License-Exempt Consumer Product Uses of Radioactive Material
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Introduction
Consumer products containing byproduct material and source material that are used by the general public are exempted from licensing requirements only if the Commission determines that the products or types of uses do not constitute an unreasonable risk to the common defense or security or to public health and safety and the environment. Radiation safety features are built into the sealed source or device or the amount of radioactive material that can initially be distributed in such a device is restricted. The Rules of General Applicability to Domestic Licensing of Byproduct Material (10 CFR Part 30 ) exempt members of the public from the requirements for an NRC license when they receive, possess, use, transfer, own, or acquire byproduct material in products such as silicon chips, electron tubes, check sources, gunsights, and smoke detectors. NRC applies regulatory control to the transfer of these products, placing specific requirements on distributions, as specified in Subpart A, 10 CFR Part 32. The regulations in 10 CFR 40.13(c) exempt members of the public from the requirements for an NRC license when they receive, possess, use, or transfer source material in products such as incandescent gas mantles, vacuum tubes, welding rods, and electric lamps. NRC applies regulatory control to the transfer of these products, placing specific requirements on distributions, as specified in 10 CFR 40.52, and 40.53.
Generally, distribution of byproduct material and source material to persons exempt from regulatory authority (i.e., the general public) can only be made by persons who have a specific license from the Commission authorizing the distribution of their products to persons exempt from the requirements for an NRC license. Manufacturers and distributors of these products must be licensed in order to initially transfer or distribute such items to persons exempt from licensing. The licensed distributor is required to satisfy the Commission that all products are manufactured, tested, and distributed in accordance with the regulations and specifications provided in its license application. These specific licenses are issued by the Commission and are referred to as "exempt distribution" or "E" licenses.
Types of License-Exempt Consumer Product Uses
Exempt Concentration Use (10 CFR 30.14)
The use of radiation to provide a desired effect, such as the coloration of gemstones or to change the electrical properties of silicon chips or wafers may result in residual byproduct material in the final product. The use of byproduct material for testing purposes, such as in tracer flow studies in a refinery, may introduce radioactive material into materials such as oil and gas. When these products and materials are released to the public by an NRC licensee, they may not contain residual byproduct material above the exempt concentration limits found in 10 CFR 30.70, Schedule A.
Certain Items Use (10 CFR 30.15)
Byproduct material is used in products such as electron tubes, self-luminous watches, or radiation measuring instruments for standardization or calibration purposes.
Exempt Quantity Use (10 CFR 30.18)
Exempt quantity use includes the use of small quantities of byproduct material such as in check sources and calibration standards for commercial distribution. It also includes the use and transfer of small quantities of byproduct material such as may occur when two labs exchange tissue samples or counting standards for inter-comparison on a noncommercial basis.
Self-Luminous Product Use (10 CFR 30.19)
Self-luminous product use includes the use of products such as gunsights and watches. These products contain tiny glass vials filled with a radioactive gas such as tritium (hydrogen-3).
Gas and Aerosol Detector Product Use (10 CFR 30.20)
Gas and aerosol detector product use of byproduct material can be found in products such as smoke detectors and chemical agent detectors. These products contain tiny foils that provide a steady source of ions in analytical chambers. The foils are coated with byproduct material such as americium-241 or nickel-63.
Radioactive Drug Use (10 CFR 30.21)
Radioactive drug use only includes the use of 1 microcurie carbon-14 urea radioactive drug capsules for in vivo diagnostic use in humans.
Certain Industrial Devices Use (10 CFR 30.22)
Byproduct material is used in products such as industrial devices used for detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere.
Certain Items Containing Source Material (10 CFR 40.13(c))
Source material is used in products such as incandescent gas mantles, vacuum tubes, welding rods, and electric lamps.