N. C. Regulations for Protection Against Radiation

15A NCAC 11 .0325          SPECIFIC LICENSES: PRODUCTS WITH EXEMPT CONCENTRATIONS

(a)  In addition to the requirements set forth in Rule .0317 of this Section, 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 Rule .0303(b) of this Section will be issued if:

(1)           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

(2)           the applicant provides a detailed analysis which demonstrates 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, use of lower concentration is not feasible and that the concentrations of radioactive material at the time of transfer, or that reconcentration of the radioactive material, will not exceed the concentrations listed in the table in Rule .0303(b) of this Section.

(A)          Many radioisotopes disintegrate into isotopes which are also radioactive.  In expressing the concentrations in the table in Rule .0303(b) of this Section, the activity stated is that of the parent isotope and takes into account the daughters.

(B)           Values are given in Column I of the table in Rule .0303(b) of this Section, only for those materials normally used as gases.

(C)           For purposes of this Rule where there is involved a combination of isotopes, the limit for the combination shall be derived as follows:

(i)            Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in the table in Rule .0303(b) of this Section for the specific isotope when not in combination.

(ii)           The sum of these ratios shall not exceed unity.

Example:

Concentration of Isotope A in Product

Exempt concentration of Isotope A                  +

Concentration of Isotope B in Product

Exempt concentration of Isotope B                   less than or equal to 1

(b)  Each person licensed under Paragraph (a) of this Rule shall file with the agency an annual report which shall identify:

(1)           the type and quantity of each product or material into which radioactive material has been introduced during the reporting period;

(2)           name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction;

(3)           the type and quantity of radionuclide introduced into each such product or material; and

(4)           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 Paragraph (a) of this Rule during the reporting period, the report shall so indicate.  The report shall cover the 12‑month period ending June 30, and shall be filed within 30 days thereafter.

History Note:        Authority G.S. 104E‑7; 104E‑10(b);

Eff. February 1, 1980;

Amended Eff. June 1, 1993.

NC Radiation Protection, 1645 Mail Service Center,
Raleigh, NC  27699-1645  919-571-4141  Fax  919-571-4148