10 C.F.R. Subpart A—Exempt Concentrations and Items
Title 10 - Energy
An application for a specific license on Form NRC–313 authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material will be approved if the applicant: (a) Satisfies the general requirements specified in §30.33 of this chapter; (b) Provides a description of the product or material into which the byproduct material will be introduced, intended use of the byproduct material and the product or material into which it is introduced, method of introduction, initial concentration of the byproduct material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and (c) Provides reasonable assurance that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in §30.70 of this chapter, that reconcentration of the byproduct material in concentrations exceeding those in §30.70 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being. [30 FR 8192, June 26, 1965, as amended at 49 FR 19625, May 9, 1984] (a) Each person licensed under §32.11 shall maintain records of transfer of material and file a report with the Director of Nuclear Material Safety and Safeguards by an appropriate method listed in §30.6(a) of this chapter. A copy of the report must be sent to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter. (b) The report must identify the: (1) Type and quantity of each product or material into which byproduct material has been introduced during the reporting period; (2) Name and address of the person who owned or possessed the product or material, into which byproduct material has been introduced, at the time of introduction; (3) The type and quantity of radionuclide introduced into each product or material; and (4) The initial concentrations of the radionuclide in the product or material at time of transfer of the byproduct material by the licensee. (c) The licensee shall file the report within 30 days following: (1) Five years after filing the preceding report; or (2) Filing an application for renewal of the license under §30.37; or (3) Notifying the Commission under §30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under §32.11. (d) The report must cover the period between the filing of the preceding report and the occurrence specified in paragraphs (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under §32.11 during the reporting period, the report shall so indicate. (e) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission. [48 FR 12333, Mar. 24, 1983; 48 FR 14863, Apr. 6, 1983, as amended at 68 FR 58804, Oct. 10, 2003] No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under §30.14 of this chapter or equivalent regulations of an Agreement State, except in accordance with a license issued pursuant to §32.11 or the general license provided in §150.20 of this chapter. [30 FR 8192, June 26, 1965] An application for a specific license to apply byproduct material to, or to incorporate byproduct material into, the products specified in §30.15 of this chapter or to initially transfer for sale or distribution such products containing byproduct material for use pursuant to §30.15 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in §30.33 of this chapter; (b) The applicant submits sufficient information regarding the product pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of byproduct material in each product; (2) Details of construction and design of each product; (3) The method of containment or binding of the byproduct material in the product; (4) Procedures for and results of prototype testing to demonstrate that the material will not become detached from the product and that the byproduct material will not be released to the environment under the most severe conditions likely to be encountered in normal use of the product; (5) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; (6) The proposed method of labeling or marking each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container with the identification of the manufacturer or initial transferor of the product and the byproduct material in the product; (7) For products for which limits on levels of radiation are specified in §30.15 of this chapter, the radiation level and the method of measurement; (8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the product. (c) Each product will contain no more than the quantity of byproduct material specified for that product in §30.15 of this chapter. The levels of radiation from each product containing byproduct material will not exceed the limits specified for that product in §30.15 of this chapter. (d) The Commission determines that: (1) The byproduct material is properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling. (2) For automobile lock illuminators, the product has been subjected to and meets the requirements of the prototype tests prescribed by §32.40, schedule A. [31 FR 5316, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 43 FR 6922, Feb. 17, 1978; 63 FR 32971, June 17, 1998] (a) Each person licensed under §32.14 shall: (1) Maintain quality assurance practices in the manufacture of the part or product, or the installation of the part into the product; (2) Subject inspection lots to such testing as may be required as a condition of the license issued under §32.14 taking a random sample of the size required by the tables in §32.110, and for Lot Tolerance Percent Defective of 5.0 percent, accept or reject inspection lots in accordance with the directions of §32.110; and (3) Visually inspect each unit, except electron tubes containing byproduct material, in inspection lots. Any unit which has an observable physical defect that could affect containment of the byproduct material shall be considered as a defective unit. (b) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (a)(2) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that the operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10. (c) No person licensed under §32.14 shall transfer to other persons for use under §30.15 of this chapter or equivalent regulations of an Agreement State: (1) Any part or product which has been tested and found defective under the criteria and procedures specified in the license issued under §32.14, unless the defective units have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under §32.14; or (2) Any inspection lot which has been rejected as a result of the procedures in §32.110 or alternative procedures in paragraph (b) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under §32.14. (d) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified. [31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978] (a) Each person licensed under §32.14 or §32.17 shall maintain records of all transfers of nuclear material and file a report with the Director of Nuclear Material Safety and Safeguards by an appropriate method listed in §30.6(a) of this chapter, with a copy to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter. (b) The report must include the following information on items transferred to other persons for use under §30.15 or §30.16 of this chapter or equivalent regulations of an Agreement State: (1) A description or identification of the type of each product; (2) For each radionuclide in each type of product, the total quantity of the radionuclide; and (3) The number of units of each type of product transferred during the reporting period. (c) The licensee shall file the report within 30 days after: (1) Five years after filing the preceding report; or (2) Filing an application for renewal of the license under §30.37; or (3) Notifying the Commission under §30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under §32.14 or §32.17. (d) The report must cover the period between the filing of the preceding report and the occurrence specified in paragraphs (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under §32.14 or §32.17 during the reporting period, the report must so indicate. (e) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission. [48 FR 12333, Mar. 24, 1983; 48 FR 23383, May 25, 1983, as amended at 68 FR 58804, Oct. 10, 2003] An application for a specific license to manufacture, or initially transfer for sale or distribution, synthetic plastic resins containing scandium–46 for use pursuant to §30.16 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in §30.33 of this chapter; (b) The product is designed to be used only for sand-consolidation in oil wells; (c) The applicant submits the following information: (1) The general description of the product to be manufactured or initially transferred. (2) A description of control procedures to be used to assure that the concentration of scandium–46 in the final product at the time of distribution will not exceed 1.4×10−3 microcurie/milliliter. (d) Each container of such product will bear a durable, legible lable approved by the Commission, which contains the following information: (1) The product name; (2) A statement that the product contains radioactive scandium and is designed and manufactured only for sand-consolidation in oil wells; (3) Instructions necessary for proper use; and (4) The manufacturer's name. [32 FR 4241, Mar. 18, 1967, as amended by 38 FR 29314, Oct. 24, 1973; 43 FR 6922, Feb. 17, 1978] An application for a specific license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct material for commercial distribution to persons exempt pursuant to §30.18 of this chapter or the equivalent regulations of an Agreement State will be approved if: (a) The applicant satisfies the general requirements specified in §30.33 of this chapter: Provided, however, That the requirements of §30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State; (b) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; (c) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and (d) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures. [35 FR 6428, Apr. 22, 1970, as amended at 43 FR 6922, Feb. 17, 1978] Each license issued under §32.18 is subject to the following conditions: (a) No more than 10 exempt quantities set forth in §30.71, Schedule B of this chapter shall be sold or transferred in any single transaction. For purposes of this requirement, an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in §30.71, Schedule B of this chapter, provided that the sum of such fractions shall not exceed unity. (b) Each quantity of byproduct material set forth in §30.71, Schedule B of this chapter shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to §30.18 of this chapter. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour. (c) The immediate container of each quantity or separately packaged fractional quantity of byproduct material shall bear a durable, legible label which (1) identifies the radioisotope and the quantity of radioactivity, and (2) bears the words “Radioactive Material.” (d) In addition to the labeling information required by paragraph (c) of this section, the label affixed to the immediate container, or an accompanying brochure, shall also (1) state that the contents are exempt from NRC or Agreement State licensing requirements; (2) bear the words “Radioactive Material—Not for Human Use—Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or Into Products Manufactured for Commercial Distribution is Prohibited—Exempt Quantities Should Not be Combined”; and (3) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material. [35 FR 6428, Apr. 22, 1970] (a) Each person licensed under §32.18 of this part shall maintain records of transfer of material identifying, by name and address, each person to whom byproduct material is transferred for use under §30.18 of this chapter or the equivalent regulations of an Agreement State and stating the kinds and quantities of byproduct material transferred. The licensee shall maintain the record of a transfer for a period of one year after the event is included in a summary report to the Commission. (b) The licensee shall file a summary report stating the total quantity of each isotope transferred under the specific license with the Director of Nuclear Material Safety and Safeguards by an appropriate method listed in §30.6(a) of this chapter, with a copy to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter. (c) The licensee shall file the summary report within 30 days following: (1) Five years after filing the preceding report; or (2) Filing an application for renewal of the license under §30.37; or (3) Notifying the Commission under §30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under §32.18. (d) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraph (c) (1), (2), or (3) of this section. If no transfers of byproduct material have been made under §32.18 during the reporting period, the report must so indicate. [48 FR 12333, Mar. 24, 1983, as amended at 68 FR 58804, Oct. 10, 2003] (a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for “in vivo” diagnostic use, to persons exempt from licensing under §30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if: (1) The applicant satisfies the general requirements specified in §30.33 of this chapter, provided that the requirements of §30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State; (2) The applicant meets the requirements under §32.72(a)(2) of this part; (3) The applicant provides evidence that each capsule contains 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process); (4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being; (5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and (6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures. (b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs. [62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001] Each license issued under §32.21 of this part is subject to the following conditions: (a) The immediate container of the capsule(s) must bear a durable, legible label which: (1) Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and (2) Bears the words “Radioactive Material.” (b) In addition to the labeling information required by paragraph (a) of this section, the label affixed to the immediate container, or an accompanying brochure also must: (1) State that the contents are exempt from NRC or Agreement State licensing requirements; and (2) Bears the words “Radioactive Material. For “In Vivo” Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution. This Material May Be Disposed of in Ordinary Trash.” [62 FR 63640, Dec. 2, 1997] (a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to initially transfer such products for use pursuant to §30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if: (1) The applicant satisfies the general requirements specified in §30.33 of this chapter: Provided, however, That the requirements of §30.33(a) (2) and (3) do not apply to an application for a license to transfer tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, or produced pursuant to a license issued by an Agreement State. (2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the self-luminous product to demonstrate that the product will meet the safety criteria set forth in §32.23. The information should include: (i) A description of the product and its intended use or uses. (ii) The type and quantity of byproduct material in each unit. (iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product. (iv) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (a)(2) (iii) and (xii) of this section. (v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product. (vi) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement. (vii) Degree of access of human beings to the product during normal handling and use. (viii) Total quantity of byproduct material expected to be distributed in the product annually. (ix) The expected useful life of the product. (x) The proposed method of labeling or marking each unit with identification of the manufacturer or initial transferor of the product and the byproduct material in the product. (xi) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product. (xii) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features. (xiii) The estimated external radiation doses and dose commitments relevant to the safety criteria in §32.23 and the basis for such estimates. (xiv) A determination that the probabilities with respect to the doses referred to in §32.23(d) meet the criteria of that paragraph. (xv) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet. (xvi) Any additional information, including experimental studies and tests, required by the Commission. (b) Notwithstanding the provisions of paragraph (a) of this section, the Commission may deny an application for a specific license under this section if the end uses of the product cannot be reasonably foreseen. [34 FR 9026, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978] An applicant for a license under §32.22 shall demonstrate that the product is designed and will be manufactured so that: (a) In normal use and disposal of a single exempt unit, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in §32.24 of this part. (b) In normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column II of the table in §32.24. (c) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life. (d)1 1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure per year for each 10,000 exempt units distributed. Negligible—not more than one such failure per year for each 1 million exempt units distributed. [34 FR 9027, June 6, 1969] [34 FR 9329, June 13, 1969] Each person licensed under §32.22 shall: (a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the byproduct material in the product can be identified; and (c) Maintain records and file reports with the Director of Nuclear Material Safety and Safeguards, by an appropriate method listed in §30.6(a), with copies to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter. (1) The report must include the following information on products transferred to other persons for use under §30.19 of this chapter or equivalent regulations of an Agreement State: (i) A description or identification of the type of each product; (ii) For each radionuclide in each type of product, the total quantity of the radionuclide; and (iii) The number of units of each type of product transferred during the reporting period. (2) The licensee shall file the report within 30 days following: (i) Five years after filing the preceding report; or (ii) Filing an application for renewal of the license under §30.37; or (iii) Notifying the Commission under §30.34(f) of the licensee's decision to permanently discontinue activities authorized under the license issued under §32.22. (3) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraphs (c)(2)(i), (ii), or (iii) of this section. If no transfers of byproduct material have been made under §32.22 during the reporting period, the report must so indicate. (4) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission. [34 FR 9027, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 48 FR 12334, Mar. 24, 1983; 68 FR 58804, Oct. 10, 2003] An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect life or property from fires and airborne hazards, or to initially transfer such products for use pursuant to §30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if: (a) The applicant satisfies the general requirements specified in §30.33 of this chapter: Provided, however, That the requirements of §30.33(a) (2) and (3) do not apply to an application for a license to transfer byproduct material in gas and aerosol detectors manufactured, processed or produced pursuant to a license issued by an Agreement State. (b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in §32.27. The information should include: (1) A description of the product and its intended use or uses; (2) The type and quantity of byproduct material in each unit; (3) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product; (4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section; (5) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product; (6) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement; (7) Degree of access of human beings to the product during normal handling and use; (8) Total quantity of byproduct material expected to be distributed in the product annually; (9) The expected useful life of the product; (10) The proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of §32.29(b); (11) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product; (12) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features; (13) The estimated external radiation doses and dose commitments relevant to the safety criteria in §32.27 and the basis for such estimates; (14) A determination that the probabilities with respect to the doses referred to in §32.27(c) meet the criteria of that paragraph; (15) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; and (16) Any additional information, including experimental studies and tests, required by the Commission. [34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980] An applicant for a license under §32.26 shall demonstrate that the product is designed and will be manufactured so that: (a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in §32.28. (b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life. (c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in §32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in §32.28.1 1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure per year for each 10,000 exempt units distributed. Negligible—not more than one such failure per year for each one million exempt units distributed. [34 FR 6654, Apr. 18, 1969] [34 FR 6654, Apr. 18, 1969] Each person licensed under §32.26 shall: (a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name of the radionuclide and quantity of activity; and (iii) An identification of the person licensed under §32.26 to transfer the detector for use pursuant to §30.20 of this chapter or equivalent regulations of an Agreement State. (2) The labeling or marking specified in paragraph (b)(1) of this section is located where its will be readily visible when the detector is removed from its mounting. (3) The external surface of the point-of-sale package has a legible, readily visible label or marking containing: (i) The name of the radionuclide and quantity of activity; (ii) An identification of the person licensed under §32.26 to transfer the detector for use pursuant to §30.20 of this chapter or equivalent regulations of an Agreement State; and (iii) The following or a substantially similar statement:
THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS. (4) Each detector and point-of-sale package is provided with such other information as may be required by the Commission; and (c) Maintain records and file a report with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with copies to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter. (1) The report must include the following information on products transfered to other persons for use under §30.20 of this chapter or equivalent regulations of an Agreement State: (i) A description or identification of the type of each product; (ii) For each radionuclide in each type of product, the total quantity of the radionuclide; and (iii) The number of units of each type of product transferred during the reporting period. (2) The licensee shall file the report within 30 days following: (i) Five years after filing the preceding report; or (ii) Filing an application for renewal of the license under §30.37; or (iii) Notifying the Commission under §30.34(f) of the licensee's decision to permanently discontinue activities authorized pursuant to the license issued under §32.26. (3) The report must cover the period between the filing of the preceding report and the occurrences specified in paragraphs (c)(2) (i), (ii), or (iii) of this section. If no transfers of byproduct material have been made under §32.26 during the reporting period, the report must so indicate. (4) The licensee shall maintain the record of a transfer for a period of one year after the event is included in a report to the Commission. [34 FR 6654, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980; 48 FR 12334, Mar. 24, 1983] An applicant for a license pursuant to §32.14 to install lock illuminators into automobile locks, or to initially transfer lock illuminators in automobile locks for use pursuant to §30.15 of this chapter shall conduct the following prototype tests on each of five prototype devices, consisting of the automobile lock with the installed illuminator in the following order: (a) The device shall be subjected to 100 hours of accelerated weathering in a suitable weathering machine which simulates the most severe conditions of normal use; (b) The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to an equivalent treatment in a test device simulating such a fall. The drop test shall be repeated 100 times from random orientations; (c) The device shall be attached to a vibratory fixture and vibrated at a rate of not less than 26 cycles per second and a vibration acceleration of not less than 2 G for a period of not less than 1 hour; (d) On completion of the foregoing tests, the device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry into the lock illuminator. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any evidence of bubbles emanating from within the lock illuminator, or water entering the lock illuminator, shall be considered leakage; (e) After each of the tests prescribed by this section, each device shall be examined for evidence of physical damage and for loss of tritium or promethium-147. Any evidence of damage to or failure of any device which could affect the containment of the tritium or promethium-147 in such devices shall be cause for rejection of the design on which such prototype devices were constructed or manufactured if the damage or failure is attributable to design defect. Loss of tritium or promethium-147 from each tested device shall be measured both by sampling the immersion test water used in paragraph (d) of this section and by wiping with filter paper the entire accessible area of the lock illuminator. Measurements of tritium or promethium-147 shall be made in an apparatus calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in the device is found in the immersion test water of the test in paragraph (d) of this section, or if more than 2,200 disintegrations per minute of tritium or promethium-147 on the filter paper is measured after any of the tests in paragraphs (a) to (d) of this section the device shall be rejected. [30 FR 8192, June 26, 1965, as amended at 31 FR 5317, Apr. 2, 1966; 43 FR 6923, Feb. 17, 1978]
Title 10: Energy
PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
Subpart A—Exempt Concentrations and Items
§ 32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: Requirements for license.
§ 32.12 Same: Records and material transfer reports.
§ 32.13 Same: Prohibition of introduction.
§ 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.
§ 32.15 Same: Quality assurance, prohibition of transfer, and labeling.
§ 32.16 Certain items containing byproduct material: Records and reports of transfer.
§ 32.17 Resins containing scandium–46 and designed for sand-consolidation in oil wells: Requirements for license to manufacture, or initially transfer for sale or distribution.
§ 32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.
§ 32.19 Same: Conditions of licenses.
§ 32.20 Same: Records and material transfer reports.
§ 32.21 Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for “in vivo” diagnostic use for humans to persons exempt from licensing; Requirements for a license.
§ 32.21a Same: Conditions of license.
§ 32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.
§ 32.23 Same: Safety criteria.
§ 32.24 Same: Table of organ doses.
------------------------------------------------------------------------ Column Column Column Column Part of body I II III IV (rem) (rem) (rem) (rem)------------------------------------------------------------------------Whole body; head and trunk: active blood- 0.001 0.01 0.5 15 forming organs; gonads: or lens of eye.Hands and forearms; feet and ankles; 0.015 0.15 7.5 200 localized areas of skin averaged over areas no larger than 1 square centimeter.............................Other organs............................ 0.003 0.03 1.5 50------------------------------------------------------------------------
§ 32.25 Conditions of licenses issued under §32.22: Quality control, labeling, and reports of transfer.
§ 32.26 Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.
§ 32.27 Same: Safety criteria.
§ 32.28 Same: Table of organ doses.
------------------------------------------------------------------------ Column Column Part of body Column II III I (rem) (rem) (rem)------------------------------------------------------------------------Whole body; head and trunk; active blood- 0.005 0.5 15 forming organs; gonads; or lens of eye......Hands and forearms; feet and ankles; 0.075 7.5 200 localized areas of skin averaged over areas no larger than 1 square centimeter..........Other organs................................. 0.015 1.5 50------------------------------------------------------------------------
§ 32.29 Conditions of licenses issued under §32.26: Quality control, labeling, and reports of transfer.
§ 32.40 Schedule A—Prototype tests for automobile lock illuminators.
