10 CFR § 40.53 - Conditions for licenses issued for initial transfer of certain items containing source material: Quality control, labeling, and records and reports.
(a) Each person licensed under § 40.52 shall ensure that the quantities or concentrations of source material do not exceed any applicable limit in § 40.13(c).
(b) Each person licensed under § 40.52 shall ensure that each product is labeled as provided in the specific exemption under § 40.13(c) and as required by their license. Those distributing products to be used under § 40.13(c)(1)(i) and (iii) or equivalent regulations of an Agreement State shall provide radiation safety precautions and instructions relating to handling, use, and storage of these products as specified in the license.
(1) Each person licensed under § 40.52 shall file a report with the Director, Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 40.5(a), including in the address: ATTN: Document Control Desk/Exempt Distribution.
(2) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee and indicate that the products are transferred for use under § 40.13(c), giving the specific paragraph designation, or equivalent regulations of an Agreement State.
(3) The report must include the following information on products transferred to other persons for use under § 40.13(c) or equivalent regulations of an Agreement State:
(i) A description or identification of the type of each product and the model number(s), if applicable;
(ii) For each type of source material in each type of product and each model number, if applicable, the total quantity of the source material; and
(iii) The number of units of each type of product transferred during the reporting period by model number, if applicable.
(4) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. Licensees who permanently discontinue activities authorized by the license issued under § 40.52 shall file a report for the current calendar year within 30 days after ceasing distribution.
(5) If no transfers of source material have been made to persons exempt under § 40.13(c) or the equivalent regulations of an Agreement State, during the reporting period, the report must so indicate.
(6) The licensee shall maintain all information concerning transfers that support the reports required by this section for 1 year after each transfer is included in a report to the Commission.