ML20003F135
| ML20003F135 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/1981 |
| From: | NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML20003F133 | List: |
| References | |
| RTR-REGGD-7.010, TASK-OS, TASK-TP-020-4, TASK-TP-20-4 REGGD-07.XXX, REGGD-7.XXX, NUDOCS 8104200266 | |
| Download: ML20003F135 (5) | |
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DRAFT VALUE/ IMPACT STATEMENT x
1.
BACKGROUND Assurance that packaging used to transport radioactive materials will not be hazardous to public health and safety depends greatly on the integrity of the safety related features of the container.
To increase confidence that designated safety-related features of particular packaging are designed, built, and used so as to minimize the risk to the public from exposure to radioactivity, prescribed systematic management and administra-tive controls need to be invoked during each phase of their design, production, and use.
These management controls are embodied in 18 criteria identified as Appendix E to 10 CFR Part 71, " Quality Assurance (QA) Criteria for Shipping Packages for Radioactive Material."
Prior to October 1977 when Appendix E became an effective rule, quality assurance programs were required only for packaging designed to transport plu-tonium, high-level waste, and irradiated fuel.
The description of the quality V
assurance program was to be included in the application for package approval and reviewed against the criteria identified in Appendix E to Part 71.
Subsequent to Appendix E becoming an effective rule and pursuant to para-graph 71.24(a) and 6 71.51, " Establishment and Maintenance of a Quality Assur-ance Program," all applicants and licensees authorized to use, possess, design, or build packages to transport radioactive material in excess of Type A quanti-ties as defined in paragraph 71.4(g) had to provide documented evidence of a QA program acceptable to the NRC.
A special provision of the rule allowed any licensee in possession of an NRC-approved QA program covering activities under 10 CFR Part 50, " Domestic Licensing of Production and Utilization facilities,"
as delineated in Appendix B to Part 50, to apply it without further approvals to activities covered by Part 71.
An NRC licensee cannot use packaging subject to 10 CFR Part 71 if its use is not covered by an NRC-approved QA program.
Also the rule clarified NRC's position as to responsibility for quality assurance by stating that it was the licensee who delivers a package to a carrier for transport who must assure himself 37 810.42o0.24(g
and the NRC that all quality assurance provisions for the package have been j
followed.
The effective date to submit to the NRC the QA program descriptions was initially set as July 1, 1978, but because of large numbers of inquiries, primarily from radiographers, the date was extended to January 1, 1979.
Licensees filing their QA program descriptions by January 1,1979, were autho-rized continued use of their packages contingent upon the determination of acceptability by the NRC.
2.
THE PROPOSED ACTION 2.1 Description The proposed action provides guidance to persons needing information on the essential elements needed to develop, establish, and maintain quality assurance programs in accordance with the requirements of Appendix E to Part 71 for packaging used to transport spent fuel, high-level waste, and plutonium.
The guide will include two annexes:
(1) Quality Assurance Programs Applicable to Design,
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Fabrication, Assembly, and Testing of Packaging Used To Transport Spent Fuel, High-Level Waste, and Plutonium and (2) Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packaging Used To Transport Spent Fuel, High-Level Waste, and Plutonium.
2.2 Need for the Proposed Action According to 71.24, applicants for package approval are required to identify their quality assurance program, and, according to 6 71.51, licensces are required to establish and maintain a quality assurance program.
Guidance is needed by (a) persons establishing QA programs, and (b) persons having NRC-approved QA programs who need to maintain them.
Guidance is also needed by the NRC staff to develop inspection plans and procedures.
Furthermore, because there is a wide disparity of applicability to the requirements of Appendix E, specific guidance concerning grading of a particular QA program to fit its potential impact on safety is needed.
The economic penalties for overcommitment resulting from uniform application of quality q
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m assurance without regard to specifics cin be as severe as not applying any quality requirements at all to achieve design objectives.
2.3 Value/ Impact of the Proposed Actions 2.3.1 NRC Staff time required for evaluation and inspection should be reduced becaust standardized QA programs should allow the use of standard review plans and uniform inspection plans and procedures.
Other than the allocation of staff resources to developing, reviewing, and issuing this guide, no impact on the NRC is anticipated.
2.3.2 Other Government Agencies Impact on other government agencies would be essentially the same as that on industry to the extent that these agencies are regulated by NRC.
2.3.3 Industry Specific guidance about QA criteria applicable to particular packaging should aid in developing, establishing, and maintaining a QA program that meets the spirit and intent of the so-called " graded approach." Formulating a program in which the QA effort expended on an activity is consistent with its importance to safety can be interpreted quite differently by different licensees.
Spelling out only the applicable criteria as well as the specific applicable safety ele-ments will result in a graded approach.
Proliferation of documentation prevalent in industry should be reduced.
2.3.4 Public No impact on the public is foreseen.
l 2.3.5 Worker No impact on the worker is foreseen.
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2.4 Decision 9
Development of this reaulatory guide should be initiated because of the benefits previously discussed.
3.
PROCEDURAL APPROACH 3.1 Alternatives No meaningful alternative exists.
Use of the general description of the QA criteria in Appendix E without further amplification would place too much responsibility on licensees for judging what constitutes an acceptable commitment.
The ANSI N14.4 Subcommittee is chartered to produce a standard based on Appen-dix E, but their ongoing effort is not expected to be completed in the near future.
3.2 Discussion A regulatory guide is the most efficient way to transmit information about what would be acceptable to the NRC.
In addition, a regulatory guide will ensure uniform transmission of information and responses from applicants and licensees.
4.
STATUTORY CONSIDERATIONS 4.1 NRC Authority The proposed guide provides guidance for the implementation of regulations promulgated in paragraph 71.24(a) and S 71.51 and described in Appendix E to 10 CFR Part 71.
Authority for these regulations is derived fron, the Atomic Energy Act of 1954, as amended, and from the Energy Reorganization Act of 1974.
4.2 Need for NEPA Assessment l
l The proposed action is not a major action as defined in 6 51.5 of 10 CFR l
Part 51 and, therefore, dces not require an environmental impact statement.
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5.
RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES Appendix E to 10 CFR Part 71 is structured identically to Appendix B to 10 CFR Part 50 describing quality assurance criteria now in effect for nuclear power plants and certain fuel cycle facilities but changed essentially only to accommodate terminology specific to transportation.
6.
SUMMARY
AND CONCLUSIONS The proposed regulatory guide will provide persons involved in activities related to the packaging for transportation of licensed material much needed information on the essential elements of QA programs acceptable to the NRC.
The proposed action discussed herein should be initiated.
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