ML063390597

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Enforcement Discretion for Facility Changes Under 10 CFR 70.72(c)(2)
ML063390597
Person / Time
Site: Nuclear Energy Institute
Issue date: 11/16/2006
From: Killar F
Nuclear Energy Institute
To: Pierson R
NRC/NMSS/FCSS
References
RIS-06-014
Download: ML063390597 (5)


Text

NUCLEAR ENERGY INSTITUTE Felix M. Killar, Jr.

SENIOR DIRECTOR, LICENSING & INSURANCE NUCLEAR GENERATION DIVISION November 16, 2006 Mr. Robert C. Pierson Division of Fuel Cycle Safety and Safeguards Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

SUBJECT:

NRC Regulatory Issue Summary 2006-14: Enforcement Discretion for Facility Changes Under 10 CFR 70.72(c)(2)

PROJECT NUMBER: 689

Dear Mr. Pierson:

The Nuclear Energy Institute (NEI)1 on behalf of its industry members has reviewed Regulatory Issue Summary (RIS) 2006-14. The Nuclear Regulatory Commission (NRC) issued this RIS to guide the staff in application of revisions to the facility change process regulations contained in a proposed direct final rule.2 NEI is very concerned with the interpretations presented in the RIS, for they conflict with the Commissions directions on the design, implementation, and functioning of a facility change process. RIS 2006-14 expounds on issues unrelated to the direct final rule, such as Items Relied on for Safety (IROFS) equivalency and new types of accident sequence, when it should be addressing the management of IROFS when present in numbers exceeding those required to meet the §70.61 performance requirements. Industry is very apprehensive that the RIS interpretations could be incorporated into NRC inspection and enforcement policies contrary to the Commission directives to adopt truly risk-informed, performance-based approaches.

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

2 Direct Final Rule: Facility Change Process Involving Items Relied on for Safety (Federal Register, Vol. 71, No. 187, p.

56344, September 27, 2006) 1776 I STREET, NW SUITE 400 W ASHINGTON, DC 20006-3708 PHONE 202.739.8126 FAX 202.533.0157 fmk@nei.org

Mr. Robert C. Pierson November 14, 2006 Page 2 The balance of this letter provides a historical review of the Commissions direction on the Part 70 facility change process. It also comments on several misstatements in RIS 2006-14 and concludes with a recommendation for its revision or withdrawal pending incorporation of stakeholder input.

Facility Change Process What was the Commissions intent for a facility change process? Industry and the Commissioners agreed upon the need for such a process in the new Part 70, Subpart H regulations. The Commission directed that the process should capture for NRC review only those few significant changes that currently would require license amendments3 The NRC would pre-approve safety-significant, high-risk facility changes. For this very reason, the ISA was not included in a facility license, for as many as 300-400 plant or procedural changes could be expected annually for a typical fuel manufacturing facility. The Commission directed the staff to place the threshold for pre-approval of changes at a level consistent with past practice4 and to delete a footnote from an early draft of §70.72 that would have defined a new accident sequence as one having a different initiator, significant change in consequence, or change in the safety function of an IROFS. This definition would have effectively included any process change and made all subject to NRC review and approval. This was very clearly never the intent of the Commission.

3 In rejecting the first draft of the proposed §70.72, the Commission directed the staff to: decide what is fundamental for NRCs regulatory purposes for inclusion as part of the license or docket and what can be justified from a public health and safety standpoint and cost-benefit basis, and assure Part 70 captures for submittal those few significant changes that currently would require license amendments: SECY 98-185 4 In proposing the revisions to the rule to address the Commissions directives, NRC staff stated The change process in that section of the rule (70.72) reflects the staffs recommended approach, which is also strongly supported by the industry. The staff recommends this approach because it focuses on high-risk changes, contains straight-forward, objective criteria, and is consistent with the direction of the SRM... NRC staff further states: The staff reviewed all license amendment requests that NRC has received for Part 70 licensees over the past three years. In addition, the Task Force determined that only substantial changes to facilities required license amendments in the past fore fuel cycle licensees, such as the creation of new processes at a facility (i.e. downblending or increased enrichment). This section (70.72) was then revised to place the threshold for pre-approval of changes at a level consistent with past practice. In addition, the subjective more than minimal words were removed and specific situations where pre-approval would be required were added :

SECY 99-147

Mr. Robert C. Pierson November 14, 2006 Page 3 The Commission directed the §70.72 facility change process to apply to changes that have risk significance and that could adversely impact public health and safety.

Changing, replacing, or removing IROFS designed to prevent or mitigate the consequences of a lower-risk accident sequence should not, therefore, require NRC pre-approval. The Commission always intended the facility change process to capture the status quo that existed prior to promulgation of the Subpart H regulations in 2000.

NEI believes the four criteria enumerated in §70.72 taken collectively provide a high degree of assurance that significant facility changes will be submitted to the NRC for review and pre-approval prior to implementation.

Final Direct Rule The final direct rule addresses the very specific situation in which a licensee has designated more IROFS than may be required to meet the §70.61 performance requirements. For such instances in which the excess safety margin afforded by these additional IROFS is available, the final direct rule allows the licensee to remove or replace an IROFS without seeking NRC pre-approval so long as the remaining IROFS are adequate to meet the §70.61 criteria. IROFS equivalency need not be considered in any such removal or replacement and does not enter the realm of enforcement discretion which is the focus of the direct final rule. The RIS, however, embarks on a confusing and irrelevant discussion of IROFS equivalency and new accident sequences even though the purpose of the rule change has nothing to do with these issues.

Stakeholder Input on IROFS Equivalency At the August 2006 Fuel Cycle Information Exchange, NRC announced two separate initiatives: (i) promulgation of the direct final rule to clarify one aspect of the

§70.72(c)(2) facility change process, and (ii) solicitation of stakeholder input to develop staff guidance for establishing IROFS equivalency. Guidance on IROFS equivalency should not be included in RIS 2006-14 until stakeholder input is solicited. Collaborative discussions with fuel cycle licensees to thoroughly explore the nuances of equivalency are required before implementation guidance is issued to the staff.

RIS 2006-14 appears to convey the staffs wish to review and approve a much larger population of facility changes than was ever envisaged by the Commission. Only through consultation with stakeholders and a review of Commission documents supporting development of Part 70, Subpart H regulations can truly risk-informed, performance-based guidance be developed. NEI is very concerned with this lack of stakeholder participation.

Mr. Robert C. Pierson November 14, 2006 Page 4 Specific Comments on the RIS RIS 2006-14 does not reflect the Commissions underlying principles for the facility change process. Issues that were resolved with the staff and thoroughly documented during the Part 70 rulemaking are now appearing to resurface without any justification. Incorporation of the risk-informed, performance-based philosophy into both the change process and the supporting inspection and enforcement policies appears to be a nebulous, misunderstood goal based upon a reading of RIS 2006-14.

The RIS introduces the notion of a Baseline ISA Summary which is a term that the NRC has neither reviewed nor approved. The ISA and ISA Summary are living documents that a licensee will maintain current and that will document facility changes. Meeting the §70.61 performance requirements is the fundamental premise underlying the Subpart H safety program; designation of IROFS in sufficient numbers and robustness, and demonstrating they are equivalent, remains the licensees responsibility.

The RIS expounds on both IROFS equivalency (§70.72(c)(2)) and new types of accident sequences (§70.72(c)(1)(i)), both of which are described in a manner that is contrary to earlier Commission directives. As noted earlier, neither equivalency nor new types of accident sequences apply to the final direct rule and should not be addressed in RIS 2006-14.

The last paragraph on Page 2 includes the statement In addition, if the equivalent replacement of an IROFS results in the creation of a new type of accident sequence (i.e. introduces a new failure mode), then NRC pre-approval is still needed... One should not equate a new type of accident sequence with a new failure mode for these are separate concepts that are not necessarily related.

The RIS conveys a misunderstanding that the NRC reviews and approves ISA Summaries. The NRC only approves the ISA methodology and checks by means of vertical slice reviews that a licensee has performed an ISA in accordance with NRC-approved methodology (ies). The NRC does not write a Safety Evaluation Report on the ISA Summary, but rather a Technical Evaluation Report , which in no way implies that the NRC has reviewed and approved the entirety of the ISA Summary.

NEI Recommendations RIS 2006-14 fails to meet its objective of providing guidance on enforcement discretion for instances in which a licensee has designated IROFS in excess of those required to meet the §70.61 performance requirements. The RIS compounds this

Mr. Robert C. Pierson November 14, 2006 Page 5 deficiency by delving into issues that have no bearing on the direct final rule and that ignore Commission direction on a facility change process.

The RIS should, therefore, be revised. The RIS does provide complementary guidance to the proposed direct final rule, but information that is not related to the RIS topic should be deleted. Specifically, the paragraph starting with To provide guidance to licensees on Page 2 through to the end of the RIS, including the Footnote on page 2, should all be deleted. Development of guidance to address IROFS equivalency and new accident sequences must await interaction with licensees and other stakeholders as encouraged by you.

If you have any questions pertaining to issues raised in this letter, please feel free to contact me at 202.739.8126; fmk@nei.org.

Sincerely, Felix M. Killar, Jr.