D
Selected Sections of the United States Code of Federal Regulations1

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10 CFR Part 20 (Standards for Protection Against Radiation) and 10 CFR Part 35 (Medical Use of Byproduct Material)



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Radiation in Medicine: A Need for Regulatory Reform D Selected Sections of the United States Code of Federal Regulations1 1   10 CFR Part 20 (Standards for Protection Against Radiation) and 10 CFR Part 35 (Medical Use of Byproduct Material)

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Radiation in Medicine: A Need for Regulatory Reform (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55071, Nov. 24, 1992] § 19.31 Application for exemptions The Commission may upon application by any licensee or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not result in undue hazard to life or property. § 19.32 Discrimination prohibited No person shall on the ground of sex be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity licensed by the Nuclear Regulatory Commission. This provision will be enforced through agency provisions and rules similar to those already established, with respect to racial and other discrimination, under title VI of the Civil Rights Act of 1964. This remedy is not exclusive, however, and will not prejudice or cut off any other legal remedies available to a discriminate. [40 FR 8783, Mar. 3, 1975] § 19.40 Criminal penalties (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 19 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 19 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 19.1, 19.2, 19.3, 19.4, 19.5, 19.8, 19.16, 19.17, 19.18, 19.30, 19.31, and 19.40. [57 FR 55071, Nov. 24, 1992] Part 20—Standards For Protection Against Radiation Subpart A—General Provisions Sec.   20.1001 Purpose. 20.1002 Scope. 20.1003 Definitions. 20.1004 Units of radiation dose. 20.1005 Units of radioactivity. 20.1006 Interpretations. 20.1007 Communications. 20.1008 [Reserved] 20.1009 Reporting, recording, and application requirements: OMB approval. Subpart B—Radiation Protection Programs 20.1101 Radiation protection programs. Subpart C—Occupational Dose Limits 20.1201 Occupational dose limits for adults. 20.1202 Compliance with requirements for summation of external and internal doses. 20.1203 Determination of external dose from airborne radioactive material. 20.1204 Determination of internal exposure. 20.1205 [Reserved] 20.1206 Planned special exposures. 20.1207 Occupational dose limits for minors. 20.1208 Dose to an embryo/fetus. Subpart D—Radiation Dose Limits for Individual Members of the Public 20.1301 Dose limits for individual members of the public. 20.1302 Compliance with dose limits for individual members of the public. Subpart E—(Reserved) Subpart F—Surveys and Moniforing 20.1501 General. 20.1502 Conditions requiring individual monitoring of external and internal occupational dose. Subpart G—Control of Exposure From External Sources in Restricted Areas 20.1601 Control of access to high radiation areas. 20.1602 Control of access to very high radiation areas.

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Radiation in Medicine: A Need for Regulatory Reform Subpart H—Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas 20.1701 Use of process or other engineering controls. 20.1702 Use of other controls. 20.1703 Use of individual respiratory protection equipment. 20.1704 Further restrictions on the use of respiratory protection equipment. Subpart I—Storage and Control of Licensed Material 20.1801 Security of stored material. 20.1802 Control of material not in storage. Subpart J—Precautionary Procedures 20.1901 Caution signs. 20.1902 Posting requirements 20.1903 Exceptions to posting requirements. 20.1904 Labeling containers. 20.1905 Exemptions to labeling requirements. 20.1906 Procedures for receiving and opening packages. Subpart K—Waste Disposal 20.2001 General requirements. 20.2002 Method for obtaining approval of proposed disposal procedures. 20.2003 Disposal by release into sanitary sewerage. 20.2004 Treatment or disposal by incineration. 20.2005 Disposal of specific wastes. 20.2006 Transfer for disposal and manifests. 20.2007 Compliance with environmental and health protection regulations. Subpart L—Records 20.2101 General provisions. 20.2102 Records of radiation protection programs. 20.2103 Records of surveys. 20.2104 Determination of prior occupational dose. 20.2105 Records of planned special exposures. 20.2106 Records of individual monitoring results. 20.2107 Records of dose to individual members of the public. 20.2108 Records of waste disposal. 20.2109 [Reserved] 20.2110 Form of records. Subpart M—Reports 20.2201 Reports of theft or loss of licensed material. 20.2202 Notification of incidents. 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits. 20.2204 Reports of planned special exposures. 20.2205 [Reserved] 20.2206 Reports of individual monitoring. Subpart N—Exemptions and Additional Requirements 20.2301 Applications for exemptions. 20.2302 Additional requirements. Subpart O—Enforcement 20.2401 Violations. 20.2402 Criminal penalties. APPENDIX A TO PART 20—PROTECTION FACTORS FOR RESPIRATORS APPENDIX B TO PART 20—ANNUAL LIMITS ON INTAKE (ALIS) AND DERIVED AIR CONCENTRATIONS (DACS) OF RADIONUCLIDES FOR OCCUPATIONAL EXPOSURE; EFFLUENT CONCENTRATIONS; CONCENTRATIONS FOR RELEASE TO SEWERAGE APPENDIX C TO PART 20—QUANTITIES OF LICENSED MATERIAL REQUIRING LABELING APPENDIX D TO PART 20—UNITED STATES NUCLEAR REGULATORY COMMISSION REGIONAL OFFICES APPENDIX E TO PART 20—[RESERVED] APPENDIX F TO PART 20—REQUIREMENTS FOR LOW-LEVEL-WASTE TRANSFER FOR DISPOSAL AT LAND DISPOSAL FACILITIES AND MANIFESTS AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (2 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). Subpart A—General Provisions SOURCE: 56 FR 23391, May 21, 1991, unless otherwise noted. § 20.1001 Purpose (a) The regulations in this part establish standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the Nuclear Regulatory Commission. These regulations are issued under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. (b) It is the purpose of the regulations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual (including doses

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Radiation in Medicine: A Need for Regulatory Reform resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation) does not exceed the standards for protection against radiation prescribed in the regulations in this part. However, nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety. § 20.1002 Scope The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under parts 30 through 36, 39, 40, 50, 60, 61, 70, or 72 of this chapter. The limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs. [56 FR 23391, May 21, 1991, as amended at 58 FR 7736, Feb. 9, 1993] § 20.1003 Definitions As used in this part: Absorbed dose means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy). Act means the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.), as amended. Activity is the rate of disintegration (transformation) or decay of radioactive material. The units of activity are the curie (Ci) and the becquerel (Bq). Adult means an individual 18 or more years of age. Airborne radioactive material means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases. Airborne radioactivity area means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations— (1) In excess of the derived air concentrations (DACs) specified in appendix B, to §§ 20.1001–20.2401, or (2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours. ALARA (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest. Annual limit on intake (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 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 Table 1, Columns 1 and 2, of appendix B to §§ 20.1001–20.2401). Background radiation means radiation from cosmic sources; naturally occurring radioactive materials, including radon (except as a decay product of source or special nuclear material) and global fallout as it exists in the environment from the testing of nuclear explosive devices. "Background radiation" does not include radiation from source, byproduct, or special nuclear materials regulated by the Commission. Bioassay (radiobioassay) means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body.

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Radiation in Medicine: A Need for Regulatory Reform Byproduct material means— (1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and (2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute ''byproduct material" within this definition. Class (or lung class or inhalation class) means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days. Collective dose is the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation. Commission means the Nuclear Regulatory Commission or its duly authorized representatives. Committed dose equivalent (HT,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake. Committed effective dose equivalent (HE.50) is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE.50 = ∑WTHT.50). Controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason. Declared pregnant woman means a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception. Deep-dose equivalent (Hd), which applies to external whole body exposure, is the dose equivalent at a tissue depth of 1 cm (1000 mg/cm2). Department means the Department of Energy established by the Department of Energy Organization Act (Pub. L. 95–91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers, and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104 (b), (c), and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93–438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95–91, 91 Stat 565 at 577–578, 42 U.S.C. 7151). Derived air concentration (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table 1, Column 3, of appendix B to §§ 20.1001–20.2401. Derived air concentration-hour (DAC-hour) is 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 one ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv). Dose or radiation dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent, as defined in other paragraphs of this section. Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv).

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Radiation in Medicine: A Need for Regulatory Reform Dosimetry processor means an individual or organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the equipment. Effective dose equivalent (HE) is the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (WT) applicable to each of the body organs or tissues that are irradiated (HE = ∑WTHT). Embryo/fetus means the developing human organism from conception until the time of birth. Entrance or access point means any location through which an individual could gain access to radiation areas or to radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use. Exposure means being exposed to ionizing radiation or to radioactive material. External dose means that portion of the dose equivalent received from radiation sources outside the body. Extremity means hand, elbow, arm below the elbow, foot, knee, or leg below the knee. Eye dose equivalent applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2). Generally applicable environmental radiation standards means standards issued by the Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material. Government agency means any executive department, commission, independent establishment, corporation wholly or partly owned by the United States of America, which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government. Gray [See § 20.1004]. High radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates. Individual means any human being. Individual monitoring means— (1) The assessment of dose equivalent by the use of devices designed to be worn by an individual: (2) The assessment of committed effective dose equivalent by bioassay (see Bioassay) or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e., DAC-hours; or (3) The assessment of dose equivalent by the use of survey data. Individual Monitoring Devices (individual monitoring equipment) means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal ("lapel") air sampling devices. Internal dose means that portion of the dose equivalent received from radioactive material taken into the body. License means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 70, or 72 of this chapter. Licensed material means source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the Commission. Licensee means the holder of a license. Limits (dose limits) means the permissible upper bounds of radiation doses. Lost or missing licensed material means licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system. Member of the public means an individual in a controlled or unrestricted area. However, an individual is not a member of the public during any period in which the individual receives an occupational dose.

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Radiation in Medicine: A Need for Regulatory Reform Minor means an individual less than 18 years of age. Monitoring (radiation monitoring, radiation protection monitoring) means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. Nonstochastic effect means health effects, 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 (also called a deterministic effect). NRC means the Nuclear Regulatory Commission or its duly authorized representatives. Occupational dose means the dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the general public. Person means— (1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department of Energy (except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842)), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity: and (2) Any legal successor, representative, agent, or agency of the foregoing. Planned special exposure means an infrequent exposure to radiation, separate from and in addition to the annual dose limits. Public dose means the dose received by a member of the public from exposure to radiation and to radioactive material released by a licensee, or to another source of radiation either within a licensee's controlled area or in unrestricted areas. It does not include occupational dose or doses received from background radiation, as a patient from medical practices, or from voluntary participation in medical research programs. Quality Factor (Q) means the modifying factor (listed in tables 1004(b).1 and 1004(b).2 of §20.1004) that is used to derive dose equivalent from absorbed dose. Quarter means a period of time equal to one-fourth of the year observed by the licensee (approximately 13 consecutive weeks), providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. Rad (See §20.1004). Radiation (ionizing radiation) means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation, as used in this part, does not include non-ionizing radiation, such as radioor microwaves, or visible, infrared, or ultraviolet light. Radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates. Reference man means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and

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Radiation in Medicine: A Need for Regulatory Reform to relate biological insult to a common base. Rem (see §20.1004). Respiratory protective device means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials. Restricted area means an area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. Sanitary sewerage means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee. Shallow-dose equivalent (Hs), which applies to the external exposure of the skin or an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over an area of 1 square centimeter. Sievert (See §20.1004). Site boundary means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee. Source material means— (1) Uranium or thorium or any combination of uranium and thorium in any physical or chemical form; or (2) Ores that contain, by weight, one-twentieth of 1 percent (0.05 percent), or more, of uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material. Special nuclear material means— (1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Commission, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material, but does not include source material; or (2) Any material artificially enriched by any of the foregoing but does not include source material. Stochastic effects means health effects that occur 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. Survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present. Total Effective Dose Equivalent (TEDE) means the sum of the deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). Unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Uranium fuel cycle means the operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocessing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle does not include mining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations, and the reuse of recovered non-uranium special nuclear and byproduct materials from the cycle. Very high radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a radiation source or from any surface that the radiation penetrates. (NOTE: At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts)). Week means 7 consecutive days starting on Sunday. Weighting factor wT, for an organ or tissue (T) is the proportion of the risk of stochastic effects resulting from irradiation

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Radiation in Medicine: A Need for Regulatory Reform 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: ORGAN DOSE WEIGHTING FACTORS Organ or tissue wT Gonads....................................................... 0.25 Breast......................................................... 0.15 Red bone marrow....................................... 0.12 Lung........................................................... 0.12 Thyroid....................................................... 0.03 Bone surfaces...................................................... 0.03 Remainder.................................................. 10.30 Whole Body.......................................................... 21.00 1 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive the highest doses. 2 For the purpose of weighting the external whole body dose (for adding it to the intemal dose), a single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued. Whole body means, for purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee. Working level (WL) is any combination of short-lived radon daughters (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in 1 liter of air that will result in the ultimate emission of 1.3×105 MeV of potential alpha particle energy. Working level month (WLM) means an exposure to 1 working level for 170 hours (2,000 working hours per year/12 months per year = approximately 170 hours per month). Year means the period of time beginning in January used to determine compliance with the provisions of this part. The licensee may change the starting date of the year used to determine compliance by the licensee provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years. [56 FR 23391, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 58 FR 7736, Feb. 9, 1993] §20.1004 Units of radiation dose (a) Definitions. As used in this part, the units of radiation dose are: Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 Joule/kilogram (100 rads). Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray). Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rads multiplied by the quality factor (1 rem = 0.01 sievert). Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rems). (b) As used in this part, the quality factors for converting absorbed dose to dose equivalent are shown in table 1004(b).1. (c) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in paragraph (b) of this section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of the regulations in this part, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from table 1004(b).2 to convert a measured tissue dose in rads to dose equivalent in rems. TABLE 1004(b).1—QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES Type of radiation Quality factor Absorbed dose equal to a unit dose equivalenta   (Q)   X-, gamma, or beta radiation 1 1 Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge 20 0.05 Neutrons of unknown energy 10 0.1 High-energy protons 10 0.1 a Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 sievert.

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Radiation in Medicine: A Need for Regulatory Reform TABLE 1004(b).2—MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS   Neutron energy (MeV) Quality factora (Q) Fluence per unit dose equivalentb (neutrons cm-2 rem-1) (thermai)................................ 2.5×10-8 2 980×106   1×107 2 980×106   1×10-6 2 810×106   1×10-5 2 810×106   1×104 2 840×106   1×10-3 2 980×106   1×10-2 2.5 1010×106   1×10-1 7.5 170×106   5×10-1 11 39×106   1 11 27×106   2.5 9 29×106   5 8 23×106   7 7 24×106   10 6.5 24×106   14 7.5 17×106   20 8 16×106   40 7 14×106   60 5.5 16×106   1×102 4 20×106   2×102 3.5 19×106   3×102 3.5 16×106   4×102 3.5 14×106 a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom. b Monoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom. §20.1005 Units of radioactivity For the purposes of this part, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multiples, or disintegrations (transformations) per unit of time. (a) One becquerel = 1 disintegration per second (s-1). (b) One curie = 3.7×1010 disintegrations per second = 3.7×1010 becquerels = 2.22×1012 disintegrations per minute. [56 FR 23391, May 21, 1991; 56 FR 61352, Dec. 3, 1991] §20.1006 Interpretations Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. §20.1007 Communications Unless otherwise specified, communications or reports concerning the regulations in this part should be addressed to the Executive Director for Operations. U.S. Nuclear Regulatory Commission, Washington. DC 20555. A communication, report, or application may be delivered in person to the Office of the Executive Director for Operations, 11555 Rockville Pike. Rockville, MD 20852. §20.1008—[Reserved] §20.1009 Reporting, recording, and application requirements: OMB approval The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number 3150–0014. The approved information collection requirements contained in this part appear in §§20.1101, 20.1202, 20.1204, 20.1206, 20.1301, 20.1501, 20.1601, 20.1703, 20.1901, 20.1902, 20.1904, 20.1906, 20.2002, 20.2004, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2206, and appendix F to 20.1001–20.2401. This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows: In §20.2104, NRC Form 4 is approved under control number 3150–0005. In §§20.2106 and 20.2206, NRC Form 5 is approved under control number 3150–0006. [57 FR 57878, Dec. 8, 1992] Subpart B—Radiation Protection Programs SOURCE: 56 FR 23396, May 21, 1991, unless otherwise noted. §20.1101 Radiation protection programs (a) Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities

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Radiation in Medicine: A Need for Regulatory Reform and sufficient to ensure compliance with the provisions of this part. (See § 20.2102 for recordkeeping requirements relating to these programs.) (b) The licensee shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). (c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation. Subpart C—Occupational Dose Limits SOURCE: 56 FR 23396, May 21, 1991, unless otherwise noted. § 20.1201 Occupational dose limits for adults. The licensee shall control the occupational dose to individual adults, except for planned special exposures under § 20.1206, to the following dose limits. An annual limit, which is the more limiting of— The total effective dose equivalent being equal to 5 rems (0.05 Sv); or 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). The annual limits to the lens of the eye, to the skin, and to the extremities, which are: An eye dose equivalent of 15 rems (0.15 Sv), and A shallow-dose equivalent of 50 rems (0.50 Sv) to the skin or to any extremity. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year (see § 20.1206(e)(1)) and during the individual's lifetime (see § 20.1206(e)(2)). The assigned deep-dose equivalent and shallow-dose equivalent must be for the part of the body receiving the highest exposure. The deep-dose equivalent, eye dose equivalent and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to §§ 20.1001–20.2401 and may be used to determine the individual's dose (see § 20.2106) and to demonstrate compliance with the occupational dose limits. In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to §§ 20.1001–20.2401). 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 § 20.2104(e)). § 20.1202 Compliance with requirements for summation of external and internal doses. (a) If the licensee is required to monitor under both §§ 20.1502(a) and (b), the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under § 20.1502(a) or only under § 20.1502(b), 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 by meeting one of the conditions specified in paragraph (b) of this section and the conditions in paragraphs (c) and (d) of this section. (NOTE: 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.) (b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit.

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Radiation in Medicine: A Need for Regulatory Reform contacted if the teletherapy unit or console operates abnormally. A licensee shall provide instruction in the topics identified in paragraph (a) of this section to all individuals who operate a teletherapy unit. A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (b) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] § 35.615 Safety precautions. A licensee shall control access to the teletherapy room by a door at each entrance. A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will: Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed; Turn the primary beam of radiation off immediately when an entrance door is opened; and Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console. A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light. A licensee shall install in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status. A radiation monitor must provide visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source, and must be observable by an individual entering the teletherapy room. A radiation monitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system. A radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients. A licensee shall maintain a record of the check required by paragraph (d)(3) of this section for three years. The record must include the date of the check, notation that the monitor indicates when its detector is and is not exposed, and the initials of the individual who performed the check. If a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in paragraph (d)(4) of this section. A licensee shall promptly repair or replace the radiation monitor if it is inoperable. A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] § 35.620 Possession of survey instrument. A licensee authorized to use byproduct material in a teletherapy unit shall have in its possession either a portable radiation detection survey instrument capable of detecting dose rate over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1,000 millirem per hour. § 35.630 Dosimetry equipment. A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met. The system must have been calibrated by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the

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Radiation in Medicine: A Need for Regulatory Reform previous two years and after any servicing that may have affected system calibration; or The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 source. The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section. The licensee shall retain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM. [51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23471, May 21, 1991] § 35.632 Full calibration measurements. A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit: Before the first medical use of the unit; and Before medical use under the following conditions: Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; Following replacement of the source or following reinstallation of the teletherapy unit in a new location; Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and At intervals not exceeding one year. To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of: The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use; The coincidence of the radiation field and the field indicated by the light beam localizing device; The uniformity of the radiation field and its dependence on the orientation of the useful beam; Timer constancy and linearity over the range of use; On-off error; and The accuracy of all distance measuring and localization devices in medical use.

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Radiation in Medicine: A Need for Regulatory Reform A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates. A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379–396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741–771, and Vol. 11, No. 2, 1984, p. 213. (Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection at the NRC Library, 7920 Norfolk Avenue, Bethesda, Maryland 20814. Copies of the documents are also on file at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. A notice of any change in the material will be published in the FEDERAL REGISTER.) A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month for cobalt-60 or six months for cesium-137. Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the licensee's teletherapy physicist. A licensee shall retain a record of each calibration for the duration of use of the teletherapy unit source. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer linearity and constancy, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 43420, Oct. 27, 1988; 57 FR 61786, Dec. 29, 1992] § 35.634 Periodic spot-checks. A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of: Timer constancy, and timer linearity over the range of use; On-off error; The coincidence of the radiation field and the field indicated by the light beam localizing device; The accuracy of all distance measuring and localization devices used for medical use; The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b) of this part; and The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay). A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the teletherapy physicist. That individual need not actually perform the spot-check measurements. A licensee shall have the teletherapy physicist review the results of each spot-check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for three years. A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month that assure proper operation of:

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Radiation in Medicine: A Need for Regulatory Reform Electrical interlocks at each teletherapy room entrance; Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism); Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; Viewing systems; Treatment room doors from inside and outside the treatment room; and Electrically assisted treatment room doors with the teletherapy unit electrical power turned off. A licensee shall arrange for prompt repair of any system identified in paragraph (d) of this section that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired. A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section for three years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer linearity and constancy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] § 35.636 Safety checks for teletherapy facilities. A licensee shall promptly check all systems listed in § 35.634(d) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by § 35.606 (a) through (d). If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in § 35.634(d), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. A licensee shall retain for three years a record of the facility checks following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] § 35.641 Radiation surveys for teletherapy facilities. Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by § 35.606 (a) through (d), the licensee shall perform radiation surveys with a portable radiation measurement survey instrument calibrated in accordance with § 35.51 of this part to verify that: The maximum and average dose rates at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 10 millirem per hour and 2 millirem per hour respectively; and With the teletherapy source in the on position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that: Radiation dose quantities per unit time in restricted areas are not likely to cause personnel exposures in excess of the limits specified in § 20.1201 of this chapter; and Radiation dose quantities per unit time in unrestricted areas do not

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Radiation in Medicine: A Need for Regulatory Reform exceed the limits specified in § 20.1301 of this chapter. If the results of the surveys required in paragraph (a) of this section indicate any radiation dose quantity per unit time in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit: Except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or Until the licensee has received a specific exemption pursuant to § 20.1301 of this chapter. A licensee shall retain a record of the radiation measurements made following installation of a source for the duration of the license. The record must include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer. [51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993] § 35.643 Modification of teletherapy unit or room before beginning a treatment program. If the survey required by § 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by § 20.1301, before beginning the treatment program the licensee shall: Either equip the unit with stops or add additional radiation shielding to ensure compliance with § 20.1301(c) of this chapter; Perform the survey required by § 35.641 again; and Include in the report required by § 35.645 the results of the initial survey, a description of the modification made to comply with paragraph (a)(1) of this section, and the results of the second survey. As an alternative to the requirements set out in paragraph (a) of this section, a licensee may request a license amendment under § 20.1301(c) of this chapter that authorizes radiation levels in unrestricted areas greater than those permitted by § 20.1301(a) of this chapter. A licensee may not begin the treatment program until the license amendment has been issued. [51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993] § 35.645 Reports of teletherapy surveys, checks, tests, and measurements. A licensee shall mail a copy of the records required in §§ 35.636, 35.641, 35.643, and the output from the teletherapy source expressed as roentgens or rads per hour at one meter from the source and determined during the full calibration required in § 35.632, to the appropriate Commission Regional Office listed in § 30.6 of this chapter within thirty days following completion of the action that initiated the record requirement. § 35.647 Five-year inspection. A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism. This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State. A licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.

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Radiation in Medicine: A Need for Regulatory Reform Subpart J—Training and Experience Requirements § 35.900 Radiation Safety Officer. Except as provided in § 35.901, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.32 to be an individual who: Is certified by: American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; or Board of Pharmaceutical Specialties in Nuclear Pharmacy; or Has had classroom and laboratory training and experience as follows: 200 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; Radiation biology; and Radiopharmaceutical chemistry; and One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or Be an authorized user identified on the licensee's license. § 35.901 Training for experienced Radiation Safety Officer. An individual identified as a Radiation Safety Officer on a Commission or Agreement State license before October 1, 1986 need not comply with the training requirements of § 35.900. § 35.910 Training for uptake, dilution, and excretion studies. Except as provided in §§ 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical in § 35.100(a) to be a physician who: Is certified in: Nuclear medicine by the American Board of Nuclear Medicine; Diagnostic radiology by the American Board of Radiology; or Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows: 40 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; Radiation biology; and Radiopharmaceutical chemistry; and 20 hours of supervised clinical experience under the supervision of an authorized user and that includes: Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; Administering dosages to patients and using syringe radiation shields; Collaborating with the authorized user in the interpretation of radioisotope test results; and Patient followup; or Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. § 35.920 Training for imaging and localization studies. Except as provided in § 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in § 35.200(a) to be a physician who: Is certified in: Nuclear medicine by the American Board of Nuclear Medicine;

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Radiation in Medicine: A Need for Regulatory Reform Diagnostic radiology by the American Board of Radiology; or Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows: 200 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; Radiopharmaceutical chemistry; and Radiation biology; and 500 hours of supervised work experience under the supervision of an authorized user that includes: Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; Calculating and safely preparing patient dosages; Using administrative controls to prevent the misadministration of byproduct material; Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the elate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and 500 hours of supervised clinical experience under the supervision of an authorized user that includes: Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; Administering dosages to patients and using syringe radiation shields; Collaborating with the authorized user in the interpretation of radioisotope test results; and Patient followup; or Has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. §35.930 Training for therapeutic use of radiopharmaceuticals. Except as provided in §35.970, the licensee shall require the authorized user of radiopharmaceuticals in §35.300 to be a physician who: Is certified by: The American Board of Nuclear Medicine; or The American Board of Radiology in radiology or therapeutic radiology; or Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows: 80 hours of classroom and laboratory training that includes: Mathematics pertaining to the use and measurement of radioactivity; and Radiation biology; and Supervised clinical experience under the supervision of an authorized user at a medical institution that includes: Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals. §35.932 Training for treatment of hyperthyroidism. Except as provided in §35.970, the licensee shall require the authorized

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Radiation in Medicine: A Need for Regulatory Reform user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows: 80 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection, Mathematics pertaining to the use and measurement of radioactivity; and Radiation biology; and Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in 10 individuals. §35.934 Training for treatment of thyroid carcinoma. Except as provided in §35.970, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows: 80 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; and Radiation biology; and Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals. §35.940 Training for use of brachytherapy sources. Except as provided in §35.970, the licensee shall require the authorized user of a brachytherapy source listed in §35.400 for therapy to be a physician who: Is certified in: Radiology or therapeutic radiology by the American Board of Radiology; Radiation oncology by the American Osteopathic Board of Radiology; Radiology, with specialization in radiotherapy, as a British ''Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or Is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows: 200 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; and Radiation biology; 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes: Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; Checking survey meters for proper operation; Preparing, implanting, and removing sealed sources; Maintaining running inventories of material on hand; Using administrative controls to prevent the misadministration of byproduct material; and Using emergency procedures to control byproduct material; and Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized

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Radiation in Medicine: A Need for Regulatory Reform user at a medical institution that includes: Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications; Selecting the proper brachytherapy sources and dose and method of administration; Calculating the dose; and Post-administration followup and review of case histories in collaboration with the authorized user. §35.941 Training for ophthalmic use of strontium-90. Except as provided in §35.970, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows: 24 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; and Radiation biology; Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes: Examination of each individual to be treated; Calculation of the dose to be administered; Administration of the dose; and Followup and review of each individual's case history. §35.950 Training for use of sealed sources for diagnosis. Except as provided in §35.970, the licensee shall require the authorized user of a sealed source in a device listed in §35.500 to be a physician, dentist, or podiatrist who: Is certified in: Radiology, diagnostic radiology, or therapeutic radiology by the American Board of Radiology; Nuclear medicine by the American Board of Nuclear Medicine; or Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or Has had 8 hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes: Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation; Radiation biology; Radiation protection; and Training in the use of the device for the uses requested. §35.960 Training for teletherapy. Except as provided in §35.970, the licensee shall require the authorized user of a sealed source listed in §35.600 in a teletherapy unit to be a physician who: Is certified in: Radiology or therapeutic radiology by the American Board of Radiology; Radiation oncology by the American Osteopathic Board of Radiology; Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, supervised work experience, and supervised clinical experience as follows: 200 hours of classroom and laboratory training that includes: Radiation physics and instrumentation; Radiation protection; Mathematics pertaining to the use and measurement of radioactivity; and

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Radiation in Medicine: A Need for Regulatory Reform Radiation biology: 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes: Review of the full calibration measurements and periodic spot checks; Preparing treatment plans and calculating treatment times; Using administrative controls to prevent misadministrations; Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and Checking and using survey meters; and Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes: Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; Selecting the proper dose and how it is to be administered; Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and Post-administration followup and review of case histories. §35.961 Training for teletherapy physicist. The licensee shall require the teletherapy physicist to be an individual who: Is certified by the American Board of Radiology in: Therapeutic radiological physics; Roentgen ray and gamma ray physics; X-ray and radium physics; or Radiological physics; or Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed one year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a teletherapy physicist at a medical institution that includes the tasks listed in §§35.59, 35.632, 35.634, and 35.641 of this part. §35.970 Training for experienced authorized users. Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or pediatric use of byproduct material on a Commission or Agreement State license issued before April 1, 1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of subpart J. §35.971 Physician training in a three month program. A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program need not comply with the requirements of §§35.910 or 35.920. §35.972 Recentness of training. The training and experience specified in this subpart must have been obtained within the five years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. Subpart K—Enforcement §35.990 Violations. The Commission may obtain an injunction or other court order to prevent a violation of the provisions of— The Atomic Energy Act of 1954, as amended; Title II of the Energy Reorganization Act of 1974, as amended; or A regulation or order issued pursuant to those Acts.

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Radiation in Medicine: A Need for Regulatory Reform The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: For violations of— Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; Section 206 of the Energy Reorganization Act; Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended. [57 FR 55074, Nov. 24, 1992] §35.991 Criminal penalties. Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 35 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. The regulations in part 35 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§35.1, 35.2, 35.8, 35.12, 35.18, 35.19, 35.57, 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and 35.999. [57 FR 55074, Nov. 24, 1992] §35.999 Resolution of conflicting requirements during transition period. If the rules in this part conflict with the licensee's radiation safety program as identified in its license, and if that license was approved by the Commission before April 1, 1987 and has not been renewed since April 1, 1987, then the requirements in the license will apply. However, if that licensee exercises its privilege to make minor changes in its radiation safety procedures that are not potentially important to safety under §35.31 of this chapter, the portion changed must comply with the requirements of this part. At the time of license renewal and thereafter, these amendments to this part shall apply. PART 36-LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Subpart A—General Provisions Sec.   36.1 Purpose and scope. 36.2 Definitions. 36.5 Interpretations. 36.8 Information collection requirements: OMB approval. Subpart B—Specific Licensing Requirements 36.11 Application for a specific license. 36.13 Specific licenses for irradiators. 36.15 Start of construction. 36.17 Applications for exemptions. 36.19 Request for written statements. Subpart C—Design and Performance Requirements for Irradiators 36.21 Performance criteria for sealed sources. 36.23 Access control. 36.25 Shielding. 36.27 Fire protection. 36.29 Radiation monitors. 36.31 Control of source movement. 36.33 Irradiator pools. 36.35 Source rack protection. 36.37 Power failures. 36.39 Design requirements. 36.41 Construction monitoring and acceptance testing. Subpart D—Operation of Irradiators 36.51 Training. 36.53 Operating and emergency procedures. 36.55 Personnel monitoring. 36.57 Radiation surveys. 36.59 Detection of leaking sources. 36.61 Inspection and maintenance. 36.63 Pool water purity. 36.65 Attendance during operation. 36.67 Entering and leaving the radiation room. 36.69 Irradiation of explosive or flammable materials. Subpart E—Records 36.81 Records and retention periods. 36.83 Reports. Subpart F—Enforcement