Each person licensed under § 32.30 shall:
(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;
(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) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards 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.
(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.
[77 FR 43692, July 25, 2012]