Generally Licensed Items

10 C.F.R. Part ..., Subpart B
in effectEffective: 2024-07-01

10 C.F.R. § 32.51 Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture, or initially transfer.

(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if: (1) The applicant satisfies the general requirements of § 30.33 of this chapter; (2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: (i) The device can be safely operated by persons not having training in radiological protection; (ii) Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in 1 year a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; and (iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24. (3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly identified and separate statement: (i) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information); (ii) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and (iii) The information called for in the following statement in the same or substantially similar form: 1 (4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, “Caution-Radioactive Material,” the radiation symbol described in § 20.1901 of this chapter, and the name of the manufacturer or initial distributor. (5) Each device meeting the criteria of § 31.5(c)(13)(i) of this chapter, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution-Radioactive Material,” and, if practicable, the radiation symbol described in § 20.1901 of this chapter. (6) The device has been registered in the Sealed Source and Device Registry. (b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Commission will consider information which includes, but is not limited to: (1) Primary containment (source capsule); (2) Protection of primary containment; (3) Method of sealing containment; (4) Containment construction materials; (5) Form of contained radioactive material; (6) Maximum temperature withstood during prototype tests; (7) Maximum pressure withstood during prototype tests; (8) Maximum quantity of contained radioactive material; (9) Radiotoxicity of contained radioactive material; and (10) Operating experience with identical devices or similarly designed and constructed devices. (c) In the event the applicant desires that the general licensee under § 31.5 of this chapter, or under equivalent regulations of an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter. The receipt, possession, use, and transfer of this device Model ____ 2, Serial No.___ 2, are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. 2 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, or initial transferor) 2

10 C.F.R. § 32.51a a Same: Conditions of licenses.

(a) If a device containing byproduct material is to be transferred for use under the general license contained in § 31.5 of this chapter, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes— (1) A copy of the general license contained in § 31.5 of this chapter; if paragraphs (c)(2) through (4) or (c)(13) of § 31.5 do not apply to the particular device, those paragraphs may be omitted. (2) A copy of §§ 31.2, 30.51, 20.2201, and 20.2202 of this chapter; (3) A list of the services that can only be performed by a specific licensee; (4) Information on acceptable disposal options including estimated costs of disposal; and (5) An indication that NRC's policy is to issue high civil penalties for improper disposal. (b) If byproduct material is to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes— (1) A copy of the Agreement State's regulations equivalent to §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy of §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted. (2) A list of the services that can only be performed by a specific licensee; (3) Information on acceptable disposal options including estimated costs of disposal; and (4) The name or title, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained. (c) An alternative approach to informing customers may be proposed by the licensee for approval by the Commission. (d) Each device that is transferred after February 19, 2002 must meet the labeling requirements in § 32.51(a)(3) through (5). (e) If a notification of bankruptcy has been made under § 30.34(h) or the license is to be terminated, each person licensed under § 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under § 32.52(c).

10 C.F.R. § 32.52 Same: material transfer reports and records.

Each person licensed under § 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section. (a) The person shall report to the Director, Office of Nuclear Material Safety and Safeguards , ATTN: GLTS, by an appropriate method listed in § 30.6(a) of this chapter, all transfers of such devices to persons for use under the general license in § 31.5 of this chapter and all receipts of devices from persons licensed under § 31.5 of this chapter. The report must be submitted on a quarterly basis on NRC Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. (1) The required information for transfers to general licensees includes— (i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use. (ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device. (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (3) For devices received from a § 31.5 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (4) If the licensee makes changes to a device possessed by a § 31.5 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (7) If no transfers have been made to or from persons generally licensed under § 31.5 of this chapter during the reporting period, the report must so indicate. (b) The person shall report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.5 of this chapter and all receipts of devices from general licensees in the Agreement State's jurisdiction to the responsible Agreement State agency. The report must be submitted on Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. (1) The required information for transfers to general licensees includes— (i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use. (ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device. (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee. (7) If no transfers have been made to or from a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency. (c) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of 3 years following the date of the recorded event.

10 C.F.R. § 32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer.

An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under § 31.7 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 each device pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3) Details of the method of binding or containing the tritium or promethium-147; (4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use; (5) Quality assurance procedures to be followed that are sufficient to ensure compliance with § 32.55; (6) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device. (c) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber. (d) The Commission determines that: (1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device; (2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it; (3) The device is so designed that it cannot easily be disassembled; and (4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (e) of this section. (e) The applicant shall subject at least five prototypes of the device to tests as follows: (1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering. (2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(3) of this section. (3) Device designs are rejected for which the following has been detected for any unit: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; or (ii) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or (iii) Any other evidence of physical damage. (f) The device has been registered in the Sealed Source and Device Registry.

10 C.F.R. § 32.54 Same: Labeling of devices.

(a) A person licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under § 31.7 of this chapter shall, except as provided in paragraph (b) of this section, affix to each device a label containing the radiation symbol prescribed by § 20.1901 of this chapter, such other information as may be required by the Commission including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement: 1 (b) If the Commission determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (a) of this section, it may waive the requirements of that paragraph and require in lieu thereof that: (1) A label be affixed to the device identifying: (i) The manufacturer, assembler, or initial transferor; and (ii) The type of radioactive material; and (2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped: (i) The name of the manufacturer, assembler, or initial transferor, (ii) The type and quantity of radioactive material, (iii) The model number, (iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of an Agreement State, and (v) Such other information as may be required by the Commission, including disposal instructions when appropriate. The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing ______ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, assembler, or initial transferor.)* *The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

10 C.F.R. § 32.55 Same: Quality assurance, prohibition of transfer.

(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147. (b) Each person licensed under § 32.53 shall: (1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under § 32.53, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded. (c) The licensee shall subject each inspection lot to: (1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion. (2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; (ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and (iii) Any other criteria specified in the license issued under § 32.53. (d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter, or under an equivalent general license of an Agreement State: (1) Any luminous safety device tested and found defective under any condition of a license issued under § 32.53, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(2) of this section, unless: (i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.53; and (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.53.

10 C.F.R. § 32.56 Same: Material transfer reports.

(a) Each person licensed under § 32.53 shall file an annual report with the Director, Office of Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/GLTS, by an appropriate method listed in § 30.6(a) of this chapter, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under § 31.7 of this chapter. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty (30) days thereafter. If no transfers have been made to persons generally licensed under § 31.7 of this chapter during the reporting period, the report must so indicate. (b) Each person licensed under § 32.53 shall report annually all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.7 of this chapter to the responsible Agreement State agency. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the agency.

10 C.F.R. § 32.57 Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if: (a) The applicant satisfies the general requirements of § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source; (2) Details of construction and design; (3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source; (4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use; (5) Details of quality control procedures to be followed in manufacture of the source; (6) Description of labeling to be affixed to the source or the storage container for the source; (7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source. (c) Each source will contain no more than 5 microcuries of americium-241 or radium-226. (d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that: (1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and (2) The source has been subjected to and has satisfactorily passed appropriate tests required by paragraph (e) of this section. (e) The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows: (1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source. (2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion. (3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(4) of this section. (4) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

10 C.F.R. § 32.58 Same: Labeling of devices.

Each person licensed under § 32.57 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement: 1 The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of manufacturer or initial transferor)

10 C.F.R. § 32.59 Same: Leak testing of each source.

Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under § 31.8 of this chapter or under equivalent regulations of an Agreement State. This test must be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper must be measured using methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in this section, the source must be rejected and must not be transferred to a general licensee under § 31.8 of this chapter, or equivalent regulations of an Agreement State.

10 C.F.R. § 32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 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 each type of device pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of strontium-90 in the device; (2) Details of construction and design of the source of radiation and its shielding; (3) Radiation profile of a prototype device; (4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use; (5) Details of quality control procedures to be followed in manufacture of the device; (6) Description of labeling to be affixed to the device; (7) Instructions for handling and installation of the device; (8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device; (c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form; (d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.1901(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices; (e) The Commission determines that: (1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device; (2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use; (3) The device is so designed that it cannot be easily disassembled; (4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (f) of this section. (5) Quality control procedures have been established to satisfy the requirements of § 32.62. (f) The applicant shall subject at least five prototypes of the device to tests as follows: (1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering. (2) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (f)(3) of this section. (3) Device designs are rejected for which the following has been detected for any unit: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or (ii) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or (iii) Any other evidence of physical damage. (g) The device has been registered in the Sealed Source and Device Registry.

10 C.F.R. § 32.62 Same: Quality assurance; prohibition of transfer.

(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90. (b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device. (c) Each person licensed under § 32.61 shall: (1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (d) of this section and in the license issued under § 32.61, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded. (d) Each person licensed under § 32.61 shall subject each inspection lot to: (1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion. (2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under § 32.61. (e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter, or under an equivalent general license of an Agreement State: (1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under § 32.61, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (c)(2) of this section, unless: (i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.61; and (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any other criteria as may be required as a condition of the license issued under § 32.61.

10 C.F.R. § 32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.

An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter. (b) The byproduct material is to be prepared for distribution in prepackaged units of: (1) Iodine-125 in units not exceeding 10 microcuries each. (2) Iodine-131 in units not exceeding 10 microcuries each. (3) Carbon-14 in units not exceeding 10 microcuries each. (4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each. (5) Iron-59 in units not exceeding 20 microcuries each. (6) Selenium-75 in units not exceeding 10 microcuries each. (7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each. (8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each. (c) Each prepackaged unit bears a durable, clearly visible label: (1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; or cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and (2) Displaying the radiation caution symbol described in § 20.1901(a) of this chapter and the words, “Caution, Radioactive Material”, and “Not for Internal or External Use in Humans or Animals.” (d) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1 (e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in § 20.2001. The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer)

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