Header:
TEXAS ADMINISTRATIVE CODE
TITLE 25. HEALTH SERVICES
PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289. RADIATION CONTROL
SUBCHAPTER D. GENERAL
Date:
03/06/2014
Document:
§ 289.202. Standards for Protection Against Radiation from Radioactive Materials
(a) Purpose.
(1) This section establishes standards for protection against ionizing radiation resulting from activities conducted in accordance with licenses issued by the agency.
(2) The requirements in this section are designed to control the receipt, possession, use, and transfer of sources of radiation by any licensee 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.
(b) Scope.
(1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer sources of radiation, unless otherwise exempted. No person may use, manufacture, produce, transport, transfer, receive, acquire, own, possess, process, or dispose of sources of radiation unless that person has a license or exemption from the agency. The dose limits in this section do not apply to doses due to background radia-tion, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with this chapter, 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.
(2) Licensees who are also registered by the agency to receive, possess, use, and transfer radiation machines must also comply with the requirements of § 289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).
(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.
(1) Air-purifying respirator--A respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
(2) 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.
(3) Assigned protection factor (APF)--The expected workplace level of respiratory protection that would be pro-vided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
(4) Atmosphere-supplying respirator--A respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
(5) 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 pur-poses of this section, lung class and inhalation class are equivalent terms.
(6) Debris--The remains of something destroyed, disintegrated, or decayed. Debris does not include soils, sludges, liquids, gases, naturally occurring radioactive material regulated in accordance with § 289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), or low-level radioactive waste received from other persons.
(7) Declared pregnant woman--A woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant.
(8) Demand respirator--An atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.
(9) Derived air concentration (DAC)--The concentration of a given radionuclide in air that, if breathed by Refer-ence 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.
(10) 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).
(11) Disposable respirator--A respirator for which maintenance is not intended and that is designed to be dis-carded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it un-suitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.
(12) Dosimetry processor--A person that processes and evaluates personnel monitoring devices in order to de-termine the radiation dose delivered to the monitoring devices.
(13) Filtering facepiece (dust mask)--A negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.
(14) Fit factor--A quantitative estimate of the fit of a particular respirator to a specific individual, and typically es-timates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.
(15) Fit test--The use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
(16) Helmet--A rigid respiratory inlet covering that also provides head protection against impact and penetration.
(17) Hood--A respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
(18) Inhalation class (see definition for Class).
(19) Loose-fitting facepiece--A respiratory inlet covering that is designed to form a partial seal with the face.
(20) Lung class (see definition for Class).
(21) Nationally tracked source--A sealed source containing a quantity equal to or greater than Category 1 or Cat-egory 2 levels of any radioactive material listed in subsection (hhh)(2) of this section. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.
(22) Negative pressure respirator (tight fitting)--A respirator in which the air pressure inside the facepiece is nega-tive during inhalation with respect to the ambient air pressure outside the respirator.
(23) 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.
(24) Planned special exposure--An infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
(25) Positive pressure respirator--A respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
(26) Powered air-purifying respirator--An air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
(27) Pressure demand respirator--A positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
(28) Qualitative fit test--A pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.
(29) Quantitative fit test--An assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
(30) Quarter--A period of time equal to one-fourth of the year observed by the licensee, approximately 13 con-secutive 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.
(31) 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."
(32) Respiratory protective equipment--An apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.
(33) 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.
(34) Self-contained breathing apparatus--An atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
(35) 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.
(36) Supplied-air respirator or airline respirator--An atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
(37) Tight-fitting facepiece--A respiratory inlet covering that forms a complete seal with the face.
(38) User seal check (fit check)--An action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.
(39) Weighting factor wT 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 wT are:
[See table, form or illustration in printed version]
(d) Implementation.
(1) Any existing license condition that is more restrictive than this section remains in force until there is an amendment or renewal of the license that modifies or removes this condition.
(2) If a license condition exempts a licensee from a provision of this section in effect on or before January 1, 1994, it also exempts the licensee from the corresponding provision of this section.
(3) If a license 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 condition remains in force until there is an amendment or renewal of the license that modifies or removes this condition.
(e) Radiation protection programs.
(1) Each licensee 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. Documentation of the radiation protection program may be incorporated in the licensee's operating, safety, and emergency procedures.
(2) The licensee shall use, to the extent practicable, procedures and engineering controls based upon sound radia-tion protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA).
(3) The licensee shall, at intervals not to exceed 12 months, ensure the radiation protection program content and implementation is reviewed. The review shall include a reevaluation of the assessments made to determine monitoring is not required in accordance with subsection (q)(1) and (3) of this section in conjunction with the licensee's current operating conditions.
(4) To implement the ALARA requirement in paragraph (2) of this subsection and notwithstanding the require-ments in subsection (n) of this section, a constraint on air emissions of radioactive material to the environment, ex-cluding radon-222 and its daughters, shall be established by licensees such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 milli-rems (mrem) (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose con-straint, the licensee shall report the exceedance as required in subsection (yy) of this section and promptly take ap-propriate corrective action.
(5) If monitoring is not required in accordance with subsection (q)(1) and (3) of this section, the licensee shall document assessments made to determine the requirements of subsection (q)(1) and (3) of this section are not appli-cable. The licensee shall maintain the documentation in accordance with subsection (rr)(5) of this section.
(f) Occupational dose limits for adults.
(1) The licensee shall control the occupational dose to individuals, except for planned special exposures in ac-cordance with subsection (k) of this section, to the following dose limits.
(A) An annual limit shall be the more limiting of: (i) the total effective dose equivalent being equal to 5 rems (0.05 Sv); or (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).
(B) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities shall be: (i) a lens dose equivalent of 15 rems (0.15 Sv); and (ii) a shallow dose equivalent of 50 rems (0.5 Sv) to the skin of the whole body or to the skin of any extremity.
(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)(6)(A) and (B) of this section.
(3) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the agency. The assigned deep dose equivalent shall be for the por-tion of the body receiving the highest exposure. The assigned shallow-dose equivalent shall be the dose averaged over the contiguous 10 square centimeters (cm2 ) of skin receiving the highest exposure.
(4) The deep dose equivalent, lens dose equivalent and shallow dose equivalent may be assessed from surveys, or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.
(5) 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.
(6) 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.
(7) The licensee 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.
(g) Compliance with requirements for summation of external and internal doses.
(1) If the licensee is required to monitor in accordance with both subsection (q)(1) and (3) of this section, the li-censee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee 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) - (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) 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:
(A) the sum of the fractions of the inhalation ALI for each radionuclide; or
(B) the total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or
(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, wT , and the committed dose equivalent, HT,50 , per unit intake is greater than 10% of the maximum weighted value of HT,50 , that is, wT HT,50 , per unit intake for any organ or tissue.
(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) 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.
(h) Determination of external dose from airborne radioactive material.
(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) 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.
(i) Determination of internal exposure.
(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the li-censee shall, when required in accordance with subsection (q) of this section, take suitable and timely measurements of:
(A) concentrations of radioactive materials in air in work areas;
(B) quantities of radionuclides in the body;
(C) quantities of radionuclides excreted from the body; or
(D) combinations of these measurements.
(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) 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:
(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;
(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
(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) 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 seven 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) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applica-ble to the mixture for use in calculating DAC-hours shall be either:
(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
(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) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionu-clides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.
(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if:
(A) the licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in subsec-tion (f) of this section and in complying with the monitoring requirements in subsection (q)(3) of this section;
(B) the concentration of any radionuclide disregarded is less than 10% of its DAC; and
(C) the sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.
(8) When determining the committed effective dose equivalent, the following information may be considered.
(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 ra-dionuclides that have their ALIs or DACs based on the committed effective dose equivalent.
(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 sto-chastic 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.
(j) Determination of occupational dose for the current year.
(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 shall determine the occupational radiation dose received during the current year.
(2) In complying with the requirements of paragraph (1) of this subsection, a licensee may:
(A) accept, as a record of the occupational dose that the individual received during the current year, BRC Form 202-2 from prior or other current 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
(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 or other current 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
(C) obtain reports of the individual's dose equivalent from prior or other current employer(s) for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee, by tele-phone, 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.
(3) The licensee shall record the exposure data for the current year, as required by paragraph (1) of this subsec-tion, on BRC Form 202-3, or other clear and legible record, of all the information required on that form.
(4) If the licensee is unable to obtain a complete record of an individual's current occupational dose while em-ployed by any other licensee, the licensee shall assume in establishing administrative controls in accordance with subsection (f)(7) 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 mrem (4.16 mSv) for each month for which records were una-vailable and the individual was engaged in activities that could have resulted in occupational radiation exposure.
(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 during the current year, the licensee shall:
(A) assume that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter;
(B) assume that the allowable dose limit for the individual is reduced by 416 mrem (4.16 mSv) for each month; or
(C) assess an occupational dose for the individual during the period of missing data using surveys, radiation meas-urements, or other comparable data for the purpose of demonstrating compliance with the occupational dose limits.
(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 shall retain the records in accordance with subsection (rr) of this section.
(k) Planned special exposures. A licensee may authorize an adult worker to receive doses in addition to and ac-counted 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) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the doses estimated to result from the planned special exposure are unavailable or impractical.
(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special ex-posure, in writing, before the exposure occurs.
(3) Before a planned special exposure, the licensee ensures that each individual involved is:
(A) informed of the purpose of the planned operation;
(B) 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
(C) instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.
(4) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:
(A) the internal and external doses from all previous planned special exposures;
(B) all doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and
(C) all lifetime cumulative occupational radiation doses.
(5) In complying with the requirements of paragraph (4)(C) of this subsection, a licensee may:
(A) accept, as the record of lifetime cumulative radiation dose, an up-to-date BRC Form 202-2 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
(B) 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 trans-mitted report cannot be established.
(6) 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:
(A) the numerical values of any of the dose limits in subsection (f)(1) of this section in any year; and
(B) five times the annual dose limits in subsection (f)(1) of this section during the individual's lifetime.
(7) 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) The licensee records the best estimate of the dose resulting from the planned special exposure in the individu-al's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special ex-posure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual in accordance with subsection (f)(1) of this section but shall be included in evaluations required by par-agraphs (4) and (6) of this subsection.
(9) The licensee shall record the exposure history, as required by paragraph (4) of this subsection, on BRC Form 202-2, 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 licen-see shall use the dose shown in the report in preparing BRC Form 202-2 or equivalent.
(l) Occupational dose limits for minors. The annual occupational dose limits for minors are 10% of the annual oc-cupational dose limits specified for adult workers in subsection (f) of this section.
(m) Dose equivalent to an embryo/fetus.
(1) If a woman declares her pregnancy, the licensee shall ensure that the dose equivalent 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) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a de-clared 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 one month.
(3) The dose equivalent to an embryo/fetus shall be taken as:
(A) the dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the de-clared pregnant woman; and
(B) the dose equivalent that is most representative of the dose equivalent to the embryo/fetus from external ra-diation, that is, in the mother's lower torso region. (i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose equivalent to the embryo/fetus. (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 equivalent to the embryo/fetus shall be the dose equivalent 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 equivalent is also the most representative deep dose equivalent for the region of the embryo/fetus.
(4) If by the time the woman declares pregnancy to the licensee, the dose equivalent to the embryo/fetus has ex-ceeded 0.45 rem (4.5 mSv), the licensee shall be deemed to be in compliance with paragraph (1) of this subsection, if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
(n) Dose limits for individual members of the public.
(1) Each licensee shall conduct operations so that:
(A) 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 background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with § 289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with subsection (gg) of this section; and
(B) the dose in any unrestricted area from licensed and/or registered external sources, exclusive of the dose con-tributions from patients administered radioactive material and released in accordance with § 289.256 of this title, does not exceed 0.002 rem (0.02 mSv) in any one hour.
(2) If the licensee 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) 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 infor-mation:
(A) demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (1) of this subsection;
(B) the licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
(C) the procedures to be followed to maintain the dose ALARA.
(4) In addition to the requirements of this section, a licensee subject to the provisions of the United States Envi-ronmental Protection Agency's (EPA) generally applicable environmental radiation standards in 40 Code of Federal Regulations (CFR), § 190 shall comply with those requirements.
(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.
(6) Notwithstanding paragraph (1)(A) of this subsection, a licensee may permit visitors to an individual who cannot be released, in accordance with § 289.256 of this title, to receive a radiation dose greater than 0.1 rem (1 mSv) if:
(A) the radiation dose received does not exceed 0.5 rem (5 mSv); and
(B) the authorized user, as defined in § 289.256 of this title, has determined before the visit that it is appropriate.
(o) Compliance with dose limits for individual members of the public.
(1) The licensee 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) A licensee shall show compliance with the annual dose limit in subsection (n) of this section by:
(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
(B) demonstrating that: (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 (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) Upon approval from the agency, the licensee may adjust the effluent concentration values in Table II, of sub-section (ggg)(2) of this section, for members of the public, to take into account the actual physical and chemical char-acteristics of the effluents, such as, aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.
(p) General surveys and monitoring.
(1) Each licensee shall make, or cause to be made, surveys that:
(A) are necessary for the licensee to comply with this chapter; and
(B) are necessary under the circumstances to evaluate: (i) the magnitude and extent of radiation levels; (ii) con-centrations or quantities of radioactive material; and (iii) the potential radiological hazards.
(2) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are operable and calibrated:
(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;
(B) at intervals not to exceed 12 months unless a different time interval is specified in another section of this chapter;
(C) after each instrument or equipment repair;
(D) for the types of radiation used and at energies appropriate for use; and
(E) at an accuracy within 20% of the true radiation level.
(3) All individual monitoring devices, except for direct and indirect reading pocket dosimeters, electronic personal dosimeters, and those individual monitoring devices used to measure the dose to any extremity, that require pro-cessing to determine the radiation dose and that are used by licensees to comply with subsection (f) of this section, with other applicable provisions of this chapter, or with conditions specified in a license, shall be processed and evalu-ated by a dosimetry processor:
(A) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Pro-gram (NVLAP) of the National Institute of Standards and Technology;
(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.
(4) All individual monitoring devices shall be appropriate for the environment in which they are used.
(q) Conditions requiring individual monitoring of external and internal occupational dose. Each licensee 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) each licensee shall monitor occupational exposure to radiation and shall supply and require the use of individ-ual monitoring devices by:
(A) adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in subsection (f)(1) of this section;
(B) minors likely to receive, in one year from sources of radiation external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
(C) declared pregnant women likely to receive during the entire pregnancy, from sources of radiation external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv); and
(D) individuals entering a high or very high radiation area;
(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:
(A) the personnel are not likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in subsection (f)(1) of this section; and
(B) the licensee complies with the requirements of subsection (e)(2) of this section; and
(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:
(A) adults likely to receive, in one 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;
(B) minors likely to receive, in one year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and
(C) declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equiva-lent in excess of 0.1 rem (1 mSv).
(r) Location and use of individual monitoring devices.
(1) Each licensee 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.
(A) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the un-shielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the loca-tion of the individual monitoring device is typically at the neck (collar).
(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 pro-tective apron being worn by the woman.
(C) An individual monitoring device used for monitoring the lens 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.
(D) An individual monitoring device used for monitoring the dose to the skin of the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii) of this section, shall be worn on the skin of 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 skin of the extremity being monitored.
(E) An individual monitoring device shall be assigned to and worn by only one individual.
(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 three months, whichever is more restrictive.
(2) Each licensee shall ensure that individual monitoring devices are returned to the dosimetry processor for proper processing.
(3) Each licensee shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individ-ual monitoring device.
(s) Control of access to high radiation areas.
(1) The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features:
(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;
(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
(C) entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
(2) In place of the controls required by paragraph (1) of this subsection for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
(3) The licensee may apply to the agency for approval of alternative methods for controlling access to high radia-tion areas.
(4) The licensee 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) The licensee is not required to control each entrance or access point to a room or other area that is a high ra-diation 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:
(A) the packages do not remain in the area longer than three days; and
(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) 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 sources of radiation in excess of the estab-lished limits in this section and to operate within the ALARA provisions of the licensee's radiation protection program.
(t) Control of access to very high radiation areas. In addition to the requirements in subsection (s) of this section, the licensee 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.
(u) Control of access to very high radiation areas for irradiators.
(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 radia-tion 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) 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.
(A) Each entrance or access point shall be equipped with entry control devices that: (i) function automatically to prevent any individual from inadvertently entering a very high radiation area; (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 (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.
(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: (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 (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.
(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: (i) the radiation level from the source of radiation is reduced be-low 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 (ii) conspicuous visible and audible alarm signals are generated to make potentially affected individu-als 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.
(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.
(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.
(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.
(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.
(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.
(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. (i) Testing shall be conducted prior to initial opera-tion with the source of radiation on any day, unless operations were continued uninterrupted from the previous day. (ii) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional in-terruption. (iii) The licensee shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.
(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.
(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) Licensees or applicants for licenses for sources of radiation within the purview of paragraph (2) of this subsec-tion 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) 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.
(v) Use of process or other engineering controls. The licensee shall use, to the extent practicable, process or other engineering controls, such as containment, decontamination, or ventilation, to control the concentrations of radioac-tive material in air.
(w) Use of other controls.
(1) When it is not practicable to apply process or other engineering controls to control the concentrations of ra-dioactive 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:
(A) control of access;
(B) limitation of exposure times;
(C) use of respiratory protection equipment; or
(D) other controls.
(2) If the licensee performs an ALARA analysis to determine whether respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee shall also consider the impact of respirator use on workers' industrial health and safety.
(x) Use of individual respiratory protection equipment.
(1) If the licensee uses respiratory protection equipment to limit intakes of radioactive material in accordance with subsection (w) of this section, the licensee shall do the following.
(A) Except as provided in subparagraph (B) of this paragraph, the licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH).
(B) If the licensee wishes to use equipment that has not been tested or certified by the NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the agency 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.
(C) The licensee shall implement and maintain a respiratory protection program that includes: (i) air sampling suf-ficient to identify the potential hazard, permit proper equipment selection, and estimate doses; (ii) surveys and bioas-says, as appropriate, to evaluate actual intakes; (iii) testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; (iv) written procedures regarding the fol-lowing:
(I) monitoring, including air sampling and bioassays;
(II) supervision and training of respirator users;
(III) fit testing;
(IV) respirator selection;
(V) breathing air quality;
(VI) inventory and control;
(VII) storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;
(VIII) recordkeeping; and
(IX) limitations on periods of respirator use and relief from respirator use; (v) determination by a physician prior to initial fitting of a face sealing respirator and the first field use of non-face sealing respirators, and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment; and (vi) fit testing, with fit factor > 10 times the APF for negative pressure devices, and a fit factor > 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing shall be performed with the facepiece operating in the negative pressure mode.
(D) The licensee shall advise each respirator user that the user may leave the area at any time for relief from res-pirator 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.
(E) The licensee shall use respiratory protection equipment within the equipment manufacturer's expressed limi-tations for type and mode of use and shall provide for vision correction, adequate communication, low-temperature work environment, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
(F) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided indi-vidual may have difficulty extricating himself or herself. The standby persons shall be equipped with respiratory pro-tection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
(G) Atmosphere-supplying respirators shall be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (Title 29, CFR, § 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include: (i) oxygen content (volume/volume) of 19.5-23.5%; (ii) hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less; (iii) carbon monoxide (CO) content of 10 parts per million (ppm) or less; (iv) carbon dioxide content of 1,000 ppm or less; and (v) lack of noticeable odor.
(H) the licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face-facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.
(I) In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radio-active material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
(2) The agency may impose restrictions in addition to those in paragraph (1) of this subsection, subsection (w) of this section, and subsection (ggg)(1) of this section, in order to:
(A) ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and
(B) limit the extent to which a licensee may use respiratory protection equipment instead of process or other en-gineering controls.
(3) The licensee shall obtain authorization from the agency before assigning respiratory protection factors in ex-cess of those specified in subsection (ggg)(1) of this section. The agency may authorize a licensee to use higher protec-tion factors on receipt of an application that:
(A) describes the situation for which a need exists for higher protection factors; and
(B) demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
(y) Security and control of licensed sources of radiation.
(1) The licensee shall secure radioactive material from unauthorized removal or access.
(2) The licensee shall maintain constant surveillance, using devices and/or administrative procedures to prevent unauthorized access to use of radioactive material that is in an unrestricted area and that is not in storage.
(3) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.
(z) Caution signs.
(1) Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors ma-genta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:
[See table, form or illustration in printed version]
(A) the cross-hatched area of the symbol is to be magenta, or purple, or black; and
(B) the background of the symbol is to be yellow.
(2) Notwithstanding the requirements of paragraph (1) of this subsection, licensees are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.
(aa) Posting requirements.
(1) The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
(2) The licensee 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) The licensee 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 may omit the word "GRAVE" from the sign or signs.
(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) The licensee shall post each area or room in which there is used or stored an amount of licensed material ex-ceeding 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)."
(bb) Exceptions to posting requirements.
(1) A licensee 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:
(A) the sources of radiation are constantly attended during these periods by an individual who takes the precau-tions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in this section; and
(B) the area or room is subject to the licensee's control.
(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 licensee control in accordance with this chapter.
(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.
(4) Rooms in medical facilities that are used for teletherapy are exempt from the requirement to post caution signs in accordance with subsection (aa) of this section provided the following conditions are met.
(A) Access to the room is controlled in accordance with this chapter; and
(B) Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this section.
(cc) Labeling containers.
(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) 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.
(dd) Exemptions to labeling requirements. A licensee is not required to label:
(1) containers holding licensed material in quantities less than the quantities listed in subsection (ggg)(3) of this section;
(2) containers holding licensed material in concentrations less than those specified in Table III of subsection (ggg)(2) of this section;
(3) containers attended by an individual who takes the precautions necessary to prevent the exposure of individ-uals in excess of the limits established by this section;
(4) containers when they are in transport and packaged and labeled in accordance with the rules of the DOT (la-beling of packages containing radioactive materials is required by the DOT if the amount and type of radioactive mate-rial 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) 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) installed manufacturing or process equipment, such as piping and tanks.
(ee) Procedures for receiving and opening packages.
(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(ee)(6) of this title (relating to Packaging and Transportation of Radioactive Material), shall make arrangements to receive:
(A) the package when the carrier offers it for delivery; or
(B) the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
(2) Each licensee shall:
(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 Title 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;
(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(ee)(6) of this title; and
(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) 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 three 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 three hours from the beginning of the next working day. If the licensee discovers there is evi-dence of degradation of package integrity, such as a package that is crushed, wet, or damaged, the package shall be surveyed immediately.
(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.
(A) Limits for removable radioactive surface contamination levels. (i) The level of removable radioactive contami-nation on the external surfaces of each package offered for shipment shall be ALARA. The level of removable radioac-tive contamination may be determined by wiping an area of 300 square centimeters (cm2) 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 10 times the limits listed in clause (ii) of this subparagraph. (ii) Removable external radioactive contamination wipe limits are as follows.
[See table, form or illustration in printed version] (iii) In the case of packages transported as exclusive use shipments by rail or highway only, the removable radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in clause (ii) of this subparagraph. The levels at the beginning of transport must not exceed the levels in clause (ii) of this subparagraph.
(B) Limits for external radiation levels. (i) External radiation levels around the package and around the vehicle, if applicable, will not exceed 200 millirems per hour (mrem/hr) (2 millisieverts per hour (mSv/hr)) at any point on the external surface of the package at any time during transportation. The transport index shall not exceed 10. (ii) For a package transported in exclusive use by rail, highway or water, radiation levels external to the package may exceed the limits specified in clause (i) of this subparagraph but shall not exceed any of the following:
(I) 200 mrem/hr (2 mSv/hr) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 1,000 mrem/hr (10 mSv/hr):
(-a-) the shipment is made in a closed transport vehicle;
(-b-) provisions are made to secure the package so that its position within the vehicle remains fixed during trans-portation; and
(-c-) there are no loading or unloading operations between the beginning and end of the transportation;
(II) 200 mrem/hr (2 mSv/hr) at any point on the outer surface of the vehicle, including the upper and lower sur-faces, or, in the case of a flat-bed style vehicle, with a personnel barrier, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load (or enclosure, if used), and on the lower external surface of the vehicle (a flat-bed style vehicle with a personnel barrier shall have radiation levels determined at vertical planes. If no personnel barrier, the package cannot exceed 200 mrem/hr (2 mSv/hr) at the surface.);
(III) 10 mrem/hr (0.1 mSv/hr) at any point 2 m from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point 2 m from the vertical planes projected from the outer edges of the vehicle; and
(IV) 2 mrem/hr (0.02 mSv/hr) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training in accordance with § 289.203(c) of this title (relating to Notices, Instructions, and Reports to Workers; Inspections).
(5) Each licensee shall:
(A) establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
(B) ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
(6) Licensees transferring special form sources in vehicles owned or operated by the licensee to and from a work site are exempt from the contamination monitoring requirements of paragraph (2) of this subsection, but are not ex-empt from the monitoring requirement in paragraph (2) of this subsection for measuring radiation levels that ensures that the source is still properly lodged in its shield.
(ff) General requirements for waste management.
(1) Unless otherwise exempted, a licensee shall discharge, treat, or decay licensed material or transfer waste for disposal only:
(A) by transfer to an authorized recipient as provided in subsection (jj) of this section, § 289.252 of this title (re-lating to Licensing of Radioactive Material), § 289.257 of this title, § 289.259 of this title, or to the United States De-partment of Energy (DOE);
(B) by decay in storage with prior approval from the agency, except as authorized in § 289.256(ee) of this title (re-lating to Medical and Veterinary Use of Radioactive Material);
(C) by release in effluents within the limits in subsection (n) of this section; or
(D) as authorized in accordance with paragraph (2) of this subsection, and subsections (gg), (hh), and (fff) of this section.
(2) Upon agency approval, emission control dust and other material from electric arc furnaces or foundries con-taminated as a result of inadvertent melting of cesium-137 or americium-241 sources may be transferred for disposal to a hazardous waste disposal facility authorized by the Texas Commission on Environmental Quality (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.
(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: (i) the owner/operator of the electric arc furnace or foundry licensed to possess, treat or transfer ce-sium-137 or americium-241 contaminated incident-related material; or (ii) a service contractor licensed by the agency, NRC, or an agreement state to possess, treat, or transfer cesium-137 or americium-241 contaminated incident-related material.
(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.
(C) The total cesium-137 or americium-241 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 appro-priate agreement state(s) and does not exceed the total activity associated with the inadvertent melting incident.
(D) The hazardous waste disposal facility operator has been notified in writing of the impending transfer of the in-cident-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.
(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.
(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.
(G) The emission control dust and other incident-related materials that have been stabilized and packaged as de-scribed 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, or pretreatment average concentrations of americium-241 that do not exceed 3 pCi/g of material, above background.
(H) The dose rate at 3.28 feet (1 m) from the surface of any package containing stabilized waste shall not exceed 20 rem per hour or 0.20 Sv per hour, above background.
(I) The unpackaged stabilized material shall contain pretreatment average concentrations of cesium-137 that do not exceed 100 pCi/g of material, above background, or pretreatment average concentrations of americium-241 that do not exceed 3 pCi/g of material, above background.
(J) The licensee transferring the cesium-137 or americium-241 contaminated incident-related material must con-sult 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 govern-ments, 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.
(K) 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.
(L) The total incident-related cesium-137 activity described in paragraph (2) of this subsection received by a facility over its operating life shall not exceed 1 Ci (37 GBq). The total incident-related americium-241 activity described in paragraph (2) of this subsection received by a facility over its operating life shall not exceed 30 mCi (1.11MBq). The agency will maintain a record of the total incident-related cesium-137 or americium-241 activity shipped by a person licensed by the agency. Upon consultation with the Commission, the agency will determine if the total incident-related activity received by a hazardous waste disposal facility over its operating life has reached 1 Ci (37 GBq) of cesium-137 or 30 mCi (1.11MBq) of americium-241. The agency will not approve shipments of cesium-137 or americium-241 con-taminated incident-related material that will cause this limit to be exceeded.
(3) A person shall be specifically licensed to receive waste containing licensed material from other persons for:
(A) treatment prior to disposal;
(B) treatment by incineration;
(C) decay in storage;
(D) disposal at an authorized land disposal facility; or
(E) storage until transferred to a storage or disposal facility authorized to receive the waste.
(4) Byproduct material as defined in § 289.201(b)(15)(C) - (E) of this title may be disposed of in accordance with Title 10, CFR, Part 61, even though it is not defined as low level radioactive waste. Therefore, any byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under Title 10, CFR, Part 61, shall meet the requirements of this chapter.
(5) A licensee may dispose of byproduct material, as defined in § 289.201(b)(15)(C) - (E) of this title, at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law.
(6) Any licensee shipping byproduct material as defined in § 289.201(b)(15)(C) - (E) of this title intended for ulti-mate disposal at a land disposal facility licensed under Title 10, CFR, Part 61, shall document the information required on the NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with § 289.257(gg) of this title.
(gg) Discharge by release into sanitary sewerage.
(1) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satis-fied:
(A) the material is readily soluble, or is readily dispersible biological material, in water;
(B) the quantity of licensed radioactive material that the licensee releases into the sewer in one 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
(C) if more than one radionuclide is released, the following additional conditions must also be satisfied: (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 (ii) the sum of the fractions for each radionuclide required by clause (i) of this subparagraph does not exceed unity; and
(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) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (1) of this subsection.
(hh) Treatment by incineration. A licensee may treat licensed material by incineration only in the form and con-centration specified in subsection (fff)(1) of this section or as authorized by the agency.
(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.
(jj) Transfer for disposal and manifests.
(1) The control of transfers of LLRW 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) 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.
(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.
(ll) General provisions for records.
(1) Each licensee shall use the International System of Units (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 in-dicate 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 subsections (ee)(4) and (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 SI units 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) 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) The licensee shall make a clear distinction among the quantities entered on the records required by this sec-tion, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equiva-lent, deep dose equivalent, or committed effective dose equivalent.
(4) Records required in accordance with § 289.201(d) of this title, and subsections (mm) - (oo) and (ss) - (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) Copies of records required in accordance with § 289.201(d) of this title, and subsections (mm) - (uu) of this section, and by license 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.
(mm) Records of radiation protection programs.
(1) Each licensee shall maintain records of the radiation protection program, including:
(A) the provisions of the program; and
(B) audits and other reviews of program content and implementation.
(2) The licensee shall retain the records required by paragraph (1)(A) of this subsection until the agency termi-nates each pertinent license requiring the record. The licensee shall retain the records required by paragraph (1)(B) of this subsection for three years after the record is made.
(nn) Records of surveys.
(1) Each licensee shall maintain records showing the results of surveys and calibrations required by subsections (p) and (ee)(2) of this section and include a unique identification of survey instrument(s). The licensee shall retain these records for three years after the record is made.
(2) The licensee shall retain each of the following records until the agency terminates each pertinent license re-quiring the record:
(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
(B) results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; and
(C) results of air sampling, surveys, and bioassays required in accordance with subsection (x)(1)(C)(i) and (ii) of this section; and
(D) results of measurements and calculations used to evaluate the release of radioactive effluents to the envi-ronment.
(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 five years after the records are made.
(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 BRC Form 202-2 or equivalent until the agency terminates each pertinent license requiring this record. The licensee shall retain records used in pre-paring BRC Form 202-2 or equivalent for three years after the record is made.
(qq) Records of planned special exposures.
(1) For each use of the provisions of subsection (k) of this section for planned special exposures, the licensee shall maintain records that describe:
(A) the exceptional circumstances requiring the use of a planned special exposure;
(B) the name of the management official who authorized the planned special exposure and a copy of the signed authorization;
(C) what actions were necessary;
(D) why the actions were necessary;
(E) what precautions were taken to assure that doses were maintained ALARA;
(F) what individual and collective doses were expected to result; and
(G) the doses actually received in the planned special exposure.
(2) The licensee shall retain the records until the agency terminates each pertinent license requiring these rec-ords.
(rr) Records of individual monitoring results.
(1) Each licensee 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, acci-dents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before Janu-ary 1, 1994, need not be changed. These records shall include, when applicable:
(A) the deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;
(B) the estimated intake of radionuclides, see subsection (g) of this section;
(C) the committed effective dose equivalent assigned to the intake of radionuclides;
(D) the specific information used to calculate the committed effective dose equivalent in accordance with subsec-tion (i)(1) and (3) of this section and when required by subsection (q)(1) of this section;
(E) the total effective dose equivalent when required by subsection (g) of this section;
(F) the total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose; and
(G) the data used to make occupational dose assessments in accordance with subsection (j)(5) of this section.
(2) The licensee shall make entries of the records specified in paragraph (1) of this subsection at intervals not to exceed 1 year and by April 30 of the following year.
(3) The licensee shall maintain the records specified in paragraph (1) of this subsection on BRC Form 202-3, in ac-cordance with the instructions for BRC Form 202-3, or in clear and legible records containing all the information re-quired by BRC Form 202-3.
(4) The licensee 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) The licensee shall retain each required form or record until the agency terminates each pertinent license re-quiring the record. The licensee shall retain records used in preparing BRC Form 202-3 or equivalent for three years after the record is made.
(ss) Records of dose to individual members of the public.
(1) Each licensee shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See subsection (n) of this section.
(2) The licensee shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license requiring the record.
(tt) Records of discharge, treatment, or transfer for disposal.
(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) The licensee shall retain the records required by paragraph (1) of this subsection until the agency terminates each pertinent license requiring the record.
(uu) Records of testing entry control devices for very high radiation areas.
(1) Each licensee 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) The licensee shall retain the records required by paragraph (1) of this subsection for three years after the rec-ord is made.
(vv) Form of records. Each record required by this chapter shall be legible throughout the specified retention pe-riod. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is au-thenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the re-quired 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 specifi-cations, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(ww) Reports of stolen, lost, or missing licensed sources of radiation.
(1) Each licensee shall report to the agency by telephone as follows:
(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
(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.
(2) Each licensee 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:
(A) a description of the licensed source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form;
(B) a description of the circumstances under which the loss or theft occurred;
(C) a statement of disposition, or probable disposition, of the licensed source of radiation involved;
(D) exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible to-tal effective dose equivalent to persons in unrestricted areas;
(E) actions that have been taken, or will be taken, to recover the source of radiation; and
(F) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed sources of radiation.
(3) Subsequent to filing the written report, the licensee shall also report additional substantive information on the loss or theft within 30 days after the licensee learns of such information.
(4) The licensee 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.
(xx) Notification of incidents.
(1) Notwithstanding other requirements for notification, each licensee shall immediately report each event in-volving a source of radiation possessed by the licensee that may have caused or threatens to cause:
(A) an individual, except a patient administered radiation for purposes of medical diagnosis or therapy, to receive: (i) a total effective dose equivalent of 25 rems (0.25 Sv) or more; (ii) a lens dose equivalent of 75 rems (0.75 Sv) or more; or (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
(B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been pre-sent 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) Each licensee shall, within 24 hours of discovery of the event, report to the agency each event involving loss of control of a licensed source of radiation possessed by the licensee that may have caused, or threatens to cause:
(A) an individual to receive, in a period of 24 hours: (i) a total effective dose equivalent exceeding 5 rems (0.05 Sv); (ii) a lens dose equivalent exceeding 15 rems (0.15 Sv); or (iii) a shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rems (0.5 Sv); or
(B) the release of radioactive material, inside or outside of a restricted area, so that, had an individual been pre-sent 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 pro-cess enclosures.
(3) Licensees 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) The licensee 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) 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.
(6) Each licensee shall notify the agency as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radioactive materials that could exceed regulatory limits or releases of radioactive materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).
(7) Each licensee shall notify the agency within 24 hours after the discovery of any of the following events involving radioactive material:
(A) an unplanned contamination event that: (i) requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (ii) involves a quantity of material greater than five times the lowest annual limit on intake specified in subsection (ggg)(2) of this section for the material; and (iii) has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
(B) an event in which equipment is disabled or fails to function as designed when: (i) the equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (ii) the equipment is required to be avail-able and operable when it is disabled or fails to function; and (iii) no redundant equipment is available and operable to perform the required safety function;
(C) an event that requires unplanned medical treatment at a medical facility of an individual with spreadable ra-dioactive contamination on the individual's clothing or body; or
(D) an unplanned fire or explosion damaging any radioactive material or any device, container, or equipment containing radioactive material when: (i) the quantity of material involved is greater than five times the lowest annual limit on intake specified in subsection (ggg)(2) of this section for the material; and (ii) the damage affects the integrity of the radioactive material or its container.
(8) Preparation and submission of reports. Reports made by licensees in response to the requirements of para-graphs (6) and (7) of this subsection shall be made as follows.
(A) Licensees shall make reports required by paragraphs (6) and (7) of this subsection by telephone to the agency. To the extent that the information is available at the time of notification, the information provided in these reports shall include: (i) the caller's name and call back telephone number; (ii) a description of the event, including date and time; (iii) the exact location of the event; (iv) the isotopes, quantities, and chemical and physical form of the radioactive material involved; and (v) any personnel radiation exposure data available.
(B) Each licensee who makes a report required by paragraphs (6) and (7) of this subsection shall submit to the agency a written follow-up report within 30 days of the initial report. Written reports prepared in accordance with other requirements of this chapter may be submitted to fulfill this requirement if the reports contain all of the neces-sary information and the appropriate distribution is made. The reports must include the following: (i) a description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (ii) the exact location of the event; (iii) the isotopes, quantities, and chemical and physical form of the radioactive material involved; (iv) date and time of the event; (v) corrective actions taken or planned and the results of any evaluations or assessments; and (vi) the extent of exposure of individuals to radioactive materials without identification of individuals by name.
(yy) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits.
(1) In addition to the notification required by subsection (xx) of this section, each licensee shall submit a written report within 30 days after learning of any of the following occurrences:
(A) incidents for which notification is required by subsection (xx) of this section;
(B) doses in excess of any of the following: (i) the occupational dose limits for adults in subsection (f) of this sec-tion; (ii) the occupational dose limits for a minor in subsection (l) of this section; (iii) the limits for an embryo/fetus of a declared pregnant woman in subsection (m) of this section; (iv) the limits for an individual member of the public in subsection (n) of this section; (v) any applicable limit in the license; or (vi) the ALARA constraints for air emissions as required by subsection (e)(4) of this section;
(C) levels of radiation or concentrations of radioactive material in: (i) a restricted area in excess of applicable limits in the license; or (ii) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the license, whether or not involving exposure of any individual in excess of the limits in subsection (n) of this section; or
(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) 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:
(A) estimates of each individual's dose;
(B) the levels of radiation and concentrations of radioactive material involved;
(C) the cause of the elevated exposures, dose rates, or concentrations; and
(D) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving con-formance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated li-cense conditions.
(3) Each report filed in accordance with paragraph (1) of this subsection shall include for each individual exposed: the name, identification 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) All licensees who make reports in accordance with paragraph (1) of this subsection shall submit the report in writing to the agency.
(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.
(aaa) Notifications and reports to individuals.
(1) Requirements for notification and reports to individuals of exposure to sources of radiation are specified in § 289.203 of this title.
(2) When a licensee 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 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 § 289.203(d)(1) of this title.
(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 five days. The report shall include the equipment involved, the test results, the date of the test, model and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, and the corrective action taken.
(ccc) Vacating premises.
(1) Each licensee or person possessing non-exempt sources of radiation shall, no less than 30 days before vacating and relinquishing possession or control of premises, notify the agency, in writing, of the intent to vacate.
(2) The licensee or person possessing non-exempt radioactive material shall decommission the premises to a de-gree consistent with subsequent use as an unrestricted area and in accordance with the requirements of subsection (ddd) of this section.
(ddd) Radiological requirements for license termination.
(1) General provisions and scope.
(A) The requirements in this section apply to the decommissioning of facilities licensed in accordance with § 289.252 of this title, § 289.255 of this title, and § 289.258 of this title (relating to Licensing and Radiation Safety Re-quirements for Irradiators).
(B) The requirements in this section do not apply to the following: (i) sites that have been decommissioned prior to October 1, 2000, in accordance with requirements identified in this section and in § 289.252 of this title; or (ii) sites that have previously submitted and received approval on a decommissioning plan by October 1, 2000.
(C) After a site has been decommissioned and the license terminated in accordance with the requirements in the subsection, the agency will require additional cleanup if it determines that the requirements of the subsection were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.
(D) When calculating TEDE to the average member of the critical group, the licensee shall determine the peak annual TEDE dose expected within the first 1,000 years after decommissioning.
(2) Radiological requirements for unrestricted use. A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are ALARA. Determination of the levels that are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.
(3) Alternate requirements for license termination.
(A) The agency may terminate a license using alternate requirements greater than the dose requirements speci-fied in paragraph (2) of this subsection if the licensee does the following: (i) provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 1 mSv per year (100 mrem per year) limit specified in subsection (o) of this section, by submitting an analysis of possible sources of exposure; (ii) reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal; and (iii) has submitted a decommissioning plan to the agency indicating the licensee's intent to decommission in accordance with the requirements in § 289.252(l)(7) of this title, and specifying that the licensee proposes to decommission by use of alternate requirements. The licensee shall document in the decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for the following:
(I) participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;
(II) an opportunity for a comprehensive, collective discussion on the issues by the participants represented; and
(III) a publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.
(B) The use of alternate requirements to terminate a license requires the approval of the agency after considera-tion of the agency's recommendations that will address any comments provided by the EPA and any public comments submitted in accordance with paragraph (4) of this subsection.
(4) Public notification and public participation. Upon receipt of a decommissioning plan from the licensee, or a proposal from the licensee for release of a site in accordance with paragraph (3) of this subsection, or whenever the agency deems such notice to be in the public interest, the agency will do the following:
(A) notify and solicit comments from the following: (i) local and state governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the de-commissioning; and (ii) the EPA for cases where the licensee proposes to release a site in accordance with paragraph (3) of this subsection; and
(B) publish a notice in the Texas Register and a forum, such as local newspapers, letters to state of local organiza-tions, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.
(5) Minimization of contamination. Applicants for licenses, other than renewals, after October 1, 2000, shall de-scribe in the application how facility design and procedures for operation will minimize, to the extent practical, con-tamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent prac-tical, the generation of LLRW.
(eee) Limits for contamination of soil, surfaces of facilities and equipment, and vegetation.
(1) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contami-nation of surfaces of facilities or equipment in unrestricted areas to the extent that the contamination exceeds the limits specified in subsection (ggg)(6) of this section.
(2) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contami-nation of soil in unrestricted areas, to the extent that the contamination exceeds, on a dry weight basis, the concen-tration limits specified in:
(A) subsection (ddd) of this section; or
(B) the effluent concentrations in Table II, Column 2 of subsection (ggg)(2)(F) of this section, with the units changed from microcuries per milliliter to microcuries per gram, for radionuclides not specified in paragraph (4) of this subsection.
(3) Where combinations of radionuclides are involved, the sum of the ratios between the concentrations present and the limits specified in paragraph (2) of this subsection shall not exceed one.
(4) Notwithstanding the limits specified in paragraph (2) of this subsection, no licensee shall cause the concentra-tion of radium-226 or radium-228 in soil in unrestricted areas, averaged over any 100 square meters (m2), to exceed the background level by more than:
(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
(B) 15 pCi/g (0.555 Bq/g), averaged over 15 cm thick layers of soil more than 15 cm below the surface.
(5) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contami-nation of vegetation in unrestricted areas to exceed 5 pCi/g (0.185 Bq/g), based on dry weight, for radium-226 or ra-dium-228.
(6) Notwithstanding the limits specified in paragraph (2) of this subsection, no licensee shall cause the concentra-tion of natural uranium with no daughters present, based on dry weight and averaged over any 100 m2 of area, to exceed the following limits:
(A) 30 pCi/g (1.11 Bq/g), averaged over the top 15 cm of soil below the surface; and
(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.
(fff) Exemption of specific wastes.
(1) A licensee may discard the following licensed material without regard to its radioactivity:
(A) 0.05 microcurie (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
(B) 0.05 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) 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) The licensee shall maintain records in accordance with subsection (tt) of this section.
(4) Any licensee may, upon agency approval of procedures required in paragraph (6) of this subsection, discard li-censed 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 Reg-ulations of the authorized regulatory agency (30 Texas Administrative Code Chapter 330), unless such licensed material also contains hazardous waste, as defined in § 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) Each licensee who discards material described in paragraphs (1) or (4) of this subsection shall:
(A) make surveys adequate to assure that the limits of paragraphs (1) or (4) of this subsection are not exceeded; and
(B) remove or otherwise obliterate or obscure all labels, tags, or other markings that would indicate that the ma-terial or its contents is radioactive.
(6) Prior to authorizations in accordance with paragraph (4) of this subsection, a licensee shall submit procedures to the agency for:
(A) the physical delivery of the material to the disposal site;
(B) surveys to be performed for compliance with paragraph (5)(A) of this subsection;
(C) maintaining secure packaging during transportation to the site; and
(D) maintaining records of any discards made under paragraph (4) of this subsection.
(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) Nothing in this section relieves the licensee from complying with other applicable federal, state, and local reg-ulations governing any other toxic or hazardous property of these materials.
(9) Licensed material discarded under this section is exempt from the requirements of § 289.252(ff) of this title.
(ggg) Appendices.
(1) Assigned protection factors for respirators. The following table contains assigned protection factors for respi-ratorsa :
[See table, form or illustration in printed version]
(2) Annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage.
(A) Introduction. (i) For each radionuclide, Table I of subparagraph (F) of this paragraph indicates the chemical form that is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 micron, and for three classes (D, W, Y) of radi-oactive material, which refer to their retention (approximately days, weeks, or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. Table II of subparagraph (F) of this paragraph provides concentration limits for air-borne and liquid effluents released to the general environment. Table III of subparagraph (F) of this paragraph provides concentration limits for discharges to sanitary sewerage. (ii) The values in Tables I, II, and III of subparagraph (F) of this paragraph are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 102 or 600, and 6E+0 represents 6 x 100 or 6.
(B) Occupational values. (i) Note that the columns in Table I of subparagraph (F) of this paragraph captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive material. (ii) The ALIs in subparagraph (F) of this paragraph are the annual intakes of given radionuclide by "Reference Man" that would result in either a committed effective dose equivalent of 5 rems (0.05 Sv), stochastic ALI, or a committed dose equiva-lent of 50 rems (0.5 Sv) to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 5 rems (0.05 Sv). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, wT . This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the definition of "weighting factor" in subsection (c) of this section. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function. (iii) A value of wT = 0.06 is applicable to each of the five organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the GI tract; stomach, small intestine, upper large intestine, and lower large intestine, are to be treated as four separate organs. (iv) The dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. (v) When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used as follows:
(I) LLI wall = lower large intestine wall;
(II) St. wall = stomach wall;
(III) Blad wall = bladder wall; and
(IV) Bone surf = bone surface. (vi)
[See table, form or illustration in printed version] (vii) The dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately. (viii) The DAC values are derived limits intended to control chronic occupational exposures. The rela-tionship between the DAC and the ALI is given by:
[See table, form or illustration in printed version] (ix) The DAC values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately. (x) The ALI and DAC values include contributions to exposure by the single radionuclide named and any in-growth of daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures. (xi) The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radio-nuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See subsection (g) of this section. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as, Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different radionuclides. (xii) It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides.
(C) Effluent concentrations. (i) The columns in Table II of subparagraph (F) of this paragraph captioned "Effluents," "Air," and "Water" are applicable to the assessment and control of dose to the public, particularly in the implementa-tion of the provisions of subsection (o) of this section. The concentration values given in Columns 1 and 2 of Table II of subparagraph (F) of this paragraph are equivalent to the radionuclide concentrations which, if inhaled or ingested con-tinuously over the course of a year, would produce a total effective dose equivalent of 0.05 rem (0.5 mSv). (ii) Con-sideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual mem-bers of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table II of subparagraph (F) of this paragraph. For this reason, the DAC and airborne effluent limits are not always proportional as they were in the pre-vious radiation protection standards. (iii) The air concentration values listed in Column I of Table II of subparagraph (F) of this paragraph were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 109 , relating the inhalation ALI to the DAC, as explained in subparagraph (B)(viii) of this paragraph, and then divided by a factor of 300. The factor of 300 includes the following components:
(I) a factor of 50 to relate the 5 rems (0.05 Sv) annual occupational dose limit to the 0.1 rem limit for members of the public;
(II) a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and
(III) a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups. (iv) For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Column 3 of Table I of subparagraph (F) of this paragraph was divided by 219. The factor of 219 is composed of a factor of 50, as described in clause (iii) of this subparagraph, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case. (v) The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 107 . The factor of 7.3 x 107 milliliters (ml) includes the following components:
(I) the factors of 50 and 2 described in clause (iii) of this subparagraph; and
(II) a factor of 7.3 x 105 (ml) which is the annual water intake of "Reference Man." (vi) Note 2 of subparagraph (F) of this paragraph provides groupings of radionuclides that are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations, and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements.
(D) Releases to sewers. The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in subsection (gg) of this section. The concentration values were derived by taking the most restrictive oc-cupational stochastic oral ingestion ALI and dividing by 7.3 x 106 (ml). The factor of 7.3 x 106 (ml) is composed of a factor of 7.3 x 105 (ml), the annual water intake by "Reference Man," and a factor of 10, such that the concentrations, if the sewage released by the licensee were the only source of water ingested by a "Reference Man" during a year, would result in a committed effective dose equivalent of 0.5 rem.
(E) List of elements.
[See table, form or illustration in printed version]
(F) Tables--Values for annual limits. The following tables contain values for annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage:
[See table, form or illustration in printed version]
(3) Quantities of licensed material requiring labeling. The following tables contain quantities of licensed material requiring labeling:
[See table, form or illustration in printed version]
(4) Classification and characteristics of low-level radioactive waste (LLRW).
(A) Classification of radioactive waste for land disposal. (i) Considerations. Determination of the classification of LLRW involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective. (ii) Classes of waste.
(I) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in subparagraph (B)(i) of this paragraph. If Class A waste also meets the stability requirements set forth in subparagraph (B)(ii) of this paragraph, it is not necessary to segregate the waste for disposal.
(II) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph.
(III) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in subparagraph (B) of this paragraph. (iii) Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in subclause (V) of this clause, classification shall be determined as follows.
(I) If the concentration does not exceed 0.1 times the value in subclause (V) of this clause, the waste is Class A.
(II) If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value in subclause (V) of this clause, the waste is Class C.
(III) If the concentration exceeds the value in subclause (V) of this clause, the waste is not generally acceptable for land disposal.
(IV) For wastes containing mixtures of radionuclides listed in subclause (V) of this clause, the total concentration shall be determined by the sum of fractions rule described in clause (vii) of this subparagraph.
(V) Classification table for long-lived radionuclides.
[See table, form or illustration in printed version] (iv) Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in clause (iii)(V) of this subparagraph, classification shall be de-termined based on the concentrations shown in subclause (VI) of this clause. However, as specified in clause (vi) of this subparagraph, if radioactive waste does not contain any nuclides listed in either clause (iii)(V) of this subparagraph or subclause (VI) of this clause, it is Class A.
(I) If the concentration does not exceed the value in Column 1 of subclause (VI) of this clause, the waste is Class A.
(II) If the concentration exceeds the value in Column 1 of subclause (VI) of this clause but does not exceed the value in Column 2 of subclause (VI) of this clause, the waste is Class B.
(III) If the concentration exceeds the value in Column 2 of subclause (VI) of this clause but does not exceed the value in Column 3 of subclause (VI) of this clause, the waste is Class C.
(IV) If the concentration exceeds the value in Column 3 of subclause (VI) of this clause, the waste is not generally acceptable for near-surface disposal.
(V) For wastes containing mixtures of the radionuclides listed in subclause (VI) of this clause, the total concentra-tion shall be determined by the sum of fractions rule described in clause (vii) of this subparagraph.
(VI) Classification table for short-lived radionuclides.
[See table, form or illustration in printed version] (v) Classification determined by both long- and short-lived radionu-clides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in clause (iii)(V) of this subparagraph and some of which are listed in clause (iv)(VI) of this subparagraph, classification shall be determined as follows:
(I) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph is less than 0.1 times the value listed in clause (iii)(V) of this subparagraph, the class shall be that determined by the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph.
(II) If the concentration of a radionuclide listed in clause (iii)(V) of this subparagraph exceeds 0.1 times the value listed in clause (iii)(V) of this subparagraph, but does not exceed the value listed in clause (iii)(V) of this subparagraph, the waste shall be Class C, provided the concentration of radionuclides listed in clause (iv)(VI) of this subparagraph does not exceed the value shown in Column 3 of clause (iv)(VI) of this subparagraph. (vi) Classification of wastes with radionuclides other than those listed in clauses (iii)(V) and (iv)(VI) of this subparagraph. If the waste does not contain any radionuclides listed in either clauses (iii)(V) and (iv)(VI) of this subparagraph, it is Class A. (vii) The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of ra-dionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the ap-propriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 curies per cubic meter (Ci/m3 (1.85 terabecquerels per cubic meter (TBq/m3 )) and Cs-137 in a concentration of 22 Ci/m3 (814 gigabecquerels per cubic meter (GBq/m3 )). Since the concentrations both exceed the values in Column 1 of clause (iv)(VI) of this subparagraph, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B. (viii) Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors, which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocurie (becquerel) per gram.
(B) Radioactive waste characteristics. (i) The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site.
(I) Wastes shall be packaged in conformance with the conditions of the license issued to the site operator to which the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of this section, the site license conditions shall govern.
(II) Wastes shall not be packaged for disposal in cardboard or fiberboard boxes.
(III) Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid.
(IV) Solid waste containing liquid shall contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume.
(V) Waste shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.
(VI) Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with subclause (VIII) of this clause.
(VII) Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable.
(VIII) Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total activity shall not exceed 100 Ci (3.7 terabecquerels (TBq)) per container.
(IX) Wastes containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials. (ii) The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.
(I) Waste shall have structural stability. A structurally stable waste form will generally maintain its physical dimen-sions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.
(II) Notwithstanding the provisions in clause (i)(III) and (IV) of this subparagraph, liquid wastes, or wastes containing liquid, shall be converted into a form that contains as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.
(III) Void spaces within the waste and between the waste and its package shall be reduced to the extent practica-ble.
(C) Labeling. Each package of waste shall be clearly labeled to identify whether it is Class A, Class B, or Class C waste, in accordance with subparagraph (A) of this paragraph.
(5) Time requirements for record keeping.
[See table, form or illustration in printed version]
(6) Acceptable surface contamination limits.
[See table, form or illustration in printed version]
(7) Concentration and activity limits of nuclides for disposal in a Type I municipal solid waste site or a hazardous waste facility (for use in subsection (fff) of this section). The following table contains concentration and activity limits of nuclides for disposal in a Type I municipal solid waste site or a hazardous waste facility.
[See table, form or illustration in printed version]
(8) Cumulative occupational exposure form. The following, RC Form 202-2, or other equivalent clear and legible record, of all the information required on that form, is to be used to document cumulative occupational exposure his-tory: (Please find RC Form 202-2 at the end of this section.)
[See table, form or illustration in printed version]
(9) Occupational exposure form. The following, RC Form 202-3, or other equivalent clear and legible record, of all the information required on that form, is to be used to document occupational exposure record for a monitoring pe-riod: (Please find RC Form 202-3 at the end of this section.)
[See table, form or illustration in printed version]
(hhh) Requirements for nationally tracked sources.
(1) Reports of transactions involving nationally tracked sources. Each licensee who manufactures, transfers, re-ceives, disassembles, or disposes of a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report as specified in the following subparagraphs for each type of transaction.
(A) Each licensee who manufactures a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report. The report shall include the following information: (i) the name, address, and li-cense number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the manufacturer, model, and serial number of the source; (iv) the radioactive material in the source; (v) the initial source strength in becquerels (curies) at the time of manufacture; and (vi) the manufacture date of the source.
(B) Each licensee that transfers a nationally tracked source to another person shall complete and submit to NRC a National Source Tracking Transaction Report. A source transfer transaction does not include transfers to a temporary domestic job site. Domestic transactions in which the nationally tracked source remains in the possession of the li-censee do not require a report to the National Source Tracking System. The report shall include the following infor-mation: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the name and license number of the recipient facility and the shipping address; (iv) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (v) the radioactive material in the source; (vi) the initial or current source strength in becquerels (curies); (vii) the date for which the source strength is reported; (viii) the shipping date; (ix) the estimated arrival date; and (x) for nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification of the container with the nationally tracked source.
(C) Each licensee that receives a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report. The report shall include the following information: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the name, address, and li-cense number of the person that provided the source; (iv) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (v) the radioactive material in the source; (vi) the initial or current source strength in becquerels (curies); (vii) the date for which the source strength is reported; (viii) the date of receipt; and (ix) for material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.
(D) Each licensee that disassembles a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report. The report shall include the following information: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (iv) the radioactive material in the source; (v) the initial or current source strength in becquerels (curies); (vi) the date for which the source strength is reported; and (vii) the disassemble date of the source.
(E) Each licensee who disposes of a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report. The report shall include the following information: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the waste manifest number; (iv) the container identification with the nationally tracked source; (v) the date of disposal; and (vi) the method of disposal.
(F) The reports discussed in subparagraphs (A) - (E) of this paragraph shall be submitted to NRC by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports shall be submitted to the National Source Tracking System by using the following: (i) the on-line National Source Tracking System; (ii) electronically using a computer-readable format; (iii) by facsimile; (iv) by mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or (v) by telephone with follow-up by facsimile or mail.
(G) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within 5 business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation shall be conducted during the month of January in each year. The reconciliation process shall include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subparagraphs (A) - (E) of this paragraph. By January 31 of each year, each licensee shall submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.
(H) Each licensee that possesses Category 1 or Category 2 nationally tracked sources listed in paragraph (2) of this subsection shall report its initial inventory of Category 1 or Category 2 nationally tracked sources to the National Source Tracking System by January 31, 2009. The information may be submitted to NRC by using any of the methods identified by subparagraph (F)(i) - (iv) of this paragraph. The initial inventory report shall include the following information: (i) the name, address, and license number of the reporting licensee; (ii) the name of the individual preparing the report; (iii) the manufacturer, model, and serial number of each nationally tracked source or, if not available, other information to uniquely identify the source; (iv) the radioactive material in the sealed source; (v) the initial or current source strength in becquerels (curies); and (vi) the date for which the source strength is reported.
(2) Nationally tracked source thresholds. The Terabecquerel (TBq) values are the regulatory standards. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical useful-ness only and are rounded after conversion.
[See table, form or illustration in printed version]
(3) Serialization of nationally tracked sources. Each licensee who manufactures a nationally tracked source after February 6, 2007, shall assign a unique serial number to each nationally tracked source. Serial numbers shall be com-posed only of alpha-numeric characters.
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