ML20207G694

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Notation Vote Response Sheet Approving & Disapproving with comments,SECY-98-300, Options for Risk-Informed Revision to 10CFR50 'Domestic Licensing of Production & Utilization Facilities.'
ML20207G694
Person / Time
Issue date: 02/08/1999
From: Merifield
NRC COMMISSION (OCM)
To: Hoyle J
NRC OFFICE OF THE SECRETARY (SECY)
Shared Package
ML20207G656 List:
References
SECY-98-300-C, NUDOCS 9906140031
Download: ML20207G694 (4)


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NOTATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER MERRIFIELD

SUBJECT:

SECY-98-300 - OPTIONS FOR RISK-INFORMED REVISIONS TO 10 CFR PART 50 " DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES" Approved v Disapproved / Abstain Not Participating COMMENTS:

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Y Si g TO RE N abA, DATE Entered on "AS" Yes [ No 61400 08 CORRESPONDENCE PDR f'706 /Voo 3/

4 COMMISSIONER MERRlFIELD'S COMMENTS ON SECY-98-300. RISK-INFORMING PART 50 l commend the staff for the progress they have made in developing options for risk-informing 10 CFR Part 50. A risk-informed approach to our regulations should serve to enhance safety, reduce unnecessary regulatory burden on licensees, and allow for more effective utilization of NRC resources. It wili allow the NRC and licensees to focus on areas that are of greatest risk significance and thus enhance our ability to protect public health and safety.

As we proceed with risk-informing Part 50, the staff should not underestimate the leadership, management, tracking, and resources that will be necessary to be successful. We owe it to our stakeholders to ensure that our efforts are technically sound, well-planned, and effectively carried out. The agency's Planning, Budgeting, and Performance Management process should be a useful tool in achieving this goal. I encourage the Executive Council to take an active leadership role on this issue and to ensure adequate resources are dedicated to it; as they have so successfully done on the issue of license renewal. The PRA Steering Committee should also provide an active leadership role in assisting the line organization with this risk-informing Part 50 effort. Finally, I encourage the staff to continue to work with our stakeholders to gain their insights into how to most e'fectively prioritize our efforts, i

I endorse a modified version of the staffs proposed Option 2 as follows:

I approve the staff's recommendation of adopting a phased approach to making 10 CFR Part 50 l more risk-informed by proceeding initially with Option 2. I agree with the staff that a phased approach appears to be consistent with comments received from stakeholders and would allow for achieving meaningful benefits in the early stages.

I encomage the staff to study Option 3 on an a90ressive timetable to identify specific requirements i meriting change and possible risk-informed alternatives to the body of Part 50. However, I cannot endorse studying Option 3 without appropriate assurances that this study will be carried out in a disciplinec4 and aggressive manner, with firmly established milestones. Thus, the staff should in the near-term provide, for Commission approval, a proposed schedule for carrying out this study.

During this study, if the staff identifies a regulatory requirement which warrants prompt revision because such a change would significantly enhance safety or significantly reduce unnecessary regulatory burden, the Commission should be notified and provided with a recommended course of action. Otherwise, once this study phase is completed, the staff should provide, for Commission approval, a detailed plan outlining its recommendations regarding specific regulatory changes that should be pursued.

I approve the staffs recommendation that the current rulemaking activities identified in Option 1 continue unimpeded, with the exception of rulemaking activities associated with the Maintenance Rule as discussed below.

I ap_ prove the staffs recommendation regarding the use of industry pilot studies involving the use of exemptions to assist in the development of the Part 50 modifications.

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I disapprove the staffs recommendation that the current rulemaking initiatives associated with paragraphs (a)(3) / (a)(4) of the 10 CFR 50.65 (Maintenance Rule) continue. Instead, this rulemaking should be suspended and its content included in a later rulemaking package which includes scope changes. This approach will avoid two separate rulemakings and optimize the use of staff resources.

I approve using the Maintenance Rule as part of the Option 2 effort, as an initial step in revising I the scope to be risk-informed and to facilitate scope revisions being developed for other Part 50 operational and qualification requirements (Option 2). Modifying the scope of the Maintenance {

Rule and other regulations to be risk-informed would result in a coherent and consistent scope of all operation-related requirements. I agree with the staffs assessment that the inspection and enforcement programs are clear areas that would benefit from a reduced Maintenance Rule scope by more closely focusing on risk-significant SSCs and activities. Also, risk-informing the scope of the Maintenance Rule could relieve licensee burden without adversely affecting plant safety. 1 i encourage the staff to expeditiously move forward with risk-informing the scope of the Maintenance Rule. Given the importance of this step in the agency's overall efforts to develop a risk-informed Part 50, it is essential that senior management provide the leadership and resources that are necessary to ensure success. In the near-term, I expect the staff to develop a rulemaking plan to risk-inform the scope of the Maintenance Rule on an aggressive schedule.

I commend Commissioner Diaz for his efforts to improve and expedite the staffs proposed .

approach to risk-inform Part 50. His insights regarding risk-informed regulation have been invaluable to the agency and to me as a new Commissioner. However, I am not prepared to support a multi-step approach to reduce the scope of the Maintenance Rule. The issue of j Maintenance Rule scope is not squarely presented by the facts of this paper. Consequently, I do i not believe it would be appropriate to decide how to address the scope issue. in the context of a l paper addressing risk-informing Part 50. I am also concerned about endorsing a multi-step j approach without having the benefit of a fully developed assessment by the staff of its overall implications. While such an approach may .esult in some burden reduction for licensees in the short-term, I believe it could divert NRC re sources away from the primary goal of developing a comprehensive, integrated rulemaking which makes the Maintenance Rule truly risk-informed. I also believe a multi-step approach could increase regulatory burden on licensees in that it would require them to change their infrastructure (program description, procedures, training) which supports implementation of the Maintenance Rule several times. It could have the same effect on the NRC's infrastructure in that inspection procedures, training, and regulatory guidance would have to be modified several times. While I generally support initiatives which expeditiously reduce 3 unnecessary regulatory burden, I do not believe I have sufficient information to fully understand the j implications of reducing the scope of the Maintenance Rule using the proposed multi-step approach. Thus, I cannot support such an approach at this time.

I approve the staffs recommendation that risk-informed implementation of Part 50 be voluntary for licensees. As the sta'1 proceeds with its efforts to risk-inform Part 50, it should provide the Commission with additional information regarding how it will manage voluntary implementation.

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I disapprove the staff's recommendation that selective implementation not be allowed. While I agree with the spirit of the no selective implementation recommendation, and agree that such selective implementation is not entirely compatible with the intent of risk-informed regulation, I cannot endorse such a inflexible position across the board. For instance, I agree with the staff that selective implementation within a program should not be allowed (i.e., decrease quality assurance requirements on low risk significant SSCs, but not increase quality assurance requirements on high risk significant SSCs). On the hand, the staff has recommended that the scope of the Maintenance Rule be changed as an early part of the risk-informing process. The staff's position would require alllicensees who desire scope changes to the Maintenance Rule to implement the entire complement of risk-informed changes. I have no safety basis upon which to conclude that the licensees benefitting from a risk-informed Maintenance Rule of reduced scope should be limited to only those that adopt the entire complement of risk-informed regulatory requirements.

There are likely other similar examples.

In addition, l question how the no selective implementation approach would affect our ability to solicit industry pilot participants. Specifically, I assume licensees that volunteer to be pilot plant participants have a vested interest in adopting the risk-informed revision to the particular regulatory requirement for which they are piloting. However, these licensees may be undecided as to whether they would be interested in adopting the entire complement of risk-informed regulatory requirements. With an inflexible no selective implementation approach, it would seem that only those licensees absolutely committed to adopting the entire complement of risk-informed regulatory requirements, a complement not yet defined, would volunteer to be a pilot plant participant.

Finally, if a no selective implementation approach is adopted, it is unclear how the staff intends to handle plants that have already been granted risk-informed initiatives. -

In summary, I am opposed to the staff's broad recommendation that selective implementation not be allowed. However, I clearly recognize that the limits to selective implementation would have to be well-defined and carefully controlled by the NRC.

I a_porove the staff's recommendation that additional guidance be developed to provide clarification on staff authority for applying risk-informed processes in regulatory activities beyond risk-informed licensing actions. This clarifying guidance should be submitted for Commission approval.

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/  % A UNITED STATES P n NUCLEAR REGULATORY COMMISSION g g WASHINGTON, D.C. 20555 0001 June 8, 1999

% * * * ,o SECRETARY MEMORANDUM TO: William D. Travers Executive Director for Operations f

FROM: Annette Vietti-Cook, Secretary \lN

SUBJECT:

STAFF REQUIREMENTS - SECY-98-300 - OPTIONS FOR RISK-INFORMED REVISIONS TO 10 CFR PART 50 -

" DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES" Option 1 The Commission has approved the staffs recommendation that current rulemaking activities identified under Option 1 continue unimpeded (50.59, 50.72, 50.73, 50.55a, and the new 50.67).

Option 2 The Commission has approved implementation of Option 2 to develop risk-informed definitions for " safety-related" and "important to safety" SSCs. This option would make changes to the scope of systems, structures, and components covered by those sections of Part 50 requiring l special treatment (e.g., Quality Assurance, Environmental Qualification, Technical Specifications,50.59, ASME code,50.72, and 50.73). This effort should proceed with early internal and external stakeholder d;cussions and utilization of industry pilot studies involving the use of exemptions to assist in the development of the Part 50 modifications.

Regarding the overall scope of the Maintenance Rule (50.65), the Commission has approved changing the existing scope to conform to the risk-informed regulatory framework being developed as part of Option 2. A rulemaking plan should be developed for Option 2 which reflects the incorporation of the Maintenance Rule activities.

(EDO) (SECY Suspense: 10/31/99)

Option 3 The Commission has approved the staffs recommendation to study Option 3. The staff should pursue this study on an aggressive timetable and provide, for Commission approval, a schedule for this activity. The staff should periodically inform the Commission on progress made in the study. The study should determine how best to proceed with risk-informing the remaining sections of Part 50, During this study, if the staff identifies a regulatory requirement which warrants prompt revision because such a change would significantly enhance safety or

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significantly reduce unt'ocessary regulatory burden, the Commission should be notmed and provided with a recommended course of action. Othenwise, once this study phase is completed, the star should provide, for Commission approval, a detailed plan outlining its recommendations regarding specific regulatory changes that should be pursued.

(EDO) (SECY Suspense: 9/30/99)

Policy issues

1. Voluntary vs. Mandatory Conformance with Modified 10 CFR Part 50 The Commission has approved the stars recommendabon that risk-informed implementation of Part 50 should be voluntary for licensees. As the staff proceeds with its efforts to risk-inform Part 50, it should provide the Commission with additional information regarding how it will manage voluntary implementation. The Commission has disapproved the stars recommendation that selective implementation not be allowed. This issue is premmurely before the Commission. A future Commission will be better able to judge the issue of selective implementation after rules are drafted and rulemakings provide comment on this issue as it iffects that rule. A "no selective implementation" approach will adversely affect NRC's atuisty to solicit industry pilot participants.
2. Industry Pilot Studies with Selected Exemptions to Part 50 The Commission has approved the stars recommendation regarding the use of industry pilot studies involving the use of exemptions to assist in the development of the Part 50 modsficahons.
3. . Modification of the Scope of the Maintenance Rule Sechon (a)(3)/(a)(4).

The Commission has approved continuation of the expeditious revision of 50.65(a)(3)/(a)(4), as discussed at the Commission meebng of May 5,1999. Specific

, Commission direction regarding the rule language and development of the regulatory guidance was provided in the SRM on the Maintenance Rule Commission briefing of May 5,1999, which was issued on May 13,1999.

4. Clanfication of Staff Authonty for Applying Risk-Informed Decision Making The Commission has approved the stars recommendabon that additional guidance be devi+cd to provide clanficabon on staff authonty for applying risk-informed processes in regulatory activities beyond risk-informed licensing actions. This clarifying guidance should be submitted for Commission approval.-

(EDO) (SECY Suspense: 9/30/99)

The staff should: 1) continue to work with stakeholders in risk-informing Part 50; 2) provide sufficient staff resources and management oversight to these high prionty initiatives to ensure effective development of the risk-informed regulatory structure and timely completion of pilot plant applications; and 3) bring policy issues promptly to the attention of the Commission.

While moving towards a risk-informed regulatory framework, the staff should keep in mind that l l

the use of quanhtstive risk analyses may not be appropnate for all applicabons, and therefore, should not be force fit into areas'that are not amenable to such an approach.

As we proceed with risk-informing Part 50, the Executive Council should take an active -

leadership role and ensure that the Planning, Budgeting, and Performance Management process is effectively utilized to allocate agency resources to this effort.

1 cc: Charman Jackson 1 Commissioner Dicus I Commissioner Diaz Commissioner McGaffigan {

Commissioner Memfield OGC CIO CFO-OCA OlG OPA j Omca Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)  !

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