 The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers before each day's use, or work shift, to ensure that: 5.12.1.1 The equipment is in good working condition;

5.12.1.2 The sources are adequately shielded; and 5.12.1.3 Required labeling is present.

5.12.2 Survey instrument operability must be performed using check sources or other appropriate means.

5.12.3 If equipment problems are found, the equipment must be removed from service until repaired. 5.12.4 Each licensee or registrant shall have written procedures for, and perform inspection and routine maintenance of, radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments. The inspection and maintenance must be performed at intervals not to exceed 3 months, or before the first use thereafter, to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment must be removed from service until repaired. 5.12.5 The licensee's inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

5.12.6 Records of equipment problems and of any maintenance performed under 5.12 must be made in accordance with 5.30.

5.13 Permanent Radiographic Installations.

5.13.1 Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either.

5.13.1.1 An entrance control of the type described in 4.19 of these regulations that causes the radiation level upon entry into the area to be reduced; or 5.13.1.2 Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.

5.13.2 The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry as designated in 5.13.1 must be tested monthly.

5.13.3 If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within 7 calendar days. The facility may continue to be used during this 7-day period, provided the licensee or registrant implements the continuous surveillance requirements of 5.22 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained in accordance with 5.31. 5.14 Labeling, Storage, and Transportation.

5.14.1 The licensee may not use a source changer or a container to store radioactive material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple or black on a yellow background, having a minimum diameter of 25 mm, and the wording:

CAUTION* RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES [or “NAME OF COMPANY” ] *or “DANGER”

5.14.2 The licensee may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in Part 17.

5.14.3 Radiographic exposure devices, source changers, storage containers, and radiation machines, must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire.

5.14.4 The licensee shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

5.14.5 The licensee's or registrant's name and city or town where the main business office is located shall be prominently displayed with a durable, clearly visible label(s) on both sides of all vehicles used to transport radioactive material or radiation machines for temporary job site use. 5.15 Conducting Industrial Radiographic Operations.

5.15.1 Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of 5.17.3. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

5.15.2 All radiographic operations must be conducted in a permanent radiographic installation unless otherwise specifically authorized by the Department.

5.15.3 Except when physically impossible, collimators shall be used in industrial radiographic operations that use radiographic exposure devices that allow the source to be moved out of the device. 5.15.4 A licensee or registrant may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Department, the Nuclear Regulatory Commission, or by another Agreement State.

5.16 Radiation Safety Officer.

The radiation safety officer shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's or registrant's program.

5.16.1 The minimum qualifications, training, and experience for radiation safety officers for industrial radiography are as follows:

5.16.1.1 Completion of the training and testing requirements of 5.17.1; 5.16.1.2 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and 5.16.1.3 Formal training in the establishment and maintenance of a radiation protection program. 5.16.2 The Department will consider alternatives to 5.16.1 when the radiation safety officer has appropriate training and experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

5.16.3 The specific duties and authorities of the radiation safety officer include: 5.16.3.1 Establishing and overseeing all operating, emergency, and ALARA procedures as required by Part 4 of these regulations and reviewing them regularly to ensure that they conform to Department regulations and to the license or registration conditions; 5.16.3.2 Overseeing and approving the training program for radiographic personnel to ensure that appropriate and effective radiation protection practices are taught; 5.16.3.3 Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

5.16.3.4 Ensuring that personnel monitoring devices are calibrated, if applicable, and used properly; that records are kept of the monitoring results; and that timely notifications are made as required by Part 4 of these regulations; and 5.16.3.5 Ensuring that operations are conducted safely and for implementing corrective actions including terminating operations.

5.17 Training.

5.17.1 The licensee or registrant may not permit any individual to act as a radiographer until the individual has received at least 40 hours of training in the subjects outlined in 5.17.7, in addition to on the job training consisting of hands-on experience under the supervision of a radiographer and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in Appendix A of this Part 5. The on-the-job training shall include a minimum of 2 months (320 hours) of active participation in the performance of industrial radiography utilizing radioactive material and/or 1 month (160 hours) of active participation in the performance of industrial radiography utilizing radiation machines. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on the job training (3 months or 480 hours). 5.17.2 In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual has:

5.17.2.1 Received copies of and instruction in the requirements described in the regulations contained in this Part, and applicable sections of Parts 4, 10 and 17 of these regulations; in the license or registration under which the radiographer will perform industrial radiography; and the licensee's or registrant's operating and emergency procedures; 5.17.2.2 Demonstrated an understanding of items in 5.17.2.1 by successful completion of a written or oral examination;

5.17.2.3 Received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and 5.17.2.4 Demonstrated understanding of the use of the equipment described in 5.17.2.3 by successful completion of a practical examination.

5.17.3 The licensee or registrant may not permit any individual to act as a radiographer's assistant until the individual has:

5.17.3.1 Received copies of and instruction in the requirements described in the regulations contained in this Part, and applicable sections of Parts 4, 10, and 17 of these regulation, in the license or registration under which the radiographer's assistant will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures; 5.17.3.2 Demonstrated an understanding of items in 5.17.3.1 by successful completion of a written or oral examination;

5.17.3.3 Under the personal supervision of a radiographer, received training in the use of the registrant's radiation machines or the licensee's radiographic exposure devices and sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and 5.17.3.4 Demonstrated understanding of the use of the equipment described in 5.17.3.3 by successful completion of a practical examination.

5.17.4 The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed 12 months. 5.17.5 Except as provided in 5.17.5.3, the radiation safety officer or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Department's regulations, license or registration requirements, and operating and emergency procedures are followed. The inspection program must:

5.17.5.1 Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed 6 months; and 5.17.5.2 If a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than 6 months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of 5.17.2.3 and the radiographer's assistant must demonstrate knowledge of the training requirements of 5.17.3.3 by a practical examination before these individuals can next participate in a radiographic operation.

5.17.5.3 The Department may consider alternative inspection programs in those situations where one individual serves as the only radiographer and the radiation safety officer. 5.17.6 The licensee or registrant shall maintain records of the above training to include certification documents, written, oral and practical examinations, refresher safety training and inspections of job performance in accordance with 5.32.

5.17.7 The licensee or registrant shall include the following subjects required in 5.17.1: 5.17.7.1 Fundamentals of radiation safety including:

(1) Characteristics of gamma and x-radiation;

(2) Units of radiation dose and quantity of radioactivity; (3) Hazards of exposure to radiation;

(4) Levels of radiation from sources of radiation; and (5) Methods of controlling radiation dose (time, distance, and shielding); 5.17.7.2 Radiation detection instruments including:

(1) Use, operation, calibration, and limitations of radiation survey instruments; (2) Survey techniques; and (3) Use of personnel monitoring equipment;

5.17.7.3 Equipment to be used including:

(1) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails);

(2) Operation and control of radiation machines;

(3) Storage, control, and disposal of sources of radiation; and (4) Inspection and maintenance of equipment.

5.17.7.4 The requirements of pertinent state and federal regulations; and 5.17.7.5 Case histories of accidents in radiography.

5.18 Operating and Emergency Procedures.

5.18.1 Operating and emergency procedures must include, as a minimum, instructions in the following: 5.18.1.1 Appropriate handling and use of sources of radiation so that no person is likely to be exposed to radiation doses in excess of the limits established in Part 4 of these regulations;

5.18.1.2 Methods and occasions for conducting radiation surveys; 5.18.1.3 Methods for posting and controlling access to radiographic areas; 5.18.1.4 Methods and occasions for locking and securing sources of radiation; 5.18.1.5 Personnel monitoring and the use of personnel monitoring equipment; 5.18.1.6 Transporting equipment to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when required, and control of the equipment during transportation as described in Part 17 of these regulations;

5.18.1.7 The inspection, maintenance, and operability checks of radiographic exposure devices, radiation machines, survey instruments, alarming ratemeters, transport containers, and storage containers;

5.18.1.8 Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly; 5.18.1.9 The procedure(s) for identifying and reporting defects and noncompliance, as required by 5.38;

5.18.1.10 The procedure for notifying proper persons in the event of an accident or incident; 5.18.1.11 Minimizing exposure of persons in the event of an accident or incident, including a source disconnect, a transport accident, or loss of a source of radiation; 5.18.1.12 Source recovery procedure if licensee will perform source recoveries; and 5.18.1.13 Maintenance of records.

5.18.2 The licensee or registrant shall maintain copies of current operating and emergency procedures in accordance with 5.33 and 5.37.

5.19 Supervision of Radiographer's Assistants.

The radiographer's assistant shall be under the personal supervision of a radiographer when using radiographic exposure devices, associated equipment, or a sealed source, or while conducting radiation surveys required by 5.21.2 to determine that the sealed source has returned to the shielded position or the radiation machine is off after an exposure. The personal supervision must include:

5.19.1 The radiographer's physical presence at the site where the sources of radiation are being used; 5.19.2 The availability of the radiographer to give immediate assistance if required; and 5.19.3 The radiographer's direct observation of the assistant's performance of the operations referred to in this section.

5.20 Personnel Monitoring.

5.20.1 The licensee or registrant shall not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading dosimeter, an operating alarming ratemeter, and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the wearing of an alarming ratemeter is not required. 5.20.1.1 Pocket dosimeters must have a range from zero to 2 millisievert (200 mrem) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

5.20.1.2 Each personnel dosimeter must be assigned to and worn by only one individual. 5.20.1.3 Film badges must be exchanged at periods not to exceed one month and other personnel dosimeters processed and evaluated by an accredited NVLAP processor must be replaced at periods not to exceed three months.

5.20.1.4 After replacement, each personnel dosimeter must be processed as soon as possible. 5.20.2 Direct reading dosimeters, such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with 5.34.

5.20.3 Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with 5.34. Acceptable dosimeters must read within plus or minus 20 percent of the true radiation exposure.

5.20.4 If an individual's pocket dosimeter indicates a reading off-scale or if the electronic personal dosimeter reading exceeds 2 millisievert (200 mrem), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter must be sent for processing within 24 hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual's radiation exposure has been made. This determination must be made by the radiation safety officer or the radiation safety officer's designee. The results of this determination must be included in the records maintained in accordance with 5.34.

5.20.5 If the personnel dosimeter that is required by 5.20.1 is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements of 5.20.1 is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with 5.34.

5.20.6 Reports received from the accredited NVLAP personnel dosimeter processor must be retained in accordance with 5.34.

5.20.7 Each alarming ratemeter must:

5.20.7.1 Be checked to ensure that the alarm functions properly before using at the start of each shift;

5.20.7.2 Be set to give an audible alarm signal at a preset dose rate of 5 millisievert (500 mrem) per hour; with an accuracy of plus or minus 20 percent of the true radiation dose rate; 5.20.7.3 Require special means to change the preset alarm function; and 5.20.7.4 Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarming ratemeter calibrations in accordance with 5.34.

5.21 Radiation Surveys.

The licensee or registrant shall:

5.21.1 Conduct all surveys with a calibrated and operable radiation survey instrument that meets the requirements of 5.9;

5.21.2 Conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment. Radiation machines shall be surveyed after each exposure to determine that the machine is off;

5.21.3 Conduct a survey of the radiographic exposure device whenever the source is exchanged and whenever a radiographic exposure device is placed in a storage area as defined in 5.3, to ensure that the sealed source is in its shielded position; and 5.21.4 Maintain records in accordance with 5.35.

5.22 Surveillance.

During each radiographic operation, the radiographer shall ensure continuous direct visual surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in Part 1 of these regulations, except at permanent radiographic installations where all entryways are locked and the requirements of 5.13 are met. 5.23 Posting.

All areas in which industrial radiography is being performed must be conspicuously posted as required by 4.28 of these regulations. The exceptions listed in 4.29 of these regulations do not apply to industrial radiographic operations.

RECORDKEEPING REQUIREMENTS 5.24 Records for Industrial Radiography.

Each licensee or registrant shall maintain a copy of its license or registration, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the Department, or until the Department terminates the license or registration.

5.25 Records of Receipt and Transfer of Sources of Radiation. 5.25.1 Each licensee or registrant shall maintain records showing the receipts and transfers of sealed sources, devices using DU for shielding, and radiation machines, and retain each record for 3 years after it is made.

5.25.2 These records must include the date, the name of the individual making the record, radionuclide, number of becquerel (curie) or mass (for DU), and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate. 5.26 Records of Radiation Survey Instruments.

Each licensee or registrant shall maintain records of the calibrations of its radiation survey instruments that are required under 5.9 and retain each record for 3 years after it is made. 5.27 Records of Leak Testing of Sealed Sources and Devices Containing DU. Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerel (microcurie). The licensee shall retain each record for 3 years after it is made or until the source in storage is removed. 5.28 Records of Quarterly Inventory.

5.28.1 Each licensee or registrant shall maintain records of the quarterly inventory of sources of radiation, including devices containing depleted uranium as required by 5.11, and retain each record for 3 years.

5.28.2 The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerel (curie) or mass (for DU) in each device, location of sources of radiation and/or devices, and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate.

5.29 Utilization Logs.

5.29.1 Each licensee or registrant shall maintain utilization logs showing for each source of radiation the following information:

5.29.1.1 A description, including the make, model, and serial number of the radiation machine or the radiographic exposure device, transport, or storage container in which the sealed source is located;

5.29.1.2 The identity and signature of the radiographer to whom assigned; 5.29.1.3 The location and dates of use, including the dates removed and returned to storage; and 5.29.1.4 For permanent radiographic installations, the dates each radiation machine is energized.

5.29.2 The licensee or registrant shall retain the logs required by 5.29.1 for 3 years. 5.30 Records of Inspection and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport and Storage Containers, Associated Equipment, Source Changers, and Survey Instruments.

5.30.1 Each licensee or registrant shall maintain records specified in 5.12 of equipment problems found in daily checks and quarterly inspections of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for 3 years after it is made. 5.30.2 The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was performed. 5.31 Records of Alarm System and Entrance Control Checks at Permanent Radiographic Installations.

Each licensee or registrant shall maintain records of alarm system and entrance control device tests required by 5.13 and retain each record for 3 years after it is made. 5.32 Records Of Training and Certification.

Each licensee or registrant shall maintain the following records for 3 years: 5.32.1 Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, the names of individuals conducting and receiving the oral and practical examinations, and a list of items tested and the results of the oral and practical examinations; and 5.32.2 Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant.

The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any noncompliance observed by the radiation safety officer or designee. 5.33 Copies of Operating and Emergency Procedures.

Each licensee or registrant shall maintain a copy of current operating and emergency procedures until the Department terminates the license or registration. Superseded material must be retained for 3 years after the change is made.

5.34 Records of Personnel Monitoring.

Each licensee or registrant shall maintain the following exposure records specified in 5.20: 5.34.1 Direct reading dosimeter readings and yearly operability checks required by 5.20.2 and 5.20.3 for 3 years after the record is made;

5.34.2 Records of alarming ratemeter calibrations for 3 years after the record is made; 5.34.3 Personnel dosimeter results received from the accredited NVLAP processor until the Department terminates the license or registration; and 5.34.4 Records of estimates of exposures as a result of off-scale personal direct reading dosimeters, or lost or damaged personnel dosimeters, until the Department terminates the license or registration.

5.35 Records of Radiation Surveys.

Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in 5.21.3.Each record must be maintained for 3 years after it is made.

5.36 Form of Records.

Each record required by this Part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records. 5.37 Location of Documents and Records.

5.37.1 Each licensee or registrant shall maintain copies of records required by this Part and other applicable Parts of these regulations at the location specified in 5.5.11. 5.37.2 Each licensee or registrant shall also maintain current copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite;

5.37.2.1 The license or registration authorizing the use of sources of radiation; 5.37.2.2 A copy of Parts 1, 4, 5 and 10 of these regulations; 5.37.2.3 Utilization logs for each source of radiation dispatched from that location as required by 5.29;

5.37.2.4 Records of equipment problems identified in daily checks of equipment as required by 5.30.1;

5.37.2.5 Records of alarm system and entrance control checks required by 5.31,if applicable; 5.37.2.6 Records of dosimeter readings as required by 5.34; 5.37.2.7 Operating and emergency procedures as required by 5.33; 5.37.2.8 Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by 5.26;

5.37.2.9 Evidence of the latest calibrations of alarming ratemeters and operability checks of dosimeters as required by 5.34;

5.37.2.10 Survey records as required by 5.35 and 4.42 of these regulations as applicable, for the period of operation at the site;

5.37.2.11 The shipping papers for the transportation of radioactive materials required by Part 17 of these regulations; and 5.37.2.12 When operating under reciprocity pursuant to Part 3 of these regulations, a copy of the applicable State license or registration, or Nuclear Regulatory Commission license authorizing the use of sources of radiation.

NOTIFICATIONS 5.38 Notifications.

5.38.1 In addition to the reporting requirements specified in 4.52 of these regulations, each licensee or registrant shall provide a written report to the Department within 30 days of the occurrence of any of the following incidents involving radiographic equipment: 5.38.1.1 Unintentional disconnection of the source assembly from the control cable; 5.38.1.2 Inability to retract the source assembly to its fully shielded position and secure it in this position;

5.38.1.3 Failure of any component, which is critical to safe operation of the device, to properly perform its intended function; or 5.38.1.4 An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the off position, or a safety interlock fails to terminate x-ray production. 5.38.2 The licensee or registrant shall include the following information in each report submitted under 5.38.1, and in each report of overexposure submitted under 4.53.2 of these regulations which involves failure of safety components of radiography equipment: 5.38.2.1 Description of the equipment problem;

5.38.2.2 Cause of each incident, if known;

5.38.2.3 Name of the manufacturer and model number of equipment involved in the incident; 5.38.2.4 Place, date, and time of the incident;

5.38.2.5 Actions taken to establish normal operations;

5.38.2.6 Corrective actions taken or planned to prevent recurrence; and 5.38.2.7 Names and qualifications of personnel involved in the incident. 5.38.3 Any licensee or registrant conducting radiographic operations or storing sources of radiation at any location not listed on the license or registration for a period in excess of 90 days in a calendar year, shall notify the Department prior to exceeding the 90 days. 5.39 Reciprocity.

5.39.1 All reciprocal recognition of licenses and registrations by the Department will be granted in accordance with Part 3 of these regulations.

5.39.2 Reciprocal recognition by the Department of an individual radiographer certification will be granted provided that:

5.39.2.1 The individual holds a valid certification in the appropriate category issued by a certifying entity, as defined in 5.3;

5.39.2.2 The requirements and procedures of the certifying entity issuing the certification affords the same or comparable certification standards as those afforded by 5.17.1; 5.39.2.3 The applicant presents the certification to the Department prior to entry into the state; and 5.39.2.4 No escalated enforcement action is pending with the Nuclear Regulatory Commission or in any other state.

5.39.3 Certified individuals who are granted reciprocity by the Department shall maintain the certification upon which the reciprocal recognition was granted, or prior to the expiration of such certification, shall meet the requirements of 5.17.1.

5.40 Specific Requirements for Personnel Performing Industrial Radiography. 5.40.1 At a job site, the following shall be supplied by the licensee or registrant: 5.40.1.1 At least one operable, calibrated survey instrument for each exposure device or radiation machine in use;

5.40.1.2 A current whole body personnel dosimeter (OSL dosimeter, TLD or film badge) for each person performing radiographic operations;

5.40.1.3 An operable, calibrated pocket dosimeter with a range of zero to 2 millisievert (200 milliroentgen) for each person performing radiographic operations; 5.40.1.4 An operable, calibrated, alarming ratemeter for each person performing radiographic operations using a radiographic exposure device; and 5.40.1.5 The appropriate barrier ropes and signs.

5.40.2 Each radiographer at a job site shall have on their person a valid certification ID card issued by a certifying entity.

5.40.3 Industrial radiographic operations shall not be performed if any of the items in 5.40.1 and 5.40.2 are not available at the job site or are inoperable.

5.40.4 During an inspection, the Department may terminate an operation if any of the items in 5.40.1 and 5.40.2 are not available or operable, or if the required number of radiographic personnel are not present. Operations shall not be resumed until all required conditions are met. PART 5, APPENDIX A:

CERTIFICATION I. Requirements for an Independent Certifying Organization. An independent certifying organization shall:

1. Be an organization such as a society or association, whose members participate in, or have an interest in, the field of industrial radiography;

2. Make its membership available to the general public nationwide. Membership shall not be restricted because of race, color, religion, sex, age, national origin or disability; 3. Have a certification program open to nonmembers, as well as members; 4. Be an incorporated, nationally recognized organization that is involved in setting national standards of practice within its fields of expertise;

5. Have an adequate staff, a viable system for financing its operations, and a policy and decision-making review board;

6. Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;

7. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization's staff in implementing the certification program;

8. Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions; 9. Have written procedures describing all aspects of its certification program and maintain records of the current status of each individual's certification and the administration of its certification program;

10. Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals; 11. Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;

12. Exchange information about certified individuals with the Nuclear Regulatory Commission and other independent certifying organizations and/or Agreement States and allow periodic review of its certification program and related records; and 13. Provide a description to the Nuclear Regulatory Commission of its procedures for choosing examination sites and for providing an appropriate examination environment. II. Requirements for Certification Programs.

All certification programs must:

1. Require applicants for certification to a. Receive training in the topics set forth in 5.17.7, or equivalent State or Nuclear Regulatory Commission regulations, and b. Satisfactorily complete a written examination covering these topics; 2. Require applicants for certification to provide documentation that demonstrates that the applicant has:

a. Received training in the topics set forth in 5.17.7or equivalent State or Nuclear Regulatory Commission regulations;

b. Satisfactorily completed a minimum period of on-the-job training as specified in 5.17.1; and c. Received verification by a State licensee or registrant or a Nuclear Regulatory Commission licensee that the applicant has demonstrated the capability of independently working as a radiographer.

3. Include procedures to ensure that all examination questions are protected from disclosure; 4. Include procedures for denying an application and revoking, suspending, and reinstating a certification;

5. Provide a certification period of not less than 3 years nor more than 5 years; 6. Include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and annual refresher training; and 7. Provide a timely response to inquiries, by telephone or letter, from members of the public, about an individual's certification status.

III. Requirements for Written Examinations All examinations must:

1. Be designed to test an individual's knowledge and understanding of the topics listed in 5.17.7 or equivalent State or Nuclear Regulatory Commission requirements; 2. Be written in a multiple-choice format;

3. Have test items drawn from a question bank containing psychometrically valid questions based on the material in 5.17.7 .

PART 6 X-RAYS IN THE HEALING ARTS RH 6.1 Purpose and Scope.

This Part establishes requirements, for which a registrant is responsible, for use of x-ray equipment by or under the supervision of an individual authorized by and licensed in accordance with State statutes to engage in the healing arts or veterinary medicine. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of these Regulations. RH 6.2 Definitions.

“Accessible surface” means the external surface of the enclosure or housing provided by the manufacturer.

“Added filtration” means any filtration which is in addition to the inherent filtration. “Aluminum equivalent” means the thickness of type 1100 aluminum alloy1 affording the same attenuation, under specified conditions, as the material in question. 1The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent minimum aluminum, 0.12 percent copper. “Attenuation block” means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy1, or other materials having equivalent attenuation. 1The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent minimum aluminum, 0.12 percent copper. “Automatic exposure control” means a device which automatically controls one or more technique factors in order to obtain at a preselected location a required quantity of radiation (See also “Phototimer”). “Barrier” (See “Protective barrier”).

“Beam axis” means a line from the source through the centers of the x-ray field. “Beam-limiting device” means a device which provides a means to restrict the dimensions of the x-ray field.

“C-arm x-ray system” means an x-ray system in which the image receptor and x-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.

“Cephalometric device” means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

“Certified components” means components of x-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968. “Certified system” means any x-ray system which has one or more certified component(s). “Changeable filters” means any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process under operator control. “Coefficient of variation” or “C” means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation: where s = Estimated standard deviation of the population.

1007_1_xmacron.jpg = Mean value of observations in sample. X i = ith observation in sample.

n = Number of observations in sample.

“Computed tomography” means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

“Control panel” means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for the operator's use for manually setting the technique factors.

“Cooling curve” means the graphical relationship between heat units stored and cooling time. “CT” (See “Computed tomography”).

“Dead-man switch” means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

“Detector” (See “Radiation detector”).

“Diagnostic source assembly” means the tube housing assembly with a beam-limiting device attached. “Diagnostic x-ray system” means an x-ray system designed and used for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization. “Diagnostic x-ray imaging system” means an assemblage of components for the generation, emission, and reception of x-rays and the transformation, storage and visual display of the resultant x-ray image. “Direct scattered radiation” means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See “Scattered radiation”). “Entrance exposure rate” means the exposure per unit time at the point where the center of the useful beam enters the patient.

“Equipment” (See “x-ray equipment”).

“Field emission equipment” means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field. “Filter” means material placed in the useful beam to preferentially absorb selected radiations. “Fluoroscopic imaging assembly” means a subsystem in which x-ray photons produce a visible image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

“Focal spot (actual)” means the area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates. “General purpose radiographic x-ray system” means any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions. “Gonad shield” means a protective barrier for the testes or ovaries. “Half-value layer (HVL)” means the thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam, is deemed to be excluded.

“Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray test for the purpose of diagnosis or treatment.

“Image intensifier” means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding visible light image and electronically amplifies the brightness of that visible image.

“Image receptor” means any device, such as a fluorescent screen or radiographic film, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.

“Image receptor support” means, for mammographic systems, that part of the system designed to support the image receptor perpendicular to the beam axis during a mammographic examination. “Inherent filtration” means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.

“Irradiation” means the exposure of matter to ionizing radiation. “Kilovolts peak” (See “Peak tube potential”).

“kV” means kilovolts.

“kVp” (See “Peak tube potential”).

“kWs” means kilowatt second.

“Lead equivalent” means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

“Leakage radiation” means radiation emanating from the diagnostic source assembly except for the useful beam.

“Leakage technique factors” means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows: (1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum- rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere seconds, or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential. (3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for that potential. “Light field” means that area of the intersection of the light beam from the beam-limiting device, and one of the set of planes parallel to, and including, the plane of the image receptor, whose perimeter is the locus of points, at which the illumination is one-fourth of the maximum in the intersection. “Line-voltage regulation” means the difference between the no-load and the load line potentials expressed as a percent of the load line potential. It is calculated using the following equation: Percent line-voltage regulation = 100 (V -V)/V n l l where:

V = No-load line potential and n V = Load line potential.

l “mA” means milliampere.

“mAs” means milliampere second.

“Maximum line current” means the root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.

“Mini c-arm x-ray system(s)” means a system that meets the following criteria: source-image receptor distance less than or equal to 50 cm; field of view less than or equal to six (6) inches; kVp less than or equal to 75 kVp; mA less than or equal to 0.25 mA; and entrance exposure rate less than or equal to 10 roentgen (1.29 mC/kg) per minute at the exit port.

“Mobile x-ray equipment” (See “x-ray equipment”).

“Optical Density (OD)” = Log (1/Transmittance), where the transmittance of the film is the fraction of incident light transmitted by the film.

“Patient” means an individual or animal subjected to healing arts examination, diagnosis, or treatment. “Peak tube potential” means the maximum value of the potential difference across the x-ray tube during an exposure.

“Phantom” means an object designed such that the interaction of ionizing radiation with the object is suitable for the evaluation of the particular characteristics of the x-ray system or anatomic region under consideration.

“Phototimer” means a method for controlling radiation exposure to image receptors by the amount of radiation which reaches a radiation monitoring device(s). The radiation monitoring device(s) is part of an electronic circuit which controls the duration of time the tube is activated (See “Automatic exposure control”).

“Position indicating device (PID)” means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

“Positive beam limitation (PBL)” means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment. “Protective apron” means an apron made of radiation absorbing materials used to reduce radiation exposure to the wearer.

“Protective barrier” means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

(1) “Primary protective barrier” means the material, excluding filters, placed in the direct useful beam, for protection purposes, to reduce the radiation exposure;

(2) “Secondary protective barrier” means the material which attenuates stray radiation. “Protective glove” means a glove made of radiation absorbing materials used to reduce radiation exposure to the wearer.

“Radiation detector” means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation. “Radiation therapy simulation system” means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

“Radiograph” means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

“Radiographic imaging system” means any system whereby a permanent or semipermanent image is recorded on an image receptor by the action of ionizing radiation. “Rating” means the operating limits as specified by the component manufacturer. “Recording” means producing a permanent form of an image resulting from x-ray photons. “Response time” means the time required for an instrument system to reach 90 percent of its final reading when the radiation-sensitive volume of the instrument system is exposed to a step change in radiation flux from zero sufficient to provide a steady state midscale reading. “Scattered radiation” means radiation that, during passage through matter, has been deviated in direction (See “Direct scattered radiation”).

“Shutter” means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

“Single occupancy room” means a room which has walls on all sides (excluding the room entrance) of a minimum of seven (7) feet high that has an x-ray attenuation (for the x-ray beam in use at the facility) equivalent to at least two (2) thicknesses of one-half inches of gypsum wallboard which is occupied by one individual at a time. This only applies to rooms with dental intraoral or panoramic machines. “Source” means the focal spot of the x-ray tube.

“Source-image receptor distance (SID)” means the distance from the source to the center of the input surface of the image receptor.

“Spot check” means a procedure which is performed to assure that a previous calibration continues to be valid.

“Spot film” means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure. “Spot-film device” means a device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph. “Source to skin distance (SSD)” means the distance between the source and the skin of the patient. “Stray radiation” means the sum of leakage and scattered radiation. “Technique chart” means a chart which specifies, for common examinations performed with a specific system, the following information:

(1) technique factors to be utilized versus patient's anatomical size; (2) type and size of the film or film-screen combination to be used; (3) type and focal distance of the grid to be used, if any; and (4) source to image receptor distance to be used.

“Technique factors” means the following conditions of operation: (1) For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs; (2) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x- ray pulses;

(3) For CT x-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs; (4) For CT x-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and (5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs. “Termination of irradiation” means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel. “Tomogram” means the depiction of the x-ray attenuation properties of a section through the body. “Traceable to a national standard” means that a quantity or a measurement has been compared to a national standard directly or indirectly through one or more intermediate steps and that all comparisons have been documented.

“Tube” means an x-ray tube, unless otherwise specified. “Tube housing assembly” means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing. “Tube rating chart” means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors. These curves are typically displayed on a graph. “Useful beam” means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the system to produce radiation.

“Variable-aperture beam-limiting device” means a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.

“Visible area” means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

“Wedge filter” means an added filter effecting continuous progressive attenuation on all or part of the useful beam.

“X-ray exposure control” means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.

“X-ray equipment” means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:

(1) “Mobile x-ray equipment” means x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.

(2) “Portable x-ray equipment” means x-ray equipment designed to be hand-carried. (3) “Stationary x-ray equipment” means x-ray equipment which is installed in a fixed location. “X-ray field” means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection. “X-ray high-voltage generator” means a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements. “X-ray subsystem” means any combination of two or more components of an x-ray system. “X-ray table” means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or above table fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, image intensifier, or spot-film device beneath the tabletop. “X-ray tube” means any electron tube which is designed to be used primarily for the production of x-rays. General Regulatory Provisions RH 6.3 General Requirements.

Effective July 1, 1995, all human use radiation machines used in Colorado shall meet the Federal Performance Standards, Subchapter J - Radiological Health, 21 CFR 1020.30 through 1020.33, effective April 1, 1997. The Department may grant exemptions to machines manufactured prior to August 4, 1974, provided the registrant can demonstrate that the exemption will not result in undue risk from excessive exposure and will benefit the patient.

6.3.1 Administrative Controls.

6.3.1.1 Registrant. The registrant shall be responsible for directing the operation of the x-ray system(s) under his administrative control. The registrant or the registrant's agent shall assure that the requirements of RH 6.3.1 are met in the operation of the x-ray system(s), including the use of licensed/certified/registered persons or companies (providers) to provide services to the facility. Such services include the operation of x-ray equipment, interpretation of exams, inspection of x- ray machines and facilities, installation, service and/or calibration of x-ray machines. 6.3.1.1.1 An x-ray system which does not meet the provisions of these Regulations, and is determined to be unsafe for human use, shall not be operated for diagnostic or therapeutic purposes.

6.3.1.1.2 Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. 6.3.1.1.2.1 In addition to RH 6.3.1.1.2, operators, except for the licensed practitioners, shall meet the training requirements, if any, of the appropriate licensing board. 6.3.1.1.2.2 In addition to RH 6.3.1.1.2 and 6.3.1.1.2.1, operators of x-ray machine systems in mammography facilities shall meet the requirements in RH 6.10.2.1.1. 6.3.1.1.3 A technique chart shall be provided in the vicinity of the diagnostic x-ray system's control panel which specifies, for all examinations performed with that system, the following information:

6.3.1.1.3.1 Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

6.3.1.1.3.2 Type and size of the film or film-screen combination to be used; 6.3.1.1.3.3 Type and focal distance of the grid to be used, if any; 6.3.1.1.3.4 Source to image receptor distance to be used (except for dental intraoral radiography);

6.3.1.1.3.5 Type and location of placement of patient shielding (i.e. gonad, etc.) to be used; and 6.3.1.1.3.6 For mammography, indication of kVp/target/filter combination. 6.3.1.1.4 Written safety procedures shall be provided to each individual operating x-ray equipment. These procedures shall include any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

6.3.1.1.5 Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic or fluoroscopic exposure. Other than the patient being examined: 6.3.1.1.5.1 All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by a minimum of 0.5 millimeter lead equivalent.

6.3.1.1.5.2 Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent, or shall be so positioned that the nearest portion of the body is at least 1.83 meters (6 feet) from both the tube head and the nearest edge of the image receptor.

6.3.1.1.5.3 Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent or shall be so positioned that the nearest portion of the body is at least 1.83 meters (6 feet) from both the tube head and the nearest edge of the image receptor.

6.3.1.1.6 Gonad shielding of not less than 0.25 millimeter lead equivalent shall be used for human patients, who have not passed beyond the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

6.3.1.1.7 Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes: 6.3.1.1.7.1 exposure of an individual for training, demonstration or other non-healing arts purposes; and 6.3.1.1.7.2 exposure of an individual for the purpose of healing arts screening except as authorized by RH 6.3.1.1.11.

6.3.1.1.8 When a patient or film must be provided with auxiliary support during a radiation exposure:

6.3.1.1.8.1 mechanical holding devices shall be used when the technique permits. The written safety procedures, required by RH 6.3.1.1.4, shall list individual projections where holding devices cannot be utilized;

6.3.1.1.8.2 written safety procedures, as required by RH 6.3.1.1.4, shall indicate the requirements for selecting a holder and the procedure the holder shall follow; 6.3.1.1.8.3 the human holder shall be protected as required by RH 6.3.1.1.5.1; 6.3.1.1.8.4 no individual shall be used routinely to hold film or patients; and 6.3.1.1.8.5 in those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material.

6.3.1.1.8.6 each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded.

6.3.1.1.9 Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. 6.3.1.1.9.1 The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objective of the examinations. 6.3.1.1.9.1.1 The radiation exposure to the patient shall be the minimum exposure required to produce images of acceptable diagnostic quality. 6.3.1.1.9.2 Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation, or when the practitioner determines that portable equipment is most suitable for the diagnostic procedure.

6.3.1.1.9.3 X-ray systems subject to RH 6.6 shall not be utilized in procedures where the source to patient distance is less than 30 centimeters, except for veterinary systems.

6.3.1.1.9.4 If anti-scatter grids are used between the patient and the image receptor to decrease scattered radiation to the film and improve contrast, the grid shall: 6.3.1.1.9.4.1 be positioned properly, i.e., tube side facing the correct direction, and grid centered to the central ray;

6.3.1.1.9.4.2 be of the proper focal distance for the SID being used. 6.3.1.1.10 All individuals who are associated with the operation of an x-ray system are subject to the requirements of RH 4.6, 4.10, 4.12, 4.13, 4.14, and 4.18 of these Regulations. In addition:

6.3.1.1.10.1 When protective clothing or devices are worn, personnel monitoring devices shall be worn, such that the requirements of RH 4.6, 4.10, 4.12, 4.13, 4.14, and 4.18 shall be met.

6.3.1.1.10.2 Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.

6.3.1.1.11 Healing Arts Screening. With the exception of FDA/MQSA approved facilities which are registered with the Department for the use of dedicated mammographic equipment, any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Department. When requesting such approval, that person shall submit the information outlined in Appendix C of this Part. If any information submitted to the Department becomes invalid or outdated, the Department shall be immediately notified.

6.3.1.1.12 Information and Maintenance Record and Associated Information. The registrant shall maintain the following information for each x-ray system for inspection by the Department:

6.3.1.1.12.1 maximum technique factors for which the machine has been rated; 6.3.1.1.12.2 model and serial numbers of each tube housing assembly and control panel;

6.3.1.1.12.2.1 The facility registrant shall assign a unique identification number to each tube housing assembly and/or control panel which lacks a clearly visible serial number from the manufacturer. The tube housing assembly and/or control panel shall be labeled or stenciled with this number. This number shall be used by the registrant to identify this machine in all correspondence with the Department.

6.3.1.1.12.3 Tube rating charts and cooling curves;

6.3.1.1.12.4 records for the previous three (3) years of surveys, measurements, calibrations, maintenance, and modifications performed on the x-ray system(s) with the names of persons who performed such services;

6.3.1.1.12.5 Except for single occupancy rooms using only dental intraoral or panoramic machines, a dimensional drawing of the room in which a stationary x-ray system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:

6.3.1.1.12.5.1 the results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions, or 6.3.1.1.12.5.2 the type and thickness of materials, or lead equivalency, of each protective barrier; and 6.3.1.1.12.6 a copy of all correspondence with this Department regarding that x-ray system.

6.3.1.1.13 Collimation. The registrant shall provide safety training to all operators on radiation safety procedures including collimation. The collimation procedure shall specify for each tube with variable collimation whether positive beam limitation (PBL) or manual collimation shall be used.

6.3.1.1.13.1 If manual collimation is used, then there shall be positive indication of collimation on all films except as provided in RH 6.10.2.6.7, or when contra indicated and diagnosis could be compromised. Tubes collimated manually need not comply with PBL requirements.

6.3.1.1.13.2 Regardless of the method of collimation, the beam size shall be limited to the smallest area which is clinically necessary.

6.3.1.1.14 Film Processing QA Program. Every human use facility which is required to be inspected on an annual basis shall have an active film processing QA program which includes:

6.3.1.1.14.1 The x-ray film must be developed following the recommendations of the film manufacturer for development time and temperature. Those manufacturers recommendations must be available for review.

6.3.1.1.14.1.1 In lieu of the requirements of RH 6.3.1.1.14.1, the facility may adopt a continuous, documented sensitometric quality control program. 6.3.1.1.14.2 If manual processing of films is done the temperature of the developer must be measured and logged each day the processing system is used. 6.3.1.1.14.3 If an automatic film processor is used then its developer temperature must be monitored and logged at least once per week.

6.3.1.1.14.4 For both manual and automated processing there must be an adequate method used to monitor and/or determine processing time. 6.3.1.1.14.5 An adequate developer replenishment system must be functional to meet the manufacturer's recommendations for automated film processors. For manual developing procedures the developer chemicals must be changed at least every month and documented in a written log.

6.3.1.1.14.6 The darkroom lighting must be such that exposure of a film to the darkroom safelight for one minute does not increase the optical density of that film by more than 0.1 optical density units when the test film has a latent image sufficient to produce a density between 1.0 and 2.0 optical density units prior to safe light exposure. If used, daylight film handling boxes shall preclude fogging of the film. 6.3.1.1.14.7 The base plus fog of an unexposed film must not exceed 0.25 optical density units when developed by the routine procedure used by the facility. 6.3.1.1.14.7.1 All film storage, including pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film. 6.3.1.1.15 Every human use facility which is required to be inspected on a three year basis shall have their film(s) developed according to the film manufacturer's recommendation for development time and temperature.

6.3.2 Plan Review and Shielding Design.

6.3.2.1 Prior to the construction of a new x-ray facility, the floor plans and equipment arrangement shall be submitted to a qualified expert for the determination of shielding requirements. Prior to the modification or renovation of an existing x-ray facility, or installation of a new x-ray machine in an existing x-ray facility, the plans and equipment arrangements shall be submitted to a qualified expert for determination of shielding requirements when there is a change in primary beam orientation, or a change in primary shielding due to the modification or renovation of a facility, or there is a projected increase in the x-ray workload from that which was used for the original x-ray shielding design. In such cases shielding shall meet the criteria in Appendix B and the recommendations of the qualified expert. The required information is denoted in Appendices A and B of this Part.

6.3.2.1.1 Facilities using only dental intraoral machines in an open bay area are exempt from the requirement of RH 6.3.2.1, provided that there is a distance of at least 1.83 meters (6 feet) between two (2) adjacent chairs. Facilities using only bone densitometry machines, mini-c-arms, dental intraoral or panoramic machines in single occupancy rooms are exempt from the requirements of RH 6.3.2.1.

6.3.2.2 The review of such plans, and determination of shielding requirements, shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in RH 4.6, 4.12, 4.13, and 4.14 of these Regulations.

Diagnostic X-Ray Systems RH 6.4 General Requirements for All Diagnostic X-Ray Systems. In addition to other requirements of this Part, all diagnostic x-ray systems shall meet the following requirements:

6.4.1 Warning Label.

The control panel containing the main power switch shall bear this or an equivalent warning statement, legible and accessible to view: “WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.” 6.4.2 Battery Charge Indicator.

On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation. 6.4.3 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 25.8 µC/kg (100 milliroentgen) in one hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. 6.4.4 Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 0.516 µC/kg (2 milliroentgen) in one hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

6.4.5 Beam Quality.

6.4.5.1 Half-Value Layer.

6.4.5.1.1 The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.

Table I Design operating range Measured potential (kVp) Half-value layer (mm of aluminum) (kVp)

Other Systems Dental Systems Below 50 30 0.3 1.5 40 0.4 1.5 49 0.5 1.5 50 to 70 50 1.2 1.5 60 1.3 1.5 70 1.5 1.5 Above 70 71 2.1 2.1 80 2.3 2.3 90 2.5 2.5 100 2.7 2.7 110 3.0 3.0 120 3.2 3.2 140 3.8 3.8 150 4.1 4.1 6.4.5.1.2 The requirements of RH 6.4.5.1.1 will be considered to have been met if it can be demonstrated that the aluminum equivalent of the total filtration in the primary beam is not less than that shown in Table II.

Table II Filtration Required vs. Operating Voltage Operating Voltage (kVp) Total Filtration (inherent Other Systems Dental Systems plus added) (mm aluminum equivalent)

Below 50 0.5 1.5 50 - 70 1.5 1.5 Above 70 2.5 2.5 6.4.5.1.3 Beryllium window tubes, except those used for mammography, shall have a minimum of 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam. 6.4.5.1.4 For capacitor energy storage equipment, compliance with the requirements of RH 6.4.5 shall be determined with the system fully charged and a minimum setting of 10 mAs for each exposure.

6.4.5.1.5 The required minimal aluminum equivalent filtration shall include the filtration contributed by all materials which are always present between the source and the patient. 6.4.5.2 Filtration Controls. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by RH 6.4.5.1 is in the useful beam for the given kVp which has been selected.

6.4.6 Multiple Tubes.

Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control and at or near the tube housing assembly which has been selected. 6.4.7 Mechanical Support of Tube Head.

The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system. 6.4.7.1 Locks. All position locking, holding, and centering devices on x-ray systems components and system shall function as designed.

6.4.8 Technique Indicators.

6.4.8.1 The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.

6.4.8.2 The requirement of RH 6.4.8.1 may be met by permanent markings on equipment having fixed technique factors.

RH 6.5 Fluoroscopic X-Ray Systems Except for Computed Tomography X-Ray Systems. All fluoroscopic x-ray systems shall meet the following requirements: 6.5.1 Limitation of Useful Beam.

6.5.1.1 Primary Barrier.

6.5.1.1.1 The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. 6.5.1.1.2 The x-ray tube used for fluoroscopy shall not produce x rays unless the barrier is in position to intercept the entire useful beam.

6.5.1.2 X-Ray Field.

6.5.1.2.1 Non-Intensified Fluoroscopic Equipment.

6.5.1.2.1.1 Only image-intensified fluoroscopic equipment shall be used. 6.5.1.2.1.2 For fluoroscopic equipment, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three (3) percent of the SID. The sum of the excess length and the excess width shall be no greater than four (4) percent of the SID. In addition:

6.5.1.2.1.3 means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field; 6.5.1.2.1.4 all equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with either stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less. If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of 5 centimeters by 5 centimeters or less;

6.5.1.2.1.5 for equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor; and the entire cross section of the useful beam shall be intercepted by the primary protective barrier at any SID. 6.5.1.2.1.6 Compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. Measurement shall be made in perpendicular directions corresponding to the vertical and horizontal directions on the video/tv monitor image. For collimating systems which are not circular, measurement shall be made along the directions closest to the vertical and horizontal direction on the video monitor image yielding the smallest dimension in each direction.

6.5.1.2.2 Spot-film devices shall meet the following additional requirements: 6.5.1.2.2.1 means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option.

6.5.1.2.2.2 Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three (3) percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed four (4) percent of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

6.5.1.2.2.3 it shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, 5 centimeters by 5 centimeters; 6.5.1.2.2.4 the center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within two (2) percent of the SID; and 6.5.1.2.2.5 on spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. 6.5.1.2.3 Override. If a means exists to override any of the automatic x-ray field size adjustments required in RH 6.5.1.2, that means:

6.5.1.2.3.1 shall be designed for use only in the event of system failure; 6.5.1.2.3.2 shall incorporate a signal visible at the operator's position which will indicate whenever the automatic field size adjustment is overridden; and 6.5.1.2.3.3 shall be clearly and durably labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE 6.5.2 Activation of the Fluoroscopic Tube.

X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images, the operator shall be able to terminate the x-ray exposure(s) at any time. 6.5.3 Exposure Rate Limits.

6.5.3.1 Entrance Exposure Rate Limits for Fluoroscopic Equipment Manufactured Before May 19, 1995. 6.5.3.1.1 Equipment with Automatic Exposure Rate Control (AERC). Fluoroscopic equipment that is provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 × 10-3 coulomb per kilogram (C/kg) per minute [10 roentgens per minute (10 R/min)] at the point where the center of the useful beam enters the patient, except:

6.5.3.1.1.1 During recording of fluoroscopic images or; 6.5.3.1.1.2 When an optional high-level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 mC/kg per minute (5 R/min) at the point where the center of the useful beam enters the patient, unless the high-level control is activated. Special means of activation of high-level controls shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high- level control is being employed.

6.5.3.1.2 Equipment Without AERC (Manual Mode). Fluoroscopic equipment that is not provided with AERC shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 mC/kg per minute (5 R/min) at the point where the center of the useful beam enters the patient, except: 6.5.3.1.2.1 during recording of fluoroscopic images, or; 6.5.3.1.2.2 when an optional high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high-level control is being employed.

6.5.3.1.3 Equipment with Both an AERC Mode and a Manual Mode. Fluoroscopic equipment that is provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 × 10-3 C/kg per minute (10 R/min) in either mode at the point where the center of the useful beam enters the patient except:

6.5.3.1.3.1 During recording of fluoroscopic images, or; 6.5.3.1.3.2 When the mode or modes have an optional high-level control, in which case that mode or modes shall not be operable at any combination of tube potential and current that will result in an entrance exposure rate in excess of 1.29 mC/kg per minute (5 R/min) at the point where the center of the useful beam enters the patient, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high-level is being employed. 6.5.3.1.3.3 Fluoroscopic units which have the high level control activated and an entrance exposure rate exceeding 5.16 × 10-3 C/kg per minute (20 R/min) shall be posted with the measured maximum entrance exposure rate, visible at the operator's position. Such sign will note that the entrance exposure rate of fluoroscopic equipment manufactured after May 19, 1995, which have the high level control activated, are limited to 5.16 × 10-3 per minute (20 R/min). 6.5.3.2 Entrance Exposure Rate Limits For Fluoroscopic Equipment Manufactured On and After May 19, 1995.

6.5.3.2.1 Fluoroscopic equipment operable at any combination of tube potential and current that results in an exposure rate greater than 1.29 mC/kg per minute (5 R/min) at the point where the center of the useful beam enters the patient shall be equipped with AERC. Provision for manual selection of technique factors may be provided. 6.5.3.2.2 Fluoroscopic equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58 × 10-3 C/kg per minute (10 R/min) at the point where the center of the useful beam enters the patient except; 6.5.3.2.2.1 During the recording of images from an x-ray image-intensifier tube using photographic film or a video camera when the x-ray source is operated in a pulsed mode; or 6.5.3.2.2.2 When the high-level control is activated, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 5.16 × 10-3 C/kg per minute (20 R/min) at the point where the center of the useful beam enters the patient. Special means of activation of high- level controls shall be required. The high-level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high-level control is being employed.

6.5.3.3 Compliance with the requirements of RH 6.5.3 shall be determined as follows: 6.5.3.3.1 If the source is below the table, exposure rate shall be measured one centimeter above the tabletop or cradle.

6.5.3.3.2 If the source is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

6.5.3.3.3 All C-arm fluoroscopes, both stationary and mobile, shall meet the entrance exposure rate limits in RH 6.5.3.1.1, 6.5.3.1.2, and 6.5.3.1.3, 30 centimeters from the input surface of the fluoroscopic imaging assembly with the source positioned at any available SID provided that the end of the spacer assembly or beam-limiting device is not closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly. 6.5.3.3.4 All lateral type fluoroscopes, both stationary and mobile, shall meet the entrance exposure rate limits in RH 6.5.3.1.1, 6.5.3.1.2, and 6.5.3.1.3; measured at a point 15 centimeters from the centerline of the table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the table. 6.5.3.3.5 Periodic measurement of entrance exposure rate shall be performed as follows: 6.5.3.3.5.1 Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate.

6.5.3.3.5.2 Conditions of periodic measurement of entrance exposure rate are as follows:

6.5.3.3.5.2.1 The measurement shall be made under the conditions that satisfy the requirements of RH 6.5.3.3;

6.5.3.3.5.2.2 The kVp shall be the maximum kVp which can be produced by the x-ray system;

6.5.3.3.5.2.3 The x-ray system(s) that incorporates automatic exposure rate control shall have the beam collimated to the size of the detector and have sufficient material placed in the useful beam to intercept the entire beam so that output of the machine is a maximum for the x-ray system; and 6.5.3.3.5.2.4 X-ray system(s) that do not incorporate an automatic exposure rate control shall utilize the maximum milliamperage typical of the clinical use of the x-ray system.2 6.5.4 Barrier Transmitted Radiation Rate Limits.

2Materials should be placed in the useful beam when conducting these periodic measurements to protect the imaging system. 6.5.4.1 The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed 0.516 µC/kg per hour (2 milliroentgen) at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate.

6.5.4.2 Measuring Compliance of Barrier Transmission.

6.5.4.2.1 The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

6.5.4.2.2 If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

6.5.4.2.3 If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters. 6.5.4.2.4 Movable grids and compression devices shall be removed from the useful beam during the measurement.

6.5.4.2.5 The attenuation block shall be positioned in the useful beam 10 centimeters from the point of measurement of entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly.

6.5.5 Indication of Potential and Current.

During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated on certified units.

6.5.6 Source-to-Skin Distance.

The SSD shall not be less than:

6.5.6.1 38 centimeters on stationary fluoroscopes installed after September 1, 1992, 6.5.6.2 35.5 centimeters on stationary fluoroscopes which were in operation on or before September 1, 1992, 6.5.6.3 30 centimeters on all mobile fluoroscopes;

6.5.6.4 20 centimeters for fluoroscopes used for specific surgical application. The written safety procedures must provide precautionary measures to be adhered to during the use of these systems; and 6.5.6.5 9 centimeters for mini c-arms.

6.5.7 Fluoroscopic Timer.

6.5.7.1 Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting. 6.5.7.2 A signal to the operator shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset 6.5.8 Control of Scattered Radiation.

6.5.8.1 Conventional fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation which originates from under the table. The attenuation required shall be not less than 0.25 millimeter lead equivalent. 6.5.8.2 Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities or head, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual: 6.5.8.2.1 is at least 120 centimeters from the center of the useful beam, or 6.5.8.2.2 the radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in RH 6.3.1.1.5.1. 6.5.8.3 The Department may grant exemptions to RH 6.5.8.2 where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the Department shall not permit such exemption. 6.5.8.4 The Department may grant exemptions to RH 6.5.8.2 when the use of drapes or self-supporting curtains are contra indicated and the diagnosis could be compromised. 6.5.9 Radiation Therapy Simulation Systems.

Radiation therapy simulation systems shall be exempt from all the requirements of RH 6.5.1, 6.5.3, 6.5.4, and 6.5.7 provided that:

6.5.9.1 such systems are designed and used in such a manner that no individual other than the patient, required staff and ancillary personnel are in the x-ray room during periods of time when the system is producing x-rays; and 6.5.9.2 systems which do not meet the requirements of RH 6.5.7 are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in such cases that the timer be reset between examinations. RH 6.6 Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, Veterinary, Computed Tomography, or Mammography X-Ray Systems.

6.6.1 Beam Limitation.

The useful beam shall be limited to the area of clinical interest. 6.6.1.1 General Purpose Stationary and Mobile X-Ray Systems. 6.6.1.1.1 There shall be provided a means for stepless adjustment of the size of the x-ray field. 6.6.1.1.2 A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two (2) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam. 6.6.1.1.3 The Department may grant an exemption on non-certified x-ray systems to RH 6.6.1.1.1 and 6.6.1.1.2 provided the registrant makes a written application for such exemption and in that application:

6.6.1.1.3.1 demonstrates it is impractical to comply with RH 6.6.1.1.1 and 6.6.1.1.2; and 6.6.1.1.3.2 the purpose of RH 6.6.1.1.1 and 6.6.1.1.2 will be met by other methods. 6.6.1.2 Additional Requirements for Stationary General Purpose X-Ray Systems. In addition to the requirements of RH 6.6.1.1, stationary general purpose x-ray systems, shall meet the following requirements:

6.6.1.2.1 A method shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within two (2) percent of the SID, and to indicate the SID to within two (2) percent;

6.6.1.2.2 The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and 6.6.1.2.3 Indication of field size dimensions and SID's shall be specified in inches and/or centimeters, and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam- limiting device to within two (2) percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.

6.6.1.3 X-Ray Systems Designed for One Image Receptor Size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within two (2) percent of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. 6.6.1.4 X-Ray Systems Other Than Those Described in RH 6.6.1.1, 6.6.1.2 and 6.6.1.3. 6.6.1.4.1 Means shall be provided to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two (2) percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

6.6.1.4.2 Means shall be provided to align the center of the x-ray field with the center of the image receptor to within two (2) percent of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.

6.6.1.4.3 RH 6.6.1.4.1 and 6.6.4.2 may be met with a system that meets the requirements for a general purpose x-ray system as specified in RH 6.6.1.1 or, when alignment means are also provided, may be met with either:

6.6.1.4.3.1 an assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or 6.6.1.4.3.2 a beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

6.6.2 Radiation Exposure Control Devices.

6.6.2.1 Timers. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a “zero” or “off” position if either position is provided. 6.6.2.2 X-Ray Control.

6.6.2.2.1 An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for: 6.6.2.2.1.1 exposure of one-half (0.5) second or less, or 6.6.2.2.1.2 during serial radiography when a means shall be provided to permit completion of any single exposure of the series in process. 6.6.2.2.2 Except for bone mineral densitometry devices, each x-ray control shall be located in such a way as to meet the following requirements:

6.6.2.2.2.1 stationary x-ray systems, and mobile or portable systems used routinely in one location, shall be required to have the x-ray control permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure.

6.6.2.2.2.2 mobile and portable x-ray systems not routinely used in one location shall be required to have an exposure switch so arranged that the operator can stand at least 1.83 meters (6 feet) from the patient, the x-ray tube and the useful beam. Mobile and portable x-ray systems used in surgery are considered to be not routinely used in one location.

6.6.2.2.2.3 The x-ray control shall provide visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated. 6.6.2.3 Automatic Exposure Controls. When an automatic exposure control is provided: 6.6.2.3.1 indication shall be made on the control panel when this mode of operation is selected; 6.6.2.3.2 if the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two (2) pulses;

6.6.2.3.3 the minimum exposure time for all equipment other than that specified in RH 6.6.2.3.2 shall be equal to or less than one-sixtieth (1/60) second or a time interval required to deliver 5 mAs, whichever is greater;

6.6.2.3.4 either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kWs per exposure, or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except that, when the x-ray tube potential is less than 50 kVp, the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and 6.6.2.3.5 a visible signal shall indicate when an exposure has been terminated at the limits required by RH 6.6.2.3.4, and manual resetting shall be required before further automatically timed exposures can be made.

6.6.2.4 Timer Reproducibility. With a timer setting of 0.5 seconds or less, the average exposure period (T ) shall be greater than or equal to five (5) times the maximum exposure period (T ) minus avg max the minimum exposure period (T ) when four (4) timer tests exposures are performed: min T ≥ 5(T - T ).

avg max min 6.6.3 Source-to-Skin Distance.

All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 centimeters.

6.6.4 Exposure Reproducibility.

When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05. The facility registrant may request an exemption for any machines manufactured prior to 1974, which cannot meet this requirement. The exemption request must verify that this exposure reproducibility variation will not result in unnecessary patient radiation exposure due to the need for repeat examinations.

6.6.5 Radiation from Capacitor Energy Storage Equipment in Standby Status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of 0.516 µC/kg (2 milliroentgen) per hour at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open. 6.6.6 Additional Requirements Applicable to Certified Systems Only. Diagnostic x-ray systems incorporating one or more certified component(s) shall be required to comply with the following additional requirement(s) which relate to that certified component(s). 6.6.6.1 Linearity. When the equipment allows a choice of x-ray tube current or mAs settings for any fixed x-ray tube potential within the range of 40 to 100 percent of the maximum rating, the average ratio of exposure to the indicated milliampere-seconds product obtained at any two (2) consecutive tube current or mAs settings shall not differ by more than 0.10 times their sum: |1007_1_xmacron.jpg - 1007_1_xmacron.jpg | ≤ 0.10 (1007_1_xmacron.jpg + 1 2 1 1007_1_xmacron.jpg ), 2 where 1007_1_xmacron.jpg and 1007_1_xmacron.jpg are the average mR/mAs 1 2 (microcoulomb/kilogram per mAs) values obtained at each of two (2) consecutive tube current settings or at two settings differing by no more than a factor of two (2) when the mAs selector provides continuous selection.

6.6.6.2 Accuracy. Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer. If manufacturer specifications are not available, the following criteria shall be used:

6.6.6.2.1 The kVp shall not deviate from indicated values by more than ten (10) percent. 6.6.6.2.2 The timer accuracy shall not deviate from indicated values by more than: 6.6.6.2.2.1 ten (10) percent for an indicated time of greater than 20 ms; or 6.6.6.2.2.2 fifty (50) percent for an indicated time of 20 ms or less. 6.6.6.3 Beam Limitation for Stationary and Mobile General Purpose X-Ray Systems. 6.6.6.3.1 There shall be provided a means of stepless adjustment of the size of the x-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters.

6.6.6.3.2 When a light localizer is used to define the x-ray field, it shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement. 6.6.6.3.3 For collimators manufactured prior to August 1, 1974, average net illuminance measurement made in the approximate center of each quadrant of the light field shall not be less than the values indicated below:

Column 1 Column 2 Ambient Light Net Minimum Light Illuminance Illuminance Above Ambient 5 to 25 lux 25 lux 26 to 50 lux 50 lux 51 to 75 lux 75 lux 76 to 100 lux 100 lux 101 to 159 lux 100 lux 6.6.6.3.3.1 If the ambient light was reduced to achieve a net light localizer illuminance of any value in column 2, operating procedures shall be written, describing steps which must be taken for reducing the ambient light to allow enhancement of the light field during positioning. All x-ray machine operators shall be trained in these procedures. The operating procedures shall be filed in the written safety procedures manual and maintained on the premises of the registered facility. 6.6.6.4 Beam Limitation for Portable X-Ray Systems. Beam limitation for portable x-ray systems shall meet the beam limitation requirements of RH 6.6.1.1 and 6.6.6.3. 6.6.6.5 Positive Beam Limitation (PBL).

6.6.6.5.1 When a PBL system is provided, it shall prevent x-ray production when: 6.6.6.5.1.1 either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than three (3) percent of the SID; or 6.6.6.5.1.2 The sum of the length and width differences as stated in RH 6.6.6.5.1.1 of this section without regard to sign exceeds four (4) percent of the SID. 6.6.6.5.1.3 The beam limiting device is at a SID for which PBL is not designed for sizing. 6.6.6.5.2 Conditions for PBL. When provided, the PBL system shall function as described in RH 6.6.6.5.1 of this section whenever all the following conditions are met: 6.6.6.5.2.1 The image receptor is inserted into a permanently mounted cassette holder; 6.6.6.5.2.2 The image receptor length and width are less than 50 centimeters; 6.6.6.5.2.3 The x-ray beam axis is within ±three (3) degrees of vertical and the SID is 90 centimeters to 130 centimeters inclusive; or the x-ray beam axis is within ±three (3) degrees of horizontal and the SID is 90 centimeters to 205 centimeters inclusive;

6.6.6.5.2.4 The x-ray beam axis is perpendicular to the plane of the image receptor to within ±three (3) degrees;

6.6.6.5.2.5 Neither tomographic nor stereoscopic radiography is being performed; 6.6.6.5.2.6 Manual collimation is not used;

6.6.6.5.2.7 The machine is used for procedures other than therapy simulation; and 6.6.6.5.2.8 The PBL system has not been intentionally overridden. 6.6.6.5.3 If a means of overriding the PBL system exists, that means: 6.6.6.5.3.1 Shall be designed for use only in the event of PBL system failure, or if the system is being serviced; and 6.6.6.5.3.2 If in a position that the operator would consider it part of the operational controls, or if it is referenced in the operator's manual, or in other materials intended for the operator, 6.6.6.5.3.2.1 shall require that a key be utilized to defeat the PBL; 6.6.6.5.3.2.2 shall require that the key remain in place during the entire time the PBL system is overridden; and 6.6.6.5.3.2.3 shall require that the key or key switch be clearly and durably labeled as follows:

FOR X-RAY FIELD LIMITATION SYSTEM FAILURE 6.6.6.5.4 Compliance with RH 6.6.6.5 shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of RH 6.6.6.5.2 are met. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor.

6.6.6.5.5 The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters. 6.6.6.5.6 The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in RH 6.6.6.5, then any change of image receptor size or SID must cause the automatic return. 6.6.6.6 Timers. Except for dental panoramic systems, termination of exposure shall cause automatic resetting of the timer to its initial setting or to “zero”. RH 6.7 Intraoral Dental Radiographic Systems.

In addition to the provisions of RH 6.3 and 6.4, the requirements of RH 6.7 apply to x-ray equipment and associated facilities used for dental radiography. Requirements for extra-oral dental radiographic systems are covered in RH 6.6.

6.7.1 Source-to-Skin Distance (SSD).

X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit SSD, to not less than:

6.7.1.1 18 centimeters if operable above 50 kVp, or 6.7.1.2 10 centimeters if not operable above 50 kVp.

6.7.2 Field Limitation.

Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

6.7.2.1 if the minimum SSD is 18 centimeters or more, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 7 centimeters; and 6.7.2.2 if the minimum SSD is less than 18 centimeters, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 6 centimeters. 6.7.3 Timers.

Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition: 6.7.3.1 It shall not be possible to make an exposure when the timer is set to a “zero” or “off” position if either position is provided.

6.7.3.2 Termination of exposure shall cause automatic resetting of the timer to its initial setting or to “zero”.

6.7.3.3 Timer Reproducibility. With a timer setting of 0.5 seconds or less, the average exposure period (T ) shall be greater than or equal to five (5) times the maximum exposure period (T ) minus avg max the minimum exposure period (T ) when four (4) timer tests are performed: min T ≥ 5(T - T ).

avg max min 6.7.4 X-Ray Control.

6.7.4.1 An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time, except for exposures of one-half (0.5) second or less. 6.7.4.2 Each x-ray control shall be located in such a way as to meet the following requirements: 6.7.4.2.1 stationary x-ray systems, and mobile or portable systems used routinely in one location, shall be required to have the x-ray control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure, or the exposure control shall be such that the operator can stand at least 1.83 meters (6 feet) from the patient, the x-ray tube and the useful beam; 6.7.4.2.2 mobile and portable x-ray systems not routinely used in one location shall be required to have an exposure switch so arranged that the operator can stand at least 1.83 meters (6 feet) from the patient, the x-ray tube and the useful beam. 6.7.4.3 The x-ray control shall provide visual indication observable at or from the operator's protected position whenever x-rays are produced.

6.7.5 Exposure reproducibility.

The estimated coefficient of variation of radiation exposure shall be no greater than 0.05, for any specific combination of selected technique factors.

6.7.6 Linearity.

When the equipment allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer in accordance with the requirements of applicable Federal standards, for any fixed x-ray tube potential within the range of 40 to 100 percent of the maximum rating, the average ratios of exposure to the indicated milliampere-seconds product obtained at any two (2) consecutive tube current or mAs settings shall not differ by more than 0.10 times their sum: |1007_1_xmacron.jpg - 1007_1_xmacron.jpg | ≤ 0.10 (1007_1_xmacron.jpg + 1 2 1 1007_1_xmacron.jpg ), 2 where 1007_1_xmacron.jpg and 1007_1_xmacron.jpg are the average mR/mAs values obtained at each 1 2 of two (2) consecutive tube current or mAs settings.

6.7.7 Accuracy.

Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer. If those are not available, accuracy of all exposure factors shall be within ten (10) percent of the selected factor(s).

6.7.8 Beam Quality.

All certified dental x-ray systems manufactured on and after December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters aluminum equivalent Systems operating above 70 kVp are subject to the filtration requirements of RH 6.4.5.1.

6.7.9 Administrative Controls.

6.7.9.1 Patient and film holding devices shall be used when the techniques permit. 6.7.9.2 The tube housing and the PID shall not be hand-held during an exposure. 6.7.9.3 The x-ray system shall be operated in such a manner that the area of the useful beam at the patient's skin is minimized.

6.7.9.4 Dental fluoroscopy without image intensification shall not be used. Other Diagnostic X-Ray Systems RH 6.8 Veterinary Medicine Radiographic Installations.

6.8.1 Equipment.

6.8.1.1 The protective tube housing shall be equivalent to the requirements of RH 6.4.3. 6.8.1.2 Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing. 6.8.1.3 The total filtration permanently in the useful beam shall meet the requirement of RH 6.4.5.1. 6.8.1.4 Exposure Reproducibility. The coefficient of variation of exposure shall not exceed 0.10 when all technique factors are held constant.

6.8.1.5 A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 5 (five) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam. 6.8.1.6 A device shall be provided to terminate the exposure after a preset time or exposure. 6.8.1.7 A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator can stand out of the useful beam. 6.8.2 Structural Shielding.

All wall, ceiling, and floor areas shall be equivalent to or provided with applicable protective barriers to assure compliance with RH 4.6, 4.12, 4.13, and 4.14 of these Regulations. 6.8.2.1 Veterinary facilities are exempt from the requirements of Appendix B, provided that the operator is adequately protected by distance and/or shielding.

6.8.3 Operating Procedures.

6.8.3.1 Whenever possible, the operator shall stand well away from the useful beam and the animal during radiographic exposures.

6.8.3.2 No individual, other than the operator, shall be in the x-ray room while exposures are being made, unless such individual's assistance is required and the person is adequately protected by shielding and/or distance.

6.8.3.3 When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron, and he/she shall be so positioned that no part of his/her body will be struck by the useful beam. The exposure of any individual used for this purpose shall be maintained below the limits specified in RH 4.6, 4.12, and 4.13.

6.8.3.4 No human shall hold the image receptor during radiography unless that individual is protected with appropriate shielding devices, such as protective gloves and apron, and that any part of his/her body struck by the useful beam shall be monitored. The exposure of any individual used for this purpose shall be maintained below the limits specified in RH 4.6, 4.12, and 4.13. RH 6.9 Computed Tomography X-Ray Systems.

6.9.1 Definitions.

In addition to the definitions provided in RH 1.4 and 6.2 of these Regulations, the following definitions shall be applicable to RH 6.9:

“Computed tomography dose index (CTDI)” means the integral from -7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is: CTDI = 1 ? -7T nT +7T where:

z = Position along a line perpendicular to the tomographic plane. D(z) = Dose at position z.

T = Nominal tomographic section thickness.

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z=0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT. “Contrast scale (CS)” means the change in the linear attenuation coefficient per CTN relative to water, that is:

CS = µx - µw (CTN)x - (CTN)w where:

µ = Linear attenuation coefficient of the material of interest. x µ = Linear attenuation coefficient of water.

w (CTN) = CTN of the material of interest.

x (CTN) = CTN of water.

w “CT conditions of operation” means all selectable parameters governing the operation of a CT x- ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in RH 6.2.

“CT gantry” means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components. “CT number (CTN)” means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

CTN = k (µx - µw)

µw where:

k = A constant3 3The constant has a normal value of 1,000 when the Houndsfield scale of CTN is used. µ = Linear attenuation coefficient of the material of interest. x µ = Linear attenuation coefficient of water.

w “Dose profile” means the dose as a function of position along a line. “Elemental area” means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted. (See also “Picture element”).

“Multiple tomogram system” means a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram. “Noise” means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (S ) is calculated using the following expression: n Sn = 100 × CS × s µw where:

CS = Contrast scale µ = Linear attenuation coefficient of water.

w s = Estimated standard deviation of the CTN of picture elements in a specified area of the CT image.

“Nominal tomographic section thickness” means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

“Picture element” means an elemental area of a tomogram. “Reference plane” means a plane which is displaced from and parallel to the tomographic plane. “Scan” means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

“Scan increment” means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement. “Scan sequence” means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

“Scan time” means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.

“Single tomogram system” means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

“Tomographic plane” means that geometric plane which is identified as corresponding to the output tomogram.

“Tomographic section” means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

6.9.2 Requirements for Equipment.

6.9.2.1 Termination of Exposure.

6.9.2.1.1 Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a backup timer or devices which monitor equipment function.

6.9.2.1.2 A visible signal shall indicate when the x-ray exposure has been terminated through the means required by RH 6.9.2.1.1.

6.9.2.1.3 The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration. 6.9.2.2 Tomographic Plane Indication and Alignment.

6.9.2.2.1 For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. 6.9.2.2.2 For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

6.9.2.2.3 If a device using a light source is used to satisfy RH 6.9.2.2.1 or 6.9.2.2.2, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux (46 foot candles).

6.9.2.3 Beam-On and Shutter Status Indicators and Control Switches. 6.9.2.3.1 The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed. 6.9.2.3.2 Each emergency button or switch shall be clearly labeled as to its function. 6.9.2.4 Indication of CT Conditions of Operation.

The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

6.9.2.5 Extraneous Radiation.

When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by RH 6.4.3.

6.9.2.6 Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry Manufactured After September 2, 1992.

6.9.2.6.1 The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters.

6.9.2.6.2 If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

6.9.2.6.3 The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

6.9.2.6.4 Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan. 6.9.3 Facility Design Requirements.

6.9.3.1 Aural Communication.

Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

6.9.3.2 Viewing Systems.

6.9.3.2.1 Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

6.9.3.2.2 Patient scanning shall be allowed only when a viewing system is available and in use. 6.9.4 Surveys, Evaluations, Calibrations, Spot Checks, and Operating Procedures. 6.9.4.1 Surveys and Evaluations.

6.9.4.1.1 All CT x-ray systems installed after September 1, 1992 and those systems not previously surveyed shall have a shielding survey made by, or under the direction of, a qualified expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

6.9.4.1.2 The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to the Department upon request. 6.9.4.1.3 Notwithstanding the provisions of RH 2.5.1.2, CT x-ray systems that have undergone a tube change within 12 months of the last annual evaluation do not require a complete calibration provided that the CT x-ray system operation after the tube change meets the criteria established by the qualified expert. The certification evaluation (CE) need not be performed each time an x- ray tube is replaced. However, each CT system shall receive a CE at least within one year of the previous CE.

6.9.4.2 Radiation Calibrations.

6.9.4.2.1 The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified expert who is physically present at the facility during such calibration. 6.9.4.2.2 The calibration of a CT x-ray system shall be performed at intervals, not exceeding one year, specified by a qualified expert.

6.9.4.2.3 The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two (2) years. 6.9.4.2.4 CT dosimetry phantom(s) shall be used in determining the radiation output of a CT x-ray system. Such phantom(s) shall meet the following specifications and conditions of use: 6.9.4.2.4.1 CT dosimetry phantom(s) shall be right circular cylinders of water or polymethyl methacrylate. The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32 centimeters for testing CT x-ray systems designed to image any section of the body and 16 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode.

6.9.4.2.4.2 CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1 centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided.

6.9.4.2.4.3 Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom.

6.9.4.2.4.4 All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present. 6.9.4.2.5 The calibration shall be required for each common type of head, body, or whole-body scan performed at the facility.

6.9.4.2.6 Calibration shall meet the following requirements: 6.9.4.2.6.1 The CTDI4 along the two axes specified in RH 6.9.4.2.4.2 shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant.

4For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized.

6.9.4.2.6.2 The spot checks specified in RH 6.9.4.3 shall be made. 6.9.4.2.7 Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for a period of three (3) years for inspection by the Department. 6.9.4.3 Spot Checks.

6.9.4.3.1 The spot-check procedures shall be in writing and shall have been developed by a qualified expert.

6.9.4.3.2 The spot-check procedures shall incorporate the use of a CT performance phantoms which has a capability of providing an indication of contrast scale, noise, nominal tomographic section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.

6.9.4.3.3 All spot checks shall be included in the calibration required by RH 6.9.4.2 and at time intervals and under system conditions specified by a qualified expert. 6.9.4.3.4 Spot checks shall include acquisition of images obtained with the CT performance phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations required by RH 6.9.4.2. The images shall be retained, until a new calibration is performed, as follows:

6.9.4.3.4.1 photographic copies of the images obtained from the image recording device; or 6.9.4.3.4.2 images stored in digital form on a storage medium compatible with the CT x-ray system.

6.9.4.3.5 Written records of the spot checks performed shall be maintained for inspection by the Department.

6.9.4.4 Operating Procedures 6.9.4.4.1 The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.

6.9.4.4.2 Information shall be available at the control panel regarding the operation of the system. Information regarding calibration of the system shall be readily available. Such information shall include the following:

6.9.4.4.2.1 dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

6.9.4.4.2.2 instructions on the use of the CT performance phantom(s) including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system; 6.9.4.4.2.3 the distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and 6.9.4.4.2.4 when operators must select technique factors, a current technique chart shall be available at the control panel which specifies for each routine examination the CT conditions of operation and the typical number of scans per examination. 6.9.4.4.3 If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified expert, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.

RH 6.10 Mammography.

6.10.1 Definitions.

“Continuing education unit (CEU)” means one contact hour of training or education, which is documentable.

“Established operating level” means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program. “Facility” means a hospital, outpatient Department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities, including the following: operation of equipment to produce a mammogram, initial interpretation of the mammogram, and maintaining viewing conditions for that interpretation.

“Laterality” means the designation of either the right or left breast. “Mammogram” means a radiographic image produced through mammography. “Mammography” means radiography of the breast, but for the purposes of this Part, does not include: radiography of the breast performed during invasive interventions for localization or biopsy procedures; or radiography of the breast performed with an investigational mammography device as part of a scientific study conducted.

“Mammography phantom” means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. For the purpose of this section, phantom means mammography phantom. “Mammography medical outcomes audit” means a systematic collection of mammography results and the comparison of those results with outcomes data.

“Patient” means any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a physician or is self-referred. “Standard breast” means a 4.2 centimeter (cm) thick compressed breast consisting of fifty(50) percent glandular and fifty (50) percent adipose tissue.

6.10.2 Quality Standards.

6.10.2.1 Personnel.

6.10.2.1.1 Radiologic Technologists. All mammographic examinations shall be performed by a person who meets the following requirements.

6.10.2.1.1.1 General Requirements. Be approved by the Department as a mammographer, as defined in RH 2.2 and has met the requirement of RH 2.4.4.1.1.1; or as a provisional mammographer, as specified under RH 2.4.4; or as a student radiographer working under the provision of RH 2.4.4.1.3; and 6.10.2.1.1.2 Continuing Education. The mammographer shall document fifteen (15) hours of continuing education which are no more than 36 months old. Mammographers who fail to meet this continuing education requirement shall obtain a sufficient number of continuing education units (CEU) in mammography to bring their total up to at least fifteen (15) CEU. 6.10.2.1.1.3 Continuing Experience. The mammographer shall have performed a minimum of 200 mammography examinations every 24 months. Mammographers who fail to meet the continuing experience requirement of RH 6.10.2.1.1.3 shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified mammographer, before resuming the performance of unsupervised mammography examinations. 6.10.2.1.2 Qualified Inspectors. All qualified inspectors conducting mammography facility and x-ray machine evaluations shall meet the requirements of Appendix B, c. of Part 2. 6.10.2.2 Equipment.

Only x-ray systems meeting the following standards shall be used: 6.10.2.2.1 System Design. The x-ray system shall be specifically designed for mammography; and 6.10.2.2.2 Image Receptor Sizes. Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 × 24 centimeters (cm) and 24 × 30 cm. The image receptors shall be equipped with moving grids matched to all image receptor sizes provided. Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor;

6.10.2.2.3 Beam Limitation and Light Fields. All systems shall have beam-limiting devices that allow the useful beam to extend to or beyond the chest wall edge of the image receptor and shall meet the requirement of RH 6.10.2.6.8. When a light localizer is used to define the x-ray field, it shall meet the requirement of RH 6.6.6.3.2.

6.10.2.2.4 Magnification. Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator. Systems used for magnification procedures shall provide, as a minimum, at least one magnification value within the range of 1.4 to 2.0.

6.10.2.2.5 Focal Spot Selection. When more than one focal spot is provided, the system shall indicate, prior to the exposure, which focal spot is selected. When more than one target material is provided, the system shall indicate, prior to the exposure, the preselected target material. When the target material and/or focal spot is automatically selected by the machine, the system shall display, after the exposure, the used target material and/or focal spot. 6.10.2.2.6 Compression. All mammography systems shall incorporate a compression device. 6.10.2.2.6.1 Application of Compression. Effective October 28, 2002, each system shall provide an initial power driven compression activated by hands-free controls and fine adjustment compression controls operable from both sides of the patient. 6.10.2.2.6.2 Compression Paddle. Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. 6.10.2.2.6.2.1 The compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1 cm at any point on the surface of the compression paddle when compression is applied. 6.10.2.2.6.2.2 Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements. Such equipment is exempt from the requirement of RH 6.10.2.2.6.2.1. 6.10.2.2.6.2.3 The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

6.10.2.2.6.2.4 The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

6.10.2.2.7 Technique Factor Selection and Display. Manual selection of milliampere seconds (mAs) or at least one of its component parts [milliampere (mA) and time] shall be available. 6.10.2.2.7.1 The technique factors (kVp, mA and time in second or milliseconds, or mAs) to be used during an exposure shall be indicated prior to the exposure, except when the automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated.

6.10.2.2.7.2 Following AEC mode use, the system shall indicate the actual kVp and mAs used during the exposure. The mAs may be displayed as mA and time. 6.10.2.2.8 Automatic Exposure Control. All systems shall provide an AEC mode that is operable in all combinations of equipment configuration provided, i.e., grid, nongrid, magnification, non- magnification, and various target-filter combinations.

6.10.2.2.8.1 The size and available positions of the detector shall be clearly indicated on the compression paddle.

6.10.2.2.8.2 The system shall provide means for the operator to vary the selected optical density (OD) from the normal or zero setting to the positive and/or negative values of density settings.

6.10.2.2.9 X-ray Film and Intensifying Screens. The registrant shall use x-ray film and intensifying screens that have been designated by the manufacturers as appropriate and screen/film compatible for mammography.

6.10.2.2.10 Film Processing Solutions. The registrant shall use chemical solutions that are capable of developing the mammography films in a manner equivalent to the minimum requirements specified by the film manufacturer.

6.10.2.2.11 Lighting. Hot lights, capable of producing light levels greater than that provided by the view box, shall be available for use.

6.10.2.2.12 Film Masking Devices. The registrant shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available and used.

6.10.2.2.13 Viewboxes used for interpreting mammograms and clinical quality review by the technologist shall be capable of producing a luminance of at least 3,000 candela per square meter (cd/m ). 2 6.10.2.3 Medical Records And Mammography Reports.

6.10.2.3.1 Contents and Terminology. The registrant shall prepare a written report of the results of each mammography examination performed. The report shall include: the name of the patient and an additional patient identifier; the date of the examination; the name of the interpreting physician who interpreted the mammogram; and the overall final assessment of findings. 6.10.2.3.2 Communication of Mammography Results to the Patient. The registrant shall maintain a system to ensure that the results of each mammography examination are communicated to the patient in a timely manner.

6.10.2.3.2.1 The registrant shall send the mammography report, as described in RH 6.10.2.3.1, in addition to a written notification of results in lay terms, within thirty (30) days from the date of the mammography examination, to all patients who do not name a health care provider to receive the report.

6.10.2.3.2.2 Registrants that accept patients who do not have a primary care provider shall maintain a system for referring such patients to a health care provider when clinically needed.

6.10.2.3.3 Communication of Mammography Results to Health Care Providers. When the patient has named a referring health care provider, the registrants shall provide a written report of the mammography examination, within thirty (30) days from the date of the exam, to that provider. 6.10.2.3.4 Record Keeping. The registrant shall maintain mammography films and reports in a permanent medical record of the patient for a period of not less than five (5) years, or not less than ten (10) years if no additional mammograms of the patient are performed at the facility. 6.10.2.3.4.1 The registrant shall upon request or on behalf of, by the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports as directed by the patients or their representatives.

6.10.2.3.4.2 Any fee charged to the patients for providing the services described in RH 6.10.2.3.4.1 shall not exceed the documented costs associated with this service. 6.10.2.3.5 Mammographic Image Identification. Each mammography image shall clearly indicate the patient's name and an additional patient identifier; the date of the examination; the view and laterality; the facility name and location; the technologist identification; the cassette/screen identification; and the mammography unit.

6.10.2.4 Quality Assurance - General Requirements.

The registrant shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility. 6.10.2.5 Quality Assurance - Quality Control of Mammography Operations. 6.10.2.5.1 All tests specified in RH 6.10.2.5 shall be performed by a qualified mammographer or provisional mammographer.

6.10.2.5.2 Daily Quality Control Tests. Film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be done on each day that examinations are provided prior to clinical films being developed. The test shall include the following assessment: 6.10.2.5.2.1 The base plus fog density shall be within 0.03 of the established operating level. 6.10.2.5.2.2 The mid-density shall be within ± 0.15 of the established operation level. 6.10.2.5.2.3 The density difference shall be within ± 0.15 of the established operation level. For any mammography registrant using film processors at multiple locations, such as a mobile service processor performance by sensitometric strips shall be performed prior to the development of patient's films.

6.10.2.5.3 Weekly Quality Control Tests. Facilities with screen-film systems shall perform an image quality evaluation test, using an FDA-approved phantom, at least weekly. The test shall include the following assessment:

6.10.2.5.3.1 The optical density at the center of the phantom image shall be at least 1.20 when using clinical technique factors.

6.10.2.5.3.2 The optical density at the center of the phantom image shall not change by more than ± 0.20 from the established operating level.

6.10.2.5.3.3 The phantom image shall achieve at least the minimum score to observe the image of a 0.75 mm fiber, 0.32 mm speck, and a 0.75 mm mass.

6.10.2.5.3.4 The density difference between the background of the phantom and an added test object, used to assess image contrast, shall not vary by more than ± 0.05 from the established operating level.

6.10.2.5.4 Quarterly Quality Control Tests. Facilities with screen-film systems shall perform the following tests at least quarterly:

6.10.2.5.4.1 Fixer Retention in Film. The residual fixer shall be no more than 5 micrograms per square cm.

6.10.2.5.4.2 Repeat Analysis. If the total repeat or reject rate changes from the previously determined rate by more than two (2) percent of the total films included in the analysis, the reason(s) for the change shall be determined. Any corrective actions shall be recorded and the results of these corrective actions shall be assessed. 6.10.2.5.5 Semiannual Quality Control Tests. Facilities with screen-film systems shall perform the following tests at least semiannually:

6.10.2.5.5.1 Darkroom Fog. The darkroom fog level of a phantom image with an optical density of at least 1.20 and shall not exceed 0.05 OD. The fog test film shall be exposed to typical darkroom conditions for two (2) minutes with the emulsion side up. 6.10.2.5.5.2 Screen-film Contact. All cassettes used at the facility for mammography shall be tested using 40 mesh copper screen. Cassettes shall not be used for mammography if one or more areas >1 cm in diameter or poor contact that are not eliminated by screen cleaning. Five or more small areas <1 cm in diameter are acceptable, and the cassette may be returned to clinical use.

6.10.2.5.5.3 Compression Device Performance. A compression force of at least 111 newtons (25 pounds) shall be provided. Effective October 28, 2002, the maximum compression force of the initial power drive shall be between 111 newtons (25 pounds) and 209 newtons (47 pounds).

6.10.2.6 Quality Assurance - Facility and Equipment Evaluation. Facilities with screen-film systems shall perform the following tests at least annually. 6.10.2.6.1 All tests specified in RH 6.10.2.6 shall be performed by a mammography approved qualified inspector.

6.10.2.6.2 Automatic Exposure Control Performance. The AEC shall be capable of maintaining film optical density within ± 0.30 of the mean OD when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically. If this requirement cannot be met, a technique chart shall be developed showing appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions that must be used so that an OD within ± 0.30 of the average under phototimed conditions can be produced.

6.10.2.6.2.1 After October 28, 2002, the AEC shall be capable of maintaining film OD within ± 0.15 of the mean OD.

6.10.2.6.2.2 The OD at the center of the phantom image shall not be less than 1.20. 6.10.2.6.3 kVp Accuracy and Reproducibility. The kVp shall be accurate within ± five (5) percent of the indicated kVp at:

6.10.2.6.3.1 The lowest clinical kVp that can be measured by a kVp test device; 6.10.2.6.3.2 The most commonly used clinical kVp;

6.10.2.6.3.3 The highest available clinical kVp; and 6.10.2.6.3.4 At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.02. Not all commonly used clinical settings of kVp need to be tested.

6.10.2.6.4 Focal Spot Condition. Focal spot condition shall be evaluated either by determining system resolution or by measuring focal spot dimensions. After October 28, 2002, facilities shall evaluate focal spot condition only by determining the system resolution. 6.10.2.6.4.1 System Resolution. Mammography systems, in combination with the mammography screen-film combination, shall provide a minimum resolution of 11 cycles/millimeter (line- pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis.

6.10.2.6.4.1.1 The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within one cm of the chest wall edge of the image receptor. 6.10.2.6.4.1.2 When more than one target is provided, the measurement described in RH 6.10.2.6.3.1 shall be made using the magnification and contact radiography with all available targets.

6.10.2.6.4.1.3 When more than one SID is provided, the test shall be performed at the most commonly used clinical SID.

6.10.2.6.4.1.4 The kVp shall be set at the clinical value for a standard breast and the system resolution test shall be performed such that the background optical density of the film should be between 1.2 and 1.8.

6.10.2.6.4.2 Focal Spot Dimensions. Measured values of the focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) shall be within the tolerance limits specified in Table I. Table I Focal Spot Tolerance Limit Nominal Focal Spot Size Maximum Measured Dimensions (mm)

Width (mm) Length (mm)

0.10 0.15 0.15 0.15 0.23 0.23 0.20 0.30 0.30 0.30 0.45 0.65 0.40 0.60 0.85 0.50 0.90 1.30 6.10.2.6.5 Beam Quality and Half-value Layer (HVL). The HVL shall meet the following specifications for minimum HVL.

kVp ≤ HVL 100 6.10.2.6.6 Breast Entrance Air Kerma and AEC Reproducibility. The coefficient of variation for both air kerma and mAs shall not exceed 0.05.

6.10.2.6.7 Dosimetry. The average glandular dose delivered during a single cranio-caudal view of an FDA-accepted phantom simulating a standard breast, using the clinical technique factors and conditions for that phantom, shall not exceed 3.0 milligray (0.3 rad) per exposure. 6.10.2.6.8 X-ray Field/Light Field/Image Receptor/Compression Alignment. All systems shall have beam -limiting devices that allow the useful x-ray beam to extend to or beyond the edges of the image receptor but by no more than two (2) percent of the SID at the chest wall side. 6.10.2.6.8.1 If a light localizer is provided, the resultant light field shall be aligned with the x-ray field so that the total of any misalignment of the edges of the light field and the x-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed two (2) percent of the SID. 6.10.2.6.8.2 The chest wall edge of the compression paddle shall not extend beyond the chest wall edge of the image receptor by more than one percent of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness.

6.10.2.6.9 Uniformity of Screen Speed. Uniformity of screen speed of all the cassettes shall be tested and the difference between the maximum and minimum optical densities shall not exceed 0.3. Screen artifacts shall also be evaluated during this test. 6.10.2.6.10 System Artifacts. System artifacts shall be performed for all cassettes sizes using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically. 6.10.2.6.11 Radiation Output. The system shall be capable of producing a minimum output of 4.5 mGy air kerma per second (513 milliroentgen per second) when operating at 28 kVp in the moly/moly mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place as clinically used. After October 28, 2002, the system, under the same measuring conditions shall be capable of producing a minimum output of 7.0 mGy air kerma per second (800 milli roentgen per second).

6.10.2.6.11.1 The system shall be capable of maintaining the required minimum radiation output averaged over a three (3) second period.

6.10.2.6.12 Decompression. If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, the system shall be tested to confirm that it provides:

6.10.2.6.12.1 An override capability to allow maintenance of compression; 6.10.2.6.12.2 A continuous display of the override status; and 6.10.2.6.12.3 A manual emergency compression release that can be activated in the event of power or automatic release failure.

6.10.2.7 Additional Mammography Equipment Evaluations.

An evaluation of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is dissembled and reassembled at the same or new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be performed by a mammography approved qualified inspector. 6.10.2.8 Quality Control Tests-Other Modalities.

For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems as specified in RH 6.10.2.6.6.

6.10.2.9 Mobile Units.

Mobile mammography systems shall meet the requirements of RH 6.10.2.5 through 6.10.2.8. In addition, at each examination location, the registrant shall verify satisfactory performance of such units using a test method that establishes the adequacy of the image quality produced by the unit, prior to its use on patients.

6.10.2.10 Facility Cleanliness.

The registrant shall establish and implement adequate protocols for maintaining darkroom, screen, and view box cleanliness. The registrant shall document that all cleaning procedures are performed at the frequencies specified in the protocols.

6.10.2.11 Infection Control.

The registrant shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography systems after contact with blood or other potentially infectious materials.

6.10.2.12 Quality Assurance-Mammography Medical Outcomes Audit. Each registrant shall establish and maintain a mammography medical outcomes audit program to follow up positive mammographic assessments and to correlate pathology results with the interpreting physician's findings. The facility's first audit analysis shall be initiated no later than twelve (12) months after the date the facility becomes certified, or twelve (12) months after the effective date of these Regulations whichever date is latest. This audit analysis shall be completed within an additional twelve (12) months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every twelve (12) months. 6.10.2.13 All mammography facilities which have a current MQSA certificate or provisional certificate and a certification evaluation (not exceeding twelve (12) months old) performed by a qualified inspector authorized in mammography are considered to have met the requirements of RH 6.10, only if any deficiencies or violations cited have been corrected within thirty (30) days. RH 6.11 Severability.

The provisions of these Regulations are severable, and if any provisions or the application of the provisions to any circumstances is held invalid, the application of such provision to other circumstances, and the remainder of these Regulations shall not be affected thereby. PART 6 APPENDIX A. INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS In order to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information shall be submitted to the qualified expert. 1. The plans shall show, as a minimum, the following:

(a) The normal location of the x-ray system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; the location of the operator's booth; and the location of the x-ray control panel. (b) The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.

(c) The dimensions of the room(s) concerned and inter-floor distances if occupied. (d) The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present.

(e) The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.)

(f) The type of examination(s) or treatment(s) which will be performed with the equipment. 2. Information on the anticipated workload of the x-ray system(s). 5 PART 6 APPENDIX B. DESIGN REQUIREMENTS FOR AN OPERATOR'S BOOTH 5Exceptions from the above design requirements may be granted by the Department. To apply for such an exception, the facility registrant must submit a facility design review from a Qualified Expert to the Department. The review must specify the reason for the exception and it must demonstrate that the operator will have equivalent protection from radiation by use of the proposed shielding design.

1. Space Requirements:

(a) The operator shall be allotted not less than 7.5 square feet (0.697 m2) of unobstructed floor space in the booth.

(b) The operator's booth may be of any geometric configuration with no dimension of less than 2 feet (0.61 m).

(c) The space shall be allotted excluding any encumbrance by the x-ray control panel, such as overhang, cables, or other similar encroachments.

(d) The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall cassette cannot reach the operator's location within the booth.

2. Structural Requirements:

(a) The booth walls shall be permanently fixed barriers of at least 7 feet (2.13 m) high. (b) When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed in its shielding position.

(c) Shielding shall be provided to meet the requirements of Part 4 of these Regulations. 3. Viewing System Requirements:

(a) Each booth shall have at least one viewing device which will: (1) Be so placed that the operator can view the patient during any exposure, and (2) The device shall be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then that door must have either an interlock controlling the exposure which will prevent the exposure if the door is not closed; or a warning light must be activated at the control panel when the door is opened. (b) When the viewing system is a window, the following requirements also apply: (1) The viewing area shall be at least 1 square foot (0.0929 m2). (2) The design of the booth shall be such that the operator's expected position when viewing the patient and operating the x-ray system is at least 18 inches (0.457 m) from the edge of the booth.

(3) The material constituting the window shall have the same lead equivalence as that required in the booth's wall in which it is mounted.

(c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of paragraph 3.(a) of this Appendix. (d) When the viewing system is by electronic means:

(1) The camera shall be so located as to accomplish the general requirements of paragraph 3.(a) of this Appendix.

(2) There shall be an alternate viewing system as a backup for the primary system, unless the x-ray room is not used in the case of viewing system failure. PART 6 APPENDIX C. INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS SCREENING Persons requesting that the Agency approve a healing arts screening program shall submit the following information and evaluation:

1. Name and address of the applicant and, when applicable, the names and addresses of all locations within this State, where the service will be provided.

2. Diseases or conditions for which the x-ray examinations are to be used in diagnoses. 3. A detailed description of the x-ray examinations proposed in the screening program. 4. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information.

5. An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations.

6. An evaluation by a qualified expert of the x-ray system(s) to be used in the screening program prior to being placed into operation. The evaluation by the qualified expert shall show that such system(s) do satisfy all requirements of these Regulations.

7. A description of the diagnostic film quality control program, if applicable. 8. A copy of the technique chart for the x-ray examination procedures to be used. 9. The qualifications of each individual who will be operating the x-ray system(s). In the case of non- licensed operators of bone densitometry unit(s), include a copy of the waiver granted by the Board of Medical Examiners to the non-licensed operators from taking the limited scope examination.

10. The qualifications of the individual who will be supervising the operators of the x-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified. 11. The name and address of the individual who will interpret the radiograph(s) or other results from the x-ray examinations.

12. Name and current license from Board of Medical Examiners of Physician(s) who will oversee the program.

13. A copy of the order prescribed by a Colorado licensed practitioner for the healing art screening program to be conducted.

14. A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated.

15. A description of the procedures for the retention or disposition of the radiographs, if applicable, and other records pertaining to the x-ray examinations.

PART 7:

USE OF RADIONUCLIDES IN THE HEALING ARTS 7.1 Purpose and Scope.

7.1.1 Authority Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1- 108, 25-1.5-101(1)(l), and 25-11-104, CRS.

7.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations. A copy may be obtained from the Department. 7.1.3 Scope.

This part establishes requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in these regulations.

7.1.4 Applicability.

The requirements and provisions of these regulations apply to applicants and licensees subject to this part unless specifically exempted.

7.2 Definitions.

As used in this part, the following definitions apply:

"Accredited institution" means a teaching facility for nuclear medicine technology or radiation therapy technology whose standards are accepted by the United States Department of Education.

“Address of use” means the building(s) identified on the license where radioactive material may be produced, prepared, received, used or stored.

“Area of use” means a portion of an address of use that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material. "Authorized medical physicist" (AMP) means an individual who meets the requirements of Appendix 7B.

"Authorized nuclear pharmacist" (ANP) means a pharmacist who meets the requirements of Appendix 7C.

"Authorized user" (AU) means a physician, dentist, or podiatrist who meets the training and experience requirements for a use of radioactive material specified in the applicable appendix of Appendix 7D through Appendix 7M.

“Brachytherapy” means a method of radiation therapy in which plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or interstitial application. "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

“Client” means, for mobile medical service, the person for whom, or in conjunction with whom, medical service is provided.

"Client's address" means the address of use for the purpose of providing mobile medical service in accordance with 7.27.

“Dedicated check source” means a radioactive source that is used to assure the consistent response of a radiation detection or measurement device over several months or years. "Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice dentistry. "Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in the case of sealed sources for diagnosis, the procedure. “HDR",see high dose-rate remote afterloader.

"High dose-rate remote afterloader" (HDR) means a device that remotely delivers a dose rate in excess of 12 gray (1200 rad) per hour at the treatment site. “LDR",see low dose-rate remote afterloader.

"Low dose-rate remote afterloader" (LDR) means a device that remotely delivers a dose rate of less than or equal to 2 gray (200 rad) per hour at the treatment site (at the specified distance). “Management” means the chief executive officer, or other individual having the authority to manage, direct, or administer the licensee's activities, or such person’s’ delegate(s). "Manual brachytherapy" means a type of therapy in which brachytherapy sources are manually applied or inserted.

“MDR",see medium dose-rate remote afterloader".

“ Medical institution ” means an organization in which two or more medical disciplines are practiced.

"Medical use" means, for the purposes of Part 7, the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

"Medium dose-rate remote afterloader" (MDR) means a device that remotely delivers a dose rate of greater than 2 gray (200 rad), but less than, or equal to, 12 gray (1200 rad) per hour at the treatment site (at the specified distance).

“Misadministration” means an event that meets the criteria in 7.21. “Mobile medical service” means the transportation of radioactive material to, or its medical use at, the client’s address and/or a temporary job site.

"Nuclear medicine technologist" (NMT) means an individual who meets the requirements of Appendix 7N and who under the supervision of an authorized user prepares or administers radioactive drugs to patients or human research subjects, or performs in vivo or in vitro measurements for medical purposes.

"Nuclear medicine technology" means the science and art of in vivo and in vitro detection and measurement of radioactivity and the administration of radioactive drugs to patients or human research subjects for diagnostic and therapeutic purposes. “Output” means the exposure rate, dose rate, or a quantity related in a known manner to these rates, from a brachytherapy source, or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit, for a specified set of exposure conditions. "Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

“PDR",see pulsed dose-rate remote afterloader.

"Pharmacist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice pharmacy. (See also Authorized nuclear pharmacist)

"Physician" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine. "Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice podiatry. "Preceptor" means an individual who provides, directs or verifies training and experience required for an individual to become an a radiation safety officer, an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a nuclear medicine technologist, or a radiation therapy technologist (see appendices 7A through 7O). "Prescribed dosage" means the specified activity or range of activity of a radioactive drug as documented in:

(1) A written directive as specified in 7.11; or (2) Accordance with the directions of the authorized user for procedures performed pursuant to 7.30, 7.32, or 7.36.

"Prescribed dose" means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

"Pulsed dose-rate remote afterloader" (PDR) means a special type of remote afterloading device that uses a single source capable of delivering dose rates (at the specified distance) in the "high dose-rate" range, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and (2) Is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour.

"Radiation safety officer" (RSO) means, for the purposes of Part 7, an individual who has demonstrated sufficient knowledge to apply radiation protection regulations appropriately, who in accord with 7.7 has been assigned such responsibility by the licensee, and who meets the requirements in Appendix 7A.

"Radiation therapy technologist" (RTT) means an individual who meets the requirements of Appendix 7O and is under the supervision of an authorized user to perform procedures and apply radiation emitted from sealed radioactive sources to human beings for therapeutic purposes. "Radiation therapy technology" means the science and art of applying radiation emitted from sealed radioactive sources to patients or human research subjects for therapeutic purposes. "Radioactive drug" means any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in the diagnosis, treatment, or prevention of disease or other abnormal condition. "Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling. "Sealed Source and Device Registry" means the national registry that contains the registration certificates maintained by the Nuclear Regulatory Commission, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

"Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to precisely deliver a dose to a treatment site. "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training. "Teletherapy", as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject. "Temporary job site", as used in Part 7, means a location where mobile medical services are confined to the mobile unit not at a licensed address of use. "Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment. "Therapeutic dose" means a radiation dose delivered from a sealed source containing radioactive material to a patient or human research subject for palliative or curative treatment. "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

“Trunnion” means a support bar sometimes used as a bearing instead of a socket. "Type of use" means use of radioactive material as specified under 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62.

"Unit dosage" means a dosage that:

(1) Is obtained or prepared in accordance with the regulations for uses described in 7.30, 7.32, or 7.36; and (2) Is to be administered as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared. "Written directive" means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in 7.11.

GENERAL REGULATORY REQUIREMENTS 7.3 License Required.

7.3.1 A person shall manufacture, produce, prepare, acquire, receive, possess, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the Department, an Agreement State or NRC, or as allowed in 7.3.2 or 7.3.3. 7.3.1.1 Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in this part under the supervision of an authorized user as provided in 7.10.

7.3.1.2 Unless prohibited by license condition, an individual may prepare unsealed radioactive material for medical use in accordance with the regulations in this part under the supervision of an authorized nuclear pharmacist or authorized user as provided in 7.10. 7.3.2 Provisions for Research Involving Human Subjects. A licensee may conduct research involving human subjects using radioactive material provided that:

7.3.2.1 The research is conducted, funded, supported, or regulated by a federal agency which has implemented federal policy for the protection of human subjects; 7.3.2.2 A licensee not authorized pursuant to 3.11 shall apply for and receive approval of a specific amendment to its Department license before conducting such research; 7.3.2.3 At a minimum, the licensee shall obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" in accordance with the meaning of these terms as defined and described in federal policy for the protection of human subjects;

7.3.2.4 The research involving human subjects authorized in 7.3.2.1 shall be conducted using radioactive material authorized for medical use in the license; and 7.3.2.5 Nothing in 7.3.2 relieves licensees from complying with the other requirements in this part.

7.3.3 Nothing in this part relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs or devices. 7.3.4 Application for License, Amendment, or Renewal.

7.3.4.1 An application shall be signed by the applicant's or licensee's management. 7.3.4.2 An application for a license for medical use of radioactive material as described in 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62 must be made by:

(1) Filing an original and one copy of Department Form R-12, and (2) Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as applicable.

7.3.4.3 A request for a license amendment or renewal must be made by: (1) Submitting an original and one copy in letter format. (2) Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as applicable.

7.3.4.4 In addition to the requirements in 7.3.4.2 and 7.3.4.3, an application for a license or amendment for medical use of radioactive material as described in 7.62 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in 7.1 through 7.29, as well as any specific information on: (1) Radiation safety precautions and instructions;

(2) Training and experience of proposed users;

(3) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (4) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

7.3.4.5 The applicant or licensee shall also provide any other information requested by the Department in its review of the application.

7.3.4.6 An applicant that satisfies the requirements specified in 3.11 may apply for a Type A specific license of broad scope.

7.3.5 Mobile Medical Service Administrative Requirements. 7.3.5.1 The Department shall license mobile medical services or clients of such services. The mobile medical service shall be licensed if the service receives, uses or possesses radioactive material. The client of the mobile medical service shall be licensed if the client receives or possesses radioactive material to be used by a mobile medical service. 7.3.5.2 Mobile medical service licensees shall obtain a letter signed by the management of each location where services are rendered that authorizes use of radioactive material at the client's address of use. This letter shall clearly delineate the authority and responsibility of both the client and the mobile medical service. If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile medical service.

7.3.5.3 A mobile medical service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client, unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license. 7.3.5.4 A mobile medical service shall inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered. 7.3.5.5 A licensee providing mobile medical services shall retain the letter required in 7.3.5.2 for 3 years after the last provision of service.

7.3.5.6 A mobile medical service licensee shall, at a minimum, maintain the following documents on each mobile unit:

(1) The current operating and emergency procedures;

(2) A copy of the license;

(3) Copies of the letter required by 7.3.5.2;

(4) Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and (5) Survey records covering uses associated with the mobile unit during, at a minimum, the preceding 30 calendar days.

7.3.5.7 The mobile medical service shall designate and manage each area of use in the client’s facility as a restricted area while radioactive material is present. For each location where radioactive materials will be routinely used, the licensee shall provide to the Department: (1) A diagram of the location of use, including information about the placement of required postings; and (2) Calculation(s) or survey(s) results that demonstrate compliance with applicable dose limits in 4.14 and 4.15 at the location of use.

7.3.5.8 The mobile medical service shall ensure that:

(1) Supervision by an authorized user is in accordance with 7.10.1; (2) Radiation exposures to the client’s personnel working in the client facility are: (a) Below the dose limits to members of the public listed in 4.14; or (b) The client’s personnel are instructed as described in 10.3 and monitored for exposure in accordance with 4.18 unless the licensee can demonstrate that 4.18 does not apply.

7.3.5.9 A mobile medical service licensee shall maintain all records required by Parts 4 and 7 of these regulations at a location within the Department's jurisdiction that is: (1) A single address of use:

(a) Identified as the records retention location; and (b) Staffed at all reasonable hours by individual(s) authorized to provide the Department with access for purposes of inspection; or (2) When no address of use is identified on the license for records retention, the mobile unit:

(a) Identified in the license; and (b) Whose current client's address of use and area of use schedule is reported to the Department.

7.3.6 A licensee possessing a Type A specific license of broad scope for medical use is exempt from: 7.3.6.1 The provisions of 7.3.4.4 regarding the need to file an amendment to the license for medical uses of radioactive material as described in 7.62; 7.3.6.2 The provisions of 7.4.2 regarding the need to file an amendment before permitting anyone to work as an authorized user, an authorized nuclear pharmacist or an authorized medical physicist under the license;

7.3.6.3 The provisions of 7.4.5 regarding additions to or changes in the areas of use at the addresses specified in the license;

7.3.6.4 The provisions of 7.5.1 regarding notification to the Department for new authorized users, new authorized nuclear pharmacists and new authorized medical physicists; 7.3.6.5 The provisions of 7.14 regarding suppliers for sealed sources. 7.3.7 The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in Part 7 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

7.4 License Amendments.

A licensee shall apply for and shall have received a license amendment before the licensee: 7.4.1 Receives, prepares, or uses radioactive material for a type of use that is permitted under this part but that is not authorized on the licensee’s current license issued pursuant to this part; 7.4.2 Permits anyone to work as an authorized user, authorized medical physicist, or an authorized nuclear pharmacist under the license other than an individual who meets the training and experience requirements specified in:

7.4.2.1 The applicable appendix of Appendix 7D through Appendix 7M for an authorized user for a type of use of radioactive material;

7.4.2.2 Appendix 7B for an authorized medical physicist; 7.4.2.3 Appendix 7C for an authorized nuclear pharmacist; and 7.4.3 Changes a Radiation Safety Officer, except as provided in 7.7.6; 7.4.4 Receives radioactive material in excess of the amount or in a different physical or chemical form than is authorized on the license;

7.4.5 Adds to or changes the area(s) of use or address(es) of use identified in the application or on the license, except as specified in 7.5.2.4; and 7.4.6 Changes statements, representations, and procedures which are incorporated into the license; or 7.4.7 Releases licensed facilities for unrestricted use. 7.5 Notifications; Maintenance of Records.

7.5.1 A licensee shall provide to the Department required documentation of adequate radiation safety training and experience under Appendix 7B for each authorized medical physicist pursuant to 7.4.2, under Appendix 7C for each authorized nuclear pharmacist, and under the applicable appendix of Appendix 7D through Appendix 7M for each individual authorized user. 7.5.2 A licensee shall notify the Department in writing within 30 days after: 7.5.2.1 An authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change;

7.5.2.2 The licensee's mailing address changes;

7.5.2.3 The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 3.15.2 of these regulations; or 7.5.2.4 The licensee has added to or changed the areas where radioactive material is used in accordance with 7.30 and 7.32.

7.5.3 Maintenance of Records.

Each record required by this part must be legible throughout the retention period specified by each Department regulation. The record may be the original, a reproduced copy, or a microform provided that the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. 7.6 License Issuance.

7.6.1 The Department shall issue a license for the medical use of radioactive material if: 7.6.1.1 The applicant has filed Department Form R-12 in accordance with the instructions in 7.3.4;

7.6.1.2 The applicant has paid any applicable fee;

7.6.1.3 The applicant meets the requirements of Part 3 of these regulations; and 7.6.1.4 The Department finds the applicant equipped and committed to observe the safety standards established by the Department in these regulations for the protection of the public health and safety.

7.6.2 The Department shall issue a license for mobile services if the applicant: 7.6.2.1 Meets the requirements in 7.6.1, and in particular 7.3.5; and 7.6.2.2 Assures that individuals to whom radioactive drugs or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with 7.26.

ADDITIONAL OVERALL REQUIREMENTS 7.7 Authority and Responsibilities for the Radiation Protection Program 7.7.1 In addition to the radiation protection program requirements of 4.5 of these regulations, a licensee's management must approve in writing:

7.7.1.1 Requests for license application, renewal, or amendments before submittal to the Department;

7.7.1.2 Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist; and 7.7.1.3 Radiation protection program changes that do not require a license amendment and are permitted under 7.7.

7.7.2 A licensee’s management shall appoint a Radiation Safety Officer (RSO), who agrees in writing to be responsible for implementing the radiation safety program. The licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements.

7.7.3 A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation Safety Officer, and of the Alternate RSO, if required.

7.7.4 A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

7.7.4.1 Identify radiation safety problems;

7.7.4.2 Initiate, recommend, or provide corrective actions; 7.7.4.3 Stop unsafe operations; and 7.7.4.4 Verify implementation of corrective actions.

7.7.5 A license shall retain a record of actions taken pursuant to 7.7.1, 7.7.2 and 7.7.3 for 5 years, including:

7.7.5.1 A summary of the actions taken (and a signature of licensee management) in accordance with 7.7.1;

7.7.5.2 A signed copy of the RSO’s agreement (including the signature of the RSO and licensee management) to be responsible for implementing the radiation safety program, as required by 7.7.2; and 7.7.5.3 A current copy of the authorities, duties and responsibilities of the RSO as required by 7.7.3.

7.7.6 For up to sixty days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in 7.7.4, provided the licensee takes the actions required in 7.7.2, 7.7.3, 7.7.4 and 7.7.5. A licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure that the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the different uses of radioactive material permitted by the license.

7.8 Radiation Safety Committee.

7.8.1 Licensees that are authorized for two or more different types of radioactive material use under 7.36, 7.42, 7.48, 7.62 or two or more types of units under 7.48 shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license. 7.8. 2 The Committee shall:

7.8.2.1 Include:

(1) An authorized user of each type of use permitted by the license; (2) The Radiation Safety Officer (3) A representative of the nursing service (4) A representative of management who is neither an authorized user nor a Radiation Safety Officer; and (5) Other members as the licensee deems appropriate.

7.8.1.2 Meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months. 7.8.1.3 Maintain minutes of each meeting, including:

(1) The date of the meeting;

(2) Members present;

(3) Members absent; and (4) Summary of deliberations and discussions.

7.9 Radiation Protection Program Changes.

7.9.1 A licensee may revise its radiation protection program without Department approval if: 7.9.1.1 The revision does not require an amendment under 7.4; 7.9.1.2 The revision is in compliance with the regulations and the license; 7.9.1.3 The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and licensee's Radiation Safety Committee (if applicable); and 7.9.1.4 The affected individuals are instructed on the revised program before the changes are implemented.

7.9.2 A licensee shall retain a record of each change for 5 years, including 7.9.2.1 A copy of the old and new procedures;

7.9.2.2 The effective date of the change; and 7.9.2.2 The signature of the licensee management that reviewed and approved the change. 7.10 Supervision.

7.10.1 A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by 7.3.2 shall: 7.10.1.1 In addition to the requirements of 10.3 of these regulations, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the use of radioactive material; and;

7.10.1.2 Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the medical use of radioactive material.

7.10.2 A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 7.3.3, shall:

7.10.2.1 Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's use of radioactive material; and 7.10.2.2 Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures, the regulations of Part 7, and license conditions.

7.10.3 Unless physical presence as described in other sections of Part 7 is required, a licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require an authorized user to be immediately available (by telephone within ten minutes) to communicate with the supervised individual, and able to be physically present within one hour, unless otherwise authorized by the Department with prior written approval; and 7.10.4 A licensee who permits supervised activities under 7.10.1 and 7.10.2 is responsible for the acts and omissions of the supervising authorized user and supervised individual(s). 7.11 Written Directives.

7.11.1 A written directive must be dated and signed by an authorized user, including the signatory’s printed or typed name, prior to administration of:

7.11.1.1 I-131 sodium iodide greater than 1.11 MBq (30 µCi), or 7.11.1.1 Any therapeutic dosage of radioactive material, or 7.11.1.1 Any therapeutic dose of radiation from radioactive material. 7.11.2 The written directive must contain the patient or human research subject's name and the following: 7.11.2.1 For an administration of a dosage of radioactive drug containing radioactive material, the name of the radioactive drug containing radioactive material, dosage, and route of administration;

7.11.2.2 For gamma stereotactic radiosurgery, the total dose, treatment site, and number of target coordinate settings per treatment for each anatomically distinct treatment site; 7.11.2.3 For teletherapy, the total dose, dose per fraction, number of fractions, and treatment site;

7.11.2.4 For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or 7.11.2.5 For all other brachytherapy including LDR, MDR, and PDR: (1) Prior to implantation: treatment site, the radionuclide, and dose; and (2) After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time (or the total dose).

7.11.3 If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented as soon as possible in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive. 7.11.4 A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. 7.11.5 If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.

7.11.6 The licensee shall retain a copy of each written directive and/or written revision to an existing written directive for 3 years.

7.12 Procedures for Administrations Requiring a Written Directive. 7.12.1 For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that: 7.12.1.1 The patient's or human research subject's identity is verified before each administration; and 7.12.1.2 Each administration is in accordance with the written directive. 7.12.2 The procedures required by 7.12.1 must, at a minimum, address the following items that are applicable for the licensee's use of radioactive material: 7.12.2.1 Verifying the identity of the patient or human research subject; 7.12.2.2 Verifying that the specific details of the administration are in accordance with the treatment plan, if applicable, and the written directive; 7.12.2.3 Checking both manual and computer-generated dose calculations; and 7.12.2.4 Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 7.48 7.13 Duties of Authorized User and Authorized Medical Physicist. 7.13.1 A licensee shall assure that only authorized users for the type of radioactive material used: 7.13.1.1 Prescribe the radiopharmaceutical dosage and/or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; and 7.13.1.2 Direct, as specified in 7.10 and 7.12, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects; 7.13.1.3 Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, in accordance with 7.3.2, 7.3.3 and 7.10; 7.13.1.4 Perform the final interpretation of the results of tests, studies, or treatments. 7.13.2 A licensee shall assure that only authorized medical physicists perform, as applicable: 7.13.2.1 Full calibration measurements as described in 7.54, 7.55, and 7.56; 7.13.2.2 Periodic spot checks as described in 7.58, 7.59 and 7.61; and 7.13.2.3 Radiation surveys as described in 7.57.

7.14 Suppliers for Sealed Sources or Devices for Medical Use. For medical use, a licensee shall use only:

7.14.1 Sealed sources or devices initially manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to these regulation or the equivalent regulations of another Agreement State, a Licensing State or the NRC; and 7.14.2 Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the NRC.

SPECIFIC REQUIREMENTS 7.15 Quality Control of Diagnostic Equipment.

Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or procedures which have been approved by the Department. The licensee shall conduct quality control of diagnostic equipment in accordance with written procedures.

7.16 Possession, Use, and Testing of Instruments to Measure the Activity of Unsealed Radioactive Materials.

7.16.1 For direct measurements performed in accordance with 7.18, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive materials prior to administration to each patient or human research subject.

7.16.2 A licensee shall test the instrumentation required in 7.16.1 in accordance with nationally recognized standards or the manufacturer's instructions. 7.16.3 The tests required in 7.16.2 shall at a minimum include tests for constancy, linearity, accuracy and geometry dependence, as appropriate to demonstrate proper operation of the instrument. 7.16.4 A licensee shall retain a record of each instrument test required by 7.16 for 3 years. The record shall include the:

7.16.4.1 Model and serial number of the instrument;

7.16.4.2 Date of the calibration;

7.16.4.3 Results of the calibration; and 7.16.4.4 Name of the individual who performed the calibration. 7.17 Calibration of Survey Instruments.

7.17.1 A licensee shall ensure that the survey instruments used to show compliance with Part 4 and Part 7 have been calibrated before first use, annually, and following any repair that will affect the calibration.

7.17.2 To satisfy the requirements of 7.17.1 the licensee shall: 7.17.2.1 Calibrate all required scale readings up to 10 mSv (1 rem) per hour with a radiation source;

7.17.2.2 Have each radiation survey instrument calibrated as follows, or by acceptable equivalent methods:

(1) At energies appropriate for use and at intervals not to exceed 12 months or after instrument servicing, except for battery changes;

(2) For linear scale instruments, at 2 points located approximately one-third and two- thirds of full-scale on each scale;

(3) For logarithmic scale instruments, at mid-range of each decade and at 2 points of at least one decade;

(4) For digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 mrem) per hour; and (5) For dose rate instruments, so that an accuracy within plus or minus 20 percent of the true radiation dose rate can be demonstrated at each point checked. 7.17.2.3 Conspicuously note on the instrument the date of calibration. 7.17.3 The licensee shall not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is greater than 20 percent. 7.17.4 The licensee shall retain a record of each survey instrument calibration required by 7.17 for 3 years. The record shall include the:

7.17.4.1 Model and serial number of the instrument;

7.17.4.2 Date of the calibration;

7.17.4.3 Results of the calibration; and 7.17.4.4 Name of the individual who performed the calibration. 7.18 Determination of Dosages of Radioactive Material for Medical Use. 7.18.1 A licensee shall determine and record the activity of each dosage prior to medical use. 7.18.1.1 For photon-emitting radioactive material, this determination shall be within 30 minutes prior to medical use.

7.18.1.2 For all other radioactive material, this determination shall be within the period before medical use that is no greater than 10 percent of the physical half-life of the radioactive material.

7.18.2 For a unit dosage, the determination by 7.18.1 shall be made either by direct measurements or by a decay correction, based on the measurement made by a manufacturer or preparer licensed pursuant to Part 3 of these regulations or equivalent provisions of another Agreement State, a Licensing State or NRC.

7.18.3 For other than a unit dosage, the determination by 7.18.1 shall be made by direct measurement of radioactivity or by a combination of measurements of radioactivity and mathematical calculations or combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed pursuant to Part 3 of these regulations or equivalent provisions of another Agreement State, a Licensing State or NRC. 7.18.4 Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent. 7.18.5 A license shall retain a record of the each dosage determination required by 7.18.1 for 3 years. The record shall contain the:

7.18.5.1 Name of the radioactive drug;

7.18.5.2 Patient's or human research subject’s name, and identification number if one has been assigned;

7.18.3.3 Prescribed dosage;

7.18.3.4 Determined dosage; or a notation that the total activity is less than 1.1 MBq (30 µCi); 7.18.3.5 Date and time of the dosage determination; and 7.18.3.6 Name of the individual who determined the dosage. 7.19 Authorization for Calibration, Transmission and Reference Sources. Any person authorized by 7.3 for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use: 7.19.1 Sealed sources manufactured and distributed by persons specifically licensed pursuant to Part 3 of these regulations or equivalent provisions of the another Agreement State, a Licensing State, or NRC, and that do not exceed 1.11 GBq (30 mCi) each;

7.19.2 Any radioactive material with a half-life not longer than 120 days or less in individual amounts not to exceed 555 MBq (15 mCi);

7.19.3 Any radioactive material with a half life greater than 120 days in individual amounts not to exceed the smaller of:

7.19.3.1 7.4 MBq (200 µCi);

7.19.3.2 1000 times the quantities in Appendix 3B; and 7.19.4 Technetium-99m in amounts as needed.

7.20 Requirements for Possession of Sealed Sources and Brachytherapy Sources. 7.20.1 A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the Department and shall maintain the instructions for the duration of source use in a legible form convenient to users.

7.20.2 A licensee in possession of a sealed source shall test the source for leakage: 7.20.2.1 In accordance with Part 4 of these regulations; and 7.20.2.2 At intervals not to exceed 6 months or at intervals approved by the Department, another Agreement State, a Licensing State or the NRC in the Sealed Source and Device Registry.

7.20.3 If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall:

7.20.3.1 Immediately withdraw the sealed source from use and store, dispose or cause it to be repaired in accordance with the requirements of these regulations; and 7.20.3.2 File a written report with the Department within 5 days of receiving the leak test result, including the model number and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, the date and results of the test, and the action taken.

7.20.4 A licensee in possession of a sealed source or brachytherapy source, except for a gamma stereotactic radiosurgery source, shall conduct a semi-annual physical inventory of all such sources. The licensee shall retain each inventory record for 3 years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, and the name of the individual who performed the inventory.

7.21 Reports and Notifications of Misadministrations.

7.21.1 Other than events that result from intervention by a patient or human research subject, a licensee shall report any event in which the administration of radioactive material or radiation from radioactive material results in:

7.21.1.1 A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and either (1) The total dose delivered differs from the prescribed dose by 20 percent or more; (2) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or (3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

7.21.1.2 A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:

(1) An administration of a wrong radioactive drug;

(2) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

(3) An administration of a dose or dosage to the wrong individual or human research subject;

(4) An administration of a dose or dosage delivered by the wrong mode of treatment; or (5) A leaking sealed source.

7.21.1.3 A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sievert (50 rem) to an organ or tissue and 50 percent of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site). 7.21.2 A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results, or will result in, unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

7.21.3 The licensee shall notify the Agency by telephone no later than the next calendar day after discovery of the misadministration.

7.21.4 The licensee shall submit a written report to the Agency within 15 days after discovery of the misadministration.

7.21.4.1 The written report must include:

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individual(s) who received the administration; (6) Actions, if any, that have been taken, or are planned, to prevent recurrence; (7) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

7.21.4.2 The report may not contain the individual's name or any other information that could lead to identification of the individual.

7.21.5 The licensee shall provide notification of the misadministration to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

7.21.6 Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians. 7.21.7 A licensee shall retain a record of a misadministration for 3 years. The record must contain: 7.21.7.1 The licensee's name;

7.21.7.1 Names of the individuals involved;

7.21.7.1 The social security number or other identification number if one has been assigned, of the individual who is the subject of the misadministration; 7.21.7.1 A brief description of the event and why it occurred; 7.21.7.1 The effect, if any, on the individual;

7.21.7.1 The actions, if any, taken, or planned, to prevent recurrence; and 7.21.7.1 Whether the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.

7.21.8 A copy of the record required under 7.21.7 shall be provided to the referring physician if other than the licensee, within 15 days after discovery of the misadministration. 7.22 Notification to the Department of Deceased Patients or Human Research Subjects Containing Radioactive Material.

7.22.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive exposures in excess of 4.14 as a result of the deceased's body. 7.22.2 The licensee shall submit a written report to the Department within 30 days after discovery that the patient or human research subject referenced in 7.22.1 has died. The written report must include the:

7.22.2.1 Licensee's name;

7.22.2.2 Date of death;

7.22.2.3 Radionuclide, chemical and physical form and calculated activity at time of death; and, 7.22.2.4 Names (or titles) and address(es) of known individuals who might have received exposures exceeding 5 mSv (500 mrem).

7.22.3 The licensee shall retain a record of each written report required by 7.22 for 3 years. 7.23 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child. 7.23.1 A licensee shall report any dose to an embryo/fetus that is greater than 5 mSv (500 mrem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

7.23.2 A licensee shall report any dose to a nursing child, that was not specifically approved, in advance, by the authorized user, that is a result of an administration of radioactive material to a breast feeding individual that:

7.23.2.1 Is greater than 5 millisievert (500 mrem) total effective dose equivalent; or 7.23.2.2 Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

7.23.3 The licensee shall notify by telephone the Agency no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2. 7.23.4 The licensee shall submit a written report to the Agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2. 7.23.4.1 The written report must include:

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect on the embryo/fetus or the nursing child; (6) What actions, if any, have been taken, or are planned, to prevent recurrence; and (7) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not. 7.23.4.2 The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child. 7.23.5 The licensee shall notify the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under 7.23.1 or 7.23.2, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested. 7.23.6 A licensee shall retain a record of a dose to an embryo/fetus or a nursing child for 3 years. The record must contain:

7.23.6.1 The licensee's name;

7.23.6.2 Names of all the individuals involved;

7.23.6.3 Social security number or other identification number if one has been assigned to the pregnant individual or nursing child who is the subject of the event; 7.23.6.4 A brief description of the event and why it occurred; 7.23.6.5 The effect, if any, on the embryo/fetus or nursing child; 7.23.6.6 The actions, if any, taken, or planned, to prevent recurrence; and 7.23.6.7 Whether the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.

7.23.7 A copy of the record required under 7.23.6 shall be provided to the referring physician, if other than the licensee, within 15 days after discovery of the event. 7.24 Vial Shields and Labels.

7.24.1 A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield. 7.24.2 Each syringe and vial that contains a radioactive drug shall be labeled to identify the radioactive drug, to include the isotope and amount of radioactivity. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded. 7.25 Surveys for Contamination and Ambient Radiation Dose Rate. 7.25.1 Except as provided in 7.25.2, at the end of each day of use, a licensee shall survey, with a radiation detection instrument, all areas where radioactive drugs containing radioactive material requiring a written directive were prepared for use or administered. 7.25.2 At least once each week, a licensee shall survey, with a radiation detection instrument, all areas where radioactive drugs or radioactive wastes are stored. 7.25.3 A licensee shall conduct the surveys required by 7.25.1 and 7.25.2 using an instrument capable of measuring dose rates as low as 1 uSv (0.1 mrem) per hour. 7.25.4 A licensee shall establish dose rate action levels for the surveys required by 7.25.1 and 7.25.2 and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level.

7.25.5 Each day of use a licensee shall survey for removable contamination each day of use all areas where generators and bulk radioactive drugs are prepared for use or administered. Each week The licensee shall perform removable contamination surveys in all areas where radioactive materials are stored.

7.25.6 A licensee shall conduct the surveys required by 7.25.5 using instrumentation capable of detecting contamination on each wipe sample of 33.3 Bq (2000 disintegrations per minute). 7.25.7 A licensee shall establish removable contamination action levels for the surveys required by 7.25.5 and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels.

7.25.8 A licensee does not need to perform the surveys required by 7.25.1 in an area where patients or human research subjects are confined when they cannot be released pursuant to 7.26. 7.25.9 A licensee shall retain a record of each survey required by 7.25.1, 7.25.2 and 7.25.5 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey (including, if applicable, that the instrument was checked for consistent response with a dedicated check source prior to each daily use), and the name of the individual who performed the survey.

7.26 Release of Individuals Containing Radioactive Drugs or Implants. 7.26.1 A licensee may authorize the release from the licensee’s control of any individual who has been administered radioactive drugs or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).

7.26.2 Instructions to Individuals:

7.26.2.1 A licensee shall provide the released individual, or the individual's parent or guardian, with oral and written safety instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable.

7.26.2.2 If a breast-feeding infant or child could receive a radiation dose as a result of the release of the patient, the instructions shall also include: (1) Guidance on the interruption or discontinuation of breast-feeding; and (2) Information on the consequences of failure to follow the guidance. 7.26.3 Release of the patient must be approved by an individual listed as an authorized user on the license from the Department who is approved for the type of radioactive material use in the patient being released.

7.26.4 The licensee shall maintain a record, signed by the authorized user, for 3 years after the date of release, of:

7.26.4.1 The basis for authorizing the release of an individual; and 7.26.4.2 Instructions that were provided to a breast-feeding woman. 7.26.5 Reports of Patient Departure Prior to Authorized Release. 7.26.5.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient or human research subject has departed from the licensee's facility without authorization under 7.26.

7.26.5.2 The licensee shall submit a written report to the Department within 30 days after discovery of the unauthorized departure. The written report must include: (1) The licensee's name;

(2) The date and time of the unauthorized departure;

(3) The projected date and time when release would have occurred; (4) The address of the patient's or human research subject's home or anticipated destination following departure;

(5) The radionuclide, chemical and physical form and calculated activity at time of release;

(6) The apparent reason(s) for the departure prior to authorized release; and (7) A description of any changes in the licensee's patient release criteria or patient instructions that are designed to avoid a recurrence of such an event. 7.27 Mobile Nuclear Medicine Service Technical Requirements. A licensee providing mobile nuclear medicine service shall: 7.27.1 Transport to each client’s address of use only syringes or vials containing prepared drugs or radioactive materials that are intended for reconstitution of radioactive drug kits; 7.27.2 Bring into each client’s address of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste; 7.27.3 Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at a client’s address of use;

7.27.4 Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function shall include a constancy check; 7.27.5 Check survey instruments for consistent response with a dedicated check source before use at each client's address;

7.27.6 Prior to leaving a client’s address of use, perform area surveys and survey for removable contamination in all areas of use, to ensure compliance with Part 4 of these regulations; 7.27.7 Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Department for compliance with airborne release standards; and 7.27.8 Retain a record of each survey required by 7.27.6 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

7.28 Storage of Volatiles and Gases.

7.28.1 A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and container.

7.28.2 A licensee shall store and use a multi-dose container in a properly functioning fume hood. 7.28.3 A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed in Part 4 of these regulations. 7.28.3.1 The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. 7.28.3.2 A licensee shall check the operation of collection systems monthly. Records of these checks shall be maintained for 3 years.

7.29 Decay-In-Storage.

7.29.1 A licensee may hold radioactive material with a physical half-life of less than 120 days for decay- in-storage before disposal without regard for its radioactivity if the licensee: 7.29.1.1 Monitors radioactive material at the container surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;

7.29.1.3 Removes or obliterates all radiation labels, except for material that will be handled as biomedical waste after release; and 7.29.1.4 Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal.

7.29.2 Records of Decay-in-Storage.

For radioactive material disposed in accordance with 7.29.1, the licensee shall retain a record of each disposal for 3 years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey. SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES 7.30 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for which a Written Directive is Not Required.

7.30.1 A licensee may use any unsealed radioactive material, in quantities that do not require a written directive, as described in 7.11, for a diagnostic use involving measurements of uptake, dilution, or excretion that is:

7.30.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or; 7.30.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.30.2, or an individual under the supervision of either as specified in 7.10;

7.30.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or 7.30.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.

7.30.2 Authorized User Training For Uptake, Dilution, And Excretion Studies. The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.30 to meet the requirements of Appendix 7D. 7.31 Possession of Survey Instrument.

A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour. The instrument shall be operable and calibrated in accordance with 7.17.

SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE NOT REQUIRED 7.32 Use of Unsealed Radioactive Material for Imaging and Localization Studies for which a Written Directive is Not Required.

7.32.1 A licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive, as described in 7.11, that is: 7.32.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or; 7.32.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.32.2, or an individual under the supervision of either as specified in 7.10;

7.32.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or 7.32.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.

7.32.2 Authorized User Training for Imaging and Localization Studies for which a Written Directive is Not Required.

The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.32 to meet the requirements of Appendix 7E. 7.33 Radionuclide Contaminants.

7.33.1 A licensee shall not administer to humans a radioactive drug containing: 7.33.1.1 More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of 99 Mo per mCi of 99m Tc).

7.33.1.2 More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of 82 Sr per mCi of 82 Rb chloride);

7.33.1.3 More than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 µCi of 85 Sr per mCi of 82 Rb).

7.33.2 To demonstrate compliance with 7.33.1, the licensee preparing radioactive drugs from radionuclide generators shall measure the concentration of radionuclide contaminant in: 7.33.2.1 The first eluate after receipt of a molybdenum-99/technetium-99m generator; 7.33.2.2 Each eluate or extract, as appropriate for other than molybdenum-99/technetium-99m generator systems.

7.33.3 Records of Radionuclide Purity.

A licensee who must measure radionuclide contaminant concentration shall retain a record of each radionuclide contaminant test for 3 years. The record shall include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kBq of contaminant per MBq of desired radionuclide (µCi/ mCi), the time and date of the test, and the name of the individual who made the measurement.

7.33.4 Immediate Report.

A licensee shall report immediately to the Department each occurrence of radionuclide contaminant concentration exceeding a limit specified in 7.33.1. 7.34 Aerosols and Gases.

Provided the conditions of 7.28 are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Department. 7.35 Radiation Detection Capability.

A licensee authorized to use radioactive material for pursuant to 7.32, 7.36, or 7.42 shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour. The instruments shall be operable and calibrated in accordance with 7.17.

SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL – WRITTEN DIRECTIVE REQUIRED 7.36 Use of Unsealed Radioactive Material for Which A Written Directive Is Required. 7.36.1 A licensee may use any unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required that has been:

7.36.1.1 Obtained from a manufacturer or preparer licensed pursuant to 3.12.10 or equivalent regulations of another Agreement State, a Licensing State, or NRC; or 7.36.1.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 7.36.2, 7.36.3 or 7.36.4, or an individual under the supervision of either as specified in 7.10;

7.36.1.3 Obtained from and prepared by a Department, Agreement State, Licensing State or NRC licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or 7.36.1.4 Prepared by the licensee in accordance with a Radioactive Drug Research Committee- approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.

7.36.2 Authorized User Training For Use Of Any Unsealed Radioactive Material For Diagnostic Or Therapeutic Medical Use For Which A Written Directive Is Required. The licensee shall require an authorized user of an unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required under 7.36 to meet the requirements of Appendix 7F.

7.36.3 Authorized User Training For Oral Administration Of </ = 1.22 GBq I-131 (33 mCi) Sodium Iodide Requiring A Written Directive.

The licensee shall require an authorized user of an unsealed radioactive material for oral administration of </ = 1.22 GBq I-131 (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7G.

7.36.4 Authorized User Training For Oral Administration Of > 1.22 GBq I-131 (33 mCi) Sodium Iodide Requiring A Written Directive.

The licensee shall require an authorized user of an unsealed radioactive material for oral administration of > 1.22 GBq I-131 (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7H.

7.36.5 Authorized User Training For Parenteral Administration Requiring A Written Directive. The licensee shall require an authorized user of an unsealed radioactive material for parenteral administration requiring a written directive under 7.36 to meet the requirements of Appendix 7I. 7.37 Safety Instruction.

In addition to the requirements of Part 10 of these regulations: 7.37.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received therapy with a radioactive drug, and cannot be released in accordance with 7.26.

7.37.2 The instruction required by 7.37.1 shall be appropriate for the duties of the personnel and include: 7.37.2.1 Patient or human research subject control;

7.37.2.2 Visitor control, to include the following;

(1) Routine visitation to hospitalized individuals in accordance with Part 4 of these regulations;

(2) Contamination control;

(3) Waste control; and (4) Notification of the RSO, or his or her designee, and the authorized user if the patient or the human research subject dies or has a medical emergency. 7.37.3 A licensee shall keep a record of individuals receiving instruction required by 7.37.1 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction.

7.38 Safety Precautions.

7.38.1 For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with 7.26, a licensee shall: 7.38.1.1 Quarter the patient or the human research subject either in: (1) A private room with a private sanitary facility; or (2) A room, with a private sanitary facility, with another individual who also has received similar radiopharmaceutical therapy and who cannot be released in accordance with 7.26; and 7.38.1.2 Visibly post the patient's or the human research subject’s door with a "Caution: Radioactive Material" sign and note on the door or on the patient's or the human research subject’s chart where and how long visitors may stay in the patient's or the human research subject’s room;

7.38.1.3 Either monitor material and items removed from the patient's or the human research subject’s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle such materials and items as radioactive waste.

7.38.2 A licensee shall notify the RSO, or his or her designee, and the authorized user immediately if the hospitalized patient dies or has a medical emergency and notify the Department as required by 7.39.

7.39 Emergency Notification.

The licensee shall notify the Department in accordance with 7.22 if it is possible that any individual could receive exposures in excess of 4.14 as a result of a deceased's body. SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR DIAGNOSIS 7.40 Use of Sealed Sources for Diagnosis.

7.40.1 A licensee shall use for diagnostic medical uses only sealed sources: 7.40.1.1 Approved in the Sealed Source and Device Registry; and 7.40.1.2 Handled in accordance with the manufacturer's radiation safety and handling instructions:

7.40.2 Authorized User Training For Use Of Sealed Sources For Diagnosis. The licensee shall require an authorized user under 7.40 to meet the requirements of Appendix 7J.

SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR MANUAL BRACHYTHERAPY 7.41 Calibration Measurements of Brachytherapy Sealed Sources. 7.41.1 Prior to the first medical use of a brachytherapy sealed source on or after October 25, 2005, a licensee shall perform the following:

7.41.1.1 Determine the source output or activity using a dosimetry system that meets the requirements of 7.53;

7.41.1.2 Determine source positioning accuracy within applicators; and 7.41.1.3 Use published protocols accepted by nationally recognized bodies to meet the requirements of 7.41.1.1 and 7.41.1.2.

7.41.2 A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with 7.41.1.

7.41.3 A licensee shall mathematically correct the outputs or activities determined in 7.41.1 for physical decay at intervals consistent with 1.0 percent physical decay. 7.41.4 An authorized medical physicist shall perform or review the measurements and calculations made pursuant to 7.41.1, 7.41.2, or 7.41.3.

7.41.5 Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The actual source output shall consider decay based on the activity determined in accordance with paragraphs 7.41.1, 7.41.2, or 7.41.3.

7.41.6 A licensee shall retain a record of each calibration on brachytherapy sources required by 7.41.1 for 3 years after the last use of the source. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source; the source output or activity; source positioning accuracy within applicators; and the signature of the authorized medical physicist. 7.41.7 A licensee shall retain a record of decay calculations required by 7.41.5 for the life of the source. The record must include the date and initial activity of the source as determined under 7.41, and for each decay calculation, the date, the source activity and the signature of the authorized medical physicist.

7.42 Use of Sealed Sources For Manual Brachytherapy.

7.42.1 A licensee shall use for manual brachytherapy only sealed sources: 7.42.1.1 Approved in the Sealed Source and Device Registry; or 7.42.1.2 In research in accordance with an effective Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met. 7.42.2 Authorized User Training For Use Of Sealed Sources For Manual Brachytherapy. The licensee shall require an authorized user under 7.42 to meet the requirements of Appendix 7K.

7.42.3 Authorized User Training For Use Of Strontium-90 Sealed Sources For Ophthalmic Uses. The licensee shall require an authorized user of strontium-90 sealed sources for ophthalmic uses under 7.42 to meet the requirements of Appendix 7L.

7.43 Safety Instruction.

7.43.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that are undergoing implant therapy and cannot be released in accordance with 7.26.

7.43.2 The instruction required by 7.43.1 shall be commensurate with the duties of the personnel and include:

7.43.2.1 Size and appearance of the brachytherapy sources; 7.43.2.2 Safe handling and shielding instructions in case of a dislodged source; 7.43.2.3 Patient or human research subject control;

7.43.2.4 Visitor control, including both;

(1) Routine visitation to hospitalized individuals in accordance with 4.14.1.1; and (2) Visitation authorized in accordance with 4.14.3; and 7.43.2.5 Notification of the RSO, or his or her designee, and the authorized user if the patient or the human research subject dies or has a medical emergency. 7.43.3 A licensee shall keep a record of individuals receiving instruction required by 7.43.1 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction.

7.44 Safety Precautions.

7.44.1 For each patient or the human research subject that is receiving brachytherapy and cannot be released in accordance with 7.26, a licensee shall:

7.44.1.1 Not place the patient or the human research subject in the same room with a patient who is not receiving radiation therapy;

7.44.1.2 Visibly post the patient's or human research subject’s door with a "Caution: Radioactive Material" sign and note on the door or on the patient's or human research subject’s chart where and how long visitors may stay in the patient's or human research subject’s room. 7.44.2 A licensee shall have emergency response equipment available near each treatment room to respond to a source that inadvertently becomes:

7.44.2.1 Dislodged from the patient; or 7.44.2.2 Lodged within the patient following removal of the source applicators. 7.44.3 A licensee shall notify the RSO, or his or her designee, and the authorized user immediately if the hospitalized patient dies or has a medical emergency and notify the Department as required by 7.39.

7.45 Brachytherapy Sources Inventory.

7.45.1 A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. 7.45.2 Promptly after removing brachytherapy sources from a patient, a licensee shall return brachytherapy sources to a secure storage area and count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned. 7.45.3 A licensee shall maintain a record of brachytherapy source accountability for 3 years. 7.45.3.1 For temporary implants, the record must include the number and activity of sources: (1) Removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and (2) Not implanted, the time and date they were returned to storage, and the name of the individual who returned them to storage.

7.45.3.2 For permanent implants, the record must include the number and activity of sources: (1) Removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

(2) Returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and (3) Permanently implanted in the patient or human research subject. 7.46 Surveys After Source Implant and Removal.

7.46.1 Immediately after implanting sources in a patient or a human research subject, the licensee shall perform a survey to locate and account for all sources that have not been implanted. 7.46.2 Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.

7.46.2 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.46.1 and 7.6.2 for 3 years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey. 7.47 Therapy-related Computer Systems.

7.47.1 The licensee shall perform acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies. 7.47.2 At a minimum, the acceptance testing required by 7.47.1 shall include, as applicable, verification of:

7.47.2.1 The source-specific input parameters required by the dose calculation algorithm; 7.47.2.1 The accuracy of dose, dwell time, and treatment time calculations at representative points;

7.47.2.1 The accuracy of isodose plots and graphic displays; and 7.47.2.1 The accuracy of the software used to determine radioactive source positions from radiographic images.

SPECIFIC REQUIREMENTS FOR PHOTON-EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS 7.48 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, and Gamma Stereotactic Radiosurgery Unit.

7.48.1 A licensee shall use sealed sources in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for therapeutic medical uses: 7.48.1.1 Approved in the Sealed Source and Device Registry; and 7.48.1.2 In research in accordance with an effective Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met. 7.48.2 Authorized User Training For Use of a Remote Afterloader Unit, Teletherapy Unit, and Gamma Stereotactic Radiosurgery Unit.

The licensee shall require an authorized user under 7.48 to meet the requirements of Appendix 7M.

7.49 Installation, Maintenance, Adjustment, and Repair. 7.49.1 Only a person specifically licensed by the Department, another Agreement State, or the NRC shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). 7.49.2 Except for low dose-rate remote afterloader units, only a person specifically licensed by the Department, another Agreement State, a Licensing State, or the NRC shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. 7.49.3 For a low dose-rate remote afterloader unit, only a person specifically licensed by the Department, another Agreement State, a Licensing State, or the NRC, or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit. 7.49.4 A licensee shall retain a record of the installation, maintenance, adjustment and repair done on remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years. The record shall include the date, description of the service, and name(s) of the individual(s) who performed the work.

7.50 Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader Unit. 7.50.1 Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe, shielded position. 7.50.1 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.50.1 for 3 years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey. 7.51 Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.

7.51.1 A licensee shall:

7.51.1.1 Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

7.51.1.2 Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source(s), if such presence is necessary and justified;

7.51.1.3 Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and 7.51.1.4 Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. This procedure must include: (1) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and (3) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.

7.51.2 A copy of the procedures required by 7.51.1.4 shall be physically located at the unit console. 7.51.3 A licensee shall conspicuously post instructions at the unit console to inform the operator of the names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally. 7.51.4 A licensee shall provide instruction, initially and at least annually, to all individuals who operate a unit, as appropriate to the individual's assigned duties, in: 7.51.4.1 The procedures identified in 7.51.1.4; and 7.51.4.2 The operating procedures for the unit.

7.51.5 A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually. 7.51.6 A licensee shall keep a record of individuals receiving instruction required by 7.51.4 and maintain such records for 3 years. The record shall include a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who gave the instruction.

7.52 Doors, Interlocks, and Warning Systems.

7.52.1 A licensee shall control access to the treatment room by a door at each entrance. 7.52.2 A licensee shall equip each entrance to the treatment room with an electrical interlock system that shall:

7.52.2.1 Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

7.52.2.2 Cause the source(s) to be shielded promptly when an entrance door is opened; and 7.52.2.3 Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s)’ on/off control is reset at the console.

7.52.3 A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels. 7.52.4 Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation. 7.52.5 For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

7.52.6 In addition to the requirements specified in 7.52.1 through 7.52.5, a licensee shall: 7.52.6.1 For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units, require:

(1) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during the initiation of all patient treatments involving the unit; and (2) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

7.52.6.2 For high dose-rate remote afterloader units, require: (1) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and (2) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

7.52.6.3 For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

7.52.6.4 During radiation therapy for a medical emergency of a patient or research subject cease the therapy shall immediately, remove the source(s) and provide appropriate care to the patient or research subject.

7.52.6.5 If the patient expires during treatment, remove the source(s) before further actions are taken.

7.52.6.6 Notify the RSO, or his or her designee, and an authorized user as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies.

7.52.7 A licensee shall have emergency response equipment available near each treatment room, to respond to a situation in which a source inadvertently: 7.52.7.1 Remains in the unshielded position; or 7.52.7.2 Lodges within the patient following completion of the treatment. 7.53 Dosimetry Equipment.

7.53.1 Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met: 7.53.1.1 The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or 7.53.1.2 The system shall have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The results of the intercomparison must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

7.53.2 The licensee shall have available for use a dosimetry system for spot-check output measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 7.53.1. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in 7.53.1. 7.53.3 The licensee shall maintain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include:

7.53.3.1 The date;

7.53.3.2 The manufacturer’s name, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 7.53.1 and 7.53.2; 7.53.3.3 The correction factor that were determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; 7.53.3.4 The names of the individuals who performed the calibration, intercomparison, or comparison.

7.54 Full Calibration Measurements on Teletherapy Units. 7.54.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

7.54.1.1 Before the first medical use of the unit;

7.54.1.2 Before medical use under the following conditions: (1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and (3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and 7.54.1.3 At intervals not exceeding 1 year.

7.54.2 To satisfy the requirement of 7.54.1, full calibration measurements shall include determination of: 7.54.2.1 The output within +/- 3 percent for the range of field sizes and for the distance or range of distances used for medical use;

7.54.2.2 The coincidence of the radiation field and the field indicated by the light beam localizing device;

7.54.2.3 The uniformity of the radiation field and its dependence on the orientation of the useful beam;

7.54.2.4 Timer accuracy, constancy, and linearity;

7.54.2.5 "On off" error; and 7.54.2.6 The accuracy of all distance measuring and localization devices in medical use. 7.54.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.54.2.1 may then be made using a dosimetry system that indicates relative dose rates. 7.54.4 A licensee shall make full calibration measurements required by 7.54.1 in accordance with published protocols accepted by nationally recognized bodies. 7.54.5 A licensee shall correct mathematically the outputs determined in 7.54.2.1 for physical decay for intervals not exceeding 1 month for cobalt 60, 6 months for cesium 137, or at intervals consistent with 1 percent decay for all other nuclides.

7.54.6 Full calibration measurements required by 7.54.1 and physical decay corrections required by 7.54.5 shall be performed by the authorized medical physicist. 7.54.7 A licensee shall maintain a record of each calibration for the duration of the license. The record shall include:

7.54.7.1 The date of the calibration;

7.54.7.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source(s), and instruments used to calibrate the teletherapy unit; 7.54.7.3 The results and assessments of the full calibrations; and 7.54.7.4 The signature of the authorized medical physicist who performed the full calibration. 7.55 Full Calibration Measurements on Remote Afterloader Units. 7.55.1 A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

7.55.1.1 Before the first medical use of the unit;

7.55.1.2 Before medical use under the following conditions: (1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and (2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and 7.55.1.3 At intervals not exceeding one (1) calendar quarter for high dose-rate, medium dose- rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and 7.55.1.4 At intervals not exceeding 1 year for low dose-rate remote afterloader units. 7.55.2 To satisfy the requirement of 7.55.1, full calibration measurements must include, as applicable, determination of:

7.55.2.1 The output within +/- 5 percent;

7.55.2.2 Source positioning accuracy to within +/- 1 millimeter; 7.55.2.3 Source retraction with backup battery upon power failure; 7.55.2.4 Length of the source transfer tubes;

7.55.2.5 Timer accuracy and linearity over the typical range of use; 7.55.2.6 Length of the applicators; and 7.55.2.7 Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

7.55.3 In addition to the requirements for full calibrations for low dose-rate remote afterloader units in 7.55.2, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter. 7.55.4 A licensee shall use the dosimetry system described in 7.53 to measure the output. 7.55.5 A licensee shall make full calibration measurements required by 7.55.1 of this section in accordance with published protocols accepted by nationally recognized bodies. 7.55.6 For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with 7.55.1 through 7.55.5. 7.55.7 A licensee shall mathematically correct the outputs determined in 7.55.2.1 for physical decay at intervals consistent with 1 percent physical decay.

7.55.8 Full calibration measurements required by 7.55.1 and physical decay corrections required by 7.55.7 must be performed by the authorized medical physicist. 7.55.9 A licensee shall retain a record of each calibration for the duration of the license. The record shall include:

7. 55.9.1 The date of the calibration;

7. 55.9.2 The manufacturer's name, model number, and serial number for the remote afterloader unit, source(s), and instruments used to calibrate the remote afterloader unit; 7. 55.9.3 The results and assessments of the full calibrations; 7. 55.9.4 The results of the autoradiograph required for low dose-rate remote afterloader units; and 7. 55.9.5 The signature of the authorized medical physicist who performed the full calibration. 7.56 Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units. 7.56.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

7.56.1.1 Before the first medical use of the unit;

7.56.1.2 Before medical use under the following conditions: (1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and (3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and 7.56.1.3 At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

7.56.2 To satisfy the requirement of 7.56.1, full calibration measurements must include determination of: 7.56.2.1 The output within +/-3 percent;

7.56.2.2 Relative helmet factors;

7.56.2.3 Isocenter coincidence;

7.56.2.4 Timer accuracy and linearity over the range of use; 7.56.2.5 On-off error;

7.56.2.6 Trunnion centricity;

7.56.2.7 Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

7.56.2.8 Helmet microswitches;

7.56.2.9 Emergency timing circuits; and 7.56.2.10 Stereotactic frames and localizing devices (trunnions). 7.56.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.56.2.1 may be made using a dosimetry system that indicates relative dose rates. 7.56.4 A licensee shall make full calibration measurements required by 7.56.1 in accordance with published protocols accepted by nationally recognized bodies. 7.56.5 A licensee shall mathematically correct the outputs determined in 7.56.2.1 at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

7.56.6 Full calibration measurements required by 7.56.1 and physical decay corrections required by 7.56.5 must be performed by the authorized medical physicist. 7.56.7 A licensee shall retain a record of each calibration for the duration of the license. The record shall include:

7. 56.7.1 The date of the calibration;

7. 56.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source(s), and instruments used to calibrate the gamma stereotactic radiosurgery unit;

7. 56.7.3 The results and assessments of the full calibrations; 7. 56.7.4 The signature of the authorized medical physicist who performed the full calibration. 7.57 Radiation Surveys of Therapeutic Treatment Units.

7.57.1 A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour. The instruments shall be operable and calibrated in accordance with 7.17. 7.57.2 In addition to the survey requirements in Part 4 of these regulations, a person licensed pursuant to Part 7 shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the Sealed Source and Device Registry. 7.57.3 The licensee shall make the survey required by 7.57.2 at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). 7.57.4 A licensee shall retain a record of the radiation surveys required by 7.57.2 for the duration of use of the unit. The record must include:

7.57.4.1 The date of the measurements;

7.57.4.2 The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; 7.57.4.3 Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and 7.57.4.4 The signature of the authorized medical physicist who performed the test. 7.58 Periodic Spot Checks for Teletherapy Units.

7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit once in each calendar month, including determination of: 7.58.1.1 Timer accuracy and timer linearity over the range of use; 7.58.1.2 "On off" error;

7.58.1.3 The coincidence of the radiation field and the field indicated by the light beam localizing device;

7.58.1.4 The accuracy of all distance measuring and localization devices used for medical use; 7.58.1.5 The output for one typical set of operating conditions measured with the dosimetry system described in 7.53; and 7.58.1.6 The difference between the measurement made in 7.58.1.5 and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay). 7.58.2 A licensee shall perform spot checks required by 7.58.1 in accordance with procedures established by the authorized medical physicist. That individual need not actually perform the output spot-check measurements.

7.58.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each spot check.

7.58.4 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

7.58.4.1 Electrical interlocks at each teletherapy room entrance; 7.58.4.2 Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on off" mechanism;

7.58.4.3 Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

7.58.4.4 Viewing and intercom systems;

7.58.4.5 Treatment room doors from inside and outside the treatment room; and 7.58.4.6 Electrically assisted treatment room doors with the teletherapy unit electrical power turned "off".

7.58.5 If the results of the checks required in 7.58.4 indicate the malfunction of any system, a licensee shall lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. 7.58.6 A licensee shall maintain a record of each spot check required by 7.58.1 and 7.58.5 for 3 years. The record shall include:

7.58.6.1 The date of the spot check;

7.58.6.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source, and instrument used to measure the output of the teletherapy unit; 7.58.6.3 An assessment of timer linearity and constancy; 7.58.6.4 The calculated "on off" error;

7.58.6.5 A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device 7.58.6.6 The determined accuracy of each distance measuring or localization device; 7.58.6.7 The difference between the anticipated output and the measured output; 7.58.6.8 Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and 7.58.6.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. 7.59 Periodic Spot Checks for Remote Afterloader Units. 7.59.1 A licensee authorized to use remote afterloader units for medical use shall perform spot checks of each remote afterloader facility and on each unit:

7.59.1.1 At the beginning of each day of use of a high dose-rate, medium dose-rate or pulsed dose-rate remote afterloader unit;

7.59.1.2 Prior to each patient treatment with a low dose-rate remote afterloader unit; and 7.59.1.3 After each source installation.

7.59.2 The licensee shall have the authorized medical physicist establish written procedures for performing the spot checks required in 7.59.1 The authorized medical physicist need not actually perform the spot-check measurements.

7.59.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.

7.59.4 To satisfy the requirements of 7.59.1, spot checks must, at a minimum, assure proper operation of:

7.59.4.1 Electrical interlocks at each remote afterloader unit room entrance; 7.59.4.2 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

7.59.4.3 Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility;

7.59.4.4 Emergency response equipment;

7.59.4.5 Radiation monitors used to indicate the source position; 7.59.4.6 Timer accuracy;

7.59.4.7 Clock (date and time) in the unit's computer; and 7.59.4.8 Decayed source(s) activity in the unit's computer. 7.59.5 If the results of the checks required in 7.59.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. 7.59.6 A licensee shall retain a record of each check required by 7.59.4 for 3 years. The record must include, as applicable:

7.59.6.1 The date of the spot check;

7.59.6.2 The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

7.59.6.3 An assessment of timer accuracy;

7.59.6.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and 7.59.6.5 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. 7.60 Additional Technical Requirements for Mobile Remote Afterloader Units. 7.60.1 A licensee providing mobile remote afterloader service shall: 7.60.1.1 Check survey instruments for consistent response before medical use at each address of use or on each day of use, whichever is more frequent; and 7.60.1.2 Account for all sources before departure from a client's address of use. 7.60.2 In addition to the periodic spot checks required by 7.59, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of: 7.60.2.1 Electrical interlocks on treatment area access points; 7.60.2.2 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

7.60.2.3 Viewing and intercom systems;

7.60.2.4 Applicators, source transfer tubes, and transfer tube-applicator interfaces; 7.60.2.5 Radiation monitors used to indicate room exposures; 7.60.2.6 Source positioning (accuracy); and 7.60.2.7 Radiation monitors used to indicate whether the source has returned to a safe shielded position.

7.60.3 In addition to the requirements for checks in 7.60.2, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

7.60.4 If the results of the checks required in 7.60.2 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. 7.60.5 A licensee shall retain a record of each check required by 7.60.2 for 3 years. The record must include:

7.60.5.1 The date of the check;

7.60.5.2 The manufacturer's name, model number, and serial number of the remote afterloader unit;

7.60.5.3 Notations accounting for all sources before the licensee departs from a facility; 7.60.5.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and source transfer tubes, and source positioning accuracy; and 7.60.5.5 The signature of the individual who performed the check. 7.61 Periodic Spot Checks for Gamma Stereotactic Radiosurgery Units. 7.61.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot checks of each gamma stereotactic radiosurgery facility and on each unit: 7.61.1.1 Monthly;

7.61.1.2 At the beginning of each day of use; and 7.61.1.3 After each source installation.

7.61.2 The licensee shall have the authorized medical physicist: 7.61.2.1 Establish written procedures for performing the spot checks required in 7.61.1; and 7.61.2.2 Review the results of each spot check required by 7.61.1.1 within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements. The authorized medical physicist shall notify the licensee as soon as possible, in writing, of the results of the spot check. 7.61.3 To satisfy the requirements of 7.61.1.1 spot checks must, at a minimum: 7.61.3.1 Assure proper operation of:

(1) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(2) Helmet microswitches;

(3) Emergency timing circuits; and (4) Stereotactic frames and localizing devices (trunnions). 7.61.3.2 Determine:

(1) The output for one typical set of operating conditions measured with the dosimetry system described in 7.53.2;

(2) The difference between the measurement made in 7.61.3.2(1) and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay); (3) Source output against computer calculation;

(4) Timer accuracy and linearity over the range of use; (5) On-off error; and (6) Trunnion centricity.

7.61.4 To satisfy the requirements of 7.61.1.2 and 7.61.1.3, spot checks must assure proper operation of: 7.61.4.1 Electrical interlocks at each gamma stereotactic radiosurgery room entrance; 7.61.4.2 Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

7.61.4.3 Viewing and intercom systems;

7.61.4.4 Timer termination;

7.61.4.5 Radiation monitors used to indicate room exposures; and 7.61.4.6 Emergency off buttons.

7.61.5 A licensee shall arrange for prompt repair of any system identified in 7.61.3 that is not operating properly.

7.61.6 If the results of the checks required in 7.61.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. 7.61.7 A licensee shall retain a record of each check required by 7.61.3 and 7.61.4 for 3 years. The record must include:

7.61.7.1 The date of the spot check;

7.61.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; 7.61.7.3 An assessment of timer linearity and accuracy; 7.61.7.4 The calculated on-off error;

7.61.7.5 A determination of trunnion centricity;

7.61.7.6 The difference between the anticipated output and the measured output; 7.61.7.7 An assessment of source output against computer calculations; 7.61.7.8 Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and 7.61.7.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check. 7.62 Other Medical Uses of Radioactive Material or Radiation From Radioactive Material. 7.62.1 A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Part 7 if:

7.62.1.1 The applicant or licensee has submitted the information required by 7.3.4.2, 7.3.4.3, and 7.3.4.4; and 7.62.1.2 The applicant or licensee has received written approval from the an Agreement State, Licensing State, or NRC in a license and uses the material in accordance with the regulations and specific conditions that the Agreement State, Licensing State, or NRC considers necessary for the medical use of the material. 7.63 Five Year Inspection.

7.63.1 A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism. 7.63.2 This inspection and servicing shall only be performed by persons specifically licensed to do so by the Department, another Agreement State, a Licensing State, or the NRC. 7.63.3 A licensee shall keep a record of the inspection and servicing for the duration of the license. The record shall contain:

7.63.3.1 The inspector's radioactive materials license number; 7.63.3.2 The date of inspection;

7.63.3.3 The manufacturer's name and model number and serial number of both the treatment unit and source;

7.63.3.4 A list of components inspected and serviced;

7.63.3.5 A list of components inspected and serviced, and the type of service; 7.63.3.6 A list of components replaced; and 7.63.3.7 The signature of the inspector.

PART 7, APPENDIX 7A:

RADIATION SAFETY OFFICER (RSO) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the individual fulfilling the responsibilities of the Radiation Safety Officer (RSO) as provided in 7.7 to:

PART 7, APPENDIX 7B:

AUTHORIZED MEDICAL PHYSICIST (AMP) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require each authorized medical physicist to:

PART 7, APPENDIX 7C:

AUTHORIZED NUCLEAR PHARMACIST (ANP) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require each authorized nuclear pharmacist to:

PART 7, APPENDIX 7D:

AUTHORIZED USER FOR UPTAKE, DILUTION AND EXCRETION STUDIES (7.30) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.30 to:

PART 7, APPENDIX 7E:

AUTHORIZED USER FOR IMAGING AND LOCALIZATION STUDIES (7.32) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.32 to:

APPENDIX 7F:

AUTHORIZED USER FOR DIAGNOSTIC OR THERAPEUTIC USE (7.36) OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized under 7.36 to:

APPENDIX 7G:

AUTHORIZED USER FOR ORAL ADMINISTRATION (7.36) OF </ = 1.22 GBq I 131 (33 MCI) SODIUM IODIDE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user for the oral administration of </ = 1.22 GBq (33 mCi) of Na I 131 for which a written directive is required under 7.36 to:

APPENDIX 7H:

AUTHORIZED USER FOR ORAL ADMINISTRATION (7.36) OF > / = 1.22 GBq I 131 (33 mCi) SODIUM IODIDE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user for the oral administration of quantities of Na I-131 greater than 1.22 GBq (33 mCi) for which a written directive is required under 7.36 to:

APPENDIX 7I:

AUTHORIZED USER FOR PARENTERAL ADMINISTRATION (7.36) OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user for parenteral administration of unsealed radioactive material for which a written directive is required under 7.36 to:

APPENDIX 7J:

AUTHORIZED USER FOR USE (7.40) OF SEALED SOURCES FOR DIAGNOSIS ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of a diagnostic sealed source for use in a device authorized under 7.40 to:

APPENDIX 7K:

AUTHORIZED USER FOR MANUAL BRACHYTHERAPY SOURCE USE (7.42) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an manual brachytherapy source for the uses authorized under 7.42 to:

APPENDIX 7L:

AUTHORIZED USER FOR OPHTHALMIC USE (7.42) OF STRONTIUM-90 ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of an Strontium 90 source for ophthalmic radiotherapy authorized under 7.42 to:

APPENDIX 7M:

AUTHORIZED USER FOR USE (7.48) OF SEALED SOURCES IN REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require an authorized user of a diagnostic sealed source for use in a device authorized under 7.48 to:

PART 7, APPENDIX 7N:

NUCLEAR MEDICINE TECHNOLOGIST (NMT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the nuclear medicine technologist using radioactive materials under the supervision of an authorized user to:

PART 7, APPENDIX 7O:

RADIATION THERAPY TECHNOLOGIST (RTT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The licensee shall require the radiation therapy technologist using radioactive materials under the supervision of an authorized user to:

PART 8 RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT RH 8.1 Purpose and Scope.

This part provides special requirements for analytical x-ray equipment. The requirements of this part are in addition to, and not in substitution for, applicable requirements in other parts of these regulations. RH 8.2 Definitions.

As used in this part, the following definitions apply:

“Analytical x-ray equipment” means equipment used for x-ray diffraction or fluorescence analysis. “Analytical x-ray system” means a group of components utilizing x or gamma rays to determine the elemental composition, or to examine the microstructure of materials. “Fail-safe characteristics” mean a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.

“Local components” mean part of an analytical x-ray system and include areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels. “Normal operating procedures” mean step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures, which are related to radiation safety.

“Open-beam configuration” means an analytical x-ray system in which an individual could accidentally place some part of his body in the primary beam path during normal operation. “Primary beam” means ionizing radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.

General Regulatory Provisions and Specific Requirements RH 8.3 Equipment Requirements.

8.3.1 Safety Device. A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path, or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant or licensee may apply to the Department for an exemption from the requirement of a safety device. Such application shall include: 8.3.1.1 a description of the various safety devices that have been evaluated; 8.3.1.2 the reason each of these devices cannot be used; and 8.3.1.3 a description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices. 8.3.2 Warning Devices.

8.3.2.1 Open-beam configurations shall be provided with a readily discernible indication of: 8.3.2.1.1 x-ray tube “on-off” status located near the radiation source housing, if the primary beam is controlled in this manner; and/or 8.3.2.1.2 shutter “open-closed” status located near each port on the radiation source housing, if the primary beam is controlled in this manner. 8.3.2.2 An easily visible warning light labeled with the words “X-RAY ON”, or words having a similar intent, shall be located:

8.3.2.2.1 near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized; or 8.3.2.2.2 in the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open. 8.3.2.3 Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after October 1, 1978, warning devices shall have fail-safe characteristics. 8.3.3 Ports. Unused ports on radiation source housings shall be secured in the closed position, in a manner which will prevent casual opening.

8.3.4 Labeling. All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

8.3.4.1 “CAUTION - HIGH INTENSITY X-RAY BEAM”, or words having a similar intent, on the x- ray source housing; and 8.3.4.2 “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED”, or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube; or 8.3.4.3 “CAUTION - RADIOACTIVE MATERIAL”, or words having a similar intent, on the source housing in accordance with RH 4.30 of these regulations if the radiation source is a radionuclide.

8.3.5 Shutters. On open-beam configurations installed after October 1, 1978, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.

8.3.6 Reserved.

8.3.7 Radiation Source Housing. Each radiation source housing shall be subject to the following requirements:

8.3.7.1 Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing, or if the housing is disassembled. 8.3.7.2 Each radioactive source housing, or port cover or each x-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of 5 centimeters from its surface is not capable of producing a dose in excess of 2.5 millirems (0.025 mSv) in one hour. For systems utilizing x-ray tubes, this limit shall be met at any specified tube rating.

8.3.8 Generator Cabinet. Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem (2.5 uSv) in one hour. RH 8.4 Area Requirements.

8.4.1 Radiation Levels. The local components of an analytical x- ray system shall be located and arranged and shall include sufficient shielding, or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in RH 4.14 of these regulations. For systems utilizing x-ray tubes, these levels shall be met at any specified tube rating. 8.4.2 Surveys.

8.4.2.1 Radiation surveys, as required by RH 4.17 of these regulations, of all analytical x-ray systems sufficient to show compliance with RH 8.4.1 shall be performed: 8.4.2.1.1 upon installation of the equipment, and at least once every 12 months thereafter;

8.4.2.1.2 following any change in the initial arrangement, number, or type of local components in the system;

8.4.2.1.3 following any maintenance requiring the disassembly, or removal of a local component in the system;

8.4.2.1.4 during the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled, or removed;

8.4.2.1.5 any time a visual inspection of the local components in the system reveals an abnormal condition; and 8.4.2.1.6 whenever personnel monitoring devices show a significant increase over the previous monitoring period, or the readings are approaching the limits specified in RH 4.6 of these regulations.

8.4.2.2 Radiation survey measurements shall not be required if a registrant or licensee can demonstrate compliance with RH 8.4.1 to the satisfaction of the Department. 8.4.3 Posting. Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign, or signs bearing the radiation symbol and the words “CAUTION - X-RAY EQUIPMENT” or words having a similar intent in accordance with RH 4.28 of these regulations. RH 8.5 Operating Requirements.

8.5.1 Procedures. Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer.

8.5.2 Bypassing. No individual shall bypass a safety device or interlock, unless such individual has obtained the written approval of the radiation safety officer. Such approval shall be for a specified period of time. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words “SAFETY DEVICE NOT WORKING”, or words having a similar intent, shall be placed on the radiation source housing.

8.5.3 Repair or Modification of X-Ray Tube Systems. Except as specified in RH 8.5.2, no operation involving removal of covers, shielding materials, or tube housings, or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs. 8.5.4 Radioactive Source Replacement, Testing, or Repair. Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. RH 8.6 Personnel Requirements.

8.6.1 Instruction. No individual shall be permitted to operate or maintain analytical x-ray equipment unless such individual has received instruction in and demonstrated competence as to: 8.6.1.1 identification of radiation hazards associated with the use of the equipment; 8.6.1.2 significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases; 8.6.1.3 proper operating procedures for the equipment;

8.6.1.4 recognition of symptoms of an acute localized exposure; and 8.6.1.5 proper procedures for reporting an actual or suspected exposure. 8.6.2 Personnel Monitoring.

8.6.2.1 Finger or wrist dosimetric devices shall be provided to and shall be used by: 8.6.2.1.1 analytical x-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and 8.6.2.1.2 personnel maintaining analytical x-ray equipment if the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed. 8.6.2.2 Reported dose values shall not be used for the purpose of determining compliance with RH 4.6 of these regulations unless evaluated by a qualified expert. PART 9 RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS NOT USED IN THE HEALING ARTS RH 9.1 Purpose and Scope.

9.1.1 This part establishes procedures for the registration and the use of particle accelerators not used in the healing arts.

9.1.2 In addition to the requirements of this part, all registrants are subject to the applicable requirements of Parts 1, 2, 4, and 10 of these Regulations. Registrants engaged in industrial radiographic operations are subject to the applicable requirements of Part 5 of these Regulations, and registrants engaged in the healing arts are subject to the requirements of Part 20 of these Regulations. Registrants whose operations result in the production of radioactive material are subject to the applicable requirements of Part 3 of these Regulations. Registration Procedure RH 9.2 Registration Requirements. No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except as authorized in a registration issued pursuant to Part 2 of these Regulations.

RH 9.3 General Requirements for the Issuance of a Registration for Particle Accelerators. In addition to the requirements of Part 2 of these Regulations, a registration application for use of a particle accelerator will be approved only if the Department determines that: 9.3.1 the applicant is qualified by reason of training and experience to use the accelerator in question for the purpose requested in accordance with this part and Parts 4 and 10 of these Regulations in such a manner as to minimize danger to public health and safety or property;

9.3.2 the applicant's proposed or existing equipment, facilities, and operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;

9.3.3 the issuance of the registration will not be inimical to the health and safety of the public, and the applicant satisfies any applicable special requirement in RH 9.4; 9.3.4 the applicant has appointed a radiation safety officer; 9.3.5 the applicant and the applicant's staff has substantial experience in the use of particle accelerators and training sufficient for application to their intended uses; 9.3.6 the applicant has established a radiation safety committee to approve, in advance, proposals for uses of particle accelerators, whenever deemed necessary by the Department; and 9.3.7 the applicant has an adequate training program for operators of particle accelerators. Radiation Safety Requirements for the Use of Particle Accelerators 9.4 A registrant shall use the accelerator in accordance with the manufacturer's radiation safety and operating instructions.

9.5 Limitations.

9.5.1 No registrant shall permit any individual to act as an operator of a particle accelerator until such individual:

9.5.1.1 has been instructed in radiation safety and shall have demonstrated an understanding thereof;

9.5.1.2 has received copies of and instruction in this part and the applicable requirements of Parts 4 and 10 of these Regulations, pertinent registration conditions and the registrant's operating and emergency procedures, and shall have demonstrated understanding thereof; and 9.5.1.3 has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed.

RH 9.6 Shielding and Safety Design Requirements.

9.6.1 A qualified expert, registered with the Department, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation. For the purpose of this section, a qualified expert shall:

9.6.1.1 Be certified by the American Board of Radiology in: 9.6.1.1.1 Radiological Physics or Therapeutic Radiological Physics; 9.6.1.2 Be certified by the American Board of Medical Physics in Radiological Oncology Physics; or 9.6.1.3 Be certified by the American Board of Health Physics; or 9.6.1.4 Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics or medical physics, and have completed one year of documented full time training in radiation protection and also one year of documented full time work experience under the supervision of a qualified expert meeting the criteria in this section.

9.6.2 Each particle accelerator installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with RH 4.6 and RH 4.14 of these Regulations.

RH 9.7 Particle Accelerator Controls and Interlock Systems. 9.7.1 Instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible.

9.7.2 Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine under conditions of barrier penetration. 9.7.3 Each safety interlock shall be on a circuit which shall allow it to operate independently of all other safety interlocks.

9.7.4 All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator. 9.7.5 When a safety interlock system has been tripped, it shall only be possible to resume operation of the accelerator after the condition causing the interrupt has been corrected. 9.7.6 A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

RH 9.8 Warning Devices.

9.8.1 Each location designated as high radiation area, and each entrance to such location, shall be equipped with easily observable warning lights that operate when, and only when, radiation is being produced.

9.8.2 Except in facilities designed for human exposure, each high radiation area shall have an audible warning device which shall be activated for fifteen (15) seconds prior to the possible creation of such high radiation area. Such warning device shall be clearly discernible in all high radiation areas.

9.8.3 Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be posted in accordance with RH 4.28 of these Regulations. RH 9.9 Operating Procedures.

9.9.1 Particle accelerators, when not in operation, shall be secured to prevent unauthorized use. 9.9.2 The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.

9.9.3 Safety Checks.

9.9.3.1 All safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed three months. Results of such tests shall be maintained at the accelerator facility for inspection by the Department. To satisfy the requirement of RH 9.9.3, safety checks shall assure, as appropriate, proper operation of:

9.9.3.1.1 Electrical interlocks at each room entrance;

9.9.3.1.2 Timer, dose terminator, emergency off and door interlocks; 9.9.3.1.3 Beam condition indicator lights on the accelerator unit, on the control panel, and in the facility;

9.9.3.1.4 Viewing systems;

9.9.3.1.5 Doors from inside and outside the accelerator room; and 9.9.3.1.6 Electrically assisted room doors with the accelerator unit electrical power turned off.

9.9.3.2 A registrant shall promptly repair any system identified in RH 9.9.3.1 that is not operating properly. The accelerator shall not be used until all repairs are completed.

9.9.3.3 Records. A registrant shall maintain a record of each safety check required by RH 9.9.3.1 for three (3) years. The record shall include the date of the safety check, the manufacturer's name, model number, and serial number for the accelerator, and the manufacturer's name, model number, serial number and calibration date of the instrument used to conduct any measurements, notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, doors, and the signature of the individual who performed the periodic spot checks. 9.9.3.4 If the result of the safety checks required in RH 9.9.3.1 indicate the malfunction of any system specified in RH 9.9.3.1, the registrant shall lock the control console in the “off” position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

9.9.4 Electrical circuit diagrams of the accelerator and the associated safety interlock systems shall be kept current and maintained for inspection by the Department and shall be available to the operator at each accelerator facility. 9.9.5 If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:

9.9.5.1 authorized by the radiation safety officer;

9.9.5.2 recorded in a permanent log and a notice posted at the accelerator control console; and 9.9.5.3 terminated as soon as possible.

9.9.6 Safety Instructions.

9.9.6.1 A copy of the current operating and the emergency procedures shall be maintained at the accelerator control panel. These instructions shall inform the operator of:

9.9.6.1.1 The procedure to be followed if the operator is unable to turn the accelerator off with controls at the control panel or any other abnormal operation occurs; and 9.9.6.1.2 The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the accelerator or console operates abnormally; and 9.9.6.2 A registrant shall provide instruction in the topics identified in RH 9.9.6.1 to all individuals who operate an accelerator and shall provide appropriate refresher training to individuals at intervals not to exceed one year. 9.9.6.3 A registrant shall maintain a record of individuals receiving instructions required by RH 9.9.6.2, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for three (3) years. RH 9.10 Radiation Monitoring Requirements.

9.10.1 There shall be available at each particle accelerator facility appropriate portable monitoring equipment which is operable and has been appropriately calibrated for the radiations being produced at the facility. Such equipment shall be tested for proper functioning prior to each day of accelerator operation and calibrated at intervals not to exceed one year and after each servicing and repair.

9.10.2 A radiation protection survey shall be performed and documented by a qualified expert, acceptable to the Department, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

9.10.2.1 A registrant shall maintain a record of the radiation measurements made following installation of the accelerator for the duration of the registration and when subsequent changes occur that could potentially affect the radiation levels in adjacent areas. The record shall include the date of the measurements, the manufacturer's name, model number and serial number of the accelerator, a description of the accelerator configuration including whether there were any test objects in the accelerator beam, the instrument used to measure radiation levels, a plan of the areas surrounding the accelerator that were surveyed, the measured dose rate at several points in each area expressed in microsieverts (millirems) per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.

9.10.3 The radiation levels in all high radiation areas not in the exposure room shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.

9.10.4 All area monitors shall be calibrated at intervals not to exceed one year and after each servicing and repair.

9.10.5 Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present.

9.10.6 All surveys shall be made in accordance with the written procedures established by a qualified expert, registered with the Department, or the Radiation Safety Officer. 9.10.7 Records of all radiation protection surveys, calibrations, and instrumentation tests shall be maintained for three (3) years at the accelerator facility for inspection by the Department. RH 9.11 Ventilation Systems.

9.11.1 Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in Part 4, Appendix B, Table I of these Regulations.

9.11.2 A registrant shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits specified in Part 4, Appendix B, Table II of these Regulations, except as authorized pursuant to RH 4.33 of these Regulations. For purposes of RH 9.11.1, concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable. PART 10:

NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS: INSPECTIONS 10.1 Purpose and Scope.

10.1.1 Authority.

Rules and regulations set forth herein are adopted pursuant to the provisions of Sections 25-1- 108, 25-1.5-101(1)(k) and (1)(l), and 25-11-104, and 24-60-2205, CRS. 10.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department. 10.1.3 Scope.

This part establishes requirements for notices, instructions, and reports by licensees or registrants to individuals engaged in activities under a license or registration and options available to such individuals in connection with Department inspections of licensees or registrants to ascertain compliance with the provisions of the Act and regulations, orders, and licenses issued thereunder regarding radiological working conditions.

10.1.4 Applicability The regulations in this part apply to all persons who receive, possess, use, own, transfer or dispose sources of radiation registered with or licensed by the Department pursuant to Part 2 and/or Part 3 of these regulations.

General Regulatory Provisions and Specific Requirements 10.2 Posting of Notices to Workers.

10.2.1 Each licensee or registrant shall post current copies of the following documents: 10.2.1.1 The regulations in this part and in Part 4 of these regulations; 10.2.1.2 The license, certificate of registration, conditions, or documents incorporated into the license by reference and amendments thereto;

10.2.1.3 The operating procedures applicable to activities under the license or registration; and 10.2.1.4 Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Part 1 of these regulations, and any response from the licensee or registrant.

10.2.2 If posting of a document specified in 10.2.1.1, 10.2.1.2, or 10.2.1.3 is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.

10.2.3 Department Form R-15 Notice to Employees shall be posted by each licensee or registrant as required by these regulations.

10.2.4 Department documents posted pursuant to 10.2.1.4 shall be posted within 5 working days after receipt of the documents from the Department; the licensee's or registrant's response, if any, shall be posted within 5 working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.

10.2.5 Documents, notices, or forms posted pursuant to 10.2 shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered. 10.3 Instructions to Workers.

10.3.1 All individuals who in the course of employment are likely to receive in a year an occupational dose (see also 10.3.2) in excess of 1 millisievert (100 mrem) shall be: 10.3.1.1 Kept informed of the storage, transfer, or use of sources of radiation; 10.3.1.2 Instructed in the health protection problems associated with exposure to radiation and/or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; 10.3.1.3 Instructed in, and required to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material;

10.3.1.4 Instructed of their responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of the Act, these regulations, and licenses or registrations, or unnecessary exposure to radiation and/or radioactive material;

10.3.1.5 Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and 10.3.1.6 Advised as to the radiation exposure reports which workers shall be furnished pursuant to 10.4.

10.3.2 In determining those individuals subject to the requirements of 10.3.1, licensees and registrants must take into consideration:

10.3.2.1 Assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed or registered facility; and 10.3.2.2 The result of instruction for maintaining exposures ALARA pursuant to 4.5.2. 10.3.3 The extent of these instructions shall be commensurate with potential radiological health protection problems present in the work place.

10.4 Notification and Reports to Individuals.

10.4.1 Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in 10.4. The information reported shall include data and results obtained pursuant to these regulations, orders, or license or registration conditions, as shown in records maintained by the licensee or registrant pursuant to 4.46 of these regulations. Each notification and report shall:

10.4.1.1 Be in writing;

10.4.1.2 Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

10.4.1.3 Include the individual's exposure information; and 10.4.1.4 Contain the following statement:

“This report is furnished to you under the provisions of Colorado Rules and Regulations Pertaining to Radiation Control, Part 10. You should preserve this report for further reference.”

10.4.2 Each licensee or registrant shall advise each worker annually of the worker's dose as shown in records maintained by the licensee or registrant pursuant to 4.46 of these regulations. 10.4.3 Each licensee or registrant shall furnish a report of the worker's exposure to sources of radiation at the request of a worker formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to 4.18 of these regulations. Such report shall be furnished within 30 days from the date of the request or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated. 10.4.4 When a licensee or registrant is required pursuant to 4.53 of these regulations to report to the Department any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Department. 10.4.5 At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

10.5 Presence of Representatives of Licensees or Registrants and Workers During Inspections. 10.5.1 Each licensee or registrant shall afford to the Department at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to these regulations.

10.5.2 During an inspection, Department inspectors may consult privately with workers as specified in 10.6. The licensee or registrant may accompany Department inspectors during other phases of an inspection.

10.5.3 If, at the time of inspection, an individual has been authorized by the workers to represent them during Department inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions. 10.5.4 Each workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in 10.3. 10.5.5 Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors. 10.5.6 With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany Department inspectors during the inspection of physical working conditions.

10.5.7 Notwithstanding the other provisions of 10.5, Department inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

10.6 Consultation with Workers During Inspections.

10.6.1 Department inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of these regulations and licenses or registrations to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.

10.6.2 During the course of an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or cause any violation of the Act, these regulations, or license or registration condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of 10.7.1.

10.6.3 The provisions of 10.6.2 shall not be interpreted as authorization to disregard instructions pursuant to 10.3.

10.7 Requests by Workers for Inspections.

10.7.1 Any worker or representative of workers believing that a violation of the Act, these regulations, or license or registration conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the Department. Any such complaint shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the Department no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Department except for good cause shown.

10.7.2 If, upon receipt of such notice, the Department determines that the complaint meets the requirements set forth in 10.7.1, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspection pursuant to 10.7 need not be limited to matters referred to in the complaint.

10.7.3 No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified, or is about to testify in any such proceeding, or because of the exercise by such worker on behalf of such worker or others of any option afforded by this part. 10.8 Inspections Not Warranted; Informal Review.

10.8.1 If the Department determines, with respect to a complaint under 10.7, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the Department shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Department. The Department will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant and the name of individuals referred to therein. The licensee or registrant may submit an opposing written statement of position with the Department. The Department will provide the complainant with a copy of such statement by certified mail. 10.8.1.1 Upon the request of the complainant, the Department may hold an informal conference in which the complainant and the licensee or registrant may each orally present its views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant or individuals referred to in the complaint will be made only following receipt of written authorization from the complainant. 10.8.1.2 After considering all written and oral views presented, the Department shall affirm, modify, or reverse the determination and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefor. 10.8.2 If the Department determines that an inspection is not warranted because the requirements of 10.7.1 have not been met, the complainant shall be notified in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of 10.7.1.

PART 11 SPECIAL LAND OWNERSHIP REQUIREMENTS GENERAL PROVISIONS 11.1 Purpose.

The purpose of these regulations is to protect the public health, safety, and environment by establishing requirements for private ownership of sites used for the concentration, storage or disposal of radioactive materials in lieu of government ownership of such sites. 11.2 Scope.

These regulations apply to any application under RH 1.5.1 for an exemption from the land ownership requirements of § 25-11-103 (7), C. R. S., as amended, and are in addition to any appropriate requirements of Parts 3, 14 or 18 of these regulations. CONTROL REQUIREMENTS 11.3 Demonstration of Control.

Before any application under RH 1.5.1 for an exemption from the land ownership requirements of §25-11- 103 (7) may be granted, the applicant must demonstrate a degree of control of the site equivalent to that which would be achieved by government ownership of the site. At a minimum, the applicant shall be required to provide the following:

11.3.1 Financial Assurance.

Pursuant to Part 3 of these regulations, the licensee shall provide a long term care warranty. 11.3.2 Trust Agreement.

The licensee shall enter into a trust agreement with the department giving the department exclusive control over the licensee's long term care funds to enable the department to conduct long term care and maintenance of the site in the event the owner of the site is unable or unwilling to do so. 11.3.3 Institutional Control Program.

The licensee shall establish and, after completion of decommissioning and decontamination activities, conduct a Department approved institutional control program. The institutional control program shall include, but not be limited to: conducting an environmental monitoring program at the disposal site, periodic site surveillance, custodial care, and administration of funds to cover the costs for these activities.

11.3.4 Restrictive Covenants.

The applicant shall record with the county clerk and recorder in the county where the site is located Department-approved restrictive covenants providing for the following: 11.3.4.1 Except as necessary to maintain or repair the site, no construction or excavation of any kind shall be allowed;

11.3.4.2 No use shall be made of the property which may impair the site's ability to contain or control the waste.

11.3.4.3 Any change in the use of the property shall require the prior written approval of the Department.

11.3.4.4 Ownership of the property, and any interest in the property, shall not be conveyed without the prior written approval of the Department, and any conveyance shall have adequate and complete provision for the continued maintenance of the property and financial assurance warranties.

11.3.4.5 The owners shall erect and continuously maintain on the property at locations approved by the Department markers and monuments, approved by the Department, warning of the presence of radioactive materials.

11.3.4.6 The covenants shall run with the property and be binding upon the heirs, successors or assigns of the licensee.

11.3.4.7 The covenants shall inure to the benefit of, and shall be enforceable in a court of law by, the Department and the United States Nuclear Regulatory Commission and any successor agencies, as well by any other federal, state, or local government agency affected by any violations of the covenants.

11.3.5 Deed Annotations.

The licensee shall record with the county clerk and recorder an annotation to its deed to the property which shall include a description, by metes and bounds, of the locations where radioactive materials were disposed of, and a description of the types, form, and volumes of radioactive materials disposed of, and approximate time periods during which disposal of the wastes took place. 11.3.6 Easements.

The licensee shall grant to the Department and the United States Nuclear Regulatory Commission and their successor agencies an easement giving them and their designees the unlimited right to access the property for purposes of inspecting the property; determining compliance with restrictive covenants and applicable laws, regulations, permits, and licenses; taking samples and measurements; and for any other purpose reasonably within the power and authority of the Department and the United States Nuclear Regulatory Commission.

11.3.7 As-built Drawings.

One year after issuance of the license to the applicant, and annually thereafter, the licensee shall provide the Department with “as-built’ drawings of the disposal facility until license termination. 11.3.8 Transfer of Records.

Within six months after the completion of decommissioning and decontamination activities, the licensee shall at no cost transfer copies of all records of the location and quantity of wastes contained in the disposal site to: the governing body of the nearest municipality, the governing body of the county in which the facility is located, the local planning agency having jurisdiction over the area in which the facility is located, the Department, and any other state, local, and federal agency designated by the department. PART 12:

FEES FOR MATERIALS LICENSES AND OTHER RADIATION CONTROL SERVICES 12.1 Purpose and Scope 12.1.1 Authority.

Rules and regulations set forth herein are adopted pursuant to the provisions of Sections 25-1- 108, 25-1.5-101(1)(k) and 25-1.5-101(1)(l), and 25-11-104(6), CRS. 12.1.2 Basis and Purpose.

A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department. 12.1.3 Scope The regulations in this part establish fees for radiation control services rendered by the Department as authorized by the Act.

12.1.4 Applicability Except for persons who apply for, or hold specific licenses exempted in 12.3, the regulations in this part apply to radiation control services for a person who is an applicant for, or holder of, a specific radioactive material license or a general radioactive material license, issued pursuant to Part 3 of these regulations. This part also applies to a specific request for evaluation of sealed sources and devices containing radioactive material, for a special project review, which the Department completes or makes whether or not in conjunction with a license application on file or which may be filed, and for other services as specified in this part. 12.2 Definitions.

As used in this part:

“Abandoned application” means any application filed with the Department for which the Department has in writing requested additional information needed to process the application and the Department does not receive a written reply from the applicant within forty-five (45) days to its most recent written request for additional information. “Anniversary Date” means that date upon which annual fees shall be due and payable. Anniversary Date is determined as the last day of the month corresponding to the month listed as the licensee's expiration date.

“Application” means any request filed with the Department for a permit, license, approval, exemption, certificate, other permission, or for any other service. “Full cost fees” mean fees based on reasonable and actual professional staff time and appropriate contractual support services expended for certain radiation control activities as specified in Appendix 12A.

“Inspections” (routine or non-routine) means:

(1) “Routine inspections” designed to evaluate the licensee's activities within the context of the licensee having primary responsibility for protection of the public and environment.

(2) “Non-routine inspections” in response or reaction to an incident, allegation, followup to inspection deficiencies, inspections to determine implementation of safety issues including radioactive waste control services pursuant to CRS Sections 25- 11-101–305 and Sections 24-60-2201–2212 and these regulations. A non-routine or reactive inspection has the same purpose as the routine inspection. “Low-Level Radioactive Waste Access Approval” means those reviews and on-site evaluations necessary to assure waste generator compliance with low-level radioactive waste site access criteria as established by the Rocky Mountain Low-Level Radioactive Waste Board (the Board) or by a compact with which the Board has an agreement to accept low-level radioactive waste from Colorado or by a state with which the Board has an agreement to accept low-level radioactive waste from Colorado or by any state or site to which a Colorado generator ships low-level radioactive waste.

“Open Records Act” means the Colorado Open Records Act, CRS 24-72-201 et seq. “Special Projects” means those requests submitted to the Department for review for which fees are not otherwise specified in this chapter. Examples of special projects include, but are not limited to, early site reviews, consultation, emergency response plan reviews, assessment of responses to Department orders, contamination surveys in response to license termination or relocation, and financial surety reviews.

12.3 Exemptions.

12.3.1 No fees pursuant to 12.4.1 through 12.4.5 shall be required for: 12.3.1.1 A radioactive materials license authorizing the use of source material as shielding only in devices and containers, provided that all other licensed radioactive material in the device or container will be subject to the fees described in Appendix 12A. 12.3.1.2 An application for possession and use of radioactive material applied for by, or issued to, an agency of Colorado or any political subdivision thereof, except for licenses which authorize distribution of radioactive material or products containing radioactive material or licenses authorizing services to any person other than an agency or political subdivision of the State. This exemption does not apply to fees for inspection or annual fees for such licensees.

12.3.1.3 A general license for reciprocity pursuant to 3.24. This exemption does not apply to fees for inspection of, or annual fees for such licensees.

12.3.2 Application for Exemptions 12.3.2.1 The Department may, upon application by an interested person, or upon its own initiative, grant such exemptions from the requirements of this part for good cause as it determines are authorized by law and are otherwise in the public interest. 12.3.2.2 Applications for exemption under this section may include activities such as, but not limited to, the use of licensed materials for educational or noncommercial public displays or scientific collections.

12.4 Specific Radioactive Materials Licensees.

12.4.1 Application Fees 12.4.1.1 Application fees for new radioactive materials licenses not subject to full cost fees must accompany the application when it is filed. Except for licenses subject to full cost, no application for a new license, for the reinstatement of an expired license, or for an application for amendment to a materials license that would place the licensee in a higher fee category will be accepted for filing or processed prior to payment of the full amount specified in Appendix 12A 1 . Applications for which no remittance is received may be returned to the applicant.

1 Licensing fees are not charged for routine amendments or renewals for licensees not subject to full cost fees. 12.4.1.2 An application for renewal of a license not subject to full cost fees which has expired and for which a renewal was not timely filed pursuant to 3.17.2 shall be accompanied by a reinstatement fee of $400.

12.4.1.3 Application fees for new radioactive materials licenses, renewals, amendments, other required approvals and requests for dismantling, decommissioning and termination of licensed activities, that are subject to the full cost fees are payable upon notification by the Department.

12.4.1.4 All licensing fees will be charged irrespective of the Department's disposition of the application or a withdrawal of the application.

12.4.1.5 Abandoned Applications (1) In the case of an abandoned amendment application, if the licensee desires to submit a new amendment application for the same or similar authorization, the reapplication shall be accompanied by a $100 reapplication fee. (2) In the case of an abandoned new license application, if the applicant desires to submit a new application, then the applicant is subject to the application fee specified in Appendix 12A.

12.4.1.6 Expedited License Review.

An hourly rate for direct staff time associated with the review of an application will be assessed for an expedited review. This fee only applies when, by consent of the applicant, a licensing request is taken out of the date order in which it was received.

12.4.2 Termination Fees 12.4.2.1 Applications for license termination for licensees not subject to full cost fees will not be subject to fees provided that the licensee notifies the Department and requests termination pursuant to 3.16, as appropriate, and provided that there is no decommissioning or decontamination involved subsequent to the request for termination. Licensees subject to full cost fees shall be billed for the full cost of the review of the application for termination.

12.4.2.2 Staff time spent in obtaining information which is not provided by the licensee as required by 3.16.6 and 3.16.7 when decontamination is necessary, or in supervising the licensee's decommissioning or decontamination of the site, will be billed at the Department's hourly rate.

12.4.2.3 The charges for staff time billed under 12.4.2 are payable upon notification by the Department.

12.4.3 Inspection Fees.

Inspection costs include reasonable and actual preparation time, time on site, documentation time, any associated contractual service costs, and time involved in the processing and issuance of a notice of violation or civil penalty.

12.4.3.1 Fees for inspection of licensees not subject to full cost fees. (1) Routine inspections.

Fees for routine inspections are included in the annual fee and will not be charged separately.

(2) Non-Routine Inspections.

Fees for all non-routine inspections will be assessed on a per inspection basis and are payable upon notification by the Department.

12.4.3.2 Fees for Inspections of Licensees Subject to Full Costs Fees. Inspection fees will be assessed to recover the full cost for each specific inspection as specified in Appendix 12A, including licensee-specific performance reviews and assessments, evaluations, and incident investigations. Inspection fees for licensees subject to full cost fees, and for inspections other than routine, are due upon notification by the Department.

12.4.4 Annual fees 12.4.4.1 Persons who hold specific radioactive materials licenses shall pay an annual fee. (1) The licensee shall pay the fee in Appendix 12A for each license the person holds on the date the annual fee is due.

(2) If a person holds more than one license, the fee will be the cumulative total of the annual fee for all licenses held by that person.

(3) For those licenses that authorize more than one activity (e.g., human use and irradiator activities), annual fees will be assessed for each category applicable to the license.

(4) Persons with licenses authorizing permanent, multiple locations of use and/or storage that are separated by more than one mile shall increase the annual fee by 75 percent for the second location; 50 percent for the third location; and 25 percent if more than three locations of use are authorized. For purpose of this regulation, a permanent location is defined as one where radioactive materials are used and/or stored for more than 180 days in any calendar year. 12.4.4.2 Small Entities.

A licensee who is required to pay an annual fee under this section may qualify as a small entity. If a licensee qualifies as a small entity and provides the Department with the proper certification, the licensee may pay reduced annual fees as shown below. Entity Category Size Standard Maximum Annual Fee Per Licensed Category Small businesses not $350,000 - $5,000,000 $2,300 engaged in manufacturing gross annual receipts and small not-for-profit organizations . Less than $350,000 gross $500 annual receipts Manufacturing entities 35 to 500 employees $2,300 that have an annual average of 500 employees or less . Less than 35 employees $500 Small governmental 20,000 - 50,000 $2,300 jurisdictions (including population cities, counties, towns, townships, villages, school districts, special districts or publicly supported educational institutions)

. Less than 20,000 $500 population Educational institutions 35 to 500 employees $2,300 that are not state or publicly supported, and have 500 employees or less . Less than 35 employees $500 (1) A licensee who is a subsidiary of a large entity does not qualify as a small entity for purposes of this section.

(2) A licensee who seeks to establish status as a small entity for purpose of paying the annual fees required under this section shall file a certification statement with the Department.

(3) The licensee shall file the required “radioactive materials licensee certification of small entity status,” Department Form R-62, for each license under which the licensee is billed.

(4) For the licensee to be granted small entity status by the Department, a completed Form R-62, signed by the owner of the entity or an official empowered to act on behalf of the entity, shall accompany each application for a new license and each annual fee.

(5) The licensee shall provide a new Department Form R-62, signed by the owner of the entity or an official empowered to act on behalf of the entity, within thirty days from receipt of such a request from the Department.

(6) Failure to file a small entity certification, or to provide an updated certification upon the request of the Department, could result in the denial of the fee reduction that might otherwise be granted.

12.4.4.3 Reciprocal Recognition Fee.

An annual management fee shall be charged for persons operating in the state under reciprocity as follows:

(1) Any radioactive material brought into the state for use under reciprocity shall pay a fee equal to 75 percent of the appropriate annual fee in Appendix 12A. (2) Reciprocal fees shall be due and payable prior to entry into the state. (3) An acknowledgement of fee payment will be provided by the Department. The acknowledgement of fee payment shall be retained by the licensee and maintained with the pertinent documents prescribed in 3.24.1.1(6). (4) Reciprocal fees shall not be transferred or refunded. (5) Reciprocal fees shall expire 12 months from the issue date 2 . 2 Pursuant to 3.24, an out-of-state licensee may operate in Colorado under reciprocity for no more than 180 days in any calendar year.

12.4.4.4 Payment of Annual Fees.

(1) The annual fees shall be due and payable each year on the anniversary date. The annual fees are not refundable except in those cases where the Department has determined that the fee is not required.

(2) Annual fees shall be charged and payment required for any license that has not been terminated on or before the anniversary date or for which a request for termination has not been submitted to the Department pursuant to 3.16.7. 12.5 General Licenses.

12.5.1 Persons who hold general licenses under the following categories shall pay an annual fee: 12.5.1.1 Depleted uranium in industrial products and devices authorized under 3.5.5; 12.5.1.2 Possession of more than 1 kilogram of source material other than depleted uranium for shielding under 3.5;

12.5.1.3 Measuring, gauging and controlling devices under 3.6.4; and 12.5.1.4 In vitro licenses under 3.6.9.

12.5.2 The basis for the annual fee is to cover the Department's cost associated with the regulation and control of these sources, and to cover the Department's administrative costs for those generic activities directly related to the regulation of materials licensees. 12.5.3 Fees for general licenses are listed in Appendix 12A and shall be payable every July 1, for as long as the license remains in effect.

12.5.4 Fees for inspection of licenses, authorized under 3.5.5 and 3.6, that are based on the full cost of the inspection are payable upon notification by the Department. 12.6 Special Project Fees.

Fees for special projects are assessed for the full cost of the review, as specified in Appendix 12A. They will be based on reasonable and actual professional staff time. Appropriate contractual support services expended for certain radiation control activities will also be included. Fees for special projects are payable upon notification by the Department. 12.7 Low-Level Radioactive Waste Access Approval Fees.

Fees for services required for low-level radioactive waste access approval are payable upon notification by the Department.

SEARCH, REVIEW, DUPLICATION AND SPECIAL SERVICE FEES 12.8 Search, Review, Duplication and Special Service Fees. 12.8.1 Search, Review, and Special Service Fees 12.8.1.1 The Department charges fees for search, duplication and review. (1) The Direct Costs of Searching for Department Records. The Department may assess fees even when no Department records are located as a result of the search or when Department records that are located as a result of the search are not disclosed; and, (2) If the public record is a result of a computer output, other than word processing, the fee for a copy, printout, or other photograph thereof may be based on recovery of the actual incremental costs of providing the electronic services and products together with a reasonable portion of the costs associated with building and maintaining the information system.

(a) The Department shall charge a reasonable fee, if, in response to a specific request, it has performed a manipulation of data so as to generate a record in a form not used by the State. Such fees shall not exceed the actual cost of manipulating the said data and generating the said record in accordance with the request. Persons making subsequent requests for the same or similar records may be charged a fee not in excess of the original fee.

12.8.1.2 The Department shall charge requesters who request the following services for the direct costs of the service:

(1) Certifying that records are true copies; or (2) Sending records by special methods, such as Express Mail, package delivery service, etc.

12.8.2 Duplication Fees 12.8.2.1 The charge for duplicating records shall be computed on the basis of Department's direct costs, including both the cost of staff and the cost of the actual copy. 12.8.2.2 Copyrighted material shall not be reproduced in violation of the copyright laws. 12.8.3 Fees for Search and Review of Department Records by Department Personnel. The Department shall charge the following hourly rates for search and review of Department records by Department personnel:

12.8.3.1 Clerical search, review, and duplication at a rate that is equivalent to the actual cost of an Administrative Assistant III at the five-year rate;

12.8.3.2 Professional search, review, and duplication at a rate that is equivalent to the actual cost of an Environmental Protection Specialist II at the five year rate; and 12.8.3.3 Senior management search, review, and duplication at a rate that is equivalent to the actual cost of an Environmental Protection Specialist V at the five-year rate. 12.8.4 Search and Duplication Provided Without Charge 12.8.4.1 The Department may not bill any requester for fees if the cost of collecting the fee would be equal to or greater than the fee itself.

12.8.4.2 The Department may aggregate requests in determining search and duplication to be provided without charge as provided in 12.8.4.1, if the Department finds a requester, or multiple requestors acting in concert, has filed multiple requests for only portions of a Department record or similar Department records for the purpose of avoiding charges. 12.8.5 Assessment of Fees 12.8.5.1 If the request is expected to require the Department to assess fees in excess of $25 for search and/or duplication, the Department shall notify the requester that fees will be assessed unless the requester has indicated in advance the willingness to pay fees as high as estimated.

12.8.5.2 In the notification, the Department shall include the estimated cost of search fees and the nature of the search required and estimated cost of duplicating fees. 12.8.5.3 The Department will encourage requesters to discuss with the Department the possibility of narrowing the scope of the request with the goal of reducing the cost while retaining the requester's original objective.

12.8.5.4 If the fee is determined to be in excess of $250, the Department may require payment at the time the information is provided.

12.8.6 Requests for Waiver or Reduction of Fees 12.8.6.1 The Department shall collect fees for searching for, reviewing, and duplicating Department records, except as provided in 12.8.4, unless a requester submits a request in writing for a waiver or reduction of fees and the Department approves such request. To assure that there will be no delay in the processing of open records act requests, the request for a waiver or reduction of fees should be included in the initial open records act request letter.

12.8.6.2 Each request for a waiver or reduction of fees must be addressed to the Director, Hazardous Materials and Waste Management Division, Colorado Department of Public Health and Environment.

12.8.6.3 A person requesting the Department to waive or reduce search, review, or duplication fees shall:

(1) Describe the purpose for which the requester intends to use the requested information;

(2) Explain the extent to which the requester will extract and analyze the substantive content of the Department record;

(3) Describe the nature of the specific activity or research in which the Department records will be used and the specific qualifications the requester possesses to utilize information for the intended use in such a way that it will contribute to public understanding;

(4) Describe the likely impact on the public's understanding of the subject as compared to the level of understanding of the subject existing prior to disclosure; (5) Describe the size and nature of the public to whose understanding a contribution will be made;

(6) Describe the intended means of dissemination to the general public; (7) Indicate if public access to information will be provided free of charge or provided for an access fee or publication fee; and (8) Describe any commercial or private interest the requester or any other party has in the Department records sought.

12.8.6.4 The Department may waive or reduce the fee if, from information provided with the request for Department records made under 12.8.6.3, the Department determines that disclosure of the information in the Department records is for a public purpose, including public agency program support, nonprofit activities, journalism, and academic research, and is not primarily in the commercial interest of the requester. 12.8.6.5 In making a determination regarding a request for a waiver or reduction of fees, the Department may consider the following factors:

(1) If disclosure is likely to contribute significantly to public understanding of government operations or activities;

(2) If, and the extent to which, the requester has a commercial interest that would be furthered by the disclosure of the requested Department records; and (3) If the magnitude of the identified commercial interests of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is primarily in the commercial interest of the requester.

12.9 Partial Payment of Fees.

In the case of services, which are subject to full cost fees, the Department may bill monthly for any service rendered.

12.10 Method of Payment.

Approved credit cards, checks, drafts or money orders for payment of fees shall be payable to the Colorado Department of Public Health and Environment.

12.11 Schedule of Fees for Materials Licenses and Other Radiation Control Services. 12.11.1 Applicants for radioactive materials licenses, other regulatory services and holders of materials licenses shall pay fees for the categories of services listed in Appendix 12A. License applications received prior to the effective date of this rule shall be billed in accordance with the fee schedule, as updated by the hourly rate in effect at that time the service is performed. 12.11.2 For each service provided subject to full cost fees, records will be maintained of time spent, using reasonable accounting procedures by at least 15 minute intervals. A summary of time spent on any activity will be provided upon request.

12.11.3 The Department will adjust all fees and the cost per man-hour every six (6) months from the effective date of these regulations based on the Denver Consumer Price Index for All Urban Consumers (March 1, 2005 11-year summary). An updated version of the fee schedule will be available upon request. Every two (2) years from the effective date of these regulations, the Department will review the fees and the Department's costs. If the adjusted fees and costs for any categories differ by more than ten percent (10%), the Department will propose a revised fee to the Board of Health for those categories.

12.12 Failure by Applicant or Licensee to Pay Prescribed Fee. In any case where the Department finds that an applicant or a licensee has failed to pay a prescribed fee for any licensing or inspection activities required in this Part, the Department will not process any application, may suspend or revoke any license involved pursuant to 3.23 and may request action pursuant to CRS 25-11-107(4). Staff time expended in collection of any fee not paid within sixty (60) days of the date due will be billed at the Department's hourly rate. 12.13 Penalties.

12.13.1 A $15.00 penalty will be assessed for checks returned to the Department due to insufficient funds.

12.13.2 Late Payments 12.13.2.1 A penalty shall be assessed to any person whose fee is collected by a collection agency.

12.13.2.2 The penalty shall be equal to the fee charged by the collection agency. 12.14 Severability.

The provisions of this regulation are severable, and if any provisions or the application of the provisions to any circumstances is held invalid, the application of such provision to other circumstances, and the remainder of this regulation shall not be affected thereby. PART 12, APPENDIX A:

SCHEDULE OF FEES FOR RADIOACTIVE MATERIALS LICENSEES AND OTHER SERVICES 3,4,5,6 3 Applications for new licenses, applications to reinstate expired or terminated licenses, except those subject to fees assessed at full costs, must be accompanied by the prescribed application fee for each category. 4 Application for amendments to licenses that would place the license in a higher fee category or add anew fee category must be accompanied by the prescribed application fee for each category. 5 Renewal fees – Fees for applications for renewal of materials licenses will not be charged, except that fees for applications for renewal of licensees subject to full cost fees are due upon notification by the Department. 6 Inspection Fees: (a) Fees for routine inspections at locations authorized by the license or reciprocity permit will not be charged, except that routine inspections subject to full cost fees are due upon notification by the Department. (b) Separate charges will be assessed for each non-routine inspection which is performed. The frequency of routine inspections are those established in the Hazardous Materials And Waste Management Division Radiation Program Inspection and Enforcement Manual, and will be in accord with the frequencies established by the U.S. Nuclear Regulatory Commission for similar types of licenses. CATEGORY 1 - SPECIAL NUCLEAR MATERIAL 7,8 7 Applications for licenses covering more than one fee category of special nuclear material or source material must be accompanied by the prescribed application fee for the highest fee category. 8 Applications for new licenses that cover both special nuclear material and radioactive material and/or naturally occurring and accelerator produced material in sealed sources for use of gauging devices will pay the appropriate processing fee for category 1.C only.

1.A Licenses for possession and use of 200 grams or more of plutonium in unsealed form or 350 grams or more of U-235 in unsealed form or 200 grams or more of U-233 in unsealed form. This includes applications to terminate licenses as well as licenses authorizing possession only. NOTE: Colorado does not license this category of license. Application Not Applicable Annual Fee Not Applicable Inspection Not Applicable 1.B Licenses for receipt and storage of spent fuel at an independent spent fuel storage installation (ISFSI).

NOTE: Colorado does not license this category of license. Application Not Applicable Annual Fee Not Applicable Inspection Not Applicable 1.C Licenses for possession and use of special nuclear material in sealed sources contained in devices used in industrial measuring systems including x-ray fluorescence analyzers. Application $660 Annual Fee $1,070 Inspection $830 1.D All other special nuclear material licenses, except licenses authorizing special nuclear material in unsealed form in combinations that would constitute a critical quantity. Application $1,300 Annual Fee $2,540 Inspection $1,880 CATEGORY 2 - SOURCE MATERIAL 2.A1 Licenses for possession and use of source material for refining uranium mill concentrates to uranium hexafluoride.

NOTE: Colorado does not license this category of license. Annual Fee Not Applicable Licensing and Inspection Not Applicable 2.A2 Licenses for possession and use of source material in recovery operations such as milling, in situ leaching, heap-leaching, ore buying stations, ion exchange facilities and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material (tailings) from source material recovery operations, and licenses authorizing decommissioning, reclamation or restoration activities as well as licenses authorizing the possession and maintenance of a facility in a standby mode.

2.A2 Class I License includes mill licenses issued for the extraction of uranium from uranium ore. Annual Fee $72,610 Licensing and Inspection Full Cost 2.A2 Class II License includes solution mining licenses (in-situ and heap leach) issued for the extraction of uranium from uranium ores including research and development licenses. Annual Fee $60,830 Licensing and Inspection Full Cost 2.A2 Class III “Other” license includes licenses for extraction of metals, heavy metals, and rare earths. Annual Fee $23,020 Licensing and Inspection Full Cost 2.A3 Licenses that authorize the receipt of uranium waste tailings generated by milling operations from other persons for possession and disposal, except those licenses subject to the fees in category 2.A2 or category 2.A4.

Annual Fee $44,810 Licensing and Inspection Full Cost 2.A4 Licenses that authorize the receipt of uranium waste tailings generated by milling operations from other persons for possession and disposal incidental to the disposal of the uranium waste tailings generated by the licensee's milling operations, except those licenses subject to the fees in category 2.A2.

Annual Fee $7,080 Licensing and Inspection Full Cost 2.B Licenses for possession and use of source material for shielding . Application $160 Annual Fee $530 Inspection $940 2.C All other source material licenses.

Application $5,700 Annual Fee $8,470 Inspection $3,480 CATEGORY 3 - BYPRODUCT MATERIAL, NATURALLY OCCURRING AND ACCELERATOR PRODUCED RADIOACTIVE MATERIAL 3.A Licenses of broad scope for possession and use of radioactive material issued pursuant to 3.11 for processing or manufacturing of items containing radioactive material for commercial distribution. Application $6,700 Annual Fee $15,780 Inspection $6,660 3.B Other licenses for possession and use of radioactive material for processing or manufacturing of items containing radioactive material for commercial distribution. Application $2,200 Annual Fee $4,080 Inspection $1,940 3.C Licenses authorizing the processing or manufacture and distribution or redistribution of radiopharmaceuticals, generators, reagent kits, and/or sources and devices containing radioactive material.

Application $8,700 Annual Fee $9,470 Inspection $1,940 3.D Licenses authorizing distribution of radiopharmaceuticals, generators, reagent kits, and/or sources or devices not involving processing of radioactive material. Application $2,400 Annual Fee $3,000 Inspection $1,000 3.E Licenses for possession and use of radioactive material in sealed sources for irradiation of materials where the source is not removed from its shield (self-shielded units). Application $1,700 Annual Fee $2,460 Inspection $1,060 3.F Licenses for possession and use of less than 370 TBq (10,000 Ci) of radioactive material in sealed sources for irradiation of materials where the source is exposed for irradiation purposes. Application $3,400 Annual Fee $4,460 Inspection $1,650 3.G Licenses for possession and use of 370 TBq (10,000 Ci) or more of radioactive material in sealed sources for irradiation of materials where the source is exposed for irradiation purposes. This category includes under water irradiators for irradiation of materials where the source is not exposed.

Application $8,000 Annual Fee $16,090 Inspection $3,180 3.H Licenses issued to distribute items containing radioactive material which requires device review to persons exempt from the licensing requirements of Part 3. Application $2,300 Annual Fee $2,460 Inspection $1,000 3.I Licenses issued to distribute items containing radioactive material or quantities of radioactive material which do not require device evaluation to persons exempt from the licensing requirements of Part 3 except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.

Application $3,400 Annual Fee $3,540 Inspection $1,180 3.J Licenses issued to distribute items containing radioactive material which require sealed source and/or device review to persons generally licensed. This category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under Part 3.

Application $1,000 Annual Fee $1,610 Inspection $1,100 3.K Licenses issued to distribute items containing radioactive material or quantities of radioactive material that do not require sealed and/or device review to persons generally licensed. This category does not include specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under Part 3. Application $590 Annual Fee $1,070 Inspection $590 3.L Licenses of a broad scope for possession and use of radioactive material for research and development which do not authorize commercial distribution . Application $5,700 Annual Fee $7,700 Inspection $2,710 3.M Other licenses for possession and use of radioactive material for research and development which do not authorized commercial distribution.

Application $2,500 Annual Fee $3,390 Inspection $1,350 3.N Licenses that authorize services for other licensees, except (1) licenses that authorize calibration and/or leak testing services only are subject to the fees specified in fee category 3.Q, and (2) licensees that authorize waste disposal services are subject to the fees specified in fee Categories 4.A, 4.B., or 4.C.

Application $2,600 Annual Fee $3,690 Inspection $1,590 3.O Licenses for possession and use of radioactive material for industrial radiography operations. Application $4,200 Annual Fee $9,630 Inspection $2,060 3.P Portable gauge radioactive material licensees.

Application $1,300 Annual Fee $1,850 Inspection $1,290 3.Q All other specific radioactive material licensees, except those in fee categories 1, 2, 3.A through 3.P, and 4.A. through 9.D.

Application $1,300 Annual Fee $1,850 Inspection $1,290 CATEGORY 4 - WASTE HANDLERS 4.A Licenses specifically authorizing the receipt of waste byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material from other persons for the purpose of commercial disposal by land burial by the licensee; or licenses authorizing contingency storage of low-level radioactive waste at the site of nuclear power reactors; or licenses for treatment or disposal by incineration and transfer of packages to another person authorized to receive or dispose of waste material.

Annual Fee 9 Not Applicable 9 There are no existing Colorado licenses in these fee categories. Once Colorado issues a license for these categories, the Department will consider establishing an annual fee for that type of license. Licensing and Inspection Full Cost 4.B Licenses specifically authorizing the receipt of waste byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material from other persons for the purpose of packaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material. Application $1,700 Annual Fee $7,540 Inspection $1,940 4.C Licenses specifically authorizing the receipt of prepackaged waste byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material from other persons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material.

Application $2,600 Annual Fee $5,690 Inspection $2,180 CATEGORY 5 - WELL LOGGING 5.A Licenses for possession and use of byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material for well logging, well surveys, and tracer studies other than field.

Application $5,600 Annual Fee $6,770 Inspection $2,180 5.B Licenses for possession and use of byproduct material for field flooding tracer studies. Annual Fee $8,000 Licensing and Inspection Full Cost CATEGORY 6 - NUCLEAR LAUNDRIES 6.A Licenses for commercial collection and laundry of items contaminated with radioactive material, source material, special nuclear material, or naturally occurring and accelerator produced material.

Application $11,500 Annual Fee $13,010 Inspection $3,180 CATEGORY 7 - HUMAN AND VETERINARY USE OF RADIOACTIVE MATERIAL 7.A Licenses issued for human or veterinary use of radioactive material, source material, special nuclear material, or naturally occurring and accelerator produced material in sealed sources contained in teletherapy devices.

Application $6,300 Annual Fee $10,700 Inspection $1,820 7.B Licenses of broad scope issued to medical institutions or two or more physicians or veterinarians authorizing research and development including human and/or veterinary use of radioactive material, source material, special nuclear material, or naturally occurring and accelerator produced material except material in sealed sources.

Application $4,500 Annual Fee $18,630 Inspection $4,890 7.C Other licenses issued for human or veterinary use of radioactive material, source material, and/or naturally occurring and accelerator produced material except material in sealed sources contained in teletherapy devices.

Application $2,200 Annual Fee $3,540 Inspection $1,710 CATEGORY 8- CIVIL DEFENSE 8.A Licenses for possession and use of radioactive material for civil defense activities. Application $330 Annual Fee $840 Inspection $1,410 CATEGORY 9 - DEVICE, PRODUCT, OR SEALED SOURCE SAFETY EVALUATION 9.A Safety evaluation of devices or products containing byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material except reactor fuel devices, for commercial distribution.

Annual Fee $4,460 Licensing and Inspection Full Cost 9.B Safety evaluation of devices or products containing radioactive material, source material, special nuclear material, or naturally occurring and accelerator produced material manufactured in accordance with the unique specifications of, and for use by a single applicant, except reactor fuel devices.

Annual Fee $4,460 Licensing and Inspection Full Cost 9.C Safety evaluation of sealed sources containing byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material, except reactor fuel, for commercial distribution.

Annual Fee $1,300 Licensing and Inspection Full Cost 9.D Safety evaluation of sealed sources containing byproduct material, source material, special nuclear material, or naturally occurring and accelerator produced material, manufactured in accordance with the unique specifications of, and for use by a single applicant, except reactor fuel. Annual Fee $450 Licensing and Inspection Full Cost CATEGORY 10 - TRANSPORTATION OF RADIOACTIVE MATERIAL Note: Colorado does not license this category of license. CATEGORY 11 - REVIEW OF STANDARDIZED SPENT FUEL FACILITIES Note: Colorado does not license this category of license. CATEGORY 12 - SPECIAL PROJECTS 12.A Special Projects and all uses of radioactive material which are not included in any other category. Application Full Cost Annual Fee Full Cost Inspection Full Cost CATEGORY 13 - SPENT FUEL STORAGE COSTS Note: Colorado does not license this category of license. CATEGORY 14 14.A Byproduct material, source material, special nuclear material, naturally occurring or accelerator produced radioactive material licenses and other approvals authorizing decommissioning, decontamination, reclamation or site restoration activities. Annual Fee 10 Not Applicable 10 Licensees in this category are not assessed an annual fee because they are charged an annual fee in other categories while they are licensed to operate.

Licensing and Inspection Full Cost CATEGORY 15 - EMERGENCY RESPONSE 15.A Emergency response requiring over 10 person-hours in any 12 consecutive months. Full Cost 15.B Emergency response planning and exercises.

Full Cost 11 11 Fees will be charged only when service is requested or required by an authorized person outside of the Department who has legal authority to make such requests.

CATEGORY 16 - ANALYTICAL PROCEDURES Full Cost CATEGORY 17 - GENERAL LICENSES 12 12 Fees are for each license at each facility. Fees for general licenses are annual fees, and are due July 1 each year. Non-routine inspections of general licensees related to (1) exposures to individuals; or (2) release of radioactive materials in excess of limits established in Part 4 of these regulations.

17.A Source material, gauges and other similar devices pursuant to 12.5.1.1 through 12.5.1.3. Annual Fee $100 Inspection Full Cost 17.B In-Vitro pursuant to 12.5.1.4.

Annual Fee $50 Inspection Full Cost CATEGORY 18 - LOW-LEVEL RADIOACTIVE WASTE ACCESS APPROVAL Full Cost CATEGORY 19 - HOURLY RATE $85 CATEGORY 20 - TRANSFER OF RECORDS TO DEPARTMENT PURSUANT TO 4.40 THROUGH 4.50 Per box for indexed paper records submitted in state storage boxes $35 For records not indexed and/or requiring repackaging in standard storage boxes Full Cost PART 13 PENALTIES FOR VIOLATIONS RH 13.1 Purpose and Scope 13.1.1 The regulations in this Part set the criteria and specific procedures for notification of violations and the imposition of civil penalties under 25-11-107(5), CRS 1973 as amended. RH 13.2 Definitions 13.2.1 “Civil Penalty” means any monetary penalty levied against a licensee or registrant because of violations of statutes, regulations, licenses, registration provision or order issued thereunder. Civil penalty does not include any criminal penalty levied under 25-1-114 or 25-11-107, C.R.S. 1973 as amended.

13.2.2 “Material False Statement” means a statement that is false by omission or commission and is relevant to the regulatory process.

RH 13.3 Penalties and Severity Levels 13.3.1 Any person who violates any license or registration provision of 25-11-103 or 25-11-104, CRS 1973 as amended, regulation, or any license or registration certificate condition, regulation or order issued thereunder shall be subject to these civil penalty regulations except as provided for under 13.4.

13.3.2 Violations are categorized in six levels of severity to reflect their public health or worker safety or environmental significance. Severity Level I represents the most significant actual or potential hazard; Severity Level VI represents the least significant actual or potential hazard. 13.3.2.1 Examples are provided in Appendix A for determining the appropriate severity level and will be presumptively correct. However, the severity level of a violation will be determined based upon the criteria in 13.3.2, above. The examples are not and do not create new requirements, but are predicated on existing regulatory requirements. 13.3.2.2 For violations not listed in Appendix A, the severity of a violation will be characterized at the severity level best-suited to the significance of the particular violation. RH 13.4 Exemptions 13.4.1 A civil penalty will not generally be assessed for a violation which was unavoidable to prevent loss of life, personal injury or severe property damage or there were no feasible alternatives, and provided that proper notification was provided to the Department. 13.4.2 A civil penalty will not generally be assessed for violations resulting from matters beyond the control of the licensee or registrant, such as equipment failures that were unavoidable by reasonable quality assurance measures or management controls. 13.4.3 A civil penalty will not generally be assessed if interlocks are bypassed for short periods for maintenance or for quality control procedures provided that alternative safety procedures are implemented.

RH 13.5 Notification and Imposition 13.5.1 If the Department has reason to believe, based upon facts available to the Department, that a person has committed any violation of any licensing or registration provision of 25-11-103 or 25- 11-104, CRS 1973 as amended, regulation, any license or registration certificate, or order issued thereunder, it shall notify such person within a reasonable time specifying: 13.5.1.1 The date and factual basis of each act or omission with which such person is charged; 13.5.1.2 The particular provision of the statute, rule, regulation, order, license, or registration certificate violated; and 13.5.1.3 Necessary actions required to bring the licensee or registrant into compliance. 13.5.2 The notification required by RH 13.5.1 shall be sent by the Department by certified or registered mail, return receipt requested, to the last known address of the alleged violator. Any notice may be served by the Department by publication in a newspaper of general circulation in the area of the licensed facility or activity that is the subject of the notice, if the Department's efforts to serve by mail are unsuccessful. Service shall not be incomplete due to any refusal to accept service. 13.5.3 The alleged violator shall have thirty (30) days following the receipt of publication of the notice to submit a written response containing data, views, and arguments concerning the alleged violations and proposing a reasonable time for abatement. In addition, the alleged violator may request an informal conference with Department personnel to discuss the alleged violations. Such conference is to be held within the thirty (30) days allowed for a written response. 13.5.4 Within thirty (30) days after the time allowed for the written response and informal conference, the Department shall issue an order affirming or dismissing or otherwise disposing of the violation and, if the violation is affirmed, setting a time for abatement. 13.5.4.1 The time for abatement shall be that reasonably necessary to achieve compliance given the severity of the violation and the actions necessary to correct the violation. 13.5.4.2 The order may be modified and the time for abatement extended for good cause shown. 13.5.4.3 Immediate abatement may be ordered to the extent necessary to remove an imminent danger to public health, worker safety or the environment. 13.5.5 Any person failing to comply with an order issued pursuant to RH 13.5.4 shall be subject to a civil penalty of not more than five thousand dollars ($5,000.00) for each violation specified in the order.

13.5.5.1 The amount will be based on the following Severity Level Table as adjusted in the discretion of the Department based on consideration of willfulness of the violation and good faith of the alleged violator in achieving compliance, but in no event may the penalty exceed $5,000 for a single violation.

Dollar Amounts of Civil Penalties Severity Level Penalty I $5,000 II $2,500 III $1,250 IV $ 625 V $ 300 VI NONE 13.5.5.2 The Department may compromise, mitigate, or remit any such civil penalty as justified by written documentation.

13.5.6 Upon determining that a person has failed to comply with an order issued pursuant to RH 13.5.4, the Department shall notify the person within ten (10) days by certified or registered mail, return receipt requested, of the proposed amount of any civil penalty. Such person shall have ten (10) days after receipt of the notification of the proposed penalty within which to request, in writing, an informal conference in which all relevant information concerning the violation and penalty, including all information which the alleged violator may submit, shall be reviewed by the alleged violator and an authorized representative of the Department. If such conference is requested, the alleged violator shall provide the Department with all relevant information, in writing, at least three (3) days prior the conference.

13.5.7 Following the conference pursuant to RH 13.5.6, or upon the expiration of time allowed for requesting the conference if no conference is requested, the Department shall either dismiss the penalty or order the penalty fixed and shall cause the order to be served personally on the alleged violator or his designated agent within forty-five (45) days of the mailing of the proposed penalty pursuant to RH 13.5.1. The order shall notify the alleged violator of the right to request a hearing within thirty (30) days, such hearing to be held in accordance with 24-4-105, C.R.S. 1973 as amended, to determine all of the following:

13.5.7.1 Whether the alleged violation exists or did exist; 13.5.7.2 Whether the actions taken or to be taken are or will be adequate to correct the violation; 13.5.7.3 Whether the time set for abatement was reasonable; and 13.5.7.4 Whether the civil penalty is reasonable in light of the statutory criteria upon which it is based.

13.5.8 Upon the request for such a hearing, the order shall be stayed pending the results of the hearing and any subsequent judicial review.

13.5.9 At the request of the Department, the Attorney General may institute a civil action to collect any civil penalty imposed pursuant to these regulations.

APPENDIX A SEVERITY LEVEL EXAMPLES Severity Level I 1. Single exposure of a worker in excess of 25 rem to the whole body, 150 rem to the skin of the whole body, or 375 rem to the hands, forearms, feet or ankles. 2. Annual whole body exposure of a member of the public in excess of 0.5 rem. 3. Release of radioactive material to an uncontrolled area in excess of ten times the limits of RH 4.35.1.2 of these regulations.

4. Exposure of workers in controlled areas in excess of ten times the limits of RH 4.6.1.1 of these regulations.

5. Violation of Department of Transportation (DOT) requirements pursuant to RH 17.15.10 of these regulations resulting in whole body radiation exposure of a member of the public in excess of 0.5 rem.

6. Breach of package integrity resulting in surface contamination or external radiation levels in excess of ten times DOT limits.

7. Radiation levels, contamination levels, or releases that exceed ten times the limits specified in the license.

8. A system designed to prevent or mitigate a serious safety event not being operable when actually required to perform its design function.

9. A Material False Statement in which the statement made was deliberately false. 10. Deliberate action by management to discriminate against an employee for attempting to communicate or actually communicating with the Department as specified in RH 10.5, RH 10.6, and RH 10.7 of these regulations.

Severity Level II 1. Single exposure of a worker in excess of 5 rem to the whole body, 30 rem to the skin of the whole body, or 75 rem to hands, forearms, feet or ankles.

2. Annual whole body exposure of a member of the public in excess of 0.1 rem. 3. Release of radioactive material to an uncontrolled area in excess of five times the limits of RH 4.35.1.2 of these regulations.

4. Failure to make an immediate notification as required by RH 4.35.1.2 of these regulations. 5. Exposure of a worker in controlled areas in excess of five times the limits of RH 4.6.1.1 of these regulations.

6. Exposure of a worker in controlled areas in excess of five times the limits of RH 4.4 of these regulations.

7. Breach of package integrity resulting in surface contamination or external radiation levels in excess of DOT limits.

8. Surface contamination or external radiation levels in excess of three times DOT limits that did not result from a breach of package integrity.

9. Failure to make required initial notifications associated with Severity Level I or II violations. 10. Radiation levels, contamination levels, or releases that exceed five times the limits specified in the license or regulations.

11. A system designed to prevent or mitigate a serious safety event being inoperable. 12. A Material False Statement or a reporting failure, involving information which, had it been available to the Department and accurate at the time the information should have been submitted, would have resulted in the Department seeking further information. 13. A Material False Statement in which the false statement was made with careless disregard. Severity Level III 1. Single exposure of a worker in excess of 3 rem to the whole body, 7.5 rem to the skin of the whole body, or 18.75 rem to the hands, forearms, feet or ankles. 2. A radiation level in an uncontrolled area that exceeds 100 millirem/hour for a one-hour period. 3. Failure to make a 24-hour notification as required by RH 4.52.2 these regulations. 4. Substantial potential for an exposure or release in excess of Part IV of these regulations whether or not such exposure or release occurs.

5. Release of radioactive material to an uncontrolled area in excess of limits of RH 4.35.1.2 these regulations.

6. Improper disposal of licensed material not covered in Severity Levels I or II. 7. Exposure of a worker in controlled areas in excess of limits of RH 4.6.1.1 of these regulations. 8. Release for uncontrolled use of contaminated or radioactive material or equipment which poses a realistic potential for significant exposure to members of the public, or which reflects a programmatic (rather than isolated) weakness in the radiation control program. 9. Cumulative worker exposure above regulatory limits when such cumulative exposure reflects a programmatic rather that an isolated weakness in radiation protection. 10. Conduct of activities by a technically unqualified person. 11. Significant failure to control licensed material.

12. Breach of package integrity.

13. Surface contamination or external radiation levels in excess of, but less than a factor of three above DOT requirements, that did not result from a breach of transport container. 14. Any noncompliance with labeling, placarding, shipping paper, packaging, loading or other requirements that could reasonably result in the following: a. Improper identifications of the type, quantity, or form of material. b. Failure of the carrier or recipient to exercise adequate controls. c. Substantial potential for personnel exposure or contamination, or improper transfer of material. 15. Failure to control access to licensed materials for radiation purposes as specified by Department regulations, license conditions and orders.

16. Possession or use of unauthorized materials or equipment in the conduct of licensee activities. 17. Use of radioactive material on humans where such use is not authorized. 18. Radiation levels, contamination levels, or releases that exceed the limits specified in the license or regulations.

19. Medical therapeutic misadministrations.

20. A Material False Statement not amounting to a Severity Level I or II Violation. Severity Level IV 1. Exposure in excess of the limits of Part 4 of these regulations not constituting Severity Level I, II, or III violations.

2. A radiation level in an uncontrolled area such that an individual could receive greater than 2 millirem in a one hour period or 100 millirem in any seven consecutive days. 3. Failure to make a 30-day notification as required by RH 4.53.1 of these regulations. 4. Failure to make a written report as required by RH 4.54 or 4.59 of these regulations. 5. Package selection or preparation which does not meet DOT requirements, but does not result in a breach of package integrity or surface contamination or external radiation levels in excess of DOT requirements.

6. Failure to maintain patients hospitalized who have had cobalt-60, cesium-137, or iridium-192 implants. 7. Medical diagnostic misadministrations.

8. Failure to conduct required leakage or contamination tests. 9. Failure to use properly calibrated equipment.

10. Other violations that have more than minor safety or environmental significance. Severity Level V 1. Public health or worker safety or environmental items of minor significance. Severity Level VI 1. No public health or worker safety or environmental items of significance. PART 14 LICENSING REQUIREMENTS FOR LAND DISPOSAL OF LOW LEVEL RADIOACTIVE WASTE General Provisions RH 14.1 Purpose and Scope.

14.1.1 The regulations in this part establish procedures, criteria, and terms and conditions upon which the Department issues licenses for the land disposal of low-level radioactive wastes received from other persons. The requirements of this part are in addition to, and not in substitution for, other applicable requirements of these regulations.

14.1.2 The regulations in this part do not apply to disposal of byproduct material as defined in the second definition of “byproduct material” in RH 1.4 of these regulations in quantities greater than 10,000 kilograms containing more than 185 MBq (5 millicuries) of radium-226, or disposal of waste as provided for in Part 4 of these regulations.

14.1.3 This part establishes procedural requirements and performance objectives applicable to any method of land disposal. It establishes specific technical requirements for near-surface disposal of low-level radioactive waste which involves disposal in the uppermost portion of the earth, approximately 30 meters. Burial deeper than 30 meters may also be satisfactory. RH 14.2 Definitions.

As used in this part, the following definitions apply:

“Active maintenance” means any significant activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in RH 14.18 and 14.19 are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass. “Buffer zone” means a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site. “Chelating agent” means amine polycarboxylic acids, hydroxy-carboxylic acids, gluconic acid and polycarboxylic acids.

“Commencement of construction” means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values. “Custodial Agency” means an agency of the government designated to act on behalf of the federal or state government owner of the disposal site. “Disposal” means the isolation of radioactive wastes from the biosphere inhabited by man and his food chains by emplacement in a land disposal facility with no intention of retrieval. “Disposal site” means that portion of a land disposal facility which is used for disposal of waste. It consists of disposal units and a buffer zone.

“Disposal unit” means a discrete portion of the disposal site into which waste is placed for disposal. For near-surface disposal the unit is usually a trench. “Engineered barrier” means a man-made structure or device that is intended to improve the land disposal facility's ability to meet the performance objectives in this part. “Explosive material” means any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

“Hazardous waste” means those wastes designated as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR Part 261.

“Hydrogeologic unit” means any soil or rock unit or zone which by virtue of its porosity or permeability, or lack thereof, has a distinct influence on the storage or movement of groundwater. “Inadvertent intruder” means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling construction, or other pursuits in which an individual might be unknowingly exposed to radiation from the waste. “Intruder barrier” means a sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in this part, or engineered structures that provide equivalent protection to the inadvertent intruder.

“Land disposal facility” means the land, buildings and structures, and equipment which are intended to be used for the disposal of low-level radioactive wastes. “Monitoring” means observing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

“Near-surface disposal facility” means a land disposal facility in which low-level radioactive waste is disposed of within approximately the upper 30 meters of the earth's surface. “Pyrophoric liquid” means any liquid that ignites spontaneously in dry or moist air at or below 130 F (54.4 C).

“Pyrophoric solid” means any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

“Site closure and stabilization” means those actions that are taken upon completion of operations that prepare the disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

“Stability” means structural stability.

“Surveillance” means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

“Waste” means radioactive waste other than:

1. Waste generated as a result of the defense activities of the federal government or federal research and development activities;

2. High-level waste such as irradiated reactor fuel, liquid waste from reprocessing irradiated reactor fuel, or solids into which any such liquid waste has been converted; 3. Waste material containing transuranic elements with contamination levels greater than one hundred nanocuries (3700 Bq) per gram of material;

4. Byproduct material as defined in Section 11.e.(2) of the “Atomic Energy Act of 1954”, as amended on November 8, 1978;* or *The disposal of these materials are licensed under Part III of the regulations. 5. Waste from mining, milling, smelting, or similar processing of ores and mineral-bearing material primarily for minerals other than radium;* *The disposal of these materials are licensed under Part III of the regulations. RH 14.3 License Required.

14.3.1 No person may receive, possess, and dispose of waste received from other persons at a land disposal facility unless authorized by a license issued by the Department pursuant to this part, and Part III of these regulations.

14.3.2 Each person shall file an application with the Department pursuant to RH 3.8 of these regulations and obtain a license as provided in this part before commencement of construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license. RH 14.4 Reserved RH 14.5 Content of Application.

In addition to the requirements set forth in RH 3.9 of these regulations, an application to receive from others, possess and dispose of wastes shall consist of general information, specific technical information, institutional information, and financial information as set forth in RH 14.6 through 14.10. 14.5.1 The licensee shall submit written statements under oath upon request of the Department, to enable the Department to determine the qualifications of individuals, the status of site operators, and whether or not additional actions at the site might be warranted. RH 14.6 General Information.

The general information shall include each of the following: 14.6.1 Identity of the applicant including:

14.6.1.1 The full name, address, telephone number and description of the business or occupation of the applicant;

14.6.1.2 If the applicant is a partnership, the name and address of each partner and the principal location where the partnership does business;

14.6.1.3 If the applicant is a corporation or an unincorporated association, (i) the state where it is incorporated or organized and the principal location where it does business, and (ii) the names and addresses of its directors and principal officers; and 14.6.1.4 If the applicant is acting as an agent or representative of another person in filing the application, all information required under 14.6.1 must be supplied with respect to the other person.

14.6.2 Qualifications of the applicant:

14.6.2.1 The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise; 14.6.2.2 The technical qualifications, including training and experience, of the applicant and members of the applicant's staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling key positions described in 14.6.2.1 must be provided.

14.6.2.3 A description of the applicant's personnel training program; and 14.6.2.4 The plan to maintain an adequate complement of trained personnel to carry out waste receipt, handling, and disposal operations in a safe manner. 14.6.3 A description of:

14.6.3.1 The location of the proposed disposal site;

14.6.3.2 The general character of the proposed activities; 14.6.3.3 The types and quantities of waste to be received, possessed, and disposed of; 14.6.3.4 Plans for use of the land disposal facility for purposes other than disposal of wastes; and 14.6.3.5 The proposed facilities and equipment.

14.6.4 Proposed schedules for construction, receipt of waste, and first emplacement of waste at the proposed land disposal facility.

RH 14.7 Specific Technical Information.

The specific technical information shall include the following information needed for demonstration that the performance objectives and the applicable technical requirements of this part will be met: 14.7.1 A description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description shall include, but not be limited to, geologic, geotechnical, geochemical, ecologic, archeological, hydrologic, meteorologic, climatologic, and biotic features of the disposal site and vicinity. 14.7.2 A description of the design features of the land disposal facility and the disposal units. For near- surface disposal, the description shall include those design features related to infiltration of water; integrity of covers for disposal units; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicable of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

14.7.3 A description of the principal design criteria and their relationship to the performance objectives. 14.7.4 A description of the design basis natural events or phenomena and their relationship to the principal design criteria.

14.7.5 A description of codes and standards which the applicant has applied to the design and which will apply to construction of the land disposal facilities.

14.7.6 A description of the construction and operation of the land disposal facility. The description shall include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes. The description shall also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other non-radiological substances that might affect meeting the performance objectives of this part.

14.7.7 A description of the disposal site closure plan, including those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance. 14.7.8 An identification of the known natural resources at the disposal site, whose exploitation could result in inadvertent intrusion into the waste after removal of active institutional control. 14.7.9 A description of the kind, amount, classification and specifications of the radioactive materials proposed to be received, possessed, and disposed of at the land disposal facility. 14.7.10 A description of the quality assurance program developed and applied by the applicant for the determination of natural disposal site characteristics and for quality control during the design, construction, operation and closure of the land disposal facility and the receipt, handling, and emplacement of waste. Audits and managerial controls must be included. 14.7.11 A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the performance objective in RH 14.19 and occupational radiation exposure to ensure compliance with the requirements of Part IV of these regulations and to control contamination of personnel, vehicles, equipment, buildings, and the disposal site. Both routine operations and accidents shall be addressed. The program description must include procedures, instrumentation, facilities, and equipment. 14.7.12 A description of the environmental monitoring program to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration is indicated.

14.7.13 A description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

14.7.14 A description of the facility electronic recordkeeping system as required in RH 14.33. RH 14.8 Technical Analyses.

The specific technical information shall also include the following analyses needed to demonstrate that the performance objectives of this part will be met:

14.8.1 Pathways analyzed in demonstrating protection of the general population from releases of radioactivity shall include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses shall clearly demonstrate that there is reasonable assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in RH 14.19.

14.8.2 Analyses of the protection of individuals from inadvertent intrusion shall include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided. 14.8.3 Analyses of the protection of individuals during operations shall include assessments of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses shall provide reasonable assurance that exposures will be controlled to meet the requirements of Part IV of these regulations.

14.8.4 Analyses of the long-term stability of the disposal site and the need for ongoing active maintenance after closure shall be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses shall provide reasonable assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

RH 14.9 Institutional Information.

The institutional information submitted by the applicant shall include: 14.9.1 A certification by the federal or state custodial agency which owns the disposal site that the federal or state agency is prepared to accept transfer of the license when the provisions of RH 14.16 are met, and will assume responsibility for institutional control after site closure and postclosure observation and maintenance.

14.9.2 Where the proposed disposal site is on land not owned by the federal or a state government, the applicant shall submit evidence that arrangements have been made for assumption of ownership in fee by the federal or a state agency before the Department issues a license. RH 14.10 Financial Information.

The financial information shall be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements of this part.

RH 14.11 Requirements for Issuance of a License.

A license for the receipt, possession, and disposal of waste containing or contaminated with radioactive material will be issued by the Department upon finding that: 14.11.1 The issuance of the license will not constitute an unreasonable risk to the health and safety of the public;

14.11.2 The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property; 14.11.3 The applicant's proposed disposal site, disposal design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and postclosure institutional control are adequate to protect the public health and safety in that they provide reasonable assurance that the general population will be protected from releases of radioactivity as specified in the performance objective in RH 14.19;

14.11.4 The applicant's proposed disposal site, disposal site design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and postclosure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that individual inadvertent intruders are protected in accordance with the performance objective in RH 14.20;

14.11.5 The applicant's proposed land disposal facility operations, including equipment, facilities, and procedures, are adequate to protect the public health and safety in that they will provide reasonable assurance that the standards for radiation protection set out in Part IV of these regulations will be met;

14.11.6 The applicant's proposed disposal site, disposal site design, land disposal facility operations, disposal site closure, and postclosure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that long-term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing active maintenance of the disposal site following closure; 14.11.7 The applicant's demonstration provides reasonable assurance that the applicable technical requirements of this part will be met;

14.11.8 The applicant's proposal for institutional control provides reasonable assurance that such control will be provided for the length of time found necessary to ensure the findings in RH 14.11.3 through 14.11.6 and that the institutional control meets the requirements of 14.28; and 14.11.9 The financial or surety arrangement meets the requirements of this part. RH 14.12 Conditions of Licensure.

14.12.1 A license issued under these regulations for the purpose of near-surface land disposal of low- level radioactive wastes, or any right thereunder, may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, only if the Department finds, after securing full information, that the transfer is in accordance with the provisions of the Act and gives its consent in writing in the form of a license amendment.

14.12.2 The license will be terminated only on the full implementation of the final closure plan as approved by the Department, including postclosure observation and maintenance. 14.12.3 The licensee shall be subject to the provisions of the Act now or hereafter in effect, and to all rules, regulations, and orders of the Department. The terms and conditions of the license are subject to amendment, revision, or modification, by reason of amendments to, or by reason of rules, regulations, and orders issued in accordance with the terms of the Act. 14.12.4 Each person licensed by the Department pursuant to the regulations in this part shall confine possession and use of materials to the locations and purposes authorized in the license. 14.12.5 The licensee shall not dispose of waste until the Department has inspected the land disposal facility and has found it to be in conformance with the description, design, and construction described in the application for a license.

14.12.6 The Department may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, additional requirements and conditions with respect to the licensee's receipt, possession, and disposal of waste as it deems appropriate or necessary in order to:

14.12.6.1 Protect health or to minimize danger to life or property; 14.12.6.2 Require reports and the keeping of records, and to provide for inspections of activities under the license that may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

14.12.7 The authority to dispose of wastes expires on the date stated in the license. Any expiration date on a license applies only to the above ground activities and to the authority to dispose of waste. Failure to renew the license shall not relieve the licensee of responsibility for carrying out site closure, postclosure observation and transfer of the license to the site owner. RH 14.13 Application for Renewal or Closure.

14.13.1 An application for renewal, or an application for closure under RH 14 must be filed at least one year prior to license expiration.

14.13.2 Applications for renewal of a license must be filed in accordance with RH 14.5 through 14.10. Applications for closure must be filed in accordance with RH 14.14. Information contained in previous applications, statements or reports filed with the Department under the license may be incorporated by reference if the references are clear and specific. 14.13.3 In any case in which a licensee has filed an application in proper form for renewal of a license, the license does not expire until the Department has taken final action on the application for renewal.

14.13.4 In determining whether a license will be renewed, the Department will apply the criteria set forth in RH 14.11.

RH 14.14 Contents of Application for Site Closure and Stabilization. 14.14.1 Prior to final closure of the disposal site, or as otherwise directed by the Department, the applicant shall submit an application to amend the license for closure. This closure application shall include a final revision and specific details of the disposal site closure plan included as part of the license application submitted under RH 14.7.8 that includes each of the following: 14.14.1.1 Any additional geologic, hydrologic, or other data pertinent to the long-term containment of emplaced wastes obtained during the operational period. 14.14.1.2 The results of tests, experiments, or any other analyses relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments, or analysis pertinent to the long-term containment of emplaced waste within the disposal site.

14.14.1.3 Any proposed revision of plans for:

14.14.1.3.1 Decontamination and/or dismantlement of surface facilities; 14.14.1.3.2 Backfilling of excavated areas; or 14.14.1.3.3 Stabilization of the disposal site for post closure care. 14.14.1.4 Any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

14.14.2 Upon review and consideration of an application to amend the license for closure submitted in accordance with RH 14.14.1, the Department shall issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives of this part will be met. RH 14.15 Post-Closure Observation and Maintenance.

The licensee shall observe, monitor, and carry out necessary maintenance and repairs at the disposal site until the site closure is complete and the license is transferred by the Department in accordance with RH 14.16. Responsibility for the disposal site must be maintained by the licensee for 5 years following closure. A shorter or longer time period for post-closure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions. RH 14.16 Transfer of License.

Following closure and the period of post-closure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license shall be transferred when the Department finds:

14.16.1 That the closure of the disposal site has been made in conformance with the licensee's disposal site closure plan, as amended and approved as part of the license; 14.16.2 That reasonable assurance has been provided by the licensee that the performance objectives of this part are met;

14.16.3 That any funds and necessary records for care will be transferred to the disposal site owner; 14.16.4 That the post-closure monitoring program is operational for implementation by the disposal site owner; and 14.16.5 That the federal or state agency which will assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional requirements found necessary under RH 14.11.8 will be met.

RH 14.17 Termination of License.

14.17.1 Following any period of institutional control needed to meet the requirements found necessary under RH 14.11, the licensee may apply for an amendment to terminate the license. 14.17.2 This application will be reviewed in accordance with the provisions of RH 3.8 of these regulations.

14.17.3 A license shall be terminated only when the Department finds: 14.17.3.1 That the institutional control requirements found necessary under RH 14.11.8 have been met;

14.17.3.2 That any additional requirements resulting from new information developed during the institutional control period have been met; and 14.17.3.3 That permanent monuments or markers warning against intrusion have been installed. Performance Objectives RH 14.18 General Requirement.

Land disposal facilities shall be sited, designed, operated, closed, and controlled after closure so that reasonable assurance exists that exposures to individuals are within the requirements established in the performance objectives in RH 14.19 through 14.22.

RH 14.19 Protection of the General Population from Releases of Radioactivity. Concentrations of radioactive material which may be released to the general environment in ground water, surface water, air, soil, plants, or animals shall not result in an annual dose exceeding an equivalent of 25 millirems (0.25 mSv) to the whole body, 75 millirems (0.75 mSv) to the thyroid, and 25 millirems (0.25 mSv) to any other organ of any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

RH 14.20 Protection of Individuals from Inadvertent Intrusion. Design, operation, and closure of the land disposal facility shall ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after active institutional controls over the disposal site are removed. RH 14.21 Protection of Individuals During Operations.

Operations at the land disposal facility shall be conducted in compliance with the standards for radiation protection set out in Part IV of these regulations, except for releases of radioactivity in effluents from the land disposal facility, which shall be governed by RH 14.19. Every reasonable effort should be made to maintain radiation exposures as low as is reasonably achievable. RH 14.22 Stability of the Disposal Site After Closure.

The disposal facility shall be sited, designed, used, operated, and closed to achieve long-term stability of the disposal site and to eliminate, to the extent practicable, the need for ongoing active maintenance of the disposal site following closure so that only surveillance, monitoring, or minor custodial care are required.

Technical Requirements for Land Disposal Facilities RH 14.23 Disposal Site Suitability Requirements for Land Disposal. 14.23.1 Disposal Site Suitability for Near-Surface Disposal. The primary emphasis in near-surface disposal site suitability is given to isolation of wastes, and to the disposal site features that ensure that the long-term performance objectives are met.

14.23.1.1 The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

14.23.1.2 Within the region where the facility is to be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this part. 14.23.1.3 Areas shall be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of this part. 14.23.1.4 The disposal site shall be generally well drained and free of areas of flooding or frequent ponding. Waste disposal shall not take place in a 100-year flood plain, coastal high-hazard area or wetland, as defined in Executive Order 11988, “Floodplain Management Guidelines.”

14.23.1.5 Upstream drainage areas shall be minimized to decrease the amount of runoff which could erode or inundate waste disposal units.

14.23.1.6 The disposal site shall provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur. The Department will consider an exception to this requirement to allow disposal below the water table if it can be conclusively shown that disposal site characteristics will result in molecular diffusion being the predominant means of radionuclide movement and the rate of movement will result in the performance objectives being met. In no case will waste disposal be permitted in the zone of fluctuation of the water table. 14.23.1.7 The hydrogeologic unit used for disposal shall not discharge ground water to the surface within the disposal site.

14.23.1.8 Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanism may occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part or may preclude defensible modeling and prediction of long-term impacts. 14.23.1.9 Areas shall be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding, or weathering occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part, or may preclude defensible modeling and prediction of long-term impacts. 14.23.1.10 The disposal site must not be located where nearby facilities or activities could adversely impact the ability of the site to meet the performance objectives of this part or significantly mask the environmental monitoring program. 14.23.2 Reserved RH 14.24 Disposal Site Design for Land Disposal.

14.24.1 Disposal Site Design for Near-Surface Disposal. 14.24.1.1 Site design features shall be directed toward long-term isolation and avoidance of the need for continuing active maintenance after site closure.

14.24.1.2 The disposal site design and operation shall be compatible with the disposal site closure and stabilization plan and lead to disposal site closure that provides reasonable assurance that the performance objectives will be met.

14.24.1.3 The disposal site shall be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives will be met. 14.24.1.4 Covers shall be designed to minimize to the extent practicable water infiltration, to direct percolating or surface water away from the disposed waste, and to resist degredation by surface geologic processes and biotic activity.

14.24.1.5 Surface features shall direct surface water drainage away from disposal units at velocities and gradients which will not result in erosion that will require ongoing active maintenance in the future. 14.24.1.6 The disposal site shall be designed to minimize to the extent practicable the contact of water with waste during storage, the contact of standing water with waste during disposal, and the contact of percolating or standing water with wastes after disposal. 14.24.2 Reserved RH 14.25 Land Disposal Facility Operation and Disposal Site Closure. 14.25.1 Near-Surface Disposal Facility Operation and Disposal Site Closure. 14.25.1.1 Wastes designated as Class A pursuant to Part 4, Appendix E of these regulations shall be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives of this part. This segregation is not necessary for Class A wastes if they meet the stability requirements in Part 4, Appendix E, II(b) of these regulations.

14.25.1.2 Wastes designated as Class C pursuant to Part 4, Appendix E of these regulations shall be disposed of so that the top of the waste is a minimum of sixteen feet (5 meters) below the top surface of the cover or must be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least 500 years. 14.25.1.3 Except as provided in RH 14.25.1.12 only waste classified as Class A, B, or C shall be acceptable for near-surface disposal. All waste shall be disposed of in accordance with requirements of RH 14.25.1.4 through 14.25.1.11.

14.25.1.4 Wastes shall be emplaced in a manner that maintains the package integrity during emplacement, minimizes the void spaces between packages, and permits the void spaces to be filled.

14.25.1.5 Void spaces between waste packages shall be filled with earth or other material to reduce future subsidence witnin the fill.

14.25.1.6 Waste shall be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of RH 4.15.2.2 of these regulations at the time the license is transferred pursuant to RH 14.16.

14.25.1.7 The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Near-surface disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, shall be established on the site to facilitate surveys. The USGS or NGS control stations shall provide horizontal and vertical controls as checked against USGS or NGS record files.

14.25.1.8 A buffer zone of land shall be maintained between any buried waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in RH 14.26.4 and take mitigative measures if needed.

14.25.1.9 Closure and stabilization measures as set forth in the approved site closure plan shall be carried out as each disposal unit is filled and covered. 14.25.1.10 Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

14.25.1.11 Only wastes containing or contaminated with radioactive material shall be disposed of at the disposal site.

14.25.1.12 Proposals for disposal of waste that is not generally acceptable for near-surface disposal because the waste form and disposal methods must be different, and in general more stringent than those specified for Class C waste may be submitted to the Department for approval. 14.25.2 Reserved RH 14.26 Environmental Monitoring.

14.26.1 At the time a license application is submitted, the applicant shall have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, geology, geochemistry, and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a twelve month period. 14.26.2 During the land disposal facility site construction and operation, the licensee shall maintain an environmental monitoring program. Measurements and observations must be made and recorded to provide data to evaluate the potential health and environmental impacts during both the construction and the operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system must be capable of providing early warning of releases of waste from the disposal site before they leave the site boundary. 14.26.3 After the disposal site is closed, the licensee responsible for post-operational surveillance of the disposal site shall maintain a monitoring system based on the operating history and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of waste from the disposal site before they leave the site boundary. 14.26.4 The licensee shall have plans for taking corrective measures if the environmental monitoring program detects migration of waste which would indicate that the performance objectives may not be met.

RH 14.27 Alternative Requirements for Design and Operations. The Department may, upon request or on its own initiative, authorize provisions other than those set forth in RH 14.24 through 14.26 for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if it finds reasonable assurance of compliance with the performance objectives of this part.

RH 14.28 Institutional Requirements.

14.28.1 Land Ownership.

Disposal of waste received from other persons may be permitted only on land owned in fee by the federal or a state government.

14.28.2 Institutional Control.

The land owner or custodial agency shall conduct an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program shall also include, but not be limited to, conducting an environmental monitoring program at the disposal site, periodic surveillance, minor custodial and other requirements as determined by the Department; and administration of funds to cover the costs for these activites. The period of controls will be determined by the Department, but controls may not be relied upon for more than 100 years following transfer of control of the disposal site to the owner. RH 14.29 Alternative Requirements for Waste Classification and Characteristics. The Department may, upon request or on its own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation of the specific characteristics of the waste, disposal site, method of disposal, it finds reasonable assurance of compliance with the performance objectives specified in this part.

Financial Assurances RH 14.30 Applicant Qualifications and Assurances.

Each applicant shall show that it either possesses the necessary funds or has reasonable assurance of obtaining the necessary funds, or by a combination of the two, to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and disposal.

RH 14.31 Funding for Disposal Site Closure and Stabilization. 14.31.1 The applicant shall provide assurances prior to the commencement of operations that sufficient funds will be available to carry out disposal site closure and stabilization, including: (1) decontamination or dismantlement of land disposal facility structures; and (2) closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner, the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance, and monitoring are required. These assurances shall be based on Department-approved cost estimates reflecting the Department-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

14.31.2 In order to avoid unnecessary duplication and expense, the Department will accept financial sureties that have been consolidated with earmarked financial or surety arrangements established to meet requirements of federal or other state agencies for such decontamination, closure and stabilization. The Department will accept these arrangements only if they are considered adequate to satisfy the requirements of RH 14.31 and that the portion of the surety which covers the closure of the disposal site is clearly identified and committed for use in accomplishing these activities.

14.31.3 The licensee's financial surety arrangement shall be submitted annually for review by the Department to assure that sufficient funds will be available for completion of the closure plan. 14.31.4 The amount of the licensee's financial surety arrangement shall change in accordance with changes in predicted costs of closure and stabilization. Factors affecting closure and stabilization cost estimates include: inflation, increases in the amount of disturbed land, changes in engineering plans, closure and stabilization that has already been accomplished, and any other conditions affecting costs. The financial or surety arrangement shall be sufficient at all times to cover the costs of closure and stabilization of the disposal units that are expected to be used before the next license renewal.

14.31.5 The financial or surety arrangement shall be written for a specified period of time and shall be automatically renewed unless the person who issues the surety notifies the Department, the beneficiary (the site owner), and the principal (the licensee) not less than 90 days prior to the renewal date of its intention not to renew. In such a situation the licensee must submit a replacement surety within 30 days after notification of cancellation. If the licensee fails to provide a replacement acceptable to the Department, the beneficiary may collect on the original surety arrangement.

14.31.6 Proof of forfeiture shall not be necessary to collect the surety so that in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above shall be clearly stated on any surety instrument.

14.31.7 Financial or surety arrangements generally acceptable to the Department include: surety bonds, cash deposits, certificates of deposit, deposits of government securities, escrow accounts, irrevocable letters or lines of credit, trust funds, and combinations of the above or such other types of arrangements as may be approved by the Department. Self-insurance, or any arrangement which essentially constitutes self-insurance shall not satisfy the surety requirement for private sector applicants.

14.31.8 The licensee's financial surety arrangement shall remain in effect until the closure and stabilization program has been completed and approved by the Department, and the license has been transferred to the site owner.

RH 14.32 Financial assurances for institutional controls. 14.32.1 Prior to the issuance of the license, the applicant shall provide a binding arrangement for Department approval, between the applicant and the disposal site owner that ensures that sufficient funds will be available to cover the costs of monitoring and any required maintenance during the institutional control period. The binding arrangement shall be reviewed annually by the Department to ensure that changes in inflation, technology, and disposal facility operations are reflected in the arrangements.

14.32.2 Subsequent changes to the binding arrangement specified in RH 14.32.1 relevant to institutional control shall have prior approval by the Department.

Records, Reports, Tests, and Inspections RH 14.33 Maintenance of Records, Reports, and Transfers. 14.33.1 Each licensee shall maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the Department.

14.33.2 Records which are required by these regulations or by license conditions shall be maintained for a period specified by the appropriate regulations or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in RH 14.33.4 as a condition of license termination unless the Department otherwise authorizes their disposition.

14.33.3 Records which shall be maintained pursuant to this part may be the original or a reproduced copy or microfilm if this reproduced copy or microfilm is capable of producing copy that is clear and legible at the end of the required retention period. 14.33.4 Notwithstanding RH 14.33.1 through 14.33.3, copies of records of the location and the quantity of wastes contained in the disposal site must be transferred upon license termination to the chief executive of the nearest municipality, the chief executive of the county in which the facility is located, the county zoning board or land development and planning agency, the state governor and other local, state and federal governmental agencies as designated by the Department at the time of license termination.

14.33.5 Following receipt and acceptance of a shipment of radioactive waste, the licensee shall record the date that the shipment is received at the disposal facility, the date of disposal of the waste, a traceable shipment manifest number, a description of any engineered barrier or structural overpack provided for the disposal of the waste, the location of disposal at the disposal site, the containment integrity of the waste disposal containers as received, any discrepancies between materials listed on the manifest and those received, the volume of any pallets, bracing, or other shipping or onsite generated materials that are contaminated, and are disposed of as contaminated or suspect materials, and any evidence of leaking or damaged disposal containers or radiation or contamination levels in excess of limits specified in the U.S. Department of Transportation and Department regulations. The licensee shall briefly describe any repackaging operations of any of the disposal containers included in the shipment, plus any other information required by the Department as a license condition. The licensee shall retain these records in accordance with RH 3.15.4 until the license that authorizes the activities described in this section is transferred or terminated.

14.33.6 Each licensee authorized to dispose of waste received from other persons shall file a copy of its financial report or a certified financial statement annually with the Department in order to update the information base for determining financial qualifications. 14.33.7 Annual Reports.

14.33.7.1 Each licensee authorized to dispose of waste received from other persons, pursuant to this part, shall submit annual reports to the Department. Reports shall be submitted by the end of the first calendar quarter of each year for the preceeding year. 14.33.7.2 The reports shall include:

14.33.7.2.1 specification of the quantity of each of the principal contaminants released to unrestricted areas in liquid and in airborne effluents during the preceeding year, 14.33.7.2.2 the results of the environmental monitoring program, 14.33.7.2.3 a summary of licensee disposal unit survey and maintenance activities, 14.33.7.2.4 a summary, by waste class, of activities and quantities of radionuclides disposed of, 14.33.7.2.5 any instances in which observed site characteristics were significantly different from those described in the application for a license, and 14.33.7.2.6 any other information the Department may require. 14.33.7.3 If the quantities of waste released during the reporting period, monitoring results, or maintenance performed are significantly different from those predicted, the report must cover this specifically.

14.33.8 In addition to the other requirements of this section, the licensee shall store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system.

14.33.8.1 The manifest information that must be electronically stored is: 14.33.8.1.1 That required in Appendix G of Part 4, with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; 14.33.8.1.2 That information required in RH 14.33.5.

14.33.8.2 As specified in facility license conditions, the licensee shall report the stored information, or subsets of this information, on a computer readable medium. RH 14.34 Tests on Land Disposal Facilities.

Each licensee shall perform, or permit the Department to perform, any tests the Department deems appropriate or necessary for the administration of the regulations in this part, including, but not limited to, tests of:

14.34.1 Wastes;

14.34.2 Facilities used for the receipt, storage, treatment, handling or disposal of wastes; 14.34.3 Radiation detection and monitoring instruments; and 14.34.4 Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage, or disposal of waste.

RH 14.35 Agency Inspections of Land Disposal Facilities. 14.35.1 Each licensee shall afford to the Department at all reasonable times opportunity to inspect radioactive waste not yet disposed of, and the premises, equipment, operations, and facilities in which wastes are received, possessed, handled, treated, stored, or disposed. 14.35.2 Each licensee shall make available to the Department for inspection, upon reasonable notice, records kept by it pursuant to these regulations. Authorized representatives of the Department may copy and take away copies of, for the Department's use, any record required to be kept pursuant to these regulations.

PART XV COLORADO LOW-LEVEL RADIOACTIVE WASTE RATE REGULATIONS RH 15.1 Authority.

These regulations are promulgated in accordance with 24-60-2212 C.R.S. 1982. In the event of conflict between these rules and 24-60-2212, C.R.S. 1982, the latter shall control. RH 15.2 Basis and Purpose.

The basis and purpose of these regulations is to achieve, in the application of these regulations pursuant to the requirements stated herein, just and reasonable rates for the management of low-leves radioactive waste at facilities. The regulations are intended to effect the legislative intent of Section 24-60-2212, C.R.S. 1982, prescribing the powers and duties of the Board of Health as the designated agency responsible for regulating low-level radioactive waste management charges at facilities in the State. The rationale for these regulations as promulgated herein is to establish a regulatory scheme based upon that employed for the regulation of public utilities rates.

RH 15.3 Amendment of Rules.

These rules may be amended at any time by the Board of Health as provided by law. RH 15.3 Definitions.

As used in these rules, the following words shall have meaning indicated unless context otherwise requires.

“Board” means Board of Health of the State of Colorado. “Closure” means those actions that are taken upon completion of operations to prepare the facility for custodial care and that assure that the facility will remain stable and will not need ongoing active maintenance as defined in RH 14.2.

“Facility” means a low-level radioactive waste facility capable of serving as a regional disposal or management site in compliance with all pertinent federal and state laws and rules and regulations and which also complies with the provisions of the “Rocky Mountain Low-Level Radioactive Waste Compact” set forth in 24-60-2212, C.R.S. 1982 “Management” means collection, consolidation, storage, treatment, incineration or disposal. “Normalization” is the requirement that a company reflect in its financial accounting income statement a deferred tax so that the entire federal income tax is equal to that which the company normally would have had to pay if it had chosen to use straight-line depreciation for tax purposes as well as for financial accounting.

“Reasonable cost” means a cost which in its nature or amount does not exceed that which would be incurred by a prudent person under the circumstances prevailing at the time the decision was made to incur the cost.

“Straight-line basis” is the distribution of the depreciable cost of an asset in equal amounts over its useful life.

Rate Review and Approval Process RH 15.5 The licensee shall establish a schedule of rates for the management of low-level radioactive waste subject to approval by the Board, pursuant to 24-60-2212(3)(2), C.R.S. 1982 and in accordance with the procedures set forth in these regulations as follows: 15.5.1 The licensee shall file with the Board, at least sixty days prior to the proposed effective date, proposed schedules showing all rates, charges, and classifications collected or enforced or to be collected or enforced, and a filing fee in the amount of $1000. Such rates, when effective, shall be posted and open to public inspection at the facility. 15.5.2 Within ten (10) days of receipt, the Board shall make available for public inspection the filing and supporting information and provide reasonable public notice thereof. 15.5.3 Unless the Board otherwise orders, no change shall be made in any rate, charge, or classification collected or enforced or to be collected or enforced by a facility except after sixty days of filing with the Board. All filings shall be kept open for public inspection with new schedules stating plainly the changes to be made in the schedules then in force and the time when the changes will go into effect.

15.5.4 The Board shall not approve or disapprove a filing without a public hearing. If the Board does not disapprove or schedule a hearing on a filing within sixty (60) days of receipt by the Board, the filing shall automatically become effective. 15.5.5 During the sixty-day (60) review period, the Board may conclude that it is in the public interest to hold a public hearing, or any interested person may request a public hearing by written petition to the Board.

15.5.6 Whenever the Board after a hearing upon its own motion or upon petition finds, based upon the record and investigation by the Board, that the rates or charges, enforced or to be enforced by any facility are unjust, unreasonable, discriminatory, or violative of any provision of law or that such rates, charges, or classifications are insufficient, the Board shall determine the just, reasonable, or sufficient rates, charges, classifications, rules, regulations, or practices to be thereafter observed and in force and shall fix the same by order of the Board.

15.5.7 The Board has the authority, after a hearing upon its own motion or upon complaint, to investigate a single rate, charge, classification, or practice of any facility and to establish new rates, charges, classifications or practices in lieu thereof. 15.5.8 Within ten (10) days of Board approval of the rate schedules or within 10 days after becoming automatically effective, the rate schedules shall be forwarded to the Rocky Mountain Low-Level Radioactive Waste Board for approval pursuant to 24-60-2212, (3) (D), C.R.S. 1982.

RH 15.6 The rates for managing low-level radioactive waste at facilities shall remain in effect until modified by the Board upon application by the licensee or upon the Board's own motion or until a new rate application becomes effective automatically pursuant to RH 15.5. RH 15.7 Initial rates for the facility shall be based on a forecasted twelve (12) month test year which shall include an estimate of the revenues expected to be derived from the projected volume of waste to managed at the facility and the cost projected to be incurred to provide such service associated with the estimated volume of waste to be disposed. If the revenue derived from the actual volume of waste managed differs from the initial projections by 15% after twelve (12) months, the licensee shall petition the Board to adjust the rates to correct for the error in projection. RH 15.8 Two (2) years after the facility has been operated, the licensee shall petition the Board to determine the rates using a historic test period of no less than twelve (12) continuous months, adjusted for known and certain future expenditures that will be incurred by the licensee which are reasonable and necessary for the operation of the facility. RH 15.9 In the event the licensee or the board determines that various classes of low-level radioactive waste will be managed at the facility which will impact upon the cost of service, rates shall be designated which best reflect the actual costs incurred in order to manage a particular class of low-level radioactive waste, so that the various classes do not subsidize costs associated with the management of another class of waste.

RH 15.10 When applying for approval of a proposed rate schedule by the Board, the licensee shall submit the following:

15.10.1 Identification including name, location of business, and licensee number; 15.10.2 Proposed rate schedules according to waste classes which may be characterized by chemical, physical form, container type, or by radiation quantity and concentration; and 15.10.3 Estimated allowable expenses and proposed rate of return in accordance with RH 15.17 through 15.20.

RH 15.11 Calculation of the Rates 15.11.1 Rates are based upon the licensee's cost of rendering service to the public. 15.11.2 The two components of cost of service are allowable expenses and return on invested capital.

RH 15.12 Allowable expenses. Only those expenses which are reasonable and necessary to provide service shall be included in allowable expenses. Allowable expenses may include, but are not limited to the following general categories:

15.12.1 Site operating costs incurred during the daily operation of the facility (labor, supplies, and maintenance costs).

15.12.2 Depreciation expense based on original cost of all buildings and equipment used on the facility computed on a straight line basis for a period extending from the date of purchase to the expected date of closure.

15.12.3 Amortization expense based on the original costs for site acquisition, environmental and geotechnical studies, licensing site development, and administrative and legal expenses incurred prior to the start of site operations, computed on a straight line basis for a period extending from the date such costs and expenses are incurred to the expected date of closure.

15.12.4 Assessments and taxes other than income taxes.

15.12.5 Federal and state income taxes normalized to reflect the taxes that would have been paid had the licensee elected to use straight line depreciation. 15.12.6 Cost of financial assurance required by the Department for facility closure and post- closure monitoring and maintenance pursuant to Parts III and XIV. 15.12.7 State surcharge of one percent of gross revenue and local surcharge of up to two percent of annual gross revenue as provided in 24-60-2212, C.R.S. 1982. 15.12.8 Compact surcharge as authorized in 24-60-2212. C.R.S. 1982 15.12.9 Annual license fee and attendant legal fees pursuant to regulations. 15.12.10 Cost of liability insurance for both sudden and accidental or slow and gradual contamination to people and/or property off site.

15.12.11 Legal fees necessary to the safe operation and management of the facility. RH 15.13 Costs Not Allowed. The following expenses shall never be allowed as a component of cost of service:

15.13.1 Legislative advocacy expenses, whether made directly or indirectly, including but not limited to legislative advocacy expenses included in professional or trade association dues.

15.13.2 Funds expended in support of political candidates, any political movement or in the promotion of political or religious causes.

15.13.3 Funds expended in support of or membership in social, recreational, fraternal, or religious clubs or organizations.

15.13.4 Funds expended to mail any material containing any of the items mentioned in RH 15.13 through 15.13.3.

15.13.5 Criminal penalties or fines, and civil penalties or fines. 15.13.5 Any other expenditure found by the Board to be unreasonable, unnecessary, or not in the public interest, including but not limited to executive salaries, advertising expenses, legal expenses incurred in suits initiated against the State of Colorado, or the Rocky Mountain Low-Level Radioactive Waste Board, or penalties and interest on overdue taxes. RH 15.14 Return on invested capital. The return on invested capital is the rate of return multiplied by invested capital (also known as rate base). Invested capital includes the original cost of plant, property and equipment, less accumulated depreciation authorized under these rules and the accumulated amortization expenses associated with start up costs incurred prior to the start of site operations, which were prudently incurred and are used and useful in rendering service to the public. Components to be included in determining the overall rate base are as follows: 15.14.1 Costs incurred prior to the start of site operations, less accumulated amoritization espenses associated with such costs which shall include: 15.14.1.1 Site acquisition costs including but not limited to costs incurred to acquire the site for low-level radioactive waste management.

15.14.1.2 Licensing costs and costs associated with site selection, and the development of any plans, reports, design, manuals or schedules.

15.14.1.3 Site development costs including but not limited to the costs for grading, development of roads, installation of fencing and lighting. 15.14.1.4 Administrative costs and legal fees.

15.14.2 Plant in service, less accumulated depreciation actually incurred and as reported on federal and state income tax returns.

15.14.3 Working capital, which shall include:

15.14.3.1 Reasonable inventories of materials, and supplies held specifically for purposes of permitting efficient operation of the facility. 15.14.3.2 Reasonable prepayments for operating expenses. RH 15.15 Rate of Return. The Board shall allow the licensee an opportunity to earn a reasonable return on its invested capital and shall fix the rate of return in accordance with the following principles: 15.15.1 The return should be sufficient to assure confidence in the financial soundness of the facility and should be adequate, under efficient management, to maintain and support its credit and enable it to raise the money necessary for proper discharge of its public duties. A rate of return may be reasonable at one time and become too high or too low by changes affecting opportunities for investment, the money market, inflation, deflation, the growth rate of the sevice area, business conditions generally and the need for the facility to attract necessary capital.

15.15.2 The Board shall consider the risks associated with the unique character of this facility and the risks which the licensee must incur in order to establish, operate and maintain the facility. In evaluating these risks, the Board may consider such factors as the amount of capital expended and required to establish the facility, the potential liability which the licensee incurs while operating the facility, the potential liability the licensee may incur after closure, and whether the licensee is a small business which is not a public corporation or whether the licensee is a public corporation, and whether the licensee operates the facility as its sole business rather than a portion of a larger business. Rate Review Documentation RH 15.16 For puprose of verifying the rate base upon which rates have been proposed or established, including any rate base changes affecting the calculation of proposed rates, the licensee shall supply the following reports and records to the Department. 15.16.1 Semiannual reports of all allowable costs to operate the facility. 15.16.2 Semiannual reports on the quantity of waste managed at the facility. 15.16.3 An annual financial report which includes complete data on the rates charged for each type of waste managed at the facility, all surcharges collected and paid by the licensee, the actual return on invested capital received by the licensee, and the data used or proposed to be used by the licensee in the calculation of the rate base and/or rates for the facility. This report shall be due within three months after the close of the licensee's fiscal year.

RH 15.17 All contracts made by the licensee which require payments by the licensee of five percent or more of the latest annual reported gross revenue shall require that an independent audit report be made available to the Board.

RH 15.18 The books and records supporting the reports referred to in this part shall be maintained in a form capable of review and audit by the Board or its staff, and the Board or its staff shall have the right to inspect these books and records.

RH 15.19 All documents submitted pursuant to these rules which are proprietary, private or confidential shall be so identified by the applicant or licensee or any parties who apply to become the licensee of the facility. The Board may issue such protective orders as are necessary to protect such proprietary, private or confidential material, subject to the provisions of 24-72-204, C.R.S. 1982. PART 16:

RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES 16.1 Purpose.

The regulations in this part establish radiation safety requirements for using sources of radiation for wireline service operations including mineral-logging, radioactive markers, and subsurface tracer studies. The requirements of this part are in addition to, and not in substitution for, the requirements of Parts 1, 2, 3, 4, and 10 of these regulations. 16.2 Scope.

The regulations in this part apply to all licensees or registrants who use sources of radiation for wireline service operations including mineral-logging, radioactive markers, or subsurface tracer studies.

16.3 Definitions.

As used in this part, the following definitions apply:

“Energy compensation source” (ECS) means a small sealed source, with an activity not exceeding 3.7 MBq (100 microcurie), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use. “Field station” means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary jobsites.

“Injection tool” means a device used for controlled subsurface injection of radioactive tracer material.

“Irretrievable well-logging source” means any sealed source containing licensed material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended.

“Logging assistant” means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by 16.22.

“Logging supervisor” means the individual who uses sources of radiation or provides personal supervision of the utilization of sources of radiation at the well site. “Logging tool” means a device used subsurface to perform well-logging. “Mineral logging” means any logging performed for the purpose of mineral exploration other than oil or gas.

“Personal supervision” means guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required. “Radioactive marker” means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation. “Safety review” means a periodic review provided by the licensee for its employees on radiation safety aspects of well-logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions. “Source holder” means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations. “Subsurface tracer study” means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

“Temporary jobsite” means a location where radioactive materials are present for the purpose of performing wireline service operations or subsurface tracer studies. “Tritium neutron generator target source” means a tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications. “Uranium sinker bar” means a weight containing depleted uranium used to pull a logging tool down toward the bottom of a well.

“Well-bore” means a drilled hole in which wireline service operations and subsurface tracer studies are performed.

“Well-logging” means all operations involving the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well or adjacent formations. “Wireline” means a cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.

“Wireline service operation” means any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.

PROHIBITION 16.4 Prohibition.

No licensee shall perform wireline service operations with a sealed source(s) unless, prior to commencement of the operation, the licensee has a written agreement with the well-operator, well-owner, drilling contractor, or land owner that:

16.4.1 In the event a sealed source is lodged downhole, a reasonable effort at recovery will be made; and 16.4.2 In the event a decision is made to abandon the sealed source downhole, the requirements of 16.25 and of any other State agency having applicable regulations shall be met. EQUIPMENT CONTROL 16.5 Limits on Levels of Radiation.

Sources of radiation shall be used, stored, and transported in such a manner that the transportation requirements of Part 17 and the dose limitation requirements of Part 4 of these regulations are met.

16.6 Storage Precautions.

16.6.1 Each source of radiation, except an accelerator, shall be provided with a storage or transport container. The container shall be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal of, or exposure to, the source of radiation. 16.6.2 Sources of radiation shall be stored in a manner which will minimize danger from explosion or fire. 16.7 Transport Precautions.

Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

16.8 Radiation Survey Instruments.

16.8.1 The licensee or registrant shall keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this part and by Part 4 of these regulations. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour. 16.8.2 Each radiation survey instrument shall be calibrated: 16.8.2.1 At intervals not to exceed 6 months and after each instrument servicing; 16.8.2.2 For linear scale instruments, at two points located approximately 1/3 and 2/3 of full- scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade; and for digital instruments, at appropriate points; and 16.8.2.3 So that accuracy within 20 percent of the true radiation level can be demonstrated on each scale.

16.8.3 Calibration records shall be maintained for a period of 2 years for inspection by the Department. 16.9 Leak Testing of Sealed Sources.

16.9.1 Requirements.

Each licensee using sealed sources of radioactive material shall have the sources tested for leakage. Records of leak test results shall be kept in units of becquerel (Bq) (or microcurie, µCi) and maintained for inspection by the Department for 6 months after the next required leak test is performed or until transfer or disposal of the sealed source. 16.9.2 Method of Testing.

Tests for leakage shall be performed using a leak test kit or method approved by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The test sample shall be taken from the nearest accessible point to the surface of the sealed source where contamination is likely to accumulate. The test sample shall be analyzed for radioactive contamination. The analysis shall be capable of detecting the presence of 185 Bq (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically approved by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform the analysis. 16.9.3 Interval of Testing.

16.9.3.1 Each sealed source of radioactive material (except an energy compensation source (ECS)) shall be tested at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, the sealed source shall not be used until tested. 16.9.3.2 Each ECS that is not exempt from testing in accordance with 16.9.5 must be tested at intervals not to exceed 3 years. In the absence of a certificate from a transferor indicating that a test has been made within the 3 years prior to the transfer, the ECS shall not be used until tested.

16.9.4 Leaking or Contaminated Sources.

If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical. 16.9.4.1 If the test reveals the presence of 185 Bq (0.005 microcurie) or more of removable radioactive material, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated and repaired, or disposed of, by a licensee authorized by the Department, U.S. Nuclear Regulatory Commission, Agreement State, or a Licensing State to perform these functions.

16.9.4.2 The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by a licensee authorized by the Department, U.S. Nuclear Regulatory Commission, Agreement State, or a Licensing State to perform these functions. 16.9.4.3 A report describing the equipment involved, the test results, and the corrective action taken shall be filed with the Department within 5 days of receiving the test results. 16.9.5 Exemptions.

The following sources are exempted from the periodic leak test requirements of 16.9.1 through 16.9.4:

16.9.5.1 Hydrogen-3 (tritium) sources;

16.9.5.2 Sources of radioactive material with a half-life of 30 days or less; 16.9.5.3 Sealed sources of radioactive material in gaseous form; 16.9.5.4 Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 MBq (100 microcurie) or less; and 16.9.5.5 Sources of alpha-emitting radioactive material with an activity of 0.37 MBq (10 microcurie) or less.

16.10 Quarterly Inventory.

Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation. Records of inventories shall be maintained for 2 years from the date of the inventory for inspection by the Department and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory, and the name of the individual conducting the inventory.

16.11 Utilization Records.

Each licensee or registrant shall maintain current records, which shall be kept available for inspection by the Department for 2 years from the date of the recorded event. 16.11.1 The records shall show the following information for each source of radiation: 16.11.1.1 Make, model number, and a serial number or a description of each source of radiation used;

16.11.1.2 The identity of the well-logging supervisor or field unit to whom assigned; and 16.11.1.3 Locations where used and dates of use.

16.11.2 In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

16.12 Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole Operations.

16.12.1 Each sealed source, except energy compensation sources (ECS) and those containing radioactive material in gaseous form, used in downhole operations and manufactured after December 30, 1986, shall be certified by the manufacturer, or other testing organization acceptable to the Department, to meet the following minimum criteria: 16.12.1.1 Be of doubly encapsulated construction;

16.12.1.2 Contain radioactive material whose chemical and physical forms are as insoluble and non-dispersible as practical; and 16.12.1.3 Satisfies the requirements of 16.12.3.1, 16.12.3.2, or 16.12.3.3, as appropriate. 16.12.2 For sealed sources, except those containing radioactive material in gaseous form, acquired after December 30, 1986, in the absence of a certificate from a transferor certifying that an individual sealed source meets the requirements of 16.12.1, the sealed source shall not be put into use until such determinations and testing have been performed.

16.12.3 Each sealed source, except energy compensation sources (ECS) and those containing radioactive material in gaseous form, used in downhole operations after December 30, 1986, shall be certified by the manufacturer, or other testing organization acceptable to the Department, as meeting the sealed source performance requirements for oil well-logging: 16.12.3.1 For a sealed source manufactured on or before July 14, 1989, a licensee may use the sealed source, for use in well logging applications, if it meets the requirements of United States Of America Standards Institute (USASI) N5.10-1968, “Classification of Sealed Radioactive Sources” (1968), or the requirements in 16.12.3.2 or 16.12.3.3. 16.12.3.2 For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well logging applications, if it meets the oil well logging requirements of American National Standards Institute / Health Physics Society (ANSI/HPS) N43.6-1997, “Sealed Radioactive Sources Classification” (November 1997). 16.12.3.3 For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well logging applications, if the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests: (1) Temperature test. The test source must be held at 40 o C for 20 minutes, 600 o C for 1 hour, and then be subject to a thermal shock test with a temperature drop from 600 o C to 20 o C within 15 seconds.

(2) Impact test. A 5-kg steel hammer, 2.5 cm in diameter, must be dropped from a height of 1 m onto the test source.

(3) Vibration test. The test source must be subject to a vibration from 25 Hz to 500Hz at 5 g amplitude for 30 minutes.

(4) Puncture test. A 1-gram hammer and pin, 0.3 cm pin diameter, must be dropped from a height of 1 m onto the test source.

(5) Pressure test. The test source must be subject to an external pressure of 1.695 x 10 7 pascal [24,600 pounds per square inch absolute].

16.12.4 Certification documents shall be maintained for inspection by the Department for a period of 2 years after source disposal. If the source is abandoned downhole, the certification documents shall be maintained until the Department authorizes disposition. 16.12.5 Use of an energy compensation source (ECS) is subject to this part, except that if the ECS is contained within a logging tool, or other tool components, and contains quantities of licensed material not exceeding 3.7 MBq (100 microcurie), the ECS is only subject to the requirements: 16.12.5.1 Of 16.9, 16.10 and 16.11 for well logging applications with a surface casing for protecting fresh water aquifers; or 16.12.5.2 Of 16.9, 16.10, 16.11, 16.12 and 16.25 for well logging applications without a surface casing for protecting fresh water aquifers.

16.12.6 Use of a tritium neutron generation target source is subject to this part, except the requirements: 16.12.6.1 Of 16.12 and 16.25 do not apply for use of a tritium neutron generation target source containing quantities not exceeding 1,110 MBq (30 curie) and in a well with a surface casing for protecting fresh water aquifers; and 16.12.6.2 Of 16.12 do not apply for use of a tritium neutron generation target source containing quantities exceeding 1,110 MBq (30 curie) or in a well without a surface casing for protecting fresh water aquifers.

16.13 Labeling.

16.13.1 Each source, source holder, or logging tool containing radioactive material shall bear a durable, legible, and clearly visible marking or label, which has, as a minimum, the standard radiation caution symbol, without the conventional color requirement, and the following wording: DANGER* – RADIOACTIVE *or “CAUTION”

This labeling shall be on the smallest component transported as a separate piece of equipment. 16.13.2 Each transport container shall have permanently attached to it a durable, legible, and clearly visible label which has, as a minimum, the standard radiation caution symbol and the following wording:

DANGER*- RADIOACTIVE NOTIFY CIVIL AUTHORITIES [OR NAME OF COMPANY] *or “CAUTION”

16.13.3 The licensee may use a uranium sinker bar in well logging applications only if it is legibly impressed with the following wording:

CAUTION--RADIOACTIVE--DEPLETED URANIUM and NOTIFY CIVIL AUTHORITIES [OR COMPANY NAME] IF FOUND 16.14 Inspection and Maintenance.

16.14.1 Each licensee or registrant shall conduct, at intervals not to exceed 6 months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of 2 years for inspection by the Department.

16.14.2 If any inspection conducted pursuant to 16.14.1 reveals damage to labeling or components critical to radiation safety, the device shall be removed from service until repairs have been made. 16.14.3 If a sealed source is stuck in the source holder, the licensee shall not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform this operation.

16.14.4 The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

REQUIREMENTS FOR PERSONNEL SAFETY 16.15 Training Requirements.

16.15.1 No licensee or registrant shall permit any individual to act as a logging supervisor as defined in this part until such individual has:

16.15.1.1 Received, in a course recognized by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, instruction in the subjects outlined in Appendix A of this part and demonstrated an understanding thereof; 16.15.1.2 Read and received instruction in the regulations contained in this part and the applicable sections of Parts 1, 4, and 10 of these regulations or their equivalent, conditions of appropriate license or certificate of registration, and the licensee's or registrant's operating and emergency procedures, and demonstrated an understanding thereof; and 16.15.1.3 Demonstrated competence to use sources of radiation, related handling tools, and radiation survey instruments which will be used on the job. 16.15.2 No licensee or registrant shall permit any individual to assist in the handling of sources of radiation until such individual has:

16.15.2.1 Read or received instruction in the licensee's or registrant's operating and emergency procedures and demonstrated an understanding thereof; and 16.15.2.2 Demonstrated competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools, and radiation survey instruments which will be used on the job.

16.15.2.3 The licensee or registrant shall maintain employee training records for inspection by the Department for 2 years following termination of the individual's employment. 16.16 Operating and Emergency Procedures.

The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following:

16.16.1 Handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the standards established in Part 4 of these regulations; 16.16.2 Methods and occasions for conducting radiation surveys; 16.16.3 Methods and occasions for locking and securing sources of radiation; 16.16.4 Personnel monitoring and the use of personnel monitoring equipment; 16.16.5 Transportation to temporary jobsites and field stations, including the packaging and placing of sources of radiation in vehicles, placarding of vehicles, and securing sources of radiation during transportation;

16.16.6 Minimizing exposure of individuals in the event of an accident; 16.16.7 Procedure for notifying proper personnel in the event of an accident; 16.16.8 Maintenance of records;

16.16.9 Use, inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools;

16.16.10 Procedure to be followed in the event a sealed source is lodged downhole; 16.16.11 Procedures to be used for picking up, receiving, and opening packages containing radioactive material;

16.16.12 For the use of tracers, decontamination of the environment, equipment, and personnel; 16.16.13 Maintenance of records generated by logging personnel at temporary jobsites; 16.16.14 Notifying proper persons in the event of an accident; and 16.16.15 Actions to be taken if a sealed source is ruptured, including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive material and actions to obtain suitable radiation survey instruments as required by 16.8. 16.17 Personnel Monitoring.

16.17.1 No licensee or registrant shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each such individual wears, at all times during the handling of such sources, a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor. Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges must be replaced at least monthly and each other personnel dosimeter must be replaced at least quarterly. After replacement, each personnel dosimeter must be promptly processed. 16.17.2 Personnel monitoring records shall be maintained for inspection until the Department authorizes disposition.

PRECAUTIONARY PROCEDURES IN LOGGING AND SUBSURFACE TRACER OPERATIONS 16.18 Security.

During each logging or tracer application, the logging supervisor or other designated employee shall maintain direct surveillance of the operation to protect against unauthorized or unnecessary entry into a restricted area, as defined in Part 1 of these regulations. 16.19 Handling Tools.

The licensee shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.

16.20 Subsurface Tracer Studies.

16.20.1 Protective gloves and other appropriate protective clothing and equipment shall be used by all personnel handling radioactive tracer material. Precautions shall be taken to avoid ingestion or inhalation of radioactive material.

16.20.2 No licensee shall cause the injection of radioactive material into potable aquifers without prior written authorization from the Department and any other appropriate State agency. 16.21 Particle Accelerators.

No licensee or registrant shall permit aboveground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in areas or facilities controlled or shielded so that the requirements of 4.6 and 4.14 of these regulations, as applicable, are met.

RADIATION SURVEYS AND RECORDS 16.22 Radiation Surveys.

16.22.1 Radiation surveys or calculations shall be made and recorded for each area where radioactive materials are stored.

16.22.2 Radiation surveys or calculations shall be made and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive material. Such surveys and calculations shall include each source of radiation or combination of sources to be transported in the vehicle.

16.22.3 If the sealed source assembly is removed from the logging tool before departing the jobsite, the logging tool detector shall be energized, or a survey meter used, to assure that the logging tool is free of contamination.

16.22.4 Radiation surveys shall be made and recorded at the jobsite or wellhead for each tracer operation, except those using hydrogen-3, carbon-14, and sulfur-35. These surveys shall include measurements of radiation levels before and after the operation. 16.22.5 Records required pursuant to 16.22.1 through 16.22.4 shall include the dates, the identification of individual(s) making the survey, the identification of survey instrument(s) used, and an exact description of the location of the survey. Records of these surveys shall be maintained for inspection by the Department for 2 years after completion of the survey. 16.23 Documents and Records Required at Field Stations. Each licensee or registrant shall maintain, for inspection by the Department, the following documents and records for the specific devices and sources used at the field station: 16.23.1 Appropriate license, certificate of registration, or equivalent document(s); 16.23.2 Operating and emergency procedures;

16.23.3 Applicable regulations;

16.23.4 Records of the latest survey instrument calibrations pursuant to 16.8; 16.23.5 Records of the latest leak test results pursuant to 16.9; 16.23.6 Records of quarterly inventories required pursuant to 16.10; 16.23.7 Utilization records required pursuant to 16.11; 16.23.8 Records of inspection and maintenance required pursuant to 16.14; 16.23.9 Survey records required pursuant to 16.22; and 16.23.10 Training records required pursuant to 16.15.

16.24 Documents and Records Required at Temporary Jobsites. Each licensee or registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the Department: 16.24.1 Operating and emergency procedures;

16.24.2 Survey records required pursuant to 16.22 for the period of operation at the site; 16.24.3 Evidence of current calibration for the radiation survey instruments in use at the site; 16.24.4 When operating in the State under reciprocity, a copy of the appropriate license, certificate of registration, or equivalent document(s); and 16.24.5 Shipping papers for the transportation of radioactive material. NOTIFICATION 16.25 Notification of Incidents, Abandonment, and Lost Sources. 16.25.1 Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of 4.52 of these regulations. 16.25.2 Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee shall:

16.25.2.1 Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and 16.25.2.2 Notify the Department immediately by telephone and subsequently within 30 days by confirmatory letter if the licensee knows or has reason to believe that a sealed source has been ruptured. This letter shall identify the well or other location, describe the magnitude and extent of the escape of radioactive material, assess the consequences of the rupture, and explain efforts being planned or taken to mitigate these consequences. 16.25.3 When it becomes apparent that efforts to recover the radioactive source will not be successful, the licensee shall:

16.25.3.1 Advise the well operator of the regulations of the Department regarding abandonment and an appropriate method of abandonment, which shall include: (1) The immobilization and sealing in place of the radioactive source with a cement plug; (2) The setting of a whipstock or other deflection device; and (3) The mounting of a permanent identification plaque at the surface of the well, containing the appropriate information required by 16.25.4; 16.25.3.2 Notify the Department by telephone, giving the circumstances that resulted in the inability to retrieve the source; and (1) Obtain department approval to implement abandonment procedures; or (2) Notify the department that the licensee implemented abandonment before receiving department approval because the licensee believed there was an immediate threat to public health and safety; and 16.25.3.3 File a written report with the Department within 30 days of the abandonment. The licensee shall send a copy of the report to the appropriate State agency that issued permits or otherwise approved of the drilling operation. The report shall contain the following information:

(1) Date of occurrence;

(2) A description of the well-logging source involved, including the radionuclide and its quantity, chemical, and physical form;

(3) Surface location and identification of the well;

(4) Results of efforts to immobilize and seal the source in place; (5) A brief description of the attempted recovery effort; (6) Depth of the source;

(7) Depth of the top of the cement plug;

(8) Depth of the well;

(9) The immediate threat to public health and safety justification for implementing abandonment if prior Department approval was not obtained in accordance with 16.25.3.2(1);

(10) Any other information, such as a warning statement, contained on the permanent identification plaque; and (11) The names of State Agencies receiving a copy of this report. 16.25.4 Whenever a sealed source containing radioactive material is abandoned downhole, the licensee shall provide a means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations, and shall provide a permanent plaque 1 for posting the well or well-bore. This plaque shall:

1 An example of a suggested plaque is shown in Appendix B of this part. 16.25.4.1 Be constructed of long-lasting material, such as stainless steel, brass, bronze, or monel;

16.25.4.2 Be mounted at the surface of the well, unless the mounting of the plaque is not practical;

16.25.4.3 Be at least 17 cm (7 inches) square and 3 mm (1/8th inch) thick; and 16.25.4.4 Contain the following information engraved on its face: (1) The word “CAUTION” ;

(2) The radiation symbol prescribed in 4.27 without the conventional color requirement; (3) The date of abandonment;

(4) The name of the well-operator or well-owner;

(5) The well name and well identification number(s) or other designation; (6) The sealed source(s) by radionuclide and activity;

(7) The source depth and the depth to the top of the plug; and (8) An appropriate warning, depending on the specific circumstances of each abandonment 2 .

2 Appropriate warnings may include: (a) "Do not drill below plug - back depth"; (b) "Do not enlarge casing"; or (c)"Do not re - enter the hole", followed by the words, "before contacting the Colorado Department of Public Health and Environment, Hazardous Materials And Waste Management Division.”

16.25.5 The licensee shall immediately notify the Department by telephone and subsequently by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable aquifer. Such notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss, and explain efforts planned or being taken to mitigate these consequences. PART 16, APPENDIX A:

SUBJECTS TO BE INCLUDED IN TRAINING COURSES FOR LOGGING SUPERVISORS I. Fundamentals of Radiation Safety A. Characteristics of radiation B. Units of radiation dose and quantity of radioactivity C. Significance of radiation dose 1. Radiation protection standards 2. Biological effects of radiation dose D. Levels of radiation from sources of radiation E. Methods of minimizing radiation dose 1. Working time 2. Working distances 3. Shielding F. Radiation safety practices including prevention of contamination and methods of decontamination II. Radiation Detection Instrumentation To Be Used A. Use of radiation survey instruments 1. Operation 2. Calibration 3. Limitations B. Survey techniques C. Use of personnel monitoring equipment III. Equipment To Be Used A. Handling equipment B. Sources of radiation C. Storage and control of equipment D. Operation and control of equipment IV. The Requirements of Pertinent Federal and State Regulations V. The Licensee's or Registrant's Written Operating and Emergency Procedures VI. The Licensee's or Registrant's Record Keeping Procedures PART 16, APPENDIX B:

EXAMPLE OF PLAQUE FOR IDENTIFYING WELLS CONTAINING SEALED SOURCES CONTAINING RADIOACTIVE MATERIAL ABANDONED DOWNHOLE The size of the plaque should be convenient for use on active or inactive wells, e.g., a 7-inch square. Letter size of the word “CAUTION” should be approximately twice the letter size of the rest of the information, e.g., 1/2-inch and 1/4-inch letter size, respectively. PART 17 TRANSPORTATION OF RADIOACTIVE MATERIAL RH 17.1 Purpose and Scope.

The regulations in this part establish requirements for packaging, preparation for shipment, and transportation of radioactive material and apply to any person who transports radioactive material or delivers radioactive material to a carrier for transport. RH 17.2 Definitions.

As used in this part, the following definitions apply:

“Carrier” means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft. “Closed transport vehicle” means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be either temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the “see-through” type.

“Exclusive use” means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

“Fissile material” means plutonium-238, plutonium-239, plutonium-241, uranium-233, and uranium-235, or any combination of these radionuclides. Unirradiated natural uranium and depleted uranium, and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition.1 1Department jurisdiction extends only to “special nuclear material in quantities not sufficient to form a critical mass” as defined in Part 1 of these regulations.

“Fissile material package” means a fissile material packaging together with its fissile material contents.

“Low specific activity (LSA) material” means radioactive material that satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups:

(1) LSA-I.

i. Ores containing only naturally occurring radionuclides (e.g., uranium, thorium) and uranium or thorium concentrates of such ores; or ii. Solid unirradiated natural uranium, depleted uranium, natural thorium, or their solid or liquid compounds or mixtures; or iii. Radioactive material, other than fissile material, for which the A value is unlimited; or 2 iv. Mill tailings, contaminated earth, concrete, rubble, other bulk debris, and activated material in which the radioactive material is essentially uniformly distributed, and the average specific activity does not exceed 10-6 A /g. 2 (2) LSA-II.

i. Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/liter); or ii. Material in which the radioactive material is distributed throughout, and the average specific activity does not exceed 10-4 A /g for solids and gases, and 10-5 A /g for 2 2 liquids.

(3) LSA-III. Solids (e.g., consolidated wastes, activated materials) in which: i. The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.); and ii. The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for 7 days, would not exceed 0.1 A ; and 2 iii. The average specific activity of the solid does not exceed 2 × 10-3 A /g. 2 “Low toxicity alpha emitters” means natural uranium, depleted uranium, natural thorium; uranium- 235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates; or alpha emitters with a half-life of less than 10 days. “Packaging” means the assembly of components necessary to ensure compliance with the packaging requirements of 49 CFR Part 173 Subpart I. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

“Regulations of the U.S. Department of Transportation” means the regulations in 49 CFR Parts 100–189 and Parts 390–397.

“Regulations of the U.S. Nuclear Regulatory Commission” means the regulations in 10 CFR 71 for purposes of this Part.

“Specific activity” of a radionuclide means the radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material. “State” means a State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

“Surface contaminated object” (SCO) means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits: 1. SCO-I: a solid object on which:

i. The non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4 Bq/cm2 (10-4 microcurie/cm2) for beta, gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (10-5 microcurie/cm2) for all other alpha emitters;

ii. The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4×104 Bq/cm2 (1.0 microcurie/cm2) for beta, gamma and low toxicity alpha emitters, or 4×103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters; and iii. The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4×104 Bq/cm2 (1 microcurie/cm2) for beta, gamma and low toxicity alpha emitters, or 4×103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters. 2. SCO-II: a solid object on which the limits for SCO-I are exceeded and on which: i. The non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 400 Bq/cm2 (10-2 microcurie/cm2) for beta, gamma and low toxicity alpha emitters or 40 Bq/cm2 (10- 3 microcurie/cm2) for all other alpha emitters;

ii. The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8×105 Bq/cm2 (20 microcuries/cm2) for beta, gamma and low toxicity alpha emitters, or 8×104 Bq/cm2 (2 microcuries/cm2) for all other alpha emitters; and iii. The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8×105 Bq/cm2 (20 microcuries/cm2) for beta, gamma and low toxicity alpha emitters, or 8×104 Bq/cm2 (2 microcuries/cm2) for all other alpha emitters. “Transport index” means the dimensionless number, rounded up the next tenth, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number expressing the maximum radiation level at 1 meter (3.3 feet) from the external surface of the package in millisievert (mSv) per hour multiplied by 100 (equivalent to the maximum radiation level in millirem per hour at 1 meter). “Type A quantity” means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A for special form radioactive material or A for normal form radioactive 1 2 material, where A and A are given in Appendix A of this Part 17 or may be determined by 1 2 procedures described in Appendix A of this Part 17.

“Type A package” means a packaging that, together with its radioactive contents limited to A or 1 A as appropriate, meets the requirements of 49 CFR 173.410 and 173.412 and is designed to 2 retain the integrity of containment and shielding under normal conditions of transport as demonstrated by the tests set forth in 173.465 or 173.466, as appropriate. “Type B package” means a Type B packaging together with its radioactive contents.2 2A Type B package design is designated as B(U) or B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, refer to 49 CFR Part 173. A Type B package approved prior to September 6, 1983 was designated only as Type B. Limitations on its use are specified in RH 17.8. “Type B packaging” means a packaging designed to retain the integrity of containment and shielding when subjected to the normal conditions of transport and hypothetical accident test conditions set forth 10 CFR Part 71.

“Type B quantity” means a quantity of radioactive material greater than a Type A quantity. General Regulatory Provisions RH 17.3 Requirement for License.

No person shall transport radioactive material or deliver radioactive material to a carrier for transport except as authorized in a general or specific license issued by the Department or as exempted in RH 17.4.

RH 17.4 Exemptions.

17.4.1 Common and contract carriers, freight forwarders, and warehouse workers which are subject to the requirements of the U.S. Department of Transportation in 49 CFR 170 through 189 or the U.S. Postal Service in the Postal Service Manual (Domestic Mail Manual), are exempt from the requirements of this part to the extent that they transport or store radioactive material in the regular course of their carriage for others or storage incident thereto. Common and contract carriers who are not subject to the requirements of the U.S. Department of Transportation or U.S. Postal Service are subject to RH 17.3 and other applicable requirements of these regulations. 17.4.2 Any licensee is exempt from the requirements of this part to the extent that the licensee delivers to a carrier for transport a package containing radioactive material having a specific activity not greater than 70 Bq/g (0.002 microcurie per gram).

RH 17.5 Transportation of Licensed Material.

17.5.1 Each licensee who transports licensed material outside the site of usage, as specified in the Department license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall:

17.5.1.1 Comply with the applicable requirements, appropriate to the mode of transport, of the regulations of the U.S. Department of Transportation, particularly the regulations of U.S. Department of transportation in the following areas:

(1) Packaging - 49 CFR Part 173: Subparts A and B and I. (2) Marking and labeling - 49 CFR Part 172: Subpart D, §§ 172.400 through 172.407, §§ 172.436 through 172.440, and Subpart E.

(3) Placarding - 49 CFR Part 172: Subpart F, especially §§ 172.500 through 172.519, 172.556, and Appendices B and C.

(4) Accident reporting - 49 CFR Part 171: §§ 171.15 and 171.16. (5) Shipping papers and emergency information - 49 CFR Part 172: Subparts C and G. (6) Hazardous material employee training - 49 CFR Part 172: Subpart H. (7) Hazardous material shipper/carrier registration - 49 CFR Part 107: Subpart G. 17.5.1.2 The licensee shall also comply with applicable U.S. Department of Transportation regulations pertaining to the following modes of transportation: (1) Rail - 49 CFR Part 174: Subparts A through D and K. (2) Air - 49 CFR Part 175.

(3) Vessel - 49 CFR Part 176: Subparts A through F and M. (4) Public highway - 49 CFR Part 177 and Parts 390 through 397. 17.5.1.3 Assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee.

17.5.2 If, for any reason, the regulations of the U.S. Department of Transportation are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of 49 CFR Parts 170 through 189 appropriate to the mode of transport to the same extent as if the shipment was subject to the regulations.

General Licenses RH 17.6 General Licenses for Carriers.

17.6.1 A general license is hereby issued to any common or contract carrier not exempt under RH 17.4 to receive, possess, transport, and store radioactive material in the regular course of their carriage for others or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting.3 3Notification of an incident shall be filed with, or made to, the Department as prescribed in 49 CFR, regardless of and in addition to the notification made to the U.S. Department of Transportation or other agencies. 17.6.2 A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting.3 3Notification of an incident shall be filed with, or made to, the Department as prescribed in 49 CFR, regardless of and in addition to the notification made to the U.S. Department of Transportation or other agencies. 17.6.3 Persons who transport radioactive material pursuant to the general licenses in RH 17.6.1 or 17.6.2 are exempt from the requirements of Parts 4 and 10 of these regulations to the extent that they transport radioactive material.

RH 17.7 General License: Nuclear Regulatory Commission-Approved Packages. 17.7.1 A general license is hereby issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance, or other approval has been issued by the Nuclear Regulatory Commission. 17.7.2 This general license applies only to a licensee who: 17.7.2.1 Has a copy of the specific license, certificate of compliance, or other approval by the Nuclear Regulatory Commission of the package and has the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the action to be taken prior to shipment; 17.7.2.2 Complies with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission, as applicable, and the applicable requirements of this Part 17;

17.7.2.3 Prior to the licensee's first use of the package, has registered with the Nuclear Regulatory Commission; and 17.7.2.4 Has a quality assurance program required by RH 17.20. 17.7.3 The general license in RH 17.7.1 applies only when the package approval authorizes use of the package under this general license.

17.7.4 For a Type B or fissile material package, the design of which was approved by Nuclear Regulatory Commission before April 1, 1996, the general license is subject to additional restrictions of RH 17.8.

RH 17.8 General License: Previously Approved Type B Packages. 17.8.1 A Type B package previously approved by the Nuclear Regulatory Commission, but not designated as B(U) or B(M) in the Nuclear Regulatory Commission certificate of compliance, may be used under the general license of RH 17.7 with the following additional conditions: 17.8.1.1 Fabrication of the packaging was satisfactorily completed before August 31, 1986, as demonstrated by application of its model number in accordance with Nuclear Regulatory Commission regulations at 10 CFR 71.85(c);

17.8.1.2 A package used for a shipment to a location outside the United States is subject to multilateral approval, as defined in U.S. Department of Transportation regulations at 49 CFR 173.403; and 17.8.1.3 A serial number which uniquely identifies each packaging which conforms to the approved design is assigned to, and legibly and durably marked on, the outside of each packaging.

17.8.2 A Type B(U) package, a Type B(M) package, a low specific activity (LSA) material package or a fissile material package, previously approved by the nuclear regulatory commission but without the designation “-85” in the identification number of the Nuclear Regulatory Commission certificate of compliance, may be used under the general license of RH 17.8 with the following additional conditions:

17.8.2.1 Fabrication of the package is satisfactorily completed by April 1, 1999, as demonstrated by application of its model number in accordance with Nuclear Regulatory Commission regulations at 10 CFR 71.85(c);

17.8.2.2 A package used for a shipment to a location outside the United States is subject to multilateral approval except approved under special arrangement in accordance with U.S. Department of Transportation regulations at 49 CFR 173.403; and 17.8.2.3 A serial number that uniquely identifies each packaging which conforms to the approved design is assigned to, and legibly and durably marked on, the outside of each packaging. RH 17.9 General License: U.S. Department of Transportation Specification Container. 17.9.1 A general license is issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a specification container for fissile material or for a Type B quantity of radioactive material as specified in 49 CFR Parts 173 and 178. 17.9.2 This general license applies only to a licensee who: 17.9.2.1 Has a copy of the specification;

17.9.2.2 Complies with the terms and conditions of the specification and the applicable requirements of this Part 17; and 17.9.2.3 Has a quality assurance program required by 17.20. 17.9.3 The general license in RH 17.9.1 is subject to the limitation that the specification container may not be used for a shipment to a location outside the United States except by multilateral approval as defined in 49 CFR 173.403.

RH 17.10 General License: Use of Foreign Approved Package. 17.10.1 A general license is issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate and revalidated by the U.S. Department of Transportation as meeting the applicable requirements of 49 CFR 171.12. 17.10.2 This general license applies only to international shipments. 17.10.3 This general license applies only to a licensee who: 17.10.3.1 Has a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment; 17.10.3.2 Complies with the terms and conditions of the certificate and revalidation, and with the applicable requirements of this Part 17; and 17.10.3.3 Has a quality assurance program approved by the Nuclear Regulatory Commission. RH 17.11 General License: Fissile Material, Limited Quantity per Package. 17.11.1 A general license is hereby issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. 17.11.2 This general license applies only when a package contains no more than a Type A quantity of radioactive material, including only one of the following: 17.11.2.1 Up to 40 grams of uranium-235; or 17.11.2.2 Up to 30 grams of uranium-233; or 17.11.2.3 Up to 25 grams of the fissile radionuclides of plutonium, except that for encapsulated plutonium-beryllium neutron sources in special form, an A quantity of plutonium may be 1 present; or 17.11.2.4 A combination of fissile radionuclides in which the sum of the ratios of the amount of each radionuclide to the corresponding maximum amount in RH 17.11.2.1, 17.11.2.2, and 17.11.2.3 does not exceed unity.

17.11.3 For packages where fissile material is mixed with substances having an average hydrogen density greater than water, this general license applies only when a package contains no more than a type a quantity of radioactive material, including only one of the following: 17.11.3.1 Up to 29 grams of uranium-235; or 17.11.3.2 Up to 18 grams of uranium-233; or 17.11.3.3 Up to 18 grams of the fissile radionuclides of plutonium; or 17.11.3.4 A combination of fissile radionuclides in which the sum of the ratios of the amount of each radionuclide to the corresponding maximum amount in RH 17.11.3.1, 17.11.3.2, and 17.11.3.3 does not exceed unity.

17.11.4 Except as specified in RH 17.11.4.2, this general license applies only when all of the following requirements are met:

17.11.4.1 A package containing fissile radionuclides is labeled with a transport index not less than the number given by the following equation:

Minimum Transport Index = (0.25x + 0.33y + 0.4z)

where the package contains x grams of uranium-235, y grams of uranium-233, and z grams of the fissile radionuclides of plutonium;

17.11.4.2 For a package in which the only fissile material is encapsulated plutonium-beryllium neutron sources in special form, the transport index based on criticality considerations may be taken as 0.025 times the number of grams of the fissile radionuclides of plutonium.

17.11.4.3 In all cases, the transport index must be rounded up to one decimal place and shall not exceed 10.0.

17.11.4.4 Except for the beryllium contained within the special form plutonium-beryllium sources authorized in rh 17.11.2, beryllium, graphite, or hydrogenous material enriched in deuterium is not present in quantities exceeding 0.1% of the fissile material mass. 17.11.4.5 The licensee has a quality assurance program approved by the nuclear regulatory commission.

RH 17.12 General License: Fissile Material, Limited Moderator per Package. 17.12.1 A general license is hereby issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. 17.12.2 This general license applies only when all of the following requirements are met. 17.12.2.1 The package contains no more than a Type A quantity of radioactive material. 17.12.2.2 Neither beryllium nor hydrogenous material enriched in deuterium is present. 17.12.2.3 The total mass of graphite present does not exceed 7.7 times the total mass of uranium-235 plus plutonium.

17.12.2.4 Substances having a higher hydrogen density than water, for example certain hydrocarbon oils, are not present, except that polyethylene may be used for packing or wrapping.

17.12.2.5 Uranium-233 is not present, and the amount of plutonium does not exceed 1 percent of the amount of uranium-235.

17.12.2.6 The amount of uranium-235 is limited as follows: 17.12.2.6.1 If the fissile radionuclides are not uniformly distributed, the maximum amount of uranium-235 per package may not exceed the value given in the following Table 1:

17.12.2.6.2 If the fissile radionucludes are distributed uniformly, for example, cannot form a lattice arrangement within the packaging, the maximum amount of uranium-235 per package may not exceed the value given in the following Table 2: 17.12.2.7 The transport index of each package based on criticality considerations is taken as 10 times the number of grams of uranium-235 in the package divided by the maximum allowable number of grams per package in accordance with Table 1 or 2 of this section as applicable.

TABLE 1: PERMISSIBLE MASS OF URANIUM-235 PER FISSILE MATERIAL PACKAGE [NONUNIFORM DISTRIBUTION] Uranium enrichment in Permissible maximum weight percent of grams of uranium-235 per uranium-235 not package exceeding 24 40 20 42 15 45 11 48 10 51 9.5 52 9 54 8.5 55 8 57 7.5 59 7 60 6.5 62 6 65 5.5 68 5 72 4.5 76 4 80 3.5 88 3 100 2.5 120 2 164 1.5 272 1.35 320 1 * 680 0.92 * 1200 *Pursuant to the Department's agreement with the Nuclear Regulatory Commission, jurisdiction extends only to 350 grams of uranium-235.

TABLE 2: PERMISSIBLE MASS OF URANIUM-235 PER FISSILE MATERIAL PACKAGE [UNIFORM DISTRIBUTION] Uranium enrichment in Permissible maximum weight percent of grams of uranium-235 per uranium-235 not package exceeding 4 84 3.5 92 3 112 2.5 148 2 240 1.5 * 560 1.35 * 800 *Pursuant to the Department's agreement with the Nuclear Regulatory Commission, jurisdiction extends only to 350 grams of uranium-235.

Operating Controls and Procedures RH 17.13 Fissile Material: Assumptions as to Unknown Properties of Fissile Material. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties had credible values that would cause the maximum neutron multiplication.

RH 17.14 Preliminary Determinations.

Prior to the first use of any packaging for the shipment of radioactive material: 17.14.1 The licensee shall ascertain that there are no defects which could significantly reduce the effectiveness of the packaging;

17.14.2 Where the maximum normal operating pressure will exceed 35 kilopascal (5 pounds per square inch) gauge, the licensee shall test the containment systems at an internal pressure at least 50 percent higher than the maximum normal operating pressure to verify the capability of that system to maintain its structural integrity at that pressure; 17.14.3 The licensee shall determine that the packaging has been fabricated in accordance with the design approved by the Nuclear Regulatory Commission; and 17.14.4 The licensee shall conspicuously and durably mark the packaging with its model number, serial number, gross weight, and a package identification number as assigned by the Nuclear Regulatory Commission.

RH 17.15 Routine Determinations.

Prior to each shipment of licensed material, the licensee shall determine that: 17.15.1 The package is proper for the contents to be shipped; 17.15.2 The package is in unimpaired physical condition except for superficial defects such as marks or dents;

17.15.3 Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

17.15.4 Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

17.15.5 Any pressure relief device is operable and set in accordance with written procedures; 17.15.6 The package has been loaded and closed in accordance with written procedures; 17.15.7 Any structural part of the package which could be used to lift or tie down the package during transport is rendered inoperable for the purpose unless it satisfies design requirements specified in 10 CFR 71.45;

17.15.8 The level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable. 17.15.8.1 The level of non-fixed (removable) radioactive contamination may be determined by wiping an area of 300 square centimeters of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in RH 17.15.8.2, the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in Table 3 below at any time during transport. Other methods of assessment of equal or greater efficiency may be used. When other methods are used, the detection efficiency of the method used must be taken in account and in no case may the removable contamination on the external surfaces of the package exceed 10 times the limits listed in Table 3. 17.15.8.2 In the case of packages transported as exclusive use shipments by rail or highway only, the non-fixed (removable) radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in RH 17.15.8.1. The levels at the beginning of transport must not exceed the levels in RH 17.15.8.1. 17.15.9 External radiation levels around the package and around the vehicle, if applicable will not exceed 2 mSv/h (200 millirems per hour) at any point on the external surface of the package at any time during transportation. The transport index shall not exceed 10.0; TABLE 3: NON-FIXED (REMOVABLE) EXTERNAL RADIOACTIVE CONTAMINATION WIPE LIMITS Maximum Permissible Limits Contaminant Bq/cm2 2 2 uCi/cm dpm/cm Beta and gamma emitters 0.4 -5 22 10 and low toxicity alpha emitters All other alpha emitting 0.04 -6 2.2 10 radionuclides 17.15.10 For a package transported in exclusive use by rail, highway or water, radiation levels external to the package may exceed the limits specified in RH 17.15.9 but shall not exceed any of the following:

17.15.10.1 2 mSv/h (200 millirems per hour) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 10 mSv/h (1000 millirems per hour);

17.15.10.1.1 The shipment is made in a closed transport vehicle, 17.15.10.1.2 Provisions are made to secure the package so that its position within the vehicle remains fixed during transportation, and 17.15.10.1.3 There are no loading or unloading operations between the beginning and end of the transportation.

17.15.10.2 2 mSv/h (200 millirems per hour) at any point on the outer surface of the vehicle, including the upper and lower surfaces, or, in the case of a flat-bed style vehicle, with a personnel barrier*, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load (or enclosure, if used), and on the lower external surface of the vehicle;

*A flat-bed style vehicle with a personnel barrier shall have radiation levels determined at vertical planes. If no personnel barrier is in place, the package cannot exceed 2 mSv/h (200 millirems per hour) at any accessible surface. 17.15.10.3 0.1 mSv/h (10 millirems per hour) at any point 2 meters from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point 2 meters from the vertical planes projected from the outer edges of the vehicle; and 17.15.10.4 0.02 mSv/h (2 millirems per hour) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training in accordance with RH 10.3 of these regulations; and 17.15.11 A package must be prepared for transport so that in still air at 100 degrees Fahrenheit (38 degrees Celsius) and in the shade, no accessible surface of a package would have a temperature exceeding 122 degrees Fahrenheit (50 degrees Celsius) in a nonexclusive use shipment or 180 degrees Fahrenheit (82 degrees Celsius) in an exclusive use shipment. Accessible package surface temperatures shall not exceed these limits at any time during transportation. 17.15.12 A package may not incorporate a feature intended to allow continuous venting during transport. 17.15.13 “Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with 4.32.5.2.” RH 17.16 Air Transport of Plutonium.

Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this part or included indirectly by citation of the U.S. Department of Transportation regulations, as may be applicable, the licensee shall assure that plutonium in any form is not transported by air, or delivered to a carrier for air transport, unless:

17.16.1 The plutonium is contained in a medical device designed for individual human application; or 17.16.2 The plutonium is contained in a material in which the specific activity is not greater than 70 Bq/g (0.002 microcuries per gram) of material and in which the radioactivity is essentially uniformly distributed; or 17.16.3 The plutonium is shipped in a single package containing no more than an A quantity of 2 plutonium in any isotope or form and is shipped in accordance with RH 17.5; or 17.16.4 The plutonium is shipped in a package specifically authorized (in the certificate of compliance issued by the Nuclear Regulatory Commission for that package) for the shipment of plutonium by air and the licensee requires, through special arrangement with the carrier, compliance with 49 CFR 175.704, the U.S. Department of Transportation regulations applicable to the air transport of plutonium.

RH 17.17 Shipment Records.

Each licensee shall maintain, for a period of 2 years after shipment, a record of each shipment of licensed material not exempt under RH 17.4 showing, where applicable: 17.17.1 Identification of the packaging by model number and serial number; 17.17.2 Verification that the packaging, as shipped, had no significant defect; 17.17.3 Volume and identification of coolant;

17.17.4 Type and quantity of licensed material in each package, and the total quantity of each shipment; 17.17.5 Date of the shipment;

17.17.6 Name and address of the transferee;

17.17.7 Address to which the shipment was made; and 17.17.8 Results of the determinations required by RH 17.15 and by the conditions of the package approval.

RH 17.18 Reports.

The licensee shall report to the Department within 30 days: 17.18.1 Any instance in which there is significant reduction in the effectiveness of any packaging during use; and 17.18.2 Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence; or 17.18.3 Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.

RH 17.19 Advance Notification of Transport of Nuclear Waste. 17.19.1 Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport to the governor, or governor's designee, 4of each state through which the waste will be transported. 4A list of the mailing addresses of the governors and governors' designees is available upon request from the Director, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. The list will be published annually in the Federal Register on or about June 30 to reflect any changes in information. 17.19.2 Advance notification is required only when:

17.19.2.1 The nuclear waste is required to be in Type B packaging for transportation; 17.19.2.2 The nuclear waste is being transported into, within, or through, a state enroute to a disposal facility or to a collection point for transport to a disposal facility; and 17.19.2.3 The quantity of licensed material in a single package exceeds any one of the following: 17.19.2.3.1 3000 times the A value of the radionuclides as specified in Appendix A, 1 Table A-1 for special form radioactive material;

17.19.2.3.2 3000 times the A value of the radionuclides as specified in Appendix A, 2 Table A-1 for normal form radioactive material;

17.19.2.3.3 1000 TBq (27,000 Ci);

17.19.3 Each advance notification required by RH 17.19.1 shall contain the following information: 17.19.3.1 The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;

17.19.3.2 A description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d);

17.19.3.3 The point of origin of the shipment and the 7-day period during which departure of the shipment is estimated to occur;

17.19.3.4 The 7-day period during which arrival of the shipment at state boundaries is estimated to occur;

17.19.3.5 The destination of the shipment, and the 7-day period during which arrival of the shipment is estimated to occur; and 17.19.3.6 A point of contact with a telephone number for current shipment information. 17.19.4 The notification required by RH 17.19.1 shall be made in writing to the office of each appropriate governor, or governor's designee, and to the Department. A notification delivered by mail must be postmarked at least 7 days before the beginning of the 7-day period during which departure of the shipment is estimated to occur. A notification delivered by messenger must reach the office of the governor, or governor's designee, at least 4 days before the beginning of the 7-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for 3 years.

17.19.5 The licensee shall notify each appropriate governor, or governor's designee, and the Department of any changes to schedule information provided pursuant to RH 17.19.1. Such notification shall be by telephone to a responsible individual in the office of the governor, or governor's designee, of the appropriate state or states. The licensee shall maintain for 3 years a record of the name of the individual contacted.

17.19.6 Each licensee who cancels a nuclear waste shipment, for which advance notification has been sent, shall send a cancellation notice to the governor, or governor's designee, of each appropriate state and to the Department. A copy of the notice shall be retained by the licensee for 3 years. Quality Assurance RH 17.20 Quality Assurance Reguirements.

17.20.1 Unless otherwise authorized by the agency, each licensee shall establish, maintain, and execute a quality assurance program to verify by procedures such as checking, auditing, and inspection that deficiencies, deviations, and defective material and equipment relating to the shipment of packages containing radioactive material are promptly identified and corrected. 17.20.2 The licensee shall identify the material and components to be covered by the quality assurance program.

17.20.3 Each licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which packaging is used.

17.20.4 Prior to the use of any package for the shipment of radioactive material, each licensee shall obtain approval by the Department of its quality assurance program. 17.20.5 The licensee shall maintain sufficient written records to demonstrate compliance with the quality assurance program. Records of quality assurance pertaining to the use of a package for shipment of radioactive material shall be maintained for a period of 3 years after shipment. 17.21 Referenced Materials 17.21.1 This Part 17 of these regulations incorporates by reference material originally published elsewhere. Certified copies of the complete text of incorporated materials referenced are available for public inspection during regular business hours at the radiation control division. Copies of referenced material will be provided at cost upon request. Information regarding how the incorporated material may be obtained or examined is available from: Director, Radiation Control Division (RCD-DO-B1) Colorado Department of Public Health and Environment 4300 Cherry Creek Drive South Denver, Colorado 80222-1530 17.21.2 Any material that has been incorporated by reference may be examined in any state publications depository library. Copies of the incorporated materials have been sent to the state publications depository and distribution center, and are available for interlibrary loan. 17.21.3 Material referenced in this Part 17 of the regulations does not include amendments to or revised editions of the material published later than the effective date of the relevant section. Appendix A to Part 17 - Determination of A1 and A2 I. Values of A and A for individual radionuclides, which are the bases for many activity limits elsewhere 1 2 in these regulations are given in Table A-1. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) figure. The curie values are expressed to three significant figures to assure that the difference in the TBq and Ci quantities is one tenth of one percent or less. Where values of A or A are unlimited, it is for radiation control purposes only. 1 2 For nuclear criticality safety, some materials are subject to controls placed on fissile material. II. For individual radionuclides whose identities are known, but which are not listed in Table A-1, the determination of the values of A and A requires Department approval, except that the values of 1 2 A and A in Table A-2 may be used without obtaining Agency approval. 1 2 III. In the calculations of A and A for a radionuclide not in Table A-1, a single radioactive decay chain, in 1 2 which radionuclides are present in their naturally occurring proportions, and in which no daughter nuclide has a half-life either longer than 10 days, or longer than that of the parent nuclide, shall be considered as a single radionuclide, and the activity to be taken into account, and the A or A 1 2 value to be applied shall be those corresponding to the parent nuclide of that chain. In the case of radioactive decay chains in which any daughter nuclide has a half-life either longer than 10 days, or greater than that of the parent nuclide, the parent and those daughter nuclides shall be considered as mixtures of different nuclides.

IV. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply:

(a) For special form radioactive material, the maximum quantity transported in a Type A package: ∑ B(i) less than or equal to 1 i A1 (i)

(b) For normal form radioactive material, the maximum quantity transported in a Type A package: ∑ B(i) less than or equal to 1 i A2 (i)

where B(i) is the activity of radionuclide I and A (i) and A (i) are the A and A values for 1 2 1 2 radionuclide respectively.

Alternatively, an A value for mixtures of special form material may be determined as follows: 1 where f(i) is the fraction of activity of nuclide i in the mixture and A (i) is the appropriate A value 1 1 for nuclide i.

V. When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A or A value, as 1 2 appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A or A values for the alpha emitters and beta/gamma 1 2 emitters.

Table A-1: A and A Values for Radionuclides 1 2 Symbol of Radionuclide Element and Atomie No A1 (TBq) A1 (Ci) a International shipments of Einsteinium require multilateral approval of A1 and A2 values. b International shipments of Fermium require multilateral approval of A1 and A2 values. c 99 20 Ci for Mo for domestic use.

Ac-225 Actinium(89) 0.6 16.2 Ac-227 40 1080 Ac-228 0.6 16.2 Ag-105 Silver(47) 2 54.1 Ag-108m 0.6 16.2 Ag-110m 0.4 10.8 Ag-111 0.6 16.2 Al-26 Aluminum(13) 0.4 10.8 Am-241 Americium(95) 2 54.1 Am-242m 2 54.1 Am-243 2 54.1 Ar-37 Argon(18) 40 1080 Ar-39 20 541 Ar-41 0.6 16.2 Ar-42 0.2 5.41 As-72 Arsenic(33) 0.2 5.41 As-73 40 1080 As-74 1 27.0 As-76 0.2 5.41 As-77 20 541 At-211 Astatine(85) 30 811 Au-193 Gold(79) 6 162 Au-194 1 27.0 Au-195 10 270 Au-196 2 54.1 Au-198 3 81.1 Au-199 10 270 Ba-131 Barium(56) 2 54.1 Ba-133m 10 270 Ba-133 3 81.1 Ba-140 0.4 10.8 Be-7 Beryllium(4) 20 541 Be-10 20 541 Bi-205 Bismuth(83) 0.6 16.2 Bi-206 0.3 8.11 Bi-207 0.7 18.9 Bi-210m 0.3 8.11 Bi-210 0.6 16.2 Bi-212 0.3 8.11 Bk-247 Berkelium(97) 2 54.1 Bk-249 40 1080 Br-76 Bromine(35) 0.3 8.11 Br-77 3 81.1 Br-82 0.4 10.8 C-11 Carbon(6) 1 27 C-14 40 1080 Ca-41 Calcium(20) 40 1080 Ca-45 40 1080 Ca-47 0.9 24.3 Cd-109 Cadmium(48) 40 1080 Cd-113m 20 541 Cd-115m 0.3 8.11 Cd-115 4 108 Ce-139 Cerium(58) 6 162 Ce-141 10 270 Ce-143 0.6 16.2 Ce-144 0.2 5.41 Cf-248 Californium(98) 30 811 Cf-249 2 54.1 Cf-250 5 135 Cf-251 2 54.1 Cf-252 0.1 2.70 Cf-253 40 1080 Cf-254 -3 -2 3×10 8.11×10 Cl-36 Chlorine(17) 20 541 Cl-38 0.2 5.41 Cm-240 Curium(96) 40 1080 Cm-241 2 54.1 Cm-242 40 1080 Cm-243 3 81.1 Cm-244 4 108 Cm-245 2 54.1 Cm-246 2 54.1 Cm-247 2 54.1 Cm-248 -2 1.08 4×10 Co-55 Cobalt(27) 0.5 13.5 Co-56 0.3 8.11 Co-57 8 216 Co-58m 40 1080 Co-58 1 27.0 Co-60 0.4 10.8 Cr-51 Chromium(24) 30 811 Cs-129 Cesium(55) 4 108 Cs-131 40 1080 Cs-132 1 27.0 Cs-134m 40 1080 Cs-134 0.6 16.2 Cs-135 40 1080 Cs-136 0.5 13.5 Cs-137 2 54.1 Cu-64 Copper(29) 5 135 Cu-67 9 243 Dy-159 Dysprosium(66) 20 541 Dy-165 0.6 16.2 Dy-166 0.3 8.11 Er-169 Erbium(68) 40 1080 Er-171 0.6 16.2 Es-253 a 200 5400 Einsteinium(99)

Es-254 30 811 Es-254m 0.6 16.2 Es-255 — — Eu-147 Europium(63) 2 54.1 Eu-148 0.5 13.5 Eu-149 20 541 Eu-150 0.7 18.9 Eu-152m 0.6 16.2 Eu-152 0.9 24.3 Eu-154 0.8 21.6 Eu-155 20 541 Eu-156 0.6 16.2 F-18 Fluorine(9) 1 27.0 Fe-52 Iron(26) 0.2 5.41 Fe-55 40 1080 Fe-59 0.8 21.6 Fe-60 40 1080 Fm-255 b 40 1080 Fermium(100)

Fm-257 10 270 Ga-67 Gallium(31) 6 162 Ga-68 0.3 8.11 Ga-72 0.4 10.8 Gd-146 Gadolinium(64) 0.4 10.8 Gd-148 3 81.1 Gd-153 10 270 Gd-159 4 108 Ge-68 Germanium(32) 0.3 8.11 Ge-71 40 1080 Ge-77 0.3 8.11 H-3 Hydrogen(1) See T-Tritium Hf-172 Hafnium(72) 0.5 13.5 Hf-175 3 81.1 Hf-181 2 54.1 Hf-182 4 108 Hg-194 Mercury(80) 1 27.0 Hg-195m 5 135 Hg-197m 10 270 Hg-197 10 270 Hg-203 4 108 Ho-163 Holmium(67) 40 1080 Ho-166m 0.6 16.2 Ho-166 0.3 8.11 I-123 Iodine(53) 6 162 I-124 0.9 24.3 I-125 20 541 I-126 2 54.1 I-129 Unlimited Unlimited I-131 3 81.1 I-132 0.4 10.8 I-133 0.6 16.2 I-134 0.3 8.11 I-135 0.6 16.2 In-111 Indium(49) 2 54.1 In-113m 4 108 In-114m 0.3 8.11 In-115m 6 162 Ir-189 Iridium(77) 10 270 Ir-190 0.7 18.9 Ir-192 1 27.0 Ir-193m 10 270 Ir-194 0.2 5.41 K-40 Potassium(19) 0.6 16.2 K-42 0.2 5.41 K-43 1.0 27.0 Kr-81 Krypton(36) 40 1080 Kr-85m 6 162 Kr-85 20 541 Kr-87 0.2 5.41 La-137 Lanthanum(57) 40 1080 La-140 0.4 10.8 Lu-172 Lutetium(71) 0.5 13.5 Lu-173 8 216 Lu-174m 20 541 Lu-174 8 216 Lu-177 30 811 MFP For mixed fission products, use formula for mixtures or Table A-2. Mg-28 Magnesium(12) 0.2 5.41 Mn-52 Manganese(25) 0.3 8.11 Mn-53 Unlimited Unlimited Mn-54 1 27.0 Mn-56 0.2 5.41 Mo-93 Molybdenum(42) 40 1080 Mo-99 0.6 16.2 N-13 Nitrogen(7) 0.6 16.2 Na-22 Sodium(11) 0.5 13.5 Na-24 0.2 5.41 Nb-92m Niobium(41) 0.7 18.9 Nb-93m 40 1080 Nb-94 0.6 16.2 Nb-95 1 27.0 Nb-97 0.6 16.2 Nd-147 Neodymium(60) 4 108 Nd-149 0.6 16.2 Ni-59 Nickel(28) 40 1080 Ni-63 40 1080 Ni-65 0.3 8.11 Np-235 Neptunium(93) 40 1080 Np-236 7 189 Np-237 2 54.1 Np-239 6 162 Os-185 Osmium(76) 1 27.0 Os-191m 40 1080 Os-191 10 270 Os-193 0.6 16.2 Os-194 0.2 5.41 P-32 Phosphorus(15) 0.3 8.11 P-33 40 1080 Pa-230 Protactinium(91) 2 54.1 Pa-231 0.6 16.2 Pa-233 5 135 Pb-201 Lead(82) 1 27.0 Pb-202 40 1080 Pb-203 3 81.1 Pb-205 Unlimited Unlimited Pb-210 0.6 16.2 Pb-212 0.3 8.11 Pd-103 Palladium(46) 40 1080 Pd-107 Unlimited Unlimited Pd-109 0.6 16.2 Pm-143 Promethium(61) 3 81.1 Pm-144 0.6 16.2 Pm-145 30 811 Pm-147 40 1080 Pm-148m 0.5 13.5 Pm-149 0.6 16.2 Pm-151 3 81.1 Po-208 Polonium(84) 40 1080 Po-209 40 1080 Po-210 40 1080 Pr-142 Praseodymium(59) 0.2 5.41 Pr-143 4 108 Pt-188 Platinum(78) 0.6 16.2 Pt-191 3 81.1 Pt-193m 40 1080 Pt-193 40 1080 Pt-195m 10 270 Pt-197m 10 270 Pt-197 20 541 Pu-236 Plutonium(94) 7 189 Pu-237 20 541 Pu-238 2 54.1 Pu-239 2 54.1 Pu-240 2 54.1 Pu-241 40 1080 Pu-242 2 54.1 Pu-244 0.3 8.11 Ra-223 Radium(88) 0.6 16.2 Ra-224 0.3 8.11 Ra-225 0.6 16.2 Ra-226 0.3 8.11 Ra-228 0.6 16.2 Rb-81 Rubidium(37) 2 54.1 Rb-83 2 54.1 Rb-84 1 27.0 Rb-86 0.3 8.11 Rb-87 Unlimited Unlimited Rb (natural) Unlimited Unlimited Re-183 Rhenium(75) 5 135 Re-184m 3 81.1 Re-184 1 27.0 Re-186 4 108 Re-187 Unlimited Unlimited Re-188 0.2 5.41 Re-189 4 108 Re (natural) Unlimited Unlimited Rh-99 Rhodium(45) 2 54.1 Rh-101 4 108 Rh-102m 2 54.1 Rh-102 0.5 13.5 Rh-103m 40 1080 Rh-105 10 270 Rn-222 Radon(86) 0.2 5.41 Ru-97 Ruthenium(44) 4 108 Ru-103 2 54.1 Ru-105 0.6 16.2 Ru-106 0.2 5.41 S-35 Sulfur(16) 40 1080 Sb-122 Antimony(51) 0.3 8.11 Sb-124 0.6 16.2 Sb-125 2 54.1 Sb-126 0.4 10.8 Sc-44 Scandium(21) 0.5 13.5 Sc-46 0.5 13.5 Sc-47 9 243 Sc-48 0.3 8.11 Se-75 Selenium(34) 3 81.1 Se-79 40 1080 Si-31 Silicon(14) 0.6 16.2 Si-32 40 1080 Sm-145 Samarium(62) 20 541 Sm-147 Unlimited Unlimited Sm-151 40 1080 Sm-153 4 108 Sn-113 Tin(50) 4 108 Sn-117m 6 162 Sn-119m 40 1080 Sn-121m 40 1080 Sn-123 0.6 16.2 Sn-125 0.2 5.41 Sn-126 0.3 8.11 Sr-82 Strontium(38) 0.2 5.41 Sr-85m 5 135 Sr-85 2 54.1 Sr-87m 3 81.1 Sr-89 0.6 16.2 Sr-90 0.2 5.41 Sr-91 0.3 8.11 Sr-92 0.8 21.6 T Tritium(1) 40 1080 Ta-178 Tantalum(73) 1 27.0 Ta-179 30 811 Ta-182 0.8 21.6 Tb-157 Terbium(65) 40 1080 Tb-158 1 27.0 Tb-160 0.9 24.3 Tc-95m Technetium(43) 2 54.1 Tc-96m 0.4 10.8 Tc-96 0.4 10.8 Tc-97m 40 1080 Tc-97 Unlimited Unlimited Tc-98 0.7 18.9 Tc-99m 8 216 Tc-99 40 1080 Te-118 Tellurium(52) 0.2 5.41 Te-121m 5 135 Te-121 2 54.1 Te-123m 7 189 Te-125m 30 811 Te-127m 20 541 Te-127 20 541 Te-129m 0.6 16.2 Te-129 0.6 16.2 Te-131m 0.7 18.9 Te-132 0.4 10.8 Th-227 Thorium(90) 9 243 Th-228 0.3 8.11 Th-229 0.3 8.11 Th-230 2 54.1 Th-231 40 1080 Th-232 Unlimited Unlimited Th-234 0.2 5.41 Th (natural) Unlimited Unlimited Ti-44 Titanium(22) 0.5 13.5 Tl-200 Thallium(81.1) 0.8 21.6 Tl-201 10 270 Tl-202 2 54.1 Tl-204 4 108 Tm-167 Thulium(69) 7 189 Tm-168 0.8 21.6 Tm-170 4 108 Tm-171 40 1080 U-230 Uranium(92) 40 1080 U-232 3 81.1 U-233 10 270 U-234 10 270 U-235 Unlimited Unlimited U-236 10 270 U-238 Unlimited Unlimited U (natural) Unlimited Unlimited U (enriched 5% or less) Unlimited Unlimited U (enriched more than 5%) 10 270 U (depleted) Unlimited Unlimited V-48 Vanadium(23) 0.3 8.11 V-49 40 1080 W-178 Tungsten(74) 1 27.0 W-181 30 811 W-185 40 1080 W-187 2 54.1 W-188 0.2 5.41 Xe-122 Xenon(54) 0.2 5.41 Xe-123 0.2 5.41 Xe-127 4 108 Xe-131m 40 1080 Xe-133 20 541 Xe-135 4 108 Y-87 Yttrium(39) 2 54.1 Y-88 0.4 10.8 Y-90 0.2 5.41 Y-91m 2 54.1 Y-91 0.3 8.11 Y-92 0.2 5.41 Y-93 0.2 5.41 Yb-169 Ytterbium(70) 3 81.1 Yb-175 30 811 Zn-65 Zinc(30) 2 54.1 Zn-69m 2 54.1 Zn-69 4 108 Zr-88 Zirconium(40) 3 81.1 Zr-93 40 1080 Zr-95 1 27.0 Zr-97 0.3 8.11 Table A-2: General Values for A1 and A2 A1 A2 Contents (TBq) (Ci) (TBq)

Only beta- or gamma- 0.2 5 0.02 emitting nuclides are known to be present.

Alpha-emitting nuclides 0.10 2.70 -5 2×10 are known to be present, or no relevant data are available.

Table A-3: Activity-mass Relationships for Uranium Uranium Enrichment* wt Specific Activity % U-235 present TBq/g Ci/g *The figures for uranium include representative values for the activity of the uranium-235 which is concentrated during the enrichment process. 0.45 -8 -7 1.8×10 5.0×10 0.72 -8 -7 2.6×10 7.1×10 1.0 -8 -7 2.8×10 7.6×10 1.5 -8 -6 3.7×10 1.0×10 5.0 -7 -6 1.0×10 2.7×10 10.0 -7 -6 1.8×10 4.8×10 20.0 -7 -5 3.7×10 1.0×10 35.0 -7 -5 7.4×10 2.0×10 50.0 -7 -5 9.3×10 2.5×10 90.0 -6 -5 2.2×10 5.8×10 93.0 -6 -5 2.6×10 7.0×10 95.0 -6 -5 3.4×10 9.1×10 PART 18 LICENSING REQUIREMENTS FOR URANIUM AND THORIUM PROCESSING RH 18.1 Purpose and Scope.

18.1.1 The regulations in this part establish criteria, terms and conditions upon which the Department issues licenses to receive title to, receive, possess, use, transfer, or deliver source and byproduct materials, to operate uranium and thorium processing facilities and for the disposition of the resulting byproduct material. The requirements of this part are in addition to, and not in substitution for, other applicable requirements of these regulations. 18.1.2 This part establishes performance objectives and procedural requirements applicable to any uranium or thorium material processing operation, to waste systems for byproduct material as in definition (2) of RH 1.4, and to related activities concerning uranium- bearing and thorium-bearing materials. It establishes specific technical and financial requirements for siting, construction, operation, and decontamination, reclamation and ultimate stabilization, as well as requirements for license transfer and termination, long- term site monitoring and surveillance, and ownership and ultimate custody of source material milling facilities and byproduct material impoundments. 18.1.3 The requirements of this part apply to byproduct material that is located at a site where milling operations are no longer active, if such site is not covered by the remedial action program of Title I of the Uranium Mill Tailings Radiation Control Act (UMTRCA) OF 1978 (92 STAT. 3021; 42 U.S.C. 7901). The regulations in this part do not establish procedures and criteria for the issuance of licenses for materials covered under Title I of the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021) unless that program fails to accomplish remedial action. Disposal at a uranium or thorium processing site of radioactive material which is not type 2 byproduct material must not inhibit reclamation of the tailings impoundment or the ability of the U.S. Government to take title to the impoundment as long-term custodian.

RH 18.2 As used in this regulation:

“Active maintenance” means any significant activity needed during the period of long term care including ongoing activities such as the pumping and treatment of water from a site or one-time measures such as replacement of a disposal site's cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal site cover, and general disposal site upkeep such as mowing grass.

“Aquifer” means a geologic formation, group of formations, or part of a formation capable of yielding a significant amount of ground water to wells or springs. Any saturated zone created by uranium or thorium operations would not be considered an aquifer unless the zone is or potentially is:

(1) hydraulically interconnected to a natural aquifer;

(2) capable of discharge to surface water; or (3) reasonably accessible because of migration beyond the vertical projection of the boundary of the land transferred for long-term government ownership and care in accordance with Criterion 9 of Appendix A to this Part 18.

“As expeditiously as practicable considering technological feasibility”, for the purposes of Criterion 6A, means as quickly as possible considering: the physical characteristics of the tailings and the site; the limits of available technology; the need for consistency with mandatory requirements of other regulatory programs; and factors beyond the control of the licensee. The phrase permits consideration of the cost of compliance only to the extent specifically provided for by use of the term available technology.

“Available radon barrier technology” means technologies and methods for emplacing a final radon barrier on uranium mill tailings piles or impoundments. This term shall not be construed to include extraordinary measures or techniques that would impose costs that are grossly excessive as measured by practice within the industry (or one that is reasonably analogous), (such as, by way of illustration only, unreasonable overtime, staffing, or transportation requirements, etc., considering normal practice in the industry; laser fusion of soils, etc.), provided there is reasonable progress toward emplacement of the final radon barrier. To determine grossly excessive costs, the relevant baseline against which cost shall be compared is the cost estimate for tailings impoundment closure contained in the licensee's approved reclamation plan, but costs beyond these estimates shall not automatically be considered grossly excessive. “Closure” means the activities following operations to decontaminate and decommission the buildings and site used to produce byproduct materials and reclaim the tailings and/or waste disposal area.

“Closure plan” means the Department approved plan to accomplish closure. “Compliance period” begins when the Department sets secondary ground-water protection standards and ends when the owner or operator's license is terminated and the site is transferred to the State or Federal agency for long-term care.

“Dike” means an embankment or ridge of either natural or man-made materials used to prevent the movement of liquids, sludges, solids, or other materials. “Disposal area” means the area containing byproduct materials to which the requirements of Criterion 6 of Appendix A to this Part 18 apply.

“Disposal site” means all land that is subject to transfer to a government agency after termination of the license.

“Existing portion” means that land surface area of an existing surface impoundment on which significant quantities of uranium or thorium byproduct materials had been placed prior to September 30, 1983.

“Factors beyond the control of the licensee” means factors proximately causing delay in meeting the schedule in the applicable reclamation plan for the timely emplacement of the final radon barrier notwithstanding the good faith efforts of the licensee to complete the barrier in compliance with paragraph (1) of Criterion 6A. These factors may include, but are not limited to: (1) physical conditions at the site;

(2) inclement weather or climatic conditions;

(3) an act of god;

(4) an act of war;

(5) a judicial or administrative order or decision, or change to the statutory, regulatory, or other legal requirements applicable to the licensee's facility that would preclude or delay the performance of activities required for compliance;

(6) labor disturbances;

(7) any modifications, cessation or delay ordered by state, federal, or local agencies; (8) delays beyond the time reasonably required in obtaining necessary government permits, licenses, approvals, or consent for activities described in the reclamation plan proposed by the licensee that result from agency failure to take final action after the licensee has made a good faith, timely effort to submit legally sufficient applications, responses to requests (including relevant data requested by the agencies), or other information, including approval of the reclamation plan; and (9) an act or omission of any third party over whom the licensee has no control. “Final radon barrier” means the earthen cover (or approved alternative cover) over tailings or waste constructed to comply with Criterion 6 of this Appendix (excluding erosion protection features).

“Ground water” means water below the land surface in a zone of saturation. For purposes of Appendix A to this Part 18, ground water is the water contained within an aquifer as defined above.

“Leachate” means any liquid, including any suspended or dissolved components in the liquid that has percolated through or drained from the byproduct material. “Licensed site” means the area contained within the boundary of a location under the control of persons generating or storing radioactive materials under a Department license. “Liner” means a continuous layer of natural or man-made materials, beneath or on the sides of a surface impoundment, which restricts the downward or lateral escape of byproduct material, hazardous constituents, or leachate.

“Long term care” means the observation and maintenance of a site following the postclosure period and termination of the license.

“Milestone” means an action or event that is required to occur by an enforceable date. “Monitoring” means observing and making measurements to provide data to evaluate the performance and characteristics of a site.

“Operation” means that a uranium or thorium mill tailings pile or impoundment is being used for the continued placement of byproduct material or is in standby status for such placement. A pile or impoundment is in operation from the day that byproduct material is first placed in the pile or impoundment until the day final closure begins.

“Point of compliance” is the site specific location in the uppermost aquifer where the ground-water protection standard must be met.

“Postclosure” means the period of time from completion of the site closure plan for decontamination, reclamation, and stabilization of the site and disposal area and prior to the termination of the license.

“Reclamation plan”, for the purposes of Criterion 6A of Appendix A of this Part 18, means the plan detailing activities to accomplish reclamation of the tailings or waste disposal area in accordance with the technical criteria of Appendix A of this Part. The reclamation plan must include a schedule for reclamation milestones that are key to the completion of the final radon barrier including as appropriate, but not limited to, wind blown tailings retrieval and placement on the pile, interim stabilization (including dewatering or the removal of freestanding liquids and recontouring), and final radon barrier construction. (Reclamation of tailings must also be addressed in the closure plan; the detailed reclamation plan may be incorporated into the closure plan.)

“Surface impoundment” means a natural topographic depression, man-made excavation, or diked area, which is designed to hold an accumulation of liquid wastes or wastes containing free liquids, and which is not an injection well.

“Surveillance” means the observation of the site for the purposes of visual detection of the need for maintenance, custodial care, evidence of unauthorized access, and compliance with other license and regulatory requirements.

“Third-party contractor” or “Third-party agreement” means a legal or contractual mechanism whereby an applicant or licensee voluntarily agrees to pay for the services, solely selected and supervised by the Department, of qualified persons not Department staff nor under contract directly to the Department.

“Uppermost aquifer” means the geologic formation nearest the natural ground surface that is an aquifer, as well as lower aquifers that are hydraulically interconnected with this aquifer within the facility's property boundary.

RH 18.3 Special Requirements for Issuance of Specific Licenses For Source Material Milling. In addition to the requirements set forth in RH 3.8 and 3.9, a specific license for source material milling will be issued if the applicant submits to the Department a complete and accurate application that clearly demonstrates how objectives and requirements of this Part are met. Failure to clearly so demonstrate shall be grounds for refusing to accept an application. 18.3.1 An application for a license or to amend or renew an existing license to receive, possess, and use source material for milling or byproduct material as in definition (2) of RH 1.4 shall include all information required under these regulations and such other information as the Department may deem necessary, and shall address the following: 18.3.1.1 Description of the proposed project or action; 18.3.1.2 Area/site characteristics including geology, topography, hydrology and meteorology;

18.3.1.3 Radiological and nonradiological impacts of the proposed project or action, including waterway and groundwater impacts;

18.3.1.4 Environmental effects of accidents;

18.3.1.5 Tailings disposal and decommissioning;

18.3.1.6 Site and project alternatives.

18.3.2 The applicant shall provide procedures describing the means employed to meet the following requirements during the operational phase of any project. 18.3.2.1 Milling operations shall be conducted so that all releases are reduced to as low as is reasonably achievable below the limits of Part 4. 18.3.2.2 The mill operator shall conduct at least daily inspection of any tailings or waste retention systems. The inspection shall be performed by a person who is qualified and approved by the Department. Records of such inspections shall be maintained for review by the Department.

18.3.2.3 The mill operator shall immediately notify the Department of the following: 18.3.2.3.1 Any failure in a tailings or waste retention system which results in a release of tailings or waste into uncontrolled areas; and 18.3.2.3.2 Any unusual conditions which are not contemplated in the design of the retention system and which if not corrected could lead to failure of the system and result in a release of tailings or waste into uncontrolled areas.

18.3.3 During any one full year prior to any major site construction, the applicant/licensee shall conduct a preoperational monitoring program to provide complete baseline data on a milling site and its environs. Throughout the construction and operating phases of the mill, the applicant/licensee shall conduct an operational monitoring program to measure or evaluate compliance with applicable standards and regulations, to evaluate performance of control systems and procedures, to evaluate environmental impacts of operation, and to detect potential long-term effects.

18.3.4 The environmental report required by RH 3.8.8 shall contain all information deemed necessary by the agency to assist the agency in the evaluation of the short-term and long-range environmental impact of the project and activity so that the agency may weigh environmental, economic, technical, and other benefits against environmental costs, while considering available alternatives. The environmental report shall be submitted nine (9) months prior to the anticipated commencement of construction unless an exemption as provided by RH 3.8.7.1 has been obtained from the Department. 18.3.5 The following types of actions require an applicant's environmental report: i. Issuance or renewal of a source material milling license; ii. Issuance of an amendment that would authorize or result in: (1) A significant expansion of a site;

(2) A significant change in the types of releases;

(3) A significant increase in the amounts of releases;

(4) A significant increase in individual or cumulative occupational radiation exposure; or (5) A significant increase in the potential for or consequences from radiological accidents.

18.3.6 An application for a license to receive, possess and use source material for milling or byproduct material as in definition (2) of RH 1.4 shall contain proposed specifications relating to the milling operations and the disposition of tailings or wastes resulting from such milling activities to achieve the requirements and objectives set forth in the criteria listed in Appendix A to this Part 18. Each application for a new license or for license renewal must clearly demonstrate how the requirements and objectives set forth in Appendix A to this Part 18 have been addressed. Failure to clearly demonstrate how the requirements and objectives in Appendix A to this Part 18 have been addressed shall be grounds for refusing to accept an application.

RH 18.4 Environmental Impact Analysis 18.4.1 For each license application or application to amend or renew an existing license to receive, possess, or use source material for uranium or thorium milling or byproduct material as in definition (2) of RH 1.4 which will have a significant impact on the environment, the Department shall prepare a written analysis of the impact of the licensed activity on the environment, which shall be available to the public and for review by the U.S. Nuclear Regulatory Commission at the time of public notice of hearing, which analysis shall include:

18.4.1.1 An assessment of the radiological and nonradiological impacts to the public health;

18.4.1.2 An assessment of any impact on any waterway and ground water; 18.4.1.3 Consideration of alternatives to the activities to be conducted; and 18.4.1.4 Consideration of the long-term impacts of the licensed activities. 18.4.2 In preparing the environmental impact analysis, the Department may use and incorporate by reference the environmental report prepared by the applicant as required by RH 3.8.8 and environmental assessments prepared by Federal, State or local agencies. 18.4.3 The environmental impact analysis, or any part thereof, shall be prepared directly by the Department or the Department shall utilize the third party method set forth in RH 3.13. RH 18.5 Prior to issuance of the license, the applicant shall (1) establish financial assurance arrangements, as provided by RH 3.9.5, to ensure decontamination and decommissioning of the facility and (2) provide a fund adequate to cover the payment of the cost for long-term care and monitoring as provided by RH 3.9.5.10. Such fund shall be sufficient to meet the requirements of RH 3.9.5.10.4. The Department will consider proposals to combine the two types of financial assurance. Financial assurance shall be provided prior to commencement of construction or operation.

RH 18.6 License Hearings 18.6.1 There shall be an opportunity for public hearings to be held in accordance with the procedures in 24-4-104 and 24-4-105, C.R.S. 1973, as amended, and RH 18.6, prior to the granting, denial or renewal of a specific license permitting the receipt, possession or use of source material for milling or byproduct material as in definition (2) of RH 1.4. 18.6.2 Notice of Hearing 18.6.2.1 All hearings shall be preceded by written notice containing: 18.6.2.1.1 The nature of the hearing and its time and place; 18.6.2.1.2 The legal authority and jurisdiction under which the hearing is to be held;

18.6.2.1.3 The matters of fact and law asserted or to be considered; 18.6.2.1.4 A description of the proposed licensing action and a statement of the availability of its text from the Department;

18.6.2.1.5 A description of the right of any interested person to make written comments to the Department or present oral comments at the hearing; 18.6.2.1.6 The procedure for applying to become a party to the hearing; and 18.6.2.1.7 A description of the procedures to be followed at the hearing and at a prehearing conference if required.

18.6.2.2 The notice of the hearing shall be mailed by the Department to the licensee or applicant and to each person who has filed a written request to receive notice of such proceedings. The licensee or applicant shall cause the notice to be published for three (3) days in a newspaper of statewide circulation and in local newspapers designated by the Department in the area to be affected by the proposed action. The notice shall be mailed and published not less than ninety (90) days prior to the hearing.

18.6.2.3 The time and place of hearing will be fixed with due regard for the convenience of the parties or their representatives, and the public interest. The hearing will be held in the locale of the site to be licensed.

18.6.2.4 The cost of any licensing action hearing shall be at the expense of the applicant. These costs shall include, but not be limited to, the hearing officer, the meeting room, the court reporter and transcript copies, and the required notices. The costs shall not include the expenses of other parties to the hearing. 18.6.3 Party Status 18.6.3.1 A person who may be affected or aggrieved by Department action may apply for party status not less than twenty (20) days prior to the hearing. Thereafter, application to be made a party shall not be considered except upon motion for good cause shown.

18.6.3.2 Application for party status must identify the individual or group applying, including the address or phone number where they may be contacted, state the nature of their interest in the hearing and the specific ground on which they claim to be affected or aggrieved, and the specific aspects of the hearing which they wish to address.

18.6.3.3 The Department, or the hearing officer, will grant or deny party status within five (5) days after receipt of the request for party status based on the nature and extent of the person's property, financial or other interest in the hearing and the possible effect of any order which may be entered as a result of the hearing on the person's interest. Any person applying for or granted party status may, by motion to the hearing officer or Department, as appropriate, challenge the right of any other person to be a party.

18.6.3.4 Parties shall have the right to initiate discovery. Parties shall have the right to make motions or objections, present evidence, cross-examine witnesses, and appeal from the decision of the hearing as provided by the Colorado Administrative Procedures Act, 24-4-101 et seq., C.R.S. 1973, as amended. 18.6.3.5 A person who is not a party will be permitted to submit written comments to the Department and may be permitted to make an oral presentation at the hearing, but will not have the other rights of a party.

18.6.4 Prehearing Conference 18.6.4.1 The Department or hearing officer, on its own motion or at the request of any party or any person who has applied to become a party, may direct the parties to appear at a specific time and place for a conference to consider: 18.6.4.1.1 The simplification and clarification of the issues; 18.6.4.1.2 The obtaining of stipulations and admissions of fact and of the contents and authenticity of documents to avoid unnecessary proof; 18.6.4.1.3 Identification of witnesses and the limitation of the number of expert witnesses, and other steps to expedite the presentation of evidence; 18.6.4.1.4 The setting of a hearing schedule;

18.6.4.1.5 Granting or denying requests for party status, if such decisions have not previously been made;

18.6.4.1.6 Such other matters as may aid in the orderly disposition of the hearing.

18.6.4.2 At such conference each party or person who has applied to become a party shall present to every other person, party, and the Department a prehearing statement containing the following:

18.6.4.2.1 A brief summary of the nature of the claim of the party and the basis therefore;

18.6.4.2.2 A copy of all exhibits proposed to be introduced; and 18.6.4.2.3 A list of all witnesses who may be called and a brief description of their testimony.

18.6.4.3 Except for good cause shown or for evidence or testimony accepted as rebuttal, no witness may testify nor may any exhibits be introduced on behalf of a party who had notice of the prehearing conference unless such witness has been previously listed and/or his written testimony and related exhibits have been presented to opposing parties at the prehearing conference. 18.6.4.4 The Department or hearing officer shall issue a written summary of the action taken at the conference and agreements by the parties, which limits the issues or defines the matters in controversy to be determined in the hearing. 18.6.5 Discovery 18.6.5.1 Any party may initiate discovery in the form of interrogatories to another party, requests for admission to another party, requests for production of documents to another party, or depositions of any persons, or any combination thereof. The Colorado Rules of Civil Procedure, to the extent not inconsistent with the Colorado Administrative Procedure Act, shall apply. Such discovery may be modified by a motion for protective order filed with the Department or hearing officer within seven (7) days of receipt of the notice or request for discovery. Motions for protective order shall set forth the grounds in support thereof and shall be ruled upon immediately. Discovery shall be completed no later than ten (10) days preceding the hearing date, except as otherwise ordered by the Department or hearing officer.

18.6.6 Conduct of Hearings 18.6.6.1 Hearing presentations will proceed in the following order unless otherwise directed by the Department or hearing officer.

18.6.6.1.1 Call to order, introductory remarks, and action on applications for party status, if not already decided.

18.6.6.1.2 Presentation of any stipulations or agreements of the parties, and any other matters which were required to be dealt with at the prehearing conference, if held.

18.6.6.1.3 Opening statement by the party upon whom the burden of proof rests. 18.6.6.1.4 Opening statements by all other parties.

18.6.6.1.5 Presentation of case by party upon whom burden of proof rests. 18.6.6.1.6 Presentation by all other persons wishing to offer evidence in the order to be determined by the Department or hearing officer. 18.6.6.1.7 Rebuttal by the party upon whom the burden of proof rests, followed by rebuttal of other parties.

18.6.6.1.8 Closing statements by party upon whom the burden of proof rests, followed by closing statements of all other parties.

18.6.6.2 Public participation as provided for in these rules shall be allowed at that time or times during the hearing as determined by the Department or hearing officer in their discretion to be appropriate.

18.6.6.3 At the conclusion of any witness's testimony, or at the conclusion of the party's entire presentation, as may be determined by the Department or hearing officer, all parties may then cross-examine such witness or witnesses. The Department or hearing officer may examine and cross-examine any witness. A person who is not a party shall not have the right to cross-examine.

18.6.6.4 Any person, not a party to the proceeding, wishing to present testimony may do so by indicating his desire in writing. A form will be available prior to and during the hearing. This form will request the person's name, address, whom he represents, the general nature of his testimony, and the time required for his presentation. This form is to be presented to a representative of the Department during the hearing. Voluntary testimony not specifically requested on or by the written form may also be allowed. Any person presenting testimony shall be under oath and be subject to cross examination.

18.6.6.5 The proponent of any motion, order, or license issuance bears the burden of proof.

18.6.6.6 No interested person, party, or applicant for party status outside the Department will have any oral or written communication with any Department personnel or hearing officer relevant to the merits of a hearing pending before the Department unless reasonable prior notice is given to all participants in the hearing. This prohibition shall apply after the hearing is noticed. Any Department employee or hearing officer who is involved in such a prohibited communication shall make a written record of it and transmit it to all the parties to the hearing. 18.6.7 Department Decision 18.6.7.1 Any party to a hearing may, or if so directed by the Department or the hearing officer shall, file proposed findings of fact and conclusions of law and a proposed form of order or decision within twenty (20) days after the record is closed. A party who has the burden of proof may reply within ten (10) days after service of proposed findings of fact and conclusions of law.

18.6.7.2 After due consideration of the hearing record, the Department or hearing officer shall issue its findings of fact, conclusions of law, and decision and order. RH 18.7 Operational Requirements. Each licensee authorized to receive, possess or use source material for milling or byproduct material as in definition (2) of RH 1.4 shall: 18.7.1 Operate in accordance with the requirements of this Part 18, in particular the procedures required by RH 18.3.2, monitoring required by 18.3.3, and the requirements and objectives of Appendix A to this Part 18.

18.7.2 Submit a report to the Department within 60 days after January 1 and July 1 of each year, specifying the quantity of each of the radioactive materials released to unrestricted areas in liquid and in gaseous effluents during the previous six months of operation, and such other information as the Department may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases. If quantities of radioactive materials released during the reporting period are significantly above the licensee's design objectives previously reviewed as part of the licensing action, the report shall cover this specifically. On the basis of such reports and any additional information the Department may obtain from the licensee or others, the Department may from time to time require the licensee to take such action as the Department deems appropriate. RH 18.8 Decommissioning Requirements.

18.8.1 In addition to the information required under RH 3.16, each licensee authorized to receive, possess or use source material for milling or byproduct material as in definition (2) of RH 1.4 shall submit a plan for completion of decommissioning if the procedures necessary to carry out decommissioning:

18.8.1.1 Have not been previously approved by the Department; and 18.8.1.2 Could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

18.8.1.2.1 Procedures would involve techniques not applied routinely during cleanup or maintenance operations; or 18.8.1.2.2 Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered; or 18.8.1.2.3 Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or 18.8.1.2.4 Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation. 18.8.2 Procedures with potential health and safety impacts may not be carried out prior to approva of the decommissioning plan.

18.8.3 The proposed decommissioning plan, if required by RH 18.8.1 or by license condition, must include:

18.8.3.1 Description of planned decommissioning activities; 18.8.3.2 Description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning; 18.8.3.3 A description of the planned final radiation survey; and 18.8.3.4 An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning. 18.8.4 The proposed decommissioning plan will be approved by the Department if the information therein demonstrates that the decommissioning will be completed as soon as is reasonable and that the health and safety of workers and the public will be adequately protected.

18.8.5 Upon approval of the decommissioning plan by the Department, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall submit the information required in RH 3.16.4.1.5 and shall certify the disposition of accumulated wastes from decommissioning. 18.8.6 If the information submitted under RH 3.16.4.1.5 or 18.8 does not adequately demonstrate that the premises are suitable for release for unrestricted use, the Department will inform the licensee of the appropriate further actions required for termination of license. PART 18 APPENDIX A CRITERIA RELATING TO THE OPERATION OF MILLS AND THE DISPOSITION OF THE TAILINGS OR WASTES FROM THESE OPERATIONS Introduction: Every applicant for a license to possess and use radioactive material in conjunction with uranium or thorium milling, or byproduct material at sites formerly associated with such milling, is required by the provisions of RH 18.3 to include in a license application proposed specifications relating to milling operations and the disposition of tailings or wastes resulting from such milling activities. This appendix establishes technical, ownership, and long-term site surveillance criteria relating to the siting, operation, decontamination, decommissioning, and reclamation of mills and tailings or waste systems and sites at which such mills and systems are located.

As used in this appendix, the term “as low as is reasonably achievable” has the same meaning as in RH 1.4.

In many cases, flexibility is provided in the criteria to allow achieving an optimum tailings disposal program on a site-specific basis. However, in such cases the objectives, technical alternatives and concerns which must be taken into account in developing a tailings program are identified. As provided by the provisions of RH 18.3, applications for licenses must clearly demonstrate how the criteria have been addressed.

The specifications shall be developed considering the expected full capacity of tailings or waste systems and the lifetime of mill operations. Where later expansions of systems or operations may be likely (for example, where large quantities of ore now marginally uneconomical may be stockpiled), the amenability of the disposal system to accommodate increased capacities without degradation in long-term stability and other performance factors shall be evaluated.

Licensees or applicants may propose to the Department alternatives to meet the specific requirements in this Appendix. The alternative proposals may take into account local or regional conditions, including geology, topography, hydrology, and meteorology. The Department may find that the proposed alternatives meet the Department's requirements if the alternatives will achieve a level of stabilization and containment of the sites concerned and a level of protection for public health, safety, and the environment from radiological and nonradiological hazards associated with the site, which is equivalent to, to the extent practicable, or more stringent than the level which would be achieved by the requirements of this Appendix and the standards promulgated by the Environmental Protection Agency in 40 CFR Part 192, Subparts D and E. Proposed alternatives to specific regulations in this Part 18 require notice and opportunity for hearing before the U.S. Nuclear Regulatory Commission. All site-specific licensing decisions based on the criteria in this Appendix or alternatives proposed by licensees or applicants will take into account the risk to the public health and safety and the environment with due consideration to the economic costs involved and any other factors the Department determines to be appropriate. In implementing this Appendix, the Department will consider “practicable” and “reasonably achievable” as equivalent terms. Decisions involving these terms will take into account the state of technology. and the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to the utilization of atomic energy in the public interest.

Criterion 1.

Criterion 1A.

The general goal or broad objective in siting and design decisions is permanent isolation of tailings and associated contaminants by minimizing disturbance and dispersion by natural forces, and to do so without ongoing maintenance. For practical reasons, specific siting decisions and design standards must involve finite times (e.g., the longevity design standard in Criterion 6). The following site features which will contribute to such a goal or objective must be considered in selecting among alternative tailings disposal sites or judging the adequacy of existing tailings sites: (1) Remoteness from populated areas;

(2) Hydrologic and other natural conditions as they contribute to continued immobilization and isolation of contaminants from ground-water sources; and (3) Potential for minimizing erosion, disturbance, and dispersion by natural forces over the longterm.

Criterion 1B.

The site selection process must be an optimization to the maximum extent reasonably achievable in terms of the features in Criterion 1A.

Criterion 1C.

In the selection of disposal sites, primary emphasis must be given to isolation of tailings or wastes, a matter having long-term impacts, as opposed to consideration only of short-term convenience or benefits, such as minimization of transportation or land acquisition costs. While isolation of tailings will be a function of both site and engineering design, overriding consideration must be given to siting features given the long-term nature of the tailings hazards.

Criterion 1D.

Tailings should be disposed of in a manner that no active maintenance is required to preserve conditions of the site.

Criterion 2.

To avoid proliferation of small waste disposal sites and thereby reduce perpetual surveillance obligations, byproduct material as in definition (2) of RH 1.4, from in situ extraction operations, such as residues from solution evaporation or contaminated control processes, and wastes from small remote above ground extraction operations shall be disposed of at existing large mill tailings disposal sites; unless considering the nature of the wastes, such as their volume and specific activity and the costs and environmental impacts of transporting the wastes to a large disposal site, such offsite disposal is demonstrated to be impracticable or the advantages of onsite burial clearly outweigh the benefits of reducing the perpetual surveillance obligations.

Criterion 3.

The “prime option” for disposal of tailings is placement below grade, either in mines or specially excavated pits (that is, where the need for any specially constructed retention structure is eliminated). The evaluation of alternative sites and disposal methods performed by mill operators in support of their proposed tailings disposal program (provided in applicants' environmental reports) must reflect serious consideration of this disposal mode. In some instances, below grade disposal may not be the most environmentally sound approach, such as might be the case if a ground-water formation is relatively close to the surface or not very well isolated by overlying soils and rock. Also, geologic and topographic conditions might make full below grade burial impracticable: For example, bedrock may be sufficiently near the surface that blasting would be required to excavate a disposal pit at excessive cost, and more suitable alternative sites are not available. Where full below grade burial is not practicable, the size of retention structures, and size and steepness of slopes associated with exposed embankments must be minimized by excavation to the maximum extent reasonably achievable or appropriate given the geologic and hydrologic conditions at a site. In these cases, it must be demonstrated that an above grade disposal program will provide reasonably equivalent isolation of the tailings from natural erosional forces. Criterion 4.

The following site and design criteria must be adhered to whether tailings or wastes are disposed of above or below grade.

Criterion 4A.

Upstream rainfall catchment areas must be minimized to decrease erosion potential and the size of the floods, which could erode or wash out sections of the tailings disposal area. Criterion 4B.

Topographic features should provide good wind protection. Criterion 4C.

Embankment and cover slopes must be relatively flat after final stabilization to minimize erosion potential and to provide conservative factors of safety assuring long-term stability. The broad objective should be to contour final slopes to grades which are as close as possible to those which would be provided if tailings were disposed of below grade: this could, for example, lead to slopes of about 10 horizontal to 1 vertical (10h:1v) or less steep. In general, slopes should not be steeper than about 5h:1v. Where steeper slopes are proposed, reasons why a slope less steep than 5h:1v would be impracticable should be provided and compensating factors and conditions, which make such slopes acceptable, should be identified. Criterion 4D.

A full self-sustaining vegetative cover must be established or rock cover employed to reduce wind and water erosion to negligible levels.

(1) Where a full vegetative cover is not likely to be self-sustaining due to climatic or other conditions, such as in semi-arid and arid regions, rock cover must be employed on slopes of the impoundment system. The Department will consider relaxing this requirement for extremely gentle slopes such as those, which may exist on the top of the pile.

(2) The following factors must be considered in establishing the final rock cover design to avoid displacement of rock particles by human and animal traffic or by natural process, and to preclude undercutting and piping:

(a) Shape, size, composition, and gradation of rock particles (excepting bedding material average particles size must be at least cobble size or greater); (b) Rock cover thickness and zoning of particles by size; and (c) Steepness of underlying slopes.

(3) Individual rock fragments must be dense, sound, and resistant to abrasion, and must be free from cracks, seams, and other defects that would tend to unduly increase their destruction by water and frost actions. Weak, friable, or laminated aggregate may not be used. (4) Rock covering of slopes may be unnecessary where top covers are very thick (on the order of 10m or greater); impoundment slopes are very gentle (on the order of 10h:1v or less); bulk cover materials have inherently favorable erosion resistance characteristics; and, there is negligible drainage catchment area upstream of the pile and good wind protection as described in Criteria 4A and 4B.

(5) Furthermore, all impoundment surfaces must be contoured to avoid areas of concentrated surface runoff or abrupt or sharp changes in slope gradient. In addition to rock cover on slopes, areas toward which surface runoff might be directed must be well protected with substantial rock cover (rip rap). In addition to providing for stability of the impoundment system itself, overall stability, erosion potential, and geomorphology of surrounding terrain must be evaluated to assure that there are not ongoing or potential processes, such as gully erosion, which would lead to impoundment instability.

Criterion 4E.

The impoundment may not be located near a capable fault that could cause a maximum credible earthquake larger than that which the impoundment could reasonably be expected to withstand. As used in this criterion, the term “capable fault” has the same meaning as defined in section III(g) of Appendix A of 10 CFR Part 100. The term “maximum credible earthquake” means that earthquake which would cause the maximum vibratory ground motion based upon an evaluation of earthquake potential considering the regional and local geology and seismology and specific characteristics of local subsurface material. Criterion 4F.

The impoundment, where feasible, should be designed to incorporate features, which will promote deposition. For example, design features, which promote deposition of sediment suspended in any runoff, which flows into the impoundment area, might be utilized; the object of such a design feature would be to enhance the thickness of cover over time.

Criterion 5.

Criteria 5A-5D and Criterion 10 incorporate the basic ground-water protection standards imposed by the Environmental Protection Agency in 40 CFR Part 192, Subparts D and E (48 FR 45926; October 7, 1983) which apply during operations and prior to the end of closure. Groundwater monitoring to comply with these standards is required by Criterion 7A.

Criterion 5A.

(1) The primary ground-water protection standard is a design standard for surface impoundments used to manage byproduct material. Unless exempted under paragraph 5A(3) of this criterion, surface impoundments (except for an existing portion) shall have a liner that is designed, constructed, and installed to prevent any migration of wastes out of the impoundment to the adjacent subsurface soil, ground water, or surface water at any time during the active life (including the closure period) of the impoundment. The liner may be constructed of materials that may allow wastes to migrate into the liner (but not into the adjacent subsurface soil, ground water, or surface water) during the active life of the facility, provided that impoundment closure includes removal or decontamination of all waste residues, contaminated containment system components (liners, etc.) contaminated subsoils, and structures and equipment contaminated with waste and leachate. For impoundments that will be closed with the liner material left in place, the liner must be constructed of materials that can prevent wastes from migrating into the liner during the active life of the facility.

(2) The liner required by paragraph 5A(1) above shall be: (a) Constructed of materials that have appropriate chemical properties and sufficient strength and thickness to prevent failure due to pressure gradients (including static head and external hydrogeologic forces), physical contact with the waste or leachate to which they are exposed, climatic conditions, the stress of installation, and the stress of daily operation; (b) Placed upon a foundation or base capable of providing support to the liner and resistance to pressure gradients above and below the liner to prevent failure of the liner due to settlement, compression, or uplift; and (c) Installed to cover all surrounding earth likely to be in contact with the wastes or leachate. (3) The applicant or licensee will be exempted from the requirements of paragraph 5A(1) of this criterion if the Department finds, based on a demonstration by the applicant or licensee, that alternate design and operating practices, including the closure plan, together with site characteristics will prevent the migration of any hazardous constituents into ground water or surface water at any future time.

In deciding whether to grant an exemption, the Department will consider: (a) The nature and quantity of the wastes;

(b) The proposed alternate design and operation;

(c) The hydrogeologic setting of the facility, including the attenuative capacity and thickness of the liners and soils present between the impoundment and ground water or surface water; and (d) All other factors which would influence the quality and mobility of the leachate produced and the potential for it to migrate to ground water or surface water. (4) A surface impoundment must be designed, constructed, maintained, and operated to prevent overtopping resulting from normal or abnormal operations, overfilling, wind and wave actions, rainfall, or run-on; from malfunctions of level controllers, alarms, and other equipment; and from human error.

(5) When dikes are used to form the surface impoundment, the dikes must be designed, constructed, and maintained with sufficient structural integrity to prevent massive failure of the dikes. In ensuring structural integrity, it must not be presumed that the liner system will function without leakage during the active life of the impoundment.

Criterion 5B.

(1) Uranium and thorium byproduct material in definition (2) of RH 1.4 shall be managed to conform to the following secondary ground-water protection standard: hazardous constituents entering the ground water from a licensed site must not exceed the specified concentration limits in the uppermost aquifer beyond the point of compliance during the compliance period. Hazardous constituents are those constituents identified by the Department pursuant to paragraph 5B(2) of this criterion. Specified concentration limits are those limits established by the Department as indicated in paragraph 5B(5) of this criterion. The Department will also establish the point of compliance and compliance period on a site-specific basis through license conditions and orders. The objective in selecting the point of compliance is to provide the earliest practicable warning that the impoundment is releasing hazardous constituents to the ground water. The point of compliance must be selected to provide prompt indication of ground-water contamination on the hydraulically downgradient edge of the disposal area. The Department shall identify hazardous constituents, establish concentration limits, set the compliance period, and may adjust the point of compliance if needed to accord with developed data and site information as to the flow of ground water or contaminants, when the detection monitoring established under Criterion 7A indicates leakage of hazardous constituents from the disposal area. (2) A constituent becomes a hazardous constituent subject to paragraph 5B(5) only when the constituent meets all three of the following tests:

(a) The constituent is reasonably expected to be in or derived from the uranium and thorium byproduct material in the disposal area;

(b) The constituent has been detected in the ground water in the uppermost aquifer; and (c) The constituent is listed in Criterion 10 of this appendix. (3) Even when constituents meet all three tests in paragraph 5B(2) of this criterion, the Department may exclude a detected constituent from the set of hazardous constituents on a site-specific basis if it finds that the constituent is not capable of posing a substantial present or potential hazard to human health or the environment. In deciding whether to exclude constituents, the Department will consider the following:

(a) Potential adverse effects on ground-water quality, considering (i) The physical and chemical characteristics of the waste in the licensed site, including its potential for migration;

(ii) The hydrogeological characteristics of the facility and surrounding land; (iii) The quantity of ground water and the direction of ground water flow; (iv) The proximity and withdrawal rates of ground-water users; (v) The current and future uses of ground water in the area; (vi) The existing quality of ground water, including other sources of contamination and their cumulative impact on the ground water quality;

(vii) The potential for health risks caused by human exposure to waste constituents; (viii) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents;

(ix) The persistence and permanence of the potential adverse effects. (b) Potential adverse effects on hydraulically-connected surface waterquality, considering (i) The volume and physical and chemical characteristics of the waste in the licensed site; (ii) The hydrogeological characteristics of the facility and surrounding land; (iii) The quantity and quality of ground water and the direction of ground water flow; (iv) The patterns of rainfall in the region;

(v) The proximity of the licensed site to surface waters; (vi) The current and future uses of surface waters in the area and any water quality standards established for those surface waters;

(vii) The existing quality of surface water, including other sources of contamination and the cumulative impact on surface water quality;

(viii) The potential for health risks caused by human exposure to waste constituents; (ix) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents; and (x) The persistence and permanence of the potential adverse effects. (4) In making any determinations under paragraphs 5B(3) and 5B(6) of this criterion about the use of ground water in the area around the facility, the Department will consider any identification of underground sources of drinking water and exempted aquifers made by the Colorado Water Quality Control Commission, as in 5 CCR 1002-8, or other agency having jurisdiction. (5) At the point of compliance, the concentration of a hazardous constituent must not exceed: (a) The Department-approved background concentration of that constituent in the ground water; (b) The respective value given in the table in paragraph 5C if the constituent is listed in the table and if the background level of the constituent is below the value listed; or (c) An alternate concentration limit established by the Department. (6) Conceptually, background concentrations pose no incremental hazards and the drinking water limits in Criterion 5C state acceptable hazards but these two options may not be practically achievable at a specific site. Alternate concentration limits that present no significant hazard may be proposed by licensees for Department consideration. Licensees must provide the basis for any proposed limits including consideration of practicable corrective actions, that limits are as low as reasonably achievable, and information on the factors the Department must consider. The Department will establish a site specific alternate concentration limit for a hazardous constituent as provided in paragraph 5B(5) of this criterion if it finds that the proposed limit is as low as reasonably achievable after considering practicable corrective actions, and that the constituent will not pose a substantial present or potential hazard to human health or the environment as long as the alternate concentration limit is not exceeded. In making the present and potential hazard finding, the Department will consider the following factors:

(a) Potential adverse effects on ground water quality, considering: (i) The physical and chemical characteristics of the waste in the licensed site including its potential for migration;

(ii) The hydrogeological characteristics of the facility and surrounding land; (iii) The quantity of ground water and the direction of ground water flow; (iv) The proximity and withdrawal rates of ground water users; (v) The current and future uses of ground water in the area; (vi) The existing quality of ground water, including other sources of contamination and their cumulative impact on the ground water quality;

(vii) The potential for health risks caused by human exposure to waste constituents; (viii) The potential damage to wildlife, crops, vegetation, and physical structures caused by exposure to waste constituents;

(ix) The persistence and permanence of the potential adverse effects. (b) Potential adverse effects on hydraulically-connected surface water quality, considering: (i) The volume and physical and chemical characteristics of the waste in the licensed site; (ii) The hydrogeological characteristics of the facility and surrounding land; (iii) The quantity and quality of ground water, and the direction of ground water flow; (iv) The patterns of rainfall in the region;

(v) The proximity of the licensed site to surface waters; (vi) The current and future uses of surface waters in the area and any water quality standards established for those surface waters;

(vii) The existing quality of surface water including other sources of contamination and the cumulative impact on surface water quality;

(viii) The potential for health risks caused by human exposure to waste constituents; (ix) The potential damage to wildlife, crops, vegetations, and physical structures caused by exposure to waste constituents; and (x) The persistence and permanence of the potential adverse effects. Criterion 5C.

Maximum Values for Ground Water Protection Constituent or property Maximum Concentration (Milligrams per liter):

Arsenic 0.05 Barium 1.0 Cadmium 0.01 Chromium 0.05 Lead 0.05 Mercury 0.002 Selenium 0.01 Silver 0.05 Endrin (1,2,3,4,10, 10- 0.0002 hexachloro-1,7-expoxy- 1,4,4a,5,6,7,8, 9a- octahydro-1, 4-endo, endo-5, 8-dimethano naphthalene)

Lindane (1,2,3,4,5,6- 0.004 hexachloro-cyclohexane, gamma isomer)

Methoxychlor (1,1,1- 0.1 Trichloro-2, 2-bis, p- methoxyphenylethane)

Toxaphene (C10H10Cl6, 0.005 Technical chlorinated camphene, 67–69 percent chlorine)

2,4-D (2,4- 0.1 Dichlorophenoxyacetic acid)

2,4,5-TP Silvex (2,4,5- 0.01 Trichloro- phenoxypropionic acid)

Becquerels per liter PicoCuries per liter:

Combined radium-226 0.185 5 and radium-228 Gross alpha-particle 0.555 15 activity (excluding radon and uranium when producing uranium byproduct material or radon and thorium when producing thorium byproduct material)

Criterion 5D.

If the ground water protection standards established under paragraph 5B(1) of this criterion are exceeded at a licensed site, a corrective action program must be put into operation as soon as is practicable, and in no event later than eighteen (18) months after the Department finds that the standards have been exceeded. The licensee shall submit the proposed corrective action program and supporting rationale for Department approval prior to putting the program into operation, unless otherwise directed by the Department. The objective of the program is to return hazardous constituent concentration levels in ground water to the concentration limits set as standards. The licensee's proposed program shall address removing the hazardous constituents that have entered the ground water at the point of compliance or treating then in place. The program shall also address removing or treating in place any hazardous constituents that exceed concentration limits in ground water between the point of compliance and the downgradient facility property boundary. The licensee shall continue corrective action measures to the extent necessary to achieve and maintain compliance with the ground water protection standard. The Department will determine when the licensee may terminate corrective action measures based on data from the ground water monitoring program and other information that provide reasonable assurance that the ground water protection standard will not be exceeded. Criterion 5E.

In developing and conducting ground water protection programs, applicants and licensees shall also consider the following:

(1) Installation of bottom liners (Where synthetic liners are used, a leakage detection system must be installed immediately below the liner to ensure major failures are detected if they occur. This is in addition to the ground water monitoring program conducted as provided in Criterion 7. Where clay liners are proposed or relatively thin, in situ clay soils are to be relied upon for seepage control, tests must be conducted with representative tailings solutions and clay materials to confirm that no significant deterioration of permeability or stability properties will occur with continuous exposure of clay to tailings solutions. Tests must be run for a sufficient period of time to reveal any effects if they are going to occur (in some cases deterioration has been observed to occur rather rapidly after about nine months of exposure)).

(2) Mill process designs which provide the maximum practicable recycle of solutions and conservation of water to reduce the net'input of liquid to the tailings impoundment. (3) Dewatering of tailings by process devices and/or in situ drainage systems (At new sites, tailings must be dewatered by a drainage system installed at the bottom of the impoundment to lower the phreatic surface and reduce the driving head of seepage, unless tests show tailings are not amenable to such a system. Where in situ dewatering is to be conducted, the impoundment bottom must be graded to assure that the drains are at a low point. The drains must be protected by suitable filter materials to assure that drains remain free running. The drainage system must also be adequately sized to assure good drainage).

(4) Neutralization to promote immobilization of hazardous constituents. Criterion 5F.

Where ground water impacts are occurring at an existing site due to seepage, action must be taken to alleviate conditions that lead to excessive seepage impacts and restore ground water quality. The specific seepage control and ground water protection method, or combination of methods, to be used must be worked out on a site-specific basis. Technical specifications must be prepared to control installation of seepage control systems. A quality assurance, testing, and inspection program, which includes supervision by a qualified engineer or scientist, must be established to assure the specifications are met. Criterion 5G.

In support of a tailings disposal system proposal, the applicant/operator shall supply information concerning the following:

(1) The chemical and radioactive characteristics of the waste solutions. (2) The characteristics of the underlying soil and geologic formations particularly as they will control transport of contaminants and solutions. This includes detailed information concerning extent, thickness, uniformity, shape, and orientation of underlying strata. Hydraulic gradients and conductivities of the various formations must be determined. This information must be gathered from borings and field survey methods taken within the proposed impoundment area and in surrounding areas where contaminants might migrate to ground water. The information gathered on boreholes must include both geological and geophysical logs in sufficient number and degree of sophistication to allow determining significant discontinuities, fractures, and channeled deposits of high hydraulic conductivity. If field survey methods are used, they should be in addition to and calibrated with borehole logging. Hydrologic parameters such as permeability may not be determined on the basis of laboratory analysis of samples alone; a sufficient amount of field testing (e.g., pump tests) must be conducted to assure actual field properties are adequately understood. Testing must be conducted to allow estimating chemi-sorption attenuation properties of underlying soil and rock.

(3) Location, extent, quality, capacity and current uses of any ground water at and near the site. Criterion 5H.

Steps must be taken during stockpiling of ore to minimize penetration of radionuclides into underlying soils; suitable methods include lining and/or compaction of ore storage areas. Criterion 6.

(1) In disposing of waste byproduct material, licensees shall place an earthen cover (or approved alternative) over tailings or wastes at the end of milling operations and shall close the waste disposal area in accordance with a design1 which provides reasonable assurance of control of radiological hazards to (i) be effective for 1,000 years, to the extent reasonably achievable, and, in any case, for at least 200 years, and (ii) limit releases of radon-222 from uranium byproduct materials, and radon-220 from thorium byproduct materials, to the atmosphere so as not to exceed an average2 release rate of 0.74 Becquerel per square meter per second (Bq/m2s), or 20 picocuries per square meter per second (pCi/m2s), to the extent practicable throughout the effective design life determined pursuant to (1)(i) of this criterion. In computing required tailings cover thicknesses, moisture in soils in excess of amounts found normally in similar soils in similar circumstances may not be considered. Direct gamma exposure from the tailings or wastes should be reduced to background levels. The effects of any thin synthetic layer may not be taken into account in determining the calculated radon exhalation level. If non-soil materials are proposed as cover materials, it must be demonstrated that these materials will not crack or degrade by differential settlement, weathering, or other mechanism, over long-term intervals. 1In the case of thorium byproduct materials, the standard applies only to design. Monitoring for radon emissions from thorium byproduct materials after installation of an appropriately designed cover is not required. 2This average applies to the entire surface of each disposal area over a period of a least one year, but a period short compared to 100 years. Radon will come from both byproduct materials and from covering materials. Radon emissions from covering materials should be estimated as part of developing a closure plan for each site. The standard, however, applies only to the emissions from byproduct materials to the atmosphere.

(2) As soon as reasonably achievable after emplacement of the final cover to limit releases of radon-222 from uranium byproduct material and prior to placement of erosion protection barriers or other features necessary for long-term control of the tailings, the licensee shall verify through appropriate testing and analysis that the design and construction of the final radon barrier is effective in limiting releases of radon-222 to a level not exceeding 0.74 Bq/m2s (20 pCi/m2s) averaged over the entire pile or impoundment using the procedures described in 40 CFR Part 61, Appendix B, Method 115, or another method of verification approved by the Department as being at least as effective in demonstrating the effectiveness of the final radon barrier. (3) When phased emplacement of the final radon barrier is included in the applicable reclamation plan, the verification of radon-222 release rates required in paragraph (2) of this Criterion must be conducted for each portion of the pile or impoundment as the final radon barrier for that portion is emplaced.

(4) Within ninety days of the completion of all testing and analysis relevant to the required verification in paragraphs (2) and (3) of this Criterion, the uranium mill licensee shall report to the Department the results detailing the actions taken to verify that levels of release of radon-222 do not exceed 0.74 Bq/m2s (20 pCi/m2s) when averaged over the entire pile or impoundment. The licensee shall maintain records until termination of the license documenting the source of input parameters including the results of all measurements on which they are based, the calculations and/or analytical methods used to derive values for input parameters, and the procedure used to determine compliance. These records shall be kept in a form suitable for transfer to the custodial agency at the time of transfer of the site to the U.S. Department of Energy or State for long-term care if requested.

(5) Near surface cover materials, i.e., within the top three meters (10 feet), may not include waste or rock that contains elevated levels of radium; soils used for near surface cover must be essentially the same, as far as radioactivity is concerned, as that of surrounding surface soils. This is to ensure that surface radon exhalation is not significantly above background because of the cover material itself.

(6) The design requirements in this Criterion for longevity and control of radon releases apply to any portion of a licensed and/or disposal site unless such portion contains a concentration of radium in land, averaged over areas of 100 square meters, which as a result of byproduct material, does not exceed the background level by more than: (i) 0.18 Becquerels (5 picocuries) per gram of radium-226, or, in the case of thorium byproduct material, radium-228, averaged over the first 15 centimeters (cm) below the surface, and (ii)0.56 Becquerels (15 pCi) of radium-226, or, in the case of thorium byproduct material, radium-228, averaged over 15-cm thick layers more than 15 cm below the surface.

Byproduct material containing concentrations of radionuclides other than radium in soil, and surface activity on remaining structures, must not result in a total effective dose equivalent (TEDE) exceeding the dose from cleanup of radium contaminated soil to the above standard (benchmark dose), and must be at levels which are as low is reasonably achievable. If more than one residual radionuclide is present in the same 100 square-meter area, the sum of the ratios for each radionuclide of concentration present to the concentration limit will not exceed “1” (unity). A calculation of the potential peak annual TEDE within 1000 years to the average member of the critical group that would result from applying the radium standard (not including radon) on the site must be submitted for approval. The use of decommissioning plans with benchmark doses which exceed 1 millisievert per year (100 mrem/year), before application of ALARA, requires the approval of the Department. This requirement for dose criteria does not apply to sites that have decommissioning plans for soil and structures approved before the effective date of this Criterion 6(6).

(7) The licensee shall also address the nonradiological hazards associated with the wastes in planning and implementing closure. The licensee shall ensure that disposal areas are closed in a manner that minimizes the need for further maintenance. To the extent necessary to prevent threats to human health and the environment, the licensee shall control minimize, or eliminate post-closure escape of nonradiological hazardous constituents, leachate, contaminated rainwater, or waste decomposition products to the ground or surface waters or to the atmosphere. Criterion 6A.

(1) For impoundments containing uranium byproduct materials, the final radon barrier must be completed as expeditiously as practicable considering technological feasibility after the pile or impoundment ceases operation in accordance with a written, Department-approved reclamation plan. (The term as expeditiously as practicable considering technological feasibility as specifically defined in RH 18.2 includes factors beyond the control of the licensee). Deadlines for completion of the final radon barrier and, if applicable, the following interim milestones must be established as a condition of the individual license: windblown tailings retrieval and placement on the pile and interim stabilization including dewatering or the removal of freestanding liquids and recontouring. The placement of erosion protection barriers or other feature necessary for long-term control of the tailings must also be completed in a timely manner in accordance with a written, Department- approved reclamation plan.

(2) The Department may approve a licensee's request to extend the time for performance of milestones related to emplacement of the final radon barrier if, after providing an opportunity for public participation, the Department finds that the licensee has adequately demonstrated in the manner required in paragraph (2) of Criterion 6 that releases of radon-222 do not exceed an average of 0.74 Becquerel/m2s (20 pCi/m2s). If the delay is approved on the basis that the radon releases do not exceed 0.74 Becquerel/m2s (20 pCi/m2s), a verification of radon levels, as required by paragraph (2) of Criterion 6, must be made annually during the period of delay. In addition, once the Department has established the date in the reclamation plan for the milestone for completion of the final radon barrier, the Department may extend that date based on cost if after providing an opportunity for public participation, the Department finds that the licensee is making good faith efforts to emplace the final radon barrier, the delay is consistent with the definition of available technology, and the radon releases caused by the delay will not result in a significant incremental risk to the public health.

(3) The Department may authorize by license amendment, upon licensee report, a portion of the impoundment to accept uranium byproduct material or such materials that are similar in physical, chemical, and radiological characteristics to the uranium mill tailings and associated wastes already in the pile or impoundment from other sources, during the closure process. No such authorization will be made if it results in a delay or impediment to emplacement of the final radon barrier over the remainder of the impoundment in a manner that will achieve levels of radon-222 releases not exceeding 0.74 Becquerel/m2s (20 pCi/m2s) averaged over the entire impoundment. The verification required in paragraph (2) of Criterion 6 may be completed with a portion of the impoundment being used for further disposal if the Department makes a final finding that the impoundment will continue to achieve a level of radon-222 release not exceeding 0.74 Becquerel/m2s (20 pCi/m2s) averaged over the entire impoundment. In this case, after the final radon barrier is complete except for the continuing disposal area, (a) only byproduct material will be authorized for disposal, (b) the disposal will be limited to the specified existing disposal area, and (c) this authorization will only be made after providing opportunity for public participation. Reclamation of the disposal area, as appropriate, must be completed in a timely manner after disposal operations cease in accordance with paragraph (1) of Criterion 6; however, these actions are not required to be complete as part of meeting the deadline for final radon barrier construction.

Criterion 7.

The licensee shall establish a detection monitoring program needed for the Department to set the site- specific ground water protection standards in paragraph 5B(1) of this appendix. For all monitoring under this paragraph, the licensee or applicant will propose for Department approval as license conditions which constituents are to be monitored on a site-specific basis. A detection monitoring program has two purposes. The initial purpose of the program is to detect leakage of hazardous constituents from the disposal area so that the need to set ground water protection standards is monitored. If leakage is detected, the second purpose of the program is to generate data and information needed for the Department to establish the standards under Criterion 5B. The data and information must provide a sufficient basis to identify those hazardous constituents which require concentration limit standards and to enable the Department to set the limits for those constituents and the compliance period. They may also need to provide the basis for adjustments to the point of compliance. The detection monitoring programs must be in place when specified by the Department in orders or license conditions. Once ground water protection standards have been established pursuant to paragraph 5B(1), the licensee shall establish and implement a compliance monitoring program. The purpose of the compliance monitoring program is to determine that the hazardous constituent concentrations in ground water continue to comply with the standards set by the Department. In conjunction with a corrective action program, the licensee shall establish and implement a corrective action monitoring program. The purpose of the corrective action monitoring program is to demonstrate the effectiveness of the corrective actions. Any monitoring program required by this paragraph may be based on existing monitoring programs to the extent the existing programs can meet the stated objective for the program. Criterion 8.

Milling operations must be conducted so that all airborne effluent releases are reduced to levels as low as is reasonably achievable. The primary means of accomplishing this must be by means of emission controls. Institutional controls, such as extending the site boundary and exclusion area, may be employed to ensure that offsite exposure limits are met, but only after all practicable measures have been taken to control emissions at the source. Notwithstanding the existence of individual dose standards, strict control of emissions is necessary to assure that population exposures are reduced to the maximurn extent reasonably achievable and to avoid site contamination. The greatest potential sources of offsite radiation exposure (aside from radon exposure) are dusting from dry surfaces of the tailings disposal area not covered by tailings solution and emissions from yellowcake drying and packaging operations. During operations and prior to closure, radiation doses from radon emissions from surface impoundments of uranium or thorium byproduct materials must be kept as low as is reasonably achievable. Checks must be made and logged hourly for all parameters (e.g., differential pressures and scrubber water flow rates) that determine the efficiency of yellowcake stack emission control equipment operation. The licensee shall retain each log as a record for three years after the last entry in the log is made. It must be determined whether or not conditions are within a range prescribed to ensure that the equipment is operating consistently near peak efficiency; corrective action must be taken when performance is outside of prescribed ranges. Effluent control devices must be operative at all times during drying and packaging operations and whenever air is exhausting from the yellowcake stack. Drying and packaging operations must terminate when controls are inoperative. When checks indicate the equipment is not operating within the range prescribed for peak efficiency, actions must be taken to restore parameters to the prescribed range. When this cannot be done without shutdown and repairs, drying and packaging operations must cease as soon as practicable. Operations may not be restarted after cessation due to off-normal performance until needed corrective actions have been identified and implemented. All these cessations, corrective actions, and restarts must be reported to the Department as indicated in Criterion 8A, in writing, within ten days of the subsequent restart.

To control dusting from tailings, that portion not covered by standing liquids must be wetted or chemically stabilized to prevent or minimize blowing and dusting to the maximum extent reasonably achievable. This requirement may be relaxed if tailings are effectively sheltered from wind, such as may be the case where they are disposed of below grade and the tailings surface is not exposed to wind. Consideration must be given in planning tailings disposal programs to methods which would allow phased covering and reclamation of tailings impoundments because this will help in controlling particulate and radon emissions during operation. To control dusting from diffuse sources, such as tailings and ore pads where automatic controls do not apply, operators shall develop written operating procedures specifying the methods of control which will be utilized.

Milling operations producing or involving uranium and thorium byproduct materials must be conducted in such a manner as to provide reasonable assurance that the annual dose equivalent does not exceed 0.25 millisievert (25 millirem) to the whole body, 0.75 millisievert (75 millirem) to the thyroid, and 0.25 millisievert (25 millirem) to any other organ of any member of the public as a result of exposures to the planned discharge of radioactive material, radon and its progeny excepted, to the general environment. Uranium and thorium byproduct materials must be managed so as to conform to the applicable provisions of Title 40 of the Code of Federal Regulations, Part 440, “Ore Mining and Dressing Point Source Category: Effluent Limitations Guidelines and New Source Performance Standards, Subpart C, Uranium, Radium, and Vanadium Ores Subcategory”, as codified on January 1, 1983. Criterion 8A.

Inspections of tailings or waste retention systems must be conducted daily during operations, or at an alternate frequency approved by the Department for other conditions. Such inspections shall be conducted by, or under the supervision of, a qualified engineer or scientist, and documented. The licensee shall retain the documentation for each inspection as a record for three years after the documentation is made. The Department must be immediately notified of any failure in a tailings or waste retention system that results in a release of tailings or waste into unrestricted areas, or any unusual conditions (conditions not contemplated in the design of the retention system) that if not corrected could indicate the potential or lead to failure of the system and result in a release of tailings or waste into unrestricted areas.

Criterion 9.

Criterion 9A.

These criteria relating to ownership of tailings and their disposal sites became effective on November 8, 1981, and apply to all licenses terminated, issued, or renewed after that date. Criterion 9B.

Any uranium or thorium milling license or tailings license must contain such terms and conditions as the U.S. Nuclear Regulatory Commission and Department determine necessary to assure that prior to termination of the license, the licensee will comply with ownership requirements of this criterion for sites used for tailings disposal.

Criterion 9C.

Title to the byproduct material licensed under this Part 18 and land, including any interests therein (other than land owned by the United States or by the State), which is used for the disposal of any such byproduct material, or is essential to ensure the long-term stability of such disposal site, must be transferred to the United States or the State in which such land is located, at the option of such State. In view of the fact that physical isolation must be the primary means of long-term control, and Government land ownership is a desirable supplementary measure, ownership of certain severable subsurface interests (for example, mineral rights) may be determined to be unnecessary to protect the public health and safety and the environment. In any case, however, the applicant/operator must demonstrate a serious effort to obtain such subsurface rights, and must in the event that certain rights cannot be obtained, provide notification in local public land records of the fact that the land is being used for the disposal of radioactive material and is subject to either a U.S. Nuclear Regulatory Commission or Department general or specific license prohibiting the disruption and disturbance of the tailings. In some rare cases, such as may occur with deep burial where no ongoing site surveillance will be required, surface land ownership transfer requirements may be waived with the approval of the Department and U.S. Nuclear Regulatory Commission. For licenses issued before November 8, 1981, the Department and U.S. Nuclear Regulatory Commission may take into account the status of the ownership of such land, and interests therein, and the ability of a licensee to transfer title and custody thereof to the United States or the State. Criterion 9D.

If the U.S. Nuclear Regulatory Commission, or the Department if title is held by the State, subsequent to title transfer determines that use of the surface or subsurface estates, or both, of the land transferred to the United States or to a State will not endanger the public health, safety, welfare, or environment, the U.S. Nuclear Regulatory Commission, or the Department if title is held by the State, may permit the use of the surface or subsurface estates, or both, of such and in a manner consistent with the provisions provided in these criteria. If the U.S. Nuclear Regulatory Commission, or the Department if title is held by the state, permits such use of such land, it will provide the person who transferred such land with the right of first refusal with respect to such use of such land. Criterion 9E.

Material and land transferred to the United States or the State in accordance with this Criterion 9 must be transferred to the United States or the State without cost other than administrative or legal costs incurred in carrying out such transfer.

Criterion 9F.

The provisions of this part respecting transfer of title and custody to land and tailings and wastes do not apply in the case of lands held in trust by the United States for any Indian tribe or lands owned by such Indian tribe subject to a restriction against alienation imposed by the United States. In the case of such lands which are used for the disposal of uranium or thorium byproduct material, as defined in Part 1, the licensee shall enter into arrangements with the U.S. Nuclear Regulatory Commission as may be appropriate to assure the long-term surveillance of such lands by the United States. Criterion 10.

Secondary ground-water protection standards required by Criterion 5 of this Appendix are concentration limits for individual hazardous constituents. The following list of constituents identifies the constituents for which standards must be set and complied with if the specific constituent is reasonably expected to be in or derived from the radioactive material and has been detected in ground water. For purposes of this Appendix, the property of gross alpha activity will be treated as if it is a hazardous constituent. Thus, when setting standards under paragraph 5B(5) of Criterion 5, the Department will also set a limit for gross alpha activity. The Department does not consider the following list imposed by 40 CFR Part 192 to be exhaustive and may determine other constituents to be hazardous on a case-by-case basis, independent of those specified by the U.S. Environmental Protection Agency in Part 192. PART 18 CRITERION 10 HAZARDOUS CONSTITUENTS - Acetonitrile (Ethanenitrile)

- Acetophenone (Ethanone, 1-phenyl)

- 3-(alpha-Acetonylbenzyl)-4-hydroxycoumarin and salts (Warfarin) - 2-Acetylaminofluorene (Acetamide, N-(9H- fluoren-2-yl)-) - Acetyl chloride (Ethanoyl chloride)

- 1-Acetyl-2-thiourea (Acetamide, N- (aminothioxomethyl)-) - Acrolein (2-Propenal)

- Acrylamide (2-Propenamide)

- Acrylonitrile (2-Propenenitrile)

- Aflatoxins - Aldrin (1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a,8b-hexahydro-endo,exo-1,4:5,8-Dimethanonaphthalene) - Allyl alcohol (2-Propen-1-ol)

- Aluminum phosphide - 4-Aminobiphenyl ([1,1-Biphenyl])-4-amine)

- 6-Amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methyl-carbamate azirino(2,3:3,4)pyrrolo(1,2-a]indole-4,7-dione,(ester) (Mitomycin C) (Azirino[2,3:3,4]pyrrolo(1,2-a)indole- 4,7-dione,6-amino-8-[((amino-cabonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a methoxy-5-methyl-) - 5-(Aminomethyl)-3-isoxazolol (3(2H)-Isoxazolone, 5-(aminomethyl)-)4-Aminopyridine (4-Pyridinamine) - Amitrole (1H-1,2,4-Triazol-3-amine)

- Aniline (Benzenamine)

- Antimony and compounds, N.O.S.3 - Aramite (Sulfurous acid,2-chloroethyl-,2-(4-(1,1-dimethylethyl)phenoxy)-1-methylethyl ester) - Arsenic and compounds, N.O.S.3 - Arsenic acid (Orthoarsenic acid)

- Arsenic pentoxide (Arsenic (V) oxide)

- Arsenic trioxide (Arsenic (III) oxide)

- Auramine (Benzenamine,4,4-carbonimidoylbis (N,N-Dimethyl-,monohydrochloride) - Azaserine (L-Serine, diazoacetate (ester))

- Barium and compounds, N.O.S.3 - Barium cyanide - Benz(c)acridine (3.4-Benzacridine)

- Benz(a)anthracene (1,2-Benzanthracene)

- Benzene (Cyclohexatriene)

- Benzenearsonic acid (Arsonic acid, phenyl-)

- Benzene, dichloromethyl-(Benzal chloride)

- Benzenethiol (Thiophenol)

- Benzidine ([1,1-Biphenyl]-4,4 diamine)

- Benzo(b)fluoranthene (2,3-Benzofluoranthene)

- Benzo(j)fluoranthene (7,8-Benzofluoranthene)

- Benzo(a)pyrene (3,4-Benzopyrene)

- p-Benzoquinone (1,4-Cyclohexadienedione)

- Benzotrichloride (Benzene, Trichloromethyl)

- Benzyl chloride (Benzene, (chloromethyl)-)

- Beryllium and compounds, N.O.S.3 - Bis(2-chloroethoxy)methane (Ethane,1,1-(methylenebis(oxy)]bis[2-chloro-]) - Bis(2-chloroethyl) ether (Ethane, 1,1-oxybis (2-chloro-)) - N,N-Bis(2-chloroethyl)-2-naphthylamine (Chlornaphazine) - Bis(2-Chloroisopropyl) ether (Propane, 2,2-oxybis[2-chloro-]) - Bis(chloromethyl) ether (methane,oxybis[chloro-])

- Bis(2-ethylhexyl) phthalate (1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester) - Bromoacetone (2-Propanone, 1-bromo-)

- Bromomethane (Methyl bromide)

- 4-Bromophenyl phenyl ether (Benzene, 1-bromo-4-phenoxy-) - Brucine (Strychnidin-10-one, 2,3-dimethoxy-)

- 2-Butanone peroxide (Methyl ethyl ketone,peroxide)

- Butyl benzyl phthalate (1,2-Benzenedicarboxylic acid, butylphenylmethyl ester) - 2-sec-Butyl-4,6-dinitrophenol (DNBP) (Phenol,2,4-dinitro-6-(1-methylpropyl)-) - Cadmium and compounds, N.O.S.3 - Calcium chromate (Chromic acid, calcium salt)

- Calcium cyanide - Carbon disulfide (Carbon bisulfide)

- Carbon oxyfluoride (Carbonyl fluoride)

- Chloral (Acetaldehyde, trichloro-)

- Chlorambucil (Butanoic acid, 4-(bis(2-chloroethyl)amino)benzene-) - Chlordane (alpha and gamma isomers)4,7-Methanoindan, 1,2,4,5,6,7,8,8-octachloro-3,4,7,7a- tetrahydro-) (alpha and gammaisomers)

- Chlorinated benzenes, N.O.S.3 - Chlorinated ethane, N.O.S.3> - Chlorinated fluorocarbons, N.O.S.3 - Chlorinated naphthalene, N.O.S.3 - Chlorinated phenol, N.O.S.3 - Chloroacetaldehyde (Acetaldehyde, chloro-)

- Chloroalkyl ethers N.O.S.3 - p-Chloroaniline (Benzenamine, 4-chloro-)

- Chlorobenzene (Benzene, chloro-)

- Chlorobenzilate (Benzeneacetic acid, 4-chloro-alpha-(4-chlorophenyl)-alpha-hydroxy-,ethyl ester) - p-Chloro-m-cresol (Phenol, 4-chloro-3-methyl)

- 1-Chloro-2,3-epoxypropane (Oxirane, 2-(chloromethyl)-) - 2-Chloroethyl vinyl ether (Ethene, (2-chloroethoxy)-) - Chloroform (Methane, trichloro-)

- Chloromethane (Methyl chloride)

- Chloromethyl methyl ether (Methane,chloromethoxy-)

- 2-Chloronaphthalene (Naphthalene,betachloro-)

- 2-Chlorophenol (Phenol, o-chloro-)

- 1-(o-Chlorophenyl) thiourea (Thiourea, (2-chlorophenyl)-) - 3-Chloropropionitrile (Propanenitrile, 3-chloro-)

- Chromium and compounds, N.O.S.3 - Chrysene (1,2-Benzphenanthrene)

- Citrus red No. 2 (2-Naphthol, 1-((2,5-dimethoxyphenyl)azo)-) - Coal tars - Copper cyanide - Creosote (Creosote, wood)

- Cresols (Cresylic acid) (Phenol, methyl-)

- Crotonaldehyde (2-Butenal)

- Cyanides (soluble salts and complexes),N.O.S.3 - Cyanogen (Ethanedinitrile)

- Cyanogen bromide (Bromine cyanide)

- Cyanogen chloride (Chlorine cyanide)

- Cycasin (beta-D-Glucopyranoside, (methyl-ONN-azoxy)methyl-) - 2-Cyclohexyl-4,6-dinitrophenol (phenol, 2-cyclohexyl-4,6-dinitro-) - Cyclophosphamide (2H-1,3,2-Oxazaphosphorine (bis(2-chloroethyl)amino)-tetrahydro-,2-oxide) - Daunomycin (5,12-Naphthacenedione, (8S-cis)-8-acetyl-10-((3-amino-2,3,6-trideoxy)-alpha-L-lyxo- hexopyranosyl)oxy)7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-) - DDD (Dichlorodiphenyldichloroethane)(Ethane, 1,1-dichloro-2,2-bis(p-chlorophenyl)-) - DDE (Ethylene, 1,1-dichloro-2,2-bis(4-chlorophenyl)-) - DDT (Dichlorodiphenyltrichloroethane) (Ethane, 1,1,1-trichloro-2,2-bis (p-chlorophenyl)-) - Diallate (S-(2,3-dichloroallyl)diisopropylthiocarbamate) - Dibenz(a,h)acridine(1,2,5,6-Dibenzacridine)

- Dibenz(a,j)acridine(1,2,7,8-Dibenzacridine)

- Dibenz(a,h)anthracene (1,2,5,6-Dibenzanthracene - 7H-Dibenzo(c,g)carbazole (3,4,5,6-Dibenzcarbazole)

- Dibenzo(a,e)pyrene(1,2,4,5-Dibenzpyrene)

- Dibenzo(a,h)pyrene(1,2,5,6-Dibenzpyrene)

- Dibenzo(a,i)pyrene(1,2,7,8-Dibenzpyrene)

- 1,2-Dibromo-3-chloropropane (Propane, 1,2-dibromo-3-chloro-) - 1,2 Dibromoethane (Ethylene dibromide)

- Dibromomethane (Methylene bromide)

- Di-n-butyl phthalate (1,2-Benzenedicarboxylic acid, dibutyl ester) - o-Dichlorobenzene (Benzene, 1,2-dichloro-)

- m-Dichlorobenzene (Benzene, 1,3-dichloro-)

- p-Dichlorobenzene (Benzene, 1,4-dichlor-)

- Dichlorobenzene, N.O.S.3 (Benzene, dichloro-N.O.S.3)

- 3,3-Dichlorobenzidine ([1,1, Biphenyl]-4,4-diamine, 3,3-dichloro-) - 1,4-Dichloro-2-butene (2-Butene, 1,4-dichloro-)

- Dichlorodifluoromethane (Methane, dichlorodifluoro-)

- 1,1 Dichloroethane (Ethylidene dichloride)

- 1,2 Dichloroethane (Ethylene dichloride)

- trans-1,2-Dichloroethene (1,2-Dichloroethylene)

- Dichloroethylene, N.O.S.3 (Ethene, dichloro-N.O.S.3 - 1,1-Dichloroethylene (Ethene, 1,1-dichloro-)

- Dichloromethane (Methylene chloride)

- 2,4-Dichlorophenol (Phenol, 2,4-dichloro-)

- 2,6-Dichlorophenol (Phenol, 2,6-dichloro-)

- 2,4-Dichlorophenoxyacetic acid (2,4-D), saltsand esters (Acetic acid, 2,4-dichlorophenoxy-, salts and esters)

- Dichlorophenylarsine (Phenyl dichloroarsine)

- Dichloropropane, N.O.S.3 (Propane, dichloro-N.O.S.3 - 1,2-Dichloropropane (Propylene dichloride)

- Dichloropropanol, N.O.S.3 (Propanol, dichloro-N.O.S.3) - Dichloropropene, N.O.S.3 (Propene, dichloro-N.O.S.3 - 1,3-Dichloropropene (1-Propene, 1,3-dichloro-)

- Dieldin (1,2,3,4,10,10-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octa-hydro-endo,exo-1,4:5,8- Dimethanonaphthalene)

- 1,2:3,4-Diepoxybutane (2,2,-Bioxirane)

- Diethylarsine (Arsine, diethyl-)

- N,N-Diethylhydrazine (Hydrazine, 1,2-diethyl)

- O,O-Diethyl S-methyl ester of phosphorodithioic acid (Phosphorodithioic acid, O,O-diethyl S-methyl ester)

- O,O-Diethylphosphoric acid, O-p-nitrophenyl ester (Phosphoric acid, diethyl p-nitrophenyl ester) - Diethyl phthalate (1,2-Benzenedicarboxylic acid, diethyl ester) - O,O-Diethyl O-2-pyrazinyl phosphorothioate (Phosphorothioic acid, O,0-diethyl O-pyrazinyl ester) - Diethylstilbesterol (4,4-Stilbenediol,alpha,alpha-diethyl,bis(dihydrogen phosphate, (E)-) - Dihydrosafrole (Benzene, 1,2-methylenedioxy-4-propyl-) - 3,4-Dihydroxy-alpha-(methylamino)methylbenzyl alcohol (1,2-Benzenediol, 4-(1-hydroxy-2 (methylamino)ethyl))

- Dilsopropylfluorophosphate (DFP) (Phosphorofluoridic acid, bis(1-methylethyl) ester) - Dimethoate (Phosphorodithioic acid, O,O-dimethyl S-(2-(methylamino)-2-oxoethyl) ester) - 3,3,-Dimethoxybenzidine ((1,1,-Biphenyl)-4,4,-diamine, 3-3,-dimethoxy-) - p-Dimethylaminoazobenzene (Benzenamine, N,N-dimethyl-4-(phenylazo)-) - 7,12-Dimethylbenz(a)anthracene(1,2-Benzathracene, 7,12-dimethyl-) - 3,3-Dimethylbenzidine (1,1-Biphenyl)-4,4,diamine, 3,3-dimethyl-) - Dimethylcarbamoyl chloride (Carbamoyl chloride, dimethyl) - 1,1 Dimethylhydrazine (Hydrazine, 1,1-dimethyl-)

- 1,2-Dimethylhydrazine (Hydrazine, 1,2-dimethyl-)

- 3,3-Dimethyl-1-(methylthio)-2-butanone, O-[(methylamino) carbonyl] oxime (Thiofanox) - alpha,alpha-Dimethylphenethylamine (Ethanamine, 1,1-dimethyl-2-phenyl-) - 2,4-Dimethylphenol (Phenol, 2,4-dimethyl-)

- Dimethyl phthalate (1,2-Benzenedicarboxylic acid, dimethyl ester) - Dimethyl sulfate (Sulfuric acid, dimethyl ester)

- Dinitrobenzene, N.O.S.3 (Benzene, dinitro-N.O.S.3)

- 4,6-Dinitro-o-cresol and salts (Phenol, 2,4-dinitro-6-methyl-, and salts) - 2,4-Dinitrophenol (Phenol, 2,4-dinitro-)

- 2,4-Dinitrotoluene (Benzene, 1-methyl-2,4-dinitro-)

- 2,6-Dinitrotoluene (Benzene, 1-methyl 2,6-dinitro-)

- Di-n-octyl phthalate (1,2-Benzenedicarboxylic acid, dioctyl ester) - 1,4-Dioxane (1,4-Diethylene oxide)

- Diphenylamine (Benzenamine, N-phenyl-)

- 1,2-Diphenylhydrazine (Hydrazine, 1,2-diphenyl-)

- Di-n-propylnitrosamine (N-Nitroso-di-n-propylamine)

- Disulfoton (O,O-diethyl S-(2-(ethylthio)ethyl) phosphorodithioate) - 2,4-Dithiobiuret (Thiomidodicarbonic diamide)

- Endosulfan (5-Norbomene, 2,3-dimethanol,1,4,5,6,7,7-hexachloro-cyclic sulfite) - Endrin and metabolites (1,2,3,4,10,10-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-endo, endo- 1,4,5,8-dimethanonaphthalene, and metabolites)

- Ethyl carbamate (Urethan) (Carbamic acid, ethyl ester) - Ethyl cyanide (Propanenitrile)

- Ethylenebisdithiocarbamic acid, salts, and esters (1,2-Ethanediyl-biscarbamodithioic acid, salts and esters)

- Ethyleneimine (Aziridine)

- Ethylene oxide (Oxirane)

- Ethylenethiourea (2-Imidazolidinethione)

- Ethyl methacrylate (2-Propenoic acid, 2-methyl-, ethyl ester) - Ethyl methanesulfonate (Methanesulfonic acid, ethyl ester) - Fluoranthene (Benzo[j,k]fluorene)

- Fluorine - 2-Fluoroacetamide (Acetamide, 2-fluoro-)

- Fluoroacetic acid, sodium salt (Acetic acid, fluoro-sodium salt) - Formaldehyde (Methylene oxide)

- Formic acid (Methanoic acid)

- Glycidylaldehyde (1-Propanol-2,3 epoxy)

- Halomethane, N.O.S.3 - Heptachlor (4,7-Methano-1H-indene.1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-tetrahydro-) - Heptachlor epoxide (alpha, beta, and gamma isomers) (4,7-Methano-1H-indene, 1,4,5,6,7,8,8- heptachloro-2,3-epoxy-3a,4,7,7-tetrahydro-,alpha, beta, and gamma isomers) - Hexachlorobenzene (Benzene, hexachloro-)

- Hexachlorobutadiene (1,3-Butadiene, 1,1,2,3,4,4-hexachloro-) - Hexachlorocyclohexane (all isomers) (Lindane and isomers) - Hexachlorocyclopentadiene (1,3-Cyclopentadiene, 1,2,3,4,5,5-hexachloro-) - Hexachloroethane (Ethane, 1,1,1,2,2,2-hexachloro-)

- 1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4,5,8-endo,endo-dimethanonaphthalene (Hexachlorohexa-hydro-endo,endo-dimethanonaphthalene)

- Hexachlorophene (2,2,-Methylenebis(3,4,6-trichlorophenol) - Hexachloropropene (1-Propene, 1,1,2,3,3,3-hexachloro-) - Hexaethyl tetraphosphate (Tetraphosphoric acid, hexaethyl ester) - Hydrazine (Diamine)

- Hydrocyanic acid (Hydrogen cyanide)

- Hydrofluoric acid (Hydrogen fluoride)

- Hydrogen sulfide (Sulfur hydride)

- Hydroxydimethylarsine oxide (Cacodylic acid)

- Indeno (1,2,3-cd)pyrene(1,10-(1,2-phenylene)pyrene)

- Iodomethane (Methyl iodide)

- Iron dextran (Ferric dextran)

- Isocyanic acid, methyl ester (Methyl isocyanate)

- Isobutyl alcohol (1-Propanol, 2-methyl-)

- Isosafrole (Benzene, 1,2-methylenedioxy-4-allyl-)

- Kepone (decachlorooctahydro-1,3,4-Methano-2H-cyclobuta[cd]pentalen-2-one) - Lasiocarpine (2-Butenoic acid, 2-methyl-,7-[(2,3-dihydroxy-2-(1-methoxyethyl)-3-methyl-1-oxobutoxy) methyl]2,3,5,7a-tetrahydro-1H-pyrrolizin-1-yl-ester)

- Lead and compounds, N.O.S.3 - Lead acetate (Acetic acid, lead salt)

- Lead phosphate (Phosphoric acid, lead salt)

- Lead subacetate (Lead, bis(acetato-O)tetrahydroxytri-) - Maleic anhydride (2,5-Furandione)

- Maleic hydrazide (1,2-Dihydro-3,6-pyridazinedione)

- Malononitrile (Propanedinitrile)

- Melphalan (Alanine, 3-(p-bis(2-chloroethyl)amino)phenyl-L-)- Mercury fulminate (Fulminic acid, mercury salt)

- Mercury and compounds, N.O.S.3 - Methacrylonitrile (2-Propenenitrile,2-methyl-)

- Methanethiol (Thiomethanol)

- Methapyrilene (Pyridine, 2-[(2-dimethylamino)ethyl)]-2-thenylamino-) - Metholmyl (Acetimidic acid, N-[(methylcarbamoyl)oxy] thio-,methyl ester) - Methoxychlor (Ethane, 1,1,1-trichloro-2,2,-bis(p-methoxyphenyl)-) - 2-Methylaziridine (1,2-Propylenimine)

- 3-Methlycholanthrene (Benz[j]aceanthrylene,1,2-dihydro-3-methyl-) - Methyl chlorcarbonate (Carbonochloridicacid, methyl ester) - 4,4-Methylenebis (2-chloroaniline) Benzenamine, 4,4-methylenebis-(2-chloro-) - Methyl ethyl ketone (MEK) (2-Butanone)

- Methyl hydrazine (Hydrazine methyl-)

- 2-Methyllactonitrile (Propanenitrile 2-hydroxy-2-methyl-) - Methyl methacrylate (2-Propenoic acid, 2-methyl-, methyl ester) - Methyl methanesulfonate Methanesulfonicacid, methyl ester) - 2-Methyl-2-(methylthio)propionaldehyde-o-(methylcarbonyl) oxime (Propanal,2-methyl-2(methylthio-0- [(methylamino)carbonyl]oxime)

- N-Methyl-N,-nitro-N-nitrosoguanidine (Guanidine, N-nitroso-N-methyl-N,-nitro-) - Methyl parathion (0,0-dimethyl 0-(40 nitrophenyl) phosphorothioate) - Methylthiouracil (4-IH-Pyrimidinone, 2,3-dihydro-6-methyl-2-thioxo-) - Molybdenum and compounds, N.O.S.3 - Mustard gas (Sulfide, bis(2-chloroethyl)-)

- Naphthalene - 1,4-Naphthoquinone (1,4-Naphthalenedione)

- 1-Naphthylamine (alpha-Naphthylamine)

- 2-Naphthylamine (beta-Naphthylamine)

- 1-Naphthyl-2-thiourea (Thiourea, 1-naphthalenyl-)

- Nickel and compounds, N.O.S.3 - Nickel carbonyl (Nickel tetracarbonyl)

- Nickel cyanide (Nickel (II) cyanide)

- Nicotine and salts (Pyridine, (S)-3-(1-methyl-2-pyrrolidinyl)-, and salts) - Nitric oxide (Nitrogen (II) oxide)

- p-Nitroaniline (Benzenamine, 4-nitro-)

- Nitrobenzine (Benzene, nitro-)

- Nitrogen dioxide (Nitrogen (IV) oxide)

- Nitrogen mustard and hydrochloride salt (Ethanamine, 2-chloro-,N-(2-chloroethyl)-N-methyl-, and hydrochloride salt)

- Nitrogen mustard N-Oxide and hydrochloride salt (Ethanamine, 2-chloro,N-(2-chloroethyl)-N-methyl-and hydrochloride salt)

- Nitroglycerine (1,2,3-Propanetriol, trinitrate)

- 4-Nitrophenol (Phenol, 4-nitro)

- 4-Nitroquinoline-1-oxide (Quinoline,4-nitro-1-oxide-) - Nitrosamine, N.O.S.3 - N-Nitrosodi-n-butylamine (1-Butanamine,N-butyl-N-nitroso-) - N-Nitrosodiethanolamine (Ethanol, 2,2-(nitrosoimino)bis-) - N-Nitrosodiethylamine (Ethanamine, N-ethyl-N-nitroso-) - N-Nitrosodimethylamine (Dimethylnitrosamine)

- N-Nitroso-N-ethylurea (Carbamide, N-ethyl-N-nitroso-) - N-Nitrosomethylethylamine (Ethanamine, N-methyl-N-nitroso-) - N-Nitroso-N-methylurea (Carbamide, N-methyl-N-nitroso-) - N-Nitroso-N-methylurethane (Carbamic acid, methylnitroso-, ethyl ester) - N-Nitrosomethylvinylamine (Ethenamine,N-methyl-N-nitroso-) - N-Nitrosomorpholine (Morpholine,-N-nitroso-)

- N-Nitrosonomicotine (Nornicotine,-N-nitroso-)

- N-Nitrosopiperidine (Pyridine, hexahydro-,N-nitroso-) - Nitrosopyrrolidine (Pyrrole, tetrahydro-N-nitroso-)

- N-Nitrososarcosine (Sarcosine,-N-nitroso-)

- 5-Nitro-o-toluidine (Benzenamine, 2-methyl-5-nitro-)

- Octamethylpyrophosphoramide (Diphosphoramide, octamethyl-) - Osmium tetroxide (Osmium(VIII)oxide)

- 7-Oxabicyclo(2,2,1)heptane-2,3-dicarboxylic acid (Endothal) - Paraldehyde (1,3,5-Trioxane, 2,4,6-trimethyl-)

- Parathion (Phosphorothioic acid O,O-diethylO-(p-nitrophenyl) ester) - Pentachlorobenzene (Benzene, pentachloro-)

- Pentachloroethane (Ethane, pentachloro-)

- Pentachloronitrobenzene (PCNB) (Benzene, Pentachloronitro-) - Pentachlorophenol (Phenol, pentachloro-)

- Phenacetin (Acetamide, N-(4-ethoxyphenyl)-)

- Phenol (Benzene, hydroxy-)

- Phenylenediamine (Benzenediamine)

- Phenylmercury acetate (Mercury acetatophenyl-)

- N-Phenylthiourea (Thiourea, phenyl-)

- Phosgene (Carbonyl chloride)

- Phosphine (Hydrogen phosphide)

- Phosphorodithioic acid, O,O-diethyl S-[(ethylthio)methyl]ester (Phorate) - Phosphorothioic acid, O,O-dimethyl O-(p-[(dimethylamino)sulfonyl)phenyl]ester (Famphur) - Phthalic acid esters, N.O.S.3 (Benzene, 1,2-dicarboxylic acid, esters, N.O.S.3) - Phthalic anhydride (1,2-Benzenedicarboxylic acid anhydride) - 2-Picoline (Pyridine, 2-methyl-)

- Polychlorinated biphenyl, N.O.S.3 - Potassium cynanide - Potassium silver cyanide (Argentate(1-),dicyano-,potassium) - Pronamide (3,5-Dichloro-N-(1,1-dimethyl-2-propynyl)benzamide) - 1,3 Propane sultone (1,2-Oxathiolane, 2,2-dioxide)

- n-Propylamine (1-Propanamine)

- Propylthiouracil (Undecamethylenediamine,N,N-bis(2-chlorobenzyl-),dihydrochloride) - 2-Propyn-1-ol (Propargyl alcohol)

- Pyridine - Radium-226 and -228 - Reserpine (Yohimban-16-carboxylic acid,11,17-dimethoxy-18-[3,4,5-trimethoxybenzoyl)oxy]-, methyl ester)

- Resorcinol (1,3-Benzenediol)

- Saccharin and salts (1,2-Benzoisothiazolin-3-one, 1,1-dioxide, and salts) - Safrele (Benzene, 1,2-methylenedioxy-4-allyl-)

- Selenious acid (Selenium dioxide)

- Selenium and compounds, N.O.S.3 - Selenium sulfide (Sulfur selenide)

- Selenourea (Carbamimidoselenoic acid)

- Silver and compounds, N.O.S.3 - Silver cyanide - Sodium cyanide - Streptozotocin (D-Glucopyranose, 2-deoxy-2-(3-methyl-3-nitrosoureido)-) - Strontium sulfide - Strychnine and salts (Strychnidin-10-one, and salts)

- 1,2,4,5-Tetrachlorobenzene (Benzene,1,2,4,5-tetrachloro-) - 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) (Dibenzo-p-dioxin, 2,3,7,8-tetrachloro-) - Tetrachloroethane, N.O.S.3 (Ethane, tetrachloro-N.O.S.3 - 1,1,1,2-Tetrachlorethane (Ethane, 1,1,1,2-tetrachloro-) - 1,1,2,2-Tetrachlorethane (Ethane 1,1,2,2-tetrachloro-) - Tetrachlorethane (Ethene, 1,1,2,2-tetrachloro-)

- Tetrachloromethane (Carbon tetrachloride)

- 2,3,4,6-Tetrachlorophenol (Phenol 2,3,4,6-tetrachloro-) - Tetraethyldithiopyrophosphate (Dithiopyrophosphoric acid, tetraethyl-ester) - Tetraethyl lead (Plumbane, tetraethyl-)

- Tetraethylpyrophosphate (Pyrophosphoricacide, tetraethyl ester) - Tetranitromethane (Methane, tetranitro-)

- Thallium and compounds, N.O.S.3 - Thallic oxide (Thallium (III) oxide)

- Thallium (I) acetate (Acetic acid, thallium (I) salt) - Thallium (I) carbonate (Carbonic acid dithallium (I) salt) - Thallium (I) chloride - Thallium (I) nitrate (Nitric acid, thallium (I) salt) - Thallium selenite - Thallium (I) sulfate (Sulfuric acid, thallium (I) salt) - Thioacetamide (Ethanethioamide)

- Thiosemicarbazide (Hydrazinecarbothioamide)

- Thiourea (Carbamide thio-)

- Thiuram (Bis(dimethylthiocarbamoyl) disulfide)

- Thorium and compounds, N.O.S.3 when producing thorium byproduct material - Toluene (Benzene, methyl-)

- Toluenediamine (Diaminotoluene)

- o-Toluidine hydrochloride (Benzenamine, 2-methyl-,hydrochloride) - Tolylene diisocyanate (Benzene, 1,3-diisocyanatomethyl-) - Toxaphene (Camphene, octachloro-)

- Tribromomethane (Bromoform)

- 1,2,4-Trichlorobenzene (Benzene, 1,2,4-trichloro-)

- 1,1,1-Trichloroethane (Methyl chloroform)

- 1,1,2-Trichloroethane (Ethane, 1,1,2-trichloro-)

- Trichloroethene (Trichloroethylene)

- Trichloromethanethiol (Methanethiol, trichloro-)

- Trichloromonofluoromethane (Methane, trichlorofluoro-) - 2,4,5-Trichlorophenol (Phenol, 2,4,5-trichloro-)

- 2,4,6-Trichlorophenol (Phenol, 2,4,6-trichloro-)

- 2,4,5-Trichlorophenoxyacetic acid (2,4,5-T) (Acetic acid, 2,4,5-trichlorophenoxy-) - 2,4,5-Trichlorophenoxypropionic acid (2,4,5-TP) (Silvex) (Propionoic acid, 2-(2,4,5-trichlorophenoxy)-) - Trichloropropane, N.O.S.3 (Propane, trichloro-, N.O.S.3) - 1,2,3-Trichloropropane (Propane, 1,2,3-trichloro-)

- O,O,O-Triethyl phosphorothioate (Phosphorothioic acid, O,O,O-triethyl ester) - sym-Trinitrobenzene (Benzene, 1,3,5-trinitro-)

- Tris(1-azridinyl) phosphine sulfide (Phosphine sulfide, tris(1-aziridinyl-) - Tris(2,3-dibromopropyl) phosphate (1-Propanol, 2,3-dibromo-, phosphate) - Trypan blue (2,7-Naphthalenedisulfonic acid, 3,3,-((3,3,-dimethyl (1,1,-biphenyl)-4,4,diyl)bis(azo))bis(5- amino-4-hydroxy-tetrasodium salt)

- Uracil mustard (Uracil-5-[bis(2-chloroethyl]amino)-)

- Uranium and compounds, N.O.S.3 - Vanadic acid, ammonium salt (ammonium vanadate)

- Vanadium pentoxide (Vanadium (V) oxide)

- Vinyl chloride (Ethene, chloro-)

- Zinc cyanide - Zinc phosphide 3The abbreviation N.O.S. (not otherwise specified) signifies those members of the general class not specifically listed by name in this list.

PART 19:

LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS 19.1 Purpose and Scope.

19.1.1 Part 19 contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. Part 19 also contains requirements for operating irradiators. The requirements of this part are in addition to the requirements of Parts 3, 4, 10, 12, 13, and 17. Nothing in this part relieves the licensee from complying with other applicable Federal, State and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities. 19.1.2 The regulations in this part apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 5 gray (500 rad) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this part.

19.1.3 The regulations in this part do not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations. 19.2 Definitions.

As used in this part, the following definitions apply.

“Doubly encapsulated sealed source” means a sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule. “Irradiator” means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 5 gray (500 rad) per hour exist at 1 meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel. “Irradiator operator” means an individual who has successfully completed the training and testing described in 19.18 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

“Panoramic dry-source-storage irradiator” means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations. “Panoramic irradiator” means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators. “Panoramic wet-source-storage irradiator” means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

“Pool irradiator” means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators. “Product conveyor system” means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

“Radiation room” means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

“Seismic area” means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10 percent, as designated by the U.S. Geological Survey.

“Underwater irradiator” means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

SPECIFIC LICENSING REQUIREMENTS 19.3 Application For a Specific License.

19.3.1 A person shall file an application for a specific license authorizing the use of sealed sources in an irradiator pursuant to 3.8 of the regulations.

19.4 Specific Licenses for Irradiators.

19.4.1 The Department will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section. 19.4.2 The applicant shall satisfy the general requirements specified in 3.9 of the regulations and the requirements contained in this part.

19.4.3 The applicant must describe the training provided to irradiator operators including: 19.4.3.1 Classroom training;

19.4.3.2 On-the-job or simulator training;

19.4.3.3 Safety reviews;

19.4.3.4 Means employed by the applicant to test each operator's understanding of the Department's regulations and licensing requirements and the irradiator operating and emergency procedures; and 19.4.3.5 Minimum training and experience of personnel who may provide training. 19.4.4 The application must include an outline of the written operating and emergency procedures listed in 19.19 that describes the radiation safety aspects of the procedures. 19.4.5 The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer.

19.4.6 The application must include a description of the access control systems required by 19.8, the radiation monitors required by 19.11, the method of detecting leaking sources required by 19.22 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

19.4.7 If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the Department. The description must include the:

19.4.7.1 Instruments to be used;

19.4.7.2 Methods of performing the analysis; and 19.4.7.3 Pertinent experience of the individual who analyzes the samples. 19.4.8 If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by an organization specifically authorized by the U.S. Nuclear Regulatory Commission or an Agreement State to load or unload irradiator sources.

19.4.9 The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 19.23.

19.5 Start of Construction.

19.5.1 The applicant may not begin construction of a new irradiator prior to the submission to the Department of both the application for a license for the irradiator and the fee required by Part 12 of the regulations. As used in this section, the term “construction” includes the construction of any portion of the permanent irradiator structure on the site but does not include: engineering and design work, purchase of a site, site surveys or soil testing, site preparation, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Act, and rules, regulations, and orders issued under the Act.

19.6 Applications for Exemptions.

19.6.1 Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this part. The Department will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public. DESIGN AND PERFORMANCE REQUIREMENTS FOR IRRADIATORS 19.7 Requirements and Performance Criteria for Sealed Sources. Sealed sources must:

19.7.1 Have a certificate of registration issued by the U.S. Nuclear Regulatory Commission or an Agreement State;

19.7.2 Be doubly encapsulated;

19.7.3 Use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator; 19.7.4 Be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are used in irradiator pools; and 19.7.5 In prototype testing of the sealed source, have been leak tested and found leak-free after each of the tests described in 19.7.5.1 through 19.7.5.6.

19.7.5.1 Temperature test. The test source must be held at -40°C for 20 minutes, 600°C for 1 hour, and then be subjected to a thermal shock test with a temperature drop from 600°C to 20°C within 15 seconds.

19.7.5.2 Pressure test. The test source must be twice subjected for at least 5 minutes to an external pressure (absolute) of 2 million newtons per square meter. 19.7.5.3 Impact test. A 2-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source.

19.7.5.4 Vibration test. The test source must be subjected 3 times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of 5 times the acceleration of gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency found.

19.7.5.5 Puncture test. A 50-gram weight and pin, 0.3-centimeter pin diameter, must be dropped from a height of 1 meter onto the test source.

19.7.5.6 Bend test. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source must be subjected to a force of 2000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source. 19.8 Access Control.

19.8.1 Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving. 19.8.2 In addition, each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm must also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and be prepared to promptly render or summon assistance.

19.8.3 A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, must activate the alarm described in 19.8.2. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

19.8.4 Before the sources move from their shielded position in a panoramic irradiator, the source control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give individuals enough time to leave the room before the sources leave the shielded position. 19.8.5 Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.

19.8.6 Each radiation room of a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control. 19.8.7 Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator must be posted as required by 4.28. Radiation postings for panoramic irradiators must comply with the posting requirements of 4.28, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

19.8.8 If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating. 19.8.9 Underwater irradiators must have a personnel access barrier around the pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance.

19.9 Shielding.

19.9.1 The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 millirem) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 centimeters. Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirem) per hour must be locked, roped off, or posted.

19.9.2 The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 millirem) per hour when the sources are in the fully shielded position. 19.9.3 The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 millirem) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 millirem) per hour. 19.10 Fire Protection.

19.10.1 The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.

19.10.2 The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas. 19.11 Radiation Monitors.

19.11.1 Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph. 19.11.2 Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly.

19.12 Control of Source Movement.

19.12.1 The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be used at any time, and only one operator or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.

19.12.2 The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.

19.12.3 The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.

19.12.4 Each control for a panoramic irradiator must be clearly marked as to its function. 19.13 Irradiator Pools.

19.13.1 Irradiator pools must either:

19.13.1.1 Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or 19.13.1.2 Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee shall have a method to safely store the sources during repairs of the pool. 19.13.2 Irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water.

19.13.3 A means must be provided to replenish water losses from the pool. 19.13.4 A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level. 19.13.5 Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly. 19.13.6 A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations. 19.13.7 If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 0.02 millisievert (2 millirem) per hour. 19.14 Source Rack Protection.

19.14.1 If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism. 19.15 Power Failures.

19.15.1 If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position.

19.15.2 The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.

19.15.3 During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter. 19.16 Design Requirements.

19.16.1 Irradiators must meet the design requirements of this section. 19.16.1.1 Shielding. For panoramic irradiators, the licensee shall design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entranceways to meet the radiation shielding requirements of 19.9. If the irradiator will use more than 2 - 10 17 becquerel (5 million curie) of activity, the licensee shall evaluate the effects of heating of the shielding walls by the irradiator sources.

19.16.1.2 Foundations. For panoramic irradiators, the licensee shall design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.

19.16.1.3 Pool integrity. For pool irradiators, the licensee shall design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of 19.13.2, and that metal components are metallurgically compatible with other components in the pool.

19.16.1.4 Water handling system. For pool irradiators, the licensee shall verify that the design of the water purification system is adequate to meet the requirements of 19.13.5. The system must be designed so that water leaking from the system does not drain to unrestricted areas without being monitored.

19.16.1.5 Radiation monitors. For all irradiators, the licensee shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by 19.11.1. The licensee shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For pool irradiators, if the licensee uses radiation monitors to detect contamination under 19.22.2, the licensee shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.

19.16.1.6 Source rack. For pool irradiators, the licensee shall verify that there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the source. For panoramic irradiators, the licensee shall determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee shall review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

19.16.1.7 Access control. For panoramic irradiators, the licensee shall verify from the design and logic diagram that the access control system will meet the requirements of 19.8. 19.16.1.8 Fire protection. For panoramic irradiators, the licensee shall verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The licensee shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage. 19.16.1.9 Source return. For panoramic irradiators, the licensee shall verify that the source rack will automatically return to the fully shielded position if facility power is lost for more than 10 seconds.

19.16.1.10 Seismic. For panoramic irradiators to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as current national standards or local building codes.

19.16.1.11 Wiring. For panoramic irradiators, the licensee shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.

19.17 Construction Monitoring and Acceptance Testing.

19.17.1 The requirements of this section must be met for all irradiators subject to this part prior to loading sources.

19.17.1.1 Shielding. For panoramic irradiators, the licensee shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete. 19.17.1.2 Foundations. For panoramic irradiators, the licensee shall monitor the construction of the foundations to verify that their construction meets design specifications. 19.17.1.3 Pool integrity. For pool irradiators, the licensee shall verify that the pool meets design specifications and shall test the integrity of the pool. The licensee shall verify that outlets and pipes meet the requirements of 19.13.2.

19.17.1.4 Water handling system. For pool irradiators, the licensee shall verify that the water purification system, the conductivity meter, and the water level indicators operate properly.

19.17.1.5 Radiation monitors. For all irradiators, the licensee shall verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by 19.11.1. For pool irradiators, the licensee shall verify the proper operation of the radiation monitors and the related alarm if used to meet 19.22.2. For underwater irradiators, the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by 19.11.2. 19.17.1.6 Source rack. For panoramic irradiators, the licensee shall test the movement of the source racks for proper operation prior to source loading, and testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in 19.14 are met for protection of the source rack and the mechanism that moves the rack. Testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

19.17.1.7 Access control. For panoramic irradiators, the licensee shall test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work properly.

19.17.1.8 Fire protection. For panoramic irradiators, the licensee shall test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. The licensee shall test the operability of the fire extinguishing system.

19.17.1.9 Source return. For panoramic irradiators, the licensee shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power. 19.17.1.10 Computer systems. For panoramic irradiators that use a computer system to control the access control system, the licensee shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable. 19.17.1.11 Wiring. For panoramic irradiators, the licensee shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications. OPERATION OF IRRADIATORS 19.18 Training.

19.18.1 Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in:

19.18.1.1 The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, Department dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator); 19.18.1.2 The requirements of Parts 4, 10 and 19 of these regulations that are relevant to the irradiator;

19.18.1.3 The operation of the irradiator;

19.18.1.4 Those operating and emergency procedures listed in 19.19 that the individual is responsible for performing; and 19.18.1.5 Case histories of accidents or problems involving irradiators. 19.18.2 Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision. 19.18.3 Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating procedures that he or she is to perform. 19.18.4 The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following:

19.18.4.1 Changes in operating and emergency procedures since the last review, if any; 19.18.4.2 Changes in regulations and license conditions since the last review, if any; 19.18.4.3 Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any;

19.18.4.4 Relevant results of inspections of operator safety performance; 19.18.4.5 Relevant results of the facility's inspection and maintenance checks; and 19.18.4.6 A drill to practice an emergency or abnormal event procedure. 19.18.5 The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed. 19.18.6 Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in 19.19 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.

19.18.7 Individuals who must be prepared to respond to alarms required by 19.8.2, 19.8.9, 19.10.1, 19.11.1, 19.11.2, and 19.22.2 shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

19.19 Operating and Emergency Procedures.

19.19.1 The licensee shall have and follow written operating procedures for: 19.19.1.1 Operation of the irradiator, including entering and leaving the radiation room; 19.19.1.2 Use of personnel dosimeters;

19.19.1.3 Surveying the shielding of panoramic irradiators; 19.19.1.4 Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

19.19.1.5 Leak testing of sources;

19.19.1.6 Inspection and maintenance checks required by 19.23; 19.19.1.7 Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and 19.19.1.8 Inspection of movable shielding required by 19.8.8, if applicable. 19.19.2 The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:

19.19.2.1 Sources stuck in the unshielded position;

19.19.2.2 Personnel overexposures;

19.19.2.3 A radiation alarm from the product exit portal monitor or pool monitor; 19.19.2.4 Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;

19.19.2.5 A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

19.19.2.6 A prolonged loss of electrical power;

19.19.2.7 A fire alarm or explosion in the radiation room; 19.19.2.8 An alarm indicating unauthorized entry into the radiation room, area around the pool, or another alarmed area;

19.19.2.9 Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and 19.19.2.10 The jamming of automatic conveyor systems.

19.19.3 The licensee may revise operating and emergency procedures without Department approval only if all of the following conditions are met:

19.19.3.1 The revisions do not reduce the safety of the facility; 19.19.3.2 The revisions are consistent with the outline or summary of procedures submitted with the license application;

19.19.3.3 The revisions have been reviewed and approved by the radiation safety officer; and 19.19.3.4 The users or operators are instructed and tested on the revised procedures before they are put into use.

19.20 Personnel Monitoring.

19.20.1 Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be accredited for high-energy photons in the normal and accident dose ranges (see 4.17.3). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be replaced at least monthly and each other personnel dosimeter must be replaced at least quarterly. After replacement, each personnel dosimeter must be promptly processed.

19.20.2 Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within 30 percent of the true radiation dose. 19.21 Radiation Surveys.

19.21.1 A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed 3 years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

19.21.2 If the radiation levels specified in 19.9 are exceeded, the facility must be modified to comply with the requirements in 19.9.

19.21.3 Portable radiation survey meters must be calibrated at least annually to an accuracy of 20 percent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates.

19.21.4 Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in Part 4, Appendix B, Table 1, “Annual Limits on Intakes (ALIs) and Derived Air Concentrations (DACs)” , or Table 3, “Release to sewers.”

19.21.5 Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be released only if the survey does not detect radiation levels above background levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour.

19.22 Detection of Leaking Sources.

19.22.1 Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed 6 months using a leak test kit or method approved by the U.S. Nuclear Regulatory Commission or an Agreement State. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of 200 becquerel (0.005 microcurie) of radioactive material and must be performed by a person approved by the U.S. Nuclear Regulatory Commission or an Agreement State to perform the test.

19.22.2 For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the 6 months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. This check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results must be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures. 19.22.3 If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by a U.S. Nuclear Regulatory Commission or Agreement State licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by a U.S. Nuclear Regulatory Commission or Agreement State licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Part 4, Appendix B, Table 3 (See 4.52 and 4.53 of these regulations for notification and reporting requirements).

19.23 Inspection and Maintenance.

19.23.1 The licensee shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application: 19.23.1.1 Operability of each aspect of the access control system required by 19.8; 19.23.1.2 Functioning of the source position indicator required by 19.12.2; 19.23.1.3 Operability of the radiation monitor for radioactive contamination in pool water required by 19.22.2, using a radiation check source, if applicable; 19.23.1.4 Operability of the over-pool radiation monitor at underwater irradiators as required by 19.11.2;

19.23.1.5 Operability of the product exit monitor required by 19.11.1; 19.23.1.6 Operability of the emergency source return control required by 19.12.3; 19.23.1.7 Leak-tightness of systems through which pool water circulates (visual inspection); 19.23.1.8 Operability of the heat and smoke detectors and extinguisher system required by 19.10 (but without turning extinguishers on);

19.23.1.9 Operability of the means of pool water replenishment required by 19.13.3; 19.23.1.10 Operability of the indicators of high and low pool water levels required by 19.13.4; 19.23.1.11 Operability of the intrusion alarm required by 19.8.9, if applicable; 19.23.1.12 Functioning and wear of the system, mechanisms and cables used to raise and lower sources;

19.23.1.13 Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 19.14;

19.23.1.14 Amount of water added to the pool to determine if the pool is leaking; 19.23.1.15 Electrical wiring on required safety systems for radiation damage; and 19.23.1.16 Pool water conductivity measurements and analysis as required by 19.24.2. 19.23.2 Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.

19.24 Pool Water Purity.

19.24.1 Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.

19.24.2 The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity instruments must be calibrated at least annually. 19.25 Attendance During Operations.

19.25.1 Both an irradiator operator and at least one individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:

19.25.1.1 Whenever the irradiator is operated using an automatic product conveyor system; and 19.25.1.2 Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

19.25.2 At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in 19.18.7 must be onsite.

19.25.3 At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in 19.18.6 and 19.18.7. Static irradiations may be performed without a person present at the facility.

19.26 Entering and Leaving the Irradiation Room.

19.26.1 Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

19.26.2 Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

19.26.2.1 Visually inspect the entire radiation room to verify that no one else is in it; and 19.26.2.2 Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

19.26.3 During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by 19.11.2 is operating with backup power.

19.27 Irradiation of Explosive or Flammable Materials.

19.27.1 Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Department. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel. 19.27.2 Irradiation of more than small quantities of flammable material (flash point below 140°C) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Department. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to the sealed sources or safety systems and without radiation overexposures of personnel. RECORDS 19.28 Records and Retention Periods.

19.28.1 The licensee shall maintain the following records at the irradiator for the periods specified: 19.28.1.1 A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the Department terminates the license for documents not superseded; 19.28.1.2 Records of each individual's training, tests, and safety reviews provided to meet the requirements of 19.18.1, 19.18.2, 19.18.3, 19.18.4, 19.18.6, and 19.18.7 until 3 years after the individual terminates work;

19.28.1.3 Records of the annual evaluations of the safety performance of irradiator operators required by 19.18.5 for 3 years after the evaluation;

19.28.1.4 A copy of the current operating and emergency procedures required by 19.19 until superseded or the Department terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by 19.19.3.3 retained for 3 years from the date of the change;

19.28.1.5 Records of personnel dosimetry (film badge, optically stimulated luminescence and thermoluminescence dosimeter) results required by 19.20 in accordance with 4.46 of these regulations;

19.28.1.6 Records of radiation surveys required by 19.21 for 3 years from the date of the survey; 19.28.1.7 Records of radiation survey meter calibrations required by 19.21.3 and pool water conductivity meter calibrations required by 19.24.2 until 3 years from the date of calibration;

19.28.1.8 Records of the results of leak tests required by 19.22.1 and the results of contamination checks required by 19.22.2 for 3 years from the date of each test; 19.28.1.9 Records of inspection and maintenance checks required by 19.23 for 3 years; 19.28.1.10 Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for 3 years after repairs are completed;

19.28.1.11 Records of the receipt, transfer, and disposal of all licensed sealed sources as required by 3.22 and 4.48 of these regulations;

19.28.1.12 Records on the design checks required by 19.16 and the construction control checks as required by 19.17 until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included; and 19.28.1.13 Records related to decommissioning of the irradiator as required by 3.16.6.8 of these regulations.

19.29 Reports.

19.29.1 In addition to the reporting requirements in other parts of the regulations, the licensee shall report the following events:

19.29.1.1 Source stuck in an unshielded position;

19.29.1.2 Any fire or explosion in a radiation room;

19.29.1.3 Damage to the source racks;

19.29.1.4 Failure of the cable or drive mechanism used to move the source racks; 19.29.1.5 Inoperability of the access control system;

19.29.1.6 Detection of radiation source by the product exit monitor; 19.29.1.7 Detection of radioactive contamination attributable to licensed radioactive material; 19.29.1.8 Structural damage to the pool liner or walls; 19.29.1.9 Abnormal water loss or leakage from the source storage pool; or 19.29.1.10 Pool water conductivity exceeding 100 microsiemens per centimeter. 19.29.2 The report must include a telephone report within 24 hours as described in 4.52.2, and a written report within 30 days as described in 4.53.1.2 of these regulations. PART 20 PARTICLE ACCELERATORS AND THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS RH 20.1 Purpose and Scope.

20.1.1 This Part establishes requirements, for which the registrant is responsible, for use of particle accelerators and therapeutic radiation machines in the healing arts. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of these Regulations. 20.1.2 The use of therapeutic radiation machines for human use shall be by, or under the direct or general supervision of, a licensed practitioner of the healing arts who meets the training and experience criteria established by RH 20.3.1 20.1.3 The use of therapeutic radiation machines for veterinary applications shall be by, or under the direct or general supervision of a licensed veterinarian. RH 20.2 Definitions.

As used in this Part, the following definitions apply:

“Absorbed dose (D)” means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The Sl unit of absorbed dose is joule per kilogram and the name of the unit of absorbed dose is the gray (Gy). The previously used unit of absorbed dose, the rad, is being replaced by the gray.

“Absorbed dose rate” means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

“Air kerma (K)” means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles (electrons) liberated by uncharged ionizing particles (photons) in air of mass dM. The Sl unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).

“Authorized user” means a practitioner of the healing arts who is authorized to prescribe and/or administer the radiation therapy treatment to the patients. “Beam-limiting device” means a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam. “Beam monitoring system” means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.

“Beam scattering foil” means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

“Contact therapy system” means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five (5) centimeters. “Dose monitor unit (DMU)” means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

“External beam radiation therapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.

“Field-flattening filter” means a filter used to homogenize the absorbed dose rate over the radiation field.

“Filter” means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to RH 20.7.

“Gantry” means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

“Gray (Gy)” means the Sl unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray. 1 Gy=100 rad.

“Interlock” means a device preventing the start or continued operation of equipment unless certain predetermined conditions exist.

“Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel. “Isocenter” means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

“Kilo electron volt (keV)” means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. “Kilovolt (kV)”(Thousand volts) is a unit used to measure the nominal accelerating potential of charged particles used to create an x-ray beam.

“Leakage radiation” means radiation emanating from the radiation therapy system except for the useful beam.

“Light field” means the area illuminated by light, simulating the radiation field. “Mega electron volt (MeV)” means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. AMegavolt (MV)@(Million volts) is a unit used to measure the nominal accelerating potential of charged particles used to create an x-ray beam.

“Moving beam radiation therapy” means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy. “Nominal treatment distance” means:

a. For electron irradiation, the distance from the scattering foil or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

b. For X-ray irradiation, the target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.

“Periodic quality assurance check” means a procedure which is performed periodically to ensure that a previous calibration continues to be valid.

“Primary dose monitoring system” means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.

“Radiation head” means the structure from which the useful beam emerges. “Radiation Therapy Physicist” means a qualified expert in accordance with RH 20.3.2 “Redundant beam monitoring system” means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.

“Shadow tray” means a device attached to the radiation head to support auxiliary beam blocking material.

“Sievert (Sv)” means the Sl unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the Sievert. 1 Sv=100 rem.

“Simulator (radiation therapy simulation system)” means any x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.

“Stationary beam radiation therapy” means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation. “Target” means that part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles. “Target-skin distance (TSD)” means the distance measured along the beam axis from the center of the front surface of the x-ray target or the nominal position of the electron source to the surface of the irradiated object or patient.

“Tenth-value layer (TVL)” means the thickness of a specified material which attenuates x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point. “Therapeutic radiation machine” means x-ray or electron-producing equipment designed and used for external beam radiation therapy.

“Virtual source” means a point from which radiation appears to originate. RH 20.3 General Administrative Requirements for Facilities Using Therapeutic Radiation Machines.

20.3.0 Administrative Controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Department. The registrant or the registrant's agent shall ensure that the requirements of this Part are met in the operation of the therapeutic radiation machines. For therapeutic radiation machines used only for veterinary applications, the registrant may request an exemption from those criteria of this Part that are not applicable to the practices of veterinary medicine.

20.3.1 Training for External Beam Radiation Therapy Authorized Users. The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall require the authorized user to be a physician who:

20.3.1.1 Is certified in:

20.3.1.1.1 Radiology or therapeutic radiology by the American Board of Radiology; or 20.3.1.1.2 Radiation oncology by the American Osteopathic Board of Radiology; or 20.3.1.1.3 Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or 20.3.1.1.4 Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or 20.3.1.2 Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of three (3) years of supervised clinical experience.

20.3.1.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include:

20.3.1.2.1.1 Radiation physics and instrumentation;

20.3.1.2.1.2 Radiation protection;

20.3.1.2.1.3 Mathematics pertaining to the use and measurement of ionization radiation; and 20.3.1.2.1.4 Radiation biology.

20.3.1.2.2 To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include: 20.3.1.2.2.1 Review of the full calibration measurements and periodic quality assurance checks;

20.3.1.2.2.2 Evaluation of prepared treatment plans, calculation of treatment times, and patient treatment settings;

20.3.1.2.2.3 Using administrative controls to prevent misadministrations; 20.3.1.2.2.4 Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and 20.3.1.2.2.5 Checking and using radiation survey meters. 20.3.1.2.3 To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

20.3.1.2.3.1 Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;

20.3.1.2.3.2 Selecting proper dose and how it is to be administered; 20.3.1.2.3.3 Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and 20.3.1.2.3.4 Post-administration follow-up and review of case histories. 20.3.1.3 Reserved 20.3.1.4 Reserved 20.3.2 Training for Radiation Therapy Physicist. The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall require the Radiation Therapy Physicist to: 20.3.2.1 Be registered with the Department, under the provisions of Part 2 of these Regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and 20.3.2.2 Be certified by the American Board of Radiology in: 20.3.2.2.1 Therapeutic radiological physics; or 20.3.2.2.2 Roentgen-ray and gamma-ray physics; or 20.3.2.2.3 X-ray and radium physics; or 20.3.2.2.4 Radiological physics; or 20.3.2.3 Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or 20.3.2.4 Be certified by the Canadian College of Medical Physics; or 20.3.2.5 Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a Radiation Therapy Physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in RH 20.4.1, 20.7.16 or 20.8.19, and 20.7.17 or 20.8.20 under the supervision of a Radiation Therapy Physicist during the year of work experience.

20.3.2.6 Notwithstanding the provisions of RH 20.3.2.5, certification pursuant RH 20.3.2.2, 20.3.2.3, and 20.3.2.4 shall be required on or before December 31, 1999. 20.3.3 Qualifications of Operators.

20.3.3.1 Individuals who will be operating a therapeutic radiation machine for human use shall be:

20.3.3.1.1 American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists, or 20.3.3.1.2 individuals as specified by the authorized user(s). Such individuals shall submit to the authorized users evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology; or 20.3.3.1.3 an authorized user as specified in RH 20.3.1. 20.3.3.2 The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least two (2) years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility. 20.3.4 Written safety procedures and rules shall be developed by a Radiation Therapy Physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

20.3.5 Operating procedures required by RH 20.7.18 and 20.8.18 shall specifically address how the Radiation Therapy Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Radiation Therapy Physicist can be contacted. 20.3.6 Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts who meets the training requirements specified in RH 20.3.1. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.

20.3.7 Reserved 20.3.7.1 Reserved 20.3.7.2 Reserved 20.3.7.3 Reserved 20.3.8 Reserved 20.3.9 Information and Maintenance Record and Associated Information. The registrant shall maintain records for the following tests completed on or after September 30, 1999, in a separate file or package for each therapeutic radiation machine, for inspection by the Department: 20.3.9.1 Report of acceptance testing;

20.3.9.2 Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required in this Part, as well as the name(s) of person(s) who performed such activities;

20.3.9.3 Records of maintenance and/or modifications performed on the therapeutic radiation machine after September 30, 1999, as well as the name(s) of person(s) who performed such services;

20.3.10 Records Retention. All records required by this Part shall be retained for a period of three (3) years from the date of completion.

RH 20.4 General Technical Requirements for Facilities Using Therapeutic Radiation Machines. 20.4.1 Protection Surveys.

20.4.1.1 The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with RH 20.9. The radiation protection survey shall be performed by, or under the direction of, a Radiation Therapy Physicist or a qualified expert and shall verify that, with the therapeutic radiation machine in a “BEAM-ON” condition and the machine parameters set to produce the maximum scattering and leakage conditions:

20.4.1.1.1 Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in RH 4.6.1 of these Regulations.; and 20.4.1.1.2 Radiation levels in unrestricted areas do not exceed the limits specified in RH 4.14.1 of these Regulations.

20.4.1.2 In addition to the requirements of RH 20.4.1.1, a radiation protection survey-shall also be performed prior to the first medical use:

20.4.1.2.1 After making any change in the treatment room shielding; 20.4.1.2.2 After making any change in the location of the therapeutic radiation machine within the treatment room;

20.4.1.2.3 After relocating the therapeutic radiation machine; or 20.4.1.2.4 Before using the therapeutic radiation machine in a manner that could result in increased radiation levels relative to the levels measured and documented in the last survey, in areas outside the external beam radiation therapy treatment room.

20.4.1.3 The survey record shall indicate all instances where the facility, in the opinion of the Radiation Therapy Physicist or a qualified expert, is in violation of applicable Regulations. The survey record shall also include: the date of the measurements; the reason the survey is required; the manufacturer's name; model number and serial number of the therapeutic radiation machine; the instrument(s) used to measure radiation levels; a plan of the areas surrounding the treatment room that were surveyed; the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; the calculated maximum level of radiation over a period of one year for each restricted and unrestricted area; and the signature of the individual responsible for conducting the survey;

20.4.1.4 If the results of the surveys required by RH 20.4.1.1 or 20.4.1.2 indicate any radiation levels in excess of the respective limit specified in RH 20.4.1.1, the registrant shall lock the control in the “OFF” position and not use the unit: 20.4.1.4.1 Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or 20.4.1.4.2 Until the registrant has received a specific exemption from the Department. 20.4.2 Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program. If the survey required by RH 20.4.1 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by RH 4.14.1 of these Regulations, before beginning the treatment program the registrant shall:

20.4.2.1 Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with RH 4.14.1 of these Regulations; 20.4.2.2 Perform the survey required by RH 20.4.1 again; and 20.4.2.3 Include in the records required by RH 20.4.4 the results of the initial survey, a description of the modification made to comply with RH 20.4.2.1, and the results of the second survey; or 20.4.2.4 Request and receive an authorization under RH 4.14.3 of these Regulations allowing radiation levels in unrestricted areas greater than those permitted by RH 4.14.1 of these Regulations.

20.4.3 Dosimetry Equipment.

20.4.3.1 The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration; or have been performed within the previous 36 months if the Radiation Therapy Physicist has performed an intercomparison with a dosimetry system that has been calibrated by NIST, AAPM, or ADCL, within the previous 24 months; and 20.4.3.1.1 The dosimetry system shall have been calibrated at an energy range appropriate for the radiation being measured;

20.4.3.2 The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with RH 20.4.3.1. This comparison shall have been performed within the previous twelve (12) months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in RH 20.4.3.1; 20.4.3.3 The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license and/or registration. For each calibration, intercomparison, or comparison, the record shall include: the date; the model numbers and serial numbers of the instruments that were calibrated, inter- compared, or compared as required by RH 20.4.3.1 and 20.4.3.2; the correction factors that were determined; the names of the individuals who performed the calibration, intercomparison, or comparison; and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a Radiation Therapy Physicist.

20.4.4 Records of External Beam Radiation Therapy Surveys and Measurements. The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall maintain a copy of the records required in RH 20.4.1 and 20.4.2 for Department inspection. RH 20.5 Reserved RH 20.6 Radiation Therapy Physicist Support.

20.6.1 The services of a Radiation Therapy Physicist shall be required in facilities having therapeutic radiation machines. The Radiation Therapy Physicist shall be responsible for: 20.6.1.1 Full calibration(s) required by RH 20.7.16 and 20.8.19 and protection surveys required by RH 20.4.1;

20.6.1.1.1 Supervision and review of dosimetry;

20.6.1.1.2 Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

20.6.1.1.3 Quality assurance, including quality assurance check review required by RH 20.7.17 and 20.8.20.

20.6.1.1.4 Consultation with the authorized user in treatment planning, as needed; and 20.6.1.1.5 Perform calculations/assessments regarding misadministrations. RH 20.7 Therapeutic Radiation Machines of Less Than 500 kV. 20.7.1 Leakage Radiation.

When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:

20.7.1.1 5-50 kV Systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 1 mGy (100 mrad) in any one hour. 20.7.1.2 >50 to <500 kV Systems. The leakage air kerma rate measured at a distance of 1 meter from the target in any direction shall not exceed 1 cGy (1 rad) in any one hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.

20.7.1.3 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH 20.7.1.1 and 20.7.1.2 for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department. 20.7.2 Permanent Beam Limiting Devices.

Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly. 20.7.3 Adjustable or Removable Beam Limiting Devices.

20.7.3.1 All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five (5) percent of the useful beam for the most penetrating beam used; 20.7.3.2 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

20.7.4 Filter System.

The filter system shall be so designed that:

20.7.4.1 Filters can not be accidentally displaced at any possible tube orientation; 20.7.4.2 For equipment installed after September 30, 1999, an interlock system prevents irradiation if the proper filter is not in place;

20.7.4.3 The air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per hour at one meter under any operating conditions; and 20.7.4.4 Each filter shall be marked as to its material of construction and its thickness. 20.7.5 Tube Immobilization.

20.7.5.1 The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and 20.7.5.2 The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

20.7.6 Source Marking.

The tube housing assembly shall be so marked that it is possible to determine the location of the source to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures. 20.7.7 Beam Block.

Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

20.7.8 Timer.

A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

20.7.8.1 A timer with a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time or time remaining indicator; 20.7.8.2 The timer shall be a cumulative timer that activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator; 20.7.8.3 The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation; 20.7.8.4 The timer shall permit accurate pre-setting and determination of exposure times as short as one second;

20.7.8.5 The timer shall not permit an exposure if set at zero; 20.7.8.6 The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and 20.7.8.7 Timer shall be accurate to within one percent of the selected value or one second, whichever is greater.

20.7.9 Control Panel Functions.

The control panel, in addition to the displays required by other provisions in RH 20.7, shall have: 20.7.9.1 An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

20.7.9.2 An indication of whether x-rays are being produced; 20.7.9.3 A means for indicating x-ray tube potential and current; 20.7.9.4 A means for terminating an exposure at any time; 20.7.9.5 Therapeutic radiation machines installed after November 30, 1994, shall have a locking device which will prevent unauthorized use of the therapeutic radiation machine; and 20.7.9.6 For therapeutic radiation machines manufactured after September 30. 1999, a positive display of specific filter(s) in the beam.

20.7.10 Multiple Tubes.

When a control panel may energize more than one x-ray tube: 20.7.10.1 It shall be possible to activate only one x-ray tube at any time; 20.7.10.2 There shall be an indication at the control panel identifying which x-ray tube is activated; and 20.7.10.3 There shall be an indication at the tube housing assembly when that tube is energized. 20.7.11 Target-to-Skin Distance (TSD).

There shall be a means of determining the central axis TSD to within one centimeter and of reproducing this measurement to within 2 millimeters thereafter.

20.7.12 Shutters.

Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds after the x-ray “ON” switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

20.7.13 Low Filtration X-ray Tubes.

Each therapeutic radiation machine equipped with a beryllium or other low-filtration window (HVL < 0.1 mm of Al) shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present. 20.7.14 Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating in the Range 50 kV to 500 kV.

In addition to shielding adequate to meet requirements of RH 20.10, the treatment room shall meet the following design requirements:

20.7.14.1 Aural Communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel, except for: 20.7.14.1.1 Intraoperative radiotherapy (IORT) rooms where the patient is under general anesthesia; and no staff remains in the room.

20.7.14.2 Viewing Systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational. 20.7.15 Additional Requirements.

Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:

20.7.15.1 All protective barriers shall be fixed except for entrance doors or beam interceptors; 20.7.15.2 The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling;

20.7.15.3 Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and 20.7.15.4 When any door referred to in RH 20.7.15.3 is opened while the x-ray tube is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.

20.7.16 Full Calibration Measurements.

20.7.16.1 Full calibration of a therapeutic radiation machine subject to RH 20.7 shall be performed by, or under the direct supervision of, a Radiation Therapy Physicist: 20.7.16.1.1 Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

20.7.16.1.2 At intervals not exceeding one year; and 20.7.16.1.3 Before medical use under the following conditions: 20.7.16.1.3.1 Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled; and 20.7.16.1.3.2 Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

20.7.16.1.4 Notwithstanding the requirements of RH 20.7.16.1.3: 20.7.16.1.4.1 Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and 20.7.16.1.4.2 If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in RH 20.7.16.1.3.1. 20.7.16.2 To satisfy the requirement of RH 20.7.16.1, full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, “Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV” (1981), unless the radiation therapy physicist determines that a particular recommendation of the NCRP Report 69 is not warranted for the clinical tasks for which the equipment will be used. 20.7.16.3 The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the Radiation Therapy Physicist responsible for performing the calibration. 20.7.17 Periodic Quality Assurance Checks.

20.7.17.1 Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to RH 20.7, which are capable of operation at greater than or equal to 50 kV. 20.7.17.2 To satisfy the requirement of RH 20.7.17.1, quality assurance checks shall meet the following requirements:

20.7.17.2.1 The registrant shall perform quality assurance checks in accordance with written procedures established by the Radiation Therapy Physicist; and 20.7.17.2.2 The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in RH 20.7.16.1. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in RH 20.7.16.1, shall be stated. 20.7.17.3 The cause for a parameter exceeding a tolerance set by the Radiation Therapy Physicist shall be investigated and corrected before the system is used for patient irradiation; 20.7.17.4 Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the Radiation Therapy Physicist's quality assurance check procedures, the system shall be recalibrated as required in RH 20.7.16.1; 20.7.17.5 The registrant shall use the dosimetry system described in RH 20.4.3.2 to make the quality assurance check required in RH 20.7.17.2;

20.7.17.6 The registrant shall have the Radiation Therapy Physicist review and sign the results of each radiation output quality assurance check within one month of the date that the check was performed;

20.7.17.7 The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to RH 20.7 are performed at intervals not to exceed one month; 20.7.17.8 Notwithstanding the requirements of RH 20.7.17.6 and 20.7.17.7, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by RH 20.7.17.6 and 20.7.17.7 have been performed within the 30 day period immediately prior to said administration;

20.7.17.9 To satisfy the requirement of RH 20.7.17.7, safety quality assurance checks shall ensure proper operation of:

20.7.17.9.1 Electrical interlocks at each external beam radiation therapy room entrance; 20.7.17.9.2 The “BEAM-ON” and termination switches;

20.7.17.9.3 If applicable, beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;

20.7.17.9.4 Viewing systems;

20.7.17.9.5 If applicable, electrically operated treatment room doors from inside and outside the treatment room;

20.7.17.10 The registrant shall maintain a record of each quality assurance check required by RH 20.7.17.1 and 20.7.17.7 for three (3) years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name; model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check. 20.7.18 Operating Procedures.

20.7.18.1 The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of RH 20.7.16 and 20.7.17 have been met;

20.7.18.2 Therapeutic radiation machines shall not be left unattended unless secured pursuant to RH 20.7.9.5;

20.7.18.3 When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

20.7.18.4 The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;

20.7.18.5 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and 20.7.18.6 No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of RH 4.6 of these Regulations. 20.7.19 Possession of Survey Instrument(s).

Each facility location authorized to use a therapeutic radiation machine in accordance with RH 20.7 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with RH 20.9.

RH 20.8 Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above).

20.8.1 Possession of Survey Instrument(s).

Each facility location authorized to use a therapeutic radiation machine in accordance with RH 20.8 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with RH 20.9.

20.8.2 Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes. 20.8.2.1 The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient plane), shall not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

20.8.2.2 Except for the area defined in RH 20.8.2.1, the absorbed dose due to leakage radiation (excluding neutrons) at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;

20.8.2.3 For equipment manufactured after September 30, 1999, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998; and 20.8.2.4 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH 20.8.2.1 through RH 20.8.2.3 for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department. 20.8.3 Leakage Radiation Through Beam Limiting Devices. 20.8.3.1 Photon Radiation.

All adjustable or interchangeable beam limiting devices, excluding secondary custom blocks, shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed two (2) percent of the maximum absorbed dose on the central axis of the useful beam measured in a 10 centimeter by 10 centimeter radiation field;

20.8.3.2 Electron Radiation.

All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed: 20.8.3.2.1 A maximum of two (2) percent and average of 0.5 percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 7 centimeters outside the periphery of the useful beam; and 20.8.3.2.2 A maximum of ten (10) percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 2 centimeters outside the periphery of the useful beam.

20.8.3.3 Measurement of Leakage Radiation.

20.8.3.3.1 Photon Radiation. Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) TVLs of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding 10 square centimeters;

20.8.3.3.2 Electron Radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one centimeter of water equivalent build up material.

20.8.4 Filters/Wedges.

20.8.4.1 Each wedge filter that is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined; 20.8.4.1.1 If the absorbed dose rate information required by RH 20.8.9 relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable from the system only by the use of tools;

20.8.4.1.2 For equipment manufactured after September 30, 1999, which utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils: 20.8.4.1.2.1 Irradiation shall not be possible until a selection of a filter or a positive selection to use “no filter” has been made at the treatment control panel, either manually or automatically;

20.8.4.1.2.2 An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position as selected by the operator or as required by the energy/mode selected by the operator;

20.8.4.1.2.3 A display shall be provided at the treatment control panel showing the wedge filter(s); and 20.8.4.1.2.4 An interlock shall be provided to prevent irradiation if there is a mismatch between the filter and/or beam scattering foil selected by the operator or required for the energy/modality selected by the operator.

20.8.5 Stray Radiation in the Useful Beam.

For equipment manufactured after September 30, 1999, the registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation in the useful x-ray beam are in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998.

20.8.6 Beam Monitors.

All therapeutic radiation machines subject to RH 20.8 shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

20.8.6.1 Equipment manufactured after September 30, 1999, shall be provided with at least two (2) independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element. 20.8.6.2 Equipment manufactured on or before September 30, 1999, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system; 20.8.6.3 The detector and the system into which that detector is incorporated shall meet the following requirements:

20.8.6.3.1 Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;

20.8.6.3.2 Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated; 20.8.6.3.3 Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and 20.8.6.3.4 For equipment manufactured after September 30, 1999, the design of the beam monitoring systems shall ensure that the:

20.8.6.3.4.1 Malfunctioning of one system shall not affect the correct functioning of the other systems; and 20.8.6.3.4.2 Failure of either system shall terminate irradiation or prevent the initiation of radiation.

20.8.6.3.5 Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after September 30, 1999, each display shall: 20.8.6.3.5.1 Maintain a reading until intentionally reset; 20.8.6.3.5.2 Have only one scale and no electrical or mechanical scale multiplying factors;

20.8.6.3.5.3 Utilize a design such that increasing dose is displayed by increasing numbers; and 20.8.6.3.5.4 In the event of power failure, the beam monitoring information required in RH 20.8.6.3.5.3 displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty (20) minute period of time. 20.8.7 Beam Symmetry.

20.8.7.1 Bent-beam linear accelerators subject to RH 20.8 shall be provided with auxiliary device(s) to monitor beam symmetry;

20.8.7.2 The device(s) required in RH 20.8.7.1 shall be able to detect field asymmetry greater than ten (10) percent; and 20.8.7.3 The device(s) required in RH 20.8.7.1 shall be configured to terminate irradiation if the specifications in RH 20.8.7.2 can not be maintained.

20.8.8 Selection and Display of Dose Monitor Units.

20.8.8.1 Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;

20.8.8.2 The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;

20.8.8.3 After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and 20.8.8.4 For equipment manufactured after September 30, 1999, after termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.

20.8.9 Air Kerma Rate/Absorbed Dose Rate.

For equipment manufactured after September 30, 1999, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in RH 20.8.6 may form part of this system. In addition:. 20.8.9.1 The dose monitor unit rate shall be displayed at the treatment control panel; 20.8.9.2 If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant; 20.8.9.3 If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and 20.8.9.4 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum value(s) specified in RH 20.8.9.2 and 20.8.9.3 for the specified operating conditions. Records of these maximum value(s) shall be maintained at the installation for inspection by the Department.

20.8.10 Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy.

20.8.10.1 Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system;

20.8.10.2 If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen (15) percent or 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and 20.8.10.3 For equipment manufactured after September 30, 1999, an indicator on the control panel shall show which monitoring system has terminated irradiation. 20.8.11 Termination of Irradiation.

It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel. 20.8.12 Interruption of Irradiation.

If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

20.8.13 Timer.

A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

20.8.13.1 A timer shall be provided which has a display at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator; 20.8.13.2 The timer shall be a cumulative timer that activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator; 20.8.13.3 The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation. 20.8.14 Selection of Radiation Type.

Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:

20.8.14.1 Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;

20.8.14.2 The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

20.8.14.3 An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;

20.8.14.4 An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;

20.8.14.5 An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and 20.8.14.6 An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

20.8.15 Selection of Energy.

Equipment capable of generating radiation beams of different energies shall meet the following requirements:

20.8.15.1 Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

20.8.15.2 The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; 20.8.15.3 Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and 20.8.15.4 For equipment manufactured after September 30, 1999, the selection of energy shall be in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998. 20.8.16 Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements: 20.8.16.1 Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel; 20.8.16.2 The mode of operation shall be displayed at the treatment control panel; 20.8.16.3 An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;

20.8.16.4 An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel; 20.8.16.5 Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after September 30, 1999:

20.8.16.5.1 An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten (10) degrees of rotation or one cm of linear motion differs by more than twenty (20) percent from the selected value; 20.8.16.5.2 Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than five (5) percent from the dose monitor unit value selected;

20.8.16.5.3 An interlock shall be provided to prevent motion of more than five (5) degrees or one cm beyond the selected limits during moving beam radiation therapy; 20.8.16.5.4 An interlock shall be provided to require that a selection, verification, or display of direction of rotation be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy. 20.8.16.5.5 Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.

20.8.16.5.6 Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by RH 20.8.10; and 20.8.16.5.7 For equipment manufactured after September 30, 1999, an interlock system shall be provided to terminate irradiation if movement:

20.8.16.5.7.1 Occurs during stationary beam radiation therapy; or 20.8.16.5.7.2 Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.

20.8.17 Facility Design Requirements for Therapeutic Radiation Machines Operating above 500 kV.

In addition to shielding adequate to meet requirements of RH 20.10, the following design requirements are made:

20.8.17.1 Protective Barriers.

All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;

20.8.17.2 Control Panel.

In addition to other requirements specified in this Part, the control panel shall also: 20.8.17.2.1 Be located outside the treatment room;

20.8.17.2.2 Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

20.8.17.2.3 Provide an indication of whether radiation is being produced; and 20.8.17.2.4 Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine;

20.8.17.3 Viewing Systems.

Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational; 20.8.17.4 Aural Communications.

Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible; 20.8.17.5 Room Entrances.

Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is “ON” and when it is “OFF”; 20.8.17.6 Entrance Interlocks.

Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

20.8.17.7 Beam Interceptor Interlocks.

If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with RH 4.14.1 of these Regulations, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barriers;

20.8.17.8 Emergency Cutoff Switches.

At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by RH 20.8.11. All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch; 20.8.17.9 Safety Interlocks.

All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and 20.8.17.10 Surveys for Residual Radiation.

Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above ten (10) MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.

20.8.18 Operating Procedures.

20.8.18.1 No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

20.8.18.2 Therapeutic radiation machines shall not be made available for medical use unless the requirements of RH 20.4.1, 20.8.19 and 20.8.20 have been met; 20.8.18.3 Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

20.8.18.4 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field.

20.8.18.5 If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and 20.8.18.6 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

20.8.19 Acceptance Testing, Commissioning and Full Calibration Measurements. 20.8.19.1 Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to RH 20.8 shall be performed by, or under the direct supervision of, a Radiation Therapy Physicist.

20.8.19.2 Acceptance testing and commissioning shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group (TG) 45”, unless the radiation therapy physicist determines that a particular recommendation of the TG 45 Report is not warranted for the clinical tasks for which the equipment will be used; and shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.

20.8.19.3 Full calibration shall include measurement of all parameters required by Table II of “Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group (TG) 40” and shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group 45”, unless the radiation therapy physicist determines that a particular recommendation of the TG 40 Report and/or TG 45 Report is not warranted for the clinical tasks for which the equipment will be used. Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not exceeding twelve (12) calendar months, unless a more frequent interval is required in Table II. 20.8.19.4 The Radiation Therapy Physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits: 20.8.19.4.1 Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi-energy and/or multi-mode capabilities shall only require measurements for those modes and/or energies that are not within their acceptable range; and 20.8.19.4.2 Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and/or energies, measurements shall be performed on the effected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in RH 20.8.19.4.1.

20.8.19.5 The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the therapeutic radiation machine; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the Radiation Therapy Physicist responsible for performing the calibration. 20.8.20 Periodic Quality Assurance Checks.

20.8.20.1 Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to RH 20.8 at intervals not to exceed those specified in “Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group (TG) 40”, unless the radiation therapy physicist determines that a particular recommendation of the TG 40 Report is not warranted for the clinical tasks for which the equipment will be used; 20.8.20.2 To satisfy the requirement of RH 20.8.20.1, quality assurance checks shall include determination of central axis radiation output and periodic quality assurance checks contained in “Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group (TG) 40”, unless the radiation therapy physicist determines that a particular recommendation of the TG 40 Report is not warranted for the clinical tasks for which the equipment will be used;

20.8.20.3 The registrant shall use a dosimetry system that has been inter-compared within the previous twelve (12) months with the dosimetry system described in RH 20.4.3.1 to make the periodic quality assurance checks required in RH 20.8.20.2;

20.8.20.4 The registrant shall perform periodic quality assurance checks required by RH 20.8.20.1 in accordance with procedures established by the Radiation Therapy Physicist; 20.8.20.5 The registrant shall review the results of each periodic radiation output check according to the following procedures:

20.8.20.5.1 The authorized user and Radiation Therapy Physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the Radiation Therapy Physicist has determined that all parameters are within their acceptable tolerances; 20.8.20.5.2 If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or Radiation Therapy Physicist within three (3) days; and 20.8.20.5.3 The Radiation Therapy Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed one month. 20.8.20.6 Safety quality assurance checks listed in “Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group (TG) 40” shall be performed for therapeutic radiation machines subject to RH 20.8, unless the radiation therapy physicist determines that a particular recommendation of the TG 40 Report is not warranted for the clinical tasks for which the equipment will be used;

20.8.20.7 For therapeutic radiation machines not covered by TG 40, the following safety quality assurance checks, as applicable to the machines, shall be performed at intervals not to exceed one week:

20.8.20.7.1 Electrical interlocks at each external beam radiation therapy room entrance; 20.8.20.7.2 Proper operation of the “BEAM-ON”, interrupt and termination switches; 20.8.20.7.3 Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

20.8.20.7.4 Viewing systems;

20.8.20.7.5 Electrically operated treatment room door(s) from inside and outside the treatment room;

20.8.20.7.6 At least one emergency power cutoff switch. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine. 20.8.20.8 The registrant shall promptly repair any system identified in RH 20.8.20.7 that is not operating properly; and 20.8.20.9 The registrant shall maintain a record of each quality assurance check required by RH 20.8.20.1 and 20.8.20.7 for three (3) years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check. RH 20.9 Calibration of Survey Instruments.

20.9.1 The registrant shall ensure that the survey instruments used to show compliance with this Part have been calibrated before first use, at intervals not to exceed twelve (12) months, and following repair.

20.9.2 To satisfy the requirements of RH 20.9.1, the registrant shall: 20.9.2.1 Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);

20.9.2.2 Calibrate at least two (2) points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale; and 20.9.3 To satisfy the requirements of RH 20.9.2, the registrant shall: 20.9.3.1 Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than ten (10) percent; or 20.9.3.2 Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than twenty (20) percent if a correction factor or graph is conspicuously attached to the instrument.

20.9.4 The registrant shall retain a record of each calibration required in RH 20.9.1 for three (3) years. The record shall include:

20.9.4.1 A description of the calibration procedure; and 20.9.4.2 A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.

20.9.5 The registrant may obtain the services of individuals licensed by the Department, the US Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations that contain information required by RH 20.9.4 shall be maintained for three (3) years by the registrant.

20.10 Shielding and Safety Design Requirements.

20.10.1 Each therapeutic radiation machine subject to RH 20.7 or RH 20.8 shall be provided with such primary and/or secondary barriers as are necessary to ensure compliance with RH 4.6 and 4.14 of these Regulations.

20.10.2 Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted to a Department approved radiation therapy Qualified Expert for approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix A of this Part. PART 20 APPENDIX A. INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS I. All Therapeutic Radiation Machines.

A. Basic facility information including: name, telephone number and facility registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address [including room number] of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structure(s).

B. All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers. C. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers. II. Therapeutic Radiation Machines up to 150 kV (photons only). In addition to the requirements listed in Section I above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans which contain, as a minimum, the following additional information: A. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;

B. Maximum design workload for the facility including total weekly radiation output, expressed in gray (rad) or air kerma at one meter, total beam-on time or MU per day or week, the average treatment time or MU per patient, along with the anticipated number of patients to be treated per day or week;

C. A facility blueprint/drawing indicating: scale of 0.25 inch = 1 foot is typical; direction of North; normal location of the therapeutic radiation machine's radiation port(s); the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with RH 4.6 of these Regulations; D. The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

E. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; and F. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, entry doors) and shielding material in the facility: 1. If commercial software is used to generate shielding requirements, please also identify the software used and the version/ revision date.

2. If the software used to generate shielding requirements is not in the open literature, please also submit quality control sample calculations to verify the result obtained with the software.

III. Therapeutic Radiation Machines Over 150 kV.

In addition to the requirements listed in Section I above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV and/or electrons shall submit shielding plans which contain, as a minimum, the following additional information: A. Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energy(s) and type(s) of radiation produced (i.e.: photon, electron). The target to isocenter distance shall be specified; B. Maximum design workload for the facility including total weekly radiation output (expressed in gray (rad) at one meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week; C. Facility blueprint/drawing [including both floor plan and elevation views] indicating relative orientation of the therapeutic radiation machine, scale of 0.25 inch = one foot is typical, type(s), thickness and minimum density of shielding material(s), direction of North, the locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the door(s) and maze;

D. The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

E. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;

F. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze) and shielding material in the facility:

1. If commercial software is used to generate shielding requirements, identify the software used and the version/ revision date; and 2. If the software used to generate shielding requirements is not in the open literature, submit quality control sample calculations to verify the result obtained with the software. IV. Neutron Shielding In addition to the requirements listed in Section III above, therapeutic radiation machine facilities that are capable of operating above 10 MV shall submit shielding plans which contain, as a minimum, the following additional information:

A. The structural composition, thickness, minimum density and location of all neutron shielding material; B. Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas; C. At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition (i.e.: restricted and unrestricted areas, entry door(s) and maze) and neutron shielding material utilized in the facility: 1. If commercial software is used to generate shielding requirements, also identify the software used and the version/ revision date; and 2. If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software. D. The method(s) and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.

APPENDIX B Reserved APPENDIX C Reserved