NAC459.278. Specific licenses: Distribution of radioactive material in exempt quantities.

     1. An application for a specific license to distribute radioactive material other than source or by-product material to persons exempted from NAC 459.010 to 459.794, inclusive, pursuant to NAC 459.184 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, 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 Division approves the labels and brochures.

     2. The license issued under subsection 1 is subject to the following conditions:

     (a) No more than ten exempt quantities may be sold or transferred in any single transaction. An exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions does not exceed unity.

     (b) Each exempt quantity must be separately and individually packaged. No more than ten packaged exempt quantities may be contained in any outer package for transfer to persons exempt pursuant to NAC 459.184. The outer package must be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

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

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

          (2) Bears the words “Radioactive Material.”

     (d) In addition to the labeling information required by paragraph (c) the label affixed to the immediate container or an accompanying brochure must:

          (1) State that the contents are exempt from the Nuclear Regulatory Commission or agreement state requirements;

          (2) Bear the words “Radioactive Material - Not for Human Use - Introduction into Foods, Beverages, Cosmetics, Drugs, Medicines or Products Manufactured for Commercial Distribution is Prohibited - Exempt Quantities Should not be Combined”; and

          (3) Set forth appropriate radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

     3. Each person licensed under this section shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under NAC 459.184 or the equivalent regulations of an agreement 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 Division. Each report must cover the year ending June 30, and be filed within 30 days. If no transfers of radioactive material have been made pursuant to this section during the reporting period, the report must so indicate.

     4. The provisions of subsection 2 of NAC 459.262 apply to this section.

     [Bd. of Health, Radiation Control Reg. §§ 3.5.5.2-3.5.5.2.3, eff. 2-28-80]