ML20148C994

Notice of Proposed Rule 10CFR21 Re Reporting of Defects in Equipment Supplied to Nuclear Plants.Action Necessary Since Current Rule Causes Problems in Supply Equipment

ML20148C994
Person / Time
Issue date:	10/13/1978
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:
References
RULE-PR-21 NUDOCS 7811020205
Download: ML20148C994 (7)

Text

7590-01 5

. NRC PUBLIC D6CUENI RU*

Title 10 - Energy CHAPTER I - NUCLEAR REGULATORY COMMISSION Part 21 - Reporting of Defects and Noncompliance Amendments Regarding Basic Component AGENCY: Nuclear Regulatory Commission ACTION: Final Rule

SUMMARY

The Nuclear Regulatory Commission is amending its regula-tions to limit the types of items that are within the scope of its rule for reporting defects and noncompliance. This action is believed i necessary since the currently effective rule is being applied by organizations within its scope to an extent not contemplated and is causing problems relating to the supplying of equipment. The amend-i ments provide that items that are available in general commerce and which have no unique requirements imposed for nuclear application will not be within the scope of the revised rule for reporting defects and noncompliance. These amendments will alleviate the above problem.

l DATE: These amendments will be effective on October 19, 1978.

FOR FURTHER INFORMATION CONTACT: Mr. W. E. Campbell, Jr., Office of Standards Development, U.S. Nuclear Regulatory Commission, Wash-ington, D.C., 20555, 301-443-5913.

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. 7590-01 SUPPLEMENTARY INFORMATION: Notice is hereby given that the Nuclear Regulatory Commission (hereinafter the " Commission") has decided to amend 10 CFR Part 21 " Reporting of Defects and Noncompliance."

Specifically, the Commission has decided to impose limits on the types of items that are used in facilities or activities licensed pursuant to Parts 30, 40, 50, 70, or 71 that are within the scope of 10 CFR Part 21.

On March 3, 1975, 10 CFR Part 21 was published as a proposed rule (40 FR 8832). On June 6, 1977, 10 CFR Part 21 was published as -

an effective rule (42 FR 28891) with some portions of the rule to be effective on July 6,1977, and the remaining portions to be effec- ~

tive on January 6,1978. On July 7,1977, a Federal Register notice (42 FR 34886) changed the initial effective date to August 10, 1977 +

vice July 6,1977. To facilitate implementation of 10 CFR Part 21 a series of public regional meetings were held in July 1977 and based on those meetings the Commission Staff in October 1977 published NUREG-0302 Rev. 1, " Remarks Presented (Questions / Answers) Discussed at the Public Regional Meetings to Discuss Regulations (10 CFR Part 21) for Reporting Defects and Noncompliance." NUREG-0302 Rev. 1 contains staff guidance relating to the implementation and enforcement of

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10 CFR Part 21 and is available through the National Technical -

Information Service, Springfield, Virginia, 22161. In the preamble to the effective rule, the Commission stated that it intended "to examine closely the implementation of 10 CFR Part 21 with a view 2

, 7590-01 to making any clarifying or other changes that may be warranted in the light of experience."

Part 21 defines a " basic component" subject to the reporting and other requirements of the rule. In response to inquiries during and subsequent to the public regional meetings relating to "off-the-shelf" or " catalog" items, the staff provided guidance that such items may be within the scope of 10 CFR Part 21 depending on the circumstances at the time of procurement. This guidance has been construed by numerous organizations to mean that the requirements of 10 CFR Part 21 apply to manufacturers and distributors who are invc1ved to any extent in supplying basic components, or parts of basic components, of a facility or activity including supplying base material or functional . 'blies to the manufacturer of the " basic component." This meaning has lead to the imposition of 10 CFR Part 21 at a procurement stage where there are no design or specification requirements that are unique to application of the item at a nuclear facility or activity, e.g., relays.

The use of this meaning of basic component has not improved the quality of such items and, therefore, has not enhanced safety.

Instead it is causing cost increases, and inability to obtain needed supplies. To the extent that the purchaser is unable to obtain a needed item from the most qualified supplier and must turn to other less

, qualified suppliers, defining basic component to include such an item may to some extent detract from safety. To relieve the conditions that are resulting from the above interpretation and to mitigate this potential 3

. . 7590-01 reduction of safety Part 21 is being amended to remove from the scope of 10 CFR Part 21, during specific stages of procurement, tnose items of a commercial grade, e.g., bearings, relays, and bar stock that are (1) not subject to design or specification require-ments unique to facilities or activities licensed by the Commission, (2) used in applications other than facilities or activities licensed by the Commission and (3) able to be ordered from the manufacturer / distributor on the basis of the manufacturer's pub-lished specifications. At a defined stage of procurement, when the item is " dedicated" to a " basic component" (see 10 CFR 21.3(c-1))

the item will become subject to the requirements of 10 CFR Part 21.

Prior to these amendments 10 CFR Part 21 included within its scope direct inspections of licensees and suppliers as provided under Section 206 of the Energy Reorganization Act of 1974. The revised rule will narrow the scope of the NRC inspection authority based on 10 CFR Part 21. However, NRC will retain the authority to inspect suppliers of commercial grade items provided by Subsec-tion 206(d) where reasonably necessary to aid in the identification by the Commission of defects and noncompliance reportable by licen-sees and suppliers of basic components as provided in 10 CFR Part 21.

Procurement documents that were issued in accordance with 10 CFR 5 21.31 after August 10, 1977, and invoked 10 CFR Part 21 may be amended to delete reference to 10 CFR Part 21 if the item being 4

7590-01 procured complies with the definition of a " commercial grade item" (see10CFR21.3(a-1)).

The amended rule will clarify the applicability of 10 CFR Part 21 and thereby allow for precise application of the rule to those items that are subject to design or specification requirements unique to facilities or activities licensed pursuant to parts 30, 40, 50, 60 or 71 of 10 CFR Chapter 1.

Since the amendments are intended, in part, to respond to a number of requests for exemptions from 10 CFR Part 21 which may be necessary to ensure the continued availability of components for the nuclear industry and since the amendments narrow the scope of the regulation thereby relieving a restriction on persons subject to it, but without any significant adverse safety consequences, the Commis-sion has found thet good cause exists for cmitting notice of proposed rulemaking and public procedure thereon as unnecessary. Accordingly, the amendments are to be effective upon publication in the FEDERAL REGISTER.

Public comments on these amendments and on other portions of 1

l 10 CFR Part 21 are invited in order to evaluate the need for any further clarifying or other changes to 10 CFR Part 21. Comments that are received prior to December 18, 1978 will be particularly useful in evaluating the need for and content of additional amendments.

. 1. The final sentence of 5 21.2 is amended to read as follows:

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• • • Nothing in these regulations should be deemed to preclude either an individual or a manufacturer / supplier of a commercial grade item (see 5 21.3(a-1)) not subject to the regulations in this part from reporting to the Commission a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure.I

2. A new sentence is added to the end of 5 21.3(a) to read as follows:

• • • A commercial grade item is not a part of a basic component until after dedication (see 5 21.3(c-1)).

3. New paragraphs (a-1) and (c-1) are added to 5 21.3 to read as follows:

(a-1) " Commercial grade item" means an item that is (1) not subject to design or specification requirements that are unique to facilities or activities licensed pursuant to Parts 30, 40, 50, 70, or 71 of this chapter and (2) used in applications other than facilities or activities licensed pursuant to Parts 30, 40, 50, 70, or 71 of this chapter and (3) to be ordered from the manufacturer / supplier on the basis of specifications set forth in the manufacturer's published product description (for example a catalog).

(c-1) " Dedication" of a commercial grade item occurs after receipt when that item is designated for use as a basic component.

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4. A new sentence is added to the end of 5 21.7.

• • • Suppliers of commercial grade items are exempt from the pro-visions of this Part to the extent that they supply commercial grade items.

Sec.161, Pub. L.83-703, 68 Stat. 948; sec. 234, Pub. L.91-161, 83 Stat. 444; sec. 206, Pub. L.93-438, 88 Stat.1246 (42 USC 2201, 2282,5846).

Dated at Washington, D.C. , this 13th day of October, 1978.

For the Nuclear Regulatory Commission.

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V l Secretary of the Commission Samuel J. Chilk l

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