ML100920158

License Renewal Interim Staff Guidance Process Revision 2

ML100920158
Person / Time
Issue date:	06/14/2010
From:	Matthew Homiack NRC/NRR/DLR/RPOB
To:	Keys J Nuclear Energy Institute
Homiak, M, NRC/NRR/DLR/RLRB, 415-1683
References
Download: ML100920158 (20)

Text

License Renewal Interim Staff Guidance Process Revision 2 1.0 OVERVIEW Title 10 of the Code of Federal Regulations (10 CFR), Part 54, "Requirements for Renewal of Operating Licenses for Nuclear Power Plants," hereafter referred to as the "License Renewal Rule," governs the issuance of renewed operating licenses for nuclear power plants. To facilitate implementation of the License Renewal Rule and the review of license renewal applications (LRAs), the U.S. Nuclear Regulatory Commission (NRC or the staff) develops and publishes license renewal guidance documents.

The staff, industry, and stakeholders gain experience and develop lessons learned with each renewed license. Through use of the license renewal guidance documents, the staff, industry, or stakeholders may discover areas for improvement or that warrant new guidance. The staff developed a process to capture and communicate interim guidance for new insights, lessons learned, and emergent issues to create a license renewal program that progressively improves. The staff established this process in, "The Interim Staff Guidance Process," dated December 12, 2003, which is available in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No. ML023520620.

Under this process, the staff, industry, or stakeholders can propose a change to certain license renewal guidance documents. The staff evaluates the issue, develops proposed interim staff guidance (ISG), issues an ISG for public comment, evaluates any comments received, and, if necessary, issues a final ISG. The ISG is then used until the staff incorporates it into a formal license renewal guidance document revision.

This revision to the LR-ISG process is fundamentally the same as the original process, but incorporates the changes and enhancements described in Appendix A, "Change History." The staff changed the title for the process to make clear that it only applies to LR-ISGs, not other kinds of NRC ISG.

2.0 BACKGROUND

2.1 Safety Review

The License Renewal Rule governs the issuance of renewed operating licenses for nuclear power plants. To facilitate the staff's safety review of programs and activities associated with LRAs, the staff has developed these safety license renewal guidance documents:

• NUREG-1800, Revision 1, "Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants" (SRP-LR)

• NUREG-1801, Revision 1, Volumes 1 and 2, "Generic Aging Lessons Learned (GALL) Report" (GALL Report)

• Regulatory Guide (RG) 1.188, Revision 1, "Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses" (RG 1.188)

The staff published Revision 1 of the above documents in September of 2005.

The SRP-LR provides guidance to the staff reviewers in the Office 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 staff's review process. Individual SRP-LR sections address (1) who performs the review, (2) the matters that are reviewed, (3) the basis for the review, (4) the way the review is accomplished, and (5) the conclusions that are sought.

The GALL Report evaluates existing licensee programs generically to document conditions under which these programs are considered by the NRC staff to be adequate to manage identified aging effects without change, and the conditions under which these programs should be augmented for this purpose.

RG 1.188 provides guidance to an applicant on the information to be submitted in an LRA, and provides a uniform format which is acceptable to the staff for structuring and presenting this information. RG 1.188 also endorses the Nuclear Energy Institute (NEI) document NEI 95-10, Revision 6, "Industry Guideline for Implementing the Requirements of 10 CFR Part 54 - The License Renewal Rule," as an acceptable method for implementing the requirements of the License Renewal Rule. The NEI License Renewal Implementation Guideline Task Force and the NEI License Renewal Working Group developed NEI 95-10 for industry implementation of the License Renewal Rule.

2.2 Environmental Review Part 51, "Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions," of 10 CFR, hereafter referred to as the "Environmental Protection Rule," governs the environmental review of renewed operating licenses for nuclear power plants. To facilitate implementation of the Environmental Protection Rule and review of environmental impacts associated with an LRA, the staff has developed these environmental license renewal guidance documents:

• NUREG-1555, "Environmental Standard Review Plan," Supplement 1, "Operating License Renewal" (ESRP-LR)

• NUREG-1437, Volumes 1 and 2, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants" (GEIS)

• NUREG-1437, Addendum 1, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants, Main Report, Section 6.3 - Transportation, Table 9.1, Summary of findings on NEPA issues for license renewal of nuclear power plants, Final Report" (GEIS Addendum 1)

• RG 4.2, Supplement 1, "Preparation of Supplemental Environmental Reports for Applications to Renew Nuclear Power Plant Operating Licenses" The ESRP-LR provides guidance to staff reviewers in implementing provisions of the Environmental Protection Rule related to the environmental aspects of reactor operating license renewals. Reviews conducted following the ESRP-LR lead to preparation of site-specific environmental impact statement supplements to the GEIS.

The GEIS examines the possible environmental impacts that could occur as a result of renewing the licenses of individual nuclear power plants under the License Renewal Rule. The GEIS, to the extent possible, establishes the bounds and significance of potential impacts. The analyses in the GEIS encompass all operating light-water power reactors. For each type of environmental impact, the GEIS attempts to establish generic findings covering as many plants as possible. The GEIS has three principal objectives: (1) provide an understanding of the types and severity of environmental impacts that may occur as a result of license renewal of nuclear power plants under the License Renewal Rule, (2) identify and assess those impacts that are expected to be generic to license renewal, and (3) support an environmental rulemaking to define the number and scope of issues that need to be addressed by the applicants in plant-by-plant license renewal proceedings. To accomplish these objectives, the GEIS makes maximum use of environmental and safety documentation from original licensing proceedings and information from State and Federal regulatory agencies, the nuclear utility industry, publicly available documents, and professional contacts.

GEIS Addendum 1 documents the staff's analysis of the potential cumulative impacts of transporting spent nuclear fuel in the vicinity of a single high-level waste repository, and summarizes the staff's analyses undertaken to determine whether the environmental impacts of the transportation of higher enrichment and higher burnup spent nuclear fuel are consistent with the values of 10 CFR 51.52, Table S-4. The study is a generic analysis of the cumulative impacts associated with transportation of spent nuclear fuel as a result of nuclear power plant license renewal. The results of the analysis were used to amend 10 CFR 51.53 and Appendix B to Subpart A of 10 CFR Part 51, on September 2, 1999 (Volume 64, Page 48496 of the Federal Register), and were not intended to support any other regulatory decision by the NRC. This addendum also includes an appendix that summarizes comments on the draft of the addendum, and documents the staff's responses to those comments.

The purpose of RG 4.2, Supplement 1, is to provide guidance on the format and content of an Environmental Report to be submitted as part of an application for the renewal of a nuclear power plant operating license, submitted pursuant to the License Renewal Rule. This RG explains how applicants may meet the provisions for the environmental review for nuclear power plant operating licenses, as found in the Environmental Protection Rule. Use of this RG will help ensure the completeness of the information provided, assist the staff and others in locating the information, and shorten the review process.

3.0 OBJECTIVES The purpose of this LR-ISG process is to ensure that proposed changes to certain license renewal guidance documents are properly evaluated, documented, and implemented. This process provides NRR staff with the basic framework to develop and implement LR-ISGs, and establishes the roles, responsibilities, and authorities for NRR staff involved in processing proposed license renewal guidance document changes. Other goals of this process are to:

• ensure the continued health and safety of the public and protection of the environment,

• improve public confidence in the license renewal process,

• implement a documented and controlled license renewal review process, and

• maintain a consistent, effective, and efficient review process.

The structured LR-ISG process will help to provide stability, predictability, and efficiency to the NRC's license renewal program.

4.0 THE LR-ISG PROCESS 4.1 Overview

The LR-ISG process covers the basic framework and procedures for development and implementation of LR-ISGs. The flow diagram in Appendix B, "The LR-ISG Process," shows the decision logic made during the LR-ISG process. Under the LR-ISG process the staff or stakeholders may propose changes to the license renewal guidance documents within the scope of this process. These documents are:

• SRP-LR

• GALL Report

• RG 1.188

• ESRP-LR

• RG 4.2, Supplement 1 Although the GEIS is a license renewal guidance document, changes can only be made through the NRC's rulemaking process. Therefore, changes to the GEIS are not within the scope of the LR-ISG process. The public can comment on the GEIS when the staff performs updates, or request changes through the 10 CFR 2.802 petition process.

The staff will track receipt of proposed changes to the license renewal guidance documents to ensure their timely resolution. The staff will screen proposed changes, as described in Section 4.2.1, to determine whether there is a need to further evaluate them. The staff will document the issue and proceed to further evaluate it from a technical and regulatory perspective. If the staff determines that the issue warrants a change to an existing license renewal guidance document, then the staff will develop a draft LR-ISG and issue it for public comment. After the comment period closes, the staff will decide whether to issue a final LR-ISG with modifications based on the comments, or eliminate the LR-ISG. The staff will document its resolution of all comments received on the draft LR-ISG. Final LR-ISGs will be published in the Federal Register, posted on the NRC License Renewal Web site, and sent to interested stakeholders. If a draft LR-ISG is determined to be unnecessary, the staff will document closure of the issue and inform interested stakeholders.

Once approved, the final LR-ISG supersedes prior guidance in the appropriate license renewal guidance documents. The staff will follow this new guidance when reviewing LRAs. The staff will incorporate the guidance into a formal license renewal guidance document revision. Current and future license renewal applicants should address LR-ISGs in the license renewal process. Renewed license holders may voluntarily use LR-ISGs and, if certain conditions are met, they may be required to use an LR-ISG.

Public involvement is an integral part of the LR-ISG process. The NRC affords the public opportunities to obtain information and to comment on each draft LR-ISG through solicitations in the Federal Register. Further, the staff publishes LR-ISGs on the NRC License Renewal Web site, makes them available in ADAMS, and holds public meetings, as appropriate.

NRR's Division of License Renewal (DLR) administers and controls the LR-ISG process, and other NRR organizations and the Office of Nuclear Regulatory Research are the expected primary contributors. Within the Programs Operations Branch (RPOB) of DLR, an assigned LR-ISG Project Manager (PM) serves a vital role in the overall LR-ISG review process. The LR-ISG PM is principally responsible for screening proposed changes and for LR-ISG documentation, planning, tracking, coordination, resolution, and implementation. Technical reviewers within DLR and other NRR technical divisions support LR-ISG development.

4.2 LR-ISG Development 4.2.1 Screening

External stakeholders should submit proposed changes to license renewal guidance documents by letter to the Director of DLR. Changes proposed by internal staff may be submitted to DLR orally, by e-mail, or by internal memorandum, provided they have approval from a branch chief or above. DLR will document receipt of any proposed changes with either a written response to the originator or with a public meeting summary. The originator should also provide the basis for the proposed changes in writing. The basis should, but is not required to, address the need for the proposed changes and the underlying regulatory requirements.

After receipt of proposed changes, the DLR RPOB Branch Chief will assign an LR-ISG PM to manage the activities. Throughout the process the LR-ISG PM is principally responsible for entering the proposed changes into the LR-ISG tracking system, obtaining a technical assignment control (TAC) number, tracking the overall evaluation status, and ensuring the staff documents receipt of the proposed changes. The LR-ISG PM will then coordinate with the appropriate technical staff to screen the proposed changes to determine whether the issues raised could result in the potential need for interim staff guidance. Screening will assess whether the proposed changes:

• constitute a matter relevant to compliance with the license renewal requirements as established in the License Renewal Rule or the Environmental Protection Rule,

• concern a license renewal guidance document within the scope of the LR-ISG process (as stated in Section 4.1),

• address matters for which adequate guidance already exists, and

• are editorial in nature.

The screening assessment may involve, as necessary, staff from other NRR technical branches, the Office of Nuclear Regulatory Research, and the Office of the General Counsel (OGC). The LR-ISG PM will arrange teleconferences or public meetings, when necessary, to obtain clarification or additional information on proposed changes submitted by external stakeholders.

Based on the final screening determination, the staff will evaluate the changes to determine if they are relevant to documents within the scope of the LR-ISG process. The staff will develop a draft LR-ISG if the proposed changes would result in a staff position or need for guidance. The staff will not continue evaluation of the proposed changes if it determines that adequate guidance already exists or that the changes are editorial. Editorial changes improve the readability and consistency of the license renewal guidance documents, but would not need to be addressed in an LRA. The LR-ISG PM will document editorial changes for consideration when the staff develops the next license renewal guidance document revision.

The staff will respond by letter to inform the originator of the final screening determination. This letter will include the basis for the staff's screening determinations as appropriate. Disposition of proposed changes submitted orally may be reflected in a meeting summary. The staff will also communicate the screening resolution to other stakeholders. If appropriate, the staff will further evaluate the proposed changes and may, based on this evaluation, issue a draft LR-ISG for public comment.

4.2.2 Evaluation If the staff determines that a proposed change warrants further evaluation and may result in the issuance of a draft LR-ISG, the LR-ISG PM will assign an appropriate tracking number and post it on the NRC License Renewal Web site. The LR-ISG PM will also notify NEI of the potential LR-ISG.

The LR-ISG PM will prepare an evaluation plan to ensure the staff completes review of the potential LR-ISG in a timely and effective manner. The evaluation plan clearly defines the review scope, resources needed, and planned resolution schedule. During this planning, consideration should be given to the complexity of the issues, the relative need for the potential changes, and the various NRC organizations that will participate in the review. Special consideration should be given to policy issues that may warrant a Commission decision or issues that could result in a new or different applicable staff position. Also, a new or different staff position may require the draft LR-ISG to be evaluated as a "generic backfit" in accordance with NRR office instructions.

The LR-ISG PM will finalize the evaluation plan with the DLR RPOB Branch Chief and provide the schedule in the letter to the originator. The LR-ISG PM will obtain a TAC number to track the resources expended and the work activities associated with the review. The LR-ISG PM will issue work requests for completing the evaluation.

Staff evaluating and managing LR-ISGs should be knowledgeable of the appropriate license renewal guidance documents (SRP-LR, GALL Report, RG 1.188, NEI 95-10, Revision 6, ESRP-LR, GEIS, GEIS Addendum 1, and RG 4.2, Supplement 1), NRC regulations (the License Renewal Rule and the Environmental Protection Rule), and the associated statements of considerations for these Rules, as published in the Federal Register. This staff should also be knowledgeable of the requirements in Section 109, "Backfitting," of 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" (10 CFR 50.109), and of NRC backfitting procedures and guidance. Staff involved with developing or evaluating LR-ISGs must be knowledgeable to recognize situations when the potential exists for a new or different staff position or when a new or different interpretation of existing requirements is being developed as a result of a proposed staff action.

Although LR-ISGs can constitute backfitting, there is an important exception whereby the staff need not consider backfitting in its LR-ISG evaluation. This exception applies when the LR-ISG addresses "newly identified" systems, structures, and components (SSCs) per 10 CFR 54.37(b). Backfitting, in accordance with 10 CFR 50.109, does not apply to the requirements of 10 CFR 54.37(b). Therefore, the staff will first evaluate each potential LR-ISG to determine whether it addresses "newly identified" SSCs. The "Discussion" section of NRC Regulatory Issue Summary (RIS) 2007-16, "Implementation of the Requirements of 10 CFR 54.37(b) for Holders of Renewed Licenses," provides guidance as to which SSCs are considered "newly identified" and, therefore, subject to the requirements of 10 CFR 54.37(b). In addition, consultation with OGC on applicability of 10 CFR 54.37(b) is recommended. If the staff determines that the LR-ISG addresses "newly identified" SSCs, then the LR-ISG will contain appropriate documentation to support the staff's rationale as to why 10 CFR 54.37(b) applies to the LR-ISG. Documentation on applicability of 10 CFR 54.37(b) is to be provided in the "Newly Identified Systems, Structures, and Components under 10 CFR 54.37(b)" section of the LR-ISG, as indicated in Appendix C, "LR-ISG Format and Content," to this procedure.

If the potential LR-ISG does not address "newly identified" SSCs, then the staff must determine whether the LR-ISG constitutes backfitting, as defined in 10 CFR 50.109(a)(1). It is important to note that backfitting of the license renewal requirements does not apply to current or future license renewal applicants, but does apply to renewed license holders. Therefore, the staff must comply with the requirements of the backfit rule when seeking to impose new or different license renewal requirements or staff positions upon holders of renewed licenses. As LR-ISGs are generic in nature, NRR Office Instruction LIC-400, Revision 1, "Procedures for Controlling the Development of New and Revised Generic Requirements for Power Reactor Licensees,"

applies to the LR-ISG development activity, and the staff will follow its procedures to address the generic backfitting issues. In addition, detailed guidance on the backfitting process is in NUREG-1409, "Backfitting Guidelines," dated June 1990. Early consultation with an OGC backfitting expert is strongly advised if the LR-ISG raises any potential backfitting implications.

If the staff determines that the LR-ISG constitutes backfitting, then appropriate documentation must be prepared to satisfy the requirements of the backfit rule. This documentation is either (1) a systematic analysis demonstrating that the backfit results in a cost-justified substantial safety increase, as required by 10 CFR 50.109(a)(2) and 10 CFR 50.109(a)(3), or (2) a documented evaluation demonstrating applicability of one or more of the exceptions of 10 CFR 50.109(a)(4)(i) though (iii). Documentation on applicability of 10 CFR 50.109 is to be provided in the "Backfitting Discussion" section of the LR-ISG, as indicated in Appendix C to this procedure.

LR-ISGs developed to clarify existing guidance do not constitute backfits. As an example, on several previous LRA reviews, the staff may have consistently reviewed and approved the same exception concerning a specific GALL Report aging management program. Generically communicating this approved exception through an LR-ISG would not create a new or different staff position and would therefore not meet the definition of backfitting per 10 CFR 50.109(a)(1). However, if the staff revised a GALL Report aging management program to include more stringent detection methods, then this change would create a new staff position and require backfitting consideration to impose the new detection requirements upon holders of renewed licenses. The determination as to whether an LR-ISG creates a new or different staff position may be complex; therefore, the LR-ISG PM will ensure that the staff consults with appropriate management and OGC.

During the evaluation process, it may be necessary to obtain clarification or additional information from the originator of the proposed change. The LR-ISG PM will arrange teleconferences or meetings for this purpose. If the staff holds public meetings, the LR-ISG PM will prepare the meeting summary identifying any key issues discussed related to the proposed LR-ISG. The LR-ISG PM may also prepare a draft meeting summary and provide it to the appropriate meeting participants so that they may offer comments before the staff issues the final meeting summary.

Further, the staff may identify at any time during the evaluation process policy issues warranting Commission involvement. In these cases, DLR will coordinate documentation of the proposed LR-ISG, proposed options, and a staff recommendation before presenting the proposed LR-ISG for submission to the Commission.

The staff may also determine at any time during its evaluation that the proposed change does not warrant issuance of an LR-ISG. If so, the staff will document closure of the issue and inform the originator and stakeholders by letter. The LR-ISG PM will also post the staff's decision and rationale on the NRC License Renewal Web site.

The LR-ISG PM will coordinate the evaluation plan activities and report their status throughout the evaluation of the draft LR-ISG. Evaluations that involve input from multiple NRC organizations may result in scheduling and resource conflicts, or disagreements on the proposed resolution of the issue. In these cases, the LR-ISG PM is responsible for notifying management of conflicts and coordinating discussions that lead to resolution of issues.

If, as a result of its evaluation, the staff determines that the proposed changes warrant issuance of a draft LR-ISG for public comment, then the various reviewers will provide their inputs to the LR-ISG PM. Inputs should be transmitted by memorandum to the RPOB Branch Chief.

It is the responsibility of the LR-ISG PM to assemble the input and prepare the draft LR-ISG. The documentation should follow Appendix C and adequately justify the technical and regulatory issues. Special attention should be given to documenting the staff's determinations and rationale as to whether the LR-ISG involves "newly identified" SSCs, per 10 CFR 54.37(b), and if it does not, whether it constitutes backfitting for renewed license holders (i.e., whether it creates a new or different applicable staff position). Further, if the staff determines that the LR-ISG is subject to backfitting, then either a documented evaluation or backfit analysis is required per 10 CFR 50.109 and NRC backfitting instructions and guidance. The LR-ISG PM will make sure the draft LR-ISG is prepared in accordance with guidance in this instruction.

4.2.3 Resolution of Comments After development of a draft LR-ISG, the staff will make the proposed change available to the public for comment. The LR-ISG PM is responsible for transmitting the draft LR-ISG for notice of opportunity to comment in the Federal Register, and to post it on the NRC License Renewal Web site.

The draft LR-ISG will also be transmitted separately to the originator of the proposed change and stakeholders such as NEI, the Union of Concerned Scientists (UCS), current license renewal applicants, and all other stakeholders on the NRC's license renewal mailing list. The draft LR-ISG will receive review and concurrence from the technical group supporting the proposed LR-ISG, OGC, and other technical staff, as appropriate. The staff's review and concurrence process should ensure quality and consistency on the proposed resolution of the issue. The Federal Register notice will request public comments on the draft LR-ISG. The typical comment period is 30 days. For complex issues the staff may consider longer comment periods (i.e., a 45- or 60-day period). Supporting documentation will be made available in ADAMS and posted on the NRC License Renewal Web site, as appropriate in accordance with NRC policies and procedures. The Director of DLR will normally sign the Federal Register notice unless otherwise specified by NRR office instructions.

Public comments on a draft LR-ISG should be submitted as directed in the solicitation for public comment published in the Federal Register. After closing of the comment period, the staff will evaluate all comments received. As necessary, the LR-ISG PM may hold Category 3 public meetings or teleconferences (as defined in NRC Management Directive 3.5, "Attendance at NRC Staff Sponsored Meetings") with stakeholders. Following the public meetings, the LR-ISG PM will prepare a meeting summary. The LR-ISG PM may also issue a draft meeting summary for comment to the appropriate meeting participants before the staff issues the final meeting summary. The LR-ISG PM will coordinate the staff's evaluation and resolution of the public comments, and preparation of a comment response document. Comments on the draft LR-ISG will be considered resolved once the staff has made its final determinations. After receiving comments and holding public meetings as necessary, the staff's final resolution could include a recommendation to approve the draft LR-ISG with or without modification, or eliminate it. If the latter, the staff will document closure of the issue. The staff will prepare a response letter to inform the comment originator and other stakeholders of the final decision. The LR-ISG PM will also make sure to post this determination and the response to public comments on the NRC License Renewal Web site. If the staff determines the guidance to be necessary, then it will proceed to prepare and transmit an approved, final LR-ISG.

4.2.4 Final LR-ISG Issuance

After a determination is made that a final LR-ISG is necessary, the staff will prepare the final LR-ISG documentation. The LR-ISG PM makes sure that the final LR-ISG has the appropriate tracking number designation and implementation date, and that it is developed in accordance with Appendix C. The final LR-ISG documentation should include the appropriate determinations and rationale as described in Section 4.2.2 (i.e., whether the LR-ISG involves "newly identified" SSCs or whether it constitutes backfitting). The staff will issue the final LR-ISG following dispositions on all the public comments received on the draft LR-ISG. The staff dispositions of comments will be summarized or referenced in the Federal Register notice of availability.

After finalizing the LR-ISG, it is the LR-ISG PM's responsibility to transmit it by preparing letters, publishing a notice in the Federal Register, and posting it on the NRC License Renewal Web site. The final LR-ISG will be transmitted separately by letter to the originator and interested stakeholders such as NEI, UCS, current license renewal applicants, and all other stakeholders on the NRC's license renewal mailing list. In addition, if the staff has determined that the final LR-ISG constitutes backfitting under 10 CFR 50.109, or communicates "newly-identified" SSCs under the provisions of 10 CFR 54.37(b), and the staff has documented this determination accordingly, then applicable renewed license holders will be notified of the final LR-ISG as appropriate, for example by issuing plant-specific letters or a generic communication.

The final LR-ISG will receive review and concurrence from the technical group supporting the proposed LR-ISG, OGC, and other technical staff, as appropriate. The staff's review and concurrence process should ensure quality and consistency on the final resolution of the issue. The Director of DLR will normally sign the Federal Register notice unless otherwise specified by NRR office instructions. The LR-ISG PM will ensure that the appropriate documents are made publicly available in ADAMS.

4.3 LR-ISG Implementation

4.3.1 NRC Staff

The staff reviewing LRAs will follow the guidance provided in all final LR-ISGs. Depending on the timing of updates to license renewal guidance documents, the staff will incorporate final LR-ISGs into the next formal revision of the appropriate license renewal guidance documents. All LR-ISGs incorporated into license renewal guidance documents will be closed. However, the staff will maintain a history log for each closed LR-ISG on the NRC's public Web site.

4.3.2 Applicants and Renewed License Holders Current and future license renewal applicants should address all active final LR-ISGs. NEI 95-10, Revision 6, which the NRC endorsed in RG 1.188, states: "[LR-ISGs] that have not been incorporated into license renewal guidance documents should be considered by applicants." NEI 95-10 further recommends that the applicants' LRAs address the LR-ISGs and their approach to each so as to enhance the LRA review efficiency. Therefore, applicants may reference an LR-ISG in the LRA, or may address it as part of the license renewal regulatory review process, either by responding to a request for additional information, addressing an open item in the draft SER, or by supplementing the LRA. Applicants may propose and justify approaches for complying with the regulations that are different from the staff-accepted approaches in LR-ISGs or the license renewal guidance documents.

If a final LR-ISG addresses "newly identified" SSCs per 10 CFR 54.37(b), then a renewed license holder is required to comply with the requirements of 10 CFR 54.37(b), which states:

After the renewed license is issued, the [final safety analysis report] update required by 10 CFR 50.71(e) must include any [SSCs] 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 must describe 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 of extended operation.

All renewed license holders shall adhere to the plant-specific implementation schedule when implementing final LR-ISGs imposed upon them through backfitting. These final LR-ISGs will have been reviewed and found to constitute backfitting, as defined in 10 CFR 50.109(a)(1), and satisfy either of these conditions:

• Meet one or more of the exceptions in 10 CFR 50.109(a)(4)(i) through (iii).

• Constitute a substantial increase in protection to public health and safety or the common defense and security, and the cost is justified in light of the substantial increase.

Otherwise, the regulatory or technical positions in final LR-ISGs may be used by renewed license holders; however, renewed license holders are not required to use the LR-ISG. They may voluntarily choose to use the LR-ISG.

5.0 RESPONSIBILITIES AND AUTHORITIES All staff members who participate in the review and inspection of license renewal programs and activities are responsible for reading, understanding, and applying the guidance described in this LR-ISG process. The specific roles and responsibilities follow.

5.1 Division of License Renewal

DLR is the primary organization with responsibility for overseeing and implementing the LR-ISG process.

The Director of DLR is responsible for the overall development, implementation, and oversight activities of the license renewal program. The Director is also responsible for license renewal activities, process development activities, and overall regulatory compliance.

The DLR Branch Chiefs are responsible for the oversight and implementation of license renewal work planning activities. Branch Chiefs provide direction and assistance in developing and approving evaluation plans to ensure effective allocation of resources, responsiveness, and work quality. The RPOB Branch Chief assigns the lead LR-ISG PM to coordinate work with the technical staff to develop LR-ISGs.

It is the responsibility of the LR-ISG PM to:

• Screen initial proposed changes to the license renewal guidance documents.

• Maintain awareness of the appropriate license renewal guidance documents (SRP-LR, GALL Report, RG 1.188, NEI 95-10, Revision 6, ESRP-LR, GEIS, GEIS Addendum 1, and RG 4.2, Supplement 1), NRC regulations (the License Renewal Rule and the Environmental Protection Rule), and the associated statements of considerations for these rules, as published in the Federal Register. The LR-ISG PM is also knowledgeable of the requirements in 10 CFR 50.109 and of NRC backfitting procedures and guidance.

• Develop the evaluation plan for reviewing LR-ISGs, obtains TAC numbers, and prepares work requests.

• Coordinate the evaluation plan activities and monitors their status throughout the evaluation of an LR-ISG.

• Draft and revise LR-ISGs and process them through the various levels of review and concurrence, both internal and external to DLR.

• Works with staff to address and resolve issues encountered during the evaluation of LR-ISGs.

• Clarify issues with comment providers and arrange for teleconferences or meetings as necessary; prepare and issue summaries for public meetings.

• Notify NEI and other stakeholders of LR-ISGs, prepare Federal Register notices, and update the License Renewal Web site.

It is the responsibility of the engineering technical staff to:

• Evaluate technical aspects of LR-ISGs.

• Be knowledgeable of the appropriate license renewal guidance documents (SRP-LR, GALL Report, RG 1.188, and NEI 95-10, Revision 6), the License Renewal Rule, and its statements of considerations as published in the Federal Register. This staff is also knowledgeable of the requirements in 10 CFR 50.109 and of NRC backfitting procedures and guidance.

• Communicate and coordinate the review status with the designated LR-ISG PM to develop the necessary LR-ISG documentation and resolve public comments.

• Develop documented evaluations and backfit analyses when required.

• Provide lists of the affected license renewal holders.

It is the responsibility of the environmental review staff to:

• Evaluate environmental aspects of LR-ISGs.

• Be knowledgeable of the appropriate license renewal guidance documents (ESRP-LR, GEIS, GEIS Addendum 1, and RG 4.2, Supplement 1), the Environmental Protection Rule, and its statements of considerations as published in the Federal Register. This staff is also knowledgeable of the requirements in 10 CFR 50.109 and of NRC backfitting procedures and guidance.

• Communicate and coordinate the review status with the designated LR-ISG PM to develop the necessary LR-ISG documentation and resolve public comments.

In addition, DLR is responsible for maintaining the list of licensees holding renewed licenses and ensuring they are notified appropriately of the need to consider "newly identified" SSCs in accordance with 10 CFR 54.37(b).

5.2 Other NRR Staff It is the responsibility of staff in the NRR technical branches to:

• Evaluate technical aspects of LR-ISGs.

• Be knowledgeable of the appropriate license renewal guidance documents (SRP-LR, GALL Report, RG 1.188, and NEI 95-10, Revision 6), the License Renewal Rule, and its statements of considerations as published in the Federal Register. This staff is also knowledgeable of the requirements in 10 CFR 50.109 and of NRC backfitting procedures and guidance.

• Communicate and coordinate the review status with the designated LR-ISG PM to develop the necessary LR-ISG documentation and resolve public comments.

• Develop documented evaluations and backfit analyses when required.

• Provide lists of the affected license renewal holders.

NRR management, with assistance from NRC's Regional Offices, as necessary, will assist in resolving issues relating to draft and final LR-ISGs. These issues could concern schedules, resources, priorities, or technical issues.

5.3 OGC OGC reviews all LR-ISGs for consistency with the requirements of the License Renewal Rule, 10 CFR Part 54, and the NRC's requirements for compliance with the National Environmental Policy Act in 10 CFR Part 51, as appropriate. OGC also evaluates LR-ISGs for compliance with the backfit rule (10 CFR 50.109) and the Paperwork Reduction Act.

5.4 Other NRC Organizations

As appropriate, other offices, divisions, and branches are responsible for performing reviews and providing concurrences consistent with the established project schedules.

6.0 PRIMARY CONTACT

Matthew Homiack, NRR/DLR, 301-415-1683 or by e-mail at Matthew.Homiack@nrc.gov.

7.0 RESPONSIBLE ORGANIZATION NRR/DLR 8.0 EFFECTIVE DATE June 14, 2010

9.0 REFERENCES

Title 10, Part 54, "Requirements for Renewal of Operating Licenses for Nuclear Power Plants," of the Code of Federal Regulations. Title 10, Part 51, "Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions," of the Code of Federal Regulations. NRC Regulatory Guide 1.188, Revision 1, "Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses," dated September 2005 (ML051920430).

NRC Regulatory Guide 4.2, Supplement 1, "Preparation of Supplemental Environmental Reports for Applications to Renew Nuclear Power Plant Operating Licenses," dated September 2000 (ML003710495).

NUREG-1409, "Backfitting Guidelines," dated July 1990 (ML032230247).

NUREG-1437, Volumes 1 and 2, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants," dated May 1996 (ML040690705 and ML040690738).

NUREG-1437, Supplement 1, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants, Main Report, Section 6.3 - Transportation, Table 9.1, Summary of findings on NEPA issues for license renewal of nuclear power plants, Final Report," dated August 1999 (ML040690720).

NUREG-1555, "Environmental Standard Review Plan," Supplement 1, "Operating License Renewal," dated March 2000 (ML003702019).

NUREG-1800, Revision 1, "Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants," dated September 2005 (ML052770566).

NUREG-1801, Revision 1, Volumes 1 and 2, "Generic Aging Lessons Learned (GALL) Report," dated September 2005 (ML052770419 and ML052780376).

NEI 95-10, Revision 6, "Industry Guideline for Implementing the Requirements of 10 CFR Part 54 - The License Renewal Rule," dated June 2005 (ML051860406).

NRC Regulatory Issue Summary 2007-16, Revision 1, "Implementation of the Requirements of 10 CFR 54.37(b) for Holders of Renewed Licenses," dated April 28, 2010 (ML100250279).

NRC Management Directive 3.5, "Attendance at NRC Staff Sponsored Meetings," dated April 10, 2007 (ML071220010).

NRR Office Instruction LIC-202, Revision 1, "Managing Plant-Specific Backfits and 50.54(f) Information Requests," dated December 20, 2006 (ML061720504)

NRR Office Instruction LIC-400, Revision 1, "Procedures for Controlling the Development of New and Revised Generic Requirements for Power Reactor Licensees," dated December 20, 2006 (ML061720493).

Appendix A: Change History License Renewal Interim Staff Guidance Process History Date Description of ChangesDecember 12, 2003 Initial issuance of a license renewal interim staff guidance (LR-ISG) process in a document entitled, "The Interim Staff Guidance Process," which is available under ADAMS Accession No. ML023520620. August 7, 2009 Issuance of the "License Renewal Interim Staff Guidance Process, Revision 1," which updates and supersedes the previously issued process. The primary updates are:

• Extending the process to include certain guidance documents associated with the staff's environmental review of license renewal applications, in accordance with 10 CFR Part 51, "Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions."

• Augmenting the process to include evaluation and documentation requirements for determining whether LR-ISGs meet 10 CFR 54.37(b) provisions. The augmentations also focus on backfitting considerations under 10 CFR 50.109 when LR-ISGs do not meet 10 CFR 54.37(b) provisions. The staff made these clarifications and enhancements in response to the NRC's Office of the Inspector General audit on the effectiveness of the license renewal program, as documented in OIG-07-A-15, "Audit of the NRC's License Renewal Program," dated September 6, 2007 (ML072490486). In the report's seventh recommendation the Office of the Inspector General suggested that the staff, "Establish a review process to determine whether or not Interim Staff Guidance meets the provisions of 10 CFR 54.37(b), and document accordingly."

• Eliminating the "clarification" and "compliance" LR-ISG designations. As an alternative, the staff will document the basis for applicability of 10 CFR 54.37(b) or 10 CFR 50.109 in a new backfitting discussion section of each LR-ISG.

• Incorporating updated references to reflect the September 2005 publication of these revised safety license renewal guidance documents: NUREG-1800, Revision 1, "Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants" (ML052770566), NUREG-1801, Revision 1, Volumes 1 and 2, "Generic Aging Lessons Learned (GALL) Report" (ML052770419 and ML052780376), and NRC Regulatory Guide 1.188, Revision 1, "Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses" (ML051920430).

• Name changes that reflect the current Office of Nuclear Reactor Regulation staff organizations.

• Editorial changes and other clarifications.

- A-2 -License Renewal Interim Staff Guidance Process History Date Description of ChangesJune 14, 2010 Includes minor clarifications and administrative changes. Some clarifications concern the staff's review of LR-ISGs to determine applicability of 10 CFR 54.37(b) and 10 CFR 50.109. Other minor changes are in Appendix C, "LR-ISG Format and Content." NRC Regulatory Issue Summary 2007-16, Revision 1, "Implementation of the Requirements of 10 CFR 54.37(b) for Holders of Renewed Licenses,"

dated April 28, 2010, is referenced.

Appendix B: The LR-ISG Process

- B

- B Appendix C: LR-ISG Format and Content

["DRAFT" or FINAL"] LICENSE RENEWAL INTERIM STAFF GUIDANCE LR-ISG-[YEAR]-[No.]

[TITLE] INTRODUCTION

This section contains a short summary or description of the issue. Keyword searches in ADAMS could be generated from the summary, so it is best to be specific.

DISCUSSION

This section discusses the impetus for the LR-ISG and describes the issue in sufficient detail so that an informed reader can understand the issue, its basis, significance, applicability, and ramifications. The staff will document its analysis and rationale of the LR-ISG in terms of regulatory requirements, established staff positions, industry standards, or other relevant criteria.

ACTION This section describes the proposed or final action on the LR-ISG.

NEWLY IDENTIFIED SYSTEMS, STRUCTURES, AND COMPONENTS UNDER 10 CFR 54.37(b)

This section discusses the staff's determination and rationale as to whether the LR-ISG addresses newly identified systems, structures, and components under 10 CFR 54.37(b).

BACKFITTING DISCUSSION

This section discusses the staff's determination and rationale as to whether the LR-ISG constitutes backfitting (i.e., whether it creates a new or different applicable staff position). If the staff determines that the LR-ISG constitutes backfitting, then this section includes, or references, either the documented evaluation or backfit analysis, as required by 10 CFR 50.109.

APPENDICES Appendices provide additional information related to the LR-ISG, and are identified by letter (i.e., "Appendix A", "Appendix B," and so forth). As appropriate, appendices will contain mark-ups which show changes to the current license renewal guidance documents. In final LR-ISGs, the comment response document will be included as an appendix.