United States Nuclear Regulatory Commission - Protecting People and the Environment

Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees - Final Report (NUREG-1556, Volume 16)

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Publication Information

Manuscript Completed: December 2000
Date Published: December 2000

Prepared by:
S. Minnick, C. Mattsen, J. McCausland, B. Parker, D. Wiedeman

Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

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Abstract

This guide has been developed in parallel with the rulemaking on 10 CFR Parts 30, 31, and 32, "Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material." This guidance document is consistent with the final rule.

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol. 16, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees," dated December 2000, is the sixteenth program-specific guidance document developed for the new process and is intended for use by applicants, specific and general licensees, and NRC staff. It also will be available to Agreement States.

The requirements for an NRC general license for persons who receive, possess, use, transfer, own, or acquire byproduct material in generally licensed products are provided in 10 CFR Part 31, "General Domestic Licenses for Byproduct Material." The requirements to obtain an NRC general distribution license for persons who distribute or initially transfer byproduct material in generally licensed products are provided in 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material." Generally licensed products include static elimination devices, gauging devices, gas chromatograph detector cells, tritium signs, in vitro clinical or laboratory kits, and check sources. These devices/products are distributed to general licensees by companies who have a specific license from NRC or an Agreement State authorizing such distribution. This document combines and supersedes the guidance previously found in Information Notices and Policy and Guidance documents listed in Table A.1 of this NUREG.

This document provides assistance to applicants in preparing license applications for a specific license to distribute generally licensed devices. It also describes both the methods acceptable to NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the applications to determine if the proposed general distribution activity is acceptable for licensing purposes. This document was not intended for providing guidance to applicants requesting a specific license for possession and use of radioactive materials.

Appendices K and L are intended to assist specific licensees in providing their customers (general licensees) with information. They provide the general licensee with a concise listing of the regulatory requirements that apply to generally licensed devices. Appendix L does so specifically for users of self-luminous exit signs. Specific licensees may forward Appendices K or L to their customers. It is not intended, however, to take the place of the information requirements in 10 CFR 32.51a (a), (b), and (c).

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