(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 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 products are transferred for use under § 30.20 of this chapter or equivalent regulations of an Agreement State.
(3) The report must include the following information on products transferred to other persons for use under § 30.20 or equivalent regulations of an Agreement State:
(i) A description or identification of the type of each product and the model number(s);
(ii) For each radionuclide in each type of product and each model number, the total quantity of the radionuclide;
(iii) The number of units of each type of product transferred during the reporting period by model number.
(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission.
(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.26 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 § 32.26 during the reporting period, the report must so indicate.
(6) The licensee shall maintain the record of a transfer for one year after the transfer 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; 72 FR 58488, Oct. 16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]
Title 10 published on 2014-01-01
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