Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 102 - LICENSING OF RADIOACTIVE MATERIAL › Section 333-102-0245 - Introduction of Radioactive Material in Exempt Concentrations into Products or Materials, and Transfer of Ownership or Possession: Requirements for License

Current through Register Vol. 63, No. 7, July 1, 2024
An application for a specific license authorizing the
				introduction of radioactive material into a product or material owned by or in
				the possession of the licensee or another and the transfer of ownership or
				possession of the product or material containing the radioactive material: will
				be approved if the applicant:
(1)
			 Satisfies the general requirements specified in OAR
			 333-102-0200,
			 provided however, that the requirements of OAR
			 333-102-0200(2)
			 and (3)  do not apply to an application for a
			 license to introduce byproduct material into a product or material owned by or
			 in the possession of the licensee or another and the transfer of ownership or
			 possession of the product.
(2)
			 Provides a description of the product or material into which the radioactive
			 material will be introduced, intended use of the radioactive material, and the
			 product or material into which it is introduced, method of introduction,
			 initial concentration of the radioactive material in the product or material,
			 control methods to assure that no more than the specified concentration is
			 introduced into the product or material, estimated time interval between
			 introduction and transfer of the product or material, and estimated
			 concentration of the radioiosotopes in the product or material at the time of
			 transfer.
(3) Provides reasonable
			 assurance that the concentrations of radioactive material at the time of
			 transfer will not exceed the concentrations in   10 CFR Part 30.70   Schedule A,
			 that reconcentrating of the radioactive material in concentrations exceeding
			 those in 10 CFR Part 30.70 Schedule A is not likely, that use of lower
			 concentrations is not feasible, and that the product or material is not likely
			 to be incorporated in any food, beverage, cosmetic, drug or other commodity or
			 product designed for ingestion or inhalation by, or application to, a human
			 being.
(4) No person may introduce
			 radioactive material into a product or material knowing or having reason to
			 believe that it will be transferred to persons exempt under  10 CFR Part 30.14
			  or equivalent regulations of an Agreement State, except in accordance with a
			 license issued pursuant to  10 CFR Part 32.11, or the general license provided
			 in  10 CFR Part 150.20 (reciprocity).
(5) Each person licensed under this rule must
			 maintain records of transfer of material and file reports with the Authority as
			 required in OAR
			 333-102-0247.
(6) Each licensee who manufactures a
			 nationally tracked source shall assign a unique serial number to each
			 nationally tracked source. Serial numbers must be composed only of
			 alpha-numeric characters.
Stat. Auth.: ORS 453.635, 453.665
Stats. Implemented: ORS 453.605 -
				  453.807