10 CFR 32.32

Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer Each person licensed under § 32.30 shall:

a

(a) Carry out adequate control procedures in the manufacture of the device to ensure that each production lot meets the quality control standards approved by the Commission;

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(b) Label or mark each device and its point-of-sale package so that:

(1) Each item has a durable, legible, readily visible label or marking on the external surface of the device containing:

(i) The following statement: "CONTAINS RADIOACTIVE MATERIAL";

(ii) The name of the radionuclide(s) and quantity(ies) of activity;

(iii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and

(iv) 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).

(2) 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 § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and

(iii) The following or a substantially similar statement: "THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS."

(3) Each device and point-of-sale package contains such other information as may be required by the Commission; and

c

(c) Maintain records of all transfers and file a report with the Director of the Office of Federal and State Materials and Environmental Management Programs by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the devices are transferred for use under § 30.22 of this chapter or equivalent regulations of an Agreement State.

(3) The report must include the following information on devices transferred to other persons for use under § 30.22 or equivalent regulations of an Agreement State:

(i) A description or identification of the type of each device and the model number(s);

(ii) For each radionuclide in each type of device and each model number, the total quantity of the radionuclide; and

(iii) The number of units of each type of device transferred during the reporting period by model number.

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(4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year.

(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.30 shall file a report for the current calendar year within 30 days after ceasing distribution.

(5) If no transfers of byproduct material have been made under § 32.30 during the reporting period, the report must so indicate.

(6) The licensee shall maintain the record of a transfer for a period of one year after the transfer is included in a report to the Commission.

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NRC website 10 CFR 32.32

v t e Code of Federal Regulations
Title 10 Part 32 - PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Purpose and scope 2, Definitions 3, Maintenance of records 8, Information collection requirements: OMB approval 11, Exempt Concentrations and Items 12, Same: Records and material transfer reports 13, Same: Prohibition of introduction 14, Certain items containing byproduct material; requirements for license to apply or initially transfer 15, Same: Quality assurance, prohibition of transfer, and labeling 16, Certain items containing byproduct material: Records and reports of transfer 17, 18, Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license 19, Same: Conditions of licenses 20, Same: Records and material transfer reports 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 22, Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer 23, Same: Safety criteria 24, Same: Table of organ doses 25, Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer 26, Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 27, Same: Safety criteria 28, Same: Table of organ doses 29, Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer 30, Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer 31, Certain industrial devices containing byproduct material: Safety criteria 32, Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer 40, 51, Generally Licensed Items 52, Same: Material transfer reports and records 53, Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer 54, Same: Labeling of devices 55, Same: Quality assurance; prohibition of transfer 56, Same: Material transfer reports 57, Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer 58, Same: Labeling of devices 59, Same: Leak testing of each source 60, 61, Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer 62, Same: Quality assurance; prohibition of transfer 71, Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license 72, Specifically Licensed Items 74, Manufacture and distribution of sources or devices containing byproduct material for medical use 201, Serialization of nationally tracked sources 210, Sealed Source and Device Registration 211, 301, Violations 303, Criminal penalties Appendices:

10 CFR 32.32

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10 CFR 32.32

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