United States Nuclear Regulatory Commission - Protecting People and the Environment

Amended Regulations Governing Timepieces Containing Tritium


September 13, 1999


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All exempt distribution licensees.

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The U.S. Nuclear Regulatory Commission (NRC) is issuing this administrative letter to inform addressees about recent rulemaking changes to 10 CFR 32.14. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate. However, no specific action nor written response is required.

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The NRC regulations that authorize exempt distribution of timepieces containing tritium are found in 10 CFR 32.14 and 10 CFR 32.22. To obtain an exempt distribution license from NRC, product information must be submitted as outlined in 10 CFR Part 32 and, specifically, as outlined in 10 CFR 32.14, 32.15, and 32.16, for timepieces containing tritium in solid or gaseous form and 10 CFR 32.22, 32.23, 32.24 and 32.25, for timepieces containing tritium in the form Gaseous Tritium Light Sources (GTLS).

Under the previous regulations, timepieces containing tritium in solid form were licensed under a section of 10 CFR 32.14 that contained specific prototype testing requirements. Some of these prototype tests, however, were not suitable for testing timepieces containing GTLS. Applicants for a license to manufacture timepieces containing gaseous tritium had to apply pursuant to 10 CFR 32.22. In addition, pursuant to 10 CFR 32.22, the applicant is required to submit other information, such as detailed drawings, dimensions, and materials of construction for each model or series in association with a required sealed source and device review.

However, as of August 17, 1998, the NRC has amended its regulations to simplify the licensing process for timepieces containing tritium gas. The amended regulation now permits timepieces containing GTLS to be licensed under the same regulatory requirements as timepieces containing tritium in solid form, with applicable quantity limits per timepiece. Under the current regulations in 10 CFR 32.14, prototype testing has been modified to reflect a more performance based approach. Specifically, the prescriptive prototype tests, such as the bending test, which the glass vials containing gaseous tritium could not meet, have been replaced by a general product integrity requirement. The revised regulation, however, does not change the intent of the product performance standard. The applicant must still demonstrate that the tritium ". . . is properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling."

The change to 10 CFR 32.14 has now simplified the licensing process for timepieces containing GTLS and has the potential for significant savings to licensees and to the NRC. Licensees currently licensed pursuant to 10 CFR 32.22 for the distribution of timepieces containing GTLS may wish to amend their exempt distribution license to authorize distribution of timepieces pursuant to 10 CFR 32.14, if their timepieces do not exceed the 10 CFR 30.15 quantity limits. In addition, holders of NRC registration certificates may wish to amend them since they would no longer be required to maintain these certificates pursuant to 10 CFR 32.14. In this way, licensees currently licensed pursuant to 10 CFR 32.22 may be able to take advantage of potential efficiencies and cost reductions associated with the less prescriptive requirements of 10 CFR 32.14.

If you have any questions about this matter, please call the technical contact listed below or the appropriate regional office.

Signed by Josephine M. Piccone
Donald A. Cool, Director
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards


Contact: Anthony S. Kirkwood, NMSS
(301) 415-6140
E-mail: Anthony.Kirkwood@nrc.gov


Attachments: List of Recently Issued NRC Administrative Letter's.

(NUDOCS Accession Number 9909070009)

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