N. C. Regulations for Protection Against Radiation

15A NCAC 11 .0326          SPECIFIC LICENSES: EXEMPT DISTRIBUTION

(a)  An application for a specific license to distribute radioactive material other than source, byproduct or special nuclear material to persons exempt from these Rules pursuant to Rule .0304(e) of this Section will be approved if:

(1)           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;

(2)           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

(3)           The applicant submits copies of prototype labels and brochures and the agency approves their labels and brochures.

(b)  The license issued pursuant to this Rule is subject to the following conditions:

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

(2)           Each exempt quantity shall be separately and individually packaged.  No more than ten packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to Rule .0304(e) of this Section.  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.

(3)           The immediate container of each quantity of separately packaged fractional quantity of radioactive material shall bear the words "Radioactive Material".

(4)           In addition to the labeling information required by Subparagraph (b)(3) of this Rule, the label affixed to the immediate container, or an accompanying brochure, shall:

(A)          state that the contents are exempt from U.S. Nuclear Regulatory Commission or agreement state requirements;

(B)           contain the following statements:

(i)            Radioactive material;

(ii)           Not for human use;

(iii)          Introduction into foods, beverages, cosmetics, drugs, or medicinals, or into products manufactured for commercial distribution is prohibited;

(iv)          Exempt quantities should not be combined.

(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 Paragraph (a) of this Rule shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under Rule .0304(e) of this Section 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 shall be filed with the agency. Each report shall cover the 12 month period ending June 30, and shall be filed within 30 days thereafter.  If no transfers of radioactive material have been made pursuant to this Rule during the reporting period, the report shall so indicate.

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

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

Eff. February 1, 1980;

Amended Eff. May 1, 1993.

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