1. (a) Purpose.

   1. (1) This section establishes standards for protection against ionizing radiation resulting from activities conducted in accordance with licenses or certificates of registration issued by the agency. These rules are issued in accordance with the Texas Radiation Control Act.
   2. (2) The rules in this section are designed to control the receipt, possession, use, and transfer 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 this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.
2. (b) Scope. Except as specifically provided in other sections of this chapter, this section applies to persons licensed or registered by the agency to receive, possess, use, or transfer sources of radiation. The limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs. However, no radiation may be deliberately applied to human beings except by or under the supervision of an individual authorized by and licensed in accordance with Texas' statutes to engage in the healing arts.

3. (c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.

   1. (1) Annual limit on intake (ALI)--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 Reference Man that would result in a committed effective dose equivalent of 5 rems (0.05 sievert (Sv)) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section.
   2. (2) Class--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 apply 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 this section, lung class and inhalation class are equivalent terms.
   3. (3) Declared pregnant woman--A woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.
   4. (4) Derived air concentration (DAC)--The concentration of a given radionuclide in air that, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of 1 ALI. For purposes of this section, 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 Column 3 of Table I of subsection (ggg)(2) of this section.
   5. (5) Derived air concentration-hour (DAC-hour)--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 may take 2,000 DAC-hours to represent ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv).
   6. (6) Dosimetry processor--A registrant that processes and evaluates personnel monitoring devices in order to determine the radiation dose delivered to the monitoring devices.
   7. (7) Inhalation class (see definition for Class).
   8. (8) Lung class (see definition for Class).
   9. (9) Nonstochastic effect--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 this section, deterministic effect is an equivalent term.
   10. (10) Planned special exposure--An infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
   11. (11) Quarter--A period of time equal to one-fourth of the year observed by the licensee or registrant, 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.
   12. (12) Reference man--A hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of Reference Man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man."
   13. (13) Respiratory protective equipment--An apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.
   14. (14) Sanitary sewerage--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.
   15. (15) Stochastic effect--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 this section probabilistic effect is an equivalent term.
   16. (16) Very high radiation area--An area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in one hour at 1 meter (m) from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, Sv and rem.
   17. (17) Weighting factor w[sub]T[/sub] for an organ or tissue (T)--The proportion of the risk of stochastic 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[sub]T[/sub]are:

4. (d) Implementation.

   1. (1) Any existing license or certificate of registration condition that is more restrictive than this section remains in force until there is an amendment or renewal of the license or registration.
   2. (2) If a license or certificate of registration condition exempts a licensee or registrant from a provision of this section in effect on or before January 1, 1994, it also exempts the licensee or registrant from the corresponding provision of this section.
   3. (3) If a license or registration condition cites provisions of this section in effect prior to January 1, 1994, that do not correspond to any provisions of this section, 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.

5. (e) Radiation protection programs.

   1. (1) Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of this section. See subsection (mm) of this section for recordkeeping requirements relating to these programs.
   2. (2) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA).
   3. (3) The licensee or registrant shall, at intervals not to exceed 12 months, ensure the radiation protection program content and implementation is reviewed.

6. (f) Occupational dose limits for adults.

   1. (1) The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures in accordance with subsection (k) of this section, to the following dose limits.

      1. (A) An annual limit shall be the more limiting of:

         1. (i) the total effective dose equivalent being equal to 5 rems (0.05 Sv); or
         2. (ii) the sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv).

      2. (B) The annual limits to the lens of the eye, to the skin, and to the extremities shall be:

         1. (i) an eye dose equivalent of 15 rems (0.15 Sv); and
         2. (ii) a shallow dose equivalent of 50 rems (0.5 Sv) to the skin or to any extremity.
   2. (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 subsection (k)(1)(F)(i) and (ii) of this section.
   3. (3) The assigned deep dose equivalent and shallow dose equivalent shall be for the portion of the body receiving the highest exposure.
   4. (4) The deep dose equivalent, eye 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.

   5. (5) When a protective apron is worn while working with fluoroscopic equipment used for clinical diagnostic or research purposes, the effective dose equivalent for external radiation shall be determined as follows.

      1. (A) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation.
      2. (B) When only one individual monitoring device is used and it is located at the neck outside the protective apron, and the reported dose exceeds 25% of the limit specified in paragraph (1) of this subsection, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation.
      3. (C) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04.
   6. (6) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table I of subsection (ggg)(2) of this section and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See subsection (rr) of this section.
   7. (7) Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams (mg) in a week in consideration of chemical toxicity. See footnote 3 of subsection (ggg)(2) of this section.
   8. (8) 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 subsection (j)(4) of this section.

7. (g) Compliance with requirements for summation of external and internal doses.

   1. (1) If the licensee is required to monitor in accordance with both subsection (q)(1) and (3) of this section, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only in accordance with subsection (q)(1) of this section or only in accordance with subsection (q)(3) of this section, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses in accordance with paragraphs (2), (3) and (4) of this subsection. 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.

   2. (2) 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:

      1. (A) the sum of the fractions of the inhalation ALI for each radionuclide; or
      2. (B) the total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or
      3. (C) 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[sub]T[/sub], and the committed dose equivalent, H[sub]T,50[/sub], per unit intake is greater than 10% of the maximum weighted value of H[sub]T,50[/sub], that is, w[sub]T[/sub] H[sub]T,50[/sub], per uxnit intake for any organ or tissue.
   3. (3) If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.
   4. (4) The licensee 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 in accordance with this paragraph.

8. (h) Determination of external dose from airborne radioactive material.

   1. (1) Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, eye dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See footnotes 1 and 2 of subsection (ggg)(2) of this section.
   2. (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.

9. (i) Determination of internal exposure.

   1. (1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required in accordance with subsection (q) of this section, take suitable and timely measurements of:

      1. (A) concentrations of radioactive materials in air in work areas;
      2. (B) quantities of radionuclides in the body;
      3. (C) quantities of radionuclides excreted from the body; or
      4. (D) combinations of these measurements.
   2. (2) Unless respiratory protective equipment is used, as provided in subsection (x) of this section, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

   3. (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 may:

      1. (A) use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record;
      2. (B) upon prior approval of the agency, 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
      3. (C) 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 subsection (ggg)(2) of this section.
   4. (4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (1)(A) or (B) of this subsection, the licensee may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by subsections (xx) or (yy) of this section. This delay permits the licensee to make additional measurements basic to the assessments.

   5. (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:

      1. (A) the sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from subsection (ggg)(2) of this section for each radionuclide in the mixture; or
      2. (B) the ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.
   6. (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.

   7. (7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if:

      1. (A) the licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in subsection (f) of this section and in complying with the monitoring requirements in subsection (q)(3) of this section;
      2. (B) the concentration of any radionuclide disregarded is less than 10% of its DAC; and
      3. (C) the sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.

   8. (8) When determining the committed effective dose equivalent, the following information may be considered.

      1. (A) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.
      2. (B) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 Sv), that is, the stochastic ALI, is listed in parentheses in Table I of subsection (ggg)(2) of this section. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in subsection (f)(1)(A)(ii) of this section is met.

10. (j) Determination of occupational dose for the current year.

    1. (1) For each individual who is likely to receive, in a year, an occupational dose requiring monitoring in accordance with subsection (q) of this section, the licensee or registrant shall determine the occupational radiation dose received during the current year.

    2. (2) In complying with the requirements of paragraph (1) of this subsection, a licensee or registrant may:

       1. (A) accept, as a record of the occupational dose that the individual received during the current year, TRC Form 21-2 from prior employers, or other clear and legible record, of all information required on that form and indicating any periods of time for which data are not available; or
       2. (B) 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 prior employer(s) for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; or
       3. (C) obtain reports of the individual's dose equivalent from prior employer(s) 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.
    3. (3) The licensee or registrant shall record the exposure data for the current year, as required by paragraph (1) of this subsection, on TRC Form 21-3, or other clear and legible record, of all the information required on that form.
    4. (4) If the licensee or registrant is unable to obtain a complete record of an individual's current occupational dose while employed by any other licensee or registrant, the licensee or registrant shall assume in establishing administrative controls in accordance with subsection (f)(8) of this section for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts (mSv)) for each quarter; or 416 millirems (mrem) (4.16 mSv) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure.

    5. (5) If an individual has incomplete (e.g., a lost or damaged personnel monitoring device) current occupational dose data for the current year and that individual is employed solely by the licensee or registrant during the current year, the licensee or registrant shall:

       1. (A) assume that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter;
       2. (B) assume that the allowable dose limit for the individual is reduced by 416 mrem (4.16 mSv) for each month; or
       3. (C) assess an occupational dose for the individual during the period of missing data using surveys, radiation measurements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits.
    6. (6) Administrative controls established in accordance with paragraph (4) of this subsection shall be documented and maintained for inspection by the agency. Occupational dose assessments made in accordance with paragraph (5) of this subsection and records of data used to make the assessment shall be maintained for inspection by the agency. The licensee or registrant shall retain the records in accordance with subsection (rr) of this section.

11. (k) Planned special exposures.

    1. (1) A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in subsection (f) of this section provided that each of the following conditions is satisfied.

       1. (A) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical.
       2. (B) The licensee and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs.

       3. (C) Before a planned special exposure, the licensee ensures that each individual involved is:

          1. (i) informed of the purpose of the planned operation;
          2. (ii) 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
          3. (iii) instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

       4. (D) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

          1. (i) the internal and external doses from all previous planned special exposures;
          2. (ii) all doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and
          3. (iii) all lifetime cumulative occupational radiation doses.

       5. (E) In complying with the requirements of subparagraph (D)(iii) of this paragraph, a licensee may:

          1. (i) accept, as the record of lifetime cumulative radiation dose, an up-to-date TRC Form 21-2 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; and
          2. (ii) obtain reports of the individual's dose equivalent from prior employer(s) for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee, by telephone, telegram, facsimile, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

       6. (F) Subject to subsection (f)(2) of this section, the licensee 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:

          1. (i) the numerical values of any of the dose limits in subsection (f) (1) of this section in any year; and
          2. (ii) five times the annual dose limits in subsection (f)(1) of this section during the individual's lifetime.
       7. (G) The licensee maintains records of the conduct of a planned special exposure in accordance with subsection (qq) of this section and submits a written report to the agency in accordance with subsection (zz) of this section.
       8. (H) The licensee 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 in accordance with subsection (f)(1) but shall be included in evaluations required by subparagraphs (D) and (F) of this paragraph.
       9. (I) The licensee shall record the exposure history, as required by subparagraph (D) of this paragraph, on TRC Form 21-2, 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 obtains reports, the licensee shall use the dose shown in the report in preparing TRC Form 21-2 or equivalent.
    2. (2) Planned special exposures are not applicable to registrants.
12. (l) Occupational dose limits for minors. The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in subsection (f) of this section.

13. (m) Dose to an embryo/fetus.

    1. (1) If a woman declares her pregnancy, the licensee or registrant shall ensure that the dose to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational dose limits specified in subsection (f)(1) of this section are applicable to the woman. See subsection (rr) of this section for recordkeeping requirements.
    2. (2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (1) of this subsection. The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in any 1 month.

    3. (3) The dose to an embryo/fetus shall be taken as:

       1. (A) the dose to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman; and

       2. (B) the dose that is most representative of the dose to the embryo/fetus from external radiation, that is, in the mother's lower torso region.

          1. (i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo/fetus.
          2. (ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device that is most representative of the dose to the embryo/fetus shall be the dose to the embryo/fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo/fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo/fetus.
    4. (4) If by the time the woman declares pregnancy to the licensee or registrant, the dose to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the licensee or registrant shall be deemed to be in compliance with paragraph (1) of this subsection, if the additional dose to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

14. (n) Dose limits for individual members of the public.

    1. (1) Each licensee or registrant shall conduct operations so that:

       1. (A) except as provided in subparagraph (B) of this paragraph, the total effective dose equivalent to individual members of the public from the licensed and/or registered operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contribution from the licensee's disposal of radioactive material into sanitary sewerage in accordance with subsection (gg) of this section, background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs;
       2. (B) the total effective dose equivalent to individual members of the public from exposure to radiation from radiation machines does not exceed 0.5 rem (5 mSv) in a year; and
       3. (C) the dose in any unrestricted area from licensed and/or registered external sources does not exceed 0.002 rem (0.02 mSv) in any one hour.
    2. (2) If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.

    3. (3) A licensee or an applicant for a license may apply for prior agency authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). This application shall include the following information:

       1. (A) demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (1) of this subsection;
       2. (B) the licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
       3. (C) the procedures to be followed to maintain the dose ALARA.
    4. (4) In addition to the requirements of this section, a licensee subject to the provisions of the United States Environmental Protection Agency's (EPA) generally applicable environmental radiation standards in 40 Code of Federal Regulations (CFR), §190 shall comply with those requirements.
    5. (5) The agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

15. (o) Compliance with dose limits for individual members of the public.

    1. (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 as required in subsection (n) of this section.

    2. (2) A licensee or registrant shall show compliance with the annual dose limit in subsection (n) of this section by:

       1. (A) 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

       2. (B) demonstrating that:

          1. (i) the annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of subsection (ggg)(2) of this section; and
          2. (ii) if an individual were continuously present in an unrestricted area, the dose from external sources of radiation would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
    3. (3) Registrants exempt from personnel monitoring requirements in accordance with subsection (p)(4)-(5) of this section are exempt from the requirements of paragraphs (1) and (2) of this subsection.
    4. (4) Upon approval from the agency, the licensee may adjust the effluent concentration values in Table II, of subsection (ggg)(2) of this section, 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.

16. (p) General surveys and monitoring.

    1. (1) Each licensee or registrant shall make, or cause to be made, surveys that:

       1. (A) are necessary for the licensee or registrant to comply with this section; and

       2. (B) are necessary under the circumstances to evaluate:

          1. (i) radiation levels;
          2. (ii) concentrations or quantities of radioactive material; and
          3. (iii) the potential radiological hazards that could be present.

    2. (2) The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are operable and calibrated:

       1. (A) by a person licensed or registered by the agency, another agreement state, a licensing state, or the United States Nuclear Regulatory Commission (NRC) to perform such service;
       2. (B) at intervals not to exceed 12 months unless a different time interval is specified in another section of this chapter;
       3. (C) after each instrument or equipment repair;
       4. (D) for the types of radiation used and at energies appropriate for use; and
       5. (E) at an accuracy within 20% of the true radiation level.

    3. (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 subsection (f) of this section, with other applicable provisions of these rules, or with conditions specified in a license or certificate of registration, shall be processed and evaluated by a dosimetry processor:

       1. (A) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology;
       2. (B) 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; and
       3. (C) holding a current certificate of registration from the agency authorizing dosimetry processing.
    4. (4) Notwithstanding the requirements of subsection (q)(1) of this section, no personnel monitoring shall be required for personnel operating only minimal threat devices as specified in §289.201(q)(4) of this title (relating to General Provisions).
    5. (5) Notwithstanding the requirements of subsection (q)(1) of this section, no personnel monitoring shall be required for personnel operating only dental radiographic systems for healing arts purposes.

17. (q) 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 this section. As a minimum:

    1. (1) each licensee or registrant shall monitor occupational exposure to radiation and shall supply and require the use of individual monitoring devices by:

       1. (A) adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection (f)(1) of this section;
       2. (B) minors and declared pregnant women likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of any of the applicable limits in subsections (l) or (m) of this section; and
       3. (C) individuals entering a high or very high radiation area;

    2. (2) notwithstanding paragraph (1)(C) of this subsection, a licensee is exempt from supplying individual monitoring devices to healthcare personnel who may enter a high radiation area while providing patient care if:

       1. (A) the personnel are not likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection (f)(1) of this section; and
       2. (B) the licensee complies with the requirements of subsection (e)(2) of this section; and

    3. (3) each licensee shall monitor, to determine compliance with subsection (i) of this section, the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

       1. (A) adults likely to receive, in 1 year, an intake in excess of 10% of the applicable ALI in Columns 1 and 2 of Table I of subsection (ggg)(2) of this section; and
       2. (B) minors and declared pregnant women likely to receive, in one year, a committed effective dose equivalent in excess of 0.05 rem (0.5 mSv).

18. (r) Location and use of individual monitoring devices.

    1. (1) Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subsection (q)(l) of this section wear and use individual monitoring devices as follows.

       1. (A) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar).
       2. (B) If an additional individual monitoring device is used for monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance with subsection (m)(1) of this section, it shall be located at the waist under any protective apron being worn by the woman.
       3. (C) An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with subsection (f)(1)(B)(i) of this section, shall be located at the neck (collar) or at a location closer to the eye, outside any protective apron being worn by the monitored individual.
       4. (D) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii) of this section, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device, to the extent practicable, shall be oriented to measure the highest dose to the extremity being monitored.
       5. (E) An individual monitoring device shall be assigned to and worn by only one individual.
       6. (F) An individual monitoring device shall be worn for the period of time authorized by the dosimetry processor's certificate of registration or for no longer than 3 months, whichever is more restrictive.
    2. (2) Each licensee or registrant shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing.
    3. (3) Each licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.

19. (s) Control of access to high radiation areas.

    1. (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:

       1. (A) 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 0.1 rem (1 mSv) in one hour at 30 centimeters (cm) from the source of radiation from any surface that the radiation penetrates;
       2. (B) 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
       3. (C) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
    2. (2) In place of the controls required by paragraph (1) of this subsection for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
    3. (3) The licensee or registrant may apply to the agency for approval of alternative methods for controlling access to high radiation areas.
    4. (4) The licensee or registrant shall establish the controls required by paragraphs (1) and (3) of this subsection in a way that does not prevent individuals from leaving a high radiation area.

    5. (5) The licensee 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 United States Department of Transportation (DOT) provided that:

       1. (A) the packages do not remain in the area longer than 3 days; and
       2. (B) the dose rate at 1 meter from the external surface of any package does not exceed 0.01 rem (0.1 millisievert) per hour.
    6. (6) The licensee 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 this section and to operate within the ALARA provisions of the licensee's radiation protection program.
    7. (7) The 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 this subsection if the registrant has met all the specific requirements for access and control specified in other applicable sections of this chapter, such as, §289.115 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), §289.116 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine), and §289.119 of this title (relating to Radiation Safety Requirements for Particle Accelerators).

20. (t) Control of access to very high radiation areas.

    1. (1) In addition to the requirements in subsection (s) of this section, 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 500 rads (5 grays) or more in one hour at 1 m from a source of radiation or any surface through which the radiation penetrates at this level. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation.
    2. (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 paragraph (1) of this subsection if the registrant has met all the specific requirements for access and control specified in other applicable parts of this chapter, such as, §289.115 of this title, §289.116 of this title, and §289.119 of this title.

21. (u) Control of access to very high radiation areas for irradiators.

    1. (1) This subsection applies to licensees with sources of radiation in non-self-shielded irradiators. This subsection 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.

    2. (2) Each area in which there may exist radiation levels in excess of 500 rads (5 grays) in one hour at 1 m from a source of radiation that is used to irradiate materials shall meet the following requirements.

       1. (A) Each entrance or access point shall be equipped with entry control devices that:

          1. (i) function automatically to prevent any individual from inadvertently entering a very high radiation area;
          2. (ii) permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
          3. (iii) prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 0.1 rem (1 mSv) in one hour.

       2. (B) Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subparagraph (A) of this paragraph:

          1. (i) the radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
          2. (ii) conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

       3. (C) The licensee shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:

          1. (i) the radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
          2. (ii) conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.
       4. (D) When the shield for stored sealed sources is a liquid, the licensee shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.
       5. (E) 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 subparagraphs (C) and (D) of this paragraph.
       6. (F) 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.
       7. (G) 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.
       8. (H) 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 0.1 rem (1 mSv) in one hour.

       9. (I) The entry control devices required in subparagraph (A) of this paragraph shall be tested for proper functioning. See subsection (uu) of this section for recordkeeping requirements.

          1. (i) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day.
          2. (ii) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption.
          3. (iii) The licensee shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.
       10. (J) The licensee 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.
       11. (K) 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 automatically to prevent loose radioactive material from being carried out of the area.
    3. (3) Licensees or applicants for licenses for sources of radiation within the purview of paragraph (2) of this subsection that will be used in a variety of positions or in locations, such as open fields or forests, which make it impracticable to comply with certain requirements of paragraph (2) of this subsection, such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in paragraph (2) of this subsection. 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. (4) The entry control devices required by paragraphs (2) and (3) of this subsection shall be established in such a way that no individual will be prevented from leaving the area.
22. (v) Use of process or other engineering controls. The licensee shall use, to the extent practicable, process or other engineering controls, such as containment or ventilation, to control the concentrations of radioactive material in air.

23. (w) Use of other controls. When it is not practicable 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:

    1. (1) control of access;
    2. (2) limitation of exposure times;
    3. (3) use of respiratory protection equipment; or
    4. (4) other controls.

24. (x) Use of individual respiratory protection equipment.

    1. (1) If the licensee uses respiratory protection equipment to limit intakes in accordance with subsection (w) of this section.

       1. (A) Except as provided in subparagraph (B) of this paragraph, 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 (NIOSH) and the Mine Safety and Health Administration (MSHA).
       2. (B) If the licensee wishes to use equipment that has not been tested or certified by the NIOSH and the MSHA, or has not had certification extended by the NIOSH and the MSHA, 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 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.

       3. (C) The licensee shall implement and maintain a respiratory protection program that includes:

          1. (i) air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures;
          2. (ii) surveys and bioassays, as appropriate, to evaluate actual intakes;
          3. (iii) testing of respirators for operability immediately prior to each use;
          4. (iv) written procedures regarding selection, fitting, issuance, maintenance, and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bioassays; and recordkeeping; and
          5. (v) determination by a physician prior to initial fitting of respirators, and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is physically able to use the respiratory protection equipment.

       4. (D) The licensee shall issue a written policy statement on respirator usage covering:

          1. (i) the use of process or other engineering controls, instead of respirators;
          2. (ii) the routine, nonroutine, and emergency use of respirators; and
          3. (iii) the length of periods of respirator use and relief from respirator use.
       5. (E) 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.
       6. (F) 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.

    2. (2) When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes in accordance with subsection (w) of this section, provided that the following conditions, in addition to those in paragraph (1) of this subsection, are satisfied.

       1. (A) The licensee selects respiratory protection equipment that provides a protection factor, specified in subsection (ggg)(1) of this section, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Column 3 of Table I of subsection (ggg)(2) of this section. However, if the selection of respiratory protection equipment with a protection factor greater than the peak concentration is inconsistent with the goal specified in subsection (w) of this section 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.

       2. (B) The licensee shall obtain authorization from the agency before assigning respiratory protection factors in excess of those specified in subsection (ggg)(1) of this section. The agency may authorize a licensee to use higher protection factors on receipt of an application that:

          1. (i) describes the situation for which a need exists for higher protection factors; and
          2. (ii) demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
    3. (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 NIOSH and the MSHA.
    4. (4) The licensee shall notify the agency in writing at least 30 days before the date that respiratory protection equipment is first used in accordance with either paragraphs (1) or (2) of this subsection.

25. (y) Security and control of licensed or registered sources of radiation.

    1. (1) The licensee shall secure radioactive material from unauthorized removal or access.
    2. (2) The licensee shall maintain constant surveillance, using devices and/or administrative procedures to prevent unauthorized use of radioactive material that is in an unrestricted area and that is not in storage.
    3. (3) The registrant shall secure radiation machines from unauthorized removal.
    4. (4) The registrant shall use devices and/or administrative procedures to prevent unauthorized use of radiation machines.

26. (z) Caution signs.

    1. (1) Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:

27. (aa) Posting requirements.

    1. (1) 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."
    2. (2) 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."
    3. (3) 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." If the very high radiation area involves medical treatment of patients, the licensee or registrant may omit the word "GRAVE" from the sign or signs.
    4. (4) The licensee 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."
    5. (5) The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in subsection (ggg)(3) of this section with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."

28. (bb) Exceptions to posting requirements.

    1. (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:

       1. (A) 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 this section; and
       2. (B) the area or room is subject to the licensee's or registrant's control.
    2. (2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs in accordance with subsection (aa) of this section provided that the patient could be released from confinement in accordance with §289.252(f)(3) of this title (relating to Licensing of Radioactive Material).
    3. (3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source(s) provided the radiation level at 30 centimeters from the surface of the sealed source container(s) or housing(s) does not exceed 0.005 rem (0.05 mSv) per hour.

29. (cc) Labeling containers and radiation machines.

    1. (1) The licensee shall ensure that each container of licensed 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.
    2. (2) Each licensee 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.
    3. (3) Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit.

30. (dd) Exemptions to labeling requirements. A licensee is not required to label:

    1. (1) containers holding licensed material in quantities less than the quantities listed in subsection (ggg)(3) of this section;
    2. (2) containers holding licensed material in concentrations less than those specified in Table III of subsection (ggg)(2) of this section;
    3. (3) containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this section;
    4. (4) containers when they are in transport and packaged and labeled in accordance with the rules of the DOT (labeling of packages containing radioactive materials is required by the DOT if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by DOT regulations 49 CFR 173.403(m) and (w) and 173.424);
    5. (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
    6. (6) installed manufacturing or process equipment, such as piping and tanks.

31. (ee) Procedures for receiving and opening packages.

    1. (1) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in §289.201(b) of this title and specified in §289.257(s)(1) of this title (relating to Packaging and Transportation of Radioactive Material), shall make arrangements to receive:

       1. (A) the package when the carrier offers it for delivery; or
       2. (B) the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.

    2. (2) Each licensee shall:

       1. (A) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR 172.403 and 172.436-440, for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in §289.201(b) of this title; and
       2. (B) monitor the external surfaces of a labeled package, labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations 49 CFR 172.403 and 172.436-440, 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 §289.201(b) of this title and specified in §289.257(s)(1) of this title; and
       3. (C) 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.
    3. (3) The licensee shall perform the monitoring required by paragraph (2) of this subsection as soon as practicable after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than 3 hours from the beginning of the next working day. If the licensee discovers there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged, the package shall be surveyed immediately.

    4. (4) The licensee shall immediately notify the final delivery carrier and, by telephone and telegram, mailgram, or facsimile, the agency when removable radioactive surface contamination or external radiation levels exceed the limits established in subparagraphs (A) and (B) of this paragraph.

       1. (A) Limits for removable radioactive surface contamination levels.

          1. (i) The level of removable radioactive contamination on the external surfaces of each package offered for shipment shall be ALARA. The level of removable radioactive contamination may be determined by wiping an area of 300 square centimeters (cm[sup]2[/sup]) 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 clause (iii) of this subparagraph, the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in clause (ii) of this subparagraph at any time during transport. If other methods are used, the detection efficiency of the method used must be taken into account and in no case may the removable contamination on the external surfaces of the package exceed ten times the limits listed in clause (ii) of this subparagraph.
          2. (ii) Removable external radioactive contamination wipe limits are as follows.

32. (ff) General requirements for waste management.

    1. (1) Unless otherwise exempted, a licensee shall discharge, treat, or decay licensed material or transfer waste for disposal only:

       1. (A) by transfer to an authorized recipient as provided in subsection (jj) of this section or in, §289.127 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), §289.252 of this title, or §289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities), §289.257 of this title, or to the United States Department of Energy (DOE);
       2. (B) by decay in storage with prior approval from the agency;
       3. (C) by release in effluents within the limits in subsection (n) of this section; or
       4. (D) as authorized in accordance with paragraph (2) of this subsection, and subsections (gg) and (hh) of this section.

    2. (2) Upon agency approval, emission control dust and other material from electric arc furnaces or foundries, such as K061 listed hazardous waste or other listed hazardous waste, contaminated as a result of inadvertent melting of a cesium-137 source may be transferred for disposal to a hazardous waste disposal facility authorized by the Texas Natural Resource Conservation Commission (Commission) or its successor, another state's regulatory agency with jurisdiction to regulate hazardous waste as classified under Subtitle C of the Resource Conservation and Recovery Act (RCRA), or the EPA. The material may be transferred for disposal without regard to its radioactivity if the following conditions are met.

       1. (A) Contaminated material described in paragraph (2) of this subsection, whether packaged or unpackaged (i.e., bulk), must be treated through stabilization to comply with all waste treatment requirements of the appropriate state or federal regulatory agency as listed in this paragraph. The treatment operations must be undertaken by either of the following:

          1. (i) the owner/operator of the electric arc furnace or foundry licensed to possess, treat or transfer cesium-137 contaminated incident-related material; or
          2. (ii) a service contractor licensed by the agency, NRC, or an agreement state.
       2. (B) The emission control dust and other incident-related materials have been stored (if applicable) and transferred in accordance with operating and emergency procedures approved by the agency.
       3. (C) The total cesium-137 activity contained in emission control dust and other incident-related materials to be transferred to a hazardous waste disposal facility has been specifically approved by NRC or the appropriate agreement state(s) and does not exceed the total activity associated with the inadvertent melting incident.
       4. (D) The hazardous waste disposal facility operator has been notified in writing of the impending transfer of the incident-related materials and has agreed in writing to receive and dispose of the packaged or unpackaged materials. Copies of the notification and agreement shall be submitted to the agency.
       5. (E) The licensee, as listed in subparagraph (A)(i) or (ii) of this paragraph, notifies the NRC or agreement state(s) in which the transferor and transferee are located, in writing, of the impending transfer, at least 30 days before the transfer.
       6. (F) The packaged stabilized material has been packaged for transportation and disposal in non-bulk steel packaging as defined in DOT regulations at 49 CFR 173.213.
       7. (G) The emission control dust and other incident-related materials that have been stabilized and packaged as described in subparagraph (F) of this paragraph shall contain pretreatment average concentrations of cesium-137 that do not exceed 130 pCi/g of material, above background.
       8. (H) The dose rate at 3.28 feet (1 m) from the surface of any package containing stabilized waste shall not exceed 20 micro;rem per hour or 0.20 micro;Sv per hour, above background.
       9. (I) The unpackaged stabilized material shall contain pretreatment average concentrations of cesium-137 that do not exceed 100 pCi/g of material, above background.
    3. (3) The licensee transferring the cesium-137 contaminated incident-related material must consult with the agency, the Commission or its successor, another state's regulatory agency with jurisdiction to regulate hazardous waste as classified under RCRA, or the EPA and other authorized parties, including state and local governments, and obtain all necessary approvals, in addition to those of NRC and/or appropriate agreement states, for the transfers described in paragraph (2) of this subsection.
    4. (4) Nothing in this subsection shall be or is intended to be construed as a waiver of any RCRA permit condition or term, of any state or local statute or regulation, or of any federal RCRA regulation.
    5. (5) The total incident-related cesium-137 activity received by a facility over its operating life shall not exceed 1 Ci (37 GBq). The agency will maintain a record of the total incident-related cesium-137 activity shipped by a person licensed by the agency. Upon consultation with the Commission, the agency will determine if the total incident-related cesium-137 activity received by a hazardous waste disposal facility over its operating life has reached 1 Ci (37 GBq). The agency will not approve shipments of cesium-137 contaminated incident-related material that will cause this limit to be exceeded.

    6. (6) A person shall be specifically licensed to receive waste containing licensed material from other persons for:

       1. (A) treatment prior to disposal;
       2. (B) treatment by incineration;
       3. (C) decay in storage;
       4. (D) disposal at an authorized land disposal facility; or
       5. (E) storage until transferred to a storage or disposal facility authorized to receive the waste.

33. (gg) Discharge by release into sanitary sewerage.

    1. (1) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

       1. (A) the material is readily soluble, or is readily dispersible biological material, in water;
       2. (B) the quantity of licensed radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table III of subsection (ggg)(2) of this section; and

       3. (C) if more than one radionuclide is released, the following additional conditions must also be satisfied:

          1. (i) the fraction of the limit in Table III of subsection (ggg)(2) of this section represented by discharges into sanitary sewerage determined by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table III of subsection (ggg)(2) of this section; and
          2. (ii) the sum of the fractions for each radionuclide required by clause (i) of this subparagraph does not exceed unity; and
       4. (D) the total quantity of licensed radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed 5 curies (Ci) (185 gigabecquerels (GBq)) of hydrogen-3, 1 Ci (37 GBq) of carbon-14, and 1 Ci (37 GBq) of all other radioactive materials combined.
    2. (2) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (1) of this subsection.
34. (hh) Treatment by incineration. A licensee may treat licensed material by incineration only in the form and concentration specified in subsection (fff)(1) of this section or as authorized by the agency.
35. (ii) Discharge by release into septic tanks. No licensee shall discharge radioactive material into a septic tank system except as specifically approved by the agency.

36. (jj) Transfer for disposal and manifests.

    1. (1) The control of transfers of low-level radioactive waste intended for disposal at a licensed low-level radioactive waste disposal facility, the establishment of a manifest tracking system, and additional requirements concerning transfers and recordkeeping for those wastes are found in §289.257(s)(5) of this title.
    2. (2) Each person involved in the transfer of waste for disposal including the waste generator, waste collector, and waste processor, shall comply with the requirements specified in §289.257(s)(5) of this title.
37. (kk) Compliance with environmental and health protection regulations. Nothing in subsections (ff), (gg), (hh), or (jj) of this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of in accordance with subsections (ff), (gg), (hh), or (jj) of this section.

38. (ll) General provisions for records.

    1. (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 this section. Disintegrations per minute may be indicated on records of surveys performed to determine compliance with subsection (ggg)(6) of this section. To ensure compatibility with international transportation standards, all limits in this section are given in terms of dual units: The International System of Units (SI) followed or preceded by United States (U.S.) standard or customary units. The U.S. customary units are not exact equivalents, but are rounded to a convenient value, providing a functionally equivalent unit. For the purpose of this section, either unit may be used.
    2. (2) Notwithstanding the requirements of paragraph (1) of this subsection, when recording information on shipment manifests, as required in §289.257 of this title, information must be recorded in SI units or in SI and units as specified in paragraph (1) of this subsection.
    3. (3) The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this section, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, eye dose equivalent, deep dose equivalent, or committed effective dose equivalent.
    4. (4) Records required in accordance with §289.201(d) of this title, and subsections (mm), (nn), (oo), (tt), and (uu) of this section shall include the date and the identification of individual(s) making the record, and, as applicable, a unique identification of survey instrument(s) used, and an exact description of the location of the survey. Records of receipt, transfer, and disposal of sources of radiation shall uniquely identify the source of radiation.
    5. (5) Copies of records required in accordance with §289.201(d) of this title, and subsections (mm) through (uu) of this section, and by license or certificate of registration condition that are relevant to operations at an additional authorized use/storage site shall be maintained at that site in addition to the main site specified on a license or certificate of registration.

39. (mm) Records of radiation protection programs.

    1. (1) Each licensee or registrant shall maintain records of the radiation protection program, including:

       1. (A) the provisions of the program; and
       2. (B) audits and other reviews of program content and implementation.
    2. (2) The licensee or registrant shall retain the records required by paragraph (1)(A) of this subsection until the agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by paragraph (1)(B) of this subsection for 3 years after the record is made.

40. (nn) Records of surveys.

    1. (1) Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by subsections (p) and (ee)(2) of this section. The licensee or registrant shall retain these records for 3 years after the record is made.

    2. (2) The licensee or registrant shall retain each of the following records until the agency terminates each pertinent license or registration requiring the record:

       1. (A) the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents; and
       2. (B) results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; and
       3. (C) results of air sampling, surveys, and bioassays required in accordance with subsection (x)(1)(C)(i) and (ii) of this section; and
       4. (D) results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.
41. (oo) Records of tests for leakage or contamination of sealed sources. Records of tests for leakage or contamination of sealed sources required by §289.201(g) of this title shall be kept in units of becquerel or microcurie and retained for inspection by the agency for 5 years after the records are made.
42. (pp) Records of lifetime cumulative occupational radiation dose. The licensee shall retain the records of lifetime cumulative occupational radiation dose as specified in subsection (k) of this section on TRC Form 21-2 or equivalent until the agency terminates each pertinent license requiring this record. The licensee shall retain records used in preparing TRC Form 21-2 or equivalent for 3 years after the record is made.

43. (qq) Records of planned special exposures.

    1. (1) For each use of the provisions of subsection (k) of this section for planned special exposures, the licensee shall maintain records that describe:

       1. (A) the exceptional circumstances requiring the use of a planned special exposure;
       2. (B) the name of the management official who authorized the planned special exposure and a copy of the signed authorization;
       3. (C) what actions were necessary;
       4. (D) why the actions were necessary;
       5. (E) what precautions were taken to assure that doses were maintained ALARA;
       6. (F) what individual and collective doses were expected to result; and
       7. (G) the doses actually received in the planned special exposure.
    2. (2) The licensee shall retain the records until the agency terminates each pertinent license requiring these records.

44. (rr) Records of individual monitoring results.

    1. (1) Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required in accordance with subsection (q) of this section, 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:

       1. (A) the deep dose equivalent to the whole body, eye dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;
       2. (B) the estimated intake of radionuclides, see subsection (g) of this section;
       3. (C) the committed effective dose equivalent assigned to the intake of radionuclides;
       4. (D) the specific information used to calculate the committed effective dose equivalent in accordance with subsection (i)(3) of this section;
       5. (E) the total effective dose equivalent when required by subsection (g) of this section;
       6. (F) the total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose; and
       7. (G) the data used to make occupational dose assessments in accordance with subsection (j)(5) of this section.
    2. (2) The licensee or registrant shall make entries of the records specified in paragraph (1) of this subsection at intervals not to exceed 1 year and within 60 days of the end of the year.
    3. (3) The licensee or registrant shall maintain the records specified in paragraph (1) of this subsection on TRC Form 21-3, in accordance with the instructions for TRC Form 21-3, or in clear and legible records containing all the information required by TRC Form 21-3.
    4. (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.
    5. (5) The licensee or registrant shall retain each required form or record until the agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain records used in preparing TRC Form 21-3 or equivalent for 3 years after the record is made.

45. (ss) Records of dose to individual members of the public.

    1. (1) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See subsection (n) of this section.
    2. (2) The licensee or registrant shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license or registration requiring the record.

46. (tt) Records of discharge, treatment, or transfer for disposal.

    1. (1) Each licensee shall maintain records of the discharge or treatment of licensed materials made in accordance with subsection (gg) and (hh) of this section and of transfers for disposal made in accordance with subsection (jj) of this section and §289.257 of this title.
    2. (2) The licensee shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license requiring the record.

47. (uu) Records of testing entry control devices for very high radiation areas.

    1. (1) Each licensee or registrant shall maintain records of tests made in accordance with subsection (u)(2)(I) of this section on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.
    2. (2) The licensee or registrant shall retain the records required by paragraph (1) of this subsection for 3 years after the record is made.
48. (vv) Form of records. Each record required by this chapter 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 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 or registrant shall maintain adequate safeguards against tampering with and loss of records.

49. (ww) Reports of stolen, lost, or missing licensed or registered sources of radiation.

    1. (1) Each licensee or registrant shall report to the agency by telephone as follows:

       1. (A) immediately after its occurrence becomes known to the licensee, stolen, lost, or missing licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in subsection (ggg)(3) of this section, under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas; or
       2. (B) within 30 days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than 10 times the quantity specified in subsection (ggg)(3) of this section that is still missing.
       3. (C) immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine.

    2. (2) Each licensee or registrant required to make a report in accordance with paragraph (1) of this subsection shall, within 30 days after making the telephone report, make a written report to the agency setting forth the following information:

       1. (A) 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;
       2. (B) a description of the circumstances under which the loss or theft occurred;
       3. (C) a statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;
       4. (D) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;
       5. (E) actions that have been taken, or will be taken, to recover the source of radiation; and
       6. (F) 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.
    3. (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. (4) The licensee or registrant shall prepare any report filed with the agency in accordance with this subsection so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

50. (xx) Notification of incidents.

    1. (1) Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause:

       1. (A) an individual to receive:

          1. (i) a total effective dose equivalent of 25 rems (0.25 Sv) or more;
          2. (ii) an eye dose equivalent of 75 rems (0.75 Sv) or more; or
          3. (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rads (2.5 grays) or more; or
       2. (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

    2. (2) Each licensee or registrant shall, within 24 hours of discovery of the event, report to the agency 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:

       1. (A) an individual to receive, in a period of 24 hours:

          1. (i) a total effective dose equivalent exceeding 5 rems (0.05 Sv);
          2. (ii) an eye dose equivalent exceeding 15 rems (0.15 Sv); or
          3. (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rems (0.5 Sv); or
       2. (B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
    3. (3) Licensees or registrants shall make the initial notification reports required by paragraphs (1) and (2) of this subsection by telephone to the agency and shall confirm the initial notification report within 24 hours by telegram, mailgram, or facsimile to the agency.
    4. (4) The licensee or registrant shall prepare each report filed with the agency in accordance with this section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.
    5. (5) The provisions of this section 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 in accordance with subsection (zz) of this section.

51. (yy) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits.

    1. (1) In addition to the notification required by subsection (xx) of this section, each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:

       1. (A) incidents for which notification is required by subsection (xx) of this section;

       2. (B) doses in excess of any of the following:

          1. (i) the occupational dose limits for adults in subsection (f) of this section;
          2. (ii) the occupational dose limits for a minor in subsection (l) of this section;
          3. (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m) of this section;
          4. (iv) the limits for an individual member of the public in subsection (n) of this section; or
          5. (v) any applicable limit in the license or registration;

       3. (C) levels of radiation or concentrations of radioactive material in:

          1. (i) a restricted area in excess of applicable limits in the license or registration; or
          2. (ii) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the license or registration, whether or not involving exposure of any individual in excess of the limits in subsection (n) of this section; or
       4. (D) for licensees subject to the provisions of the EPA'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 requirements.

    2. (2) Each report required by paragraph (1) of this subsection shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

       1. (A) estimates of each individual's dose;
       2. (B) the levels of radiation and concentrations of radioactive material involved;
       3. (C) the cause of the elevated exposures, dose rates, or concentrations; and
       4. (D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, generally applicable environmental standards, and associated license or registration conditions.
    3. (3) Each report filed in accordance with paragraph (1) of this subsection shall include for each individual exposed: the name, social security number, and date of birth. With respect to the limit for the embryo/fetus in subsection (m) of this section, 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.
    4. (4) All licensees or registrants who make reports in accordance with paragraph (1) of this subsection shall submit the report in writing to the agency.
52. (zz) Reports of planned special exposures. The licensee shall submit a written report to the agency within 30 days following any planned special exposure conducted in accordance with subsection (k) of this section, informing the agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by subsection (qq) of this section.

53. (aaa) Notifications and reports to individuals.

    1. (1) Requirements for notification and reports to individuals of exposure to sources of radiation are specified in §289.114 of this title.
    2. (2) When a licensee or registrant is required in accordance with subsection (yy) or (zz) of this section to report to the agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to sources of radiation, the licensee or registrant shall also notify the individual and provide a copy of the report submitted to the agency, to the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of 22.13(a) of TRCR Part 22 as adopted by reference in §289.114 of this title.
54. (bbb) Reports of leaking or contaminated sealed sources. The licensee shall immediately notify the agency if the test for leakage or contamination required in accordance with §289.201(g) of this title indicates a sealed source is leaking or contaminated. A written report of a leaking or contaminated source shall be submitted to the agency within 5 days. The report shall include the equipment involved, the test results and the corrective action taken.

55. (ccc) Vacating premises.

    1. (1) Each licensee, registrant, or person possessing non-exempt sources of radiation shall, no less than 30 days before vacating or relinquishing possession or control of premises, notify the agency, in writing, of the intent to vacate.
    2. (2) The licensee or person possessing non-exempt radioactive material shall decommission the premises to a degree consistent with subsequent use as an unrestricted area and in accordance with the requirements of subsections (ddd) and (eee) of this section.
    3. (3) Notwithstanding the limits set forth in subsections (ddd) and (eee) of this section, contamination levels must be maintained in unrestricted areas so that no individual member of the public will receive an effective dose equivalent in excess of 100 mrem (1 mSv) above background per year.
    4. (4) No licensee shall vacate a facility or land, or release a facility or land for unrestricted use, until the annual total effective dose equivalent to a member of the public resulting from radioactive material remaining from licensed activities (excluding radium and its decay products) does not exceed 25 mrem (0.25 mSv) per year above background. The concentration for radium in soil shall be equivalent to or below the limits in subsection (eee) of this section. Notwithstanding the limits in this paragraph, each licensee shall make every reasonable effort to maintain any contamination of soil or vegetation ALARA. The licensee shall conduct all necessary radiation surveys and modeling and shall provide reports and documentation to demonstrate that the requirements for release for unrestricted use have been met. The Agency may require the licensee to provide any other information necessary to demonstrate that the facilities and land are suitable for release for unrestricted use.

56. (ddd) Soil contamination limits.

    1. (1) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contamination of soil in unrestricted areas, to the extent that the contamination exceeds, on a dry weight basis, the concentration limits specified in:

       1. (A) subsection (ggg)(8) of this section; or
       2. (B) the effluent concentrations in Table III of subsection (ggg)(2) of this section, with the units changed from microcuries per milliliter to microcuries per gram, for radionuclides not specified in subsection (ggg)(8) of this section or paragraph (3) of this subsection.
    2. (2) Where combinations of radionuclides are involved, the sum of the ratios between the concentrations present and the limits specified in paragraph (1) of this subsection shall not exceed one.

    3. (3) Except for the requirements in §289.127 of this title and notwithstanding the limits imposed by paragraph (1) of this subsection, the concentration of radium-226 or radium-228 in soil averaged over any 100 square meters (m[sup]2[/sup]) shall not exceed the background level by more than:

       1. (A) 5 picocuries per gram (pCi/g) (0.185 becquerel per gram (Bq/g)), averaged over the first 15 cm of soil below the surface; and
       2. (B) 15 pCi/g (0.555 Bq/g), averaged over 15 cm thick layers of soil more than 15 cm below the surface.
    4. (4) 5 pCi/g (0.185 Bq/g), based on dry weight, for radium-226 or radium-228 in vegetation; and

    5. (5) the following limits, based on dry weight, averaged over any 100 m[sup]2[/sup] of area for natural uranium with no daughters present:

       1. (A) 30 pCi/g (1.11 Bq/g), averaged over the top 15 cm of soil below the surface; and
       2. (B) 150 pCi/g (5.55 Bq/g), average concentration at depths greater than 15 centimeters below the surface so that no individual member of the public will receive an effective dose equivalent in excess of 100 mrem (1 mSv) per year.

57. (eee) Surface contamination limits for facilities and equipment.

    1. (1) Prior to vacating any facility or releasing areas or equipment for unrestricted use, each licensee shall ensure that radioactive contamination has been removed to ALARA levels. In no case shall the licensee vacate a facility or release areas or equipment for unrestricted use until radioactive surface contamination levels are below the limits specified in subsection (ggg)(6) of this section.
    2. (2) In addition to meeting the surface contamination limits of paragraph (1) of this subsection, porous materials (e.g., concrete), that are to be released for unrestricted use, shall be evaluated to determine whether radioactive materials have penetrated to the interior of the material. If radioactive contamination has penetrated into the material, analysis of the average concentration, in pCi/g, shall be made. The material may be released for unrestricted use if the radionuclide concentrations do not exceed the limits specified for soil in subsection (ddd) of this section.

58. (fff) Exemption of specific wastes.

    1. (1) A licensee may discard the following licensed material without regard to its radioactivity:

       1. (A) 0.05 microcurie (micro;Ci) (1.85 kilobecquerels (kBq)), or less, of hydrogen-3, carbon-14, or iodine-125 per gram of medium used for liquid scintillation counting or in vitro clinical or in vitro laboratory testing; and
       2. (B) 0.05 micro;Ci (1.85 kBq), or less, of hydrogen-3, carbon-14, or iodine-125, per gram of animal tissue, averaged over the weight of the entire animal.
    2. (2) A licensee shall not discard tissue in accordance with paragraph (1)(B) of this subsection in a manner that would permit its use either as food for humans or as animal feed.
    3. (3) The licensee shall maintain records in accordance with subsection (tt) of this section.
    4. (4) Any licensee may, upon agency approval of procedures required in paragraph (6) of this subsection, discard licensed material included in subsection (ggg)(7) of this section, provided that it does not exceed the concentration and total curie limits contained therein, in a Type I municipal solid waste site as defined in the Municipal Solid Waste Regulations of the authorized regulatory agency (31 TAC Chapter 330), unless such licensed material also contains hazardous waste, as defined in Section 3(15) of the Solid Waste Disposal Act, Health and Safety Code, Chapter 361. Any licensed material included in subsection (ggg)(7) of this section and which is a hazardous waste as defined in the Solid Waste Disposal Act may be discarded at a facility authorized to manage hazardous waste by the authorized regulatory agency.

    5. (5) Each licensee who discards material described in paragraphs (1) or (4) of this subsection shall:

       1. (A) make surveys adequate to assure that the limits of paragraphs (1) or (4) of this subsection are not exceeded; and
       2. (B) remove or otherwise obliterate or obscure all labels, tags, or other markings that would indicate that the material or its contents is radioactive.

    6. (6) Prior to authorizations in accordance with paragraph (4) of this subsection, a licensee shall submit procedures to the agency for:

       1. (A) the physical delivery of the material to the disposal site;
       2. (B) surveys to be performed for compliance with paragraph (5)(A) of this subsection;
       3. (C) maintaining secure packaging during transportation to the site; and
       4. (D) maintaining records of any discards made under paragraph (4) of this subsection.
    7. (7) Nothing in this section relieves the licensee of maintaining records showing the receipt, transfer, and discard of such radioactive material as specified in §289.201(d) of this title.
    8. (8) Nothing in this section relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous property of these materials.
    9. (9) Licensed material discarded under this section is exempt from the requirements of §289.252(t) of this title.

59. (ggg) Appendices.

    1. (1) Protection factors for respirators. The following table contains protection factors for respirators:

Source Note:The provisions of this §289.202 adopted to be effective May 20, 1996, 21 TexReg 4026; amended to be effective March 1, 1998, 23 TexReg 1045; amended to be effective July 12, 1998, 23 TexReg 6960.