333-102-0255 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Distribution of Radioactive Material in Exempt Quantities (1) An application for a specific license to distribute NARM to persons exempted from these rules pursuant to OAR 333-102-0035 will be approved if: (a) The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being; (b) The radioactive material is in the form of processed chemical elements, compounds or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product or device intended for commercial distribution; and (c) The applicant submits copies of prototype labels and brochures and the Authority approves such labels and brochures. (2) The license issued under this rule is subject to the following conditions: (a) No more than ten exempt quantities may be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions must not exceed unity; (b) Each exempt quantity must be separately and individually packaged. No more than ten such packaged exempt quantities must be contained in any outer package for transfer to persons exempt pursuant to OAR 333-102-0035. The outer package must be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 microSv) per hour; (c) The immediate container of each quantity or separately packaged fractional quantity of radioactive material must bear a durable, legible label which: (A) Identifies the radionuclide and the quantity of radioactivity; and (B) Bears the words Radioactive Material. (d) In addition to the labeling information required by subsection (2)(c) of this rule, the label affixed to the immediate container, or an accompanying brochure, must: (A) State that the contents are exempt from Licensing State requirements; (B) Bear the words, Radioactive Material — Not for Human Use — Introduction into Foods, Beverages, Cosmetics, Drugs or Medicinals or into Products Manufactured for Commercial Distribution is Prohibited — Exempt Quantities Should Not Be Combined; and (C) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material. (3) Each person licensed under this rule must maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under OAR 333-102-0035 or the equivalent rules of any Agreement State or Licensing State and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license must be filed with the Authority. Each report must cover the year ending June 30, and must be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to this rule during the reporting period, the report must so indicate. NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85