1. (a) In addition to the requirements in He-P 4030.09, a specific license authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under paragraph He-P 4030.03 shall be issued if:

   1. (1) The applicant submits:

      1. a. A description of the product or material into which the byproduct material will be introduced;
      2. b. The intended use of the byproduct material and the product into which it is introduced;
      3. c. The method of introduction;
      4. d. The initial concentration of the byproduct material in the product or material;
      5. e. The control methods to ensure that no more than the specified concentration is introduced into the product or material;
      6. f. The estimated time interval between introduction and transfer of the product or material; and
      7. g. The estimated concentration of the byproduct material in the product or material at the time of transfer by the licensee; and

   2. (2) The applicant provides written statements in the application that:

      1. a. The concentrations of byproduct material at the time of transfer will not exceed the concentration in He‑P 4093;
      2. b. That reconcentration of the byproduct material in concentrations exceeding those in He-P 4093 is not likely;
      3. c. That use of lower concentrations is not feasible; and material shall not 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.
2. (b) Each person licensed under He-P 4032.04 shall file an annual report with DHHS/RHS.

3. (c) The annual report in (b) above shall:

   1. (1) Identify:

      1. a. The type and quantity of each product or material into which radioactive material has been introduced during the reporting period;
      2. b. Name and address of the person who owned or possessed the product or material into which byproduct material has been introduced at the time of introduction;
      3. c. The type and quantity of radionuclide introduced into each such product or material; and
      4. d. The initial concentrations of the radionuclide in the product or material at the time of transfer of the byproduct material by the licensee;
   2. (2) Indicate if no transfers of byproduct material have been made pursuant to He-P 4032.04 during the reporting period;
   3. (3) Cover the year ending June 30; and
   4. (4) Be filed within 30 days thereafter.

Source. (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; ss by #10983, eff 11-24-15