ML023520620

the Interim Staff Guidance Process

ML023520620
Person / Time
Site:	PROJ0690
Issue date:	12/12/2003
From:	Matthews D B Division of Regulatory Improvement Programs
To:	Lochbaum D A, Marion A Nuclear Energy Institute, Union of Concerned Scientists
Cushing J, NRR/DRIP/RLEP, 415-1424
References
+KBR1SISP20050608
Download: ML023520620 (22)

Text

December 12, 2003Mr. Alex MarionNuclear Energy Institute 1776 I Street, NW., Suite 400 Washington, DC 20006-3708Mr. David LochbaumUnion of Concerned Scientists 1707 H Street, NW Suite 600 Washington, DC 20006-3919

SUBJECT:

THE INTERIM STAFF GUIDANCE PROCESS

Dear Messrs. Marion and Lochbaum:

The staff issued a draft of the interim staff guidance (ISG) process for comment on July 30, 2002. By letter dated October 29, 2002, Nuclear Energy Institute (NEI) provided comments on the draft ISG process. The staff has revise the ISG process and enclosure 1, the Process for Interim Staff Guidance Development and Implementation, provides the final guidance. NEI's comments and the staff's responses are discussed in enclosure 2.The ISG process captures lessons learned from license renewal reviews and communicatesthem to the stakeholders. The process includes interaction with stakeholders during the development of the ISG, including publishing of a Federal Register notice requesting comments. If the ISG is approved, then an applicant for a renewed license needs to address the issue. Once an ISG is approved, it will be incorporated into the next revision of the license renewalguidance (LRG) documents. The three guidance documents are NUREG-1801, "Generic Aging Lessons Learned (GALL) Report," NUREG-1800, "Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants" (SRP-LR), and Regulatory Guide 1.188, "Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses." The Nuclear Regulatory Commission (NRC) has endorsed Nuclear Energy Institute, NEI 95-10, Revision 3, "Industry Guideline for Implementing the Requirements of 10 CFR Part 54 - The License Renewal Rule," and NEI has indicated that it will update this guidance in accordance with the approved ISGs.For licensees holding a renewed license, the license renewal regulations in 10 CFR 54.37(b)requires that after the renewed license is issued, the final safety analysis report update (FSAR) required by 10 CFR 50.71(e) must include any systems, structures, and components newly identified that would have been subject to an aging management review or evaluation of time-limited aging analyses in accordance with 10 CFR 54.21. This FSAR update must describe how the effects of aging will be managed such that the intended function(s) in 10 CFR 54.4(b) will be effectively maintained during the period of extended operation.

Therefore, for ISGs involving newly identified systems, structures and components (SSCs) that would have been subject to an aging management review or evaluation of time-limited aging analyses in accordance with 10 CFR 54.21, the regulations require a licensee holding a renewed license to submit in its next FSAR update a description of how the effects of aging will be managed. ISGs apply to the period of extended operation. Since licensees will not enter the period ofextended operation until after the LRG documents are updated, the staff will wait until the ISGs have been incorporated into the LRG documents before informing the licensees of the requirement to include the information on the applicable ISGs in their next FSAR update. The review process for revising NUREGs, like NUREG 1800 and 1801, involves public comment and review by the Committee to Review Generic Requirements. After the LRG documents have been revised to include the ISGs the staff will send a letter to each licensee holding a renewed license informing them of the ISGs they need to address in their next FSAR update. Changes were made to the ISG process as a result of your comments and further staff review. Should you have questions, please contact Mr. Jack Cushing of my staff at (301) 415-1424.Sincerely, /RA/David B. Matthews, DirectorDivision of Regulatory Improvement Programs Office of Nuclear Reactor RegulationProject No. 690

Enclosures:

As stated cc w/att.: See next page ISGs apply to the period of extended operation. Since licensees will not enter the period ofextended operation until after the LRG documents are updated, the staff will wait until the ISGs have been incorporated into the LRG documents before informing the licensees of the requirement to include the information on the applicable ISGs in their next FSAR update. The review process for revising NUREGs, like NUREG 1800 and 1801, involves public comment and review by the Committee to Review Generic Requirements. After the LRG documents have been revised to include the ISGs the staff will send a letter to each licensee holding a renewed license informing them of the ISGs they need to address in their next FSAR update. Changes were made to the ISG process as a result of your comments and further staff review. Should you have questions, please contact Mr. Jack Cushing of my staff at (301) 415-1424.Sincerely, /RA/David B. Matthews, DirectorDivision of Regulatory Improvement Programs Office of Nuclear Reactor RegulationProject No. 690

Enclosures:

As stated cc w/att.: See next pageDISTRIBUTION: See next pageAccession Number: ML023520620*See previous concurrenceOFFICEPM:RLEPLA:RLEPSC:RLEPNAMEJCushingYEdmonds*SWest*

DATE10/31/039/24/039/16/03 OFFICEOGC (NLO w/comments)PD:RLEPDD:DRIPNAMERWeisman*PTKuo*DMathews (FGillespie for)DATE10/20/0310/31/0312/1203OFFICIAL RECORD COPY DISTRIBUTION: Letter to A. Marion & D. Lochbaum Re: ISG, Dated: December 12, 2003 HARD COPY RLEP RFProject ManagerE-MAIL:PUBLICJ. Craig D. Matthews F. Gillespie C. Grimes RidsNrrDe E. Imbro G. Bagchi K. Manoly W. Bateman J. Calvo R. Jenkins P. Shemanski H. Nieh J. Fair S. Black B. Boger D. Thatcher R. Pettis G. Galletti C. Li J. Moore R. Weisman M. Mayfield A. Murphy S. Zane S. Smith (srs3)

S. Duraiswamy Y. L. (Renee) Li RLEP Staff

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A. Thadani C. Julian R. Gardner M. Farber M. Modes J. Vora R. Correia C. Abbott T. Dietz M. Case J. Yerokun NUCLEAR ENERGY INSTITUTE Project No. 690

cc:Mr. Joe Bartell U.S. Department of Energy NE-42 Washington, DC 20585Ms. Christine S. Salembier CommissionerState Liaison Officer Department of Public Service 112 State St., Drawer 20 Montipelier, VT 05620-2601Mr. Fred Emerson Nuclear Energy Institute 1776 I St., N.W., Suite 400 Washington, DC 20006-3708Mr. Stephen T. HaleFlorida Power & Light Company 9760 S.W. 344 St.

Florida City, FL 33035Mr. William CorbinVirginia Electric & Power Company Innsbrook Technical Center 5000 Dominion Blvd.

Glen Allen, VA 23060Mr. Frederick W. PolaskiManager License Renewal Exelon Corporation 200 Exelon Way Kennett Square, PA 19348George WrobelManager, License Renewal R.E. Ginna Nuclear Power Plant 1503 Lake Rd.

Ontario, NY 14519Mr. David LochbaumUnion of Concerned Scientists 1707 H St., NW, Suite 600 Washington, DC 20006-3919Ronald B. ClaryManager, Plant Life Extension V.C. Summer Nuclear Station Bradham Blvd.

P.O. Box 88 Jenkinsville, SC 29065Mr. John B. HermanManager - Nuclear Licensing Omaha Public Power District Fort Calhoun Station FC-2-4 Adm.

Post Office Box 550 Fort Calhoun, NE 68023-0550Mr. Paul GunterDirector of the Reactor Watchdog Project Nuclear Information & Resource Service

1424 16 th St., NW, Suite 404Washington, DC 20036Mr. Hugh JacksonPublic Citizen's Critical Mass Energy &

Environment Program 215 Pennsylvania Ave., SE Washington, DC 20003Mary OlsonNuclear Information & Resource Service Southeast Office P.O. Box 7586 Asheville, NC 28802 Talmage B. ClementsManager - License Renewal Nuclear Engineering Services

CP&L 410 South Wilmington St.

Raleigh, NC 27602Mr. Charles R. PierceManager - License Renewal Southern Nuclear Operating Company P. O. Box 1295 Birmingham, AL 35201 Mr. Garry G. YoungManager, License Renewal Services 1448 SR 333, N-GSB-45 Russellville, AR 72802Richard J. GrumbirProject Manager, License Renewal Indiana Michigan Power Company Nuclear Generation Group 500 Circle Drive Buchanan, MI 49107Mr. Timothy E. Abney, ManagerLicensing and Industry Affairs Browns Ferry Nuclear Plant Tennessee Valley Authority P.O. Box 2000 Decatur, AL 35609 Process for Interim Staff Guidance Development and ImplementationEnclosure 1 Process for Interim Staff Guidance Development1.0POLICYPart 54 of Title 10 of the Code of Federal Regulations (10 CFR Part 54), hereafter referred toas "the rule," governs the issuance of renewed operating licenses for nuclear power plants. To facilitate the implementation of the rule and the review and inspection of programs and activities associated with a license renewal application (LRA), the staff has developed license renewal guidance (LRG) documents.The LRG documents are:

NUREG-1800, "Standard Review Plan for Review of License Renewal Applications forNuclear Power Plants" (SRP-LR)NUREG-1801, "Generic Aging Lessons Learned (GALL) Report"Regulatory Guide (RG) 1.188, "Standard Format and Content for Applications to RenewNuclear Power Plant Operating Licenses" In addition, the Nuclear Energy Institute (NEI) developed the following document that isendorsed in RG 1.188:NEI 95-10, Revision (Rev.) 3, "Industry Guideline for Implementing the Requirements of10 CFR Part 54 - The License Renewal Rule"The SRP-LR provides guidance to Nuclear Regulatory Commission (NRC) staff reviewers in theOffice of Nuclear Reactor Regulation (NRR). These reviewers perform safety reviews of applications to renew nuclear power plant licenses in accordance with the license renewal rule.

The principal purposes of the SRP-LR are to ensure the quality and uniformity of staff reviews and to present a well-defined base from which to evaluate applicant programs and activities for the period of extended operation. The SRP-LR is also intended to make information about regulatory matters widely available, to enhance communication with interested members of the public and the nuclear power industry, and to improve the public

's understanding of the staffreview process. Each of the individual SRP-LR sections addresses (1) who performs the review, (2) the matters that are reviewed, (3) the basis for review, (4) the way the review is accomplished, and (5) the conclusions that are sought.The SRP-LR references the GALL report (which evaluates existing programs), generically, todocument (1) the conditions under which existing programs are considered adequate to manage identified aging effects without change and (2) the conditions under which existing programs should be augmented for this purpose. The GALL report should be treated as an approved topical report (as explained in NUREG-1739). The purpose of RG 1.188 is to provide guidance to an applicant on the information to besubmitted in an application for renewal of a nuclear power plant operating license in a uniform format that is acceptable to the NRC staff for structuring and presenting this information. It also endorses NEI 95-10, Rev. 3, as an acceptable method for implementing the requirements of the license renewal rule. NEI 95-10 was developed by the NEI License Renewal Implementation Guideline Task Forceand the NEI License Renewal Working Group for the implementation of the license renewal rule.The license renewal program is a living program. The staff, industry, and other interestedstakeholders gain experience and develop lessons learned with each renewed license. The lessons learned address the NRC

's performance goals of maintaining safety, improvingeffectiveness and efficiency, reducing regulatory burden, and increasing public confidence.

The lessons learned are captured in interim staff guidance (ISG) for use by the staff and interested stakeholders until the LRG documents are revised.2.0OBJECTIVESThis instruction ensures that proposed changes to the LRG documents are properly evaluated,documented, and implemented. Further, this instruction establishes the responsibilities and authorities for the NRR staff in identifying changes to the LRG using the ISG process.This instruction provides NRR staff with the basic framework for processing ISGs. The goals ofthis instruction include the following:To ensure the continued health and safety of the publicTo improve public confidence in the license renewal processTo implement a documented and controlled license renewal review process, so as toreduce unnecessary regulatory burdenTo maintain a consistent, effective, and efficient review process.

3.0BACKGROUND

The LRG documents have been developed to enhance the license renewal process. It isexpected that, as lessons are learned during LRA reviews, these guidance documents may need to be modified to capture new insights or address emergent issues. This process serves to expeditiously address specific areas in the LRG documents that need to be revised and to serve as a bridge until the entire document can be revised.Public involvement is an important part of this process. The process, as described inSection 4.0 of this document, gives the public opportunities to obtain information and to comment on the proposed ISG. ISG

's will be discussed in public meetings. The staff willrespond in writing to any written comments. The public will also be able to comment when the LRG documents are revised to include the ISGs. The NRC will make ISGs available to the public by publishing them on the NRC web site, in Agency Documents Access and Management Systems (ADAMS), and by holding public meetings, as appropriate. 4.0ISG PROCESS4.1OverviewThe staff, industry, or interested members of the public may comment or propose changes toinformation provided in an LRG document. Some comments may warrant the staff

's developingand issuing an ISG prior to the next update of the LRG documents. Each ISG will be incorporated into the periodic updates of the LRG documents. For comments that do not result in an ISG, the ISG coordinator will evaluate the comments to determine if they should be addressed in the next revision of the LRG documents. Failure to follow the ISG process might adversely affect the stability and predictability of thelicense renewal program. During the course of an LRA review, the staff may discover an issue that would expand the scope of the issues being addressed under the LRG documents. The staff should not ask an applicant to address the new issue through a request for additionalinformation (RAI) until an approved ISG has been issued. The ISGs have schedule implications for current and future applicants for license renewal and licensees holding a renewed license may be required to address the ISG in their next final safety analysis report (FSAR) update.

Therefore, the structured approach described in this instruction should be followed. The process is administered and controlled by the License Renewal Section B in the LicenseRenewal and Environmental Impacts Program (RLEP), Division of Regulatory Improvement Programs (DRIP), NRR. Expected primary contributors to the process are NRR, and the Office of Nuclear Regulatory Research (RES). The ISG coordinator and ISG lead project manager (PM) play vital roles in the ISG process. They are responsible for screening, documenting, planning, tracking, coordinating, and implementing resolutions of license renewal proposed ISGs. Technical reviewers will be assigned to support the development of each ISG.The staff evaluating ISGs should be familiar with the following documents:

10 CFR Part 54 and the associated statements of consideration (60 FR 22461 as amended by 61 FR 65175 and 64 FR 72002)RG 1.188, "Standard Format and Content for Applications to Renew Nuclear PowerPlant Operating Licenses" NUREG-1800, "Standard Review Plan for Review of License Renewal Applications forNuclear Power Plants" (SRP-LR)NUREG-1801, "Generic Aging Lessons Learned (GALL) Report"NEI 95-10, Revision 3, "Industry Guideline for Implementing the Requirements of10 CFR Part 54 - The License Renewal Rule." In using these guidance documents, the staff, industry, or member of the public may discoverguidance that is unclear, incorrect, or incomplete, or may find that new guidance is warranted.

Comments can be provided to the ISG coordinator orally, by e-mail, or by letter. The ISG coordinator will document the comment. Oral comments made during public meetings will be reflected in the meeting summary. Disposition of such oral comments will either be reflected in the meeting summary, a proposed ISG, or a written response to the commenter. Once documented, the issue will be controlled by this process to ensure timely resolution. If thestaff determines that development of an ISG is warranted, then it will issue a Federal Registernotice (FRN) requesting comments (60 day comment period) on the proposed ISG. At any step during the process, a proposed ISG can be modified or determined to be unnecessary. If a proposed ISG is determined to be unnecessary, the staff will document the closure of the issue in a letter to the interested stakeholders, and a FRN. The approved ISGs will be published on the NRC license renewal web site. The ISG will be incorporated into the next revision of the LRG documents. Appendix B to this instruction provides a flow chart of the process.4.2Processing License Renewal Proposed ISGsThe basic activities are as follows:Section 4.2.1 - Screen CommentsSection 4.2.2 - Develop an Evaluation PlanSection 4.2.3 - Evaluation and Transmittal of Proposed ISGSection 4.2.4 - Resolution of Comments on the ISGSection 4.2.5 - Implementation of the Approved ISGThese basic activities are described in the sections below.4.2.1Screen CommentsThe process starts when the NRC staff, industry, or members of the public submit a commentto the ISG coordinator on the LRG documents. Stakeholder requests are expected to be brought to the NRC

's attention via letter, telephone call, or e-mail. Once RLEP is notified, theissue will be referred to the ISG coordinator for review. The ISG coordinator screens, tracks, and documents the comments. The ISG coordinator will screen the comments to determine if development of an ISG iswarranted. Development of an ISG is not necessary if adequate staff guidance is already available. No ISG is developed if the comments are determined to be purely editorial comments. These editorial comments improve the readability and consistency of the documents and would not cause a current or future applicant to revise their LRA. The ISG coordinator will ensure the comments are evaluated for inclusion in the next revision of the LRG documents. The originator will be informed of the resolution. An ISG will be developed if the comment would result in a staff position or guidance that needsto be communicated to external stakeholders, such as current or future applicants, so that they can address it in their LRAs. The staff will commence developing the ISG in accordance with the guidance contained in this document. The ISG coordinator

's actions for this section arediscussed below.ISG Coordinator ActionsThe ISG coordinator will:

Request that the originator forward the basis for the proposed ISG in writing. The basisshould include the need and the underlying regulatory requirement that the proposed ISG would address. The originator should, but is not required to, provide a markup of the LRG to communicate their proposed resolution. External stakeholders should be encouraged to submit their comments in a letter or e-mail to the RLEP program director (PD-RLEP). If needed, the ISG coordinator will arrange a conference call or public meeting to discuss the ISG.Screen the proposed ISG to determine whether interim staff guidance is necessary. The ISG coordinator may involve technical branches from other NRR divisions or NRC offices during the evaluation of the issue.

Ensure that a written response has been provided to the originator within 30 daysfollowing receipt of the proposed ISG. The response should indicate how the issue was previously resolved or the current status of the review. Issue a FRN requesting comment on the proposed ISG (60 day comment period). Thenotice will be a short summary of the proposed ISG and will include the ADAMS accession number for the proposed ISG.4.2.2Develop an Evaluation PlanPlanning the processing of a proposed ISG is a critical step in ensuring that the review iscompleted in a timely and effective manner. The plan is intended to define the scope of the review, the resources needed for the review, and the schedule for resolution.Developing the evaluation plan involves the following activities:

The ISG coordinator should determine the schedule for completing initial review anddiscuss this determination with the Chief of RLEP License Renewal Section B for confirmation.The ISG coordinator should discuss the schedule for completing the initial review with the originator.The Chief of RLEP License Renewal Section B will assign an ISG lead PM for eachproposed ISG to develop a proposed resolution. Upon acceptance of a proposed ISG, the ISG lead PM will obtain a technicalassignment control (TAC) number, if necessary. This provides a means of tracking the resources expended and the work activities on each review. Separate TAC numbers are appropriate if significant resources (i.e., more than eight hours) are expected to be expended for a particular issue.The ISG lead PM will assess the proposed ISG to define the scope, resources, andschedule for resolution. This should include a discussion with the technical branch to determine the type of ISG (i.e., clarification or compliance).The ISG lead PM will be responsible for coordinating the activities documented in theevaluation plan, monitoring the progress of these activities, and reporting the status of the review to the ISG coordinator for tracking by RLEP.The ISG lead PM will be responsible for obtaining clarification of the input from theoriginator or stakeholder. It is expected that the input will be clearly written with a proposed resolution for the identified concern. The input should, but is not required to include a markup of the guidance document that warrants modification.The ISG coordinator will track and monitor the proposed ISG

's progress towardresolution.4.2.3Evaluation and Transmittal of Proposed ISGs4.2.3.1 Evaluation of Proposed ISGsThere are two types of ISGs, (1) clarification ISGs and (2) compliance ISGs. Clarification ISGsprovide additional guidance to applicants that the staff or stakeholders feel is necessary to reduce unnecessary RAI. Clarification ISGs do not create new staff positions that have not been addressed by previous applicants. Clarification ISGs can inform applicants that more information is needed on an issue already addressed in the LRG documents. Clarification ISGs do not apply to licensees holding a renewed license. Compliance ISGs involve compliance with the regulations and therefore do apply to licensees holding a renewed license.The memorandum transmitting the proposed ISG from the branch chief of the technical branchto the PD-RLEP will specify if the ISG is a clarification or compliance ISG. The transmittal memorandum for clarification ISGs may be signed by the branch chief. The transmittal memorandum for compliance ISGs will contain a documented evaluation. The technical branch division director's concurrence in the memorandum is necessary. The ISG lead PM will coordinate the review and the proposed resolution. Office of GeneralCouncil (OGC) review of a proposed ISG is necessary. The ISG lead PM assigned to resolve the proposed ISG is also responsible for coordinating the staff

's evaluation with all involvedbranches and offices.Proposed ISGs involving multiple branches and/or offices may result in scheduling andresource conflicts or staff disagreements on the proposed resolution of the issue. The ISG lead PM is responsible for notifying management and the ISG coordinator of these conflicts and forcoordinating discussions that lead to a consensus staff position.Some proposed ISGs may involve policy issues that warrant Commission involvement. Theseissues can be identified at any time in the planning and evaluation process and need to be discussed with the PD-RLEP as soon as the potential for a Commission-level issue is identified.

RLEP will document the proposed ISG, the proposed options, and a staff recommendation before presenting the proposed ISG to management for submittal to the Commission. Upon receipt of the Commission

's directions on the ISG, the staff will take the appropriate actionimplementing the Commission

's decision. 4.2.3.2 Transmittal of Proposed ISGsOnce a proposed ISG is developed, it will be documented and transmitted to the originator andstakeholders for feedback. The ISG coordinator will issue an FRN requesting comment on the proposed ISG (60 day comment period). The notice will be a short summary of the proposed ISG and will include the ADAMS accession number for the proposed ISG. The following provides guidance for the format and content that should be used for all lSGs:Issue Heading: A short summary or description of the issue (one or two sentences). Keyword searches inADAMS could be generated from the summary, so it is beneficial to be specific.Staff Position:This section describes the proposed ISG and the proposed resolution. Rationale:This section should provide a description of the issue in sufficient detail, such that an informedreader can understand the issue, its basis, significance, applicability (e.g., generic, BWRs only),

and ramifications. The staff will document its analysis of the proposed ISG in terms of regulatory requirements, established staff positions, industry standards, or other relevant criteria.

References:

List references mentioned in the ISG text. These could include the ASME and ANSI Codes,NUREGs, other ISGs, Part 54 subsections, and Regulatory Guides.Attachments:This section contains the staff

's markup of existing or new guidance that implements orincorporates the staff

's proposed resolution of the issue (including the SRP-LR, GALL,RG 1.188, and/or NEI 95-10) and should normally be provided for all changes. 4.2.4Resolution of Comments on the ISGIt is the ISG lead PM

's responsibility to prepare a letter to solicit comments on the proposedresolution of the issue. The letter should be addressed to NEI and to the Union of Concerned Scientists (UCS), as the coordinator for public interest groups and published on the NRC license renewal web site. Current license renewal applicants, other stakeholders on the license renewal service list, and the originator will be sent a copy of the letter. Typically, the letter should be reviewed by the technical branch supporting the ISG, OGC, and PD-RLEP. Review and concurrence should ensure the quality and consistency of the proposed resolution of the issue. Typically, the letter will request comments on the proposed ISG within a 60-day period.

For complex issues, a longer comment period may be considered. At the same time a FRN requesting comments on the proposed ISG will be issued with the same comment period as the letter.Comments should be provided in writing to the PD-RLEP within the comment period. A publicmeeting or conference call (minutes to be published in ADAMS) may be conducted to clarify the concern. Appropriate comments will be addressed in approved ISG published on the NRC web

site.Once the staff has made its determination, the proposed ISG will be considered resolved. Thefinal resolution could be approval or a determination that the proposed ISG is unnecessary.

The division director of DRIP will normally sign all proposed resolution letters, unless otherwise specified by NRR Office Instruction ADM-200, "Delegation of Signature Authority." The staff will post the approved ISG on the NRC License Renewal web page for staff and industry use and will issue an FRN informing stakeholders that an ISG has been approved and is available on the NRC web site. The FRN will reference the ADAMS accession number for the approved ISG. At this point, the approved ISG will have a number designation and an implementation date. The ISG can then be referenced in an applicant

's LRA or as part of the LRA regulatoryreview process. The ISG will be incorporated into the next revision of the LRG documents. 4.2.5Implementation of the Approved ISGImplementation of compliance ISGs affects both future and current applicants. Futureapplicants will address the ISG in their LRA. Current applicants will address the approved ISG by responding to an RAI, by addressing an open item in the draft SER, or by supplementing their application.For licensees holding a renewed license, the license renewal regulation in 10 CFR 54.37(b)require:After the renewed license is issued, the FSAR update required by 10 CFR50.71(e) must include any systems, structures, and components newly identified that would have been subject to an aging management review or evaluation of time-limited aging analyses in accordance with

§54.21. This FSAR update mustdescribe how the effects of aging will be managed such that the intended function(s) in

§54.4(b) will be effectively maintained during the period ofextended operation. Therefore, only for ISGs involving newly identified systems, structures and components (SSCs)that would have been subject to an aging management review or evaluation of time-limited aging analyses in accordance with 10 CFR 54.21, the regulations require a licensee holding a renewed license to submit in its next FSAR update a description of how the effects of aging will be managed. ISGs that do not involve newly identified SSCs would for licensees holding a renewed license, be subject to the requirements of the 10 CFR 50.109, the backfit rule. For example, for licensees holding a renewed license, a change to an existing aging management program would require a backfit evaluation in accordance with 10 CFR 50.109.ISGs apply to the period of extended operation. Since licensees will not enter the period ofextended operation until after the LRG documents are updated, the staff will wait until the ISGs have been incorporated into the LRG documents before informing the licensees of the requirement to include the information on the applicable ISGs in their next FSAR update. The review process for revising NUREGs, like NUREG 1800 and 1801, involves public comment and review by the Committee to Review Generic Requirements. After the LRG documents have been revised to include the ISGs the staff will send a letter to each licensee holding a renewed license informing them of the ISGs they need to address in their next FSAR update.

5.0RESPONSIBILITIES AND AUTHORITIESAll NRC staff members who participate in the review and inspection of license renewalprograms and activities are responsible for reading, understanding, and applying the guidance in this instruction.5.1Roles and Responsibilities for the Review of ISGsA.GENERALDivision of Regulatory Improvement ProgramsThe DRIP director is responsible for the overall development and implementation of thelicense renewal program and license renewal activities.License Renewal and Environmental Impacts ProgramThe PD-RLEP is responsible for oversight of license renewal activities, processdevelopment activities, overall regulatory compliance, and implementation of the license renewal program. The Chief of RLEP License Renewal Section B (RLEP-B) is responsible for the generaloversight and implementation of license renewal work planning activities. The RLEP-B section chief will provide direction and assistance in the development and approval of evaluation plans to ensure effective allocation of resources, responsiveness, and quality of work. The RLEP-B section chief assigns the ISG coordinator, ISG lead PM and the project managers to work with the technical staff to develop the ISGs. The ISG coordinator is responsible for the initial review, tracking the ISG through toresolution. The ISG Coordinator is also responsible for maintaining the list of licensees holding renewed licenses to which the approved compliance ISG applies. The ISG Coordinator will prepare, for signature by the director of DRIP, the letter requesting the licensees holding renewed license to ensure their FSARs are updated to include the compliance ISGs. The ISG lead PM is responsible for clarifying the issue with the originator, drafting orrevising the assigned proposed ISG, obtaining a TAC number, working with the cognizant staff to address the issue, resolving any comments received during the ISG review process, and processing the draft or revised ISG through the various levels of review both inside and outside of RLEP. The ISG lead PM will be the point of contact for their assigned ISG.

Technical BranchesThe technical branches evaluate the technical aspects of the proposed ISG. Staff involved with the review should be familiar with the requirements of the rule; the guidance provided in the statements of consideration that accompanied the rule, the staff SRP-LR, the GALL report, and RG 1.188; and the industry guidance in NEI 95-10.

The technical branches are responsible for developing the documented evaluations for compliance ISGs.NRR ManagementDivision directors, program directors, and the regions will assist in resolving concernsrelating to the ISG, including schedules, resources, priorities, and technical issues.The Office of the General CounselReviews the ISG from a regulatory and legal perspective.

Offices/Divisions/BranchesOther offices, divisions, and branches are responsible for reviewing and concurringconsistent with the established schedule.6.0PERFORMANCE MEASURESThe ISG coordinator should provide an annual status update to the RLEP program director. The performance measures provide the following goals:Provide a response to the originator on the status and potential resolutionapproach within 30 days of initial contact with RLEP.Issue 90 percent of the proposed ISGs for comment within 180 days of initialcontact with RLEP. Issue 90 percent of the final ISG positions within 120 days of the end of thecomment period provided in the comment letters.Issue 100 percent of the final ISG positions within two years.7.0PRIMARY CONTACTJack Cushing, NRR/DRIP/RLEP, (301) 415-1424, JXC9@NRC.GOV8.0RESPONSIBLE ORGANIZATIONNRR/DRIP/RLEP9.0EFFECTIVE DATEAugust 15, 2003

10.0REFERENCES

1.10 CFR Part 54, "Requirement for Renewal of Operating Licenses for Nuclear PowerPlants."2.Regulatory Guide 1.188, "Standard Format and Content for Applications to RenewNuclear Power Plant Operating Licenses." 3.NUREG-1800, "Standard Review Plan for Review of License Renewal Applications forNuclear Power Plants." (SRP-LR)4.NUREG-1801, "Generic Aging Lessons Learned (GALL) Report."

5.NEI 95-10, Rev. 3, "Industry Guidelines for Implementing the Requirements of10 CFR Part 54 - The License Renewal Rule."6.NRR Office Letter No. 500, Rev. 2, "Procedures for Controlling the Development of Newand Revised Generic Requirements for Power Reactor Licensees." Appendix A: Change HistoryThis is a new instruction.

Appendix B: Interim Staff Guidance Memorandum Process Flow Chart NRC Response toNEI Comments on ISG ProcessEnclosure 2 By letter dated October 29, 2002, NEI provided the following comments on the interim staffguidance (ISG) process.NEI Comment:We believe that the backfitting of license renewal evaluations falls into twodistinct categories: those of the current term through the 10 CFR 50 regulations, and those of the extended period of operation. A license renewal backfit evaluation for the current term might apply to plants, whether or not a plant had applied for renewal.

Response:The license renewal ISG process only applies to applicants for license renewal and licenseesholding renewed licenses. The license renewal rule contains a provision in 10 CFR 54.37(b) for requiring licensees holding a renewed license to include in the final safety analysis report (FSAR) update any systems, structures and components (SSCs) newly identified that would have been subject to an aging management review or a time-limited aging analyses in accordance with 10 CFR 54.21. Therefore, license renewal ISGs involving matters covered by 10 CFR 54.37(b) do not involve backfits. However, ISGs that do not involve newly identified SSCs, would for licensees holding a renewed license, be subject to the requirements of 10 CFR 50.109, the backfit rule. For licensees holding a renewed license, the license renewal regulations in 10 CFR 54.37 (b)require:After the renewed license is issued, the FSAR update required by 10 CFR50.71(e) must include any systems, structures, and components newly identified that would have been subject to an aging management review or evaluation of time-limited aging analyses in accordance with

§54.21. This FSAR update mustdescribe how the effects of aging will be managed such that the intended function(s) in

§54.4(b) will be effectively maintained during the period ofextended operation. Therefore, only for ISGs involving newly identified SSCs that would have been subject to anaging management review or evaluation of time-limited aging analyses in accordance with 10 CFR 54.21, the regulations require a licensee holding a renewed license to submit in its next FSAR update a description of how the effects of aging will be managed. ISGs apply to the period of extended operation. Since licensees will not enter the period ofextended operation until after the license renewal guidance (LRG) are updated, the staff will wait until the ISGs have been incorporated into the LRGs before informing the licensees of the requirement to include the information on the applicable ISGs in their next FSAR update. After the LRGs have been revised to include the ISGs the staff will send a letter to each licensee holding a renewed license informing them of the ISGs they need to address in their next FSAR update. NEI Comment:Second, we have suggested a clarification and an expansion of the Office ofGeneral Counsel

's (OGC's) role in the process. We believe that OGC shoulddetermine whether the ISG is providing an improvement to the process beyond the regulations, thus, constituting a backfit, or whether the ISG represents a clarification that is necessary to comply with the regulations. In each case, OGC will provide a review and determination of the ISG's consistency with the current regulations. In the cases where backfit considerations are involved, OGC's input should clearly indicate whether the ISG was developed to establish compliance with some regulatory provisions where the industry would not necessarily otherwise be in compliance or whether the ISG represents only an improvement or clarification that is beyond the interpretation of 10 CFR 50 or 10 CFR 54 requirements (10 CFR 50.109).

Response:The ISGs are generally identified by a technical branch in the Office of Nuclear ReactorRegulation (NRR) to address a technical issue. The technical staff with branch chief review initially determines whether the issue involves a clarification only, or whether 10 CFR Part 54 requires that the license renewal applications address the issue. Only branch chief concurrence is needed for a clarification issue. If the issue involves compliance with the regulations, then the responsible division director reviews the issue. OGC's role in these matters is discussed below.NEI Comment:In each case, OGC will provide a review and determination of the ISG'sconsistency with the current regulations. In the cases where backfit considerations are involved, OGC's input should clearly indicate whether the ISG was developed to establish compliance with some regulatory provisions where the industry would not necessarily otherwise be in compliance or whether the ISG represents only an improvement or clarification that is beyond the interpretation of 10 CFR 50 or 10 CFR 54 requirements. On these issues, OGC determinations will be made available to the public.

Response:While OGC reviews all ISGs, OGC

's advice to the staff is protected by attorney-client privilegeand is not released to the public. NEI Comment:Finally, we believe this document provides an opportunity to significantly improvethe overall stability and predictability of the rule for future applicants. The method for providing this improvement rests with establishing a more formal process for determining whether those ISGs that do not pass a backfit evaluation should even be issued. We suggest that the NRC perform a formal evaluation of the ISG impact on stability and predictability of the change vs. the benefit and establish that there is a clear benefit with proceeding with issuing these ISGs.

Response:One of the staff

's goals in developing the ISG process was to reduce unnecessary regulatoryburden by increasing the stability and predictability of the license renewal process. The other goal was to improve the effectiveness and efficiency of the process of updating the license renewal guidance documents. The staff does issue a documented evaluation with each ISG.

The documented evaluation provides a description of the issue in sufficient detail, such that an informed reader can understand the issue, its basis, significance, applicability (e.g., generic, BWRs only), and ramifications. The staff will document its analysis of the proposed ISG in terms of regulatory requirements, established staff positions, industry standards, or other relevant criteria.