South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part II - LICENSING OF RADIOACTIVE MATERIAL
Section 61-63.II.RHA 2.28 - Requirements for Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products or Devices Which Contain Naturally Occurring or Accelerator-Produced Radioactive Material (NARM)

Universal Citation: SC Code Regs 61-63.II.RHA 2.28

Current through Register Vol. 48, No. 9, September 27, 2024

2.28.1 Licensing the Distribution of NARM in Exempt Quantities. [FN12] An application for a specific license to distribute NARM in exempt quantities to persons exempted from these regulations pursuant to 2.20.2.5 will be approved if:

2.28.1.1 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;

2.28.1.2 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

2.28.1.3 the applicant submits copies of prototype labels and brochures and the Department approves such labels and brochures.

2.28.2 The license issued under 2.28.1 is subject to the following conditions:

2.28.2.1 no more that 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided the sum of the fractions shall not exceed unity.

2.28.2.2 each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to 2.20.2.5. 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.

2.28.2.3 the immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:
2.28.2.3.1 identifies the radionuclide and the quantity of radioactivity, and

2.28.2.3.2 bears the words "Radioactive Material"

2.28.2.4 in addition to the labeling information required by 2.28.2.3, the label affixed to the immediate container, or an accompanying brochure, shall:
2.28.2.4.1 state that the contents are exempt from Licensing State requirements,

2.28.2.4.2 bear the words "Radioactive Material--Not for Human Use--Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited--Exempt Quantities Should Not Be Combined", and,

2.28.2.4.3 set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

2.28.3 Each person licensed under 2.28.1 shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under 2.20.2.5 or the equivalent regulations of a Licensing 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 Department. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to 2.28.1 during the reporting period, the report shall so indicate.

2.28.4 Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under 2.20.2.3 will be approved if the application satisfies requirements equivalent to those contained in Section32.26 of 10 CFR Part 32. The maximum quantity of radium 226 in each device shall not exceed 0.1 microcurie.

2.28.5 Special Requirements for License to Manufacture Calibration Sources Containing Americium 241, Plutonium or Radium 226 for Distribution to Persons Generally Licensed Under 2.4.5. An application for a specific license to manufacture calibration and reference sources containing americium 241, plutonium or radium 226 to persons generally licensed under 2.4.5 will be approved if:

2.28.5.1 the applicant satisfies the general requirements of 2.6, and

2.28.5.2 the applicant satisfies the requirements of Sections32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

[FN12] Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive 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, Wash., D.C. 20555.

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