6 CCR 1007-1
PART 1 GENERAL PROVISIONS RH 1.1 Authority.
Rules and regulations set forth herein are adopted pursuant to the provisions of Section 25-1-107(1)(s) and (1)(t), 25-1-108 and 25-11-104, CRS 1988. Rules and regulations pertaining to land disposal of low- level radioactive waste Parts 14 and 15 are adopted pursuant to the provisions of 24-60-2205. RH 1.2 Basis and Purposes.
A statement of the basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department.
RH 1.3 Scope.
Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire 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 1Attention 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 of the Commission's regulations. RH 1.4 Definitions.
As used in these regulations, these terms have the definitions set forth below. Additional definitions used only in a certain part will be found in that part.
“A1” means the maximum activity of special form radioactive material permitted in a Type A package. “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. These values are either listed in Appendix A of Part 17 of these regulations, Table A-1, or may be derived in accordance with the procedure prescribed in Appendix A of Part 17 of these regulations.
“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. “Act” means Title 25, Article 11, Colorado Revised Statutes 1989 Replacement Volume, 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 B, Table I of Part 4 of these regulations, 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
“Authorized nuclear pharmacist” means a pharmacist who is:
(1) Board certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties;
(2) Identified as an authorized nuclear pharmacist on a Department, NRC or Agreement State license that authorizes the use of radioactive material in the practice of nuclear pharmacy; or (3) Identified as an authorized nuclear pharmacist on a permit issued by a Department, NRC or Agreement State specific licensee of broad scope that is authorized to permit the use of radioactive material in the practice of nuclear pharmacy. (See also pharmacist) “As low as is reasonably achievable” (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest. “Background radiation” means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material; and including global fallout as it exists in the environment from the testing of nuclear explosive devices. “Background radiation” does not include sources of radiation from radioactive materials regulated by the Department.
“Becquerel” (Bq) means the Sl 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 sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, 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. No licensee or registrant shall change the method observed by him of determining calendar quarters for purposes of these regulations except at the beginning of a 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, gluconic acid, and polycarboxylic acids.
“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 , ) means the dose equivalent to organs or tissues of reference T50 (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 , ) is the sum of the products of the weighting factors E50 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 , = ∑ W,H, ). E50 T T50 “Curie” means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 × 1010 transformations per second (s-1). “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/cm2). “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.
“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. “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 = ∑ W H ).
“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 Sl unit of exposure is the coulomb per kilogram (C/kg). See RH 1.14 units of exposure and dose for the special unit.2 2When 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. “Eye dose equivalent” means the external dose equivalent to the lens of the eye at a tissue depth of 0.3 Centimeter (300 mg/cm2).
“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. “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 Sl unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
“Hazardous waste” means those wastes designated as hazardous by U.S. Environmental Protection Department regulations in 40 CFR Part 261.
“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. “Human use” means the internal or external administration of radiation or radioactive material to human beings.
“Individual” means any human being.
“Individual monitoring” means the assessment of:
(1) Dose equivalent:
(2) Committed effective dose equivalent:
(B) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition of DAC-hours in Part 4). “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.
“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.
“Licensing State” means any State with regulations equivalent to the Suggested State Regulations for Control of Radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
“Limits” see “dose limits”.
“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.
“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.
“Medical use” means the intentional internal or external administration of radioactive material or radiation to humans in the practice of the healing arts. “Member of the public” means an individual, except when that individual is receiving an occupational dose.
“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. It does not include byproduct, source, or special nuclear material.3 3For 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 occurring 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. “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 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 from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with RH 7.26, from voluntary participation in medical research programs, or as a member of the public.
“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.
“Personnel monitoring equipment”. [See “Individual monitoring devices”]. “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 the State of Colorado to dispense drugs in the practice of medicine.
“Public dose” means the dose received by a member of the public from sources of radiation from licensed or registered operations. Public dose does not include occupational dose, or doses received from background radiation, from any medical adminstration the individual has received, from exposure to individuals administered radioactive material and released in accordance with RH 7.26, 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:
(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; or (3) Receive approval from the Department for specific activities. “Quality factor” (Q) means the modifying factor, listed in Tables I and II of RH 1.14, that is used to derive dose equivalent from absorbed dose.
“Rad” means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 jule 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” means an individual who has the knowledge, responsibility and authority to apply appropriate radiation protection regulations.
“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”).
“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.
“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.
“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. “Roentgen” means the special unit of exposure. One roentgen (R) equals 2.58 × 10-4 coulombs/kilogram of air (see “Exposure”).
“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. “Shallow dose equivalent” (H ), which applies to the external exposure of the skin or an extremity, s means the dose equivalent at a tissue depth of 0.007 Centimeter (7 mg/cm2) averaged over an area of 1 square centimeter.
“SI” means the abbreviation for the international system of units. “Sievert” means the Sl 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 boundary” means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.
“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 U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 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:
175 (grams contained + 50 (grams contained + 235 233 U) U)
350 200 “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. “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 Colorado Rules and Regulations Pertaining to Radiation Control.
“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” 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.
“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.
“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.
“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 1.3E+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 and that no day is omitted or duplicated in consecutive years. Exemptions from the Regulatory Requirements RH 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 Govemment-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:
1.5.2.4.1 that the exemption of the prime contractor or subcontractor is authorized by law; and 1.5.2.4.2 that, 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 RH 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. RH 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, upon reasonable notice, records maintained pursuant to these regulations. RH 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 RH 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 RH 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.
RH 1.11 Impounding.
Sources of radiation shall be subject to impounding pursuant to the Act. RH 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.
Communications RH 1.13 Communications.
All communications and reports concerning these regulations, and applications filed thereunder, should be addressed to the Department.
Informational Provisions RH 1.14 The International System of Units (Sl).
1.14.1 Exposure. As used in these regulations, the unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58 × 10-4 coulomb per kilogram.
1.14.2 As used in these regulations, the units of dose are:
1.14.2.1 Gray (Gy) is the Sl 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 erg 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 Sl 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 As used in these regulations, the quality factors for converting absorbed dose to dose equivalent are shown in Table I.
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 RH 1.14.3, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these regulations, 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 II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.
TABLE II MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS Neutron energy (MeV) a Fluence per unit dose Quality factor (Q)
b equivalent (neutrons -2 -1 cm rem )
A Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom. B Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom. (thermal) 2.5 E-8 2 980 E+6 1 E-7 2 980 E+6 1 E-6 2 810 E+6 1 E-5 2 810 E+6 1 E-4 2 840 E+6 1 E-3 2 980 E+6 1 E-2 2.5 1010 E+6 1 E-1 7.5 170 E+6 5 E-1 11 39 E+6 1 11 27 E+6
1.14.5 Units of activity. For purposes of these regulations, activity is expressed in the Sl 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 E+10 disintegrations per second or transformations per second (dps or s-1) = 3.7 E+10 becquerel (Bq) = 2.22 E+12 disintegrations per minute (dpm). RH 1.15 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. RH 1.16 Referenced Materials.
1.16.1 These regulations incorporate 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 Laboratory and Radiation Services 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, Laboratory and Radiation Services Division Colorado Department of Public Health and Environment 8100 Lowry Blvd. Denver, CO 80230-6928 1.16.2 In accordance with 24-4-103 (12.5) ( c) (II) (C), copies of any material that has been incorporated by reference may be examined in any State Publications Depository Library and Distribution Center.
1.16.3 Material referenced in these regulations does not include amendments to or revised editions of the material published later than the effective date of the relevant regulation. PART 2 REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES RH 2.1 Purpose and Scope.
2.1.1 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 approval of mammographers.
2.1.2 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. RH 2.2 Definitions.
“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 rads = 114 roentgens (R) of exposure.
“ARRT” means the American Registry 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 his or her 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 that during the performance of a mammography examination or certification evaluation of the facility's equipment and quality assurance program, 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 which 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 at which one or more radiation machines are installed and/or located within one building, vehicle, or under one roof and are under the same administrative control. “FDA” means the United States Food and Drug Administration. “Intercomparison” means the direct comparison of two instruments designed to measure the same physical quantity. The comparison must be between an instrument which 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. The comparison must be made using the actual physical quantity to be routinely measured (radiation energy/quality, visible light spectrum, etc.) and be compared in the same physical geometry. Intercomparisons shall be NIST traceable. “Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.
“Mammographer” means an individual radiographer, who has specialized training in performing mammography exams, 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 radiographer, 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 and facilities and meets the criteria in Appendix B of this Part.
“Qualified instructor” means an individual whose training and experience adequately prepares him or her to carry out specified training assignments. Interpreting physicians, radiologic technologists or medical physicists who are approved through the MQSA program would be considered qualified instructors in their respective areas of mammography. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the Regulations of this Part include, but are not limited to, instructors in a post-high school training institution and manufacturer's representatives. “Qualified mammographer” means a mammographer who has successfully maintained their continuing education and experience requirements and is approved by the Department. “Radiographer” means a machine operator who has taken and passed the limited scope examination or is currently registered with ARRT.
“Radiologic technologist” means an individual who is currently registered with the American Registry of Radiologic Technologists.
“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 which function with the system are considered integral parts of the system.
Exemptions from the Regulatory Requirements RH 2.3 Exemptions.
2.3.1 Electronic equipment that produces radiation incidental to its 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 microSv (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. Electronic equipment which fail to meet the dose equivalent rate limit specified in RH 2.3.1 shall be registered with the Department and inspected in accordance with RH 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 which 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 RH 2.3.1.
2.3.6 The legal owner of electronic equipment which meet the requirements of RH 2.3.1 but which are not specifically exempted under RH 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 RH 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 RH 2.5.1. Registration RH 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 Application for registration shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions.
2.4.1.4 Designate on the application form an individual to be responsible for radiation protection.
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. Each registration shall be for a period of two (2) years.
2.4.2.2.1 Application fee(s) pursuant to Appendix A of this Part 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.
2.4.2.3 In any case in which a service company, not less than thirty (30) days prior to the expiration of their 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:
2.4.2.4.1 That they have read and understand the requirements of these Regulations; including the current version of the Federal Performance Standard (21 CFR Chapter I, Subchapter J); and 2.4.2.4.2 The services for which they are applying for registration (see RH 2.4.2.1); and 2.4.2.4.3 The training and experience that qualify them to discharge the services for which they are applying for registration; and 2.4.2.4.4 The type of measurement instruments used to determine compliance with these Regulations, the frequency of their calibration, and the source of their calibration; and 2.4.2.4.5 Service companies shall meet the instrument calibration requirements specified in RH 2.4.3.3.
2.4.2.4.6 The type of personnel monitoring supplied, frequency of reading, and replacement or exchange schedule as appropriate. (See RH 4.17 and 4.18) 2.4.2.5 For purpose(s) of this Part, services may include but shall not be limited to:
2.4.2.5.1 Installation of radiation machines and associated radiation machine components; and 2.4.2.5.2 Servicing of radiation machines and associated radiation machine components; and 2.4.2.5.3 Performance adjustments to radiation machines, radiation measurement instruments, devices; and 2.4.2.5.4 Radiation protection, health physics consultations or surveys performed by qualified experts.
2.4.2.6 No person shall perform services on radiation machine systems or facilities which are 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 the registrant with instruction manuals, manufacturer specifications and other information, as required by the Federal Performance Standard, and these Regulations, 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 RCD-65 shall be furnished to the registrant prior to beginning the service or evaluation, whenever there is a business relationship 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 are members of the same corporation, partnership or other formal business relationship.
2.4.3 Application for Registration of Qualified Inspectors.
Qualified inspectors shall meet the criteria established in Appendix B of this Part.
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 RCD 53, together with the required fee prescribed in Appendix A of this Part 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.
2.4.3.2.1 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.
2.4.3.2.2 In any case in which a qualified inspector, not less than thirty (30) days prior to the expiration of his/her 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.
2.4.3.2.3 No qualified inspector shall perform certification evaluations on radiation machine systems or facilities which are not specifically stated for that qualified inspector on the notice of registration issued by the Department.
2.4.3.2.4 Audits. The Department shall audit the evaluation findings and inspection procedures of qualified inspectors. Qualified inspectors who fail to adequately evaluate radiation machine systems and facilities, or who fail to provide complete and accurate certification reports, or fail 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 which are sufficiently sensitive to determine compliance with these Regulations. The instruments must be maintained and used in good working order. Not withstanding the requirement of RH 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. Calibrations shall be traceable to the National Institute of Standards and Technology where such traceability exists. In lieu of calibration, instrument accuracy may, with Department approval, be determined by intercomparison with a suitable and appropriately calibrated instrument. Intercomparison protocol must be submitted to the Department for review and approval.
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 must be NIST traceable and shall be calibrated with an accuracy of ±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 RH 2.2 are approved by the Department to perform mammography exams. In addition, mammographers shall meet the requirements of 21 Code of Federal Regulations (CFR), Part 900, Section 900.12, (a), (2).
2.4.4.2 Radiologic technologists 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 and pay a one time fee of $50.
2.4.4.2.1 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 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, RH 2.4.4.2.1, may not be renewed.
2.4.4.2.2 The structured training program shall include, at a minimum, 40 contact hours of documented training specific to mammography under the supervision of a qualified mammographer. The hours of documented training shall include, but not necessarily be limited to:
2.4.4.2.3 A fully trained and experienced technologist may apply for a six (6) months operator's provisional certificate subsequent to such training as described in RH 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.
2.4.4.2.4 Student radiographers, enrolled in an ARRT-approved two (2) year program, shall be exempt from the requirement of RH 2.4.4.1, as long as they remain 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. The application shall be submitted to the Department together with the applicable fee in Appendix A of this Part.
2.4.4.3.1 The provisional certificate shall be displayed in the room/area where patient exams 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 it 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 their facility is registered with the Department pursuant to the provisions of RH 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 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 RH 2.5 Certification Evaluations.
2.5.1 Frequency of Certification Evaluations.
Each radiation machine registrant shall have their radiation machine(s) and facility evaluated by a Department approved qualified inspector in accordance with the frequency established in RH 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 by Type of Radiation Machine Facility:
Hospitals, Osteopathic, Every year Medical and Chiropractic Facilities Mobile Industrial Every year Radiography Excluding Cabinet X-ray and Airport Baggage Systems Veterinary, Podiatry, and 1 Every 3 years Dental facilities Out-of-State Radiation 2 Within 1 year prior to Machines entering State All others, i.e., fixed Every 2 years radiography, airport inspection, analytical systems Machines specifically Every 3 years designed for and limited to bone densitometry 1Podiatry and dental radiation machine facilities that operate radiographic x-ray machine(s) or tomographic systems that have variable kilovoltage peak (kVp), and vanable milliamperage (mA), and variable collimation shall have these systems evaluated on an annual (every year) frequency. However, podiatry machines that operate at less than or equal to 30 mA will be evaluated every three years.
2Persons proposing to bring radiation machines into the state should note the specific requirements of RH 2.8.
2.5.1.1.1 Each certification evaluation subsequent to the initial certification evaluation shall be completed in the same month as the previous certification evaluation.
2.5.1.1.2 Not withstanding the requirements of RH 2.5.1.1.1, 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.
2.5.1.1.3 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.
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 exams.
2.5.1.3 State Inspections. Any radiation machine and/or facility not inspected in accordance with RH 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 in Appendix A of this Part.
2.5.2 Procedures for Certification Evaluations.
2.5.2.1 Inspection Procedures.
2.5.2.1.1 Evaluation of radiation machines and facilities shall be in accordance with procedures which are capable of determining compliance with the Regulations.
2.5.2.1.2 Each qualified inspector shall perform radiation machine system and facility evaluations within the category(s) authorized by the Department.
2.5.2.2 Reporting and Labeling Procedures.
2.5.2.2.1 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 RCD 59-1, in accordance with the instructions contained in that form. A clear and legible report may be substituted for the Department Form RCD 59-1, provided that it is in the same format and provides all of the information required by Department Form RCD 59-1.
2.5.2.2.2 Qualified inspectors 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.
2.5.2.2.3 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.
2.5.2.2.4 If the radiation machine fails to meet these Regulations or manufacturer's required specifications, the qualified inspector shall:
2.5.2.2.5 If the radiation machine fails to meet these Regulations or required manufacturer specifications and is determined to be unsafe for human use, as described in Appendix C of this Part, the qualified inspector shall:
2.5.2.2.6 Concealing, defacing or altering of Department issued labels is prohibited.
2.5.2.2.7 Labels shall only be affixed by a qualified inspector on the basis of the certification evaluation.
2.5.2.3 Department Actions.
2.5.2.3.1 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.
2.5.2.3.2 The Department shall confirm and, if appropriate, verify by inspection, registrants corrective actions to assure compliance of these Regulations.
2.5.2.3.3 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 RH 2.5.1, or if any item of violation has not been corrected in accordance with the compliance schedule established in RH 2.5.2.3.1. The Department inspection and fee schedule payment shall be in accordance with Appendix A of this Part.
RH 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 The registrant shall allow only individuals to operate an x-ray machine who are trained in the use of the machine; in giving the exam(s) to be performed; and in radiation safety related to the x-ray machines.
2.6.2 If a radiation machine or facility fails to meet 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;
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 compliance3 3Copies 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 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.
receptor;
2.6.3.3 The registrant shall permit radiation machine servicing or services as described in RH
2.7.1 Any person who sells, leases, transfers, lends, disposes, assembles, 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 persons who have received these 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 to include 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 and these Regulations applicable to the newly installed x- ray machine system or components have been delivered to the registrant.
2.7.1.5 A report of assembly of a diagnostic x-ray system submitted in compliance with requirements of the Federal Performance Standard (21 CFR 1020.30(d)) 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 RH 2.7.1.
2.7.1.6 The assembly is considered completed and operational when the unit is ready for its intended use.
2.7.2 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 RH 2.8 Out-of-State Radiation Machines.
2.8.1 Subject to these Regulations, any person who desires to bring radiation producing. 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 producing 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 LRS-200 and shall include all information required by that form.
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:
2.8.2 Based upon an application which 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 RH 2.8.1.
2.8.3 While in the state of Colorado, all radiation producing 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 persons work concurrently at more than one work location under an approval granted pursuant to this RH 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 producing 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 producing machine within Colorado under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable federal requirements. PART 2 APPENDIX A SCHEDULE OF FEES FOR RADIATION MACHINE SERVICES Category of Radiation Type of fee Maximum Fee Maximum Frequency Machine Services 2 $ 129 Per Hour 1. Hourly Rate 3 Certification 4 Each Enforcement Acton 2. Enforcement Action $1,157 3. Qualified Inspectors or Registration 6 Every 2 Years $ 160 Servicing and Services Footnotes:
1. Fees listed in Appendix A of this Part “schedule of fees for radiation machine services” are maximum amounts which may be billed for these categories. In no event will the fee exceed that shown in this schedule. For each 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.
2. 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 board of health for those categories.
3. Any registrant that fails the requirements of RH 2.5.1 or any violation that has not been corrected in accordance with the compliance schedule established in RH 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 which 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.
4. This represents the maximum fee which 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.
5. Qualified inspector registration fee is an individual fee. Servicing and services registration fee is a company fee.
6. 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 B MINIMUM QUALIFICATIONS FOR QUALIFIED INSPECTOR Tier I1 The established minimum criteria for individuals to meet the education and experience are listed for 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.
1. Education and Experience a. General Requirements:
Education/Certification Experience Board certified in N/A; or Diagnostic Radiological Physics or Radiological Physics by the American Board of Radiology; or Board certified in Diagnostic Imaging Physics by the American Board of Medical Physics Other Board certifications 6 months; or by the American Board of Radiology or comprehensive certification by the American Board of Health Physics Doctorate or Masters 1 year; or B.A./B.S. 2 years; or Associate Degree 3 years; or Registered Radiologic 4 years Technologist (Radiography)
b. Educational/Experience Requirements:
c. Specific Qualifications for Qualified Inspectors to Inspect Mammography Facilities: Applicants seeking authorization as a qualified inspector for mammography facilities shall additionally meet the following criteria:
2. Proficiency testing for all applicants The Department shall audit proficiency of all qualified inspectors. In addition, all applicants must demonstrate to the Department a satisfactory knowledge of the applicable provisions of the Colorado Rules and Regulations Pertaining to Radiation Control.
3. Calibration Records Applicable measuring instruments and devices shall be sufficiently sensitive and calibrated in accordance to RH 2.4.3.3 to determine compliance with the applicable provisions of the 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 II Tier II is a preparatory program for individuals who do not meet the minimum requirements for education and experience for qualified inspector status.
Individuals who meet the educational but not the experience qualifications listed for Tier I inspectors can apply for Department approval to perform evaluations under the tutelage and supervision of a Tier I inspector. Before an individual can apply for Tier II status they must have worked directly with a Tier I inspector for three (3) months. The Tier I sponsor shall provide the Department adequate documentation that these requirements are met.
All individuals in this category must submit applications to the Department prior to performing any certification evaluations. The application shall include the name(s) and signature of the Tier I individual(s) with whom they will be working.
All submitted Certification Evaluation Reports shall be signed by the Tier II inspector and the Tier I sponsor. The final responsibility for the content of the report belongs to the Tier I inspector who sponsors the Tier II inspector.
Note:
Tier I inspectors are required to meet more stringent qualifications and assume the primary responsibility for all inspections. Tier II inspectors are defined as less qualified individuals who are required to work under the direction of Tier I inspector(s). This system provides for a mechanism whereby individuals could gain the experience to qualify as Tier I inspectors. Receiving approval in one category does not automatically permit inspectors to perform inspections in other categories.
PART 2 APPENDIX C 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 which 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 mSec.
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 RH 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:
7. An electro-mechanical defect exists which endangers human life when a radiograph is made or fluoroscopy is performed.
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
3.2.3.2 source material contained in the following products:
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
3.2.3.6 natural or depleted uranium used as shielding constituting part of any shipping container, provided that:
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
3.2.3.8 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
3.2.4 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:
from any surface.
from any surface.
centimeters from any surface.
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:
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:
3.3.3.1.9 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
3.3.3.2.2 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.
3.5.5.4 A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by RH 3.5.5.1:
3.5.5.5 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.
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,
3.6.4.3.3 shall assure that other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:
3.6.4.3.4 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
3.6.4.3.5 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:
3.6.4.3.9 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:
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.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
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 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:
3.6.9.5 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
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.
3.9.1 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:
3.9.5.4 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:
for decommissioning costs based upon a financial test of the parent company and a written guarantee as contained in Appendix A of Part 3.
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.
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.
3.9.5.5 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.
3.9.5.6 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.
Regulatory Commission-licensed facilities;
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.
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.
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:
3.9.11 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:
3.9.11.2 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:
3.9.11.3 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:
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:
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
3.11.3 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:
safety evaluations of proposed uses prepared in accordance with RH
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:
3.11.4.3 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:
3.11.5.2 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
3.12.1.2 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
3.12.2 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:
3.12.2.2 The license issued under RH 3.12.2.1 is subject to the following conditions:
requirements,
Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited- Exempt Quantities Should Not Be Combined”, 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
3.12.3 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:
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
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
appropriate, in the same or substantially similar form:
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.
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.
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:
3.12.4.3 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:
such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31.
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.
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.
Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission.
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
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:
3.12.8.3 each prepackaged unit bears a durable, clearly visible label:
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:
3.12.8.5 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:
manufacturer;
3.12.10.2 A radioactive materials licensee who is also licensed by the State Board of Pharmacy:
Pharmaceutical Specialties; or
permit issued by a licensee of broad scope; and
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:
3.12.10.4 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:
3.12.12.3 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:
3.12.13 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:
3.12.13.2 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:
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;
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,
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,
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,
Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission, and
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:
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.
3.15.4.2 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
3.15.5 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:
3.16.2.5 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:
3.16.2.6 Each licensee who possesses radioactive material, including residual radioactive material attributable to licensed activities, following the expiration date specified in the license shall:
3.16.3 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:
3.16.3.3 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
3.16.4 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
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:
longer in effect then the dose criteria of RH 4.61.3.3 will be met.
for establishing a Department approved warranty prior to completion of decommissioning activities;
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
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:
3.16.4.5 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:
3.16.4.6 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
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:
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:
3.16.7 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:
Regulatory Commission, an Agreement State or a Licensing State, to receive such material, or
RH 3.3.1.
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:
3.24.1.3 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 uCi/ml Values are given in Column I only for those materials normally used as gases. 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)
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 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.
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)
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)
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 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:
2. The parent company must have:
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 RH 4.1 Purpose.
4.1.1 Part 4 establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Department. These regulations are issued pursuant to the 25-11-101 CRS, 1988.
4.1.2 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. RH 4.2 Scope.
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 RH 7.26, or to exposure from voluntary participation in medical research programs.
RH 4.3 Definitions.
As used in Part 4:
“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 Table I, Columns 1 and 2, of Appendix B. “Background radiation” means radiation from cosmic sources; naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material; and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as chernobyl that contribute to background radiation and are not under the control of the licensee. “Background radiation” does not include radiation from radioactive materials regulated by the Department. “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. “Constraint” (dose constraint) means a value above which specified licensee actions are required. “Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances. “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.
“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 Table I, Column 3, of Appendix B.
“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).
“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.
“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.
“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 the radiation source or 30 centimeters from any surface that the radiation penetrates.
“Individual Monitoring Devices” (Individual Monitoring Equipment) means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, and personal (“Lapel”) air sampling devices.
“Inhalation class” (see “Class”).
“Lens Dose Equivalent” (LDE) applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2). Lung class” (see “Class”).
“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.
“Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
“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.
“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 the International Commission on Radiological Protection Report, ICRP Publication 23, “Report of the Task Group on Reference Man.”
“Residual radioactivity” means radioactivity in structures, materials, 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.
“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.
“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.] “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.1 1At 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.
“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:
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.
b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, WT = 1.0, 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.
Gonads 0.25 Breast 0.15 Red bone marrow 0.12 Lung 0.12 Thyroid 0.03 Bone surfaces 0.03 Remainder a
Whole Body b
RH 4.4 Implementation.
4.4.1 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.
4.4.2 If a license or registration condition exempts a licensee or registrant from a provision of Part 4 in effect on or before January 1, 1994, it also exempts the licensee or registrant from the corresponding provision of revised Part 4.
4.4.3 If a license or registration condition cites provisions of Part 4 in effect prior to January 1, 1994, which do not correspond to any provisions of Part 4, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.
RADIATION PROTECTION PROGRAMS RH 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 RH 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 RH 4.5.2 and notwithstanding the requirements in RH 4.14 of this part, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, 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 millisevert per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in RH 4.53.2 and promptly take appropriate corrective action to ensure against recurrence.
OCCUPATIONAL DOSE LIMITS RH 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 RH 4.11, to the following dose limits:
4.6.1.1 An annual limit, which is the more limiting of:
4.6.1.2 The annual limits to the lens of the eye, to the skin, and to the extremities which are:
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 RH 4.11.5.1 and 4.11.5.2.
4.6.3 The assigned deep dose equivalent and shallow dose equivalent must be for the part of the body receiving the highest exposure.
4.6.3.1 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.
4.6.4 Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Table I of Appendix B and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See RH 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 Part 4 Appendix B.
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 RH 4.10.3.1 and 4.10.5.
RH 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 RH 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 RH 4.18.1 or only pursuant to RH 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 RH 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 H , 50 T T,50 per unit intake for any organ or tissue.
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 RH 4.7.4.
RH 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 B to Part 4, 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. RH 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 RH 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 these measurements.
4.9.2 Unless respiratory protective equipment is used, as provided in RH 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 B.
4.9.4 If the licensee or registrant chooses to assess intakes of Class Y material using the measurements given in RH 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 RH 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 B 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 RH 4.6 and in complying with the monitoring requirements in RH 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
RH 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 RH 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 RH 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 OR-RH-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 RH 4.10.1, on Department Form OR-RH-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 OR-RH-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 OR-RH-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 on Department Form OR-RH-16 or equivalent before January 1, 1994, 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 RH 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 OR-RH-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 OR-RH-16 or equivalent for 3 years after the record is made.
RH 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 RH 4.6 provided that each of the following conditions in RH 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 RH 4.10.2 during the lifetime of the individual for each individual involved.
4.11.5 Subject to RH 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 RH 4.6.1 in any year; and 4.11.5.2 Five times the annual dose limits in RH 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 RH 4.45 and submits a written report in accordance with RH 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 RH
4.6.1 but shall be included in evaluations required by RH 4.11.4 and 4.11.5.
RH 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 RH 4.6.
RH 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 RH 4.46 for recordkeeping requirements.
4.13.2 The licensee or registrant shall make efforts to avoid substantial variation2 above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in RH 4.13.1. 2The 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 rems), or is within 0.5 mSv (0.05 rems) 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 RH 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 RH 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 RH 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 RH 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 RH 7.26, does not exceed 0.02 milliSievert (0.002 rem) in any one hour.
4.14.2 Reserved.
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 RH 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
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 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.
RH 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 RH 4.14.
4.15.2 A licensee or registrant shall show compliance with the annual dose limit in RH 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:
4.15.3 Upon approval from the Department, the licensee or registrant may adjust the effluent concentration values in Appendix B, Table II, 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 RH 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 RH 4.15.2.1.
TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES RH 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 RH 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 RH 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 RH 3.12.12.4 and 3.12.12.5 of these regulations, an Agreement State, a Licensing State, or the 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 leakage rate of 37 Bq (0.001 µCi) of radon-222 in a 24 hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume and time.
4.16.1.7 Tests for contamination from radium daughters 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 daughter 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-222 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 RH 4.58.
SURVEYS AND MONITORING RH 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:
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 RH 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.
RH 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 RH 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 2The 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.
4.18.1.4 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 RH 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 I, Columns 1 and 2, of Appendix B to Part 4, 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). CONTROL OF EXPOSURE FROM EXTERNAL SOURCES IN RESTRICTED AREAS RH 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 RH 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 RH 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 RH 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. RH 4.20 Control of Access to Very High Radiation Areas.
4.20.1 In addition to the requirements in RH 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 RH 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. RH 4.21 Control of Access to Very High Radiation Areas - Irradiators.
4.21.1 Section RH 4.21 applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. Section RH 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:
4.21.2.2 Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by RH 4.21.2.1:
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:
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 RH 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 RH 4.21.2.1 shall be tested for proper functioning. See RH 4.49 for recordkeeping requirements.
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 RH 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 RH 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 RH 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 RH 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 RH 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 or ventilation, to control the concentrations of radioactive material in air. RH 4.23 Use of Other Controls.
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 Control of access; or
4.23.2 Limitation of exposure times; or
4.23.3 Use of respiratory protection equipment; or
4.23.4 Other controls.
RH 4.24 Use of Individual Respiratory Protection Equipment.
4.24.1 If the licensee uses respiratory protection equipment to limit intakes pursuant to RH 4.23:
4.24.1.1 Except as provided in RH 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 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:
4.24.1.4 The licensee shall issue a written policy statement on respirator usage covering:
4.24.1.5 The licensee shall 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.
4.24.1.6 The licensee shall use respiratory protection equipment within the equipment manufacturer's expressed limitations for type and mode of use and shall provide proper visual, communication, and other special capabilities, such as adequate skin protection, when needed.
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 RH 4.23, provided that the following conditions, in addition to those in RH 4.24.1, are satisfied:
4.24.2.1 The licensee selects respiratory protection equipment that provides a protection factor, specified in Appendix A, 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 B, Table I, 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 RH 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 A. The Department may authorize a licensee to use higher protection factors on receipt of an application that:
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 RH 4.24.1 or 4.24.2. STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION RH 4.25 Security of Stored Sources of Radiation.
The licensee shall secure from unauthorized removal or access licensed or registered sources of radiation that are stored in unrestricted areas.
RH 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 RH 4.27 Caution Signs.
4.27.1 Standard Radiation Symbol.
Unless otherwise authorized by the Department, the symbol prescribed by RH 4.27 shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:
1. Cross-hatched area is to be magenta, or purple, or black, and 2. The background is to be yellow.
4.27.2 Exception to Color Requirements for Standard Radiation Symbol.
Notwithstanding the requirements of RH 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. RH 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 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 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 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 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 C with a conspicuous sign or signs bearing the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL(S)” or “DANGER, RADIOACTIVE MATERIAL(S).”
RH 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 RH 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 RH 4.28 if:
4.29.4.1 Access to the room is controlled pursuant to RH 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. RH 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 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. RH 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 C; or 4.31.2 Containers holding licensed or registered material in concentrations less than those specified in Table III of Appendix B; 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;4 or 4Labeling 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.
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.
RH 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 RH 17.2 and Appendix A 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 labeled5 package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in RH 1.4 of these regulations; and 5Labeled 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.
4.32.2.2 Monitor the external surfaces of a labeled5 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 RH 17.2 and Appendix A to Part 17 of these regulations; and 5Labeled 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.
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 RH 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 RH 17.15.8 of these regulations; or 4.32.4.2 External radiation levels exceed the limits of RH 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 RH 4.32.2, but are not exempt from the monitoring requirement in RH 4.32.2 for measuring radiation levels that ensures that the source is still properly lodged in its shield. WASTE DISPOSAL RH 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 RH 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 RH 4.14; or
4.33.1.4 As authorized pursuant to RH 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. RH 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.
RH 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 III of Appendix B; and 4.35.1.3 If more than one radionuclide is released, the following conditions must also be satisfied:
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 RH 4.35.1.
RH 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 RH 4.37 or as specifically approved by the Department pursuant to RH 4.34.
RH 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 gram 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 RH 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 RH 4.48. RH 4.38 Transfer for Disposal and Manifests.
4.38.1 The requirements of RH 4.38 and Appendix G 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 G.
4.38.3 Each shipment manifest shall include a certification by the waste generator as specified in Section II of Appendix G.
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 G. RH 4.39 Compliance with Environmental and Health Protection Regulations. Nothing in RH 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 to RH 4.33, 4.34, 4.35, 4.37 or 4.38. RECORDS RH 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.
RH 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 RH 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 RH 4.41.1.2 for 3 years after the record is made. RH 4.42 Records of Surveys.
4.42.1 Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by RH 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 RH 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 OR-RH-16 or equivalent, or shall make provision with the Department for transfer to the Department.
RH 4.43 Records of Tests for Leakage or Contamination of Sealed Sources. Records of tests for leakage or contamination of sealed sources required by RH 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.
RH 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 RH 4.10 on Department Form OR-RH-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 OR-RH-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 OR-RH-16 or equivalent, or shall make provision with the Department for transfer to the Department.
RH 4.45 Records of Planned Special Exposures.
4.45.1 For each use of the provisions of RH 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 OR-RH-16 or equivalent, or shall make provision with the Department for transfer to the Department.
RH 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 RH 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 RH 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 RH 4.9.1 and RH 4.9.3, and when required by RH 4.18;
4.46.1.5 The total effective dose equivalent when required by RH 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 RH 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 RH 4.46.1 on Department Form OR-RH-17, Occupational Exposure Record for a Monitoring Period, in accordance with the instructions for Department Form OR-RH-17, or in clear and legible records containing all the information required by Department Form OR-RH-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 OR-RH-16 or equivalent, or shall make provision with the Department for transfer to the Department.
RH 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 RH 4.14.
4.47.2 The licensee or registrant shall retain the records required by RH 4.47.1 until the Department terminates each pertinent license or registration requiring the record. RH 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 RH 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 RH 4.48.1 in accordance with RH 3.15.4 until the Department terminates each pertinent license or registration requiring the record. RH 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 RH 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 RH 4.49.1 for 3 years after the record is made.
RH 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 RH 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 C 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 C 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 RH 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 RH 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.
RH 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:
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:
4.52.2.2 An unplanned contamination event that:
4.52.2.3 An event in which equipment is disabled or fails to function as designed when:
4.52.2.4 An event that requires unplanned medical treatment at a medical facility of an individual who's 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:
4.53.1 Reports made by licensees or registrants in response to the requirements of RH 4.52, must be made as follows:
4.53.1.1 Licensees or registrants shall make the reports required by RH 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:
4.53.1.2 Each licensee or registrant who makes a report required by RH 4.52.1 or 4.52.2 shall submit a written follow-up report to the Department pursuant to RH 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 RH 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 RH 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 RH 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 RH 4.52; or
4.53.2.2 Doses in excess of any of the following:
4.53.2.3 Levels of radiation or concentrations of radioactive material in:
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, 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 RH 4.53.1.2 or 4.53.2 shall include the following, as appropriate:
involved;
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 RH 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 RH 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.
RH 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 RH 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 RH 4.45.
RH 4.55 Reserved.
RH 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 a Activity Ci Gbg a The Department may require as a license condition, or by rule, regulation, or order pursuant to RH 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.
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 4.56.2 Each licensee or registrant in a category listed in RH 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 RH 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 OR-RH-17 or equivalent or Department-approved electronic media containing all the information required by Department Form OR-RH-17.
4.56.3 The licensee or registrant shall file the report required by RH 4.56.2, covering the preceding year, on or before April 30 of each year.
RH 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 RH 10.4 of these regulations.
4.57.2 When a licensee or registrant is required pursuant to RH 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 RH 10.4.1 of these regulations. RH 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 RH 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.
RH 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 of Health upon request. RH 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 A of Part 18; uranium solution extraction facilities; sites which have been decommissioned and the license terminated prior to July 1, 1999; or sites which have submitted a decommissioning plan prior to July 1, 2000 and have 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 RH 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.
RH 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.
RH 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 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;
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 RH 4.61.2 or RH 4.61.3.2, if:
Part 4 APPENDIX A. PROTECTION FACTORS FOR RESPIRATORS (4)
I. (6)
II. ATMOSPHERE-SUPPLYING RESPIRATORS
III. COMBINATION RESPIRATORS Any combination of air-purifying and atmosphere- Protection factor for type supplying respirators and mode of operation as listed above FOOTNOTES 1. For use in the selection of respiratory protective equipment to be used only where the contaminants have been identified and the concentrations, or possible concentrations, are known.
2. Only for shaven faces and where nothing interferes with the seal of tight-fitting facepieces against the skin. Hoods and suits are excepted.
3. The mode symbols are defined as follows:
CF = continuous flow D = demand NP = negative pressure, that is, negative phase during inhalation PD = pressure demand, that is, always positive pressure PP = positive pressure RD = demand, recirculating or closed circuit RP = pressure demand, recirculating or closed circuit 4. a. The protection factor is a measure of the degree of protection afforded by a respirator, defined as the ratio of the concentration of airborne radioactive material outside the respiratory protective equipment to that inside the equipment, usually inside the facepiece, under conditions of use. It is applied to the ambient airborne concentration to estimate the concentrations inhaled by the wearer according to the following formula: Concentration inhaled = Ambient airborne concentration Protection factor b. The protection factors apply:
5. Excluding radioactive contaminants that present an absorption or submersion hazard. For tritium oxide, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of less than 2 is appropriate when atmosphere—supplying respirators are used to protect against tritium oxide. If the protection factor for respiratory protective equipment is 5, the effective protection factor for tritium is about 1.4; with protection factors of 10, the effective factor for tritium oxide is about 1.7; and with protection factors of 100 or more, the effective factor for tritium oxide is about 1.9. Air-purifying respirators are not suitable for protection against tritium oxide. See also footnote 9 concerning supplied-air suits.
6. Canisters and cartridges shall not be used beyond service-life limitations.
7. Under-chin type only. This type of respirator is not satisfactory for use where it might be possible, such as, if an accident or emergency were to occur, for the ambient airborne concentrations to reach instantaneous values greater than 10 times the pertinent values in Table I, Column 3 of Appendix B of Part 4. This type of respirator is not suitable for protection against plutonium or other high- toxicity materials. The mask is to be tested for fit prior to use, each time it is donned.
8. a. Equipment shall be operated in a manner that ensures that proper air flow-rates are maintained. A protection factor of no more than 1000 may be utilized for tested-and- certified supplied-air hoods when a minimum air flow of 6 cubic feet per minute (0.17 m3/min) is maintained and calibrated air line pressure gauges or flow measuring devices are used. A protection factor of up to 2000 may be used for tested and certified hoods only when the air flow is maintained at the manufacturer's recommended maximum rate for the equipment, this rate is greater than 6 cubic feet per minute (0.17 m3/min) and calibrated air line pressure gauges or flow measuring devices are used.
b. The design of the supplied-air hood or helmet, with a minimum flow of 6 cubic feet per minute (0.17 m3/min) of air, may determine its overall efficiency and the protection it provides. For example, some hoods aspirate contaminated air into the breathing zone when the wearer works with hands-over-head. This aspiration may be overcome if a short cape-like extension to the hood is worn under a coat or overalls. Other limitations specified by the approval agency shall be considered before using a hood in certain types of atmospheres. See footnote 9.
9. Appropriate protection factors shall be determined, taking into account the design of the suit and its permeability to the contaminant under conditions of use. There shall be a standby rescue person equipped with a respirator or other apparatus appropriate for the potential hazards and communications equipment whenever supplied-air suits are used.
10. No approval schedules are currently available for this equipment. Equipment is to be evaluated by testing or on the basis of reliable test information.
11. This type of respirator may provide greater protection and 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, must be taken into account in such circumstances.
12. Quantitative fit testing shall be performed on each individual, and no more than 0.02% leakage is allowed with this type of apparatus. Perceptible outward leakage of gas from this or any positive pressure self-contained breathing apparatus is unacceptable because service life will be reduced substantially. Special training in the use of this type of apparatus shall be provided to the wearer. Note 1: Protection factors for respirators approved by the U.S. Bureau of Mines and the National Institute for Occupational Safety and Health, according to applicable approvals for respirators for type and mode of use to protect against airborne radionuclides, may be used to the extent that they do not exceed the protection factors listed in this table. The protection factors listed in this table may not be appropriate to circumstances where chemical or other respiratory hazards exist in addition to radioactive hazards. The selection and use of respirators for such circumstances should take into account applicable approvals of the U.S. Bureau of Mines and the National Institute for Occupational Safety and Health. Note 2: Radioactive contaminants, for which the concentration values in Table I, Column 3 of Appendix B of Part 4 are based on internal dose due to inhalation, may present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits.
Part 4 APPENDIX B. 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 I 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 II provides concentration limits for airborne and liquid effluents released to the general environment. Table III provides concentration limits for discharges to sanitary sewerage.
Note:
The values in Tables I, II, and III are presented in the computer “E” notation. In this notation a value of 6E-02 represents a value of 6 × 10-2 or 0.06, 6E + 2 represents 6 × 1O2 or 600, and 6E + 0 represents 6 × 100 or 6.
Table I “Occupational Values”
Note that the columns in Table I 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 RH 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 there ns is an external deep dose equivalent contribution of H , then this sum must be less than 1 - (H /50), d d 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 × 60 minutes/hour × 2 × 104 ml per minute) = (ALI/2.4 ×
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 daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter 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 RH 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 II “Effluent Concentrations”
The columns in Table II 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 RH 4.15. The concentration values given in Columns 1 and 2 of Table II 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 II. 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.
The air concentration values listed in Table II, 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 × 109, 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 I, 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 × 107. The factor of 7.3 × 107 (ml) includes the following components: the factors of 50 and 2 described above and a factor of 7.3 × 105 (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 III “Releases to Sewerage”
The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in RH 4.35. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 × 106 (ml). The factor of 7.3 × 106 (ml) is composed of a factor of 7.3 × 105 (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. LIST OF ELEMENTS Atomic Name Symbol Number Name Actinium Ac 89 Mercury Aluminum Al 13 Molybdenum Americium Am 95 Neodymium Antimony Sb 51 Neptunium Argon Ar 18 Nickel Arsenic As 33 Niobium Astatine At 85 Osmium Barium Ba 56 Palladium Berkelium Bk 97 Phosphorus Beryllium Be 4 Platinum Bismuth Bi 83 Plutonium Bromine Br 35 Polonium Cadmium Cd 48 Potassium Calcium Ca 20 Praseodymium Californium Cf 98 Promethium Carbon C 6 Protactinium Cerium Ce 58 Radium Cesium Cs 55 Radon Chlorine Cl 17 Rhenium Chromium Cr 24 Rhodium Cobalt Co 27 Rubidium Copper Cu 29 Ruthenium Curium Cm 96 Samarium Dysprosium Dy 66 Scandium Einsteinium Es 99 Selenium Erbium Er 68 Silicon Europium Eu 63 Silver Fermium Fm 100 Sodium Fluorine F 9 Strontium Francium Fr 87 Sulfur Gadolinium Gd 64 Tantalum Gallium Ga 31 Technetium Germanium Ge 32 Tellurium Gold Au 79 Terbium Hafnium Hf 72 Thallium Holmium Ho 67 Thorium Hydrogen H 1 Thulium Indium In 49 Tin Iodine I 53 Titanium Iridium Ir 77 Tungsten Iron Fe 26 Uranium Krypton Kr 36 Vanadium Lanthanum La 57 Xenon Lead Pb 82 Ytterbium Lutetium Lu 71 Yttrium Magnesium Mg 12 Zinc Manganese Mn 25 Zirconium Mendelevium Md 101 Part 4 APPENDIX C. QUANTITIES OF LICENSED OR REGISTERED MATERIAL REQUIRING LABELING Radionuclide Quantity (µCi)* Radionuclide Quantity (µCi)* * To convert µCi to kBq, multiply the µCi value by 37.
Actinium-224 1 Barium-126 1,000 Actinium-225 0.01 Barium-128 100 Actinium-226 0.1 Barium-131 100 Actinium-227 0.001 Barium-131m 1,000 Actinium-228 1 Barium-133 100 Aluminum-26 10 Barium-133m 100 Americium-237 1,000 Barium-135m 100 Americium-238 100 Barium-139 1,000 Americium-239 1,000 Barium-140 100 Americium-240 100 Barium-141 1,000 Americium-241 0.001 Barium-142 1,000 Americium-242 10 Berkelium-245 100 Americium-242m 0.001 Berkelium-246 100 Americium-243 0.001 Berkelium-247 0.001 Americium-244 10 Berkelium-249 0.1 Americium-244m 100 Berkelium-250 10 Americium-245 1,000 Beryllium-10 1 Americium-246 1,000 Beryllium-7 1,000 Americium-246 1,000 Bismuth-200 1,000 Antimony-115 1,000 Bismuth-201 1,000 Antimony-116 1,000 Bismuth-202 1,000 Antimony-116m 1,000 Bismuth-203 100 Antimony-117 1,000 Bismuth-205 100 Antimony-118m 1,000 Bismuth-206 100 Antimony-119 1,000 Bismuth-207 10 Antimony-120(16m) 1,000 Bismuth-210 1 Antimony-120(5.76d) 100 Bismuth-210m 0.1 Antimony-122 100 Bismuth-212 10 Antimony-124 10 Bismuth-213 10 Antimony-124m 1,000 Bismuth-214 100 Antimony-125 100 Bromine-74 1,000 Antimony-126 100 Bromine-74m 1,000 Antimony-126m 1,000 Bromine-75 1,000 Antimony-127 100 Bromine-76 100 Antimony-128(10.4m) 1,000 Bromine-77 1,000 Antimony-128(9.01 h) 100 Bromine-80 1,000 Antimony-129 100 Bromine-80m 1,000 Antimony-130 1,000 Bromine-82 100 Antimony-131 1,000 Bromine-83 1,000 Argon-39 1,000 Bromine-84 1,000 Argon-41 1,000 Cadmium-104 1,000 Arsenic-69 1,000 Cadmium-107 1,000 Arsenic-70 1,000 Cadmium-109 1 Arsenic-71 100 Cadmium-113 100 Arsenic-72 100 Cadmium-113m 0.1 Arsenic-73 100 Cadmium-115 100 Arsenic-74 100 Cadmium-115m 10 Arsenic-76 100 Cadmium-117 1,000 Arsenic-77 100 Cadmium-117m 1,000 Arsenic-78 1,000 Calcium-41 100 Astatine-207 100 Calcium-45 100 Astatine-211 10 Calcium-47 100 Californium-244 100 Curium-245 0.001 Californium-246 1 Curium-246 0.001 Californium-244 100 Curium-245 0.001 Californium-246 1 Curium-246 0.001 Californium-248 0.01 Curium-247 0.001 Californium-249 0.001 Curium-248 0.001 Californium-250 0.001 Curium-249 1,000 Californium-251 0.001 Dysprosium-155 1,000 Californium-252 0.001 Dysprosium-157 1,000 Californium-253 0.1 Dysprosium-159 100 Californium-254 0.001 Dysprosium-165 1,000 Carbon-11 1,000 Dysprosium-166 100 Carbon-14 1,000 Einsteinium-250 100 Cerium-134 100 Einsteinium-251 100 Cerium-135 100 Einsteinium-253 0.1 Cerium-137 1,000 Einsteinium-254 0.01 Cerium-137m 100 Einsteinium-254m 1 Cerium-139 100 Erbium-161 1,000 Cerium-141 100 Erbium-165 1,000 Cerium-143 100 Erbium-169 100 Cerium-144 1 Erbium-171 100 Cesium-125 1,000 Erbium-172 100 Cesium-127 1,000 Europium-145 100 Cesium-129 1,000 Europium-146 100 Cesium-130 1,000 Europium-147 100 Cesium-131 1,000 Europium-148 10 Cesium-132 100 Europium-149 100 Cesium-134 10 Europium-150(12.62h) 100 Cesium-134m 1,000 Europium-150(34.2y) 1 Cesium-135 100 Europium-152 1 Cesium-135m 1,000 Europium-152m 100 Cesium-136 10 Europium-154 1 Cesium-137 10 Europium-155 10 Cesium-138 1,000 Europium-156 100 Chlorine-36 10 Europium-157 100 Chlorine-38 1,000 Europium-158 1,000 Chlorine-39 1,000 Fermium-252 1 Chromium-48 1,000 Fermium-253 1 Chromium-49 1,000 Fermium-254 10 Chromium-51 1,000 Fermium-255 1 Cobalt-55 100 Fermium-257 0.01 Cobalt-56 10 Fluorine-18 1,000 Cobalt-57 100 Francium-222 100 Cobalt-58 100 Francium-223 100 Cobalt-58m 1,000 Gandolinium-145 1,000 Cobalt-60 1 Gandolinium-146 10 Cobalt-60m 1,000 Gandolinium-147 100 Cobalt-61 1,000 Gandolinium-148 0.001 Cobalt-62m 1,000 Gandolinium-149 100 Copper-60 1,000 Gandolinium-151 10 Copper-61 1,000 Gandolinium-152 100 Copper-64 1,000 Gandolinium-153 10 Copper-67 1,000 Gandolinium-159 100 Curium-238 100 Gallium-65 1,000 Curium-240 0.1 Gallium-66 100 Curium-241 1 Gallium-67 1,000 Curium-242 0.01 Gallium-68 1,000 Curium-243 0.001 Gallium-70 1,000 Curium-244 0.001 Gallium-72 100 Gallium-73 1,000 Indium-119m 1,000 Germanium-66 1,000 Iodine-120 100 Germanium-67 1,000 Iodine-120m 1,000 Germanium-68 10 Iodine-121 1,000 Germanium-69 1,000 Iodine-123 100 Germanium-71 1,000 Iodine-124 10 Germanium-75 1,000 Iodine-125 1 Germanium-77 1,000 Iodine-126 1 Germanium-78 1,000 Iodine-128 1,000 Gold-193 1,000 Iodine-129 1 Gold-194 100 Iodine-130 10 Gold-195 10 Iodine-131 1 Gold-198 100 Iodine-132 100 Gold-198m 100 Iodine-132m 100 Gold-199 100 Iodine-133 10 Gold-200 1,000 Iodine-134 1,000 Gold-200m 100 Iodine-135 100 Gold-201 1,000 Iridium-182 1,000 Hafnium-170 100 Iridium-184 1,000 Hafnium-172 1 Iridium-185 1,000 Hafnium-173 1,000 Iridium-186 100 Hafnium-175 100 Iridium-187 1,000 Hafnium-177m 1,000 Iridium-188 100 Hafnium-178m 0.1 Iridium-189 100 Hafnium-179m 10 Iridium-190 100 Hafnium-180m 1,000 Iridium-190m 1,000 Hafnium-181 10 Iridium-192(73.8d) 1 Hafnium-182 0.1 Iridium-192m(1.4m) 10 Hafnium-182m 1,000 Iridium-194 100 Hafnium-183 1,000 Iridium-194m 10 Hafnium-184 100 Iridium-195 1,000 Holmium-155 1,000 Iridium-195m 1,000 Holmium-157 1,000 Iron-52 100 Holmium-159 1,000 Iron-55 100 Holmium-161 1,000 Iron-59 10 Holmium-162 1,000 Iron-60 1 Holmium-162m 1,000 Krypton-74 1,000 Holmium-164 1,000 Krypton-76 1,000 Holmium-164m 1,000 Krypton-77 1,000 Holmium-166 100 Krypton-79 1,000 Holmium-166m 1 Krypton-81 1,000 Holmium-167 1,000 Krypton-83m 1,000 Hydrogen-3 1,000 Krypton-85 1,000 Indium-109 1,000 Krypton-85m 1,000 Indium-110(69.1m) 1,000 Krypton-87 1,000 Indium-110m(4.9h) 1,000 Krypton-88 1,000 Indium-111 100 Lanthanum-131 1,000 Indium-112 1,000 Lanthanum-132 100 Indium-113m 1,000 Lanthanum-135 1,000 Indium-114m 10 Lanthanum-137 10 Indium-115 100 Lanthanum-138 100 Indium-115m 1,000 Lanthanum-14 1,000 Indium-116m 1,000 Lanthanum-140 100 Indium-117 1,000 Lanthanum-141 100 Indium-117m 1,000 Lanthanum-143 1,000 Lead-195m 1,000 Neodymium-147 100 Lead-198 1,000 Neodymium-149 1,000 Lead-199 1,000 Neodymium-151 1,000 Lead-200 100 Neptunium-232 100 Lead-201 1,000 Neptunium-233 1,000 Lead-202 10 Neptunium-235 100 Lead-202m 1,000 Neptunium-236(1.15E + 0.001 5y)
Lead-203 1,000 Neptunium-236(22.5h) 1 Lead-205 100 Neptunium-237 0.001 Lead-209 1,000 Neptunium-238 10 Lead-210 0.01 Neptunium-239 100 Lead-211 100 Neptunium-240 1,000 Lead-212 1 Neptunium-234 100 Lead-214 100 Nickel-56 100 Lutetium-169 100 Nickel-57 100 Lutetium-170 100 Nickel-59 100 Lutetium-171 100 Nickel-63 100 Lutetium-172 100 Nickel-65 1,000 Lutetium-173 10 Nickel-66 10 Lutetium-174 10 Niobium-88 1,000 Lutetium-174m 10 Niobium-89(122 min) 1,000 Lutetium-176 100 Niobium-89m (66 min) 1,000 Lutetium-176m 1,000 Niobium-90 100 Lutetium-177 100 Niobium-93m 10 Lutetium-177m 10 Niobium-94 1 Lutetium-178 1,000 Niobium-95 100 Lutetium-178m 1,000 Niobium-95m 100 Lutetium-179 1,000 Niobium-96 100 Magnesium-28 100 Niobium-97 1,000 Manganese-51 1,000 Niobium-98 1,000 Manganese-52 100 Osmium-180 1,000 Manganese-52m 1,000 Osmium-181 1,000 Manganese-53 1,000 Osmium-182 100 Manganese-54 100 Osmium-185 100 Manganese-56 1,000 Osmium-189m 1,000 Mendelevium-257 10 Osmium-191 100 Mendelevium-258 0.01 Osmium-191m 1,000 Mercury-193 1,000 Osmium-193 100 Mercury-193m 100 Osmium-194 1 Mercury-194 1 Palladium-100 100 Mercury-195 1,000 Palladium-101 1,000 Mercury-195m 100 Palladium-103 100 Mercury-197 1,000 Palladium-107 10 Mercury-197m 100 Palladium-109 100 Mercury-199m 1,000 Phosphorus-32 10 Mercury-203 100 Phosphorus-33 100 Molybdenum-101 1,000 Platinum-186 1,000 Molybdenum-90 100 Platinum-188 100 Molybdenum-93 10 Platinum-189 1,000 Molybdenum-93m 100 Platinum-191 100 Molybdenum-99 100 Platinum-193 1,000 Neodymium-136 1,000 Platinum-193m 100 Neodymium-138 100 Platinum-195m 100 Neodymium-139 1,000 Platinum-197 100 Neodymium-139m 1,000 Platinum-197m 1,000 Neodymium-141 1,000 Platinum-199 1,000 Radium-225 0.1 Platinum-200 100 Radium-226 0.1 Plutonium-234 10 Radium-227 1,000 Plutonium-235 1,000 Radium-228 0.1 Plutonium-236 0.001 Radon-220 1 Plutonium-237 100 Radon-222 1 Plutonium-238 0.001 Rhenium-177 1,000 Plutonium-239 0.001 Rhenium-178 1,000 Plutonium-240 0.001 Rhenium-181 1,000 Plutonium-241 0.01 Rhenium-182(12.7h) 1,000 Plutonium-242 0.001 Rhenium-182(64.Oh) 100 Plutonium-243 1,000 Rhenium-184 100 Plutonium-244 0.001 Rhenium-184m 10 Plutonium-245 100 Rhenium-186 100 Polonium-203 1,000 Rhenium-186m 10 Polonium-205 1,000 Rhenium-187 1,000 Polonium-207 1,000 Rhenium-188 100 Polonium-210 0.1 Rhenium-188m 1,000 Potassium-40 100 Rhenium-189 100 Potassium-42 1,000 Rhodium-100 100 Potassium-43 1,000 Rhodium-101 10 Potassium-44 1,000 Rhodium-101m 1,000 Potassium-45 1,000 Rhodium-102 10 Praseodymium-136 1,000 Rhodium-102m 10 Praseodymium-137 1,000 Rhodium-103m 1,000 Praseodymium-138m 1,000 Rhodium-105 100 Praseodymium-139 1,000 Rhodium-106m 1,000 Praseodymium-142 100 Rhodium-107 1,000 Praseodymium-142m 1,000 Rhodium-99 100 Praseodymium-143 100 Rhodium-99m 1,000 Praseodymium-144 1,000 Rubidium-79 1,000 Praseodymium-145 100 Rubidium-81 1,000 Praseodymium-147 1,000 Rubidium-81m 1,000 Promethium-141 1,000 Rubidium-82m 1,000 Promethium-143 100 Rubidium-83 100 Promethium-144 10 Rubidium-84 100 Promethium-145 10 Rubidium-86 100 Promethium-146 1 Rudidium-87 100 Promethium-147 10 Rubidium-88 1,000 Promethium-148 10 Rubidium-89 1,000 Promethium-148m 10 Ruthenium-103 100 Promethium-149 100 Ruthenium-105 1,000 Promethium-150 1,000 Ruthenium-106 1 Promethium-151 100 Ruthenium-94 1,000 Protactinium-227 10 Ruthenium-97 1,000 Protactinium-228 1 Samarium-141 1,000 Protactinium-230 0.1 Samarium-141m 1,000 Protactinium-231 0.001 Samarium-142 1,000 Protactinium-232 1 Samarium-145 100 Protactinium-233 100 Samarium-146 1 Protactinium-234 100 Samarium-147 100 Radium-223 0.1 Samarium-151 10 Radium-224 0.1 Samarium-153 100 Samarium-155 1,000 Tantalum-182m 1,000 Samarium-156 1,000 Tantalum-183 100 Scandium-43 1,000 Tantalum-184 100 Scandium-44 100 Tantalum-185 1,000 Scandium-44m 100 Tantalum-186 1,000 Scandium-46 10 Technetium-101 1,000 Scandium-47 100 Technetium-104 1,000 Scandium-48 10 Technetium-93 1,000 Scandium-49 1,000 Technetium-93m 1,000 Selenium-70 1,000 Technetium-94 1,000 Selenium-73 100 Technetium-94m 1,000 Selenium-73m 1,000 Technetium-96 100 Selenium-75 100 Technetium-96m 1,000 Selenium-79 100 Technetium-97 1,000 Selenium-81 1,000 Technetium-97m 100 Selenium-81m 1,000 Technetium-98 10 Selenium-83 1,000 Technetium-99 100 Silicon-2 1 Technetium-99m 1,000 Silicon-31 1,000 Tellurium-116 1,000 Silver-102 1,000 Tellurium-121 100 Silver-103 1,000 Tellurium-121m 10 Silver-104 1,000 Tellurium-123 100 Silver-104m 1,000 Tellurium-123m 10 Silver-105 100 Tellurium-125m 10 Silver-106 1,000 Tellurium-127 1,000 Silver-106m 100 Tellurium-127m 10 Silver-108m 1 Tellurium-129 1,000 Silver-111 100 Tellurium-129m 10 Silver-112 100 Tellurium-131 100 Silver-115 1,000 Tellurium-131m 10 Silver-110m 10 Tellurium-132 10 Sodium-22 10 Tellurium-133 1,000 Sodium-24 100 Tellurium-133m 100 Strontium-80 100 Tellurium-134 1,000 Strontium-81 1,000 Terbium-147 1,000 Strontium-83 100 Terbium-149 100 Strontium-85 100 Terbium-150 1,000 Strontium-85m 1,000 Terbium-151 100 Strontium-87m 1,000 Terbium-153 1,000 Strontium-89 10 Terbium-154 100 Strontium-90 0.1 Terbium-155 1,000 Strontium-91 100 Terbium-156 100 Strontium-92 100 Terbium-156m(5.0h) 1,000 Sulfur-35 100 Terbium-156m(24.4h) 1,000 Tantalum-172 1,000 Terbium-157 10 Tantalum-173 1,000 Terbium-158 1 Tantalum-174 1,000 Terbium-160 10 Tantalum-175 1,000 Terbium-161 100 Tantalum-176 100 Thallium-194 1,000 Tantalum-177 1,000 Thallium-194m 1,000 Tantalum-178 1,000 Thallium-195 1,000 Tantalum-179 100 Thallium-197 1,000 Tantalum-180 100 Thallium-198 1,000 Tantalum-180m 1,000 Thallium-198m 1,000 Tantalum-182 10 Thallium-199 1,000 Thallium-200 1,000 Uranium-231 100 Thallium-201 1,000 Uranium-232 0.001 Thallium-202 100 Uranium-233 0.001 Thallium-204 100 Uranium-234 0.001 Thorium-226 10 Uranium-235 0.001 Thorium-227 0.01 Uranium-236 0.001 Thorium-228 0.001 Uranium-237 100 Thorium-229 0.001 Uranium-238 100 Thorium-230 0.001 Uranium-239 1,000 Thorium-231 100 Uranium-240 100 Thorium-232 100 Uranium-natural 100 Thorium-234 10 Vanadium-47 1,000 Thorium-natural 100 Vanadium-48 100 Thulium-162 1,000 Vanadium-49 1,000 Thulium-166 100 Xenon-120 1,000 Thulium-167 100 Xenon-121 1,000 Thulium-170 10 Xenon-122 1,000 Thulium-171 10 Xenon-123 1,000 Thulium-172 100 Xenon-125 1,000 Thulium-173 100 Xenon-127 1,000 Thulium-175 1,000 Xenon-129m 1,000 Tin-110 100 Xenon-131m 1,000 Tin-111 1,000 Xenon-133 1,000 Tin-113 100 Xenon-133m 1,000 Tin-117m 100 Xenon-135 1,000 Tin-119m 100 Xenon-135m 1,000 Tin-121 1,000 Xenon-138 1,000 Tin-121m 100 Ytterbium-162 1,000 Tin-123 10 Ytterbium-166 100 Tin-123m 1,000 Ytterbium-167 1,000 Tin-125 10 Ytterbium-169 100 Tin-126 10 Ytterbium-175 100 Tin-127 1,000 Ytterbium-177 1,000 Tin-128 1,000 Ytterbium-178 1,000 Titanium-44 1 Yttrium-86 100 Titanium-45 1,000 Yttrium-86m 1,000 Tungsten-176 1,000 Yttrium-87 100 Tungsten-177 1,000 Yttrium-88 10 Tungsten-178 1,000 Yttrium-90 10 Tungsten-179 1,000 Yttrium-90m 1,000 Tungsten-18 100 Yttrium-91 10 Tungsten-181 1,000 Yttrium-91m 1,000 Tungsten-187 100 Yttrium-92 100 Tungsten-188 10 Yttrium-93 100 Uranium-230 0.01 Yttrium-94 1,000 Yttrium-95 1,000 Zinc-62 100 Zinc-63 1,000 Zinc-65 10 Zinc-69 1,000 Zinc-69m 100 Zinc-71m 1,000 Zinc-72 100 Zirconium-86 100 Zirconium-88 10 Zirconium-89 100 Zirconium-93 1 Zirconium-95 10 Zirconium-97 100 any alpha-emitting 0.001 Any radionuclide other 0.01 radionuclide not listed than alphaemitting above or mixtures of radionuclides not listed alpha emitters of above, or mixtures of beta unknown composition emitters of unknown composition NOTE: For purposes of RH 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. 1 The quantities listed above were derived by taking 1/10th of the most restrictive ALI listed in Table I, Columns 1 and 2, of Appendix B to Part 4, 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 MBg (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. APPENDIX D RESERVED 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 I, classification shall be determined as follows:
1) If the concentration does not exceed 0.1 times the value in Table I, the waste is Class A.
2) If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value in Table I, the waste is Class C.
3) If the concentration exceeds the value in Table I, the waste is not generally acceptable for land disposal.
4) For wastes containing mixtures of radionuclides listed in Table I, the total concentration shall be determined by the sum of fractions rule described in Section I.(g) of this Appendix. TABLE I Concentration Radionuclide a b curie/cubic meter nanocurie/gram (nCi/g)
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 aTo convert the Ci/m3 values to gigabecquerel (GBq) per cubic meter, multiply the Ci/m3 value by 37. bTo 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 I, classification shall be determined based on the concentrations shown in Table II. However, as specified in Section I.(f) of this Appendix, if radioactive waste does not contain any nuclides listed in either Table I or II, 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 II, the total concentration shall be determined by the sum of fractions rule described in Section I.(g). TABLE II Radionuclide Concentration, 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 II 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 I and some of which are listed in Table II, classification shall be determined as follows:
1) If the concentration of a radionuclide listed in Table I is less than 0.1 times the value listed in Table I, the class shall be that determined by the concentration of radionuclides listed in Table II.
2) If the concentration of a radionuclide listed in Table I exceeds 0.1 times the value listed in Table I, but does not exceed the value in Table I, the waste shall be Class C, provided the concentration of radionuclides listed in Table II does not exceed the value shown in Column 3 of Table II.
f) Classification of wastes with radionuclides other than those listed in Tables I and II. If the waste does not contain any radionuclides listed in either Table I or II, 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/m3 (50 Ci/m3) and Cs- 137 in a concentration of 814 GBq/m3 (22 Ci/m3). Since the concentrations both exceed the values in Column 1, Table II, 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 (nanocurie) 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 shal 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.****** ******See RH 1.4 of these regulations for definition of pyrophoric.
8) Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed
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 (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 F. QUANTITIES FOR USE WITH DECOMMISSIONING Material * Microcurie * To convert µCi to kBq, multiply the µCi value by 37.
** Based on alpha disintegration rate of Th-232, Th- 230 and their daughter products.
*** Based on alpha disintegration rate of U-238, U- 234, and U-235.
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-IIOm 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 ** 100 Thorium (natural)
Thulium-170 10 Thulium-171 10 Tin-113 10 Tin-125 10 Tungsten-181 10 Tungsten-185 10 Tungsten-187 100 *** 100 Uranium (natural)
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 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 4 APPENDIX G. REQUIREMENTS FOR TRANSFERS OF LOW-LEVEL RADIOACTIVE WASTE FOR DISPOSAL AT LAND DISPOSAL FACILITIES AND MANIFESTS I. Manifest 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.
Licensees are not required by this department to comply with manifesting requirements of this part when they ship:
a) 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;
b) Low-level radioactive waste that is being returned to the licensee who is the “waste generator” or “generator” as defined in this Appendix; or c) Radioactively contaminated material to a “waste processor” that becomes the processor's “residual waste”.
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. As used in this Appendix, the following definitions apply: “Chelating agent” means amine polycarboxylic acids, gluconic acid, 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 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. 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. “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).
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 E. Waste not meeting the structural stability requirements of Appendix E 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 E. Waste not meeting the structural stability requirements of Appendix E 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 E of this Part;
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.
II. 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.
III. 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 (a)(1) through (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 (a)(4) through (9) of this section. A licensee shall:
1) Prepare all wastes so that the waste is classified according to Section I of Appendix E and meets the waste characteristics requirements in Section II of Appendix E;
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 E;
3) Conduct a quality assurance program to ensure compliance with Sections I and II of Appendix E; 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: (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;
6) Include Form 540 (and Form 540a, if required) with the shipment regardless of the option chosen in (a)(5) of this section;
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 RH 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 III.(e).
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 (b)(3) of this section;
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 RH 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 III.(e).
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 I.(e) of this Appendix;
3) Prepare all wastes so that the waste is classified according to Appendix E of Part 4 and meets the waste characteristics requirements in Section I of Appendix E;
4) Label each package of waste to identify whether is Class A waste, Class B waste, or Class C waste in accordance with Appendix E;
5) Conduct a quality assurance program to ensure compliance with Sections I and II of Appendix E; 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: (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;
7) Include Form 540 (and Form 540a, if required) with the shipment regardless of the option chosen in (c)(6) of this section;
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 RH 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 III.(e).
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.
e) Any shipment or part of a shipment for which acknowledgement is not received within the times set forth in this section shall:
1) Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and 2) 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.
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.
PART 5 RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS RH 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.
RH 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, and 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.
RH 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. “ANSI” means the American National Standards Institute. “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 RH 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. “Certified cabinet x-ray system” means an x-ray system that has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40.
“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, Parts 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.
“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 RH 5.16.1.2 or the hands-on experience for a radiographer as required by RH 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 RH 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 RH 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. 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.
RH 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:
5.4.1.2 Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40, 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. Devices which exceed this limit 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.
RH 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 RH 5.17:
5.5.2.1 After July 1, 2002, the applicant need not describe the initial training and examination program for radiographers in the subjects outlined in RH 5.17.7.
5.5.2.2 From July 1, 2000 to July 1, 2002, the applicant may affirm that all individuals acting as industrial radiographers will be certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in RH
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 RH 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 RH 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 RH 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 RH 5.9 and RH 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.
RH 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 RH 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:
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 RH 5.6.1 and 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.”
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.
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 RH 5.6.1, equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980, 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.
RH 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 millisieverts (200 mrem) per hour at any exterior surface, and 0.1 millisieverts (10 mrem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position. RH 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 locked1 when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in RH 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. 1If a keyed lock, the key must be removed at all times.
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 locked1 when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.
1If a keyed lock, the key must be removed at all times.
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. RH 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 millisieverts (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 RH 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 millisieverts (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 RH 5.26.
RH 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 bequerel (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 RH 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 RH 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 RH 5.27.
RH 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 RH 5.28.
RH 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 RH 5.12 must be made in accordance with RH 5.30.
RH 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 RH 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 RH 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 RH 5.22 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained in accordance with RH 5.31. RH 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. RH 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 RH 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.
5.15.1.1 The licensee or registrant shall have until June 30, 2001 to hire and train individuals to meet the requirements of RH 5.15.1.
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.
RH 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 RH 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 RH 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.
5.16.4 Licensees and registrants will have until July 1, 2002 to meet the requirements of RH 5.16.1. and 2.
RH 5.17 Training.
5.17.1 The licensee or registrant may not permit any individual to act as a radiographer until the individual:
5.17.1.1 Has received at least 40 hours of training in the subjects outlined in RH 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 Part2. 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); or 2Certification which has been suspended or revoked by the certifying entity is not considered valid.
5.17.1.2 The licensee or registrant may, until July 1, 2002, allow an individual who has not met the requirements of RH 5.17.1.1, to act as a radiographer after the individual has received:
5.17.2 In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual:
5.17.2.1 Has 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 Has demonstrated an understanding of items in RH 5.17.2.1 by successful completion of a written or oral examination;
5.17.2.3 Has 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 Has demonstrated understanding of the use of the equipment described in RH 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:
5.17.3.1 Has 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 Has demonstrated an understanding of items in RH 5.17.3.1 by successful completion of a written or oral examination;
5.17.3.3 Under the personal supervision of a radiographer, has 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 Has demonstrated understanding of the use of the equipment described in RH 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 RH 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 RH 5.17.2.3. and the radiographer's assistant must demonstrate knowledge of the training requirements of
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 RH 5.32.
5.17.7 The licensee or registrant shall include the following subjects required in RH 5.17.1:
5.17.7.1 Fundamentals of radiation safety including:
5.17.7.2 Radiation detection instruments including:
5.17.7.3 Equipment to be used including:
5.17.7.4 The requirements of pertinent state and federal regulations; and
5.17.7.5 Case histories of accidents in radiography.
5.17.8 Licensees and registrants will have until July 1, 2001 to comply with the additional training requirements specified in RH 5.17.2.1 and 5.17.3.1.
RH 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 RH 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 RH 5.33 and 5.37.
RH 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 RH 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.
RH 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 combination of direct reading dosimeter, an alarming ratemeter, and a film badge, a TLD or an optically stimulated luminescence (OSL) dosimeter. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the use of an alarming ratemeter is not required.
5.20.1.1 Pocket dosimeters must have a range from zero to 2 millisieverts (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 film badge, TLD or OSL dosimeter must be assigned to and worn by only one individual.
5.20.1.3 Film badges, TLD's or OSL dosimeters must be exchanged at periods not to exceed one month.
5.20.1.4 After replacement, each film badge, TLD or OSL dosimeter must be returned to the supplier for processing within 14 calendar days of the end of the monitoring period, or as soon as practicable. In circumstances that make it impossible to return each personnel monitoring device in 14 calendar days, such circumstances must be documented and available for review by the Department.
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 RH 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 RH 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 is found to be off-scale, or the electronic personal dosimeter reads greater than 2 millisieverts (200 mrem), the individual's film badge, TLD or OSL 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 RH 5.34.
5.20.5 If a film badge, TLD or OSL dosimeter is lost or damaged, the worker shall cease work immediately until a replacement film badge, TLD or OSL dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the film badge, TLD or OSL dosimeter. The results of the calculated exposure and the time period for which the film badge, TLD, or OSL dosimeter was lost or damaged must be included in the records maintained in accordance with RH 5.34.
5.20.6 Reports received from the film badge, TLD or OSL dosimeter processor must be retained in accordance with RH 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 millisieverts (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 RH
RH 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 RH 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 RH 5.3, to ensure that the sealed source is in its shielded position; and
5.21.4 Maintain records in accordance with RH 5.35.
RH 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 RH 5.13 are met.
RH 5.23 Posting.
All areas in which industrial radiography is being performed must be conspicuously posted as required by RH 4.28 of these regulations. The exceptions listed in RH 4.29 of these regulations do not apply to industrial radiographic operations.
Recordkeeping Requirements RH 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. RH 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 becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate. RH 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 RH 5.9 and retain each record for 3 years after it is made. RH 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 becquerels (µCi). The licensee shall retain each record for 3 years after it is made or until the source in storage is removed. RH 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 RH 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 becquerels (curies) 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.
RH 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 RH 5.29.1. for 3 years. RH 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 RH 5.12 of equipment problems found in daily cnecks 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. RH 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 RH 5.13 and retain each record for 3 years after it is made. RH 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.
RH 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.
RH 5.34 Records of Personnel Monitoring.
Each licensee or registrant shall maintain the following exposure records specified in RH 5.20:
5.34.1 Direct reading dosimeter readings and yearly operability checks required by RH 5.20.2 and 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 Reports received from the film badge, TLD or OSL dosimeter 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 film badges or TLD's, until the Department terminates the license or registration. RH 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 RH 5.21.3. Each record must be maintained for 3 years after it is made. RH 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.
RH 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 RH 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 & 10 of these regulations;
5.37.2.3 Utilization logs for each source of radiation dispatched from that location as required by RH 5.29;
5.37.2.4 Records of equipment problems identified in daily checks of equipment as required by RH 5.30.1;
5.37.2.5 Records of alarm system and entrance control checks required by RH 5.31, if applicable;
5.37.2.6 Records of dosimeter readings as required by RH 5.34;
5.37.2.7 Operating and emergency procedures as required by RH 5.33;
5.37.2.8 Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by RH 5.26;
5.37.2.9 Evidence of the latest calibrations of alarming ratemeters and operability checks of dosimeters as required by RH 5.34;
5.37.2.10 Survey records as required by RH 5.35 and RH 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 RH 5.38 Notifications.
5.38.1 In addition to the reporting requirements specified in RH 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 RH 5.38.1, and in each report of overexposure submitted under RH 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. RH 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 RH 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 RH 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 RH 5.17.1.
RH 5.40 Specific Requirements for Radiographic 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 monitor (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 millisieverts (200 milliroentgens) 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 RH 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 RH 5.40.1. and 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 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, 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 RH 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 RH 5.17.7 or equivalent State or Nuclear Regulatory Commission regulations;
(b) satisfactorily completed a minimum period of on-the-job training as specified in RH 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 be:
1. Designed to test an individual's knowledge and understanding of the topics listed in RH 5.17.7 or equivalent State or Nuclear Regulatory Commission requirements;
2. Written in a multiple-choice format;
3. Have test items drawn from a question bank containing psychometrically valid questions based on the material in RH 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:
“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.
6.3.1.1.3 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:
6.3.1.1.4 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:
6.3.1.1.6 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:
6.3.1.1.8 When a patient or film must be provided with auxiliary support during a radiation exposure:
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.
6.3.1.1.10 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:
6.3.1.1.11 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:
calibrations, maintenance, and modifications performed on the x-ray system(s) with the names of persons who performed such services;
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.
6.3.1.1.14 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:
method used to monitor and/or determine processing time.
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)
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.
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.
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:
6.5.1.2.3 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:
6.5.2 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:
6.5.3.1.2 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:
6.5.3.1.3 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
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;
6.5.3.3 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:
the requirements of RH 6.5.3.3;
x-ray system;
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
6.6.1.2 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:
6.6.2 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:
6.6.2.2.2 Except for bone mineral densitometry devices, each x-ray control shall be located in such a way as to meet the following requirements:
6.6.2.3 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 ).
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 ), 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:
6.6.6.3 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
6.6.6.4 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:
6.6.6.5.2 Conditions for PBL. When provided, the PBL system shall function as described in RH
6.6.6.5.3 If a means of overriding the PBL system exists, that means:
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
6.6.6.5.5 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 ).
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 ), 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:
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:
“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:
“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:
“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.
6.10.2.2.7 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
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 ).
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
6.10.2.3.5 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 ±
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.
6.10.2.6.4.2 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 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). 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:
(b) When the viewing system is a window, the following requirements also apply:
(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. 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 RH 7.1 Purpose and 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 safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in these regulations. The requirements and provisions of these regulations apply to applicants and licensees subject to this part unless specifically exempted.
RH 7.2 Definitions.
As used in this part, the following definitions apply:
“Area of Use” means a portion of a physical structure that has been set aside for the purpose of receiving, using, or storing radioactive material.
“Authorized user” means a practitioner of the healing arts who is identified as an authorized user on a Department, Agreement State, Licensing State or NRC license that authorizes the medical use of radiocative material.
“Brachytherapy” means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
“Dedicated check source” means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.
“Management” means the chief executive officer or that individual's designee. “Medical institution” means an organization in which several medical disciplines are practiced. “Misadministration” means the administration of:
(1) A radiopharmaceutical dosage greater than 1.11 megabecquerels (30 microcuries) of either sodium iodide I-125 or I-131:
(2) A therapeutic radiopharmaceutical dosage other than sodium iodide I-125 or I-131:
(3) A gamma stereotactic radiosurgery radiation dose:
(4) A teletherapy radiation dose:
(5) A brachytherapy radiation dose:
(6) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries of either sodium iodide I-125 or I-131, both;
“Mobile nuclear medicine service” means the transportation and medical use of radioactive material.
“Output” means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions. “Teletherapy physicist” means an individual identified as the qualified teletherapy physicist on a Department license.
“Teletherapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.
“Visiting authorized user” means an authorized user who is not identified on the license of the licensee being visited.
GENERAL REGULATORY REQUIREMENTS RH 7.3 License Required.
7.3.1 No person shall manufacture, produce, acquire, receive, possess, use, or transfer radioactive material for medical use except in accordance with a specific license issued pursuant to these regulations.
7.3.2 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 RH 7.10.
7.3.3 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 RH 7.10.
7.3.4 Nothing in this part relieves the licensee from complying with applicable FDA, Federal, and state requirements governing radioactive drugs or devices.
RH 7.4 License Amendments.
A licensee shall apply for and receive a license amendment:
7.4.1 Before using radioactive material for a method or type of medical use not permitted by the license issued under this part;
7.4.2 Before permitting anyone to work as an authorized user or an authorized nuclear pharmacist under the license, except an individual who is: a visiting authorized user described in RH 7.11 or an authorized nuclear pharmacist certified by the organization specified in RH 7.74.1;
7.4.3 Before changing a Radiation Safety Officer or Teletherapy Physicist;
7.4.4 Before receiving radioactive material in excess of the amount authorized on the license;
7.4.5 Before adding to or changing the areas of use or address or addresses of use identified in the application or on the license; and 7.4.6 Before changing statements, representations, and procedures which are incorporated into the license.
RH 7.5 Notifications.
A licensee shall notify the Department in writing within 30 days when the authorized nuclear pharmacist, authorized user, Radiation Safety Officer, or Teletherapy Physicist, permanently discontinues performance of duties under the license.
Additional Requirements RH 7.6 ALARA Program.
7.6.1 Each licensee shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable in accordance with RH 4.5.2 of these regulations.
7.6.2 To satisfy the requirement of RH 7.6.1:
7.6.2.1 The management, Radiation Safety Officer, and all authorized users shall participate in the establishment, implementation, and operation of the program as required by these regulation or the Radiation Safety Committee; or 7.6.2.2 For licensees that are not medical institutions, management and all authorized users shall participate in the program as required by the Radiation Safety Officer.
7.6.3 The ALARA program shall include an annual review by the Radiation Safety Committee for licensees that are medical institutions, or management and the Radiation Safety Officer for licensees that are not medical institutions, of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material as low as reasonably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits.
7.6.4 The licensee shall retain a current written description of the ALARA program for the duration of the license. The written description shall include:
7.6.4.1 A commitment by management to keep occupational doses as low as reasonably achievable;
7.6.4.2 A requirement that the Radiation Safety Officer brief management once each year on the radiation safety program;
7.6.4.3 Personnel exposure investigational levels as established in accordance with RH 7.8.2.8 that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure; and 7.6.4.4 Personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence. RH 7.7 Radiation Safety Officer.
7.7.1 A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through 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 radioactive material program.
7.7.2 The Radiation Safety Officer shall:
7.7.2.1 Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and disposals, and other deviations from approved radiation safety practice and implement corrective actions as necessary;
7.7.2.2 Implement written policy and procedures for:
regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations; and
7.7.2.3 For medical use not sited at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of management prior to submittal to the Department for licensing action; or 7.7.2.4 For medical use sited at a medical institution, assist the Radiation Safety Committee in the performance of its duties.
RH 7.8 Radiation Safety Committee.
Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of radioactive material.
7.8.1 The Committee shall meet the following administrative requirements:
7.8.1.1 Membership must consist of at least 3 individuals and shall include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.
7.8.1.2 The Committee shall meet at least once each calendar quarter.
7.8.1.3 To establish a quorum and to conduct business, one-half of the Committee's membership shall be present, including the Radiation Safety Officer and the management's representative.
7.8.1.4 The minutes of each Radiation Safety Committee meeting shall include:
7.8.1.5 The Committee shall provide each member with a copy of the meeting minutes, and retain one copy until the Department authorizes its disposition.
7.8.2 To oversee the use of licensed material, the Committee shall:
7.8.2.1 Be responsible for monitoring the institutional program to maintain occupational doses as low as reasonably achievable;
7.8.2.2 Review, on the basis of safety and with regard to the training and experience standards of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or Teletherapy Physicist before submitting a license application or request for amendment or renewal;
7.8.2.3 Review on the basis of safety and approve or disapprove each proposed method of use of radioactive material;
7.8.2.4 Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove procedures and radiation safety program changes prior to submittal to the Department for licensing action;
7.8.2.5 Review quarterly, with the assistance of the Radiation Safety Officer, occupational radiation exposure records of all personnel working with radioactive material;
7.8.2.6 Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving radioactive material with respect to cause and subsequent actions taken;
7.8.2.7 Review annually, with the assistance of the Radiation Safety Officer, the radioactive material program; and 7.8.2.8 Establish a table of investigational levels for occupational dose that, when exceeded, will initiate investigations and considerations of action by the Radiation Safety Officer. RH 7.9 Statement of Authorities and Responsibilities.
7.9.1 A licensee shall provide sufficient authority and organizational freedom to the Radiation Safety Officer and the Radiation Safety Committee to:
7.9.1.1 Identify radiation safety problems;
7.9.1.2 Initiate, recommend, or provide solutions; and
7.9.1.3 Verify implementation of corrective actions.
7.9.2 A licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer and the Radiation Safety Committee. RH 7.10 Supervision.
7.10.1 A licensee who permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by RH 7.3 is responsible for the acts and omissions of the supervised individual and shall:
7.10.1.1 Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material;
7.10.1.2 Review the supervised individual's use of radioactive material, provide reinstruction as needed and review records kept to reflect this use;
7.10.1.3 Reserved.
7.10.1.4 Require that an authorized user be able to communicate with the supervised individual on 1 hours notice; 1 and 1The supervising authorized user need not be present for each use of radioactive material.
7.10.1.5 Require that only those individuals specifically designated by an authorized user be permitted to administer radionuclides or radiation to patients.
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 RH 7.3.3, shall:
7.10.2.1 Instruct the supervised individual in the preparation of radioactive material for medical use and the principles of and procedures for radiation safety and in the licensee's written quality management program, as appropriate to that individual's use of radioactive material;
7.10.2.2 Require the supervised individual to follow the instructions given pursuant to RH 7.10.1 of this section and to comply with the regulations of this part and license conditions; and 7.10.2.3 require the supervising authorized nuclear pharmacist or physician who is an authorized user to periodically review the work of the supervised individual as it pertains to preparing radioactive material for medical use and the records kept to reflect that work.
7.10.3 a license shall require the supervised individual receiving, possessing, using or transferring radioactive material under RH 7.3 to:
7.10.3.1 Follow the instructions of the supervising authorized user;
7.10.3.2 Follow the procedures established by the Radiation Safety Officer; and
7.10.3.3 Comply with these regulations and the license conditions with respect to the use of radioactive material.
RH 7.11 Visiting Authorized User.
7.11.1 A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for 60 days each year if:
7.11.1.1 The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee;
7.11.1.2 The licensee has a copy of a Department, Agreement State, Licensing State or NRC license that identifies the visiting authorized user by name as an authorized user for medical use; and 7.11.1.3 Only those procedures for which the visiting authorized user is specifically authorized by the Department, Agreement State, Licensing State or NRC license are performed by that individual.
7.11.2 A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in RH 7.11.1.
7.11.3 A licensee shall retain copies of the records specified in RH 7.11.1 for 5 years from the date of the last visit.
RH 7.12 Mobile Nuclear Medicine Service Administrative Requirements.
7.12.1 The Department will only license mobile nuclear medicine services in accordance with this part and other applicable requirements of these regulations to serve clients who do not have a Department license.
7.12.2 Mobile nuclear medicine service licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of radioactive material.
7.12.3 A mobile nuclear medicine service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client's address of use. RH 7.13 Records and Reports of Misadministrations.
7.13.1 For a misadministration:
7.13.1.1 The licensee shall notify the Department by telephone no later than the next calendar day after discovery of the misadministration.
7.13.1.2 The licensee shall submit a written report to the Department within 15 days after discovery of the misadministration using Department form LARS 56 for diagnostic misadministration and form LARS 100 for therapy misadministration. The written report shall include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual who received the misadministration; what improvements are needed to prevent recurrence; the action taken to prevent recurrence; whether the licensee notified the individual or the individual's responsible relative or guardian, and if not, why not, and if the individual was notified, what information was provided to that individual. The report must not contain the individual's name or any other information that could lead to identification of the individual.
7.13.1.3 The licensee shall notify the referring physician and also notify the individual of the misadministration not 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 judgement, telling the individual would be harmful to the individual. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or individual cannot be reached within 24 hours, the licensee shall notify them as soon as possible thereafter. The licensee shall not delay appropriate medical care for the individual, including any necessary remecial care as a result of the misadministration, because of any delay in notification.
7.13.1.4 If the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual by sending either:
7.13.2 Each licensee shall retain a record of each misadministration for 5 years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration, and that individual's referring physician, if applicable), the individual's identification number, a brief description of the misadministration, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.
7.13.3 Aside from the notification requirement, nothing in RH 7.13.1 through RH 7.13.2 affects any rights or duties of licensees and physicians in relation to each other, to individuals receiving misadministrations, or to that individual's responsible relatives or guardians. RH 7.14 Suppliers.
A licensee shall use for medical use only:
7.14.1 Radioactive material manufactured, produced, labeled, prepared, compounded, 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 Reagent kits, radiopharmaceuticals, and/or radiobiologics that have been manufactured, labeled, packaged, and distributed in accordance with an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration; or 7.14.3 Radiopharmaceuticals compounded from a prescription in accordance with the regulations of the State Board of Pharmacy.
7.14.4 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 RH 7.15 Quality Control of Nuclear Medicine Imaging and Uptake Quantifying Equipment. Each licensee shall establish written quality control procedures for all equipment used to obtain images from radionuclide studies for equipment used for quantifying radionuclide uptake. As a minimum, the procedures shall include quality control procedures recommended by equipment manufacturers or procedures which have been approved by the Department. The licensee shall conduct quality control procedures in accordance with written procedures.
RH 7.16 Possession, Use, Calibration, and Check of Dose Calibrators.
7.16.1 A medical use licensee shall possess a dose calibrator and use it to measure the amount of activity administered to each individual. In the case where the ionization type dose calibrator cannot be used effectively to verify administered activity, the licensee shall use an alternative method. Any alternative method to the use of a dose calibrator shall be approved by the Department in writing. Any alternative method shall provide for acceptable verification of constancy, accuracy, linearity and geometry dependence as applicable.
7.16.2 Each licensee shall establish written quality control procedures for all dose calibrators used for measuring the amount of activity administered to a individual. As a minimum, the licensee shall:
7.16.2.1 Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. The check shall be done on a frequently used setting with a sealed source of not less than 50 microcuries (1.85 megabecquerels) of any photon- emitting radionuclide with a half-life greater than 90 days;
7.16.2.2 Test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least 2 sealed sources containing different radionuclides With activities and energies appropriate to demonstrate accuracy of the calibration. The activity of one source shall be determined by the manufacturer to be within 5 percent of the stated activity;
7.16.2.3 Test each dose calibrator for linearity upon installation and at intervals not to exceed 3 months thereafter over the range of use between 10 microcuries (370 kBq) and the highest dosage that will be assayed; and 7.16.2.4 Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.
7.16.3 A licensee shall also perform checks and tests required by RH 7.16.2 following adjustment or repair of the dose calibrator.
7.16.4 A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries (370 kBq) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
7.16.5 A licensee shall retain a record of each check and test required by RH 7.16 for 3 years. The records required by RH 7.16.2 shall include:
7.16.5.1 For RH 7.16.2.1, the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the initials of the individual who performed the check;
7.16.5.2 For RH 7.16.2.2, the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, and the identity of the individual who performed the test;
7.16.5.3 For RH 7.16.2.3, the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the identity of the individual who performed the test; and 7.16.5.4 For RH 7.16.2.4 the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the identity of the individual who performed the test or their designee.
7.16.5.5 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.
beginning of each day of use.
RH 7.17 Calibration and Check of Survey Instruments.
7.17.1 A licensee shall ensure that the survey instruments used to show compliance with this part have been calibrated before first use, annually, and following repair.
7.17.2 To satisfy the requirements of RH 7.17.1 the licensee shall:
7.17.2.1 Calibrate all required scale readings up to 1000 millirems (10 mSv) per hour with a radiation source. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour;
7.17.2.2 For each scale that shall be calibrated, calibrate two readings separated by at lease 50 percent of scale rating; and 7.17.2.3 Conspicuously note on the instrument the apparent dose rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
7.17.3 To satisfy the requirements of RH 7.17.2, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.
7.17.4 A licensee shall check each survey instrument for proper operation with the dedicated check source before each use. The licensee is not required to keep records of these checks.
7.17.5 The licensee shall retain a record of each calibration required in RH 7.17.1 for 3 years. The record shall include:
7.17.5.1 A description of the calibration procedure; and
7.17.5.2 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 identity of the individual who performed the calibration, and the date of calibration.
7.17.6 To meet the requirements of RH 7.17.1, 7.17.2 and 7.17.3, the licensee may obtain the services of individuals licensed by the Department, the NRC, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations which contain information required by RH 7.17.5 shall be maintained by the licensee. RH 7.18 Assay of Dosages of Unsealed Radioactive Material for Medical Use.. A licensee shall:
7.18.1 Assay the activity of each radiopharmaceutical dosage that contains more than 10 microcuries (370 kBq) of a photon-emitting radionuclide;
7.18.2 Assay, before medical use, by direct measurements or by combination of measurements and calculations, the activity of each radiopharmaceutical dosage emitting alpha and/or beta radiation as the radiation of principal interest, unless such radiopharmaceutical has been obtained:
7.18.2.1 In unit dose form, calibrated by the supplier for individuals; and
7.18.2.1 From a supplier which participates in a measurement quality assurance program with the national institute of standards and technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard.
7.18.3 Retain a record of the assays required by RH 7.18.1 and 7.18.2 for 3 years. To satisfy this requirement, the record shall contain the:
7.18.3.1 Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;
7.18.3.2 Patient's name, and identification number if one has been assigned;
7.18.3.3 Prescribed dosage and activity of the dosage at the time of assay, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);
7.18.3.4 Date and time of the assay and administration; and
7.18.3.5 Initials of the individual who performed the assay.
RH 7.19 Authorization for Calibration and Reference Sources. Any person authorized by RH 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 NRC, Agreement State or Licensing State and that do not exceed 15 millicuries (555 MBq) each;
7.19.2 Any radioactive material listed in RH 7.30 or 7.32 with a half-life not longer than 100 days or less in individual amounts not to exceed 15 millicuries (555 MBq);
7.19.3 Any radioactive material listed in RH 7.30 or RH 7.32 with a half life greater than 100 days in individual amounts not to exceed 200 microcuries (7.4 MBq) each; and 7.19.4 Technetium-99m in individual amounts not to exceed 50 millicuries (1.85 GBq). RH 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 assure that:
7.20.2.1 The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and 7.20.2.2 The source is tested for leakage at intervals not to exceed 6 months or at intervals approved by the Department, another Agreement State, a Licensing State or the NRC.
7.20.3 To satisfy the leak test requirements of RH 7.20.2, the licensee shall assure that:
7.20.3.1 Leak tests are capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 Bq) per 24 hours;
7.20.3.2 Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and
7.20.3.3 Test samples are taken when the source is in the “off” position.
7.20.4 A licensee shall retain leak test records for 5 years. The records shall contain the model number, and serial number, if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (becquerels), a description of the method used to measured each test sample, the date of the test, and the name and signature of the Radiation Safety Officer.
7.20.5 If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall:
7.20.5.1 Immediately withdraw the sealed source from use and store it in accordance with the requirements of these regulations; and 7.20.5.2 File a report with the Department within 5 days of receiving the leak test results describing the equipment involved, the test results, and the action taken.
7.20.6 A licensee need not perform a leak test on the following sources:
7.20.6.1 Sources containing only radioactive material with a half-life of less than 30 days;
7.20.6.2 Sources containing only radioactive material as a gas;
7.20.6.3 Sources containing 100 microcuries (3.7 MBq) or less of beta or photon-emitting material or 10 microcuries (370 kBq) or less of alpha-emmiting material;
7.20.6.4 Encased seeds of iridium-192 in nylon ribbon; and
7.20.6.5 Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.
7.20.7 A licensee in possession of a sealed source or brachytherapy source shall conduct a physical inventory of all such sources at intervals not to exceed 3 months. The licensee shall retain each inventory record for 5 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, date of the inventory, and the signature of the Radiation Safety Officer.
7.20.8 A licensee in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed 3 months all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
7.20.9 A licensee shall retain a record of each survey required in RH 7.20.8 for 3 years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the Radiation Safety Officer RH 7.21 Syringe Shields.
7.21.1 A licensee shall keep syringes that contain radioactive material to be administered in a radiation shield.
7.21.2 A licensee shall require each individual who prepares or administers radiopharmaceuticals to use a syringe radiation shield unless the use of the shield is contraindicated for the patient. RH 7.22 Syringe Labels.
Unless utilized immediately, a licensee shall conspicuously label each syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutical, with the radiopharmaceutical name or its abbreviation, the type of diagnostic study or therapy procedure to be performed, or the patient's name. RH 7.23 Vial Shields.
A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
RH 7.24 Vial Shield Labels.
A licensee shall conspicuously label each vial radiation shield that contains a vial of radiopharmaceutical with the radiopharmaceutical name or its abbreviation.
RH 7.25 Surveys for Contamination and Ambient Radiation Dose Rate.
7.25.1 A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
7.25.2 A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
7.25.3 A licensee shall conduct the surveys required by RH 7.25.1 and RH 7.25.2 so as to be able to measure dose rates as low as 0.1 millirem (1 uSv) per hour.
7.25.4 A licensee shall establish dose rate action levels for the surveys required by RH 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 A licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use or administered and each week where radioactive materials are stored.
7.25.6 A licensee shall conduct the surveys required by RH 7.25.5 so as to be able to detect contamination on each wipe sample of 2000 disintegrations per minute (33.3 Bq).
7.25.7 A licensee shall establish removable contamination action levels for the surveys required by RH 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 shall retain a record of each survey required by RH 7.25.1, 7.25.2, and 7.25.5 for 3 years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour or the removable contamination in each area expressed in disintegrations per minute (becquerels) per 100 square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey. RH 7.26 Release of Patients Containing Radiopharmaceuticals or Permanent Implants.
7.26.1 A licensee may authorize the release 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 milliSieverts (0.5 rem).
7.26.2 Instructions to individuals:
7.26.2.1 The licensee shall provide the released individual with oral and written safety instructions if the total effective dose equivalent to any other individual is likely to exceed 1 milliSievert (0.1 rem). The instructions shall include actions recommended to maintain doses to other individuals as low as is reasonably achievable.
7.26.2.2 If a radioactive drug is administered to a lactating female, and the dose to a breast- feecing infant or child could exceed 1 milliSievert (0.1 rem) assuming there were no interruptior of breast-feeding, the instructions shall also include:
7.26.3 The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if:
7.26.3.1 the release was not calculated in accordance with a Department approved methodology, or 7.26.3.2 the total effective dose equivalent to any other individual from exposure to the released individual is calculated by:
7.26.4 The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a lactating female if the radiation dose to an infant or child from continued breast- feeding could result in a total effective dose equivalent exceeding 5 milliSieverts (0.5 rem). RH 7.27 Mobile Nuclear Medicine Service Technical Requirements. A licensee providing mobile nuclear medicine service shall:
7.27.1 Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;
7.27.2 Bring into each location 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 location of use;
7.27.4 Check survey instruments and dose calibrators as required in RH 7.16.2.1, 7.16.4, 7.16.5, and 7.17.4, and check all other transported equipment for proper function before medical use at each location of use;
7.27.5 Carry a calibrated survey meter in each vehicle that is being used to transport radioactive material, and, before leaving a client location of use, survey all areas of radiopharmaceutical use with a radiation detection survey instrument to ensure that all radiopharmaceuticals and all associated radioactive waste have been removed; and 7.27.6 Retain a record of each survey required by RH 7.27.5 for 3 years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirems (microsieverts) per hour, the model and serial number of the instrument used to make the survey, and the initials of the individual who performed the survey.
RH 7.28 Storage of Volatiles and Gases.
7.28.1 A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container.
7.28.2 A licensee shall store and use a multidose container in a properly functioning fume hood. RH 7.29 Decay-In-Storage.
7.29.1 A licensee shall hold radioactive material for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of RH 4.33 of these regulations if the licensee:
7.29.1.1 Holds radioactive material for decay a minimum of 10 half-lives;
7.29.1.2 Monitors radioactive material at the container surface before disposal as ordinary trash 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; 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 For radioactive material disposed in accordance with RH 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 date on which the radioactive material was placed in storage, the model and serial number of the survey instrument used, the background dose rate, the radiation dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal. SPECIFIC REQUIREMENTS FOR THE USE OF RADIOPHARMACEUTICALS FOR UPTAKE, DILUTION, OR EXCRETION STUDIES RH 7.30 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies.
7.30.1 A licensee may use for uptake, dilution, or excretion studies any unsealed radioactive material prepared for medical use that is either:
7.30.1.1 Obtained from a manufacturer or preparer licensed pursuant to RH 3.12.10 or equivalent NRC or Agreement State or Licensing State requirements 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 RH 7.67 or an individual under the supervision of either as specified in RH 7.10;
RH 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 0.1 millirem (1.0 µSv) per hour to 50 millirem (500 µSv) per hour. The instrument shall be operable and calibrated in accordance with RH 7.17.
SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES RH 7.32 Use of Unsealed Radioactive Material1 for Imaging and Localization Studies. 1See RH 7.34 for specific requirements for use of aerosols and gasses.
7.32.1 A licensee may use for imaging and localization studies any unsealed radioactive material, (except aerosol or gaseous forms) prepared for medical use that is either:
7.32.2 Provided the conditions of RH 7.34 are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Department. RH 7.33 Permissible Molybdenum-99 Concentration.
7.33.1 A licensee shall not administer a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m).
7.33.2 A licensee preparing technetium-99m radiopharmaceuticals from molybdenum- 99/technetium-99m generators shall measure the molybdenum-99 concentration in each eluate or extract.
7.33.3 A licensee who must measure molybdenum concentration shall retain a record of each measurement for 3 years. The record shall include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries (megabecquerels), the measured activity of molybdenum expressed in microcuries (kilobecquerels), the ratio of the measures expressed as microcuries of molybdenum per millicuries of technetium (kilobecquerels of molybdenum per megabecquerel of technetium), the date of the test, and the initials of the individual who performed the test.
7.33.4 A licensee shall report immediately to the Department each occurrence of molybdenum-99 concentration exceeding the limits specified in RH 7.33.1. RH 7.34 Control of Aerosols and Gases.
7.34.1 A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed by RH 4.6 and RH 4.14 of these regulations.
7.34.2 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.
7.34.3 A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.
7.34.4 Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in Appendix A of Part 4 of these regulations. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
7.34.5 A licensee shall post the time calculated in RH 7.34.4 at the area of use, and the safety measures to be instituted in case of a spill in the area of use.
7.34.6 A licensee shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed 6 months. Records of these checks and measurements shall be maintained for 3 years.
7.34.7 A copy of the calculations required in RH 7.34.4 shall be recorded and retained for the duration of the license.
RH 7.35 A licensee authorized to use radioactive materials for imaging and localization studies shall possess the capability of detecting dose rates over the range of 0.1 millirem (1 uSv) per hour to 1000 millirems (10 mSv) per hour. The portable radiation detection survey instruments shall be operable and calibrated in accordance with RH 7.17. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour. SPECIFIC REQUIREMENTS FOR THE USE OF RADIOPHARMACEUTICALS FOR THERAPY RH 7.36 Use of Unsealed Radioactive Material for Therapeutic Administration. A licensee may use for therapeutic administration any unsealed radioactive material that is either:
7.36.1 Obtained from a manufacturer or preparer licensed pursuant to RH 3.12.10 or equivalent NRC, Agreement State or Licensing State requirements; or 7.36.2 Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in RH 7.68, or an individual under the supervision of either as specified in RH 7.10.
RH 7.37 Safety Instruction.
7.37.1 A licensee shall provide oral and written radiation safety instruction for all personnel caring for patients undergoing radiopharmaceutical therapy. Refresher training shall be provided at intervals not to exceed 1 year.
7.37.2 To satisfy RH 7.37.1, the instruction shall describe the licensee's procedures for:
7.37.3 A licensee shall keep a record of individuals receiving instruction required by RH 7.37.1, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the Department for 3 years.
RH 7.38 Safety Precautions.
7.38.1 For each patient receiving radiopharmaceutical therapy and hospitalized for compliance with RH 7.26, a licensee shall:
contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of RH 4.14 and retain for 3 years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirems per hour, the instrument used to make the survey, and the initials of the individual who made the survey. A survey of contiguous restricted and unrestricted areas need not be repeated provided the patient's dose is no greater than that for which a previous survey of contiguous areas was completed, determined to be in compliance with RH 4.6 and a record maintained;
contamination with a radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute (3.33 Bq) per 100 square centimeters; and 7.38.1.8 Measure the thyroid burden of each individual who helped prepare or administer a dosage of iodine-131 within 3 days after administering the dosage, and retain for the period required by RH 4.42.2 of these regulations a record of each thyroid burden measurement, date of measurement, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements.
7.38.2 A licensee shall notify the Radiation Safety Officer or the authorized user immediately if the patient dies or has a medical emergency.
RH 7.39 A licensee authorized to use radioactive materials for radiopharmaceutical therapy shall possess the capability of detecting dose rates over the range of 0.1 millirem (1 uSv) per hour to 1000 millirems (10 mSv) per hour. The portable radiation detection survey instruments shall be operable and calibrated in accordance with RH 7.17. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour. SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR DIAGNOSIS RH 7.40 Use of Sealed Sources for Diagnosis. A licensee shall use the following sealed sources in accordance with the manufacturers radiation safety and handling instructions:
7.40.1 Iodine-125 as a sealed source in a device for bone mineral analysis;
7.40.2 Americium-241 as a sealed source in a device for bone mineral analysis;
7.40.3 Gadolinium-153 as a sealed source in a device for bone mineral analysis; and
7.40.4 Iodine-125 as a sealed source in a portable device for imaging.
RH 7.41 A licensee authorized to use radioactive material as a sealed source for diagnosis shall possess the capability of detecting dose rates over the range of 0.1 millirem (1 uSv) per hour to 1000 millirem (10 mSv) per hour. The portable radiation detection survey instruments shall be operable and calibrated in accordance with RH 7.17. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour.
SPECIFIC REQUIREMENTS FOR THE USE OF SOURCES FOR BRACHYTHERAPY RH 7.42 Use of Sources for Brachytherapy. A licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:
7.42.1 Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
7.42.2 Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
7.42.3 Gold-198 as a sealed source in seeds for interstitial treatment of cancer;
7.42.4 Iodine-125 as a sealed source in seeds for interstitial treatment of cancer or as an applicator cell for topical treatment of cancer;
7.42.5 Iridium-192 as encased seeds for the interstitial treatment of cancer;
7.42.6 Reserved.
7.42.7 Reserved.
7.42.8 Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and 7.42.9 Palladium-103 as a sealed source in seeds for the interstitial treatment of cancer. RH 7.43 Safety Instruction.
7.43.1 The licensee shall provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training shall be provided at intervals not to exceed 1 year.
7.43.2 To satisfy RH 7.43.1, the instruction shall describe:
7.43.3 A licensee shall maintain a record of individuals receiving instruction required by RH 7.43.1, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for 2 years.
RH 7.44 Safety Precautions.
7.44.1 For each patient receiving implant therapy a licensee shall:
7.44.2 A licensee shall notify the Radiation Safety Officer or authorized user immediately if the patient dies or has a medical emergency.
RH 7.45 Brachytherapy Sources Inventory.
7.45.1 Promptly after removing brachytherapy sources from a patient, a licensee shall return them to the storage area and count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.
7.45.2 A licensee shall make a record of brachytherapy source utilization which includes:
7.45.3 Immediately after implanting sources in a patient and immediately after removal of sources from a patient, the licensee shall make a radiation survey of the patient and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.
7.45.4 A licensee shall maintain the records required in RH 7.45.2 and 7.45.3 for 3 years. RH 7.46 Release of Patients Treated with Temporary Implants.
7.46.1 Immediately after removing the last temporary implant source from a patient, 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 RH 7.46.1 for 3 years. Each record shall include the date of the survey, the name of the patient, the dose rate from the patient expressed as millirems (microsieverts) per hour and measured within 1 meter from the patient, and the initials of the individual who made the survey.
RH 7.47 A licensee authorized to use radioactive material for implant therapy shall possess the capability of detecting dose rates over the range of 0.1 millirem (1 uSv) per hour to 1000 millirems (10 mSv) per hour. The portable radiation detection survey instruments shall be operable and calibrated in accordance with RH 7.17. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour.
SPECIFIC REQUIREMENTS FOR THE USE OF A SEALED SOURCE IN TELETHERAPY RH 7.48 Use of a Sealed Source in a Teletherapy Unit. A licensee shall use cobalt-60 or cesium-137 as a sealed source in a teletherapy unit for medical use in accordance with the manufacturer's radiation safety and operating instructions.
RH 7.49 Maintenance and Repair Restrictions. Only a person specifically licensed by the Department, the NRC, or an Agreement State to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.
RH 7.50 Amendments. In addition to the requirements specified in RH 7.4, a licensee shall apply for and receive a license amendment before:
7.50.1 Making any change in the treatment room shielding;
7.50.2 Making any change in the location of the teletherapy unit within the treatment room;
7.50.3 Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;
7.50.4 Relocating the teletherapy unit; or
7.50.5 Allowing an individual not listed on the licensee's license to perform the duties of the teletherapy physicist.
RH 7.51 Safety Instruction.
7.51.1 A licensee shall conspicuously post written instructions at the teletherapy unit console. These instructions shall inform the operator of:
7.51.2 A licensee shall provide instruction in the topics identified in RH 7.51.1 to all individuals who operate a teletherapy unit and shall provide appropriate refresher training to individuals at intervals not to exceed 1 year.
7.51.3 A licensee shall maintain a record of individuals receiving instructions required by RH 7.51.2, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for 2 years.
RH 7.52 Doors, Interlocks, and Warning Systems.
7.52.1 A licensee shall control access to the teletherapy room by a door at each entrance.
7.52.2 A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that shall:
7.52.3 A licensee shall equip each entrance to the teletherapy room with a conspicuously visible beam condition indicator light.
RH 7.53 A licensee authorized to use radioactive material in a teletherapy unit shall possess the capability of detecting dose rates over the range of 0.1 millirem (1 uSv) per hour to 1000 millirems (10 mSv) per hour. The portable radiation detection survey instruments shall be operable and calibrated in accordance with RH 7.17. Licensees with specified limited authorized quantities of radioactive material may specify a different dose rate range, however, in no case will the lower level be higher than 0.1 millirem (1 uSv) per hour.
RH 7.54 Radiation Monitoring Device.
7.54.1 A licensee shall have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.
7.54.2 Each radiation monitor shall be capable of providing visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherapy room.
7.54.3 Each radiation monitor shall be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.
7.54.4 A radiation monitor shall be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients.
7.54.5 A licensee shall maintain a record of the check required by RH 7.54.4 for 3 years. The record shall include the date of the check, notation that the monitor indicates when the source is exposed, and the initials of the individual who performed the check.
7.54.6 If a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in RH 7.54.5.
7.54.7 A licensee shall promptly repair or replace the radiation monitor if it is inoperable. RH 7.55 Viewing System. A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation. RH 7.56 Dosimetry Equipment.
7.56.1 A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:
7.56.2 The licensee shall have available for use a dosimetry system for spot-check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with RH 7.56.1. 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 RH 7.56.1.
7.56.3 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 the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by RH 7.56.1 and RH 7.56.2, the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine. RH 7.57 Full Calibration Measurements.
7.57.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:
7.57.2 To satisfy the requirement of RH 7.57.1, full calibration measurements shall include determination of:
7.57.3 A licensee shall use the dosimetry system described in RH 7.56 to measure the output for one set of exposure conditions. The remaining radiation measurements required in RH
7.57.4 A licensee shall make full calibration measurements required by RH 7.57.1 in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379–396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741–771, and
7.57.5 A licensee shall correct mathematically the outputs determined in RH 7.57.2.1 for physical decay for intervals not exceeding 1 month for cobalt-60 and intervals not exceeding 6 months for cesium-137.
7.57.6 Full calibration measurements required by RH 7.57.1 and physical decay corrections required by RH 7.57.5 shall be performed by a teletherapy physicist named on the licensee's license or authorized by a license issued by the NRC or an Agreement State to perform such service.
7.57.7 A licensee shall maintain a record of each calibration for the duration of the license. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated “on-off” error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist. RH 7.58 Periodic Spot Checks.
7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit at intervals not to exceed 1 month.
7.58.2 To satisfy the requirement of RH 7.58.1, spot checks shall include determination of:
anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
7.58.3 A licensee may use the dosimetry system described in RH 7.56 to make the spot check required in RH 7.58.2.5.
7.58.4 A licensee shall perform spot checks required by RH 7.58.1 in accordance with procedures established by the teletherapy physicist. The teletherapy physicist does not need to actually perform the output spot-check measurements.
7.58.5 A licensee shall have the teletherapy physicist review the results of each output spot check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each output spot check. The licensee shall keep a copy of each written notification for 3 years.
7.58.6 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility at intervals not to exceed 1 month.
7.58.7 To satisfy the requirement of RH 7.58.6, safety spot checks shall assure proper operation of:
7.58.8 A licensee shall lock the control console in the “off” position if any door interlock malfunctions. No licensee shall use the unit until the interlock system is repaired unless specifically authorized by the Department.
7.58.9 A licensee shall promptly repair any system identified in RH 7.58.7 that is not operating properly. The teletherapy unit shall not be used until all repairs are completed.
7.58.10 A licensee shall maintain a record of each spot check required by RH 7.58.1 and 7.58.6 for 3 years. The record shall include the date of the spot check, the manufacturer's name, model number, and serial number for both the teletherapy unit, and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the measured timer accuracy, the calculated “on-off” error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated “on-off” error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot check.
RH 7.59 Radiation Surveys for Teletherapy Facilities.
7.59.1 Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by RH 7.50.1 through RH 7.50.4, the licensee shall perform radiation surveys with an operable radiation measurement survey instrument calibrated in accordance with RH 7.17 to verify that:
7.59.2 If the results of the surveys required in RH 7.59.1 indicate any radiation levels in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the “off” position and not use the unit:
7.59.3 A licensee shall maintain a record of the radiation measurements made following installation of a source for the duration of the license. The record shall include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the “off” position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.
RH 7.60 Safety Spot Check for Teletherapy Facilities.
7.60.1 A licensee shall promptly check all systems listed in RH 7.58.7 for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by RH 7.50.
7.60.2 If the result of the safety spot checks required in RH 7.60.1 indicate the malfunction of any system specified in RH 7.58, the 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.
7.60.3 A licensee shall maintain a record of the safety spot checks following installation of a source for 3 years. The record shall include 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 Radiation Safety Officer.
RH 7.61 Modification of Teletherapy Unit or Room Before Beginning a Treatment Program. If the survey required by RH 7.59 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in RH 4.14.1 of these regulations, the licensee shall, before beginning the treatment program:
7.61.1 Either equip the unit with stops or add additional radiation shielding to ensure compliance with RH 4.14 of these regulations;
7.61.2 Perform the survey required by RH 7.59 again; and
7.61.3 Include in the report required by RH 7.62 the results of the initial survey, a description of the modification made to comply with RH 7.61.1, and the results of the second survey; or 7.61.4 Request and receive a license amendment under RH 4.14.3 of these regulations that authorizes radiation levels in unrestricted areas greater than those permitted by RH
RH 7.62 Reports of Teletherapy Surveys, Checks, Tests, and Measurements. A licensee shall furnish a copy of the records required in RH 7.59, 7.60, 7.61 and the output from the teletherapy source expressed as rads (Grays) per hour at 1 meter from the source as determined during the full calibration required in RH 7.57 to the Department within 30 days following completion of the action that initiated the record requirement.
RH 7.63 Five-Year Inspection.
7.63.1 A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy 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, an Agreement State, or the NRC.
7.63.3 A licensee shall maintain a record of the inspection and servicing for the duration of the license. The record shall contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.
SPECIFIC REQUIREMENTS FOR TRAINING RH 7.64 Radiation Safety Officer.
Except as provided in RH 7.65, an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in RH 7.7 shall:
7.64.1 Be certified by the:
7.64.1.1 American Board of Health Physics in Comprehensive Health Physics;
7.64.1.2 American Board of Radiology;
7.64.1.3 American Board of Nuclear Medicine;
7.64.1.4 American Board of Science in Nuclear Medicine; or
7.64.1.5 Board of Pharmaceutical Specialties in Nuclear Pharmacy;
7.64.1.6 American Board of Medical Physics in Radiation Oncology Physics;
7.64.1.7 Royal College of Physicians and Surgeons of Canada in Nuclear Medicine;
7.64.1.8 American Osteopathic Board of Radiology;
7.64.1.9 American Osteopathic Board of Nuclear Medicine; or
7.64.2 Have had 200 hours of classroom and laboratory training as follows:
7.64.2.1 Radiation physics and instrumentation;
7.64.2.2 Radiation protection;
7.64.2.3 Mathematics pertaining to the use and measurement of radioactivity;
7.64.2.4 Radiation biology;
7.64.2.5 Radiopharmaceutical chemistry; and
7.64.2.6 1 year of full time experience in radiation safety at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Department, Agreement State, Licensing State, or NRC license that authorizes the medical use of radioactive material; or 7.64.3 Be an authorized user or authorized nuclear pharmacist for those radioactive material uses that come within the Radiation Safety Officer's responsibilities. RH 7.65 Training for Experienced Radiation Safety Officer. An individual identified as a Radiation Safety Officer on a Department, Agreement State, Licensing State, or NRC license on the effective date of this rule who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the training requirements of RH 7.64.
RH 7.66 Training for Uptake, Dilution and Excretion Studies. Except as provided in RH 7.74 and 7.75, the licensee shall require the authorized user of a radiopharmaceutical listed in RH 7.30 to be a physician who:
7.66.1 Is certified in:
7.66.1.1 Nuclear medicine by the American Board of Nuclear Medicine;
7.66.1.2 Diagnostic radiology by the American Board of Radiology; or
7.66.1.3 Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or 7.66.1.4 Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or 7.66.1.5 Nuclear Medicine by the Royal College of Physicians and Surgeons of Canada; or 7.66.2 Has completed 40 hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, and 20 hours of supervised clinical experience.
7.66.2.1 To satisfy the basic instruction requirement, 40 hours of classroom and laboratory instruction shall include:
7.66.2.2 To satisfy the requirement for 20 hours of supervised clinical experience, training must be under the supervision of an authorized user at a medical institution and shall include:
7.66.3 Has successfully completed a 6 month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all topics identified in RH 7.66.2.
RH 7.67 Training for Imaging and Localization Studies.
Except as provided in RH 7.74 and RH 7.75, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit specified in RH 7.32 to be a physician who:
7.67.1 Is certified in:
7.67.1.1 Nuclear medicine by the American Board of Nuclear Medicine;
7.67.1.2 Diagnostic radiology by the American Board of Radiology; or
7.67.1.3 Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or 7.67.1.4 Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or 7.67.1.5 Nuclear Medicine by the Royal College of Physicians and Surgeons of Canada; or 7.67.2 Has completed 200 hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, 500 hours of supervised work experience, and 500 hours of supervised clinical experience.
7.67.2.1 To satisfy the basic instruction requirement, 200 hours of classroom and laboratory training shall include:
7.67.2.2 To satisfy the requirement for 500 hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
7.67.2.3 To satisfy the requirement for 500 hours of supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
7.67.3 Has successfully completed a 6 month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in RH 7.67.2.
RH 7.68 Training for Therapeutic Use of Unsealed Radioactive Material. Except as provided in RH 7.75, the licensee shall require the authorized user of a radiopharmaceutical listed in RH 7.36 for therapy to be a physician who:
7.68.1 Is certified by:
7.68.1.1 The American Board of Nuclear Medicine;
7.68.1.2 The American Board of Radiology in radiology or therapeutic radiology or radiation oncology; or
7.68.1.3 The American Osteopathic Board of Radiology after 1984; or
7.68.1.4 Nuclear Medicine by the Royal College of Physicians and Surgeons of Canada; or 7.68.2 Has completed 80 hours of instruction in basic radionuclide handling techniques applicable to the use of therapeutic radiopharmaceuticals, and has had supervised clinical experience.
7.68.2.1 To satisfy the requirement for instruction, 80 hours of classroom and laboratory training shall include:
7.68.2.2 To satisfy the requirement for supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
7.69.1 Is certified in:
7.69.1.1 Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
7.69.1.2 Radiation oncology by the American Osteopathic Board of Radiology;
7.69.1.3 Radiology, with a specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or 7.69.1.4 Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or 7.69.2 Is in the active practice of therapeutic radiology, has completed 200 hours of instruction in basic radionuclide handling techniques applicable to the therapeutic use of brachytherapy sources and 500 hours of supervised work experience and a minimum of 3 years of supervised clinical experience.
7.69.2.1 To satisfy the requirement for instruction, 200 hours of classroom and laboratory training shall include:
7.69.2.2 To satisfy the requirement for 500 hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
7.69.2.3 To satisfy the requirement for a period of supervised clinical experience, training shall include 1 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 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
RH 7.70 Training for Ophthalmic Use of Strontium-90.
Except as provided in RH 7.75, the licensee shall require the authorized user using only strontium-90 for opnthalmic radiotherapy to be a physician who:
7.70.1 Is certified in radiology or therapeutic radiology by the American Board of Radiology; or 7.70.2 Is in the active practice of therapeutic radiology or ophthalmology, and has completed 24 hours of instruction in basic radionuclide handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy.
7.70.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include:
7.70.2.2 To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training shall be under the supervision of an authorized user at a medical institution and shall include the use of strontium-90 for the ophthalmic treatment of five individuals that includes:
RH 7.71 Training for Use of Sealed Sources for Diagnosis. Except as provided in RH 7.74 the licensee shall require the authorized user using a sealed source in a device specified in RH 7.40 to be a physician, dentist, or podiatrist who:
7.71.1 Is certified in:
7.71.1.1 Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
7.71.1.2 Nuclear medicine by the American Board of Nuclear Medicine; or
7.71.1.3 Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or 7.71.1.4 Nuclear Medicine by the Royal College of Physicians and Surgeons of Canada; or 7.71.2 Has completed 8 hours of instruction in basic radionuclide handling techniques specifically applicable to the use of the device.
7.71.2.1 To satisfy the requirement for instruction, the training shall include:
RH 7.72 Training for Teletherapy.
Except as provided in RH 7.74, the licensee shall require the authorized user of a sealed source specified in RH 7.48 in a teletherapy unit to be a physician who:
7.72.1 Is certified in:
7.72.1.1 Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;
7.72.1.2 Radiation oncology by the American Osteopathic Board of Radiology;
7.72.1.3 Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or 7.72.1.4 Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or 7.72.2 Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radionuclide techniques applicable to the use of a sealed source in a teletherapy unit, 500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience.
7.72.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include:
7.72.2.2 To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user at an institution and shall include:
abnormal operation of a teletherapy unit or console; and
7.72.2.3 To satisfy the requirement for a period of supervised clinical experience, training shall include 1 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 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
RH 7.73 Training for Teletherapy Physicist.
The licensee shall require the teletherapy physicist to be an individual who:
7.73.1 Is certified by the American Board of Radiology in:
7.73.1.1 Therapeutic radiological physics;
7.73.1.2 Roentgen-ray and gamma-ray physics;
7.73.1.3 X-ray and radium physics; or
7.73.1.4 Radiological physics; or
7.73.2 Is certified by the American Board of Medical Physics in Radiation Oncology Physics; or 7.73.3 Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full time training in therapeutic radiological physics and also 1 year of full time work experience under the supervision of a teletherapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in RH 7.20, 7.57, 7.58, and 7.59 under the supervision of a teletherapy physicist during the year of work experience.
RH 7.74 Training for an Authorized Nuclear Pharmacist.
The licensee shall require the authorized nuclear pharmacist to be a pharmacist who:
7.74.1 Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties, or 7.74.2 Has completed 700 hours in a structured educational program consisting of both:
7.74.2.1 Didactic training in the following areas:
7.74.2.2 Supervised experience in a nuclear pharmacy involving the following:
7.74.3 Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy. RH 7.75 Training for Experienced Authorized Users.
Practitioners of the healing arts identified as authorized users for the human use of radioactive material on a Department, NRC, Agreement State or Licensing State license on December 30, 1990, who perform only those methods of use for which they were authorized on that date shall be deemed to have complied with the training requirements of RH 7.64 through RH 7.76. RH 7.76 Training for Experienced Nuclear Pharmacists.
A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in RH 7.74.2.1 before July 1, 1998 and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist shall be deemed to have met the requirements on preceptor statement RH 7.74.2.2 and recentness of training (RH 7.76) to qualify as an authorized nuclear pharmacist.
RH 7.77 Physician Training in a Three-Month Program.
A physician who, before July 1, 1984, began a 3-month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program, shall be deemed to have met the requirements of RH 7.66 or RH 7.67. RH 7.78 Recentness of Training.
The training and experience specified in this part shall have been obtained within the 5 years preceding the date of application or the individual shall have had continuing applicable experience since the required training and experience was completed.
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:
8.3.2.2 An easily visible warning light labeled with the words “X-RAY ON”, or words having a similar intent, shall be located:
8.3.2.3 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
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:
procedures require the presence of a primary x-ray beam when any local component in the system is disassembled, or removed;
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:
8.6.2.2 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:
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:
9.6.2 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.
power turned off.
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:
9.9.6 Safety Instructions.
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.
9.10.1 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.
9.10.3 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 RH 10.1 Purpose and 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. The regulations in this part apply to all persons who receive, possess, use, own, or transfer sources of radiation registered with or licensed by the Department pursuant to Parts 2 and 3 of these regulations.
General Regulatory Provisions and Specific Requirements RH 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 RH 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 OR-RH-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 RH 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 RH 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. RH 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 in excess of 1 milliSievert, (100 mrem)1 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 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 instructed 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 unnecessary exposure to radiation 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 or radioactive material; and 10.3.1.6 Advised as to the radiation exposure reports which workers shall be furnished pursuant to RH 10.4.
10.3.2 In determining those individuals subject to the requirements of RH 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 RH 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.
RH 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 RH 10.4. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to RH 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:
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 RH 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 RH 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 RH 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.
RH 10.5 Presence of Representatives of Licensees or Registrants and Workers During Inspection.
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 RH 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 RH 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 RH 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.
RH 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 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 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 RH 10.7.1.
10.6.3 The provisions of RH 10.6.2 shall not be interpreted as authorization to disregard instructions pursuant to RH 10.3.
RH 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 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 notice 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 RH 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 occured. Inspection pursuant to RH 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. RH 10.8 Inspections Not Warranted; Informal Review.
10.8.1 If the Department determines, with respect to a complaint under RH 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. 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.
10.8.1.2 Upon the request of the complainant, the Department may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. 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 RH 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 RH 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 RH 12.1 Purpose and Scope 12.1.1 The Regulations in this Part establish fees for radiation control services rendered by the Department as authorized by the Act.
12.1.2 Except for persons who apply for, or hold specific licenses exempted in RH 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. RH 12.2 Definitions
12.2.1 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 this Part, Appendix A.
“Inspections” (routine or non-routine) means:
“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, Colo. Rev. Stat., Section 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.
RH 12.3 Exemptions
12.3.1 No fees pursuant to RH 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 this Part, Appendix A.
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 RH 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.
RH 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 this Part, Appendix A1. Applications for which no remittance is received may be retumed to the applicant. 1Licensing 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 RH 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
12.4.1.5.1 In the case of an abandoned amendment application, if the licensee desires to the submit a new amendment application for the same or similar authorization, the reapplication shall be accompanied by a $100 reapplication fee.
12.4.1.5.2 In the case of an abandoned new license application, if the applicant desires to the submit a new application, then the applicant is subject to the application fee specified in this Part, Appendix A.
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 RH 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 RH 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 RH 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.
12.4.3.1.1 Routine inspections. Fees for routine inspections are included in the annual fee and will not be charged separately.
12.4.3.1.2 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 this Part, Appendix A, 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.
12.4.4.1.1 The licensee shall pay the fee in Appendix A of this Part for each license the person holds on the date the annual fee is due.
12.4.4.1.2 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.
12.4.4.1.3 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.
12.4.4.1.4 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. Maximum Annual Fee Per Licensed Category Small businesses not engaged in manufacturing and small not-for-profit organizations (gross annual receipts):
12.4.4.2.1 A licensee who is a subsidiary of a large entity does not qualify as a small entity for purposes of this section.
12.4.4.2.3 A license 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. The licensee shall file the required Certification of Department RCD Form 62 for each license under which it is billed.
12.4.4.2.4 A completed RCD Form 62 must be received between May 1 and June 15 each year for a licensee to be billed under a small entity status for the period beginning July of the year in which the RCD Form 62 is due, and ending June 30 of the following year. Failure to file a small entity certification by June 15 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:
12.4.4.3.1 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 this Part, Appendix A.
12.4.4.3.2 Reciprocal fees shall be due and payable prior to entry into the state.
12.4.4.3.3 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 RH 3.24.1.1.6.
12.4.4.3.4 Reciprocal fees shall not be transferred or refunded.
12.4.4.3.5 Reciprocal fees shall expire 12 months from the issue2 date.
2Pursuant to RH 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.
12.4.4.4.1 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.
12.4.4.4.2 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 RH.3.16.7. RH 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 RH 3.5.5;
12.5.1.2 Possession of more than 1 kilogram of source material other than depleted uranium for shielding under RH 3.5;
12.5.1.3 Measuring, gauging and controlling devices under RH 3.6.4; and,
12.5.1.4 In vitro licenses under RH 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 A of this Part 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 RH 3.5.5 and 3.6, that are based on the full cost of the inspection are payable upon notification by the Department. RH 12.6 Special Project Fees.
Fees for special projects are assessed for the full cost of the review, as specified in this Part, Appendix A. 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.
RH 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 RH 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.
12.8.1.2 The Department shall charge requesters who request the following services for the direct costs of the service:
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 RH 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 his or her 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 RH 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, Laboratory and Radiation Services 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:
contribution will be made;
12.8.6.4 The Department may waive or reduce the fee if, from information provided with the request for Department records made under RH 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:
In the case of services, which are subject to full cost fees, the Department may bill monthly for any service rendered.
RH 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.
RH 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 this Part, Appendix A. 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. 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.
RH 12.12 Failure by Applicant or Licensee to Pay Prescribed Fee 12.12.1 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 RH 3.23 and may request action pursuant to Colo. Rev. Stat., Section 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. RH 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 , , , 1Applications 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. 2Application for amendments to licenses that would place the license in a higher fee category or add a new fee category must be accompanied by the prescribed application fee for each category. 3Renewal 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. 4Inspection 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 Laboratory and Radiation Services Division 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 MATERIAL5,6 5Applications 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. 6Applications 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 NA Annual Fee NA Inspection NA 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 NA Annual Fee NA Inspection NA 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 NA Licensing and Inspection NA 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 a 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 OCCURING AND ACCELERATOR PRODUCED RADIOACTIVE MATERIAL 3.A Licenses of broad scope for possession and use of radioactive material issued pursuant to RH 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 10,000 curies 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 10,000 curies 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 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.P., 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 All other specific radioactive material licensees, except those in fee categories 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 7 NA Licensing and Inspection Full Cost 7There 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. 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 veterinarian 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 Evaluations 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 Evaluations 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 Evaluations 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 Evaluations 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 8 NA Licensing and Inspection Full Cost 8Licensees 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.
CATEGORY 15 - EMERGENCY RESPONSE 15.A Emergency response requiring over 10 man-hours in any 12 consecutive months. Full Cost 15.B Emergency response planning and exercises.
Full Cost9 9Fees will be charged only 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 LICENSES10 10Fees 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 RH 12.5.11 through 12.5.1.1.3. Annual Fee $100 Inspection Full Cost 17.B In-Vitro 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 RH 4.40 THROUGH RH 4.50 Per box for indexed paper records submitted in state storage boxes. $35 Full Cost for records not indexed and/or requiring repackaging in the standard storage boxes. 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.
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:
14.14.1.4 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:
14.33.7.3 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:
14.33.8.2 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:
15.14.2 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:
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 RH 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.
RH 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. RH 16.3 Definitions.
As used in this part, the following definitions apply:
“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.
“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 RH 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. “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. “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 RH 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 RH
16.25 and of any other State Agency having applicable regulations shall be met.
Equipment Control RH 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. RH 16.6 Storage Precautions.
16.6.1 Each source of radiation, except accelerators, 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. RH 16.7 Transport Precautions.
Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.
RH 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. RH 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 microcuries (Bq) 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 only by persons specifically authorized to perform such tests by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample.
16.9.3 Interval of Testing. Each sealed source of radioactive material 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 prior to the transfer, the sealed source shall not be put into use until tested. 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 Leaking or Contaminated Sources. If the test reveals the presence of 0.005 microcurie (185 Bq) or more of leakage or contamination, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these regulations. 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 RH
16.9.1 through 16.9.4:
16.9.5.1 hydrogen-3 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 100 microcuries (3.7 MBq) or less; and 16.9.5.5 sources of alpha-emitting radioactive material with an activity of 10 microcuries (0.370
RH 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.
RH 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, showing the following information for each source of radiation:
16.11.1 make, model number, and a serial number or a description of each source of radiation used;
16.11.2 the identity of the well-logging supervisor or field unit to whom assigned;
16.11.3 locations where used and dates of use; and
16.11.4 in the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.
RH 16.12 Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole Operations.
16.12.1 Each sealed source, except 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 has been individually pressure tested to at least 24,656 pounds per square inch absolute (170 MN/m2) without failure.
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 RH 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 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 as contained in the American National Standard N43.6 “Classification of Sealed Radioactive Sources,” (formerly N542, ANSI/NBS 126) in effect on December 30, 1985.4 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. RH 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: DANGER1 RADIOACTIVE 1or 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:
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 RH 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 RH 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. RH 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 RH 16.8. RH 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 either a film badge or a thermoluminescent dosimeter (TLD). Each film badge or TLD shall be assigned to and worn by only one individual. Film badges must be exchanged at least monthly and TLD's exchanged at least quarterly. After replacement, each replaced film badge or TLD 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 RH 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. RH 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.
RH 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. RH 16.21 Particle Accelerators.
No licensee or registrant shall permit above-ground 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 RH 4.6 and 4.14 of these regulations, as applicable, are met. Radiation Surveys and Records RH 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 well-head 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 RH 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. RH 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 RH 16.8;
16.23.5 records of the latest leak test results pursuant to RH 16.9;
16.23.6 records of quarterly inventories required pursuant to RH 16.10;
16.23.7 utilization records required pursuant to RH 16.11;
16.23.8 records of inspection and maintenance required pursuant to RH 16.14;
16.23.9 survey records required pursuant to RH 16.22; and
16.23.10 training records required pursuant to RH 16.15.
RH 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 RH 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 RH 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 RH 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:
16.25.3.2 notify the Department by telephone, giving the circumstances of the loss, and request approval of the proposed abandonment procedures; 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:
16.25.4 Whenever a sealed source containing radioactive material is abandoned downhole, the licensee shall provide a permanent plaque2 for posting the well or well-bore. This plaque shall: 2An 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 or monel, and
16.25.4.2 contain the following information engraved on its face:
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. 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
D. Levels of radiation from sources of radiation E. Methods of minimizing radiation dose
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
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 APPENDIX B EXAMPLE OF PLAQUE FOR IDENTIFYING WELLS CONTAINING SEALED SOURCES CONTAINING RADIOACTIVE MATERIAL ABANDONED DOWNHOLE [COMPANY NAME] [WELL IDENTIFICATION] ONE 2 CURIE CS-137 RADIOACTIVE SOURCE ABANDONED 3-3-75 AT 8400 FT. PLUG BACK DEPTH 8200 FT. DO NOT RE-ENTER THIS WELL BEFORE CONTACTING COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 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.
(2) LSA-II.
(3) LSA-III. Solids (e.g., consolidated wastes, activated materials) in which:
“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:
2. SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:
“Type A package” means a packaging that, together with its radioactive contents limited to A or A as appropriate, meets the requirements of 49 CFR 173.410 and 173.412 and is designed to 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:
17.5.1.2 The licensee shall also comply with applicable U.S. Department of Transportation regulations pertaining to the following modes of transportation:
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 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
17.11.3 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
17.11.4 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:
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:
17.12.2.7 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 *
0.92 *
*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 *
1.35 *
*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 and low toxicity alpha emitters All other alpha emitting 0.04 -6 2.2 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);
17.15.10.2 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 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:
17.19.3 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
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: 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.
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
0.72 -8 -7
1.0 -8 -7
1.5 -8 -6
5.0 -7 -6
10.0 -7 -6
20.0 -7 -5
35.0 -7 -5
50.0 -7 -5
90.0 -6 -5
93.0 -6 -5
95.0 -6 -5
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:
18.3.2 The applicant shall provide procedures describing the means employed to meet the following requirements during the operational phase of any project.
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
18.3.5 The following types of actions require an applicant's environmental report:
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:
18.4.2 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
comments to the Department or present oral comments at the hearing;
18.6.3 Party Status
18.6.4 Prehearing Conference
hearing.
their testimony.
18.6.5 Discovery
18.6.6 Conduct of Hearings
order to be determined by the Department or hearing officer.
by rebuttal of other parties.
followed by closing statements of all other parties.
18.6.7 Department Decision
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
cleanup or maintenance operations; or
surface contamination and radiation levels are significantly higher than routinely encountered; or
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:
18.8.4 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
(b) Potential adverse effects on hydraulically-connected surface waterquality, considering
(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:
(b) Potential adverse effects on hydraulically-connected surface water quality, considering:
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)
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 RH 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 grays (500 rads) 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. RH 19.2 Definitions.
“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).
“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 grays (500 rads) 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 RH 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 RH 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 RH 3.8 of the regulations.
RH 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 RH 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 RH 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 RH 19.8, the radiation monitors required by RH 19.11, the method of detecting leaking sources required by RH 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 RH 19.23.
RH 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.
RH 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 RH 19.7 Performance Criteria for Sealed Sources.
19.7.1 Requirements. Sealed sources installed after January 1, 1997:
19.7.1.1 Must have a certificate of registration issued by the U.S. Nuclear Regulatory Commission or an Agreement State;
19.7.1.2 Must be doubly encapsulated;
19.7.1.3 Must 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;
19.7.1.4 Must 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 19.7.1.5 In prototype testing of the sealed source, must have been leak tested and found leak- free after each of the tests described in RH 19.7.1.5.1 through 19.7.1.5.6.
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 RH 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 RH 4.28. Radiation postings for panoramic irradiators must comply with the posting requirements of RH 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.
RH 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 2 millirem (0.02 millisieverts) 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 millisieverts (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. RH 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. RH 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.
RH 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. RH 19.13 Irradiator Pools.
19.13.1 For licenses initially issued after January 1, 1997, 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 For licenses initially issued after January 1, 1997, 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 millirems) per hour. RH 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. RH 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. RH 19.16 Design Requirements.
19.16.1 Irradiators whose construction begins after January 1, 1997, 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 RH 19.9. If the irradiator will use more than 2 × 1017 becquerels (5 million curies) 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 RH 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 RH 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 RH 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 RH 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 RH 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.
RH 19.17 Construction Monitoring and Acceptance Testing.
19.17.1 The requirements of this section must be met for irradiators whose construction begins after January 1, 1997. The requirements must be met 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 RH 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 RH 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 RH 19.22.2. For underwater irradiators, the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by RH 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 RH 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 RH 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 RH 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 RH 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 RH 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.
RH 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 RH 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 RH 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.
RH 19.20 Personnel Monitoring.
19.20.1 Irradiator operators shall wear either a film badge or a thermoluminescent dosimeter (TLD) while operating a panoramic irradiator or while in the area around the pool or an underwater irradiator. The film badge or TLD processor must be accredited by the National Voluntary Laboratory Accreditation Program for high energy photons in the normal and accidental dose ranges (see RH 4.17.3). Each film badge or TLD must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and TLD's must be processed at least quarterly.
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. RH 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 RH 19.9 are exceeded, the facility must be modified to comply with the requirements in RH 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 I, “Annual Limits on Intakes (ALI's) and Derived Air Concentrations (DAC's), or Table III, “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.
RH 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 becquerels (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 III. (See RH 4.52 and 4.53 of these regulations for notification and reporting requirements.)
RH 19.23 Inspection and Maintenance.
19.23.1 The licensee shall perform inspection and maintenance checks that include, as a minimurr, 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 RH 19.8.
19.23.1.2 Functioning of the source position indicator required by RH 19.12.2.
19.23.1.3 Operability of the radiation monitor for radioactive contamination in pool water required by RH 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 RH 19.11.2.
19.23.1.5 Operability of the product exit monitor required by RH 19.11.1.
19.23.1.6 Operability of the emergency source return control required by RH 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 RH
19.23.1.9 Operability of the means of pool water replenishment required by RH 19.13.3.
19.23.1.10 Operability of the indicators of high and low pool water levels required by RH 19.13.4.
19.23.1.11 Operability of the intrusion alarm required by RH 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 RH 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.
19.23.1.16 Pool water conductivity measurements and analysis as required by RH 19.24.2.
19.23.2 Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.
RH 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 meters must be calibrated at least annually. RH 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 RH 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 RH 19.18.6 and 19.18.7. Static irradiations may be performed without a person present at the facility.
RH 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 RH 19.11.2 is operating with backup power.
RH 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 RH 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 RH 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 RH 19.18.5 for 3 years after the evaluation.
19.28.1.4 A copy of the current operating and emergency procedures required by RH 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 RH 19.19.3.3 retained for 3 years from the date of the change.
19.28.1.5 Film badge and TLD results required by RH 19.20 in accordance with RH 4.46 of these regulations.
19.28.1.6 Records of radiation surveys required by RH 19.21 for 3 years from the date of the survey.
19.28.1.7 Records of radiation survey meter calibrations required by RH 19.21.3 and pool water conductivity meter calibrations required by RH 19.24.2 until 3 years from the date of calibration.
19.28.1.8 Records of the results of leak tests required by RH 19.22.1 and the results of contamination checks required by RH 19.22.2 for 3 years from the date of each test.
19.28.1.9 Records of inspection and maintenance checks required by RH 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 RH 3.22 and RH 4.48 of these regulations.
19.28.1.12 Records on the design checks required by RH 19.16 and the construction control checks as required by RH 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.
19.28.1.13 Records related to decommissioning of the irradiator as required by RH 3.16.6.8 of these regulations.
RH 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.
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 RH 4.52.2, and a written report within 30 days as described in RH 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:
“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:
20.3.1.2 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
radiation; and
assurance checks;
times, and patient treatment settings;
the abnormal operation of an external beam radiation therapy unit or console; and
determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;
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
20.3.1.3 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:
20.3.2.3 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
20.3.2.6 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:
20.3.3.2 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:
20.4.1.2 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:
20.4.1.3 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:
20.4.2 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
20.4.3.2 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;
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:
20.7.16.1.4 Notwithstanding the requirements of RH 20.7.16.1.3:
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:
20.8.5 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:
20.8.6.3.5 Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after September 30, 1999, each display shall:
20.8.7 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:
20.8.17 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