Section He-P 4032.09 - Licensing the Distribution of Byproduct Material in Exempt Quantities(a) An application for specific license to distribute byproduct material other than source or byproduct material to persons exempted from licensing pursuant to He-P 4030.08 may be approved if: (1) The byproduct 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;(2) The byproduct 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(3) The applicant submits copies of prototype labels and brochures and DHHS/RHS approves such labels and brochures.(b) The license for exempt quantities issued under He-P 4032.09 shall be subject to the following conditions: (1) No more than 10 exempt quantities as listed in He-P 4092.01, which may be composed of fractional parts, shall be sold or transferred in a single transaction, provided that the sum of the fractional parts shall not exceed one;(2) Each exempt quantity shall be separately and individually packaged;(3) No more than 10 packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to He-P 4030.03;(4) 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;(5) 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; andb. Bears the words "Radioactive Material"; and(6) In addition to the labeling information required by He-P 4032.09, 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 Medicinal, or into Products Manufactured for Commercial Distribution is Prohibited - Exempt Quantities Should Not be Combined"; andc. Set forth additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the byproduct material. (c) Each person licensed under He-P 4032.09 shall maintain records identifying, by name and address, each person to whom byproduct material is transferred for use under He-P 4030.03 or the equivalent regulations of the Nuclear Regulatory Commission or an agreement state or licensing state, and the kinds and quantities of byproduct material transferred.(d) An annual summary report shall be filed with DHHS/RHS, as follows: (1) Each report shall state the total quantity of each radionuclide transferred under the specific license;(2) Each report shall cover the year ending June 30;(3) Each report shall be filed within 30 days after the end of the quarter; and(4) If no transfers of byproduct material have been made pursuant to this section during the reporting period, the report shall so indicate.N.H. Admin. Code § He-P 4032.09
(See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07
Amended by Volume XXXV Number 49, Filed December 10, 2015, Proposed by #10983, Effective 11/24/2015, Expires11/24/2025.