Radiation in Medicine: A Need for Regulatory Reform (1996)

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SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 201 REGULATIONS 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) 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 202 REGULATIONS § 19.31 10 CFR Ch. I (1-1-94 Edition) (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 19.1, 19.2, 19.3, 19.4,19.5, 19.8, 19.16, 19.17, 104, 107, or 109 of the Atomic 19.18, 19.30, 19.31, and 19.40. Energy Act of 1954, as amended; [57 FR 55071, Nov. 24, 1992] (ii) Section 206 of the Energy Reorganiza- tion Act; PART 20—STANDARDS FOR PRO- (iii) Any rule, regulation, or order issued TECTION AGAINST RADIATION pursuant to the sections specified in paragraph Subpart A—General Provisions (b)(1)(i) of this section; (iv) Any term, condition, or limitation of Sec. any license issued under the 20.1001 Purpose. sections specified in paragraph (b)(1)(i) of this 20.1002 Scope. section. 20.1003 Definitions. (2) For any violation for which a license 20.1004 Units of radiation dose. may be revoked under section 186 of the 20.1005 Units of radioactivity. Atomic Energy Act of 1954, as amended. 20.1006 Interpretations. 20.1007 Communications. [57 FR 55071, Nov. 24, 1992] 20.1008 [Reserved] § 19.31 Application for exemptions 20.1009 Reporting, recording, and applica The Commission may upon application by any tion requirements: OMB approval. licensee or upon its owninitiative, grant such Subpart B—Radiation Protection Programs exemptions from the requirements of the regu- 20.1101 Radiation protection programs. lations in this part as it determines are author- ized by law and will not result in undue haz- Subpart C—Occupational Dose Limits ard to life or property. 20.1201 Occupational dose limits for adults. § 19.32 Discrimination prohibited 20.1202 Compliance with requirements for summation of external and internal doses. No person shall on the ground of sex be ex- 20.1203 Determination of external dose cluded from participation in, be denied the ben- from airborne radioactive material. efits of, or be subjected to discrimination un- 20.1204 Determination of internal exposure. der any program or activity licensed by the 20.1205 [Reserved] Nuclear Regulatory Commission. This provi- 20.1206 Planned special exposures. sion will be enforced through agency provi- 20.1207 Occupational dose limits for minors. sions and rules similar to those already estab- 20.1208 Dose to an embryo/fetus. lished, with respect to racial and other discrimi- nation, under title VI of the Civil Rights Act of Subpart D—Radiation Dose Limits for 1964. This remedy is not exclusive, however, Individual Members of the Public and will not prejudice or cut off any other legal 20.1301 Dose limits for individual members remedies available to a discriminate. of the public. [40 FR 8783, Mar. 3, 1975] 20.1302 Compliance with dose limits for in dividual members of the public. § 19.40 Criminal penalties Subpart E—(Reserved) (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanc- Subpart F—Surveys and Moniforing tions for willful violation of, attempted viola- 20.1501 General. tion of, or conspiracy to violate, any regula- 20.1502 Conditions requiring individual tion issued under sections 161b, 161i, or 161o monitoring of external and internal occu- of the Act. For purposes of section 223, all pational dose. the regulations in part 19 are issued under one or more of sections 161b, 161i, or 161o, ex- Subpart G—Control of Exposure From cept for the sections listed in paragraph (b) of External Sources in Restricted Areas this section. 20.1601 Control of access to high radiation (b) The regulations in part 19 that are not areas. issued under sections 161b, 161i, or 161o for 20.1602 Control of access to very high ra the purposes of section 223 are as follows: §§ diation areas. 302 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 203 REGULATIONS Nuclear Regulatory Commission § 20.1001 Subpart H—Respiratory Protection and els, and concentrations of radioactive Controls to Restrict Internal Exposure material exceeding the limits. in Restricted Areas 20.2204 Reports of planned special exposures. 20.1701 Use of process or other engineer- 20.2205 [Reserved] ing controls. 20.2206 Reports of individual monitoring. 20.1702 Use of other controls. Subpart N—Exemptions and Additional 20.1703 Use of individual respiratory pro- Requirements tection equipment. 20.1704 Further restrictions on the use of 20.2301 Applications for exemptions. respiratory protection equipment. 20.2302 Additional requirements. Subpart I—Storage and Control of Subpart O—Enforcement Licensed Material 20.2401 Violations. 20.1801 Security of stored material. 20.2402 Criminal penalties. 20.1802 Control of material not in storage. APPENDIX A TO PART 20—PROTECTION FAC- TORS FOR RESPIRATORS Subpart J—Precautionary Procedures APPENDIX B TO PART 20—ANNUAL LIM- 20.1901 Caution signs. ITS ON INTAKE (ALIs) AND DERIVED AIR 20.1902 Posting requirements C ONCENTRATIONS ( DACs ) OF 20.1903 Exceptions to posting requirements. RADIONUCLIDES FOR OCCUPATIONAL EXPO- 20.1904 Labeling containers. SURE; EFFLUENT CONCENTRATIONS; CON- 20.1905 Exemptions to labeling requirements. CENTRATIONS FOR RELEASE TO SEWERAGE 20.1906 Procedures for receiving and open- APPENDIX C TO PART 20—QUANTITIES OF LI- ing packages. CENSED MATERIAL REQUIRING LABELING Subpart K—Waste Disposal APPENDIX D TO PART 20—UNITED STATES NU- CLEAR REGULATORY COMMISSION RE- 20.2001 General requirements. GIONAL OFFICES 20.2002 Method for obtaining approval of APPENDIX E TO PART 20—[RESERVED] proposed disposal procedures. APPENDIX F TO PART 20—REQUIREMENTS FOR 20.2003 Disposal by release into sanitary LOW-LEVEL-WASTE TRANSFER FOR DIS sewerage. POSAL AT LAND DISPOSAL FACILITIES AND 20.2004 Treatment or disposal by incineration. MANIFESTS 20.2005 Disposal of specific wastes. 20.2006 Transfer for disposal and manifests. AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 20.2007 Compliance with environmental 161, 182, 186, 68 Stat. 930, 933, 935, 936, and health protection regulations. 937, 948, 953, 955, as amended (2 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, Subpart L—Records 2232, 2236), secs. 201, as amended, 202, 206, 20.2101 General provisions. 88 Stat. 1242, as amended, 1244, 1246 (42 20.2102 Records of radiation protection programs. U.S.C. 5841, 5842, 5846). 20.2103 Records of surveys. Subpart A—General Provisions 20.2104 Determination of prior occupational dose. SOURCE: 56 FR 23391, May 21, 1991, un- 20.2105 Records of planned special exposures. less otherwise noted. 20.2106 Records of individual monitoring § 20.1001 Purpose results. 20.2107 Records of dose to individual mem- (a) The regulations in this part establish bers of the public. standards for protection against ionizing ra- 20.2108 Records of waste disposal. diation resulting from activities conducted un- 20.2109 [Reserved] der licenses issued by the Nuclear Regula- 20.2110 Form of records. tory Commission. These regulations are is- sued under the Atomic Energy Act of 1954, Subpart M—Reports as amended, and the Energy Reorganization 20.2201 Reports of theft or loss of licensed Act of 1974, as amended. material. (b) It is the purpose of the regulations in 20.2202 Notification of incidents. this part to control the receipt, possession, use, 20.2203 Reports of exposures, radiation lev- transfer, and disposal of licensed material by 303 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 204 REGULATIONS § 20.1002 10 CFR Ch. I (1-1-94 Edition) any licensee in such a manner that the total present in the area without respiratory pro- dose to an individual (including doses result- tective equipment could exceed, during the ing from licensed and unlicensed radioactive hours an individual is present in a week, an material and from radiation sources other than intake of 0.6 percent of the annual limit on background radiation) does not exceed the intake (ALI) or 12 DAC-hours. standards for protection against radiation pre- ALARA (acronym for “as low as is reason- scribed in the regulations in this part. How- ably achievable”) means making every rea- ever, nothing in this part shall be construed as sonable effort to maintain exposures to radia- limiting actions that may be necessary to pro- tion as far below the dose limits in this part as tect health and safety. is practical consistent with the purpose for § 20.1002 Scope which the licensed activity is undertaken, tak- ing into account the state of technology, the The regulations in this part apply to per- economics of improvements in relation to state sons licensed by the Commission to receive, of technology, the economics of improvements possess, use, transfer, or dispose of byproduct, in relation to benefits to the public health and source, or special nuclear material or to oper- safety, and other societal and socioeconomic ate a production or utilization facility under considerations, and in relation to utilization parts 30 through 36, 39, 40, 50, 60, 61, 70, or of nuclear energy and licensed materials in 72 of this chapter. The limits in this part do the public interest. not apply to doses due to background radia- Annual limit on intake (ALI) means the de- tion, to exposure of patients to radiation for rived limit for the amount of radioactive ma- the purpose of medical diagnosis or therapy, terial taken into the body of an adult worker or to voluntary participation in medical re- by inhalation or ingestion in a year. ALI is the search programs. smaller value of intake of a given radionuclide [56 FR 23391, May 21, 1991, as amended at in a year by the reference man that would re- 58 FR 7736, Feb. 9, 1993] sult in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose § 20.1003 Definitions equivalent of 50 rems (0.5 Sv) to any indi- As used in this part: vidual organ or tissue. (ALI values for intake Absorbed dose means the energy imparted by ingestion and by inhalation of selected by ionizing radiation per unit mass of irradi- radionuclides are given in Table 1, Columns ated material. The units of absorbed dose are 1 and 2, of appendix B to §§ 20.1001– the rad and the gray (Gy). 20.2401). Act means the Atomic Energy Act of 1954 Background radiation means radiation from (42 U.S.C. 2011 et seq.), as amended. cosmic sources; naturally Activity is the rate of disintegration (trans- occurring radioactive materials, including ra- formation) or decay of radioactive material. don (except as a decay product of The units of activity are the curie (Ci) and the source or special nuclear material) and global becquerel (Bq). fallout as it exists in the environment from Adult means an individual 18 or more years the testing of nuclear explosive devices. of age. “Background radiation” does not include ra- Airborne radioactive material means radio- diation from source, byproduct, or special active material dispersed in the air in the form nuclear materials regulated by the Commis- of dusts, fumes, particulates, mists, vapors, sion. or gases. Bioassay (radiobioassay) means the deter- Airborne radioactivity area means a room, mination of kinds, quantities or enclosure, or area in which airborne radioac- concentrations, and, in some cases, the loca- tive materials, composed wholly or partly of tions of radioactive material in the licensed material, exist in concentrations— human body, whether by direct measurement (1) In excess of the derived air concentra- (in vivo counting) or by analysis tions (DACs) specified in appendix B, to §§ and evaluation of materials excreted or re- 20.1001–20.2401, or moved from the human body. (2) To such a degree that an individual Byproduct material means— 304 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 205 REGULATIONS Nuclear Regulatory Commission § 20.1003 (1) Any radioactive material (except spe- Deep-dose equivalent (Hd ), which applies cial nuclear material) yielded in, or made ra- to external whole body exposure, is the dose dioactive by, exposure to the radiation inci- equivalent at a tissue depth of 1 cm (1000 mg/ dent to the process of producing or utilizing cm2 ). special nuclear material; and Department means the Department of En- (2) The tailings or wastes produced by the ergy established by the Department of Energy extraction or concentration of uranium or tho- Organization Act (Pub. L. 95–91, 91 Stat. 565, rium from ore processed primarily for its 42 U.S.C. 7101 et seq.) to the extent that the source material content, including discrete sur- Department, or its duly authorized representa- face wastes resulting from uranium solution tives, exercises functions formerly vested in extraction processes. Underground ore bod- the U.S. Atomic Energy Commission, its ies depleted by these solution extraction op- Chairman, members, officers, and components erations do not constitute ‘’byproduct mate- and transferred to the U.S. Energy Research rial” within this definition. and Development Administration and to the Class (or lung class or inhalation class) Administrator thereof pursuant to sections 104 means a classification scheme for inhaled ma- (b), (c), and (d) of the Energy Reorganization terial according to its rate of clearance from Act of 1974 (Pub. L. 93–438, 88 Stat. 1233 at the pulmonary region of the lung. Materials 1237, 42 U.S.C. 5814) and retransferred to are classified as D, W, or Y, which applies to a the Secretary of Energy pursuant to section range of clearance half-times: for Class D 301(a) of the Department of Energy Organi- (Days) of less than 10 days, for Class W zation Act (Pub. L. 95–91, 91 Stat 565 at 577– (Weeks) from 10 to 100 days, and for Class Y 578, 42 U.S.C. 7151). (Years) of greater than 100 days. Derived air concentration (DAC) means the Collective dose is the sum of the individual concentration of a given radionuclide in air doses received in a given period of time by a which, if breathed by the reference man for a specified population from exposure to a speci- working year of 2,000 hours under conditions fied source of radiation. of light work (inhalation rate 1.2 cubic me- Commission means the Nuclear Regulatory ters of air per hour), results in an intake of Commission or its duly authorized representa- one ALI. DAC values are given in Table 1, tives. Column 3, of appendix B to §§ 20.1001– Committed dose equivalent (HT,50 ) means 20.2401. the dose equivalent to organs or tissues of ref- Derived air concentration-hour (DAC- erence (T) that will be received from an in- hour) is the product of the concentration of take of radioactive material by an individual radioactive material in air (expressed as a frac- during the 50-year period following the in- tion or multiple of the derived air concentra- take. tion for each radionuclide) and the time of Committed effective dose equivalent (HE.50 ) is exposure to that radionuclide, in hours. A li- the sum of the products of the weighting factors censee may take 2,000 DAC-hours to repre- applicable to each of the body organs or tis- sent one ALI, equivalent to a committed ef- sues that are irradiated and the committed dose fective dose equivalent of 5 rems (0.05 Sv). equivalent to these organs or tissues Dose or radiation dose is a generic term (HE.50 = ⌺WT HT.50 ). that means absorbed dose, dose equivalent, Controlled area means an area, outside of effective dose equivalent, committed dose a restricted area but inside the site boundary, equivalent, committed effective dose equiva- access to which can be limited by the licen- lent, or total effective dose equivalent, as de- see for any reason. fined in other paragraphs of this section. Declared pregnant woman means a woman Dose equivalent (HT ) means the product who has voluntarily informed her employer, of the absorbed dose in tissue, in writing, of her pregnancy and the estimated quality factor, and all other necessary modi- date of conception. fying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv). 305 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 206 REGULATIONS § 20.1003 10 CFR Ch. I (1-1-94 Edition) Dosimetry processor means an individual High radiation area means an area, acces- or organization that processes and evaluates sible to individuals, in which radiation levels individual monitoring equipment in order to could result in an individual receiving a dose determine the radiation dose delivered to the equivalent in excess of 0.1 rem (1 mSv) in 1 equipment. hour at 30 centimeters from the radiation Effective dose equivalent (HE ) is the sum source or from any surface that the radiation of the products of the dose equivalent to the penetrates. organ or tissue (HT ) and the weighting fac- Individual means any human being. tors (WT ) applicable to each of the body or- Individual monitoring means— gans or tissues that are irradiated (1) The assessment of dose equivalent by (HE = ⌺WT HT ). the use of devices designed to be worn by an Embryo/fetus means the developing human individual: organism from conception until the time of (2) The assessment of committed effective birth. dose equivalent by bioassay (see Bioassay) Entrance or access point means any loca- or by determination of the time-weighted air tion through which an individual could gain concentrations to which an individual has been access to radiation areas or to radioactive ma- exposed, i.e., DAC-hours; or terials. This includes entry or exit portals of (3) The assessment of dose equivalent by sufficient size to permit human entry, irrespec- the use of survey data. tive of their intended use. Individual Monitoring Devices (individual Exposure means being exposed to ionizing monitoring equipment) means devices de- radiation or to radioactive material. signed to be worn by a single individual for External dose means that portion of the dose the assessment of dose equivalent received from radiation sources equivalent such as film badges, outside the body. thermoluminescent dosimeters (TLDs), Extremity means hand, elbow, arm below pocket ionization chambers, and personal (“la- the elbow, foot, knee, or leg below the knee. pel”) air sampling devices. Eye dose equivalent applies to the external Internal dose means that portion of the dose exposure of the lens of the eye and is taken as equivalent received from radioactive material the dose equivalent at a tissue depth of 0.3 taken into the body. centimeter (300 mg/cm2 ). License means a license issued under the Generally applicable environmental radia- regulations in parts 30 through 36, 39, 40, 50, tion standards means standards issued by the 60, 61, 70, or 72 of this chapter. Environmental Protection Agency (EPA) un- Licensed material means source material, der the authority of the Atomic Energy Act of special nuclear material, or byproduct mate- 1954, as amended, that impose limits on ra- rial received, possessed, used, transferred or diation exposures or levels, or concentrations disposed of under a general or specific license or quantities of radioactive material, in the issued by the Commission. general environment outside the boundaries Licensee means the holder of a license. Lim- of locations under the control of persons pos- its (dose limits) means the permissible upper sessing or using radioactive material. bounds of radiation doses. Government agency means any executive Lost or missing licensed material means department, commission, independent estab- licensed material whose location is unknown. lishment, corporation wholly or partly owned It includes material that has been shipped but by the United States of America, which is an has not reached its destination and whose lo- instrumentality of the United States, or any cation cannot be readily traced in the trans- board, bureau, division, service, office, officer, portation system. authority, administration, or other establish- Member of the public means an individual ment in the executive branch of the Govern- in a controlled or unrestricted area. However, ment. an individual is not a member of the public Gray [See § 20.1004]. during any period in which the individual re- ceives an occupational dose. 306 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 207 REGULATIONS Nuclear Regulatory Commission § 20.1003 Minor means an individual less than 18 tion or any political subdivision of any such years of age. government or nation, or other entity: and Monitoring (radiation monitoring, radiation (2) Any legal successor, representative, protection monitoring) means the measure- agent, or agency of the foregoing. ment of radiation levels, concentrations, sur- Planned special exposure means an infre- face area concentrations or quantities of ra- quent exposure to radiation, separate from and dioactive material and the use of the results in addition to the annual dose limits. of these measurements to evaluate potential Public dose means the dose received by a exposures and doses. member of the public from exposure to radia- Nonstochastic effect means health effects, tion and to radioactive material released by a the severity of which varies with the dose and licensee, or to another source of radiation ei- for which a threshold is believed to exist. Ra- ther within a licensee’s controlled area or in diation-induced cataract formation is an ex- unrestricted areas. It does not include occu- ample of a nonstochastic effect (also called a pational dose or doses received from back- deterministic effect). ground radiation, as a patient from medical NRC means the Nuclear Regulatory Com- practices, or from voluntary participation in mission or its duly authorized representatives. medical research programs. Occupational dose means the dose received Quality Factor (Q) means the modifying by an individual in a restricted area or in the factor (listed in tables 1004(b).1 and 1004(b).2 course of employment in which the individual’s of §20.1004) that is used to derive dose equiva- assigned duties involve exposure to radiation and lent from absorbed dose. to radioactive material from licensed and unli- Quarter means a period of time equal to censed sources of radiation, whether in the pos- one-fourth of the year observed by the licen- session of the licensee or other person. Occupa- see (approximately 13 consecutive weeks), tional dose does not include dose received from providing that the beginning of the first quar- background radiation, as a patient from medical ter in a year coincides with the starting date practices, from voluntary participation in medi- of the year and that no day is omitted or du- cal research programs, or as a member of the plicated in consecutive quarters. general public. Rad (See §20.1004). Person means— Radiation (ionizing radiation) means alpha (1) Any individual, corporation, partnership, particles, beta particles, gamma rays, x-rays, firm, association, trust, estate, public or pri- neutrons, high-speed electrons, high-speed vate institution, group, Government agency protons, and other particles capable of pro- other than the Commission or the Department ducing ions. Radiation, as used in this part, of Energy (except that the Department shall does not include non-ionizing radiation, such be considered a person within the meaning of as radioor microwaves, or visible, infrared, the regulations in 10 CFR chapter I to the ex- or ultraviolet light. tent that its facilities and activities are subject Radiation area means an area, accessible to the licensing and related regulatory author- to individuals, in which radiation levels could ity of the Commission under section 202 of result in an individual receiving a dose equiva- the Energy Reorganization Act of 1974 (88 lent in excess of 0.005 rem (0.05 mSv) in 1 Stat. 1244), the Uranium Mill Tailings Ra- hour at 30 centimeters from the radiation diation Control Act of 1978 (92 Stat. 3021), source or from any surface that the radiation the Nuclear Waste Policy Act of 1982 (96 Stat. penetrates. 2201), and section 3(b)(2) of the Low-Level Reference man means a hypothetical ag- Radioactive Waste Policy Amendments Act gregation of human physical and physiologi- of 1985 (99 Stat. 1842)), any State or any po- cal characteristics arrived at by international litical subdivision of or any political entity consensus. These characteristics may be used within a State, any foreign government or na- by researchers and public health workers to 307 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 208 REGULATIONS § 20.1003 10 CFR Ch. I (1-1-94 Edition) standardize results of experiments and to re- cer incidence are examples of stochastic ef- late biological insult to a common base. fects. Rem (see §20.1004). Survey means an evaluation of the radio- Respiratory protective device means an ap- logical conditions and potential hazards inci- paratus, such as a respirator, used to reduce dent to the production, use, transfer, release, the individual’s intake of airborne radioactive disposal, or presence of radioactive material materials. or other sources of radiation. When appropri- Restricted area means an area, access to which ate, such an evaluation includes a physical sur- is limited by the licensee for the purpose of vey of the location of radioactive material and protecting individuals against undue risks from measurements or calculations of levels of ra- exposure to radiation and radioactive materi- diation, or concentrations or quantities of ra- als. Restricted area does not include areas used dioactive material present. as residential quarters, but separate rooms in Total Effective Dose Equivalent (TEDE) a residential building may be set apart as a means the sum of the deep-dose equivalent restricted area. (for external exposures) and the committed Sanitary sewerage means a system of pub- effective dose equivalent (for internal expo- lic sewers for carrying off waste water and sures). refuse, but excluding sewage treatment facili- Unrestricted area means an area, access to ties, septic tanks, and leach fields owned or which is neither limited nor controlled by the operated by the licensee. licensee. Shallow-dose equivalent (Hs ), which ap- Uranium fuel cycle means the operations plies to the external exposure of the skin or an of milling of uranium ore, chemical conver- extremity, is taken as the dose equivalent at a sion of uranium, isotopic enrichment of ura- tissue depth of 0.007 centimeter (7 mg/cm 2 ) nium, fabrication of uranium fuel, generation averaged over an area of 1 square centimeter. of electricity by a light-water-cooled nuclear Sievert (See §20.1004). power plant using uranium fuel, and reproc- Site boundary means that line beyond which essing of spent uranium fuel to the extent that the land or property is not owned, leased, or these activities directly support the produc- otherwise controlled by the licensee. tion of electrical power for public use. Ura- Source material means— nium fuel cycle does not include mining op- (1) Uranium or thorium or any combina- erations, operations at waste disposal sites, tion of uranium and thorium in any physical transportation of radioactive material in sup- or chemical form; or port of these operations, and the reuse of re- (2) Ores that contain, by weight, one-twen- covered non-uranium special nuclear and tieth of 1 percent (0.05 percent), or more, of byproduct materials from the cycle. uranium, thorium, or any combination of ura- Very high radiation area means an area, ac- nium and thorium. Source material does not cessible to individuals, in which radiation lev- include special nuclear material. els could result in an individual receiving an Special nuclear material means— absorbed dose in excess of 500 rads (5 grays) (1) Plutonium, uranium-233, uranium en- in 1 hour at 1 meter from a radiation source or riched in the isotope 233 or in the isotope 235, from any surface that the radiation penetrates. and any other material that the Commission, (NOTE: At very high doses received at high pursuant to the provisions of section 51 of the dose rates, units of absorbed dose (e.g., rads Act, determines to be special nuclear mate- and grays) are appropriate, rather than units rial, but does not include source material; or of dose equivalent (e.g., rems and sieverts)). (2) Any material artificially enriched by any of the foregoing but does not include source Week means 7 consecutive days starting on material. Sunday. Stochastic effects means health effects that Weighting factor wT , for an organ or tis- occur randomly and for which the probability sue (T) is the proportion of the risk of of the effect occurring, rather than its sever- stochastic effects resulting from irradiation of ity, is assumed to be a linear function of dose without threshold. Hereditary effects and can- 308 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 209 REGULATIONS Nuclear Regulatory Commission § 20.1004 that organ or tissue to the total risk of stochastic Gray (Gy) is the SI unit of absorbed dose. effects when the whole body is irradiated uni- One gray is equal to an absorbed dose of 1 formly. For calculating the effective dose Joule/kilogram (100 rads). equivalent, the values of wT are: Rad is the special unit of absorbed dose. ORGAN DOSE WEIGHTING FACTORS One rad is equal to an absorbed dose of 100 Organ or tissue wT ergs/gram or 0.01 joule/kilogram (0.01 gray). Gonads......................................... 0.25 Rem is the special unit of any of the quanti- Breast........................................... 0.15 ties expressed as dose equivalent. Red bone marrow.......................... 0.12 The dose equivalent in rems is equal to the Lung........................................... 0.12 absorbed dose in rads multiplied by the qual- Thyroid............................................. 0.03 ity factor (1 rem = 0.01 sievert). Bonsurfaces.................................. 0.03 Sievert is the SI unit of any of the quanti- 1 0.30 ties expressed as dose equivalent. The dose Remainder.......................................... Whole Body..................................... 2 1.00 equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor 1 0.30 results from 0.06 for each of 5 “re- (1 Sv = 100 rems). mainder” organs (excluding the skin and the (b) As used in this part, the quality factors lens of the eye) that receive the highest doses. for converting absorbed dose to dose equiva- 2 For the purpose of weighting the external lent are shown in table 1004(b).1. whole body dose (for adding it to the intemal (c) If it is more convenient to measure the dose), a single weighting factor, wT = 1.0, has neutron fluence rate than to determine the neu- been specified. The use of other weighting tron dose equivalent rate in rems per hour or factors for external exposure will be approved sieverts per hour, as provided in paragraph (b) on a case-by-case basis until such time as spe- of this section, 1 rem (0.01 Sv) of neutron cific guidance is issued. radiation of unknown energies may, for pur- Whole body means, for purposes of exter- poses of the regulations in this part, be as- nal exposure, head, trunk (including male go- sumed to result from a total fluence of 25 mil- nads), arms above the elbow, or legs above lion neutrons per square centimeter incident the knee. upon the body. If sufficient information ex- Working level (WL) is any combination of ists to estimate the approximate energy dis- short-lived radon daughters (for radon-222: tribution of the neutrons, the licensee may use polonium-218, lead-214, bismuth-214, and the fluence rate per unit dose equivalent or polonium-214; and for radon-220: polonium- the appropriate Q value from table 1004(b).2 216, lead-212, bismuth-212, and polonium- to convert a measured tissue dose in rads to 212) in 1 liter of air that will result in the ulti- dose equivalent in rems. mate emission of 1.3×105 MeV of potential TABLE 1004(b).1—QUALITY FACTORS AND AB- alpha particle energy. SORBED DOSE EQUIVALENCIES Working level month (WLM) means an expo- Type of radiation Absorbed Quality sure to 1 working level for 170 hours (2,000 factor dose equal working hours per year/12 months per year = (Q) to a unitdose approximately 170 hours per month). equivalent a Year means the period of time beginning in January used to determine compliance with X-, gamma, or beta radiation 1 1 the provisions of this part. The licensee may Alpha particles, multiple- change the starting date of the year used to charged particles, fission determine compliance by the licensee provided fragmentsand heavy that the change is made at the beginning of particles of unknown charge 20 0.05 the year and that no day is omitted or dupli- Neutrons of unknown energy 10 0.1 cated in consecutive years. High-energy protons 10 0.1 a Absorbed dose in rad equal to 1 rem or the absorbed [56 FR 23391, May 21, 1991, as amended at dose in gray equal to 1 sievert. 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: 309 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 210 REGULATIONS § 20.1005 10 CFR Ch. I (1-1-94 Edition) TABLE 1004(b).2—MEAN QUALITY FACTORS, Q, §20.1007 Communications AND FLUENCE PER UNIT DOSE EQUIVALENT Unless otherwise specified, communica- FOR MONOENERGETIC NEUTRONS tions or reports concerning the regulations in Neutron en- Quality Fluence per unit this part should be addressed to the Executive ergy (MeV) factora dose equivalentb Director for Operations. U.S. Nuclear Regu- (Q) (neutrons cm-2 latory Commission, Washington. DC 20555. rem-1) A communication, report, or application may (thermai).. 2.5×10 -8 2 980×106 be delivered in person to the Office of the Ex- 1×107 2 980×106 ecutive Director for Operations, 11555 1×10-6 2 810×106 Rockville Pike. Rockville, MD 20852. 1×10-5 2 810×106 §20.1008—[Reserved] 1×104 2 840×106 1×10-3 2 980×106 §20.1009 Reporting, recording, and appli- 1×10-2 2.5 1010×106 cation requirements: OMB approval 1×10-1 7.5 170×106 5×10-1 11 39×106 (a) The Nuclear Regulatory Commission 1 11 27×106 has submitted the information collection re- 2.5 9 29×106 quirements contained in this part to the Of- 5 8 23×106 fice of Management and Budget (OMB) for 7 7 24×106 approval as required by the Paperwork Re- 10 6.5 24×106 duction Act of 1980 (44 U.S.C. 3501 et seq.). 14 7.5 17×106 OMB has approved the information collec- 20 8 16×106 tion requirements contained in this part under 40 7 14×106 60 5.5 16×106 control number 3150–0014. 1×102 4 20×106 (b) The approved information collection re- 2×102 3.5 19×106 quirements contained in this part appear in 3×102 3.5 16×106 §§20.1101, 20.1202, 20.1204, 20.1206, 4×102 3.5 14×106 20.1301, 20.1501, 20.1601, 20.1703, 20.1901, a Value of quality factor (Q) at the point where the dose 20.1902, 20.1904, 20.1906, 20.2002, 20.2004, equivalent is maximum in a 30-cm diameter cylinder tis- 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, sue-equivalent phantom. 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, b Monoenergetic neutrons incident normally on a 30- 20.2202, 20.2203, 20.2204, 20.2206, and ap- cm diameter cylinder tissue-equivalent phantom. pendix F to 20.1001–20.2401. §20.1005 Units of radioactivity (c) This part contains information collec- tion requirements in addition to those approved For the purposes of this part, activity is ex- under the control number specified in para- pressed in the special unit of curies (Ci) or in graph (a) of this section. These information the SI unit of becquerels (Bq), or their multi- collection requirements and the control num- ples, or disintegrations (transformations) per bers under which they are approved are as fol- unit of time. lows: (a) One becquerel=1 disintegration per sec- (1) In §20.2104, NRC Form 4 is approved ond (s-1 ). under control number 3150–0005. (b) One curie = 3.7×1010 disintegrations per (2) In §§20.2106 and 20.2206, NRC Form 5 second = 3.7×1010 becquerels=2.22×1012 is approved under control number 3150–0006. disintegrations per minute. [57 FR 57878, Dec. 8, 1992] [56 FR 23391, May 21, 1991; 56 FR 61352, Dec. 3, 1991] Subpart B—Radiation Protection Programs §20.1006 Interpretations SOURCE: 56 FR 23396, May 21, 1991, unless otherwise Except as specifically authorized by the noted. Commission in writing, no interpretation of the meaning of the regulations in this part by §20.1101 Radiation protection programs an officer or employee of the Commission (a) Each licensee shall develop, document, other than a written interpretation by the Gen- and implement a radiation protection program eral Counsel will be recognized to be binding commensurate with the scope and extent of upon the Commission. licensed activities and sufficient to ensure 310 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 211 REGULATIONS Nuclear Regulatory Commission § 20.1202 compliance with the provisions of this part. lent and shallow-dose equivalent may be as- (See § 20.2102 for recordkeeping require- sessed from surveys or other radiation meas- ments relating to these programs.) urements for the purpose of demonstrating (b) The licensee shall use, to the extent prac- compliance with the occupational dose lim- ticable, procedures and engineering controls its, if the individual monitoring device was based upon sound radiation protection prin- not in the region of highest potential expo- ciples to achieve occupational doses and doses sure, or the results of individual monitoring to members of the public that are as low as is are unavailable. reasonably achievable (ALARA). (d) Derived air concentration (DAC) and (c) The licensee shall periodically (at least annual limit on intake (ALI) values are pre- annually) review the radiation protection pro- sented in table 1 of appendix B to §§ 20.1001– gram content and implementation. 20.2401 and may be used to determine the Subpart C—Occupational Dose Limits individual’s dose (see § 20.2106) and to dem- onstrate compliance with the occupational SOURCE: 56 FR 23396, May 21, 1991, unless otherwise dose limits. noted. (e) In addition to the annual dose limits, § 20.1201 Occupational dose limits for the licensee shall limit the soluble uranium adults. intake by an individual to 10 milligrams in a (a) The licensee shall control the occupa- week in consideration of chemical toxicity (see tional dose to individual adults, except for footnote 3 of appendix B to §§ 20.1001– planned special exposures under § 20.1206, 20.2401). to the following dose limits. (f) The licensee shall reduce the dose that (1) An annual limit, which is the more lim- an individual may be allowed to receive in iting of— the current year by the amount of occupational (i) The total effective dose equivalent be- dose received while employed by any other ing equal to 5 rems (0.05 Sv); or person (see § 20.2104(e)). (ii) The sum of the deep-dose equivalent and the committed dose equivalent to any in- § 20.1202 Compliance with requirements dividual organ or tissue other than the lens of for summation of external and internal the eye being equal to 50 rems (0.5 Sv). doses. (2) The annual limits to the lens of the eye, (a) If the licensee is required to monitor to the skin, and to the extremities, which are: under both §§ 20.1502(a) and (b), the licen- (i) An eye dose equivalent of 15 rems (0.15 see shall demonstrate compliance with the Sv), and dose limits by summing external and internal (ii) A shallow-dose equivalent of 50 rems doses. If the licensee is required to monitor (0.50 Sv) to the skin or to any extremity. only under §20.1502(a) or only under § (b) Doses received in excess of the annual 20.1502(b), then summation is not required limits, including doses received during acci- to demonstrate compliance with the dose lim- dents, emergencies, and planned special ex- its. The licensee may demonstrate compliance posures, must be subtracted from the limits with the requirements for summation of ex- for planned special exposures that the indi- ternal and internal doses by meeting one of vidual may receive during the current year the conditions specified in paragraph (b) of (see § 20.1206(e)(1)) and during the individu- this section and the conditions in paragraphs al’s lifetime (see §20.1206(e)(2)). (c) and (d) of this section. (c) The assigned deep-dose equivalent and (NOTE: The dose equivalents for the lens of the eye, shallow-dose equivalent must be for the part the skin, and the extremities are not included in the sum- of the body receiving the highest exposure. mation, but are subject to separate limits.) The deep-dose equivalent, eye dose equiva- (b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total ef- fective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit. 311 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 212 REGULATIONS Pt. 34, App. A 10 CFR Ch. I (1-1-94 Edition) of, attempted violation of, or conspiracy to 35.5 Maintenance of records. violate, any regulation issued under sections 35.8 Information collection requirements: 161b, 161i, or 161o of the Act. For purposes OMB approval. of section 223, all the regulations in part 34 35.11 License required. are issued under one or more of sections 161b, 35.12 Application for license, amendment, 161i, or 161o, except for the sections listed in or renewal. paragraph (b) of this section. 35.13 License amendments. (b) The regulations in part 34 that are not is- 35.14 Notifications. sued under sections 161b, 161i, or 161o for the 35.18 License issuance. purposes of section 223 are as follows: §§ 34.1, 35.19 Specific exemptions. 34.2, 34.3, 34.8, 34.11, 34.51, 34.61, and 34.63. Subpart B—General Administrative [57 FR 55074, Nov. 24, 1992] Requirements APPENDIX A TO PART 34 35.20 ALARA program. 35.21 Radiation Safety Officer. I. FUNDAMENTALS OF RADIATION SAFETY 35.22 Radiation Safety Committee. A. Characteristics of gamma radiation. 35.23 Statements of authority and responsi- B. Units of radiation dose (mrem) and quan- bilities. tity of radioactivity (curie). 35.25 Supervision. C. Hazards of exposure to radiation. 35.27 Visiting authorized user. D. Levels of radiation from licensed material. 35.29 Administrative requirements that ap- E. Methods of controlling radiation dose: ply to the provision of mobile nuclear 1. Working time. medicine service. 2. Working distances. 35.31 Radiation safety program changes. 3. Shielding. 35.32 Quality management program. 35.33 Notifications, reports, and records of II. RADIATION DETECTION INSTRUMENTA- misadministrations. TION TO BE USED 35.49 Suppliers. A. Use of radiation survey instruments: Subpart C—General Technical 1. Operation. Requirements 2. Calibration. 3. Limitations. 35.50 Possession, use, calibration, and check B. Survey techniques. of dose calibrators. C. Use of personnel monitoring equipment: 35.51 Calibration and check of survey in- 1. Film badges and thermoluminescent struments. dosimeters (TLD’s). 35.53 Measurement of radiopharmaceutical 2. Pocket dosimeters. dosages. 3. Alarm ratemeters 35.57 Authorization for calibration and ref- erence sources. III. RADIOGRAPHIC EQUIPMENT TO BE USED 35.59 Requirements for possession of sealed A. Remote handling equipment. sources and brachytherapy sources. B. Radiographic exposure devices. 35.60 Syringe shields and labels. C. Storage containers. 35.61 Vial shields and labels. IV. INSPECTION AND MAINTENANCE 35.70 Surveys for contamination and ambi- PERFORMED BY THE RADIOGRAPHERS ent radiation exposure rate. 35.75 Release of patients containing V. CASE HISTORIES OF RADIOGRAPHY radiopharmaceuticals or permanent im- ACCIDENTS plants. [44 FR 50808, Aug. 30, 1979, as amended at 55 FR 853, 35.80 Technical requirements that apply to Jan. 10, 1990] the provision of mobile nuclear medicine PART 35-MEDICAL USE OF service. BYPRODUCT MATERIAL 35.90 Storage of volatiles and gases. 35.92 Decay-in-storage. Subpart A—General Information Subpart D—Uptake, Dilution, and Excretion Sec. 35.100 Use of radiopharmaceuticals for up- 35.1 Purpose and scope. take, dilution, and excretion studies. 35.2 Definitions. 35.120 Possession of survey instrument. 518 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 213 REGULATIONS Nuclear Regulatory Commission § 35.2 Subpart E—Imaging and Localization 35.920 Training for imaging and localiza- 35.200 Use of radiopharmaceuticals, genera- tion studies. tors, and reagent kits for imaging and lo- 35.930 Training for therapeutic use of calization studies. radiopharmaceuticals. 35.204 Permissible molybdenum-99 concen- 35.932 Training for treatment of hyperthy- tration. roidism. 35.205 Control of aerosols and gases. 35.934 Training for treatment of thyroid car- 35.220 Possession of survey instruments. cinoma. 35.940 Training for use of brachytherapy Subpart F—Radiopharmaceuticals for sources. Therapy 35.941 Training for ophthalmic use of stron- 35.300 Use of radiopharmaceuticals for tium-90. therapy. 35.950 Training for use of sealed sources for 35.310 Safety instruction. diagnosis. 35.315 Safety precautions. 35.960 Training for teletherapy. 35.320 Possession of survey instruments. 35.961 Training for teletherapy physicist. 35.970 Training for experienced authorized Subpart G—Sources for Brachytherapy users. 35.400 Use of sources for brachytherapy. 35.971 Physician training in a three month 35.404 Release of patients treated with tem- program. porary implants. 35.972 Recentness of training. 35.406 Brachytherapy sources inventory. Subpart K—Enforcement 35.410 Safety instruction. 35.415 Safety precautions. 35.990 Violations. 35.420 Possession of survey instrument. 35.991 Criminal penalties. 35.999 Resolution of conflicting require- Subpart H—Sealed Sources for Diagnosis ments during transition period. 35.500 Use of sealed sources for diagnosis. 35.520 Availability of survey instrument. AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. Subpart I—Teletherapy 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 35.600 Use of a sealed source in a tel- 1242, as amended (42 U.S.C. 5841). etherapy unit. 35.605 Maintenance and repair restrictions. SOURCE: 51 FR 36951, Oct. 16, 1986, unless 35.606 License amendments. otherwise noted. 35.610 Safety instruction. Subpart A—General Information 35.615 Safety precautions. § 35.1 Purpose and scope. 35.620 Possession of survey instrument. This part prescribes requirements and pro- 35.630 Dosimetry equipment. visions for the medical use of byproduct mate- 35.632 Full calibration measurements. rial and for issuance of specific licenses au- 35.634 Periodic spot-checks. thorizing the medical use of this material. These 35.636 Safety checks for teletherapy facilities. requirements and provisions provide for the 35.641 Radiation surveys for teletherapy protection of the public health and safety. The facilities. requirements and provisions of this part are in 35.643 Modification of teletherapy unit or addition to, and not in substitution for, others room before beginning a treatment program. in this chapter. The requirements and provi- 35.645 Reports of teletherapy surveys, sions of parts 19, 20, 21, 30, 71, and 170 of checks, tests, and measurements. this chapter apply to applicants and licensees 35.647 Five-year inspection. subject to this part unless specifically exempted. subpart J—Training and Experience § 35.2 Definitions. Requirements Address of use means the building or build- 35.900 Radiation Safety Officer. ings that are identified on the license and where 35.901 Training for experienced Radiation byproduct material may be received, used, or Safety Officer. stored. 35.910 Training for uptake, dilution, and ex Agreement State means any State with cretion studies. which the Commission or the Atomic Energy 519 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 214 REGULATIONS § 35.2 10 CFR Ch. I (1-1-94 Edition) Commission has entered into an effective Medical Institution means an organization agreement under subsection 274b of the in which several medical disciplines are Atomic Energy Act of 1954, as amended. practiced. ALARA (as low as reasonably achievable) Medical use means the intentional internal means making every reasonable effort to main- or external administration of byproduct ma- tain exposures to radiation as far below the terial, or the radiation therefrom, to human dose limits as is practical: beings in the practice of medicine in accord- (1) Consistent with the purpose for which ance with a license issued by a State or Terri- the licensed activity is undertaken. tory of the United States, the District of Co- (2) Taking into account the state of tech- lumbia, or the Commonwealth of Puerto Rico. nology, the economics of improvements in re- Ministerial change means a change that is lation to benefits to the public health and safety, made, after ascertaining the applicable require- and other societal and socioeconomic consid- ments, by persons in authority in conform- erations, and ance with the requirements and without mak- (3) In relation to utilization of nuclear en- ing a discretionary judgment about whether ergy in the public interest. those requirements should apply in the case Area of use means a portion of an address of at hand. use that has been set aside for the purpose of Misadministration means the administra- receiving, using, or storing byproduct material. tion of: Authorized user means a physician, den- (1) A radiopharmaceutical dosage greater tist, or podiatrist who is identified as an au- than 30 microcuries of either sodium iodide thorized user on a Commission or Agreement I–125 or I–131: State license that authorizes the medical use (i) Involving the wrong patient or wrong of byproduct material. radiopharmaceutical, or Brachytherapy source means an individual (ii) When both the administered dosage dif- sealed source or a manufacturer-assembled fers from the prescribed dosage by more than source train that is not designed to be disas- 20 percent of the prescribed dosage and the sembled by the user. difference between the administered dosage Dedicated check source means a radioac- and prescribed dosage exceeds 30 microcuries. tive source that is used to assure the constant (2) A therapeutic radiopharmaceutical dos- operation of a radiation detection or meas- age, other than sodium iodide I–125 or I–131: urement device over several months or years. (i) Involving the wrong patient, wrong ra- Dental use means the intentional external diopharmaceutical, or wrong route of admin- administration of the radiation from byproduct istration; or material to human beings in the practice of (ii) When the administered dosage differs dentistry in accordance with a license issued from the prescribed dosage by more than 20 by a State or Territory of the United States, percent of the prescribed dosage. the District of Columbia, or the Common- (3) A gamma stereotactic radiosurgery ra- wealth of Puerto Rico. diation dose: Dentist means an individual licensed by a (i) Involving the wrong patient or wrong State or Territory of the United States, the Dis- treatment site; or trict of Columbia, or the Commonwealth of (ii) When the calculated total administered Puerto Rico to practice dentistry. dose differs from the total prescribed dose by Diagnostic clinical procedures manual more than 10 percent of the total prescribed dose. means a collection of written procedures that (4) A teletherapy radiation dose: describes each method (and other instructions (i) Involving the wrong patient, wrong mode and precautions) by which the licensee per- of treatment, or wrong treatment site; forms diagnostic clinical procedures; where (ii) When the treatment consists of three or each diagnostic clinical procedure has been fewer fractions and the calculated total ad- approved by the authorized user and includes ministered dose differs from the total pre- the radiopharmaceutical, dosage, and route of scribed dose by more than 10 percent of the administration. total prescribed dose; Management means the chief executive of- ficer or that person’s delegate or delegates. 520 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 215 REGULATIONS Nuclear Regulatory Commission § 35.2 (iii) When the calculated weekly adminis- United States, the District of Columbia, or tered dose is 30 percent greater than the weekly the Commonwealth of Puerto Rico. prescribed dose; or Podiatrist means an individual licensed by (iv) When the calculated total administered a State or Territory of the United States, the dose differs from the total prescribed dose by District of Columbia, or the Commonwealth more than 20 percent of the total prescribed dose. of Puerto Rico to practice podiatry. (5) A brachytherapy radiation dose: Prescribed dosage means the quantity of (i) Involving the wrong patient. wrong ra- radiopharmaceutical activity as documented: dioisotope, or wrong treatment site (exclud- (1) In a written directive; or ing, for permanent implants, seeds that were (2) Either in the diagnostic clinical proce- implanted in the correct site but migrated out- dures manual or in any appropriate record in side the treatment site): accordance with the directions of the author- (ii) Involving a sealed source that is leaking; ized user for diagnostic procedures. (iii) When, for a temporary implant, one or Prescribed dose means: more sealed sources are not removed upon (1) For gamma stereotactic radiosurgery, completion of the procedure; or the total dose as documented in the written (iv) When the calculated administered dose directive; differs from the prescribed dose by more than (2) For teletherapy, the total dose and dose 20 percent of the prescribed dose. per fraction as documented in the written di- (6) A diagnostic radiopharmaceutical dos- rective; or age, other than quantities greater than 30 (3) For brachytherapy, either the total source microcuries of either sodium iodide I–125 or strength and exposure time or the total dose, I–131, both: as documented in the written directive. (i) Involving the wrong patient, wrong ra- Radiation Safety Officer means the indi- diopharmaceutical, wrong route of adminis- vidual identified as the Radiation Safety Of- tration, or when the administered dosage dif- ficer on a Commission license. fers from the prescribed dosage; and Recordable event means the administration (ii) When the dose to the patient exceeds 5 of: rems effective dose equivalent or 50 rems dose (1) A radiopharmaceutical or radiation with- equivalent to any individual organ. out a written directive where a written direc- Mobile nuclear medicine service means the tive is required; transportation and medical use of byproduct (2) A radiopharmaceutical or radiation material. where a written directive is required without Output means the exposure rate, dose rate, daily recording of each administered radiop- or a quantity related in a known manner to harmaceutical dosage or radiation dose in the these rates from a teletherapy unit for a speci- appropriate record; fied set of exposure conditions. (3) A radiopharmaceutical dosage greater Physician means a medical doctor or doc- than 30 microcuries of either sodium iodide tor of osteopathy licensed by a State or Terri- I–125 or I–131 when both: tory of the United States, the District of Co- (i) The administered dosage differs from lumbia, or the Commonwealth of Puerto Rico the prescribed dosage by more than 10 per- to prescribe drugs in the practice of medicine. cent of the prescribed dosage, and Podiatric use means the intentional exter- (ii) The difference between the administered nal administration of the radiation from dosage and prescribed dosage exceeds 15 byproduct material to human beings in the microcuries; practice of podiatry in accordance with a li- (4) A therapeutic radiopharmaceutical dos- cense issued by a State or Territory of the age, other than sodium iodide I–125 or I–131: the the administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage; 521 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 216 REGULATIONS § 35.5 10 CFR Ch. I (1-1-94 Edition) (5) A teletherapy radiation dose when the cal- § 35.5 Maintenance of records culated weekly administered dose is 15 percent Each record required by this part must be leg- greater than the weekly prescribed dose; or ible throughout the retention period specified (6) A brachytherapy radiation dose when by each Commission regulation. The record the calculated administered dose differs from may be the original or a reproduced copy or a the prescribed dose by more than 10 percent microform provided that the copy or of the prescribed dose. microform is authenticated by authorized per- Sealed source means any byproduct mate- sonnel and that the microform is capable of rial that is encased in a capsule designed to producing a clear copy throughout the required prevent leakage or escape of the byproduct retention period. The record may also be stored material. in electronic media with the capability for pro- Teletherapy physicist means the individual ducing legible, accurate, and complete records identified as the teletherapy physicist on a during the required retention period. Records Commission license. such as letters, drawings, specifications, must Visiting authorized user means an author- include all pertinent information such as ized user who is not identified as an author- stamps, initials, and signatures. The licensee ized user on the license of the licensee being shall maintain adequate safeguards against visited. tampering with and loss of records. Written directive means an order in writ- ing for a specific patient, dated and signed by [53 FR 19247, May 27, 1988] an authorized user prior to the administration § 35.8 Information collection requirements: of a radiopharmaceutical or radiation, except OMB approval as specified in paragraph (6) of this defini- tion, containing the following information: (a) The Commission has submitted the in- (1) For any administration of quantities formation collection requirements contained greater than 30 microcuries of either sodium in this part to the Office of Management and iodide I–125 or 1–131: the dosage; Budget (OMB) for approval as required by (2) For a therapeutic administration of a the Paperwork Reduction Act of 1980 (44 radiopharmaceutical other than sodium iodide U.S.C. 3501 et seq.). OMB has approved the I–125 or I–131: the radiopharmaceutical, dos- information collection requirements in this age, and route of administration; part under control number 3150-0010. (3) For gamma stereotactic radiosurgery: (b) The approved information collection re- target coordinates, collimator size, plug pat- quirements contained in this part appear in §§ tern, and total dose; 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, (4) For teletherapy: the total dose, dose per 35.27, 35.29, 35.31, 35.50, 35.51, 35.53, fraction, treatment site, and overall treatment 35.59, 35.60, 35.61, 35.70, 35.80, 35.92, period; 35.204, 35.205, 35.310, 35.315, 35.404, (5) For high dose rate remote after loading 35.406, 35.410, 35.415, 35.606, 35.610, brachytherapy: the radioisotope, treatment site, 35.615, 35.630, 35.632, 35.634, 35.636, and total dose; or 35.641, 35.643, 35.645, and 35.647. (6) For all other brachytherapy: (c) This part contains information collec- (i) Prior to implantation: the radioisotope, tion requirements in addition to those approved number of sources, and source strengths; and under the control number specified in para- (ii) After implantation but prior to comple- graph (a) of this section. These information tion of the procedure: the radioisotope, treat- collection requirements and the control num- ment site, and total source strength and expo- bers under which they are approved as fol- sure time (or, equivalently, the total dose). lows: (1) In § 35.12, Form NRC-313 is approved [51 FR 36951, Oct. 16, 1986, as amended at 56 FR under control number 3150-0120. 34120, July 25, 1991] (d) OMB has assigned control number 3150- 0171 for the information collection 522 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 217 REGULATIONS Nuclear Regulatory Commission § 35.19 requirements contained in §§ 35.32 and § 35.13 License amendments 35.33. A licensee shall apply for and must receive [51 FR 36951, Oct. 16, 1986, as amended at 57 FR a license amendment: 41378, Sept. 10, 1992] (a) Before it receives or uses byproduct ma- terial for a clinical procedure permitted under § 35.11 License required this Part but not permitted by the license is- (a) A person shall not manufacture, pro- sued pursuant to this part; duce, acquire, receive, possess, use, or trans- (b) Before it permits anyone, except a vis- fer byproduct material for medical use except iting authorized user described in § 35.27, to in accordance with a specific license issued work as an authorized user under the license; by the Commission or an Agreement State, or (c) Before it changes Radiation Safety Of- as allowed in paragraph (b) of this section. ficers or Teletherapy Physicists; (b) An individual may receive, possess, use, (d) Before it orders byproduct material in or transfer byproduct material in accordance with excess of the amount, or radionuclide or form the regulations in this chapter under the different than authorized on the license; and supervision of an authorized user as provided in (e) Before it adds to or changes the areas of § 35.25, unless prohibited by license condition. use or address or addresses of use identified in the application or on the license. § 35.12 Application for license, amendment, or renewal § 35.14 Notifications (a) If the application is for medical use sited A licensee shall notify the Commission by in a medical institution, only the institution’s letter within thirty days when an authorized management may apply. If the application is user, Radiation Safety Officer, or Teletherapy for medical use not sited in a medical institu- Physicist permanently discontinues perform- tion, any person may apply. ance of duties under the license or has a name (b) An application for a license for medical change, or when the licensee’s mailing ad- use of byproduct material as described in §§ dress changes. The licensee shall mail the re- 35.100, 35.200, 35.300, 35.400, and 35.500 port to the appropriate address identified in § of this part must be made by filing an original 30.6 of this chapter. and one copy of Form NRC–313, ‘’Applica- § 35.18 License issuance tion for Materials License.” For guidance in completing the form, refer to the instructions The Commission shall issue a license for in the most current versions of the appropri- the medical use of byproduct material for a ate Regulatory Guides. A request for a license term of five years if: amendment or renewal may be submitted as (a) The applicant has filed Form NRC–313 an original and one copy in letter format. “Application for Materials License” in accord- (c) An application for a license for medical ance with the instructions in § 35.12; use of byproduct material as described in § (b) The applicant has paid any applicable 35.600 of this part must be made by filing an fee as provided in part 170 of this chapter; original and one copy of Form NRC–313. For (c) The Commission finds the applicant guidance in completing the form, refer to the equipped and committed to observe the safety instructions in the most current version of the standards established by the Commission in appropriate Regulatory Guide. A request for this Chapter for the protection of the public a license amendment or renewal may be sub- health and safety; and mitted as an original and one copy in letter (d) The applicant meets the requirements format. of part 30 of this chapter. (d) For copies of regulatory guides, appli- § 35.19 Specific exemptions cation forms, or to submit an application or The Commission may, upon application of any an amendment request, refer to § 30.6 of this interested person or upon its own initiative, chapter. grant such exemptions from the regulations 523 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 218 REGULATIONS § 35.20 10 CFR Ch. I (1-1-94 Edition) in this part as it determines are authorized by (b) The Radiation Safety Officer shall: law and will not endanger life or property or (1) Investigate overexposures, accidents, the common defense and security and are oth- spills, losses, thefts, unauthorized receipts, erwise in the public interest. The Commis- uses, transfers, disposals, misadministrations, sion will review requests forexemptions from and other deviations from approved radiation training and experience requirements with the safety practice and implement corrective ac- assistance of its Advisory Committee on the tions as necessary; Medical Uses of Isotopes. (2) Establish, collect in one binder or file, Subpart B—General Administrative and implement written policy and procedures Requirements for: (i) Authorizing the purchase of byproduct § 35.20 ALARA program material; (a) Each licensee shall develop and imple- (ii) Receiving and opening packages of ment a written radiation protection program byproduct material; that includes provisions for keeping doses (iii) Storing byproduct material; ALARA. (iv) Keeping an inventory record of (b) To satisfy the requirement of paragraph byproduct material; (a) of this section: (v) Using byproduct material safely; (1) At a medical institution, management, (vi) Taking emergency action if control of the Radiation Safety Officer, and all author- byproduct material is lost; ized users must participate in the program as (vii) Performing periodic radiation surveys; requested by the Radiation Safety Committee. (viii) Performing checks of survey instru- (2) For licensees that are not medical insti- ments and other safety equipment; tutions, management and all authorized users (ix) Disposing of byproduct material; must participate in the program as requested (x) Training personnel who work in or fre- by the Radiation Safety Officer. quent areas where byproduct material is used (c) The program must include notice to or stored; workers of the program’s existence and work- (xi) Keeping a copy of all records and re- ers’ responsibility to help keep dose equiva- ports required by the Commission regulations, lents ALARA, a review of summaries of the a copy of these regulations, a copy of each types and amounts of byproduct material used, licensing request and license and amendments, occupational doses, changes in radiation safety and the written policy and procedures required procedures and safety measures, and continu- by the regulations. ing education and training for all personnel (3) Brief management once each year on who work with or in the vicinity of byproduct the byproduct material program; material. The purpose of the review is to en- (4) Establish personnel exposure sure that licensees make a reasonable effort investigational levels that, when exceeded, will to maintain individual and collective occupa- initiate an investigation by the Radiation tional doses ALARA. Safety Officer of the cause of the exposure; § 35.21 Radiation Safety Officer (5) Establish personnel exposure investigational levels that, when exceeded, will (a) A licensee shall appoint a Radiation initiate a prompt investigation by the Radia Safety Officer responsible for implementing tion Safety Officer of the cause of the expo- the radiation safety program. The licensee, sure and a consideration of actions that might through the Radiation Safety Officer, shall be taken to reduce the probability of recur- ensure that radiation safety activities are be- rence; ing performed in accordance with approved (6) For medical use not at a medical institu- procedures and regulatory requirements in the tion, approve or disapprove minor changes in daily operation of the licensee’s byproduct radiation safety procedures that are not po- material program. tentially important to safety with the advice and consent of management; and 524 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 219 REGULATIONS Nuclear Regulatory Commission § 35.25 (7) For medical use at a medical institu- mitting a license application or request for tion, assist the Radiation Safety Committee amendment or renewal; in the performance of its duties. (3) Review on the basis of safety, and ap- § 35.22 Radiation Safety Committee. prove with the advice and consent of the Ra- diation Safety Officer and the management Each medical institution licensee shall es- representative, or disapprove minor changes tablish a Radiation Safety Committee to over- in radiation safety procedures that are not po- see the use of byproduct material. tentially important to safety and are permit- (a) Each Committee must meet the follow- ted under § 35.31 of this part; ing administrative requirements: (4) Review quarterly, with the assistance of (1) Membership must consist of at least the Radiation Safety Officer, a summary of the three individuals and must include an author- occupational radiation dose records of all per- ized user of each type of use permitted by the sonnel working with byproduct material; license, the Radiation Safety Officer, a repre- (5) Review quarterly, with the assistance sentative of the nursing service, and a repre- of the Radiation Safety Officer, all incidents sentative of management who is neither an involving byproduct material with respect to authorized user nor a Radiation Safety Of- cause and subsequent actions taken; and ficer. Other members may be included as the (6) Review annually, with the assistance of licensee deems appropriate. the Radiation Safety Officer, the radiation (2) The Committee must meet at least quar- safety program. terly. (3) To establish a quorum and to conduct § 35.23 Statements of authority and respon- business, at least one-half of the Committee’s sibilities. membership must be present, including the (a) A licensee shall provide the Radiation Radiation Safety Officer and the manage- Safety Officer, and at a medical institution the ment’s representative. Radiation Safety Committee, sufficient author- (4) The minutes of each Radiation Safety ity, organizational freedom, and management Committee meeting must include: prerogative, to: (i) The date of the meeting; (1) Identify radiation safety problems; (ii) Members present; (2) Initiate, recommend, or provide correc- (iii) Members absent; tive actions; and (iv) Summary of deliberations and discus- (3) Verify implementation of corrective ac- sions; tions. (v) Recommended actions and the numeri- (b) A licensee shall establish and state in cal results of all ballots; and writing the authorities, duties, responsibili- (vi) ALARA program reviews described in ties, and radiation safety activities of the Ra- § 35.20(c). diation Safety Officer, and at a medical insti- (5) The Committee must promptly provide tution the Radiation Safety Committee, each member with a copy of the meeting min- and retain the current edition of these state- utes, and retain one copy for the duration of ments as a record until the Commission ter- the license. minates the license. (b) To oversee the use of licensed material, § 35.25 Supervision. the Committee must: (a) A licensee that permits the receipt, pos- (1) Review recommendations on ways to session, use, or transfer of byproduct mate- maintain individual and collective doses rial by an individual under the supervision of ALARA; an authorized user as allowed by § 35.11(b) (2) Review, on the basis of safety and with of this part shall: regard to the training and experience stand- (1) Instruct the supervised individual in the ards in subpart J of this part, and approve or principles of radiation safety appropriate to disapprove any individual who is to be listed that individual’s use of byproduct material and as an authorized user, the Radiation Safety Officer, or a Teletherapy Physicist before sub- 525 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 220 REGULATIONS § 35.27 10 CFR Ch. I (1-1-94 Edition) in the licensee’s written quality management § 35.29 Administrative requirements that program; apply to the provision of mobile nuclear (2) Require the supervised individual to fol- medicine service. low the instructions of the supervising author- (a) The Commission will license mobile nu- ized user, follow the written radiation safety clear medicine service only in accordance with and quality management procedures estab- subparts D. E and H of this part and § 31.11 lished by the licensee, and comply with the of this chapter. regulations of this chapter and the license con- (b) Mobile nuclear medicine service licen- ditions with respect to the use of byproduct sees shall obtain a letter signed by the man- material; and agement of each client for which services are (3) Periodically review the supervised in- rendered that authorizes use of byproduct ma- dividual’s use of byproduct material and the terial at the client’s address of use. The mo- records kept to reflect this use. bile nuclear medicine service licensee shall (b) A licensee that supervises an individual retain the letter for three years after the last is responsible for the acts and omissions of provision of service. the supervised individual. (c) If a mobile nuclear medicine service pro- [51 FR 36951, Oct. 16, 1991, as amended at 56 FR vides services that the client is also author- 34121, July 25, 1991] ized to provide, the client is responsible for § 35.27 Visiting authorized user. assuring that services are conducted in accord- ance with the regulations in this chapter while (a) A licensee may permit any visiting au- the mobile nuclear medicine service is under thorized user to use licensed material for medi- the client’s direction. cal use under the terms of the licensee’s li- (d) A mobile nuclear medicine service may cense for sixty days each year if: not order byproduct material to be delivered (1) The visiting authorized user has the prior directly from the manufacturer or distributor written permission of the licensee’s manage- to the client’s address of use. ment and, if the use occurs on behalf of an institution, the institution’s Radiation Safety [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] Committee; (2) The licensee has a copy of a license is- § 35.31 Radiation safety program changes. sued by the Commission or an (a) A licensee may make minor changes in Agreement State, or a permit issued by a Com- radiation safety procedures that are not po- mission or Agreement State broad licensee that tentially important to safety, i.e., ministerial is authorized to permit medical use, that iden- changes, that were described in the applica- tifies the visiting authorized user by name as tion for license, renewal, or amendment ex- an authorized user for medical use; and cept for those changes in §§ 35.13 and 35.606 (3) Only those procedures for which the of this part. Examples of such ministerial visiting authorized user is specifically author- changes include: editing of procedures for clar- ized by the license or permit are performed ity or conformance with local drafting policy by that individual. or updating names, telephone numbers, and (b) A licensee need not apply for a license addresses; adoption of model radiation safety amendment in order to permit a visiting au- procedures published in NRC Regulatory thorized user to use licensed material as de- Guides; replacement of equipment; reassign- scribed in paragraph (a) of this section. ment of tasks among employees; or assign- (c) A licensee shall retain the records speci-ment of service contracts for services such as fied in this section for three years after the personnel dosimetry, radiation safety equip- visiting authorized user’s last use of licensed ment repair or calibration, waste disposal, and material, but may discard the records if the safety surveys. A licensee is responsible for visiting authorized user has been listed as an assuring that any change made is in compli- authorized user on the licensee’s license. ance with the requirements of the regulations [51 FR 36951, Oct. 16, 1986, as amended at 53 FR and the license. 19247, May 27, 1988] 526 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 221 REGULATIONS Nuclear Regulatory Commission § 35.32 (b) A licensee shall retain a record of each (iii) Any brachytherapy radiation dose; change until the license has been renewed or (iv) Any administration of quantities greater terminated. The record must include the ef- than 30 microcuries of either sodium iodide fective date of the change, a copy of the old I–125 or I–131; or and new radiation safety procedures, the rea- (v) Any therapeutic administration of a ra- son for the change, a summary of radiation diopharmaceutical, other than sodium iodide safety matters that were considered before I–125 or I–131; making the change, the signature of the Ra- (2) That, prior to each administration, the diation Safety Officer, and the signatures of patient’s identity is verified by more than one the affected authorized users and of manage- method as the individual named in the writ- ment or, in a medical institution, the Radia- ten directive; tion Safety Committee’s chairman and the (3) That final plans of treatment and related management representative. calculations for brachytherapy, teletherapy, § 35.32 Quality management program. and gamma stereotactic radiosurgery are in accordance with the respective written direc- (a) Each applicant or licensee under this tives; part, as applicable, shall establish and main- (4) That each administration is in accord- tain a written quality management program ance with the written directive; and to provide high confidence that byproduct ma- (5) That any unintended deviation from the terial or radiation from byproduct material will written directive is identified and evaluated, be administered as directed by the authorized and appropriate action is taken. user. The quality management program must (b) The licensee shall: include written policies and procedures to meet (1) Develop procedures for and conduct a the following specific objectives: review of the quality management program (1) That, prior to administration, a written including, since the last review, an evaluation directive 1 is prepared for: of: (i) Any teletherapy radiation dose; A representative sample of patient adminis- (ii) Any gamma stereotactic radiosurgery trations, radiation dose; (ii) All recordable events, and (iii) All misadministrations to verify com- pliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months; (2) Evaluate each of these reviews to deter- mine the effectiveness of the quality management program and, if required, make modifications to 1If, because of the patient’s condition, a delay in order to meet the objectives of paragraph (a) of this provide a written revision to an existing written directive section; and would jeopardize the patient’s health, an oral revision to an existing written directive will be acceptable, provided (3) Retain records of each review, includ- that the oral revision is documented immediately in the ing the evaluations and findings patient’s record and a revised written directive is signed of the review, in an auditable form for three by the authorized user within 48 hours of the oral revision. years. Also, a written revision to an existing written directive (c) The licensee shall evaluate and respond, may be made for any diagnostic or therapeutic procedure within 30 days after discovery of the record- provided that the revision is dated and signed by an au- able event, to each recordable event by: thorized user prior to the administration of the radiophar- (1) Assembling the relevant facts includ- maceutical dosage, the brachytherapy dose, the gamma ing the cause; stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose. If, because of the emer- (2) Identifying what, if any, corrective ac- gent nature of the patient’s condition, a delay in order to tion is required to prevent recurrence; and provide a written directive would jeopardize the patient’s (3) Retaining a record, in an auditable form, health, an oral directive will be acceptable, provided that for three years, of the relevant facts and what the information contained in the oral directive is docu- corrective action if any, was taken. mented immediately in the patient’s record and a written directive is prepared within 24 hours of the oral directive. 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 222 REGULATIONS (d) The licensee shall retain: notified the patient, or the patient’s responsi- (1) Each written directive; and ble relative or guardian (this person will be (2) A record of each administered radia- subsequently referred to as “the patient” in tion dose or radiopharmaceutical dosage where this section), and if not, why not, and if the a written directive is required in paragraph patient was notified, what information was (a)(1) above, in an auditable form, for three provided to the patient. The report must not years after the date of administration. include the patient’s name or other informa- (e) The licensee may make modifications tion that could lead to identification of the to the quality management program to increase patient. the programs’ efficiency provided the pro- (3) The licensee shall notify the referring gram’s effectiveness is not decreased. The li- physician and also notify the patient of the censee shall furnish the modification to the misadministration no later than 24 hours af- appropriate NRC Regional Office within 30 ter its discovery, unless the referring physi- days after the modification has been made. cian personally informs the licensee either that (f)(1) Each applicant for a new license, as he will inform the patient or that, based on applicable, shall submit to the appropriate medical judgment, telling the patient would NRC Regional Office in accordance with 10 be harmful. The licensee is not required to CFR 30.6 a quality management program as notify the patient without first consulting the part of the application for a license and im- referring physician. If the referring physician plement the program upon issuance of the li- or patient cannot be reached within 24 hours, cense by the NRC. the licensee shall notify the patient as soon (2) Each existing licensee, as applicable, as possible thereafter. The licensee may not shall submit to the appropriate NRC Regional delay any appropriate medical care for the pa- Office in accordance with 10 CFR 30.6 by tient, including any necessary remedial care January 27, 1992 a written certification that as a result of the misadministration, because the quality management program has been im- of any delay in notification. plemented along with a copy of the program. (4) If the patient was notified, the licensee [56 FR 34121, July 25, 1991] shall also furnish, within 15 days after dis- covery of the misadministration, a written re- § 35.33 Notifications, reports, and records port to the patient by sending either: of misadministrations. (i) A copy of the report that was submitted (a) For a misadministration: to the NRC; or (1) The licensee shall notify by telephone (ii) A brief description of both the event the NRC Operations Center 2 no later than and the consequences as they may affect the the next calendar day after discovery of the patient, provided a statement is included that misadministration. the report submitted to the NRC can be ob- (2) The licensee shall submit a written re- tained from the licensee. port to the appropriate NRC Regional Office (b) Each licensee shall retain a record of listed in 10 CFR 30.6 within 15 days after each misadministration for five years. The discovery of the misadministration. The writ- record must contain the names of all individu- ten report must include the licensee’s name; als involved (including the prescribing physi- the prescribing physician’s name; a brief de- cian, allied health personnel, the patient, and scription of the event; why the event occurred; the patient’s referring physician), the patient’s the effect on the patient; what improvements social security number or identification are needed to prevent recurrence; actions taken number if one has been assigned, a brief de- to prevent recurrence; whether the licensee scription of the misadministration, why it oc- curred, the effect on the patient, what improve- ments are needed to prevent recurrence, and the actions taken to prevent recurrence. 2 The commercial telephone number of the NRC Op- erations Center is (301) 951-0550. 528 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 223 REGULATIONS Nuclear Regulatory Commission § 35.50 (c) Aside from the notification requirement, 5 percent of its stated activity, whose activity nothing in this section affects any rights or is at least 10 microcuries for radium-226 and duties of licensees and physicians in relation 50 microcuries for any other photon-emitting to each other, patients, or the patient’s respon- radionuclide, and at least one of which has a sible relatives or guardians. principal photon energy between 100 keV and [56 FR 34122, July 25, 1991] 500 keV; (3) Test each dose calibrator for linearity § 35.49 Suppliers. upon installation and at least quarterly there- A licensee may use for medical use only: after over the range of its use between the high- (a) Byproduct material manufactured, est dosage that will be administered to a pa- labeled, packaged, and distributed in accord- tient and 10 microcuries; and ance with a license issued pursuant to the regu- (4) Test each dose calibrator for geometry lations in part 30 and § 32.72, 32.73, or 32.74 dependence upon installation over the range of this chapter or the equivalent regulations of volumes and volume configurations for of an Agreement State; which it will be used. The licensee shall keep (b) Reagent kits that have been manufac- a record of this test for the duration of the use tured, labeled, packaged, and distributed in of the dose calibrator. accordance with an approval by the Commis- (c) A licensee shall also perform appropri- sion pursuant to § 32.73 or an Agreement State ate checks and tests required by this section under equivalent regulations for the prepara- following adjustment or repair of the dose cali- tion of radiopharmaceuticals for medical use; brator. and (d) A licensee shall mathematically correct (c) Teletherapy sources manufactured and dosage readings for any geometry or linearity distributed in accordance with a license is- error that exceeds 10 percent if the dosage is sued pursuant to part 30 of this chapter or the greater than 10 microcuries and shall repair equivalent regulations of an Agreement State. or replace the dose calibrator if the accuracy Subpart C—General Technical or constancy error exceeds 10 percent. Requirements (e) A licensee shall retain a record of each check and test required by this section for three § 35.50 Possession, use, calibration, and years unless directed otherwise. The records check of dose calibrators. required in paragraphs (b)(1) through (b)(4) (a) A medical use licensee authorized to of this section must include: administer radiopharmaceuticals shall have in (1) For paragraph (b)(1) of this section, the its possession a dose calibrator and use it to model and serial number of the dose calibra- measure the amount of activity administered tor, the identity of the radionuclide contained to each patient. in the check source, the date of the check, the (b) A licensee shall: activity measured, and the initials of the indi- (1) Check each dose calibrator for constancy vidual who performed the check; with a dedicated check source at the begin- (2) For paragraph (b)(2) of this section, the ning of each day of use. To satisfy the require- model and serial number of the dose calibra- ment of this paragraph, the check must be done tor, the model and serial number of each source on a frequently used setting with a sealed used and the identity of the radionuclide con- source of not less than 10 microcuries of ra- tained in the source and its activity, the date dium-226 or 50 microcuries of any other pho- ton-emitting radionuclide; (2) Test each dose calibrator for accuracy upon installation and at least annually there- after by assaying at least two sealed sources containing different radionuclides whose ac- tivity the manufacturer has determined within 529 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 224 REGULATIONS § 35.51 10 CFR Ch. I (1-1-94 Edition) of the test, the results of the test, and the sig- § 35.53 Measurement of radiopharmaceu- nature of the Radiation Safety Officer; tical dosages. (3) For paragraph (b)(3) of this section, the A licensee shall: model and serial number of the dose calibra- (a) Measure the activity of each radiophar- tor, the calculated activities, the measured ac- maceutical dosage that contains more than 10 tivities, thedate of the test, and the signature microcuries of a photon-emitting radionuclide of the Radiation Safety Officer; and before medical use; (4) For paragraph (b)(4) of this section, the (b) Measure the activity of each radiophar- model and serial number of the dose calibra- maceutical dosage with a desired activity of tor, the configuration of the source measured, 10 microcuries or less of a photon- the activity measured for each volume meas- emittingradionuclide before medical use to ured, the date of the test, and the signature of verify that the dosage does not exceed 10 the Radiation Safety Officer. microcuries; [51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247, (c) Retain a record of the measurements May 27, 1988] required by this section for three years. To § 35.51 Calibration and check of survey satisfy this requirement, the record must con- instruments. tain the: (a) A licensee shall calibrate the survey in- (1) Generic name, trade name, or abbre- struments used to show compliance with this viation of the radiopharmaceutical, its lot part before first use, annually, and following number, and expiration dates and the repair. The licensee shall: radionuclide; (1) Calibrate all scales with readings up to (2) Patient’s name, and identification 1000 millirem per hour with a radiation source; number if one has been assigned; (2) Calibrate two separated readings on each (3) Prescribed dosage and activity of the scale that must be calibrated; and dosage at the time of measurement, or a nota- (3) Conspicuously note on the instrument tion that the total activity is less than 10 the apparent exposure rate from a dedicated microcuries; check source as determined at the time of cali- (4) Date and time of the measurement; and bration, and the date of calibration. (5) Initials of the individual who made the (b) When calibrating a survey instrument, record. the licensee shall consider a point as calibrated [51 FR 36951, Oct. 16, 1986, as amended at 53 FR if the indicated exposure rate differs from the 19247, May 27, 1988] calculated exposure rate by not more than 20 § 35.57 Authorization for calibration and percent, and shall conspicuously attach a cor- reference sources. rection chart or graph to the instrument. (c) A licensee shall check each survey in- Any person authorized by § 35.11 of this part strument for proper operation with the dedi- for medical use of byproduct material may cated check source each day of use. A licen- receive, possess, and use the following see is not required to keep records of these byproduct material for check, calibration, and checks. reference use: (d) A licensee shall retain a record of each (a) Sealed sources manufactured and dis- survey instrument calibration for three years. tributed by a person licensed pursuant to § The record must include: 32.74 of this chapter or equivalent Agreement (1) A description of the calibration proce- State regulations and that do not exceed 15 dure; and millicuries each; (2) The date of the calibration, a descrip- (b) Any byproduct material listed in §§ tion of the source used and the certified expo- 35.100 or 35.200 with a half-life not longer sure rates from the source, and the rates indi- than 100 days in individual amounts not to cated by the instrument being calibrated, the exceed 15 millicuries; correction factors deduced from the calibra- (c) Any byproduct material listed in §§ tion data, and the signature of the individual 35.100 or 35.200 with a half-life longer than who performed the calibration. 100 days in individual amounts not to exceed 200 microcuries each; and [51 FR 36951, Oct. 16, 1986, as amended at 53 FR (d) Technetium-99m in individual amounts 19247, May 27, 1988] not to exceed 50 millicuries. 530 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 225 REGULATIONS Nuclear Regulatory Commission § 35.59 § 35.59 Requirements for possession of (1) Immediately withdraw the sealed source sealed sources and brachytherapy from use and store it in accordance with the sources. requirements in parts 20 and 30 of this chap- (a) A licensee in possession of any sealed ter; and source or brachytherapy source shall follow (2) File a report within five days of the leak- the radiation safety and handling instructions age test with the appropriate NRC Office listed supplied by the manufacturer, and shall main- in § 30.6 of this chapter, with a copy to Direc- tain the instructions for the duration of source tor, Office of Nuclear Material Safety and use in a legible form convenient to users. Safeguards, U.S. Nuclear Regulatory Com- (b) A licensee in possession of a sealed mission, Washington, DC 20555, describing source shall: the equipment involved, the test results, and (1) Test the source for leakage before its the action taken. first use unless the licensee has a certificate (f) A licensee need not perform a leakage from the supplier indicating that the source test on the following sources: was tested within six months before transfer (1) Sources containing only byproduct ma- to the licensee; and terial with a half-life of less than 30 days; (2) Test the source for leakage at intervals (2) Sources containing only byproduct ma- not to exceed six months or at other intervals terial as a gas; approved by the Commission or an Agreement (3) Sources containing 100 microcuries or State and described in the label or brochure less of beta or gammaemitting that accompanies the source. material or 10 microcuries or less of alpha- (c) To satisfy the leak test requirements of emitting material; this section, the licensee must: (4) Sources stored and not being used. The (1) Take a wipe sample from the sealed licensee shall, however, test each such source source or from the surfaces of the device in for leakage before any use or transfer unless which the sealed source is mounted or stored it has been leakage-tested within six months on which radioactive contamination might be before the date of use or transfer; and expected to accumulate or wash the source in (5) Seeds of iridium-192 encased in nylon a small volume of detergent solution and treat ribbon. the entire volume as the sample; (g) A licensee in possession of a sealed (2) Take teletherapy and other device source source or brachytherapy source shall conduct test samples when the source is in the “off” a quarterly physical inventory of all such position; and sources in its possession. The licensee shall (3) Measure the sample so that the leakage retain each inventory record for five years. The test can detect the presence of 0.005 microcuries inventory records must contain the model of radioactive material on the sample. number of each source, and serial number if (d) A licensee shall retain leakage test one has been assigned, the identity of each records for five years. The records must con- source radionuclide and its nominal activity, tain the model number, and serial number if the location of each source, and the signature assigned, of each source tested, the identity of the Radiation Safety Officer. of each source radionuclide and its estimated (h) A licensee in possession of a sealed activity, the measured activity of each test sam- source or brachytherapy source shall meas- ple expressed in microcuries, a description of ure the ambient dose rates quarterly in all ar- the method used to measure each test sample, eas where such sources are stored. This does the date of the test, and the signature of the not apply to teletherapy sources in teletherapy Radiation Safety Officer. units or sealed sources in diagnostic devices. (e) If the leakage test reveals the presence (i) A licensee shall retain a record of each of 0.005 microcurie or more of removable survey required in paragraph (h) of this sec- contamination, the licensee shall: tion for three years. The record must include the date of thesurvey, a plan of each area that 531 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 226 REGULATIONS § 35.60 10 CFR Ch. I (1-1-94 Edition) was surveyed, the measured dose rate at sev- (c) A licensee shall conduct the surveys re- eral points in each area expressed in millirem quired by paragraphs (a) and (b) of this sec- per hour, the survey instrument used, and the tion so as to be able to detect dose rates as signature of the Radiation Safety Officer. low as 0.1 millirem per hour. [51 FR 36951, Oct. 16, 1986, as amended at 52 FR (d) A licensee shall establish radiation dose 31611, Aug. 21, 1987; 53 FR 19247, May 27, 1988] rate trigger levels for the surveys required by paragraphs (a) and (b) of this section. A § 35.60 Syringe shields and labels. licenseeshall require that the individual per- (a) A licensee shall keep syringes that con- forming the survey immediately notify the tain byproduct material to be administered in Radiation Safety Officer if a dose rate exceeds a radiation shield. a trigger level. (b) To identify its contents, a licensee shall (e) A licensee shall survey for removable conspicuously label each syringe, or syringe contamination once each week all areas where radiation shield that contains a syringe with a radiopharmaceuticals are routinely prepared radiopharmaceutical. The label must show the for use, administered, or stored. radiopharmaceutical name or its abbreviation, (f) A licensee shall conduct the surveys re- the clinical procedure to be performed, or the quired by paragraph (e) of this section so as patient’s name. to be able to detect contamination on each wipe (c) A licensee shall require each individual sample of 2000 disintegrations per minute. who prepares a radiopharmaceutical kit to use (g) A licensee shall establish removable con- a syringe radiation shield when preparing the tamination trigger levels for the surveys re- kit and shall require each individual to use a quired by paragraph (e) of this section. A li- syringe radiation shield when administering censee shall require that the individual per- a radiopharmaceutical by injection unless the forming the survey immediately notify the use of the shield is contraindicated for that Radiation Safety Officer if contamination ex- patient. ceeds the trigger level. § 35.61 Vial shields and labels. (h) A licensee shall retain a record of each survey for three years. The record must in- (a) A licensee shall require each individual clude the date of the survey, a plan of each preparing or handling a vial that contains a area surveyed, the trigger level established for radiopharmaceutical to keep the vial in a vial each area, the detected dose rate at several radiation shield. points in each area expressed in millirem per (b) To identify its contents, a licensee shall hour or the removable contamination in each conspicuously label each vial radiation shield area expressed in disintegrations per minute that contains a vial of a radiopharmaceutical. per 100 square centimeters, the instrument The label must show the radiopharmaceuti- used to make the survey or analyze the sam- cal name or its abbreviation. ples, and the initials of the individual who per- § 35.70 Surveys for contamination and am- formed the survey. bient radiation exposure rate. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] (a) A licensee shall survey with a radiation detection survey instrument at the end of each § 35.75 Release of patients containing day of use all areas where radiopharmaceuticals or permanent im- radiopharmaceuticals are routinely prepared plants. for use or administered. (a) A licensee may not authorize release (b) A licensee shall survey with a radiation from confinement for medical care any pa- detection survey instrument at least once each tient administered a radiopharmaceutical un- week all areas where radiopharmaceuticals or til either: radiopharmaceutical waste is stored. (1) The measured dose rate from the pa- tient is less than 5 millirems per hour at a dis- tance of one meter; or 532 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 227 REGULATIONS Nuclear Regulatory Commission § 35.100 (2) The activity in the patient is less than § 35.90 Storage of volatiles and gases. 30 millicuries. A licensee shall store volatile (b) A licensee may not authorize release radiopharmaceuticals and radioactive gases in from confinement for medical care of any pa- the shipper’s radiation shield and container. tient administered a permanent implant until A licensee shall store a multi-dose container the measured dose rate from the patient is less in a fume hood after drawing the first dosage than 5 millirems per hour at a distance of one from it. meter. § 35.92 Decay-in-storage. § 35.80 Technical requirements that apply (a) A licensee may hold byproduct mate- to the provision of mobile nuclear medi- rial with a physical half-life of less than 65 cine service. days for decay-in-storage before disposal in A licensee providing mobile nuclear medicine ordinary trash and is exempt from the require- service shall: ments of § 20.2001 of this chapter if it: (a) Transport to each address of use only (1) Holds byproduct material for decay a syringes or vials containing prepared minimum of ten half-lives; (2) Monitors radiopharmaceuticals or radiopharmaceuticals byproduct material at the container surface that are intended for reconstitution of radiop- before disposal as ordinary trash and deter- harmaceutical kits; mines that its radioactivity cannot be distin- (b) Bring into each address of use all guished from the background radiation level byproduct material to be used and, before leav- with a radiation detection survey meter set on ing, remove all unused byproduct material and its most sensitive scale and with no interposed all associated waste; shielding; (c) Secure or keep under constant surveil- (3) Removes or obliterates all radiation la- lance and immediate control all byproduct bels; and material when in transit or at an address of (4) Separates and monitors each generator use; column individually with all radiation shield- (d) Check survey instruments and dose ing removed to ensure that it has decayed to calibrators as described in § 35.50 and 35.51, background radiation level before disposal. and check all other transported equipment for (b) A licensee shall retain a record of each proper function before medical use at each disposal permitted under paragraph (a) of this address of use; section for three years. The record must in- (e) Carry a radiation detection survey me- clude the date of the disposal, the date on ter in each vehicle that is being used to trans- which the byproduct material was placed in port byproduct material, and, before leaving storage, the radionuclides disposed, the sur- a client address of use, survey all radiophar- vey instrument used, the background dose rate, maceutical areas of use with a radiation de- the dose rate measured at the surface of each tection survey meter to ensure that all waste container, and the name of the individual radiopharmaceuticals and all associated waste who performed the disposal. have been removed; [51 FR 36951, Oct. 16, 1986, as amended at 53 FR (f) Retain a record of each survey required 19247, May 27, 1988; 56 FR 23472, May 21, 1991; in paragraph (e) of this section for three years. 58 FR 67660, Dec. 22, 1993] The record must include the date of the sur- Subpart D—Uptake, Dilution, and vey, a plan of each area that was surveyed, the Excretion measured dose rate at several points in each area of use expressed in millirem per hour, § 35.100 Use of radiopharmaceuticals for the instrument used to make the survey, and uptake, dilution and excretion studies. the initials of the individual who performed A licensee may use any byproduct mate- the survey. rial in a radiopharmaceutical and for a diag- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR nostic use involving measurements of uptake, 19247, May 27, 1988] dilution, or excretion for which the Food and 533 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 228 REGULATIONS § 20.1001 10 CFR Ch. I (1-1-94 Edition) Drug Administration (FDA) has accepted a than 0.15 microcurie of molybdenum-99 per ‘’Notice of Claimed Investigational Exemp- millicurie of technetium-99m. tion for a New Drug” (IND) or approved a (b) A licensee that uses molybdenum-99/ “New Drug Application” (NDA). technetium-99m generators for preparing a § 35.120 Possession of survey instrument. technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in A licensee authorized to use byproduct mate- each elate or extract. rial for uptake, dilution, and excretion studies (c) A licensee that must measure molybde- shall have in its possession a portable radia- num concentration shall retain a record of each tion detection survey instrument capable of measurement for three years. The record must detecting dose rates over the range 0.1 millirem include, for each elution or extraction of tech- per hour to 100 millirem per hour. netium-99m, the measured activity of the tech- Subpart E—Imaging and Localization netium expressed in millicuries, the measured activity of the molybdenum expressed in § 35.200 Use of radiopharmaceuticals, gen- microcuries, the ratio of the measures ex- erators, and reagent kits for imaging and pressed as microcuries of molybdenum per localization studies. millicurie of technetium, the time and date of (a) A licensee may use any byproduct ma- the measurement, and the initials of the indi- terial in a diagnostic radiopharmaceutical or vidual who made the measurement. any generator or reagent kit for preparation [51 FR 36951, Oct. 16, 1986, as amended at 53 FR and diagnostic use of a radiopharmaceutical 19247, May 27, 1988] containing byproduct material for which the Food and Drug Administration has accepted § 35.205 Control of aerosols and gases. a “Notice of Claimed Investigational Exemp- (a) A licensee that administers radioactive tion for a New Drug” (IND) or approved a aerosols or gases shall do so in a room with a “New Drug Application” (NDA). system that will keep airborne concentrations (b) A licensee shall elute generators and within the limits prescribed by § 20.1301 of prepare reagent kits in accordance with the this chapter. The system must either be di- manufacturer’s instructions. rectly vented to the atmosphere through an (c)(1) From August 23, 1990, to December air exhaust or provide for collection and de- 31, 1994, a licensee may depart from the cay or disposal of the aerosol or gas in a manufacturer’s instructions for eluting gen- shielded container. erators and preparing reagent kits for which (b) A licensee shall administer radioactive the Food and Drug Administration (FDA) has gases only in rooms that are at negative pres- approved a “New Drug Application” (NDA), sure compared to surrounding rooms. by following the directions of an authorized (c) Before receiving, using, or storing a ra- user physician. dioactive gas, the licensee shall calculate the (2) Nothing in this section relieves the li- amount of time needed after a spill to reduce censee from complying with other applicable the concentration in the room to the occupa- NRC, FDA, and other Federal or State regu- tional limit listed in § 20.1301 of this chapter. lations. The calculation must be based on the highest [51 FR 36951, Oct. 16, 1986, as amended at 57 activity of gas handled in a single container, CFR 45568, Oct. 2, 1992; 58 FR 39132, July 22, the air volume of the room, and the measured 1993] available air exhaust rate. (d) A licensee shall make a record of the cal- § 35.204 Permissible molybdenum-99 con- culations required in paragraph (c) of this sec- centration. tion that includes the assumptions, measure- (a) A licensee may not administer to hu- ments, and calculations made and shall retain mans a radiopharmaceutical containing more 534 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 229 REGULATIONS Nuclear Regulatory Commission § 35.315 the record for the duration of use of the area. [51 FR 36951. Oct. 16, 1986. as amended at 55 FR A licensee shall also post the calculated time 34518. Aug. 23, 1990; 57 FR 45568, Oct. 2, 1992; and safety measures to be instituted in case of 58 FR 39132, July 22, 1993] a spill at the area of use. §35.310 Safety instruction. (e) A licensee shall check the operation of (a) A licensee shall provide radiation safety reusable collection systems each month, and instruction for all personnel caring for the pa- measure the ventilation rates available in ar- tient receiving radiopharmaceutical therapy eas of radioactive gas use each six months. and hospitalized for compliance with §35.75 [51 FR 36951, Oct. 16, 1986, as amended at 53 FR of this chapter. To satisfy this requirement, 27667. July 22, 1988; 58 FR 67660, Dec. 22, 1993] the instruction must describe the licensee’s §35.220 Possession of survey instruments. procedures for: (1) Patient control; A licensee authorized to use byproduct ma- (2) Visitor control; terial for imaging and localization studies shall (3) Contamination control; have in its possession a portable radiation de- (4) Waste control; and tection survey instrument capable of detect- (5) Notification of the Radiation Safety Of- ing dose rates over the range of 0.1 millirem ficer in case of the patient’s death or medical per hour to 100 millirem per hour, and a port- emergency. able radiation measurement survey instrument (b) A licensee shall keep for three years a capable of measuring dose rates over the range list of individuals receiving instruction re- 1 millirem per hour to 1000 millirem per hour. quired by paragraph (a) of this section, a de- Subpart F—Radiopharmaceuticals for scription of the instruction, the date of instruc- Therapy tion, and the name of the individual who gave §35.300 Use of radiopharmaceuticals for the instruction. therapy. [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] (a) A licensee may use any byproduct ma- terial in a radiopharmaceutical and for a thera- §35.315 Safety precautions. peutic use for which the Food and Drug Ad- (a) For each patient receiving radiophar- ministration has accepted a “Notice of Claimed maceutical therapy and hospitalized for com- Investigational Exemption for a New Drug” pliance with §35.75 of this chapter, a licensee (IND), or approved a “New Drug Applica- shall: tion” (NDA). The licensee shall comply with (1) Provide a private room with a private the package insert instructions regarding in- sanitary facility; dications and method of administration. (2) Post the patient’s door with a “Radio- (b) (1) From August 23, 1990, to Decem- active Materials” sign and note on the door or ber 31, 1994, a licensee may depart from the in the patient’s chart where and how long visi- package insert instructions regarding indica- tors may stay in the patient’s room; tions or methods of administration for a radi- (3) Authorize visits by individuals under opharmaceutical for which the Food and Drug age 18 only on a patient-by-patient basis with Administration (FDA) has approved a “New the approval of the authorized user after con- Drug Application” (NDA), provided that the sultation with the Radiation Safety Officer; authorized user physician has prepared a writ- (4) Promptly after administration of the dos- ten directive as required by §35.32(a). age, measure the dose rates in contiguous re- (2) Nothing in this section relieves the li- stricted and unrestricted areas with a radia- censee from complying with other applicable tion measurement survey instrument to dem- NRC, FDA, and other Federal or State regu- onstrate compliance with the requirements of lations. part 20 of this chapter, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in 535 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 230 REGULATIONS § 35.320 10 CFR Ch. I (1-1-94 Edition) millirem per hour, the instrument used to make Subpart G—Sources for Brachytherapy the survey, and the initials of the individual §35.400 Use of sources for brachytherapy. who made the survey. (5) Either monitor material and items re- A licensee shall use the following sources moved from the patient’s room to determine in accordance with the manufacturer’s radia- that their radioactivity cannot be distinguished tion safety and handling instructions: from the natural background radiation level (a) Cesium-137 as a sealed source in nee- with a radiation detection survey instrument dles and applicator cells for topical, intersti- set on its most sensitive scale and with no in- tial, and intracavitary treatment of cancer; terposed shielding, or handle them as radio- (b) Cobalt-60 as a sealed source in needles active waste. and applicator cells for topical, interstitial, and (6) Provide the patient with radiation safety intracavitary treatment of cancer; guidance that will help to keep radiation dose (c) Gold-198 as a sealed source in seeds to household members and the public as low for interstitial treatment of cancer; as reasonably achievable before authorizing (d) Iridium-192 as seeds encased in nylon release of the patient. ribbon for interstitial treatment of cancer; (7) Survey the patient’s room and private (e) Strontium-90 as a sealed source in an sanitary facility for removable contamination applicator for treatment of superficial eye con- with a radiation detection survey instrument ditions; and before assigning another patient to the room. (f) Iodine-125 as a sealed source in seeds The room must not be reassigned until remov- for interstitial treatment of cancer. able contamination is less than 200 (g) Palladium-103 as a sealed source in seeds disintegrations per minute per 100 square for interstitial treatment of cancer. centimeters; and [51 FR 36951, Oct. 16, 1986, as amended at 54 FR (8) Measure the thyroid burden of each in- 41821, Oct. 12, 1989] dividual who helped prepare or administer a §35.404 Release of patients treated with dosage of iodine-131 within three days after temporary implants. administering the dosage, and retain for the period required by §20.1206(a) of this chap- (a) Immediately after removing the last tem- ter a record of each thyroid burden measure- porary implant source from a patient, the li- ment, its date, the name of the individual censee shall make a radiation survey of the whose thyroid burden was measured, and the patient with a radiation detection survey in- initials of the individual who made the meas- strument to confirm that all sources have been urements. removed. The licensee may not release from (b) A licensee shall notify the Radiation confinement for medical care a patient treated Safety Officer immediately if the patient dies by temporary implant until all sources have or has a medical emergency. been removed. (b) A licensee shall retain a record of pa- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; tient surveys for three years. Each record must 58 FR 67660, Dec. 22, 1993] include the date of the survey, the name of the patient, the dose rate from the patient ex- §35.320 Possession of survey instruments. pressed as millirem per hour and measured at A licensee authorized to use byproduct ma- one meter from the patient, he survey instru- terial for radiopharmaceutical therapy shall ment used, and the initials of the individual have in its possession a portable radiation de- who made the survey. tection survey instrument capable of detect- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR ing dose rates over the range 0.1 millirem per 19247, May 27, 1988] hour to 100 millirem per hour, and a portable radiation measurement survey instrument ca- pable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour. 536 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 231 REGULATIONS Nuclear Regulatory Commission § 35.415 §35.406 Brachytherapy sources inventory. (b) A licensee shall retain for three years a (a) Promptly after removing them from a record of individuals receiving instruction re- patient, a licensee shall return brachytherapy quired by paragraph (a) of this section, a de- sources to the storage area, and count the scription of the instruction, the date of instruc- number returned to ensure that all sources tion, and the name of the individual who gave taken from the storage area have been returned. the instruction. (b) A licensee shall make a record of [51 FR 36951, Oct. 16, 1986, as amended at 53 FR brachytherapy source use which must include: 19247, May 27, 1988] (1) The names of the individuals permitted §35.415 Safety precautions. to handle the sources. (a) For each patient receiving implant (2) The number and activity of sources re- therapy, a licensee shall: moved from storage, the patient’s name and (1) Not quarter the patient in the same room room number, the time and date they were with a patient who is not receiving radiation removed from storage, the number and activ- therapy unless the licensee can demonstrate ity of the sources in storage after the removal, compliance with the requirements of and the initials of the individual who removed §20.1301(a) of this chapter at a distance of the sources from storage; one meter from the implant; (3) The number and activity of sources re- (2) Post the patient’s door with a “Radio- turned to storage, the patient’s name and active Materials” sign and note on the door or room number, the time and date they were in the patient’s chart where and how long visi- returned to storage, the number and activity tors may stay in the patient’s room; of sources in storage after the return, and the (3) Authorize visits by individuals under initials of the individual who returned the age 18 only on a patient-by-patient basis with sources to storage. the approval of the authorized user after con- (c) Immediately after implanting sources sultation with the Radiation Safety Officer; in a patient the licensee shall make a radia- and tion survey of the patient and the area of use (4) Promptly after implanting the material, to confirm that no sources have been mis- survey the dose rates in contiguous restricted placed. The licensee shall make a record of and unrestricted areas with a radiation meas- each survey. urement survey instrument to demonstrate (d) A licensee shall retain the records re- compliance with the requirements of Part 20 quired in paragraphs (b) and (c) of this sec- of this chapter, and retain for three years a tion for three years. record of each survey that includes the time [51 FR 36951, Oct. 16, 1986, as amended at 53 FR and date of the survey, a plan of the area or 19247, May 27, 1988] list of points surveyed, the measured dose rate §35.410 Safety instruction. at several points expressed in millirem per hour, the instrument used to make the survey, (a) The licensee shall provide radiation and the initials of the individual who made safety instruction to all personnel caring for the survey. the patient undergoing implant therapy. To (5) Provide the patient with radiation safety satisfy this requirement, the instruction must guidance that will help to keep radiation dose describe: to household members and the public as low (1) Size and appearance of the as reasonably achievable before releasing the brachytherapy sources; patient if the patient was administered a per- (2) Safe handling and shielding instructions manent implant. in case of a dislodged source; (b) A licensee shall notify the Radiation (3) Procedures for patient control; Safety Officer immediately if the patient dies (4) Procedures for visitor control; and or has a medical emergency. (5) Procedures for notification of the Ra- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR diation Safety Officer if the patient dies or 19247, May 27, 1988; 56 FR 23472, May 21, 1991; has a medical emergency. 58 FR 67660, Dec. 22, 1993] 537 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 232 REGULATIONS § 20.1001 10 CFR Ch. I (1-1-94 Edition) §35.420 Possession of survey instrument. §35.605 Maintenance and repair restric- A licensee authorized to use byproduct ma- tions. terial for implant therapy shall have in its pos- Only a person specifically licensed by the session a portable radiation detection survey Commission or an Agreement State to per- instrument capable of detecting dose rates over form teletherapy unit maintenance and repair the range 0.1 millirem per hour to 100 millirem shall: per hour, and a portable radiation measure- (a) Install, relocate, or remove a teletherapy ment survey instrument capable of measur- sealed source or a teletherapy unit that con- ing dose rates over the range 1 millirem per tains a sealed source; or hour to 1000 millirem per hour. (b) Maintain, adjust, or repair the source Subpart H—Sealed Sources for drawer, the shutter or other mechanism of a Diagnosis teletherapy unit that could expose the source, reduce the shielding around the source, or re- §35.500 Use of sealed sources for diagno- sult in increased radiation levels. sis. §35.606 License amendments. A licensee shall use the following sealed sources in accordance with the manufactur- In addition to the changes specified in er’s radiation safety and handling instructions: §35.13 of this part, a licensee shall apply for (a) Iodine-125, americium-241, or gadolin- and must receive a license amendment before: ium-153 as a sealed source in a device for (a) Making any change in the treatment bone mineral analysis; and room shielding; (b) Iodine-125 as a sealed source in a port- (b) Making any change in the location of able imaging device. the teletherapy unit within the treatment room; (c) Using the teletherapy unit in a manner §35.520 Availability of survey instru- that could result in increased radiation levels ment. in areas outside the teletherapy treatment A licensee authorized to use byproduct ma- room; terial as a sealed source for diagnostic pur- (d) Relocating the teletherapy unit; or poses shall have available for use a portable (e) Allowing an individual not listed on the radiation detection survey instrument capa- licensee’s license to perform the duties of the ble of detecting dose rates over the range 0.1 teletherapy physicist. millirem per hour to 100 millirem per hour or §35.610 Safety instruction. a portable radiation measurement survey in- strument capable of measuring dose rates over (a) A licensee shall post instructions at the the range 1 millirem per hour to 1000 millirem teletherapy unit console. To satisfy this re- per hour. The instrument must have been cali- quirement, these instructions must inform the brated in accordance with §35.51 of this part. operator of: (1) The procedure to be followed to ensure Subpart I—Teletherapy that only the patient is in the treatment room §35.600 Use of a sealed source in a tel- before turning the primary beam of radiation etherapy unit. on to begin a treatment or after a door inter- lock interruption; The regulations and provisions of this (2) The procedure to be followed if: subpart govern the use of teletherapy units for (i) The operator is unable to turn the pri- medical use that contain a sealed source of mary beam of radiation off with controls out- cobalt-60 or cesium-137. side the treatment room or any other abnor- mal operation occurs; and (ii) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the teletherapy unit or console operates abnormally. 538 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 233 REGULATIONS Nuclear Regulatory Commission § 35.630 (b) A licensee shall provide instruction in (4) A licensee shall maintain a record of the topics identified inparagraph (a) of this the check required by paragraph (d)(3) of this section to all individuals who operate section for three years. The record must in- ateletherapy unit. clude the date of the check, notation that the (c) A licensee shall retain for three years a monitor indicates when its detector is and is record of individuals receiving instruction re- not exposed, and the initials of the individual quired by paragraph (b) of this section, a de- who performed the check. scription of the instruction, the date of instruc- (5) If a radiation monitor is inoperable, the tion, and the name of the individual who gave licensee shall require any individual entering the instruction. the teletherapy room to use a survey instru- [51 FR 36951, Oct. 16, 1986, as amended at 53 FR ment or audible alarm personal dosimeter to 19247, May 27, 1988] monitor for any malfunction of the source ex- posure mechanism that may result in an ex- § 35.615 Safety precautions. posed or partially exposed source. The instru- (a) A licensee shall control access to the ment or dosimeter must be checked with a teletherapy room by a door at each entrance. dedicated check source for proper operation (b) A licensee shall equip each entrance to at the beginning of each day of use. The li- the teletherapy room with an electrical inter- censee shall keep a record as described in para- lock system that will: graph (d)(4) of this section. (1) Prevent the operator from turning the (6) A licensee shall promptly repair or re- primary beam of radiation on unless each treat- place the radiation monitor if it is inoperable. ment room entrance door is closed; (e) A licensee shall construct or equip each (2) Turn the primary beam of radiation off teletherapy room to permit continuous obser- immediately when an entrance door is opened; vation of the patient from the teletherapy unit and console during irradiation. (3) Prevent the primary beam of radiation [51 FR 36951, Oct. 16, 1986, as amended at from being turned on following an interlock 53 FR 19247, May 27, 1988] interruption until all treatment room entrance doors are closed and the beam on-off control § 35.620 Possession of survey instrument. is reset at the console. A licensee authorized to use byproduct ma- (c) A licensee shall equip each entrance to terial in a teletherapy unit shall have in its the teletherapy room with a beam condition possession either a portable radiation detec- indicator light. tion survey instrument capable of detecting (d) A licensee shall install in each tel- dose rate over the range 0.1 millirem per hour etherapy room a permanent radiation moni- to 100 millirem per hour or a portable radia- tor capable of continuously monitoring beam tion measurement survey instrument capable status. of measuring dose rates over the range 1 (1) A radiation monitor must provide vis- millirem per hour to 1,000 millirem per hour. ible notice of a teletherapy unit malfunction that results in an exposed or partially exposed § 35.630 Dosimetry equipment. source, and must be observable by an indi- (a) A licensee shall have a calibrated vidual entering the teletherapy room. dosimetry system available for use. To sat- (2) A radiation monitor must be equipped isfy this requirement, one of the following two with a backup power supply separate from the conditions must be met. power supply to the teletherapy unit. This (1) The system must have been calibrated backup power supply may be a battery sys- by the National Institute of Standards and tem. Technology or by a calibration laboratory ac- (3) A radiation monitor must be checked credited by the American Association of Physi- with a dedicated check source for proper op- cists in Medicine (AAPM). The calibration eration each day before the teletherapy unit is must have been performed within the previ- used for treatment of patients. 539 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 234 REGULATIONS § 35.632 10 CFR Ch. I (1-1-94 Edition) ous two years and after any servicing that may the apparent correction factor that was deter- have affected system calibration; or mined from an intercomparison, the names (2) The system must have been calibrated of the individuals who performed the calibra- within the previous four years; eighteen to tion, intercomparison, or comparison, and thirty months after that calibration, the sys- evidence that the intercomparison meeting was tem must have been intercompared at an sanctioned by a calibration laboratory or ra- intercomparison meeting with another diologic physics center accredited by AAPM. dosimetry system that was calibrated within [51 FR 36951, Oct. 16, 1986, as amended at 56 FR the past twenty-four months by the National 23471, May 21, 1991] Institute of Standards and Technology or by a calibration laboratory accredited by the § 35.632 Full calibration measurements. AAPM. The intercomparison meeting must (a) A licensee authorized to use a teletherapy be sanctioned by a calibration laboratory or unit for medical use shall perform full cali- radiologic physics center accredited by the bration measurements on each teletherapy AAPM. The results of the intercomparison unit: meeting must have indicated that the calibra- (1) Before the first medical use of the unit; tion factor of the licensee’s system had not and changed by more than 2 percent. The licensee (2) Before medical use under the follow- may not use the intercomparison result to ing conditions: change the calibration factor. When (i) Whenever spot-check measurements in- intercomparing dosimetry systems to be used dicate that the output differs by more than 5 for calibrating cobalt-60 teletherapy units, the percent from the output obtained at the last licensee shall use a teletherapy unit with a full calibration corrected mathematically for cobalt-60 source. When intercomparing radioactive decay; dosimetry systems to be used for calibrating (ii) Following replacement of the source or cesium-137 teletherapy units, the licensee shall following reinstallation of the teletherapy unit use a teletherapy unit with a cesium-137 in a new location; source. (iii) Following any repair of the teletherapy (b) The licensee shall have available for use unit that includes removal of a dosimetry system for spot-check measure- the source or major repair of the components ments. To satisfy this requirement, the sys- associated with the tem may be compared with a system that has source exposure assembly; and been calibrated in accordance with paragraph (3) At intervals not exceeding one year. (a) of this section. This comparison must have (b) To satisfy the requirement of paragraph been performed within the previous year and (a) of this section, full after each servicing that may have affected calibration measurements must include deter- system calibration. The spot-check system mination of: may be the same system used to meet the re- (1) The output within ±3 percent for the quirement in paragraph (a) of this section. range of field sizes and for the distance or (c) The licensee shall retain a record of each range of distances used for medical use; calibration, intercomparison, and comparison (2) The coincidence of the radiation field for the duration of the license. For each cali- and the field indicated by the light beam lo- bration, intercomparison, or comparison, the calizing device; record must include the date, the model num- (3) The uniformity of the radiation field and bers and serial numbers of the instruments that its dependence on the orientation of the use- were calibrated, intercompared, or compared ful beam; as required by paragraphs (a) and (b) of this (4) Timer constancy and linearity over the section, the correction factor that was deter- range of use; mined from the calibration or comparison or (5) On-off error; and (6) The accuracy of all distance measuring and localization devices in medical use. 540 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 235 REGULATIONS Nuclear Regulatory Commission § 35.634 (c) A licensee shall use the dosimetry sys- of distances used in radiation therapy, a de- tem described in § 35.630(a) to measure the termination of the coincidence of the radia- output for one set of exposure conditions. The tion field and the field indicated by the light remaining radiation measurements required beam localizing device, an assessment of timer in paragraph (b)(1) of this section may be made linearity and constancy, the calculated on-off using a dosimetry system that indicates rela- error, the estimated accuracy of each distance tive dose rates. measuring or localization device, and the sig- (d) A licensee shall make full calibration nature of the teletherapy physicist. measurements required by paragraph (a) of [51 FR 36951, Oct. 16, 1986, as amended at this section in accordance with either the pro- 53 FR 43420, Oct. 27, 1988; 57 FR 61786, cedures recommended by the Scientific Com- Dec. 29, 1992] mittee on Radiation Dosimetry of the Ameri- can Association of Physicists in Medicine that § 35.634 Periodic spot-checks. are described in Physics in Medicine and Bi- (a) A licensee authorized to use teletherapy ology Vol. 16, No. 3, 1971, pp. 379–396, or units for medical use shall perform output spot- by Task Group 21 of the Radiation Therapy checks on each teletherapy unit once in each Committee of the American Association of calendar month that include determination of: Physicists in Medicine that are described in (1) Timer constancy, and timer linearity over Medical Physics Vol. 10, No. 6, 1983, pp. 741– the range of use; 771, and Vol. 11, No. 2, 1984, p. 213. (Both (2) On-off error; of these references have been approved for (3) The coincidence of the radiation field incorporation by reference by the Director of and the field indicated by the light beam lo- the Federal Register. Copies of the documents calizing device; are available for inspection at the NRC Li- (4) The accuracy of all distance measuring brary, 7920 Norfolk Avenue, Bethesda, Mary- and localization devices used for medical use; land 20814. Copies of the documents are also (5) The output for one typical set of oper- on file at the Office of the Federal Register, ating conditions measured with the dosimetry 800 North Capitol Street NW., suite 700, system described in § 35.630(b) of this part; Washington, DC. A notice of any change in and the material will be published in the FED- (6) The difference between the measure- ERAL REGISTER.) ment made in paragraph (b)(5) of this section (e) A licensee shall correct mathematically and the anticipated output, expressed as a per- the outputs determined in paragraph (b)(1) of centage of the anticipated output (i.e., the value this section for physical decay for intervals obtained at last full calibration corrected math- not exceeding one month for cobalt-60 or six ematically for physical decay). months for cesium-137. (b) A licensee shall perform measurements (f) Full calibration measurements required required by paragraph (a) of this section in ac- by paragraph (a) of this section and physical cordance with procedures established by the decay corrections required by paragraph (e) teletherapy physicist. That individual need not of this section must be performed by the li- actually perform the spot-check measurements. censee’s teletherapy physicist. (c) A licensee shall have the teletherapy (g) A licensee shall retain a record of each physicist review the results of each spot-check calibration for the duration of use of the tel- within 15 days. The teletherapy physicist shall etherapy unit source. The record must include promptly notify the licensee in writing of the the date of the calibration, the manufactur- results of each spot-check. The licensee shall er’s name, model number, and serial number keep a copy of each written notification for for both the teletherapy unit and the source, three years. the model numbers and serial numbers of the (d) A licensee authorized to use a tel- instruments used to calibrate the teletherapy etherapy unit for medical use shall perform unit, tables that describe the output of the unit safety spot-checks of each teletherapy facil- over the range of field sizes and for the range ity once in each calendar month that assure proper operation of: 541 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 236 REGULATIONS § 35.636 10 CFR Ch. I (1-1-94 Edition) (1) Electrical interlocks at each teletherapy § 35.636 Safety checks for teletherapy fa- room entrance; cilities. (2) Electrical or mechanical stops installed (a) A licensee shall promptly check all sys- for the purpose of limiting use of the primary tems listed in § 35.634(d) for proper func- beam of radiation (restriction of source hous- tion after each installation of a teletherapy ing angulation or elevation, carriage or stand source and after making any change for which travel and operation of the beam on-off mecha- an amendment is required by § 35.606 (a) nism); through (d). (3) Beam condition indicator lights on the (b) If the results of the checks required in teletherapy unit, on the control console, and paragraph (a) of this section indicate the mal- in the facility; function of any system specified in § (4) Viewing systems; 35.634(d), the licensee shall lock the control (5) Treatment room doors from inside and console in the off position and not use the unit outside the treatment room; and except as may be necessary to repair, replace, (6) Electrically assisted treatment room or check the malfunctioning system. doors with the teletherapy unit electrical power (c) A licensee shall retain for three years a turned off. record of the facility checks following instal- (e) A licensee shall arrange for prompt re- lation of a source. The record must include pair of any system identified in paragraph (d) notations indicating the operability of each of this section that is not operating properly, entrance door interlock, each electrical or and shall not use the teletherapy unit follow- mechanical stop, each beam condition indi- ing door interlock malfunction until the inter- cator light, the viewing system, and doors, and lock system has been repaired. the signature of the Radiation Safety Officer. (f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) [51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988] of this section for three years. The record must include the date of the spot-check, the manu- § 35.641 Radiation surveys for teletherapy facturer’s name, model number, and serial facilities. number for both the teletherapy unit and (a) Before medical use, after each installa- source, the manufacturer’s name, model tion of a teletherapy source, and after making number and serial number of the instrument any change for which an amendment is re- used to measure the output of the teletherapy quired by § 35.606 (a) through (d), the licen- unit, an assessment of timer linearity and con- see shall perform radiation surveys with a port- stancy, the calculated on-off error, a determi- able radiation measurement survey instrument nation of the coincidence of the radiation field calibrated in accordance with § 35.51 of this and the field indicated by the light beam lo- part to verify that: calizing device, the calculated on-off error, (1) The maximum and average dose rates the determined accuracy of each distance at one meter from the teletherapy source with measuring or localization device, the differ- the source in the off position and the collima- ence between the anticipated output and the tors set for a normal treatment field do not measured output, notations indicating the op- exceed 10 millirem per hour and 2 millirem erability of each entrance door electrical in- per hour respectively; and terlock, each electrical or mechanical stop, (2) With the teletherapy source in the on each beam condition indicator light, the view- position with the largest clinically available ing system and doors, and the signature of the treatment field and with a scattering phantom individual who performed the periodic spot- in the primary beam of radiation, that: check. (i) Radiation dose quantities per unit time [51 FR 36951, Oct. 16, 1986, as amended at 53 FR in restricted areas are not likely to cause per- 19247, May 27, 1988] sonnel exposures in excess of the limits speci- fied in § 20.1201 of this chapter; and 542 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 237 REGULATIONS Nuclear Regulatory Commission § 35.647 (ii) Radiation dose quantities per unit time 35.645 the results of the initial survey,a in unrestricted areas do not exceed the limits description of the modification made to com- specified in § 20.1301 of this chapter. ply with paragraph (a)(1) of this section, and (b) If the results of the surveys required in the results of the second survey. paragraph (a) of this section indicate any ra- (b) As an alternative to the requirements diation dose quantity per unit time in excess set out in paragraph (a) of this section, a li- of the respective limit specified in that para- censee may request a license amendment un- graph, the licensee shall lock the control in der § 20.1301(c) of this chapter that author- the off position and not use the unit: izes radiation levels in unrestricted areas (1) Except as may be necessary to repair, greater than those permitted by § 20.1301(a) replace, or test the teletherapy unit shielding of this chapter. A licensee may not begin the or the treatment room shielding; or treatment program until the license amend- (2) Until the licensee has received a spe- ment has been issued. cific exemption pursuant to § 20.1301 of this [51 FR 36951, Oct. 16, 1986, as amended at 56 FR chapter. 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993] (c) A licensee shall retain a record of the radiation measurements made following in- § 35.645 Reports of teletherapy surveys, stallation of a source for the duration of the checks, tests, and measurements. license. The record must include the date of A licensee shall mail a copy of the records the measurements, the reason the survey is required in §§ 35.636, 35.641, 35.643, and required, the manufacturer’s name, model the output from the teletherapy source ex- number and serial number of the teletherapy pressed as roentgens or rads per hour at one unit, the source, and the instrument used to meter from the source and determined during measure radiation levels, each dose rate meas- the full calibration required in § 35.632, to ured around the teletherapy source while in the appropriate Commission Regional Office the off position and the average of all meas- listed in § 30.6 of this chapter within thirty urements, a plan of the areas surrounding the days following completion of the action that treatment room that were surveyed, the meas- initiated the record requirement. ured dose rate at several points in each area § 35.647 Five-year inspection. expressed in millirem per hour, the calculated maximum quantity of radiation over a period (a) A licensee shall have each teletherapy of one week for each restricted and unrestricted unit fully inspected and serviced during tel- area, and the signature of the Radiation Safety etherapy source replacement or at intervals Officer. not to exceed five years, whichever comes first, to assure proper functioning of the source ex- [51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993] posure mechanism. (b) This inspection and servicing may only § 35.643 Modification of teletherapy unit be performed by persons specifically licensed or room before beginning a treatment to do so by the Commission or an Agreement program. State. (a) If the survey required by § 35.641 indi- (c) A licensee shall keep a record of the cates that an individual in an unrestricted area inspection and servicing for the duration of may be exposed to levels of radiation greater the license. The record must contain the in- than those permitted by § 20.1301, before be- spector’s name, the inspector’s license ginning the treatment program the licensee shall: number, the date of inspection, the manufac- (1) Either equip the unit with stops or add turer’s name and model number and serial additional radiation shielding to ensure com- number for both the teletherapy unit and pliance with § 20.1301(c) of this chapter; source, a list of components inspected, a list (2) Perform the survey required by § 35.641 of components serviced and the type of serv- again; and ice, a list of components replaced, and the sig- (3) Include in the report required by § nature of the inspector. 543 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 238 REGULATIONS § 35.900 10 CFR Ch. I (1-1-94 Edition) Subpart J—Training and Experience (2) Diagnostic radiology by the American Requirements Board of Radiology; or § 35.900 Radiation Safety Officer. (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiol- Except as provided in § 35.901, the licen- ogy; or (b) Has had classroom and laboratory see shall require an individual fulfilling the training in basic radioisotope handling tech- responsibilities of the Radiation Safety Of- niques applicable to the use of prepared ficer as provided in § 35.32 to be an individual radiopharmaceuticals, and supervised clinical who: experience as follows: (a) Is certified by: (1) 40 hours of classroom and laboratory (1) American Board of Health Physics in training that includes: Comprehensive Health Physics; (i) Radiation physics and instrumentation; (2) American Board of Radiology; (ii) Radiation protection; (3) American Board of Nuclear Medicine; (iii) Mathematics pertaining to the use and (4) American Board of Science in Nuclear measurement of radioactivity; Medicine; or (iv) Radiation biology; and (5) Board of Pharmaceutical Specialties in (v) Radiopharmaceutical chemistry; and Nuclear Pharmacy; or (2) 20 hours of supervised clinical experi- (b) Has had classroom and laboratory train- ence under the supervision of an authorized ing and experience as follows: user and that includes: (1) 200 hours of classroom and laboratory (i) Examining patients and reviewing their training that includes: case histories to determine their suitability for (i) Radiation physics and instrumentation; radioisotope diagnosis, limitations, or (ii) Radiation protection; contraindications; (iii) Mathematics pertaining to the use and (ii) Selecting the suitable measurement of radioactivity; radiopharmaceuticals and calculating and (iv) Radiation biology; and measuring the dosages; (v) Radiopharmaceutical chemistry; and (iii) Administering dosages to patients and (2) One year of full time experience as a using syringe radiation shields; radiation safety technologist at a medical in- (iv) Collaborating with the authorized user stitution under the supervision of the individual in the interpretation of radioisotope test re- identified as the Radiation Safety Officer on sults; and a Commission or Agreement State license that (v) Patient followup; or authorizes the medical use of byproduct ma- (c) Has successfully completed a six-month terial; or training program in nuclear medicine as part (c) Be an authorized user identified on the of a training program that has been approved licensee’s license. by the Accreditation Council for Graduate § 35.901 Training for experienced Radia- Medical Education and that included class- tion Safety Officer. room and laboratory training, work experi- ence, and supervised clinical experience in all An individual identified as a Radiation the topics identified in paragraph (b) of this Safety Officer on a Commission or Agreement section. State license before October 1, 1986 need not comply with the training requirements of § § 35.920 Training for imaging and locali- 35.900. zation studies. § 35.910 Training for uptake, dilution, and Except as provided in § 35.970 or 35.971, excretion studies. the licensee shall require the authorized user of a radiopharmaceutical, generator, or rea- Except as provided in §§ 35.970 and 35.971, gent kit in § 35.200(a) to be a physician who: the licensee shall require the authorized user (a) Is certified in: of a radiopharmaceutical in § 35.100(a) to be (1) Nuclear medicine by the American a physician who: Board of Nuclear Medicine; (a) Is certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; 544 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 239 REGULATIONS Nuclear Regulatory Commission § 35.932 (2) Diagnostic radiology by the American (iii) Administering dosages to patients and Board of Radiology; or using syringe radiation shields; (3) Diagnostic radiology or radiology by (iv) Collaborating with the authorized user the American Osteopathic Board of Radiol- in the interpretation of radioisotope test re- ogy; or sults; and (b) Has had classroom and laboratory train- (v) Patient followup; or ing in basic radioisotope handling techniques (c) Has successfully completed a six-month applicable to the use of prepared training program in nuclear medicine that has radiopharmaceuticals, generators, and reagent been approved by the Accreditation Council kits, supervised work experience, and super- for Graduate Medical Education and that in- vised clinical experience as follows: cluded classroom and laboratory training, (1) 200 hours of classroom and laboratory work experience, and supervised clinical ex- training that includes: perience in all the topics identified in para- (i) Radiation physics and instrumentation; graph (b) of this section. (ii) Radiation protection; §35.930 Training for therapeutic use of (iii) Mathematics pertaining to the use and radiopharmaceuticals. measurement of radioactivity; (iv) Radiopharmaceutical chemistry; and Except as provided in §35.970, the licen- (v) Radiation biology; and see shall require the authorized user of (2) 500 hours of supervised work experi- radiopharmaceuticals in §35.300 to be a phy- ence under the supervision of an authorized sician who: user that includes: (a) Is certified by: (i) Ordering, receiving, and unpacking ra- (1) The American Board of Nuclear Medi- dioactive materials safely and performing the cine; or related radiation surveys; (2) The American Board of Radiology in (ii) Calibrating dose calibrators and diag- radiology or therapeutic radiology; or nostic instruments and performing checks for (b) Has had classroom and laboratory train- proper operation of survey meters; ing in basic radioisotope handling techniques (iii) Calculating and safely preparing pa- applicable to the use of therapeutic tient dosages; radiopharmaceuticals, and supervised clinical (iv) Using administrative controls to pre- experience as follows: vent the misadministration of byproduct ma- (1) 80 hours of classroom and laboratory terial; training that includes: (v) Using procedures to contain spilled (i) Radiation physics and instrumentation; byproduct material safely and using proper (ii) Radiation protection; decontamination procedures; and (iii) Mathematics pertaining to the use and (vi) Eluting technetium-99m from genera- measurement of radioactivity; and tor systems, measuring and testing the eluate (iv) Radiation biology; and for molybdenum-99 and alumina contamina- (2) Supervised clinical experience under the tion, and processing the elate with reagent kits supervision of an authorized user at a medi- to prepare technetium-99m labeled cal institution that includes: radiopharmaceuticals; and (i) Use of iodine-131 for diagnosis of thy- (3) 500 hours of supervised clinical expe- roid function and the treatment of hyperthy- rience under the supervision of an authorized roidism or cardiac dysfunction in 10 individu- user that includes: als; and (i) Examining patients and reviewing their (ii) Use of iodine-131 for treatment of thy- case histories to determine their suitability for roid carcinoma in 3 individuals. radioisotope diagnosis, limitations, or §35.932 Training for treatment of hyper- contraindications; thyroidism. (ii) Selecting the suitable radiopharmaceuticals and calculating and Except as provided in §35.970, the licen- measuring the dosages; see shall require the authorized user of only 545 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 240 REGULATIONS § 20.1001 10 CFR Ch. I (1-1-94 Edition) iodine-131 for the treatment of hyperthy- (1) Radiology or therapeutic radiology by roidism to be a physician with special experi- the American Board of Radiology; ence in thyroid disease who has had class- (2) Radiation oncology by the American room and laboratory training in basic radio- Osteopathic Board of Radiology; isotope handling techniques applicable to the (3) Radiology, with specialization in radio- use of iodine-131 for treating hyperthyroidism, therapy, as a British ‘’Fellow of the Faculty and supervised clinical experience as follows: of Radiology” or “Fellow of the Royal Col- (a) 80 hours of classroom and laboratory lege of Radiology”; or training that includes: (4) Therapeutic radiology by the Canadian (1) Radiation physics and instrumentation; Royal College of Physicians and Surgeons; (2) Radiation protection, or (3) Mathematics pertaining to the use and (b) Is in the active practice of therapeutic measurement of radioactivity; and radiology, has had classroom and laboratory (4) Radiation biology; and training in radioisotope handling techniques (b) Supervised clinical experience under the applicable to the therapeutic use of supervision of an authorized user that includes brachytherapy sources, supervised work ex- the use of iodine-131 for diagnosis of thyroid perience, and supervised clinical experience function, and the treatment of hyperthyroidism as follows: in 10 individuals. (1) 200 hours of classroom and laboratory §35.934 Training for treatment of thyroid training that includes: carcinoma. (i) Radiation physics and instrumentation; (ii) Radiation protection; Except as provided in §35.970, the licen- (iii) Mathematics pertaining to the use and see shall require the authorized user of only measurement of radioactivity; and iodine-131 for the treatment of thyroid carci- (iv) Radiation biology; noma to be a physician with special experi- (2) 500 hours of supervised work experi- ence in thyroid disease who has had class- ence under the supervision of an authorized room and laboratory training in basic radio- user at a medical institution that includes: isotope handling techniques applicable to the (i) Ordering, receiving, and unpacking ra- use of iodine-131 for treating thyroid carci- dioactive materials safely and performing the noma, and supervised clinical experience as related radiation surveys; follows: (ii) Checking survey meters for proper op- (a) 80 hours of classroom and laboratory eration; training that includes: (iii) Preparing, implanting, and removing (1) Radiation physics and instrumentation; sealed sources; (2) Radiation protection; (iv) Maintaining running inventories of ma- (3) Mathematics pertaining to the use and terial on hand; measurement of radioactivity; and (v) Using administrative controls to pre- (4) Radiation biology; and vent the misadministration of byproduct ma- (b) Supervised clinical experience under the terial; and supervision of an authorized user that includes (vi) Using emergency procedures to con- the use of iodine-131 for the treatment of thy- trol byproduct material; and roid carcinoma in 3 individuals. (3) Three years of supervised clinical ex- §35.940 Training for use of brachytherapy perience that includes one year in a formal sources. training program approved by the Residency Review Committee for Radiology of the Ac- Except as provided in §35.970, the licen- creditation Council for Graduate Medical Edu- see shall require the authorized user of a cation or the Committee on Postdoctoral Train- brachytherapy source listed in §35.400 for ing of the American Osteopathic Association, therapy to be a physician who: and an additional two years of clinical expe- (a) Is certified in: rience in therapeutic radiology under the su- pervision of an authorized user at a medical institution that includes: 546 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 241 REGULATIONS Nuclear Regulatory Commission § 35.960 (i) Examining individuals and reviewing source in a device listed in §35.500 to be a their case histories todetermine their suitabil- physician, dentist, or podiatrist who: ity for brachytherapy treatment, and any limi- (a) Is certified in: tations or contraindications; (1) Radiology, diagnostic radiology, or (ii) Selecting the proper brachytherapy therapeutic radiology by the American Board sources and dose and method of administra- of Radiology; tion; (2) Nuclear medicine by the American (iii) Calculating the dose; and Board of Nuclear Medicine; or (3) Diagnos- (iv) Post-administration followup and re- tic radiology or radiology by the American view of case histories in collaboration with Osteopathic Board of Radiology; or the authorized user. (b) Has had 8 hours of classroom and labo- §35.941 Training for ophthalmic use of ratory training in basic radioisotope handling strontium-90. techniques specifically applicable to the use of the device that includes: Except as provided in §35.970, the licen- (1) Radiation physics, mathematics pertain- see shall require the authorized user of only ing to the use and measurement of radioactiv- strontium-90 for ophthalmic radiotherapy to ity, and instrumentation; be a physician who is in the active practice of (2) Radiation biology; therapeutic radiology or ophthalmology, and (3) Radiation protection; and has had classroom and laboratory training in (4) Training in the use of the device for the basic radioisotope handling techniques appli- uses requested. cable to the use of strontium-90 for ophthal- mic radiotherapy, and a period of supervised §35.960 Training for teletherapy. clinical training in ophthalmic radiotherapy Except as provided in §35.970, the licen- as follows: see shall require the authorized user of a sealed (a) 24 hours of classroom and laboratory source listed in §35.600 in a teletherapy unit training that includes: to be a physician who: (1) Radiation physics and instrumentation; (a) Is certified in: (2) Radiation protection; (1) Radiology or therapeutic radiology by (3) Mathematics pertaining to the use and the American Board of Radiology; measurement of radioactivity; and (2) Radiation oncology by the American (4) Radiation biology; Osteopathic Board of Radiology; (b) Supervised clinical training in ophthal- (3) Radiology, with specialization in radio- mic radiotherapy under the supervision of an therapy, as a British “Fellow of the Faculty of authorized user at a medical institution that Radiology” or “Fellow of the Royal College includes the use of strontium-90 for the oph- of Radiology”; or thalmic treatment of five individuals that in- (4) Therapeutic radiology by the Canadian cludes: Royal College of Physicians and Surgeons; (1) Examination of each individual to be or treated; (b) Is in the active practice of therapeutic (2) Calculation of the dose to be adminis- radiology, and has had classroom and labora- tered; tory training in basic radioisotope techniques (3) Administration of the dose; and applicable to the use of a sealed source in a (4) Followup and review of each individu- teletherapy unit, supervised work experience, al’s case history. and supervised clinical experience as follows: §35.950 Training for use of sealed sources (1) 200 hours of classroom and laboratory for diagnosis. training that includes: (i) Radiation physics and instrumentation; Except as provided in §35.970, the licen- (ii) Radiation protection; see shall require the authorized user of a sealed (iii) Mathematics pertaining to the use and measurement of radioactivity; and 547 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 242 REGULATIONS § 35.961 10 CFR Ch. I (1-1-94 Edition) (iv) Radiation biology: (4) Radiological physics; or (2) 500 hours of supervised work experi- (b) Holds a master’s or doctor’s degree in ence under the supervision of an authorized physics, biophysics, radiological physics, or user at a medical institution that includes: health physics, and has completed one year (i) Review of the full calibration measure- of full time training in therapeutic radiologi- ments and periodic spot checks; cal physics and an additional year of full time (ii) Preparing treatment plans and calculat- work experience under the supervision of a ing treatment times; teletherapy physicist at a medical institution (iii) Using administrative controls to pre- that includes the tasks listed in §§35.59, vent misadministrations; 35.632, 35.634, and 35.641 of this part. (iv) Implementing emergency procedures §35.970 Training for experienced author- to be followed in the event of the abnormal ized users. operation of a teletherapy unit or console; and (v) Checking and using survey meters; and Physicians, dentists, or podiatrists identi- (3) Three years of supervised clinical ex- fied as authorized users for the medical, den- perience that includes one year in a formal tal, or pediatric use of byproduct material on training program approved by the Residency a Commission or Agreement State license is- Review Committee for Radiology of the Ac- sued before April 1, 1987 who perform only creditation Council for Graduate Medical Edu- those methods of use for which they were au- cation or the Committee on Postdoctoral Train- thorized on that date need not comply with ing of the American Osteopathic Association the training requirements of subpart J. and an additional two years of clinical expe- §35.971 Physician training in a three month rience in therapeutic radiology under the su- program. pervision of an authorized user at a medical institution that includes: A physician who, before July 1, 1984, be- (i) Examining individuals and reviewing gan a three month nuclear medicine training their case histories to determine their suitabil- program approved by the Accreditation Coun- ity for teletherapy treatment, and any limita- cil for Graduate Medical Education and has tions or contraindications; successfully completed the program need not (ii) Selecting the proper dose and how it is comply with the requirements of §§35.910 or to be administered; 35.920. (iii) Calculating the teletherapy doses and §35.972 Recentness of training. collaborating with the authorized user in the The training and experience specified in this review of patients’ progress and considera- subpart must have been obtained within the tion of the need to modify originally prescribed five years preceding the date of application or doses as warranted by patients’ reaction to the individual must have had related continu- radiation; and ing education and experience since the re- (iv) Post-administration followup and re- quired training and experience was completed. view of case histories. Subpart K—Enforcement §35.961 Training for teletherapy physicist. §35.990 Violations. The licensee shall require the teletherapy physicist to be an individual who: (a) The Commission may obtain an injunc- (a) Is certified by the American Board of tion or other court order to prevent a violation Radiology in: of the provisions of— (1) Therapeutic radiological physics; (1) The Atomic Energy Act of 1954, as (2) Roentgen ray and gamma ray physics; amended; (3) X-ray and radium physics; or (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. 548 

SELECTED SECTIONS OF THE UNITED STATES CODE OF FEDERAL 243 REGULATIONS Nuclear Regulatory Commission pt. 36 (b) The Commission may obtain a court requirements of this part. At the time of li- order for the payment of a civil penalty im- cense renewal and thereafter, these amend- posed under section 234 of the Atomic En- ments to this part shall apply. ergy Act: PART 36-LICENSES AND RADIATION (1) For violations of— SAFETY REQUIREMENTS FOR (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, IRRADIATORS 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; Subpart A—General Provisions (ii) Section 206 of the Energy Reorganiza- Sec. tion Act; 36.1 Purpose and scope. (iii) Any rule, regulation, or order issued 36.2 Definitions. pursuant to the sections specified in paragraph 36.5 Interpretations. (b)(1)(i) of this section; 36.8 Information collection requirements: (iv) Any term, condition, or limitation of OMB approval. any license issued under the sections speci- Subpart B—Specific Licensing fied in paragraph (b)(1)(i) of this section. Requirements (2) For any violation for which a license may be revoked under section 186 of the 36.11 Application for a specific license. Atomic Energy Act of 1954, as amended. 36.13 Specific licenses for irradiators. 36.15 Start of construction. [57 FR 55074, Nov. 24, 1992] 36.17 Applications for exemptions. §35.991 Criminal penalties. 36.19 Request for written statements. (a) Section 223 of the Atomic Energy Act Subpart C—Design and Performance of 1954, as amended, provides for criminal Requirements for Irradiators sanctions for willful violation of, attempted 36.21 Performance criteria for sealed sources. violation of, or conspiracy to violate, any regu- 36.23 Access control. lation issued under sections 161b, 161i, or 36.25 Shielding. 161o of the Act. For purposes of section 223, 36.27 Fire protection. all the regulations in part 35 are issued under 36.29 Radiation monitors. one or more of sections 161b, 161i, or 161o, 36.31 Control of source movement. except for the sections listed in paragraph (b) 36.33 Irradiator pools. of this section. 36.35 Source rack protection. (b) The regulations in part 35 that are not 36.37 Power failures. issued under sections 161b, 161i, or 161o for 36.39 Design requirements. the purposes of section 223 are as follows: 36.41 Construction monitoring and accept- §§35.1, 35.2, 35.8, 35.12, 35.18, 35.19, 35.57, ance testing. 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and 35.999. Subpart D—Operation of Irradiators [57 FR 55074, Nov. 24, 1992] 36.51 Training. 36.53 Operating and emergency procedures. §35.999 Resolution of conflicting require- 36.55 Personnel monitoring. ments during transition period. 36.57 Radiation surveys. If the rules in this part conflict with the li- 36.59 Detection of leaking sources. censee’s radiation safety program as identi- 36.61 Inspection and maintenance. fied in its license, and if that license was ap- 36.63 Pool water purity. proved by the Commission before April 1, 36.65 Attendance during operation. 1987 and has not been renewed since April 1, 36.67 Entering and leaving the radiation room. 1987, then the requirements in the license will 36.69 Irradiation of explosive or flammable apply. However, if that licensee exercises its materials. privilege to make minor changes in its radia- Subpart E—Records tion safety procedures that are not potentially important to safety under §35.31 of this chap- 36.81 Records and retention periods. ter, the portion changed must comply with the 36.83 Reports. Subpart F—Enforcement 549