WAC 246-235-105   Manufacture, assembly or distribution of radioactive material exempt from regulation.  (1) Licensing the introduction of radioactive material into products in exempt concentrations. In addition to the requirements set forth in WAC 246-235-020, 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 to be transferred to persons exempt under WAC 246-232-010(1) will be issued if:

     (a) The applicant submits 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 radioactive material in the product or material at the time of transfer; and

     (b) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in WAC 246-232-130, Schedule C, that reconstruction of the radioactive material in concentrations exceeding those in WAC 246-232-130, Schedule C, 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.

     (c) Each person licensed under subsection (1) of this section shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product and material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to subsection (1) of this section during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty days thereafter.

     (2) Licensing the distribution of certain radioactive material in exempt quantities.*

*Note:

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing source material or radioactive material whose subsequent possession, use, transfer and disposal by all other persons who are exempted from regulatory requirements may be obtained only from the department or the United States Nuclear Regulatory Commission, Washington, D.C. 20555.

     (a) An application for a specific license to distribute naturally occurring and accelerator-produced radioactive material (NARM) to persons exempted from these regulations pursuant to WAC 246-232-010 (2)(b) will be approved if:

     (i) 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;

     (ii) 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

     (iii) The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

     (b) The license issued under (a) of this subsection is subject to the following conditions:

     (i) No more than ten exempt quantities shall 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 shall not exceed unity.

     (ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to WAC 246-232-010 (2)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

     (iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

     (A) Identifies the radionuclide and the quantity of radioactivity; and

     (B) Bears the words "radioactive material."

     (iv) In addition to the labeling information required by (b)(iii) of this subsection, the label affixed to the immediate container, or an accompanying brochure, shall:

     (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.

     (c) Each person licensed under (a) of this subsection shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under WAC 246-232-010 (2)(b) or the equivalent regulations of a 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 shall be filed with the department. Each report shall cover the year ending June 30, and shall be filed within thirty days thereafter. If no transfers of radioactive material have been made pursuant to subsection (2) of this section during the reporting period, the report shall so indicate.

     (3) Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under WAC 246-232-012 will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32.

*Note:

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing source material or radioactive material whose subsequent possession, use, transfer and disposal by all other persons who are exempted from regulatory requirements may be obtained only from the department or the United States Nuclear Regulatory Commission, Washington, D.C. 20555.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-235-105, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 01-02-067, § 246-235-105, filed 12/29/00, effective 1/29/01; 98-13-037, § 246-235-105, filed 6/8/98, effective 7/9/98.]