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PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

Part Index

Subpart A--General Provisions

20.1001 Purpose.

20.1002 Scope.

20.1003 Definitions.

20.1004 Units of radiation dose.

20.1005 Units of radioactivity.

20.1006 Interpretations.

20.1007 Communications.

20.1008 Implementation.

20.1009 Information collection requirements: OMB approval.

Subpart B--Radiation Protection Programs

20.1101 Radiation protection programs.

Subpart C--Occupational Dose Limits

20.1201 Occupational dose limits for adults.

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

20.1203 Determination of external dose from airborne radioactive material.

20.1204 Determination of internal exposure.

20.1205 [Reserved]

20.1206 Planned special exposures.

20.1207 Occupational dose limits for minors.

20.1208 Dose equivalent to an embryo/fetus.

Subpart D--Radiation Dose Limits for Individual Members of the Public

20.1301 Dose limits for individual members of the public.

20.1302 Compliance with dose limits for individual members of the public.

Subpart E--Radiological Criteria for License Termination

20.1401 General provisions and scope.

20.1402 Radiological criteria for unrestricted use.

20.1403 Criteria for license termination under restricted conditions.

20.1404 Alternate criteria for license termination.

20.1405 Public notification and public participation.

20.1406 Minimization of contamination.

Subpart F--Surveys and Monitoring

20.1501 General.

20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Subpart G--Control of Exposure From External Sources in Restricted Areas

20.1601 Control of access to high radiation areas.

20.1602 Control of access to very high radiation areas.

Subpart H--Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

20.1701 Use of process or other engineering controls.

20.1702 Use of other controls.

20.1703 Use of individual respiratory protection equipment.

20.1704 Further restrictions on the use of respiratory protection equipment.

20.1705 Application for use of higher assigned protection factors.

Subpart I--Storage and Control of Licensed Material

20.1801 Security of stored material.

20.1802 Control of material not in storage.

Subpart J--Precautionary Procedures

20.1901 Caution signs.

20.1902 Posting requirements.

20.1903 Exceptions to posting requirements.

20.1904 Labeling containers.

20.1905 Exemptions to labeling requirements.

20.1906 Procedures for receiving and opening packages.

Subpart K--Waste Disposal

20.2001 General requirements.

20.2002 Method for obtaining approval of proposed disposal procedures.

20.2003 Disposal by release into sanitary sewerage.

20.2004 Treatment or disposal by incineration.

20.2005 Disposal of specific wastes.

20.2006 Transfer for disposal and manifests.

20.2007 Compliance with environmental and health protection regulations.

20.2008 Disposal of certain byproduct material.

Subpart L--Records

20.2101 General provisions.

20.2102 Records of radiation protection programs.

20.2103 Records of surveys.

20.2104 Determination of prior occupational dose.

20.2105 Records of planned special exposures.

20.2106 Records of individual monitoring results.

20.2107 Records of dose to individual members of the public.

20.2108 Records of waste disposal.

20.2109 [Reserved]

20.2110 Form of records.

Subpart M--Reports

20.2201 Reports of theft or loss of licensed material.

20.2202 Notification of incidents.

20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits.

20.2204 Reports of planned special exposures.

20.2205 Reports to individuals of exceeding dose limits.

20.2206 Reports of individual monitoring.

20.2207 Reports of transactions involving nationally tracked sources.

Subpart N--Exemptions and Additional Requirements

20.2301 Applications for exemptions.

20.2302 Additional requirements.

Subpart O--Enforcement

20.2401 Violations.

20.2402 Criminal penalties.

Appendix A to Part 20--Assigned 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--Nationally Tracked Source Thresholds

Appendix F to Part 20--[Reserved]

Appendix G to Part 20--Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed 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, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 U.S.C. 2014, 2021, 2021b, 2111).

[72 FR 55921, Oct. 1, 2007]

Subpart A--General Provisions

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

§ 20.1001 Purpose.

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

(b) It is the purpose of the regulations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual (including doses 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, 52, 60, 61, 63, 70, or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons required to obtain a certificate of compliance or an approved compliance plan under part 76 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, to exposure from individuals administered radioactive material and released under § 35.75, or
to exposure from voluntary participation in medical research programs.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 67 FR 77652, Dec. 19, 2002; 72 FR 49485, Aug. 28, 2007]

§ 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).

Accelerator-produced radioactive material means any material made radioactive by a particle accelerator.

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.

Air-purifying respirator means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

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).

Assigned protection factor (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

Atmosphere-supplying respirator means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

Background radiation means radiation from cosmic sources; naturally occurring radioactive material, 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 or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "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 using special nuclear material;

(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;

(3)(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or
research activity.

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

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

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

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

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

Constraint (dose constraint) means a value above which specified licensee actions are required.

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.

Critical Group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

Declared pregnant woman means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

Decommission means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits--

(1) Release of the property for unrestricted use and termination of the license; or

(2) Release of the property under restricted conditions and termination of the license.

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

Demand respirator means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

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).

Discrete source means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

Distinguishable from background means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

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

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

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

Effective dose equivalent (HE) is the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (WT) applicable to each of the body organs or tissues that are irradiated (HE = ΣWTHT).

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.

Filtering facepiece (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

Fit factor means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

Fit test means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

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].

Helmet means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

High radiation area means an area, accessible to individuals, in which radiation levels from radiation sources external to the body 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 30 centimeters from any surface that the radiation penetrates.

Hood means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

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, thermoluminescence 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.

Lens dose equivalent (LDE) 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).

License means a license issued under the regulations in parts 30 through 36, 39, 40, 50, 60, 61, 63, 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.

Loose-fitting facepiece means a respiratory inlet covering that is designed to form a partial seal with the face.

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 any individual except when that individual is receiving 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.

Nationally tracked source is a sealed source containing a quantity equal to or greater than Category 1 or Category 2
levels of any radioactive material listed in Appendix E of this part. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

Negative pressure respirator (tight fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

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 the course of employment in which the individual’s assigned duties involve exposure to radiation or 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 doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, or as a member of the public.

Particle accelerator means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

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.

Positive pressure respirator means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

Powered air-purifying respirator (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

Pressure demand respirator means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

Public dose means the dose received by a member of the public from exposure to radiation or to radioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, or from voluntary participation in medical research programs.

Qualitative fit test (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

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.

Quantitative fit test (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

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 radio- or 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).

Residual radioactivity means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 CFR part 20.

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.

Self-contained breathing apparatus (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

Shallow-dose equivalent (Hs), which applies to the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

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.

Supplied-air respirator (SAR) or airline respirator means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

Survey means an evalulation 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.

Tight-fitting facepiece means a respiratory inlet covering that forms a complete seal with the face.

Total Effective Dose Equivalent (TEDE) means the sum of the effective 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.

User seal check (fit check) means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

Very high radiation area means an area, accessible to individuals, in which radiation levels from radiation sources external to the body 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 1 meter 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)).

Waste means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs (2), (3), and (4) of the definition of Byproduct material set forth in this section.

Week means 7 consecutive days starting on Sunday.

Weighting factor WT, for an organ or tissue (T) is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of WT are:

Organ Dose Weighting Factors

Organ or Tissue WT
Gonads 0.25
Breast 0.15
Red bone marrow 0.12
Lung 0.12
Thyroid 0.03
Bone surfaces 0.03
Remainder 10.30
Whole Body 21.00
1 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive the highest doses.
2 For the purpose of weighting the external whole body dose (for adding it to the internal dose), a single weighting factor, wT=1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

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

Working level (WL) is any combination of short-lived radon daughters (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in 1 liter of air that will result in the ultimate emission of 1.3x105 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; 60 FR 36043, July 13, 1995; 60 FR 48625, Sept. 20, 1995; 61 FR 65127, Dec. 10, 1996; 62 FR 4133, Jan. 29, 1997; 62 FR 39087, July 21, 1997; 63 FR 39481, July 23, 1998; 64 FR 54556, Oct. 7, 1999; 66 FR 55789, Nov. 2, 2001; 67 FR 16304, Apr. 5, 2002; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 72 FR 55921, Oct. 1, 2007; 72 FR 68058, Dec. 4, 2007]

§ 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.

Table 1004(b).1-Quality Factors and Absorbed Dose Equivalencies

Type of radiation Quality factor Absorbed dose equal to a unit dose equivalenta
(Q)
X-, gamma, or beta radiation 1 1
Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge 20 0.05
Neutrons of unknown energy 10 0.1
High-energy protons 10 0.1
a Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 sievert.

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

Table 1004(b).2.--Mean Quality Factors, Q, and Fluence Per Unit Dose Equivalent for Monoenergetic Neutrons

  Neutron energy (MeV) Quality factora (Q) Fluence per unit dose equivalentb
(neutrons cm-2 rem -1)
(thermal)..... 2.5 x 10-8 2 980 x 106
1 x 10-7 2 980 x 106
1 x 10-6 2 810 x 106
1 x 10-5 2 810 x 106
1 x 10-4 2 840 x 106
1 x 10-3 2 980 x 106
1 x 10-2 2.5 1010 x 106
1 x 10-1 7.5 170 x 106
5 x 10-1 11 39 x 106
1 11 27 x 106
2.5 9 29 x 106
5 8 23 x 106
7 7 24 x 106
10 6.5 24 x 106
14 7.5 17 x 106
20 8 16 x 106
40 7 14 x 106
60 5.5 16 x 106
1 x 102 4 20 x 106
2 x 102 3.5 19 x 106
3 x 102 3.5 16 x 106
4 x 102 3.5 14 x 106
a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom.
b
Monoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom.

§ 20.1005 Units of radioactivity.

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

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

(b) One curie=3.7x1010 disintegrations per second=3.7x1010 becquerels=2.22x1012 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 (EDO), and sent either by mail to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html, by calling (301) 415-0439, by e-mail to EIE@nrc.gov, or by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

[68 FR 58801, Oct. 10, 2003 as amended at 70 FR 69421, Nov. 16, 2005; 72 FR 33386, Jun. 18, 2007]

§ 20.1008 Implementation.

(a) [Reserved]

(b) The applicable section of §§ 20.1001-20.2402 must be used in lieu of requirements in the standards for protection against radiation in effect prior to January 1, 19941 that are cited in license conditions or technical specifications, except as specified in paragraphs (c), (d), and (e) of this section. If the requirements of this part are more restrictive than the existing license condition, then the licensee shall comply with this part unless exempted by paragraph (d) of this section.

(c) Any existing license condition or technical specification that is more restrictive than a requirement in §§ 20.1001-20.2402 remains in force until there is a technical specification change, license amendment, or license renewal.

(d) If a license condition or technical specification exempted a licensee from a requirement in the standards for protection against radiation in effect prior to January 1, 1994,1 it continues to exempt a licensee from the corresponding provision of §§ 20.1001-20.2402.

(e) If a license condition cites provisions in requirements in the standards for protection against radiation in effect prior to January 1, 19941 and there are no corresponding provisions in §§ 20.1001-20.2402, then the license condition remains in force until there is a technical specification change, license amendment, or license renewal that modifies or removes this condition.

[59 FR 41643, Aug. 15, 1994]

1 See §§ 20.1-20.602 codified as of January 1, 1993.

§ 20.1009 Information collection requirements: OMB approval.

(a) 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 (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0014.

(b) The approved information collection requirements contained in this part appear in §§20.1003, 20.1101, 20.1202, 20.1203, 20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406, 20.1501, 20.1601, 20.1703, 20.1901, 20.1904, 20.1905, 20.1906, 20.2002, 20.2004, 20.2005, 20.2006, 20.2008, 20.2102, 20.2103, 20.2104, 20.2105, 20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 20.2205, 20.2206, 20.2207, 20.2301, and appendix G to this part.

(c) 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.

(3) In § 20.2006 and appendix G to 10 CFR Part 20, NRC Form 540 and 540A is approved under control number 3150-0164.

(4) In § 20.2006 and appendix G to 10 CFR Part 20, NRC Form 541 and 541A is approved under control number 3150-0166.

(5) In § 20.2006 and appendix G to 10 CFR Part 20, NRC Form 542 and 542A is approved under control number 3150-0165.

(6) In § 20.2207, NRC Form 748 is approved under control number 3150– 0202.

[63 FR 50128, Sept. 21, 1998, as amended at 67 FR 67099, Nov. 4, 2002; 71 FR 65686, Nov. 8, 2006; 72 FR 55922, Oct. 1, 2007]

Subpart B--Radiation Protection Programs

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

§ 20.1101 Radiation protection programs.

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

(d) To implement the ALARA requirements of § 20.1101 (b), and notwithstanding the requirements in § 20.1301 of this part, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to § 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in § 20.2203 and promptly take appropriate corrective action to ensure against recurrence.

[56 FR 23396, May 21, 1991, as amended at 61 FR 65127, Dec. 10, 1996; 63 FR 39482, July 23, 1998]

Subpart C--Occupational Dose Limits

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

§ 20.1201 Occupational dose limits for adults.

(a) 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--

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

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

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(i) A lens dose equivalent of 15 rems (0.15 Sv), and

(ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.

(b) 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)).

(c) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the NRC. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

(d) Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to part 20 and may be used to determine the individual's dose (see § 20.2106) and to demonstrate compliance with the occupational dose limits.

(e) 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 part 20).

(f) 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)).

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 FR 39482, July 23, 1998; 67 FR 16304, Apr. 5, 2002; 72 FR 68059, Dec. 4, 2007]

§ 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, and one of the following, does not exceed unity:

(1) The sum of the fractions of the inhalation ALI for each radionuclide, or

(2) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or

(3) The sum of the calculated committed effective dose equivalents to all significantly irradiated1 organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit.

(c) Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.

(d) Intake through wounds or absorption through skin. The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption.

Note: The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated.

[56 FR 23396, May 21, 1991, as amended at 57 FR 57878, Dec. 8, 1992]

1 An organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factor, wT, and the committed dose equivalent, HT,50, per unit intake is greater than 10 percent of the maximum weighted value of HT,50, (i.e., wT HT,50) per unit intake for any organ or tissue.

§ 20.1203 Determination of external dose from airborne radioactive material.

Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see appendix B to part 20, footnotes 1 and 2).

Note: Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep-dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep-dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 FR 39482, July 23, 1998]

§ 20.1204 Determination of internal exposure.

(a) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under § 20.1502, take suitable and timely measurements of--

(1) Concentrations of radioactive materials in air in work areas; or

(2) Quantities of radionuclides in the body; or

(3) Quantities of radionuclides excreted from the body; or

(4) Combinations of these measurements.

(b) Unless respiratory protective equipment is used, as provided in § 20.1703, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(c) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may--

(1) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(2) Upon prior approval of the Commission, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and

(3) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide (see appendix B to part 20) to the committed effective dose equivalent.

(d) If the licensee chooses to assess intakes of Class Y material using the measurements given in § 20.1204(a)(2) or (3), the licensee may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by §§ 20.2202 or 20.2203, in order to permit the licensee to make additional measurements basic to the assessments.

(e) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours must be either--

(1) The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, Y) from appendix B to part 20 for each radionuclide in the mixture; or

(2) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(f) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture must be the most restrictive DAC of any radionuclide in the mixture.

(g) When a mixture of radionuclides in air exists, licensees may disregard certain radionuclides in the mixture if--

(1) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in § 20.1201 and in complying with the monitoring requirements in § 20.1502(b), and

(2) The concentration of any radionuclide disregarded is less than 10 percent of its DAC, and

(3) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.

(h)(1) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.

(2) When the ALI (and the associated DAC) is determined by the nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) (the stochastic ALI) is listed in parentheses in table 1 of appendix B to part 20. In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee must also demonstrate that the limit in § 20.1201(a)(1)(ii) is met.

[56 FR 23396, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]

§ 20.1205 [Reserved]

§ 20.1206 Planned special exposures.

A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in § 20.1201 provided that each of the following conditions is satisfied--

(a) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.

(b) The licensee (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs.

(c) Before a planned special exposure, the licensee ensures that the individuals involved are--

(1) Informed of the purpose of the planned operation;

(2) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(3) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

(d) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by § 20.2104(b) during the lifetime of the individual for each individual involved.

(e) Subject to § 20.1201(b), the licensee does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed--

(1) The numerical values of any of the dose limits in § 20.1201(a) in any year; and

(2) Five times the annual dose limits in § 20.1201(a) during the individual's lifetime.

(f) The licensee maintains records of the conduct of a planned special exposure in accordance with § 20.2105 and submits a written report in accordance with § 20.2204.

(g) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not to be considered in controlling future occupational dose of the individual under § 20.1201(a) but is to be included in evaluations required by § 20.1206 (d) and (e).

[56 FR 23396, May 21, 1991, as amended at 63 FR 39482, July 23, 1998]

§ 20.1207 Occupational dose limits for minors.

The annual occupational dose limits for minors are 10 percent of the annual dose limits specified for adult workers in § 20.1201.

§ 20.1208 Dose equivalent to an embryo/fetus.

(a) The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see § 20.2106.)

(b) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.

(c) The dose equivalent to the embryo/fetus is the sum of--

(1) The deep-dose equivalent to the declared pregnant woman; and

(2) The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

(d) If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

[56 FR 23396, May 21, 1991, as amended at 63 FR 39482, July 23, 1998]

Subpart D--Radiation Dose Limits for Individual Members of the Public

Source: 56 FR 23398, May 21, 1991, unless otherwise noted.

§ 20.1301 Dose limits for individual members of the public.

(a) Each licensee shall conduct operations so that —

(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee’s disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.

(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

(c) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to an individual who cannot be released, under § 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if—

(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and

(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.

(d) A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following information in this application:

(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;

(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and

(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.

(e) In addition to the requirements of this part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those standards.

(f) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

[56 FR 23398, May 21, 1991, as amended at 60 FR 48625, Sept. 20, 1995; 62 FR 4133, Jan. 29, 1997; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]

§ 20.1302 Compliance with dose limits for individual members of the public.

(a) The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in § 20.1301.

(b) A licensee shall show compliance with the annual dose limit in § 20.1301 by--

(1) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or

(2) Demonstrating that--

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in table 2 of appendix B to part 20; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.

(c) Upon approval from the Commission, the licensee may adjust the effluent concentration values in appendix B to part 20, table 2, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, chemical form).

[56 FR 23398, May 21, 1991; 56 FR 61352, Dec. 3, 1991, as amended at 57 FR 57878, Dec. 8, 1992; 60 FR 20185, Apr. 25, 1995]

Subpart E--Radiological Criteria for License Termination

Source: 62 FR 39088, July 21, 1987, unless otherwise noted.

§ 20.1401 General provisions and scope.

(a) The criteria in this subpart apply to the decommissioning of facilities licensed under parts 30, 40, 50, 52, 60, 61, 63, 70, and 72 of this chapter, and release of part of a facility or site for unrestricted use in accordance with § 50.83 of this chapter, as well as other facilities subject to the Commission's jurisdiction under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. For high-level and low-level waste disposal facilities (10 CFR parts 60, 61, and 63), the criteria apply only to ancillary surface facilities that support radioactive waste disposal activities. The criteria do not apply to uranium and thorium recovery facilities already subject to appendix A to 10 CFR part 40 or the uranium solution extraction facilities.

(b) The criteria in this subpart do not apply to sites which:

(1) Have been decommissioned prior to the effective date of the rule in accordance with criteria identified in the Site Decommissioning Management Plan (SDMP) Action Plan of April 16, 1992 (57 FR 13389);

(2) Have previously submitted and received Commission approval on a license termination plan (LTP) or decommissioning plan that is compatible with the SDMP Action Plan criteria; or

(3) Submit a sufficient LTP or decommissioning plan before August 20, 1998 and such LTP or decommissioning plan is approved by the Commission before August 20, 1999 and in accordance with the criteria identified in the SDMP Action Plan, except that if an EIS is required in the submittal, there will be a provision for day-for-day extension.

(c) After a site has been decommissioned and the license terminated in accordance with the criteria in this subpart, or after part of a facility or site has been released for unrestricted use in accordance with § 50.83 of this chapter and in accordance with the criteria in this subpart, the Commission will require additional cleanup only, if based on new information, it determines that the criteria of this subpart were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.

(d) When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first 1000 years after decommissioning.

[62 FR 39088, July 21, 1997, as amended at 66 FR 55789, Nov. 2, 2001; 72 FR 49485, Aug. 28, 2007]

§ 20.1402 Radiological criteria for unrestricted use.

A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

§ 20.1403 Criteria for license termination under restricted conditions.

A site will be considered acceptable for license termination under restricted conditions if:

(a) The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of § 20.1402 would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are ALARA. Determination of the levels which are ALARA must take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal;

(b) The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) per year;

(c) The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms are--

(1) Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control as described in § 30.35(f)(1) of this chapter;

(2) Surety method, insurance, or other guarantee method as described in § 30.35(f)(2) of this chapter;

(3) A statement of intent in the case of Federal, State, or local Government licensees, as described in § 30.35(f)(4) of this chapter; or

(4) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.

(d) The licensee has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chapter, and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the LTP or decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice.

(1) Licensees proposing to decommission by restricting use of the site shall seek advice from such affected parties regarding the following matters concerning the proposed decommissioning--

(i) Whether provisions for institutional controls proposed by the licensee;

(A) Will provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year;

(B) Will be enforceable; and

(C) Will not impose undue burdens on the local community or other affected parties.

(ii) Whether the licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site;

(2) In seeking advice on the issues identified in § 20.1403(d)(1), the licensee shall provide for:

(i) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(ii) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(iii) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and

(e) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either--

(1) 100 mrem (1 mSv) per year; or

(2) 500 mrem (5 mSv) per year provided the licensee--

(i) Demonstrates that further reductions in residual radioactivity necessary to comply with the 100 mrem/y (1 mSv/y) value of paragraph (e)(1) of this section are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;

(ii) Makes provisions for durable institutional controls;

(iii) Provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmental custodian of a site, both to carry out periodic rechecks of the site no less frequently than every 5 years to assure that the institutional controls remain in place as necessary to meet the criteria of § 20.1403(b) and to assume and carry out responsibilities for any necessary control and maintenance of those controls. Acceptable financial assurance mechanisms are those in paragraph (c) of this section.

§ 20.1404 Alternate criteria for license termination.

(a) The Commission may terminate a license using alternate criteria greater than the dose criterion of §§ 20.1402, 20.1403(b), and 20.1403(d)(1)(i)(A), if the licensee--

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 1 mSv/y (100 mrem/y) limit of subpart D, by submitting an analysis of possible sources of exposure;

(2) Has employed to the extent practical restrictions on site use according to the provisions of § 20.1403 in minimizing exposures at the site; and

(3) Reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal.

(4) Has submitted a decommissioning plan or License Termination Plan (LTP) to the Commission indicating the licensee's intent to decommission in accordance with §§ 30.36(d), 40.42(d), 50.82 (a) and (b), 70.38(d), or 72.54 of this chapter, and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(i) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(ii) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(iii) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(b) The use of alternate criteria to terminate a license requires the approval of the Commission after consideration of the NRC staff's recommendations that will address any comments provided by the Environmental Protection Agency and any public comments submitted pursuant to § 20.1405.

§ 20.1405 Public notification and public participation.

Upon the receipt of an LTP or decommissioning plan from the licensee, or a proposal by the licensee for release of a site pursuant to §§ 20.1403 or 20.1404, or whenever the Commission deems such notice to be in the public interest, the Commission shall:

(a) Notify and solicit comments from:

(1) local and State governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and

(2) the Environmental Protection Agency for cases where the licensee proposes to release a site pursuant to § 20.1404.

(b) Publish a notice in the Federal Register and in a forum, such as local newspapers, letters to State or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.

§ 20.1406 Minimization of contamination.

(a) Applicants for licenses, other than early site permits and manufacturing licenses under part 52 of this chapter and renewals, whose applications are submitted after August 20, 1997, shall describe in the application how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.

(b) Applicants for standard design certifications, standard design approvals, and manufacturing licenses under part 52 of this chapter, whose applications are submitted after August 20, 1997, shall describe in the application how facility design will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual
decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.

[72 FR 49485, Aug. 28, 2007]

Subpart F--Surveys and Monitoring

Source: 56 FR 23398, May 21, 1991, unless otherwise noted.

§ 20.1501 General.

(a) Each licensee shall make or cause to be made, surveys that--

(1) May be necessary for the licensee to comply with the regulations in this part; and

(2) Are reasonable under the circumstances to evaluate--

(i) The magnitude and extent of radiation levels; and

(ii) Concentrations or quantities of radioactive material; and

(iii) The potential radiological hazards.

(b) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.

(c) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to determine the radiation dose and that are used by licensees to comply with § 20.1201, with other applicable provisions of this chapter, or with conditions specified in a license must be processed and evaluated by a dosimetry processor--

(1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and

(2) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

[56 FR 23398, May 21, 1991, as amended at 63 FR 39482, July 23, 1998]

§ 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum--

(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by--

(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);

(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and

(4) Individuals entering a high or very high radiation area.

(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to--

(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;

(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and

(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).

[56 FR 23398, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 FR 39482, July 23, 1998]

2 All of the occupational doses in § 20.1201 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.

Subpart G--Control of Exposure From External Sources in Restricted Areas

Source: 56 FR 23398, May 21, 1991, unless otherwise noted.

§ 20.1601 Control of access to high radiation areas.

(a) The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features--

(1) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep-dose equivalent of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates;

(2) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

(3) Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

(b) In place of the controls required by paragraph (a) of this section for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

(c) A licensee may apply to the Commission for approval of alternative methods for controlling access to high radiation areas.

(d) The licensee shall establish the controls required by paragraphs (a) and (c) of this section in a way that does not prevent individuals from leaving a high radiation area.

(e) Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the Department of Transportation provided that--

(1) The packages do not remain in the area longer than 3 days; and

(2) The dose rate at 1 meter from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.

(f) Control of entrance or access to rooms or other areas in hospitals is not required solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this part and to operate within the ALARA provisions of the licensee's radiation protection program.

§ 20.1602 Control of access to very high radiation areas.

In addition to the requirements in § 20.1601, the licensee shall institute additional measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in 1 hour at 1 meter from a radiation source or any surface through which the radiation penetrates.

Subpart H--Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

Source: 56 FR 23400, May 21, 1991, unless otherwise noted.

§ 20.1701 Use of process or other engineering controls.

The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.

[64 FR 54556, Oct. 7, 1999]

§ 20.1702 Use of other controls.

(a) When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means--

(1) Control of access;

(2) Limitation of exposure times;

(3) Use of respiratory protection equipment; or

(4) Other controls.

(b) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on workers' industrial health and safety.

[64 FR 54556, Oct. 7, 1999]

§ 20.1703 Use of individual respiratory protection equipment.

If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material,

(a) The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.

(b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.

(c) The licensee shall implement and maintain a respiratory protection program that includes:

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

(2) Surveys and bioassays, as necessary, to evaluate actual intakes;

(3) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use;

(4) Written procedures regarding--

(i) Monitoring, including air sampling and bioassays;

(ii) Supervision and training of respirator users;

(iii) Fit testing;

(iv) Respirator selection;

(v) Breathing air quality;

(vi) Inventory and control;

(vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

(viii) Recordkeeping; and

(ix) Limitations on periods of respirator use and relief from respirator use;

(5) Determination by a physician that the individual user is medically fit to use respiratory protection equipment:

(i) Before the initial fitting of a face sealing respirator;

(ii) Before the first field use of non-face sealing respirators, and

(iii) Either every 12 months thereafter, or periodically at a frequency determined by a physician.

(6) Fit testing, with fit factor > 10 times the APF for negative pressure devices, and a fit factor > 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

(d) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

(e) The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.

(f) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

(g) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include--

(1) Oxygen content (v/v) of 19.5-23.5%;

(2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;

(3) Carbon monoxide (CO) content of 10 ppm or less;

(4) Carbon dioxide content of 1,000 ppm or less; and

(5) Lack of noticable odor.

(h) The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face--facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.

(i) In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

[64 FR 54557, Oct. 7, 1999, as amended at 67 FR 77652, Dec. 19, 2002]

§ 20.1704 Further restrictions on the use of respiratory protection equipment.

The Commission may impose restrictions in addition to the provisions of §§ 20.1702, 20.1703, and Appendix A to Part 20, in order to:

(a) Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

(b) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

[64 FR 54557, Oct. 7, 1999]

§ 20.1705 Application for use of higher assigned protection factors.

The licensee shall obtain authorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to Part 20. The Commission may authorize a licensee to use higher assigned protection factors on receipt of an application that--

(a) Describes the situation for which a need exists for higher protection factors; and

(b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

[64 FR 54557, Oct. 7, 1999]

Subpart I--Storage and Control of Licensed Material

Source: 56 FR 23401, May 21, 1991, unless otherwise noted.

§ 20.1801 Security of stored material.

The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.

§ 20.1802 Control of material not in storage.

The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.

Subpart J--Precautionary Procedures

Source: 56 FR 23401, May 21, 1991, unless otherwise noted.

§ 20.1901 Caution signs.

(a) Standard radiation symbol. Unless otherwise authorized by the Commission, the symbol prescribed by this part shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed by this part is the three-bladed design:

three-bladed radiation symbol

(1) Cross-hatched area is to be magenta, or purple, or black, and

(2) The background is to be yellow.

(b) Exception to color requirements for standard radiation symbol. Notwithstanding the requirements of paragraph (a) of this section, licensees are authorized to label sources, source holders, or device components containing sources of licensed materials that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

(c) Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this part, the licensee may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

§ 20.1902 Posting requirements.

(a) Posting of radiation areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

(b) Posting of high radiation areas. The licensee shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

(c) Posting of very high radiation areas. The licensee shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."

(d) Posting of airborne radioactivity areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."

(e) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in appendix C to part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."

[56 FR 23401, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995]

§ 20.1903 Exceptions to posting requirements.

(a) A licensee is not required to post caution signs in areas or rooms containing radioactive materials for periods of less than 8 hours, if each of the following conditions is met:

(1) The materials are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation or radioactive materials in excess of the limits established in this part; and

(2) The area or room is subject to the licensee's control.

(b) Rooms or other areas in hospitals that are occupied by patients ar