Nuclear Regulatory Commission
`
`§ 20.1001
`
`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 require-
`ments.
`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 inciner-
`ation.
`20.2005 Disposal of specific wastes.
`20.2006 Transfer for disposal and manifests.
`20.2007 Compliance with environmental and
`health protection regulations.
`Subpart L—Records
`20.2101 General provisions.
`20.2102 Records of radiation protection pro-
`grams.
`20.2103 Records of surveys.
`20.2104 Determination of prior occupational
`dose.
`20.2105 Records of planned special expo-
`sures.
`20.2106 Records of individual monitoring re-
`sults.
`20.2107 Records of dose to individual mem-
`bers 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 lev-
`els, and concentrations of radioactive
`material exceeding the constraints or
`limits.
`20.2204 Reports of planned special expo-
`sures.
`20.2205 Reports to individuals of exceeding
`dose limits.
`20.2206 Reports of individual monitoring.
`Subpart N—Exemptions and Additional
`Requirements
`20.2301 Applications for exemptions.
`
`20.2302 Additional requirements.
`Subpart O—Enforcement
`20.2401 Violations.
`20.2402 Criminal penalties.
`APPENDIX A TO PART 20—ASSIGNED PROTEC-
`TION FACTORS FOR RESPIRATORS
`APPENDIX B TO PART 20—ANNUAL LIMITS ON
`INTAKE (ALIS) AND DERIVED AIR CON-
`CENTRATIONS (DACS) OF RADIONUCLIDES
`FOR OCCUPATIONAL EXPOSURE; EFFLUENT
`CONCENTRATIONS; CONCENTRATIONS FOR
`RELEASE TO SEWERAGE
`APPENDIX C TO PART 20—QUANTITIES OF LI-
`CENSED MATERIAL REQUIRING LABELING
`APPENDIX D TO PART 20—UNITED STATES NU-
`CLEAR REGULATORY COMMISSION RE-
`GIONAL OFFICES
`APPENDIXES E–F TO PART 20 [RESERVED]
`APPENDIX G TO PART 20—REQUIREMENTS FOR
`TRANSFERS OF LOW-LEVEL RADIOACTIVE
`WASTE INTENDED FOR DISPOSAL AT LI-
`CENSED 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).
`
`Subpart A—General Provisions
`SOURCE: 56 FR 23391, May 21, 1991, unless
`otherwise noted.
`§ 20.1001 Purpose.
`(a) The regulations in this part estab-
`lish standards for protection against
`ionizing radiation resulting from ac-
`tivities conducted under licenses issued
`by the Nuclear Regulatory Commis-
`sion. These regulations are issued
`under the Atomic Energy Act of 1954,
`as amended, and the Energy Reorga-
`nization Act of 1974, as amended.
`(b) It is the purpose of the regula-
`tions in this part to control the re-
`ceipt, possession, use, transfer, and dis-
`posal of licensed material by any li-
`censee in such a manner that the total
`dose to an individual (including doses
`resulting from licensed and unlicensed
`radioactive material and from radi-
`ation sources other than background
`radiation) does not exceed the stand-
`ards for protection against radiation
`prescribed in the regulations in this
`part. However, nothing in this part
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`JUBILANT EXHIBIT 1027
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`10 CFR Ch. I (1–1–05 Edition)
`§ 20.1002
`shall be construed as limiting actions
`piratory protective equipment could
`that may be necessary to protect
`exceed, during the hours an individual
`health and safety.
`is present in a week, an intake of 0.6
`percent of the annual limit on intake
`(ALI) or 12 DAC-hours.
`§ 20.1002 Scope.
`Air-purifying respirator means a res-
`The regulations in this part apply to
`pirator with an air-purifying filter,
`persons licensed by the Commission to
`cartridge, or canister that removes spe-
`receive, possess, use, transfer, or dis-
`cific air contaminants by passing am-
`pose of byproduct, source, or special
`nuclear material or to operate a pro-
`bient air through the air-purifying ele-
`duction or utilization facility under
`ment.
`Parts 30 through 36, 39, 40, 50, 60, 61, 63,
`ALARA (acronym for ‘‘as low as is
`70, or 72 of this chapter, and in accord-
`reasonably achievable’’) means making
`ance with 10 CFR 76.60 to persons re-
`every reasonable effort to maintain ex-
`quired to obtain a certificate of com-
`posures to radiation as far below the
`pliance or an approved compliance plan
`dose limits in this part as is practical
`under part 76 of this chapter. The lim-
`consistent with the purpose for which
`its in this part do not apply to doses
`the licensed activity is undertaken,
`due to background radiation, to expo-
`taking into account the state of tech-
`sure of patients to radiation for the
`nology, the economics of improve-
`purpose of medical diagnosis or ther-
`ments in relation to state of tech-
`apy, to exposure from individuals ad-
`nology, the economics of improve-
`ministered radioactive material and re-
`ments in relation to benefits to the
`leased under §35.75, or to exposure from
`public health and safety, and other so-
`voluntary participation in medical re-
`cietal and socioeconomic consider-
`search programs.
`ations, and in relation to utilization of
`nuclear energy and licensed materials
`[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9,
`in the public interest.
`2002, as amended at 67 FR 77652, Dec. 19, 2002]
`Annual limit on intake (ALI) means
`the derived limit for the amount of ra-
`§ 20.1003 Definitions.
`dioactive material taken into the body
`As used in this part:
`of an adult worker by inhalation or in-
`Absorbed dose means the energy im-
`gestion in a year. ALI is the smaller
`parted by ionizing radiation per unit
`value of intake of a given radionuclide
`mass of irradiated material. The units
`in a year by the reference man that
`of absorbed dose are the rad and the
`would result in a committed effective
`gray (Gy).
`dose equivalent of 5 rems (0.05 Sv) or a
`Act means the Atomic Energy Act of
`committed dose equivalent of 50 rems
`1954 (42 U.S.C. 2011 et seq.), as amended.
`(0.5 Sv) to any individual organ or tis-
`Activity is the rate of disintegration
`sue. (ALI values for intake by inges-
`(transformation) or decay of radio-
`tion and by inhalation of selected
`active material. The units of activity
`radionuclides are given in table 1, col-
`are the curie (Ci) and the becquerel
`umns 1 and 2, of appendix B to
`(Bq).
`§§20.1001–20.2401).
`Adult means an individual 18 or more
`Assigned protection factor (APF) means
`years of age.
`the expected workplace level of res-
`Airborne radioactive material means
`piratory protection that would be pro-
`radioactive material dispersed in the
`vided by a properly functioning res-
`air in the form of dusts, fumes, particu-
`pirator or a class of respirators to
`lates, mists, vapors, or gases.
`properly fitted and trained users. Oper-
`Airborne radioactivity area means a
`ationally, the inhaled concentration
`room, enclosure, or area in which air-
`can be estimated by dividing the ambi-
`borne radioactive materials, composed
`ent airborne concentration by the
`wholly or partly of licensed material,
`APF.
`exist in concentrations—
`Atmosphere-supplying respirator means
`(1) In excess of the derived air con-
`a respirator that supplies the res-
`centrations (DACs) specified in appen-
`pirator user with breathing air from a
`dix B, to §§20.1001–20.2401, or
`source independent of the ambient at-
`(2) To such a degree that an indi-
`mosphere, and includes supplied-air
`vidual present in the area without res-
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