(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55071, Nov. 24, 1992]

§ 19.31 Application for exemptions

The Commission may upon application by any licensee or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not result in undue hazard to life or property.

§ 19.32 Discrimination prohibited

No person shall on the ground of sex be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity licensed by the Nuclear Regulatory Commission. This provision will be enforced through agency provisions and rules similar to those already established, with respect to racial and other discrimination, under title VI of the Civil Rights Act of 1964. This remedy is not exclusive, however, and will not prejudice or cut off any other legal remedies available to a discriminate.

[40 FR 8783, Mar. 3, 1975]

§ 19.40 Criminal penalties

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 19 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 19 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 19.1, 19.2, 19.3, 19.4, 19.5, 19.8, 19.16, 19.17, 19.18, 19.30, 19.31, and 19.40.

[57 FR 55071, Nov. 24, 1992]

APPENDIX A TO PART 20—PROTECTION FACTORS FOR RESPIRATORS

APPENDIX B TO PART 20—ANNUAL LIMITS ON INTAKE (ALIS) AND DERIVED AIR CONCENTRATIONS (DACS) OF RADIONUCLIDES FOR OCCUPATIONAL EXPOSURE; EFFLUENT CONCENTRATIONS; CONCENTRATIONS FOR RELEASE TO SEWERAGE

APPENDIX C TO PART 20—QUANTITIES OF LICENSED MATERIAL REQUIRING LABELING

APPENDIX D TO PART 20—UNITED STATES NUCLEAR REGULATORY COMMISSION REGIONAL OFFICES

APPENDIX E TO PART 20—[RESERVED]

APPENDIX F TO PART 20—REQUIREMENTS FOR LOW-LEVEL-WASTE TRANSFER FOR DISPOSAL AT LAND DISPOSAL FACILITIES AND MANIFESTS

AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (2 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

SOURCE: 56 FR 23391, May 21, 1991, unless otherwise noted.

§ 20.1001 Purpose

(a) The regulations in this part establish standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the Nuclear Regulatory Commission. These regulations are issued under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended.

(b) It is the purpose of the regulations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual (including doses

resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation) does not exceed the standards for protection against radiation prescribed in the regulations in this part. However, nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety.

§ 20.1002 Scope

The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under parts 30 through 36, 39, 40, 50, 60, 61, 70, or 72 of this chapter. The limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.

[56 FR 23391, May 21, 1991, as amended at 58 FR 7736, Feb. 9, 1993]

§ 20.1003 Definitions

As used in this part:

Absorbed dose means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy).

Act means the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.), as amended.

Activity is the rate of disintegration (transformation) or decay of radioactive material. The units of activity are the curie (Ci) and the becquerel (Bq).

Adult means an individual 18 or more years of age.

Airborne radioactive material means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

Airborne radioactivity area means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations—

(1) In excess of the derived air concentrations (DACs) specified in appendix B, to §§ 20.1001–20.2401, or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.

ALARA (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest.

Annual limit on intake (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table 1, Columns 1 and 2, of appendix B to §§ 20.1001–20.2401).

Background radiation means radiation from cosmic sources; naturally occurring radioactive materials, including radon (except as a decay product of source or special nuclear material) and global fallout as it exists in the environment from the testing of nuclear explosive devices. "Background radiation" does not include radiation from source, byproduct, or special nuclear materials regulated by the Commission.

Bioassay (radiobioassay) means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body.

Byproduct material means—

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute ''byproduct material" within this definition.

Class (or lung class or inhalation class) means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.

Collective dose is the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

Commission means the Nuclear Regulatory Commission or its duly authorized representatives.

Committed dose equivalent (H_T,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

Committed effective dose equivalent (H_E.50) is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (H_E.50 = ∑W_TH_T.50).

Controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.

Declared pregnant woman means a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.

Deep-dose equivalent (H_d), which applies to external whole body exposure, is the dose equivalent at a tissue depth of 1 cm (1000 mg/cm²).

Department means the Department of Energy established by the Department of Energy Organization Act (Pub. L. 95–91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers, and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104 (b), (c), and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93–438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95–91, 91 Stat 565 at 577–578, 42 U.S.C. 7151).

Derived air concentration (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table 1, Column 3, of appendix B to §§ 20.1001–20.2401.

Derived air concentration-hour (DAC-hour) is the product of the concentration of radioactive material in air (expressed as a fraction or multiple of the derived air concentration for each radionuclide) and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv).

Dose or radiation dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent, as defined in other paragraphs of this section.

Dose equivalent (H_T) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv).

Dosimetry processor means an individual or organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the equipment.

Effective dose equivalent (H_E) is the sum of the products of the dose equivalent to the organ or tissue (H_T) and the weighting factors (W_T) applicable to each of the body organs or tissues that are irradiated (H_E = ∑W_TH_T).

Embryo/fetus means the developing human organism from conception until the time of birth.

Entrance or access point means any location through which an individual could gain access to radiation areas or to radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

Exposure means being exposed to ionizing radiation or to radioactive material.

External dose means that portion of the dose equivalent received from radiation sources outside the body.

Extremity means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

Eye dose equivalent applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm²).

Generally applicable environmental radiation standards means standards issued by the Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

Government agency means any executive department, commission, independent establishment, corporation wholly or partly owned by the United States of America, which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.

Gray [See § 20.1004].

High radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.

Individual means any human being.

Individual monitoring means—

(1) The assessment of dose equivalent by the use of devices designed to be worn by an individual:

(2) The assessment of committed effective dose equivalent by bioassay (see Bioassay) or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e., DAC-hours; or

(3) The assessment of dose equivalent by the use of survey data.

Individual Monitoring Devices (individual monitoring equipment) means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal ("lapel") air sampling devices.

Internal dose means that portion of the dose equivalent received from radioactive material taken into the body.

License means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 70, or 72 of this chapter.

Licensed material means source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the Commission.

Licensee means the holder of a license.

Limits (dose limits) means the permissible upper bounds of radiation doses.

Lost or missing licensed material means licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

Member of the public means an individual in a controlled or unrestricted area. However, an individual is not a member of the public during any period in which the individual receives an occupational dose.

Minor means an individual less than 18 years of age.

Monitoring (radiation monitoring, radiation protection monitoring) means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

Nonstochastic effect means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect (also called a deterministic effect).

NRC means the Nuclear Regulatory Commission or its duly authorized representatives.

Occupational dose means the dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the general public.

Person means—

(1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department of Energy (except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842)), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity: and

(2) Any legal successor, representative, agent, or agency of the foregoing.

Planned special exposure means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

Public dose means the dose received by a member of the public from exposure to radiation and to radioactive material released by a licensee, or to another source of radiation either within a licensee's controlled area or in unrestricted areas. It does not include occupational dose or doses received from background radiation, as a patient from medical practices, or from voluntary participation in medical research programs.

Quality Factor (Q) means the modifying factor (listed in tables 1004(b).1 and 1004(b).2 of §20.1004) that is used to derive dose equivalent from absorbed dose.

Quarter means a period of time equal to one-fourth of the year observed by the licensee (approximately 13 consecutive weeks), providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

Rad (See §20.1004).

Radiation (ionizing radiation) means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation, as used in this part, does not include non-ionizing radiation, such as radioor microwaves, or visible, infrared, or ultraviolet light.

Radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.

Reference man means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and

to relate biological insult to a common base.

Rem (see §20.1004).

Respiratory protective device means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

Restricted area means an area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

Sanitary sewerage means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

Shallow-dose equivalent (H_s), which applies to the external exposure of the skin or an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm²) averaged over an area of 1 square centimeter.

Sievert (See §20.1004).

Site boundary means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.

Source material means—

(1) Uranium or thorium or any combination of uranium and thorium in any physical or chemical form; or

(2) Ores that contain, by weight, one-twentieth of 1 percent (0.05 percent), or more, of uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material.

Special nuclear material means—

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Commission, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

Stochastic effects means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

Survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

Total Effective Dose Equivalent (TEDE) means the sum of the deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

Unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Uranium fuel cycle means the operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocessing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle does not include mining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations, and the reuse of recovered non-uranium special nuclear and byproduct materials from the cycle.

Very high radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a radiation source or from any surface that the radiation penetrates.

(NOTE: At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts)).

Week means 7 consecutive days starting on Sunday.

Weighting factor w_T, for an organ or tissue (T) is the proportion of the risk of stochastic effects resulting from irradiation

of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of w_T are:

Whole body means, for purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.

Working level (WL) is any combination of short-lived radon daughters (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in 1 liter of air that will result in the ultimate emission of 1.3×10⁵ MeV of potential alpha particle energy.

Working level month (WLM) means an exposure to 1 working level for 170 hours (2,000 working hours per year/12 months per year = approximately 170 hours per month).

Year means the period of time beginning in January used to determine compliance with the provisions of this part. The licensee may change the starting date of the year used to determine compliance by the licensee provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

[56 FR 23391, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 58 FR 7736, Feb. 9, 1993]

§20.1004 Units of radiation dose

(a) Definitions. As used in this part, the units of radiation dose are:

Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 Joule/kilogram (100 rads).

Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray).

Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rads multiplied by the quality factor (1 rem = 0.01 sievert).

Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rems).

(b) As used in this part, the quality factors for converting absorbed dose to dose equivalent are shown in table 1004(b).1.

(c) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in paragraph (b) of this section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of the regulations in this part, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from table 1004(b).2 to convert a measured tissue dose in rads to dose equivalent in rems.

§20.1005 Units of radioactivity

For the purposes of this part, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multiples, or disintegrations (transformations) per unit of time.

(a) One becquerel = 1 disintegration per second (s^-1).

(b) One curie = 3.7×10¹⁰ disintegrations per second = 3.7×10¹⁰ becquerels = 2.22×10¹² disintegrations per minute.

[56 FR 23391, May 21, 1991; 56 FR 61352, Dec. 3, 1991]

§20.1006 Interpretations

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.

§20.1007 Communications

Unless otherwise specified, communications or reports concerning the regulations in this part should be addressed to the Executive Director for Operations. U.S. Nuclear Regulatory Commission, Washington. DC 20555. A communication, report, or application may be delivered in person to the Office of the Executive Director for Operations, 11555 Rockville Pike. Rockville, MD 20852.

§20.1008—[Reserved]

§20.1009 Reporting, recording, and application requirements: OMB approval

1. The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number 3150–0014.

2. The approved information collection requirements contained in this part appear in §§20.1101, 20.1202, 20.1204, 20.1206, 20.1301, 20.1501, 20.1601, 20.1703, 20.1901, 20.1902, 20.1904, 20.1906, 20.2002, 20.2004, 20.2006, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2206, and appendix F to 20.1001–20.2401.

3. This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

   1. In §20.2104, NRC Form 4 is approved under control number 3150–0005.

   2. In §§20.2106 and 20.2206, NRC Form 5 is approved under control number 3150–0006.

[57 FR 57878, Dec. 8, 1992]

SOURCE: 56 FR 23396, May 21, 1991, unless otherwise noted.

§20.1101 Radiation protection programs

(a) Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities

and sufficient to ensure compliance with the provisions of this part. (See § 20.2102 for recordkeeping requirements relating to these programs.)

(b) The licensee shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.

SOURCE: 56 FR 23396, May 21, 1991, unless otherwise noted.

§ 20.1201 Occupational dose limits for adults.

1. The licensee shall control the occupational dose to individual adults, except for planned special exposures under § 20.1206, to the following dose limits.

   1. An annual limit, which is the more limiting of—

      1. The total effective dose equivalent being equal to 5 rems (0.05 Sv); or

      2. The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv).

   2. The annual limits to the lens of the eye, to the skin, and to the extremities, which are:

      1. An eye dose equivalent of 15 rems (0.15 Sv), and

      2. A shallow-dose equivalent of 50 rems (0.50 Sv) to the skin or to any extremity.

2. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year (see § 20.1206(e)(1)) and during the individual's lifetime (see § 20.1206(e)(2)).

3. The assigned deep-dose equivalent and shallow-dose equivalent must be for the part of the body receiving the highest exposure. The deep-dose equivalent, eye dose equivalent and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

4. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to §§ 20.1001–20.2401 and may be used to determine the individual's dose (see § 20.2106) and to demonstrate compliance with the occupational dose limits.

5. In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to §§ 20.1001–20.2401).

6. The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see § 20.2104(e)).

§ 20.1202 Compliance with requirements for summation of external and internal doses.

(a) If the licensee is required to monitor under both §§ 20.1502(a) and (b), the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under § 20.1502(a) or only under § 20.1502(b), then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (b) of this section and the conditions in paragraphs (c) and (d) of this section.

(NOTE: The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.)

(b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit.

of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 34 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 34 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 34.1, 34.2, 34.3, 34.8, 34.11, 34.51, 34.61, and 34.63.

[57 FR 55074, Nov. 24, 1992]

1. FUNDAMENTALS OF RADIATION SAFETY

1. Characteristics of gamma radiation.

2. Units of radiation dose (mrem) and quantity of radioactivity (curie).

3. Hazards of exposure to radiation.

4. Levels of radiation from licensed material.

5. Methods of controlling radiation dose:

   1. Working time.

   2. Working distances.

   3. Shielding.

2. RADIATION DETECTION INSTRUMENTATION TO BE USED

1. Use of radiation survey instruments:

   1. Operation.

   2. Calibration.

   3. Limitations.

2. Survey techniques.

3. Use of personnel monitoring equipment:

   1. Film badges and thermoluminescent dosimeters (TLD's).

   2. Pocket dosimeters.

   3. Alarm ratemeters

3. RADIOGRAPHIC EQUIPMENT TO BE USED

1. Remote handling equipment.

2. Radiographic exposure devices.

3. Storage containers.

4. INSPECTION AND MAINTENANCE PERFORMED BY THE RADIOGRAPHERS

5. CASE HISTORIES OF RADIOGRAPHY ACCIDENTS

[44 FR 50808, Aug. 30, 1979, as amended at 55 FR 853, Jan. 10, 1990]

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

SOURCE: 51 FR 36951, Oct. 16, 1986, unless otherwise noted.

§ 35.1 Purpose and scope.

This part prescribes requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 71, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.

§ 35.2 Definitions.

Address of use means the building or buildings that are identified on the license and where byproduct material may be received, used, or stored.

Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.

ALARA (as low as reasonably achievable) means making every reasonable effort to maintain exposures to radiation

as far below the dose limits as is practical:

1. Consistent with the purpose for which the licensed activity is undertaken.

2. Taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and

3. In relation to utilization of nuclear energy in the public interest.

Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or storing byproduct material.

Authorized user means a physician, dentist, or podiatrist who is identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material.

Brachytherapy source means an individual sealed source or a manufacturer-assembled source train that is not designed to be disassembled by the user.

Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

Dental use means the intentional external administration of the radiation from byproduct material to human beings in the practice of dentistry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

Management means the chief executive officer or that person's delegate or delegates.

Medical Institution means an organization in which several medical disciplines are practiced.

Medical use means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

Ministerial change means a change that is made, after ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making a discretionary judgment about whether those requirements should apply in the case at hand.

Misadministration means the administration of:

1. A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I–125 or I–131:

   1. Involving the wrong patient or wrong radiopharmaceutical, or

   2. When both the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage and the difference between the administered dosage and prescribed dosage exceeds 30 microcuries.

2. A therapeutic radiopharmaceutical dosage, other than sodium iodide I–125 or I–131:

   1. Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration; or

   2. When the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage.

3. A gamma stereotactic radiosurgery radiation dose:

   1. Involving the wrong patient or wrong treatment site; or

   2. When the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose.

4. A teletherapy radiation dose:

   1. Involving the wrong patient, wrong mode of treatment, or wrong treatment site;

   2. When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more

than 10 percent of the total prescribed dose;

3. When the calculated weekly administered dose is 30 percent greater than the weekly prescribed dose; or

4. When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.

5. A brachytherapy radiation dose:

   1. Involving the wrong patient. wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site):

   2. Involving a sealed source that is leaking;

   3. When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

   4. When the calculated administered dose differs from the prescribed dose by more than 20 percent of the prescribed dose.

6. A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries of either sodium iodide I–125 or I–131, both:

   1. Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and

   2. When the dose to the patient exceeds 5 rems effective dose equivalent or 50 rems dose equivalent to any individual organ.

Mobile nuclear medicine service means the transportation and medical use of byproduct material.

Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

Podiatric use means the intentional external administration of the radiation from byproduct material to human beings in the practice of podiatry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

Prescribed dosage means the quantity of radiopharmaceutical activity as documented:

1. In a written directive; or

2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

Prescribed dose means:

1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

2. For teletherapy, the total dose and dose per fraction as documented in the written directive; or

3. For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.

Radiation Safety Officer means the individual identified as the Radiation Safety Officer on a Commission license.

Recordable event means the administration of:

1. A radiopharmaceutical or radiation without a written directive where a written directive is required;

2. A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;

3. A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I–125 or I–131 when both:

   1. The administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage, and

   2. The difference between the administered dosage and prescribed dosage exceeds 15 microcuries;

4. A therapeutic radiopharmaceutical dosage, 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;

5. A teletherapy radiation dose when the calculated weekly administered dose is 15 percent greater than the weekly prescribed dose; or

6. A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose.

Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.

Teletherapy physicist means the individual identified as the teletherapy physicist on a Commission license.

Visiting authorized user means an authorized user who is not identified as an authorized user on the license of the licensee being visited.

Written directive means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in paragraph (6) of this definition, containing the following information:

1. For any administration of quantities greater than 30 microcuries of either sodium iodide I–125 or 1–131: the dosage;

2. For a therapeutic administration of a radiopharmaceutical other than sodium iodide I–125 or I–131: the radiopharmaceutical, dosage, and route of administration;

3. For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;

4. For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period;

5. For high dose rate remote after loading brachytherapy: the radioisotope, treatment site, and total dose; or

6. For all other brachytherapy:

1. Prior to implantation: the radioisotope, number of sources, and source strengths; and

2. After implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 34120, July 25, 1991]

§ 35.5 Maintenance of records

Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

[53 FR 19247, May 27, 1988]

§ 35.8 Information collection requirements: OMB approval

1. The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements in this part under control number 3150-0010.

2. The approved information collection requirements contained in this part appear in §§ 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, 35.27, 35.29, 35.31, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, and 35.647.

3. This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved as follows:

   (1) In § 35.12, Form NRC-313 is approved under control number 3150-0120.

4. OMB has assigned control number 3150-0171 for the information collection

requirements contained in §§ 35.32 and 35.33.

[51 FR 36951, Oct. 16, 1986, as amended at 57 FR 41378, Sept. 10, 1992]

§ 35.11 License required

1. A person shall not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of this section.

2. An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in § 35.25, unless prohibited by license condition.

§ 35.12 Application for license, amendment, or renewal

1. If the application is for medical use sited in a medical institution, only the institution's management may apply. If the application is for medical use not sited in a medical institution, any person may apply.

2. An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, and 35.500 of this part must be made by filing an original and one copy of Form NRC–313, ''Application for Materials License." For guidance in completing the form, refer to the instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.

3. An application for a license for medical use of byproduct material as described in § 35.600 of this part must be made by filing an original and one copy of Form NRC–313. For guidance in completing the form, refer to the instructions in the most current version of the appropriate Regulatory Guide. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.

4. For copies of regulatory guides, application forms, or to submit an application or an amendment request, refer to § 30.6 of this chapter.

§ 35.13 License amendments

A licensee shall apply for and must receive a license amendment:

1. Before it receives or uses byproduct material for a clinical procedure permitted under this Part but not permitted by the license issued pursuant to this part;

2. Before it permits anyone, except a visiting authorized user described in § 35.27, to work as an authorized user under the license;

3. Before it changes Radiation Safety Officers or Teletherapy Physicists;

4. Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license; and

5. Before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license.

§ 35.14 Notifications

A licensee shall notify the Commission by letter within thirty days when an authorized user, Radiation Safety Officer, or Teletherapy Physicist permanently discontinues performance of duties under the license or has a name change, or when the licensee's mailing address changes. The licensee shall mail the report to the appropriate address identified in § 30.6 of this chapter.

§ 35.18 License issuance

The Commission shall issue a license for the medical use of byproduct material for a term of five years if:

1. The applicant has filed Form NRC–313 "Application for Materials License" in accordance with the instructions in § 35.12;

2. The applicant has paid any applicable fee as provided in part 170 of this chapter;

3. The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; and

4. The applicant meets the requirements of part 30 of this chapter.

§ 35.19 Specific exemptions

The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions

from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. The Commission will review requests for exemptions from training and experience requirements with the assistance of its Advisory Committee on the Medical Uses of Isotopes.

§ 35.20 ALARA program

1. Each licensee shall develop and implement a written radiation protection program that includes provisions for keeping doses ALARA.

2. To satisfy the requirement of paragraph (a) of this section:

   1. At a medical institution, management, the Radiation Safety Officer, and all authorized users must participate in the program as requested by the Radiation Safety Committee.

   2. For licensees that are not medical institutions, management and all authorized users must participate in the program as requested by the Radiation Safety Officer.

3. The program must include notice to workers of the program's existence and workers' responsibility to help keep dose equivalents ALARA, a review of summaries of the types and amounts of byproduct material used, occupational doses, changes in radiation safety procedures and safety measures, and continuing education and training for all personnel who work with or in the vicinity of byproduct material. The purpose of the review is to ensure that licensees make a reasonable effort to maintain individual and collective occupational doses ALARA.

§ 35.21 Radiation Safety Officer

1. A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.

2. The Radiation Safety Officer shall:

   1. Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, misadministrations, and other deviations from approved radiation safety practice and implement corrective actions as necessary;

   2. Establish, collect in one binder or file, and implement written policy and procedures for:

      1. Authorizing the purchase of byproduct material;

      2. Receiving and opening packages of byproduct material;

      3. Storing byproduct material;

      4. Keeping an inventory record of byproduct material;

      5. Using byproduct material safely;

      6. Taking emergency action if control of byproduct material is lost;

      7. Performing periodic radiation surveys;

      8. Performing checks of survey instruments and other safety equipment;

      9. Disposing of byproduct material;

      10. Training personnel who work in or frequent areas where byproduct material is used or stored;

      11. Keeping a copy of all records and reports required by the Commission regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations.

   3. Brief management once each year on the byproduct material program;

   4. Establish personnel exposure investigational levels that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure;

   5. Establish personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence;

   6. For medical use not at a medical institution, approve or disapprove minor changes in radiation safety procedures that are not potentially important to safety with the advice and consent of management; and

7. For medical use at a medical institution, assist the Radiation Safety Committee in the performance of its duties.

§ 35.22 Radiation Safety Committee.

Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.

1. Each Committee must meet the following administrative requirements:

   1. Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.

   2. The Committee must meet at least quarterly.

   3. To establish a quorum and to conduct business, at least one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's representative.

   4. The minutes of each Radiation Safety Committee meeting must include:

      1. The date of the meeting;

      2. Members present;

      3. Members absent;

      4. Summary of deliberations and discussions;

      5. Recommended actions and the numerical results of all ballots; and

      6. ALARA program reviews described in § 35.20(c).

   5. The Committee must promptly provide each member with a copy of the meeting minutes, and retain one copy for the duration of the license.

2. To oversee the use of licensed material, the Committee must:

   1. Review recommendations on ways to maintain individual and collective doses ALARA;

   2. Review, on the basis of safety and with regard to the training and experience standards in subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, the Radiation Safety Officer, or a Teletherapy Physicist before submitting a license application or request for amendment or renewal;

   3. Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under § 35.31 of this part;

   4. Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material;

   5. Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and

   6. Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.

§ 35.23 Statements of authority and responsibilities.

1. A licensee shall provide the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, sufficient authority, organizational freedom, and management prerogative, to:

   1. Identify radiation safety problems;

   2. Initiate, recommend, or provide corrective actions; and

   3. Verify implementation of corrective actions.

2. A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, and retain the current edition of these statements as a record until the Commission terminates the license.

§ 35.25 Supervision.

1. A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by § 35.11(b) of this part shall:

   1. Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct

material and in the licensee's written quality management program;

2. Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct material; and

3. Periodically review the supervised individual's use of byproduct material and the records kept to reflect this use.

2. A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.

[51 FR 36951, Oct. 16, 1991, as amended at 56 FR 34121, July 25, 1991]

§ 35.27 Visiting authorized user.

1. A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for sixty days each year if:

   1. The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee;

   2. The licensee has a copy of a license issued by the Commission or an Agreement State, or a permit issued by a Commission or Agreement State broad licensee that is authorized to permit medical use, that identifies the visiting authorized user by name as an authorized user for medical use; and

   3. Only those procedures for which the visiting authorized user is specifically authorized by the license or permit are performed by that individual.

2. A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in paragraph (a) of this section.

3. A licensee shall retain the records specified in this section for three years after the visiting authorized user's last use of licensed material, but may discard the records if the visiting authorized user has been listed as an authorized user on the licensee's license.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.29 Administrative requirements that apply to the provision of mobile nuclear medicine service.

1. The Commission will license mobile nuclear medicine service only in accordance with subparts D. E and H of this part and § 31.11 of this chapter.

2. Mobile nuclear medicine service licensees shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of byproduct material at the client's address of use. The mobile nuclear medicine service licensee shall retain the letter for three years after the last provision of service.

3. If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for assuring that services are conducted in accordance with the regulations in this chapter while the mobile nuclear medicine service is under the client's direction.

4. A mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client's address of use.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.31 Radiation safety program changes.

1. A licensee may make minor changes in radiation safety procedures that are not potentially important to safety, i.e., ministerial changes, that were described in the application for license, renewal, or amendment except for those changes in §§ 35.13 and 35.606 of this part. Examples of such ministerial changes include: editing of procedures for clarity or conformance with local drafting policy or updating names, telephone numbers, and addresses; adoption of model radiation safety procedures published in NRC Regulatory Guides; replacement of equipment; reassignment of tasks among employees; or assignment of service contracts for services such as personnel dosimetry, radiation safety equipment repair or calibration, waste disposal, and safety surveys. A licensee is responsible for assuring that any change made is in compliance with the requirements of the regulations and the license.

2. A licensee shall retain a record of each change until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical institution, the Radiation Safety Committee's chairman and the management representative.

§ 35.32 Quality management program.

1. Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following specific objectives:

   1. That, prior to administration, a written directive¹ is prepared for:

      1. Any teletherapy radiation dose;

      2. Any gamma stereotactic radiosurgery radiation dose;

      3. Any brachytherapy radiation dose;

      4. Any administration of quantities greater than 30 microcuries of either sodium iodide I–125 or I–131; or

      5. Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I–125 or I–131;

   2. That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;

   3. That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;

   4. That each administration is in accordance with the written directive; and

   5. That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

2. The licensee shall:

   1. Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:

      1. A representative sample of patient administrations,

      2. All recordable events, and

      3. All misadministrations to verify compliance 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 determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and

   3. Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.

3. The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

   1. Assembling the relevant facts including the cause;

   2. Identifying what, if any, corrective action is required to prevent recurrence; and

   3. Retaining a record, in an auditable form, for three years, of the

relevant facts and what corrective action if any, was taken.

4. The licensee shall retain:

   1. Each written directive; and

   2. A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.

5. The licensee may make modifications to the quality management program to increase the programs' efficiency provided the program's effectiveness is not decreased. The licensee shall furnish the modification to the appropriate NRC Regional Office within 30 days after the modification has been made.

6. (1) Each applicant for a new license, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the NRC.

   (2) Each existing licensee, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 by January 27, 1992 a written certification that the quality management program has been implemented along with a copy of the program.

[56 FR 34121, July 25, 1991]

§ 35.33 Notifications, reports, and records of misadministrations.

1. For a misadministration:

   1. The licensee shall notify by telephone the NRC Operations Center ² no later than the next calendar day after discovery of the misadministration.

   2. The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as "the patient" in this section), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient.

   3. The licensee shall notify the referring physician and also notify the patient of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the licensee shall notify the patient as soon as possible thereafter. The licensee may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification.

   4. If the patient was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the patient by sending either:

      1. A copy of the report that was submitted to the NRC; or

      2. A brief description of both the event and the consequences as they may affect the patient, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

2. Each licensee shall retain a record of each misadministration for five years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.

3. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.

[56 FR 34122, July 25, 1991]

§ 35.49 Suppliers.

A licensee may use for medical use only:

1. Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in part 30 and § 32.72, 32.73, or 32.74 of this chapter or the equivalent regulations of an Agreement State;

2. Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval by the Commission pursuant to § 32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use; and

3. Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to part 30 of this chapter or the equivalent regulations of an Agreement State.

§ 35.50 Possession, use, calibration, and check of dose calibrators.

1. A medical use licensee authorized to administer radiopharmaceuticals shall have in its possession a dose calibrator and use it to measure the amount of activity administered to each patient.

2. A licensee shall:

   1. Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the requirement of this paragraph, the check must be done on a frequently used setting with a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon-emitting radionuclide;

   2. Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV;

   3. Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest dosage that will be administered to a patient and 10 microcuries; and

   4. Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.

3. A licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator.

4. A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.

5. A licensee shall retain a record of each check and test required by this section for three years unless directed otherwise. The records required in paragraphs (b)(1) through (b)(4) of this section must include:

   1. For paragraph (b)(1) of this section, the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check;

   2. For paragraph (b)(2) of this section, the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the signature of the Radiation Safety Officer;

   3. For paragraph (b)(3) of this section, the model and serial number of the dose calibrator, the calculated activities, the measured activities, the

date of the test, and the signature of the Radiation Safety Officer; and

4. For paragraph (b)(4) of this section, the model and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the signature of the Radiation Safety Officer.

[51 FR 36951. Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.51 Calibration and check of survey instruments.

1. A licensee shall calibrate the survey instruments used to show compliance with this part before first use, annually, and following repair. The licensee shall:

   1. Calibrate all scales with readings up to 1000 millirem per hour with a radiation source;

   2. Calibrate two separated readings on each scale that must be calibrated; and

      Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.

2. When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.

3. A licensee shall check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks.

4. A licensee shall retain a record of each survey instrument calibration for three years. The record must include:

   1. A description of the calibration procedure; and

   2. The date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.53 Measurement of radiopharmaceutical dosages.

A licensee shall:

1. Measure the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a photon-emitting radionuclide before medical use;

2. Measure the activity of each radiopharmaceutical dosage with a desired activity of 10 microcuries or less of a photon-emitting radionuclide before medical use to verify that the dosage does not exceed 10 microcuries;

3. Retain a record of the measurements required by this section for three years. To satisfy this requirement, the record must contain the:

   1. Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;

   2. Patient's name, and identification number if one has been assigned;

   3. Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 10 microcuries;

   4. Date and time of the measurement; and

   5. Initials of the individual who made the record.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.57 Authorization for calibration and reference sources.

Any person authorized by § 35.11 of this part for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use:

1. Sealed sources manufactured and distributed by a person licensed pursuant to § 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each;

2. Any byproduct material listed in §§ 35.100 or 35.200 with a half-life not longer than 100 days in individual amounts not to exceed 15 millicuries;

3. Any byproduct material listed in §§ 35.100 or 35.200 with a half-life longer than 100 days in individual amounts not to exceed 200 microcuries each; and

4. Technetium-99m in individual amounts not to exceed 50 millicuries.

§ 35.59 Requirements for possession of sealed sources and brachytherapy sources.

1. A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users.

2. A licensee in possession of a sealed source shall:

   1. Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and

   2. Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that accompanies the source.

3. To satisfy the leak test requirements of this section, the licensee must:

   1. Take a wipe sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or wash the source in a small volume of detergent solution and treat the entire volume as the sample;

   2. Take teletherapy and other device source test samples when the source is in the "off" position; and

   3. Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample.

4. A licensee shall retain leakage test records for five years. The records must contain the model number, and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety Officer.

5. If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall:

   1. Immediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this chapter; and

   2. File a report within five days of the leakage test with the appropriate NRC Office listed in § 30.6 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, describing the equipment involved, the test results, and the action taken.

6. A licensee need not perform a leakage test on the following sources:

   1. Sources containing only byproduct material with a half-life of less than 30 days;

   2. Sources containing only byproduct material as a gas;

   3. Sources containing 100 microcuries or less of beta or gammaemitting material or 10 microcuries or less of alpha-emitting material;

   4. Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or transfer; and

   5. Seeds of iridium-192 encased in nylon ribbon.

7. A licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in its possession. The licensee shall retain each inventory record for five years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.

8. A licensee in possession of a sealed source or brachytherapy source shall measure the ambient dose rates quarterly in all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.

9. A licensee shall retain a record of each survey required in paragraph (h) of this section for three years. The record must include the date of the

survey, a plan of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the survey instrument used, and the signature of the Radiation Safety Officer.

[51 FR 36951, Oct. 16, 1986, as amended at 52 FR 31611, Aug. 21, 1987; 53 FR 19247, May 27, 1988]

§ 35.60 Syringe shields and labels.

1. A licensee shall keep syringes that contain byproduct material to be administered in a radiation shield.

2. To identify its contents, a licensee shall conspicuously label each syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutical. The label must show the radiopharmaceutical name or its abbreviation, the clinical procedure to be performed, or the patient's name.

3. A licensee shall require each individual who prepares a radiopharmaceutical kit to use a syringe radiation shield when preparing the kit and shall require each individual to use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient.

§ 35.61 Vial shields and labels.

1. A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.

2. To identify its contents, a licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical. The label must show the radiopharmaceutical name or its abbreviation.

§ 35.70 Surveys for contamination and ambient radiation exposure rate.

1. A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.

2. A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored.

3. A licensee shall conduct the surveys required by paragraphs (a) and (b) of this section so as to be able to detect dose rates as low as 0.1 millirem per hour.

4. A licensee shall establish radiation dose rate trigger levels for the surveys required by paragraphs (a) and (b) of this section. A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds a trigger level.

5. A licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.

6. A licensee shall conduct the surveys required by paragraph (e) of this section so as to be able to detect contamination on each wipe sample of 2000 disintegrations per minute.

7. A licensee shall establish removable contamination trigger levels for the surveys required by paragraph (e) of this section. A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds the trigger level.

8. A licensee shall retain a record of each survey for three years. The record must include the date of the survey, a plan of each area surveyed, the trigger level established for each area, the detected dose rate at several points in each area expressed in millirem per hour or the removable contamination in each area expressed in disintegrations per minute per 100 square centimeters, the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.75 Release of patients containing radiopharmaceuticals or permanent implants.

1. A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either:

   1. The measured dose rate from the patient is less than 5 millirems per hour at a distance of one meter; or

2. The activity in the patient is less than 30 millicuries.

2. A licensee may not authorize release from confinement for medical care of any patient administered a permanent implant until the measured dose rate from the patient is less than 5 millirems per hour at a distance of one meter.

§ 35.80 Technical requirements that apply to the provision of mobile nuclear medicine service.

A licensee providing mobile nuclear medicine service shall:

1. Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;

2. Bring into each address of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all associated waste;

3. Secure or keep under constant surveillance and immediate control all byproduct material when in transit or at an address of use;

4. Check survey instruments and dose calibrators as described in § 35.50 and 35.51, and check all other transported equipment for proper function before medical use at each address of use;

5. Carry a radiation detection survey meter in each vehicle that is being used to transport byproduct material, and, before leaving a client address of use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all radiopharmaceuticals and all associated waste have been removed;

6. Retain a record of each survey required in paragraph (e) of this section for three years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who performed the survey.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.90 Storage of volatiles and gases.

A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shipper's radiation shield and container. A licensee shall store a multi-dose container in a fume hood after drawing the first dosage from it.

§ 35.92 Decay-in-storage.

1. A licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of § 20.2001 of this chapter if it:

   1. Holds byproduct material for decay a minimum of ten half-lives;

   2. Monitors byproduct material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding;

   3. Removes or obliterates all radiation labels; and

   4. Separates and monitors each generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level before disposal.

2. A licensee shall retain a record of each disposal permitted under paragraph (a) of this section for three years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]

§ 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies.

A licensee may use any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion

for which the Food and Drug Administration (FDA) has accepted a ''Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA).

§ 35.120 Possession of survey instrument.

A licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour.

§ 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.

1. A licensee may use any byproduct material in a diagnostic radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material for which the Food and Drug Administration has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA).

2. A licensee shall elute generators and prepare reagent kits in accordance with the manufacturer's instructions.

3. (1) From August 23, 1990, to December 31, 1994, a licensee may depart from the manufacturer's instructions for eluting generators and preparing reagent kits for which the Food and Drug Administration (FDA) has approved a "New Drug Application" (NDA), by following the directions of an authorized user physician.

   (2) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.

[51 FR 36951, Oct. 16, 1986, as amended at 57 CFR 45568, Oct. 2, 1992; 58 FR 39132, July 22, 1993]

§ 35.204 Permissible molybdenum-99 concentration.

1. A licensee may not administer to humans a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.

2. A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each elate or extract.

3. A licensee that must measure molybdenum concentration shall retain a record of each measurement for three years. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measurement, and the initials of the individual who made the measurement.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.205 Control of aerosols and gases.

1. A licensee that administers radioactive aerosols or gases shall do so in a room with a system that will keep airborne concentrations within the limits prescribed by § 20.1301 of this chapter. The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.

2. A licensee shall administer radioactive gases only in rooms that are at negative pressure compared to surrounding rooms.

3. Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a spill to reduce the concentration in the room to the occupational limit listed in § 20.1301 of this chapter. The calculation must be based on the highest activity of gas handled in a single container, the air volume of the room, and the measured available air exhaust rate.

4. A licensee shall make a record of the calculations required in paragraph (c) of this section that includes the assumptions, measurements, and calculations made and shall retain the record for the duration of use of the area. A licensee shall also post the calculated

time and safety measures to be instituted in case of a spill at the area of use.

5. A licensee shall check the operation of reusable collection systems each month, and measure the ventilation rates available in areas of radioactive gas use each six months.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 27667. July 22, 1988; 58 FR 67660, Dec. 22, 1993]

§35.220 Possession of survey instruments.

A licensee authorized to use byproduct material for imaging and localization studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.

§35.300 Use of radiopharmaceuticals for therapy.

1. A licensee may use any byproduct material in a radiopharmaceutical and for a therapeutic use for which the Food and Drug Administration has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND), or approved a "New Drug Application" (NDA). The licensee shall comply with the package insert instructions regarding indications and method of administration.

2. (1) From August 23, 1990, to December 31, 1994, a licensee may depart from the package insert instructions regarding indications or methods of administration for a radiopharmaceutical for which the Food and Drug Administration (FDA) has approved a "New Drug Application" (NDA), provided that the authorized user physician has prepared a written directive as required by §35.32(a).

   (2) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.

[51 FR 36951. Oct. 16, 1986. as amended at 55 FR 34518. Aug. 23, 1990; 57 FR 45568, Oct. 2, 1992; 58 FR 39132, July 22, 1993]

§35.310 Safety instruction.

1. A licensee shall provide radiation safety instruction for all personnel caring for the patient receiving radiopharmaceutical therapy and hospitalized for compliance with §35.75 of this chapter. To satisfy this requirement, the instruction must describe the licensee's procedures for:

   1. Patient control;

   2. Visitor control;

   3. Contamination control;

   4. Waste control; and

   5. Notification of the Radiation Safety Officer in case of the patient's death or medical emergency.

2. A licensee shall keep for three years a list of individuals receiving instruction required by paragraph (a) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§35.315 Safety precautions.

1. For each patient receiving radiopharmaceutical therapy and hospitalized for compliance with §35.75 of this chapter, a licensee shall:

2. Provide a private room with a private sanitary facility;

3. Post the patient's door with a "Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room;

4. Authorize visits by individuals under age 18 only on a patient-by-patient basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

5. Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 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

millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey.

6. Either monitor material and items removed from the patient's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste.

7. Provide the patient with radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient.

8. Survey the patient's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters; and

9. Measure the thyroid burden of each individual who helped prepare or administer a dosage of iodine-131 within three days after administering the dosage, and retain for the period required by §20.1206(a) of this chapter a record of each thyroid burden measurement, its date, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements.

2. A licensee shall notify the Radiation Safety Officer immediately if the patient dies or has a medical emergency.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]

§35.320 Possession of survey instruments.

A licensee authorized to use byproduct material for radiopharmaceutical therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.

§35.400 Use of sources for brachytherapy.

A licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:

1. Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

2. Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

3. Gold-198 as a sealed source in seeds for interstitial treatment of cancer;

4. Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;

5. Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and

6. Iodine-125 as a sealed source in seeds for interstitial treatment of cancer.

7. Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.

[51 FR 36951, Oct. 16, 1986, as amended at 54 FR 41821, Oct. 12, 1989]

§35.404 Release of patients treated with temporary implants.

1. Immediately after removing the last temporary implant source from a patient, the licensee shall make a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The licensee may not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.

2. A licensee shall retain a record of patient surveys for three years. Each record must include the date of the survey, the name of the patient, the dose rate from the patient expressed as millirem per hour and measured at one meter from the patient, the survey instrument used, and the initials of the individual who made the survey.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§35.406 Brachytherapy sources inventory.

1. Promptly after removing them from a patient, a licensee shall return brachytherapy sources to the storage area, and count the number returned to ensure that all sources taken from the storage area have been returned.

2. A licensee shall make a record of brachytherapy source use which must include:

   1. The names of the individuals permitted to handle the sources.

   2. The number and activity of sources removed from storage, the patient's name and room number, the time and date they were removed from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who removed the sources from storage;

   3. The number and activity of sources returned to storage, the patient's name and room number, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage.

3. Immediately after implanting sources in a patient the licensee shall make a radiation survey of the patient and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.

4. A licensee shall retain the records required in paragraphs (b) and (c) of this section for three years.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§35.410 Safety instruction.

1. The licensee shall provide radiation safety instruction to all personnel caring for the patient undergoing implant therapy. To satisfy this requirement, the instruction must describe:

   1. Size and appearance of the brachytherapy sources;

   2. Safe handling and shielding instructions in case of a dislodged source;

   3. Procedures for patient control;

   4. Procedures for visitor control; and

   5. Procedures for notification of the Radiation Safety Officer if the patient dies or has a medical emergency.

2. A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (a) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§35.415 Safety precautions.

1. For each patient receiving implant therapy, a licensee shall:

   1. Not quarter the patient in the same room with a patient who is not receiving radiation therapy unless the licensee can demonstrate compliance with the requirements of §20.1301(a) of this chapter at a distance of one meter from the implant;

   2. Post the patient's door with a "Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room;

   3. Authorize visits by individuals under age 18 only on a patient-by-patient basis with the approval of the authorized user after consultation with the Radiation Safety Officer; and

   4. Promptly after implanting the material, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 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 millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey.

   5. Provide the patient with radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before releasing the patient if the patient was administered a permanent implant.

2. A licensee shall notify the Radiation Safety Officer immediately if the patient dies or has a medical emergency.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]

§35.420 Possession of survey instrument.

A licensee authorized to use byproduct material for implant therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.

§35.500 Use of sealed sources for diagnosis.

A licensee shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions:

1. Iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis; and

2. Iodine-125 as a sealed source in a portable imaging device.

§35.520 Availability of survey instrument.

A licensee authorized to use byproduct material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour. The instrument must have been calibrated in accordance with §35.51 of this part.

§35.600 Use of a sealed source in a teletherapy unit.

The regulations and provisions of this subpart govern the use of teletherapy units for medical use that contain a sealed source of cobalt-60 or cesium-137.

§35.605 Maintenance and repair restrictions.

Only a person specifically licensed by the Commission or an Agreement State to perform teletherapy unit maintenance and repair shall:

1. Install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source; or

2. Maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.

§35.606 License amendments.

In addition to the changes specified in §35.13 of this part, a licensee shall apply for and must receive a license amendment before:

1. Making any change in the treatment room shielding;

2. Making any change in the location of the teletherapy unit within the treatment room;

3. Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;

4. Relocating the teletherapy unit; or

5. Allowing an individual not listed on the licensee's license to perform the duties of the teletherapy physicist.

§35.610 Safety instruction.

1. A licensee shall post instructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of:

   1. The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation on to begin a treatment or after a door interlock interruption;

   2. The procedure to be followed if:

      1. The operator is unable to turn the primary beam of radiation off with controls outside the treatment room or any other abnormal operation occurs; and

      2. 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.

2. A licensee shall provide instruction in the topics identified in paragraph (a) of this section to all individuals who operate a teletherapy unit.

3. A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (b) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.615 Safety precautions.

1. A licensee shall control access to the teletherapy room by a door at each entrance.

2. A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will:

   1. Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed;

   2. Turn the primary beam of radiation off immediately when an entrance door is opened; and

   3. Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console.

3. A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light.

4. A licensee shall install in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.

   1. A radiation monitor must provide visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source, and must be observable by an individual entering the teletherapy room.

   2. A radiation monitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.

   3. A radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients.

   4. A licensee shall maintain a record of the check required by paragraph (d)(3) of this section for three years. The record must include the date of the check, notation that the monitor indicates when its detector is and is not exposed, and the initials of the individual who performed the check.

   5. If a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in paragraph (d)(4) of this section.

   6. A licensee shall promptly repair or replace the radiation monitor if it is inoperable.

5. A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.620 Possession of survey instrument.

A licensee authorized to use byproduct material in a teletherapy unit shall have in its possession either a portable radiation detection survey instrument capable of detecting dose rate over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1,000 millirem per hour.

§ 35.630 Dosimetry equipment.

1. A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

   1. The system must have been calibrated by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the

previous two years and after any servicing that may have affected system calibration; or

2. The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 source.

2. The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.

3. The licensee shall retain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.

[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23471, May 21, 1991]

§ 35.632 Full calibration measurements.

1. A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

   1. Before the first medical use of the unit; and

   2. Before medical use under the following conditions:

      1. Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

      2. Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

      3. Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

   3. At intervals not exceeding one year.

2. To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:

   1. The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;

   2. The coincidence of the radiation field and the field indicated by the light beam localizing device;

   3. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

   4. Timer constancy and linearity over the range of use;

   5. On-off error; and

   6. The accuracy of all distance measuring and localization devices in medical use.

3. A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

4. A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379–396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741–771, and Vol. 11, No. 2, 1984, p. 213. (Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection at the NRC Library, 7920 Norfolk Avenue, Bethesda, Maryland 20814. Copies of the documents are also on file at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. A notice of any change in the material will be published in the FEDERAL REGISTER.)

5. A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month for cobalt-60 or six months for cesium-137.

6. Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the licensee's teletherapy physicist.

7. A licensee shall retain a record of each calibration for the duration of use of the teletherapy unit source. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer linearity and constancy, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 43420, Oct. 27, 1988; 57 FR 61786, Dec. 29, 1992]

§ 35.634 Periodic spot-checks.

1. A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

   1. Timer constancy, and timer linearity over the range of use;

   2. On-off error;

   3. The coincidence of the radiation field and the field indicated by the light beam localizing device;

   4. The accuracy of all distance measuring and localization devices used for medical use;

   5. The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b) of this part; and

   6. The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

2. A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the teletherapy physicist. That individual need not actually perform the spot-check measurements.

3. A licensee shall have the teletherapy physicist review the results of each spot-check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for three years.

4. A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month that assure proper operation of:

1. Electrical interlocks at each teletherapy room entrance;

2. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

3. Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility;

4. Viewing systems;

5. Treatment room doors from inside and outside the treatment room; and

6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

5. A licensee shall arrange for prompt repair of any system identified in paragraph (d) of this section that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired.

6. A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section for three years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer linearity and constancy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.636 Safety checks for teletherapy facilities.

1. A licensee shall promptly check all systems listed in § 35.634(d) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by § 35.606 (a) through (d).

2. If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in § 35.634(d), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

3. A licensee shall retain for three years a record of the facility checks following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]

§ 35.641 Radiation surveys for teletherapy facilities.

1. Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by § 35.606 (a) through (d), the licensee shall perform radiation surveys with a portable radiation measurement survey instrument calibrated in accordance with § 35.51 of this part to verify that:

   1. The maximum and average dose rates at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 10 millirem per hour and 2 millirem per hour respectively; and

   2. With the teletherapy source in the on position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that:

      1. Radiation dose quantities per unit time in restricted areas are not likely to cause personnel exposures in excess of the limits specified in § 20.1201 of this chapter; and

      2. Radiation dose quantities per unit time in unrestricted areas do not

exceed the limits specified in § 20.1301 of this chapter.

2. If the results of the surveys required in paragraph (a) of this section indicate any radiation dose quantity per unit time in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit:

   1. Except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or

   2. Until the licensee has received a specific exemption pursuant to § 20.1301 of this chapter.

3. A licensee shall retain a record of the radiation measurements made following installation of a source for the duration of the license. The record must include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.

[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]

§ 35.643 Modification of teletherapy unit or room before beginning a treatment program.

1. If the survey required by § 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by § 20.1301, before beginning the treatment program the licensee shall:

   1. Either equip the unit with stops or add additional radiation shielding to ensure compliance with § 20.1301(c) of this chapter;

   2. Perform the survey required by § 35.641 again; and

   3. Include in the report required by § 35.645 the results of the initial survey, a description of the modification made to comply with paragraph (a)(1) of this section, and the results of the second survey.

2. As an alternative to the requirements set out in paragraph (a) of this section, a licensee may request a license amendment under § 20.1301(c) of this chapter that authorizes radiation levels in unrestricted areas greater than those permitted by § 20.1301(a) of this chapter. A licensee may not begin the treatment program until the license amendment has been issued.

[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]

§ 35.645 Reports of teletherapy surveys, checks, tests, and measurements.

A licensee shall mail a copy of the records required in §§ 35.636, 35.641, 35.643, and the output from the teletherapy source expressed as roentgens or rads per hour at one meter from the source and determined during the full calibration required in § 35.632, to the appropriate Commission Regional Office listed in § 30.6 of this chapter within thirty days following completion of the action that initiated the record requirement.

§ 35.647 Five-year inspection.

1. A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

2. This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.

3. A licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.

§ 35.900 Radiation Safety Officer.

Except as provided in § 35.901, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.32 to be an individual who:

1. Is certified by:

   1. American Board of Health Physics in Comprehensive Health Physics;

   2. American Board of Radiology;

   3. American Board of Nuclear Medicine;

   4. American Board of Science in Nuclear Medicine; or

   5. Board of Pharmaceutical Specialties in Nuclear Pharmacy; or

2. Has had classroom and laboratory training and experience as follows:

   1. 200 hours of classroom and laboratory training that includes:

      1. Radiation physics and instrumentation;

      2. Radiation protection;

      3. Mathematics pertaining to the use and measurement of radioactivity;

      4. Radiation biology; and

      5. Radiopharmaceutical chemistry; and

   2. One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or

3. Be an authorized user identified on the licensee's license.

§ 35.901 Training for experienced Radiation Safety Officer.

An individual identified as a Radiation Safety Officer on a Commission or Agreement State license before October 1, 1986 need not comply with the training requirements of § 35.900.

§ 35.910 Training for uptake, dilution, and excretion studies.

Except as provided in §§ 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical in § 35.100(a) to be a physician who:

1. Is certified in:

   1. Nuclear medicine by the American Board of Nuclear Medicine;

   2. Diagnostic radiology by the American Board of Radiology; or

   3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

2. Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows:

   1. 40 hours of classroom and laboratory training that includes:

      1. Radiation physics and instrumentation;

      2. Radiation protection;

      3. Mathematics pertaining to the use and measurement of radioactivity;

      4. Radiation biology; and

      5. Radiopharmaceutical chemistry; and

   2. 20 hours of supervised clinical experience under the supervision of an authorized user and that includes:

1. Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

2. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

3. Administering dosages to patients and using syringe radiation shields;

4. Collaborating with the authorized user in the interpretation of radioisotope test results; and

5. Patient followup; or

3. Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.

§ 35.920 Training for imaging and localization studies.

Except as provided in § 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in § 35.200(a) to be a physician who:

1. Is certified in:

   1. Nuclear medicine by the American Board of Nuclear Medicine;

2. Diagnostic radiology by the American Board of Radiology; or

3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

2. Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows:

   1. 200 hours of classroom and laboratory training that includes:

      1. Radiation physics and instrumentation;

      2. Radiation protection;

      3. Mathematics pertaining to the use and measurement of radioactivity;

      4. Radiopharmaceutical chemistry; and

      5. Radiation biology; and

   2. 500 hours of supervised work experience under the supervision of an authorized user that includes:

      1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

      2. Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;

      3. Calculating and safely preparing patient dosages;

      4. Using administrative controls to prevent the misadministration of byproduct material;

      5. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

      6. Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the elate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and

   3. 500 hours of supervised clinical experience under the supervision of an authorized user that includes:

      1. Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

      2. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

      3. Administering dosages to patients and using syringe radiation shields;

      4. Collaborating with the authorized user in the interpretation of radioisotope test results; and

      5. Patient followup; or

3. Has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.

§35.930 Training for therapeutic use of radiopharmaceuticals.

Except as provided in §35.970, the licensee shall require the authorized user of radiopharmaceuticals in §35.300 to be a physician who:

1. Is certified by:

   1. The American Board of Nuclear Medicine; or

   2. The American Board of Radiology in radiology or therapeutic radiology; or

2. Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows:

   1. 80 hours of classroom and laboratory training that includes:

      1. Mathematics pertaining to the use and measurement of radioactivity; and

      2. Radiation biology; and

   2. Supervised clinical experience under the supervision of an authorized user at a medical institution that includes:

      1. Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and

      2. Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.

§35.932 Training for treatment of hyperthyroidism.

Except as provided in §35.970, the licensee shall require the authorized

user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows:

1. 80 hours of classroom and laboratory training that includes:

   1. Radiation physics and instrumentation;

   2. Radiation protection,

   3. Mathematics pertaining to the use and measurement of radioactivity; and

   4. Radiation biology; and

2. Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in 10 individuals.

§35.934 Training for treatment of thyroid carcinoma.

Except as provided in §35.970, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows:

1. 80 hours of classroom and laboratory training that includes:

   1. Radiation physics and instrumentation;

   2. Radiation protection;

   3. Mathematics pertaining to the use and measurement of radioactivity; and

   4. Radiation biology; and

2. Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals.

§35.940 Training for use of brachytherapy sources.

Except as provided in §35.970, the licensee shall require the authorized user of a brachytherapy source listed in §35.400 for therapy to be a physician who:

1. Is certified in:

   1. Radiology or therapeutic radiology by the American Board of Radiology;

   2. Radiation oncology by the American Osteopathic Board of Radiology;

   3. Radiology, with specialization in radiotherapy, as a British ''Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

   4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

2. Is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows:

   1. 200 hours of classroom and laboratory training that includes:

      1. Radiation physics and instrumentation;

      2. Radiation protection;

      3. Mathematics pertaining to the use and measurement of radioactivity; and

      4. Radiation biology;

   2. 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

      1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

      2. Checking survey meters for proper operation;

      3. Preparing, implanting, and removing sealed sources;

      4. Maintaining running inventories of material on hand;

      5. Using administrative controls to prevent the misadministration of byproduct material; and

      6. Using emergency procedures to control byproduct material; and

   3. Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized

user at a medical institution that includes:

1. Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;

2. Selecting the proper brachytherapy sources and dose and method of administration;

3. Calculating the dose; and

4. Post-administration followup and review of case histories in collaboration with the authorized user.

§35.941 Training for ophthalmic use of strontium-90.

Except as provided in §35.970, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows:

1. 24 hours of classroom and laboratory training that includes:

   1. Radiation physics and instrumentation;

   2. Radiation protection;

   3. Mathematics pertaining to the use and measurement of radioactivity; and

   4. Radiation biology;

2. Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes:

   1. Examination of each individual to be treated;

   2. Calculation of the dose to be administered;

   3. Administration of the dose; and

   4. Followup and review of each individual's case history.

§35.950 Training for use of sealed sources for diagnosis.

Except as provided in §35.970, the licensee shall require the authorized user of a sealed source in a device listed in §35.500 to be a physician, dentist, or podiatrist who:

1. Is certified in:

   1. Radiology, diagnostic radiology, or therapeutic radiology by the American Board of Radiology;

   2. Nuclear medicine by the American Board of Nuclear Medicine; or

   3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

2. Has had 8 hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes:

   1. Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;

   2. Radiation biology;

   3. Radiation protection; and

   4. Training in the use of the device for the uses requested.

§35.960 Training for teletherapy.

Except as provided in §35.970, the licensee shall require the authorized user of a sealed source listed in §35.600 in a teletherapy unit to be a physician who:

1. Is certified in:

   1. Radiology or therapeutic radiology by the American Board of Radiology;

   2. Radiation oncology by the American Osteopathic Board of Radiology;

   3. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

   4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

2. Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, supervised work experience, and supervised clinical experience as follows:

   1. 200 hours of classroom and laboratory training that includes:

      1. Radiation physics and instrumentation;

      2. Radiation protection;

      3. Mathematics pertaining to the use and measurement of radioactivity; and

4. Radiation biology:

2. 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

   1. Review of the full calibration measurements and periodic spot checks;

   2. Preparing treatment plans and calculating treatment times;

   3. Using administrative controls to prevent misadministrations;

   4. Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and

   5. Checking and using survey meters; and

3. Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes:

   1. Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications;

   2. Selecting the proper dose and how it is to be administered;

   3. Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and

   4. Post-administration followup and review of case histories.

§35.961 Training for teletherapy physicist.

The licensee shall require the teletherapy physicist to be an individual who:

1. Is certified by the American Board of Radiology in:

   1. Therapeutic radiological physics;

   2. Roentgen ray and gamma ray physics;

   3. X-ray and radium physics; or

   4. Radiological physics; or

2. Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed one year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a teletherapy physicist at a medical institution that includes the tasks listed in §§35.59, 35.632, 35.634, and 35.641 of this part.

§35.970 Training for experienced authorized users.

Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or pediatric use of byproduct material on a Commission or Agreement State license issued before April 1, 1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of subpart J.

§35.971 Physician training in a three month program.

A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program need not comply with the requirements of §§35.910 or 35.920.

§35.972 Recentness of training.

The training and experience specified in this subpart must have been obtained within the five years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

§35.990 Violations.

1. The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

   1. The Atomic Energy Act of 1954, as amended;

   2. Title II of the Energy Reorganization Act of 1974, as amended; or

   3. A regulation or order issued pursuant to those Acts.

2. The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

   1. For violations of—

      1. Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

      2. Section 206 of the Energy Reorganization Act;

      3. Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

      4. Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

   2. For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55074, Nov. 24, 1992]

§35.991 Criminal penalties.

1. Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 35 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

2. The regulations in part 35 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§35.1, 35.2, 35.8, 35.12, 35.18, 35.19, 35.57, 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and 35.999.

[57 FR 55074, Nov. 24, 1992]

§35.999 Resolution of conflicting requirements during transition period.

If the rules in this part conflict with the licensee's radiation safety program as identified in its license, and if that license was approved by the Commission before April 1, 1987 and has not been renewed since April 1, 1987, then the requirements in the license will apply. However, if that licensee exercises its privilege to make minor changes in its radiation safety procedures that are not potentially important to safety under §35.31 of this chapter, the portion changed must comply with the requirements of this part. At the time of license renewal and thereafter, these amendments to this part shall apply.