ML20135E665
| ML20135E665 | |
| Person / Time | |
|---|---|
| Issue date: | 03/03/1997 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Russell M AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9703100092 | |
| Download: ML20135E665 (2) | |
Text
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UNITED STATES
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E WASHINGTON, D.C. 2055H001 s.,,, /
v March 3, 1997 Michael J. Russell 1726 Avenida Crescenta San Clemente, CA 92672
Dear Mr. Russell:
This is in response to your December 30,1996, e-mail requesting technical information on several issues related to the use of foil source contained smoke detectors. For clarity, I have enclosed some information and provided the following discussion for your use.
A brief explanation of the NRC's exempt distribution licensing process may help to better understand the issues associated with licensing and to define persons that are exempt from the requirements for a license. There is no " point" in the manufacturing process when a smoke detector becomes a device acceptable for distribution to persons exempt from licensing. The smoke detector becomes " acceptable" for distribution only after a safety evaluation and registration of the detector has been performed and a license has been issued authorizing the product for exempt distribution.
To possess and use byproduct material, as in the manufacture of smoke detectors, a specific license authorizing possession and use of byproduct material must be obtained from NRC or, by an Agreement State. This specific license covers manufacturing, processing, producing and distribution of products containing byproduct material, provided the products are distributed to persons who have a specific license that authorizes them to possess such byproduct material.
In accordance with $150.15(a)(6), NRC retains jurisdiction for the transfer of buoroduct material to persons exempt from licensing. Thus, applicants who wish to distribute or initially transfer products containing byproduct material, such as smoke detectors, to persons who are exempt from licensing, must also obtain a separate exempt distribution license from the NRC pursuant to $32.26 (Enclosure 1). Before licensing smoke detectors for distribution, NRC would also perform a device safety review resulting in the issuance of a device registration certificate. Only after the device review is completed and the exempt distribution license is issued is the smoke detector authorized for distribution to persons exempt from licensing.
It is also importan i nderstand that smoke detectors are not considered exempt to the manufacturer /initie A butor. The exemption only applies to those persons who receive the products from persons who are authorized to distribute under an exempt distribution license.
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10 CFR 530.20 (Enclosure 2), provides an exemption for the possession of byproduct l
i material when used in gas and aerosol detectors manufactured, processed, produced, or i
initially transferred in accordance with a specific license issued pursuant to 10 CFR 532.26. If the material remains in an assembled gas or aerosol detector, the exemption in
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Section 30.20 applies. However,if the materialis removed from the detector and used for another purpose, the exemption in 530.20 no longer applies. Therefore, under the provisions of 530.20, a person is exempt from licensing requirements as to his possession and use of the smoke detectors. However, once the byproduct material or foil sources are removed from the detector and used for another purpose, the exemption in 530.20, no longer applies.
Incorporation of the foil sources into check sources require a specific license from an Agreement State in your case, California for the possession, use and distribution of the material. The use of material for a purpose other than a source in gas, and aerosol detectors, requires a specific license, in this case, from the State of California.
A specific license to manufacture or initially transfer calibration or reference sources containing Americium-241, for distribution to persons generally licensed, must be obtained pursuant to Section 32.57 or an Agreement State's equivalent regulation. We note that, generally, the provisions in Section 32.18 require a specific license 'or the commercial distribution of those exempt quantities covered under Section 30.18 and identified in Section 30.71, Schedule B. However, Section 32.18 does not appit m this context because Section 30.71, Schedule B does not include a listing for Americium-241.
If you have any questions regarding this correspondence, please contact me at (301)415-7273.
Sincerely,
/6 Steven L. Baggett, Section Chief Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated DISTRIBUTION:
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