ML23219A073

TEC-002 Rev 4 Procedures for Processing Generic Issues

ML23219A073
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Issue date:	06/04/2024
From:	O'Donnell E NRC/RES/DE/RGDB
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TEC-002, Rev 4
Download: ML23219A073 (43)

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OFFICE OF NUCLEAR REGULATORY RESEARCH RES OFFICE INSTRUCTION Office Instruction No.

TEC-002, Revision 4 Approved by: John R. Tappert, Acting Date: June 4, 2024 Office Instruction Title Procedures for Processing Generic Issues Effective Date Review Date June 4, 2024 June 4, 2029 Primary Contact Edward ODonnell Responsible Division RES/DE ADAMS Accession No. ML23219A073 Training None

SUMMARY

OF CHANGES: This revision to TEC-002, Procedures for Processing Generic Issues, updates the office instruction to conform with Management Directive 6.4, Generic Issues Program.

Incorporate recommendations from an internal review of the GI program by NRCs EMBARK Ventures Studio that include an annual review of issues that are in the Assessment Stage to determine if they should continue in the GI program, and provision for a team of technical experts in the Screening Stage Name Action Signature Date RGPMB Concurrence Edward ODonnell 5/30/2024 BC:RGPMB Concurrence Meraj Rahimi 5/1/2024 D:DE Concurrence Michele Sampson 6/3/2024 D:DRA Concurrence Christian Araguas 5/21/2024 D:DSA Concurrence Kimberly Webber 5/28/2024 OGC NLO Christina England 5/16/2024 D:PMDA Concurrence Michael Brezovec 5/17/2024 D:RES Approval John Tappert, Acting (M. Bailey for) 6/4/2024 OI Coordinator For Follow-on Actions Kevin Johnson 6/5/2024

RES OFFICE INSTRUCTION Page 2 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

1. PURPOSE This office instruction (OI) provides guidance for the project management of the U.S. Nuclear Regulatory Commissions (NRCs) Generic Issues (GI) Program, a function of the Regulatory Guide and Programs Management Branch within the Office of Nuclear Regulatory Research (RES). This OI provides guidance for processing GIs through each stage of the GI process, as well as tracking and reporting. This guidance supplements the process in Management Directive (MD) 6.4, Generic Issues Program.

2. BACKGROUND MD 6.4 delineates the NRCs program for addressing GIs and unresolved safety issues (USIs). MD 6.4 describes the overall agency policy, responsibilities, and legal basis. MD 6.4 also specifies the objectives for the GI Program and the roles and responsibilities of the staff.

The MD 6.4 Handbook introduces the GI Program, including an historical perspective, purpose, definitions, criteria, principles, and goals. The MD 6.4 Handbook also provides an overview of the three-stage process for GIs: (1) Screening, (2) Assessment, and (3)

Regulatory Office Implementation (ROI). As MD 6.4 specifies, RES is responsible for overall GI Program management.

3. DEFINITIONS MD 6.4 provides a glossary of terms for the GI Program.

4. RESPONSIBILITIES AND AUTHORITIES MD 6.4 identifies the organizational responsibilities of the GI Program.

5. INSTRUCTIONS These instructions are intended to provide specific guidance to the staff for processing a GI through the three stages of the GI process. The instructions explain the process and provide guidance for tracking and managing the GIs as they transition through the stages.

The relative complexity of each GI may warrant some variation or modification in the execution of specific steps. As stated in MD 6.4, the staff should use a graded approach to the rigor applied during the generic issues process. The extent of review effort should be commensurate with the GI's potential safety, security, and risk significance. The Responsible Project Manager (RPM) can request an initial risk determination from the RES Division of Risk Assessment to help in determining the risk significance. The appropriate amount of process rigor for GI screening and review panels depends on the significance, importance, or scope of applicability of the GI, thereby reducing the process burden for processing GIs of low-risk significance. The GI program staff can use this risk determination to screen out GIs of low-risk significance or importance without using a formal review panel. Complex GIs or those with potentially high-risk significance may warrant formal and sometimes extensive reviews, thereby requiring a review by expert panel members. The value added from expert panel meetings (e.g., group synergy and open debates) varies with GI risk significance and uncertainty. Formal panel meetings add less value when there is a low-risk significance, importance, uncertainty, or large safety margins for error tolerance. In cases of moderate risk

RES OFFICE INSTRUCTION Page 3 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues significance or importance, virtual panel meetings by teleconference, electronic mail, or other methods that do not require the physical presence of all the panel members in the same room at the same time may suffice. More process rigor and resources may be applied as an issue proceeds through each GI Program stage.

The GI Program uses a consistent approach to correspondence and program reports to gain efficiencies and effectiveness in communicating with internal and external stakeholders.

Appendix E, Examples of Generic Issues Documents and Generic Issue-related websites, to this OI lists example correspondence and program reports that are on the GI Program SharePoint site, as well as links to program information on GI-related websites.

An important function of the GI Program is to identify the NRC regulatory office most suitable to address the issue. The GI Program staff solicit management support for allocating resources to evaluate and disposition the proposed GI to reach a consensus on the appropriate regulatory office to address the issue. It is expected that GIs will be processed in an open and collaborative work environment.

Anyone can propose a GI. Identification of an issue is primarily accomplished outside the program. Submitters, whether a member of the public or NRC staff, can submit a proposed GI into the GI Program using the online GI proposal form on the NRC public website, which automatically sends an e-mail to GIP.Resource@nrc.gov, notifying all GI Program staff members of the submittal. Submitters can also print and mail the GI proposal form through the U.S. mail. In addition, NRC staff can send an interoffice memorandum to submit a GI.

The GI Program staff will assist the submitter as needed. Before submitting a proposed GI, NRC staff and management are encouraged to contact the GI Program staff for assistance in determining whether the proposed GI is in fact a candidate for the GI Program and thus meets the criteria to continue through the GI Program.

Once an individual submits a proposed GI, the GI Program Manager and GI Program staff inform RES management of the proposed GI and begin Stage 1, Screening, of the GI process.

5.1 Stage 1Screening (target for completing screening is typically 6 to 12 months)

The purpose of the Screening Stage is to evaluate whether the proposed GI meets all seven screening criteria, as described in MD 6.4 and provided in Appendix A, Screening Criteria, to this OI. The proposed GI must meet all seven criteria in order to proceed to Stage 2, Assessment. If the proposed GI does not meet the criteria, then it should exit the GI process. The GI Program staff can use the following steps to process the proposed GI.

5.1.1 Steps to Process the Receipt of a Proposed GI

1. Upon receipt of a proposed GI, whether from the public or NRC staff, the GI Program Manager assigns an RPM from the GI Program staff in the Regulatory Guide and Programs Management Branch.

2. Proposed GIs that are obviously not candidates for the GI program (e.g.,

request for information, worker harassment claims, personnel safety issues)

RES OFFICE INSTRUCTION Page 4 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues can be rejected, and the submitter should be informed as to their rejection from the program.

3. The RPM prepares a memorandum or letter (if from a member of the public) from the GI Program Manager to the submitter acknowledging receipt of the issue. At any time, the RPM may contact the submitter to request clarification or additional information about the issue.

4. The RPM will update the internal GI Program status and tracking database (GI Dashboard) to reflect the outcome of the Screening Stage. The RPM enters the information from the proposed GI into the Generic Issues Management Control System (GIMCS) and assigns a tracking number (e.g., PRE-GI-0##).

The GI Dashboard is used as the database for the GIMCS.

5.1.2 Steps to Review for an Immediate Safety Concern

1. The RPM forwards the proposed GI to the appropriate regulatory office point of contact to evaluate whether the proposed GI is an immediate safety concern. The RPM requests an immediate safety concern determination through an e-mail and telephone call directly to the regulatory office point of contact, then the RPM follows up with a corresponding memorandum from the GI Program Manager to the regulatory office point of contact to document the activity.

For GIs related to the Office of Nuclear Reactor Regulation (NRR), the RPM coordinates resources through the NRR GI Program point of contact. For other offices, the RPM coordinates with the GI Program point of contact for that office.

2. The regulatory offices follow their respective OIs to determine whether the GI is an immediate safety concern (e.g., NRR follows OI LIC-504, Integrated Risk-Informed Decision-Making Process for Emergent Issues).

3. If the regulatory office determines that the proposed GI is an immediate safety concern, the GI Program Manager immediately transfers the proposed GI to that regulatory office so it can be addressed using the appropriate regulatory process.

4. If the proposed GI is transferred to a regulatory office, the GI Program Manager sends a memorandum to the submitter stating that the proposed GI has exited the GI process, and that the appropriate regulatory office is dispositioning the issue.

5. If the regulatory office determines that the proposed GI is not an immediate safety concern, then the regulatory office responds by memorandum to the GI Program Manager, documenting the basis for this determination and stating why the potentially affected facilities may continue to operate despite the proposed GI. The memorandum should also include the following:

RES OFFICE INSTRUCTION Page 5 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

a. Characterization of the safety and risk significance, the basis for determining there is no immediate safety concern, and the justification for ongoing operation (JOO) of the facilities while the staff is assessing the issue (may include circumstances that exist or compensatory measures that are in place)

b. Timeframe that the justification for ongoing operation is appropriate for the potentially affected facilities, assuming there are no additional compensatory or remedial actions that are implemented (typically the duration of the Assessment Stage of the GI process)

c. Potential impact on a nuclear facility if the safety issue identified in the proposed GI occurs (e.g. core damage, containment breach, etc.).

Note: If the RPM identifies information at any time while the proposed GI is in the GI process that invalidates or is contrary to the basis of the immediate safety concern determination, then the RPM shall immediately notify the appropriate managers in the responsible office and follow up with a memorandum from the GI Program Manager addressing the situation.

5.1.3 Steps to Perform an Initial Review

1. Concurrently with sending the proposed GI to the regulatory office for a determination of immediate safety concern, the RPM reviews the proposed GI to determine whether it is an allegation or a physical security issue.

If the proposed GI is an allegation or a physical security issue, then the RPM takes immediate action to coordinate with the GI Program Manager to transfer the proposed GI to the NRC Office of Enforcement or Office of Nuclear Security and Incident Response, respectively.

a. If the issue is referred to the Office of Enforcement or the Office of Nuclear Security and Incident Response, the issue typically exits the GI process.

However, the Office of Enforcement or the Office of Nuclear Security and Incident Response may request that the proposed GI continue in the GI process for tracking purposes.

b. If the issue exits the GI process, the RPM will draft a closure memorandum for GI Program Manager signature to the submitter, explaining why the issue was closed.

2. The RPM performs a literature search of the issue, particularly within NUREG-0933, Resolution of Generic Safety Issues, to verify that the issue has not already been resolved within the scope of previous GIs.

3. If the proposed GI is not an allegation or physical security issue, and has not already been resolved, the RPM will draft an acceptance memorandum for GI Program Manager signature to the submitter, acknowledging receipt of the issue, assigning a PRE-GI number, and explaining that the first step in the GI

RES OFFICE INSTRUCTION Page 6 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues process is a quick screening to determine whether the issue meets all seven screening criteria.

5.1.4 Steps to Perform a Quick Screening

1. After the initial review, the RPM performs a quick screening of the proposed GI against the seven screening criteria (see MD 6.4 and Appendix A to this OI) to determine whether any criteria are obviously not met. If the RPM needs assistance in determining if the proposed GI is an allegation or physical security issue, then the RPM may reach out as needed to the Office of Enforcement or the Office of Nuclear Security and Incident Response for assistance.

2. The RPM also identifies potential challenges in assessing the GI to determine whether the screening and assessment can be completed within the GI process timeliness guidelines in MD 6.4. The timeliness issue is specifically addressed in Criterion 5 of the seven screening criteria, which states that the issues safety or risk significance can be adequately determined in a timely manner.

3. Per MD 6.4 the target for completing the screening is 6 to 12 months, and the target for completing the assessment is 1 to 3 years. If the RPM determines that an excessive amount of time is necessary to perform extensive research to resolve the issue, the RPM may propose that the GI exit the GI process. At management's discretion, the GI can be closed so the appropriate RES division can further study the issue. Subsequently, a work request will be submitted to evaluate the proposed issue in accordance with PRM-001, "Process for Responding to Work Requests: Informal Assistance, Research Assistance, User Needs, and Research Plans." After the additional research is performed, the safety issue is re-evaluated. If a safety issue still exists, then the issue should be re-submitted into the GI program for screening and assessment as a new GI.

4. If the quick screening finds that the proposed GI appears to meet all seven screening criteria, the RPM initiates the process of forming a Generic Issues Review Panel (GIRP) to perform a more comprehensive, detailed evaluation of the issue against the screening criteria. The RPM will send a memorandum to the GI Program Manager stating the results of the quick screening, the basis for the results, and the need to assemble the GIRP.

5. If the quick screening finds that the proposed GI fails to meet all seven screening criteria, the RPM drafts a memorandum of nonacceptance for GI program Manager signature to the submitter, describing this determination and explaining why the proposed GI exited the GI process. The immediate safety concern review, the initial review, and the quick screening should be completed within 6 months of initial receipt of the proposed GI.

RES OFFICE INSTRUCTION Page 7 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues 5.1.5 Steps for Assembling a Generic Issues Review Panel

1. The RPM initiates informal communication with appropriate regulatory offices to identify possible staff members to serve on a GIRP. Then the RPM formally coordinates with the appropriate regulatory office(s), any internal stakeholders, and the GI Program Manager to determine the number of panel members, needed expertise, and who will be the chairperson.

a. The GIRP normally consists of at least three staff members, with a Senior Executive Service manager as the chairperson.

b. The chairperson should be from the regulatory office that would likely receive the issue during Stage 3, Regulatory Office Implementation (ROI).

The chairperson may, but not necessarily will, be from the division that would be responsible for the issue during the ROI stage.

c. The GIRP should include staff from the regulatory office that would likely receive the issue during the ROI stage as well as any other affected regulatory offices. The GIRP should also include staff from RES that would be involved in the Assessment Stage. The GIRP can also include staff from the originating office.

d. A typical GIRP includes a risk expert, a subject matter expert, a systems specialist, the RPM, and the chairperson. The GIRP members are selected to provide expert, but broad and diverse, perspectives on the GI.

e. The GI Program Manager may elect to augment the composition of the GIRP for more complicated issues.

2. The GI Program Manager sends a memorandum to the appropriate regulatory office(s) requesting staff members to serve on the GIRP.

3. The appropriate regulatory office(s) should respond within two weeks, through a memorandum, identifying the members of the GIRP, including the chairperson.

5.1.6 Steps for GIRP to Perform Screening Evaluation

1. The GI Program Manager establishes an appropriate timeframe and milestones for evaluating the proposed GI based upon its urgency, complexity, and management discretion.

2. If at any point during the Screening or Assessment Stage new information becomes evident that the proposed GI poses an immediate safety concern to a nuclear facility, the RPM will contact the appropriate regulatory office and the proposed generic issue will be immediately transferred to the regulatory office and it will bypass the formal Assessment Stage.

3. The GIRP chairperson decides upon the degree of formality of the GIRPs proceedings. It will depend largely on whether the panel members can reach a

RES OFFICE INSTRUCTION Page 8 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues decision that is clear, without large uncertainties, and with consensus of all the members. Any member opinions which differ from the panel consensus should be noted in the screening report.

4. The GIRPs first task is to make a screening plan. The plan should be a detailed document that specifies how the GIRP will complete the evaluation of the proposed GI. The screening plan should contain the following:

a. It should have a clear goal(s).

b. It should limit scope creep.

c. It should be detailed enough to understand what is required by all parties involved.

d. It should have a plan to screen the proposed GI against all 7 screening criteria.

e. The goals should have designated responsible individuals.

f. There should be clear time frames on when the individual goals should be completed by.

5. The GIRP's screening plan should identify if any other agency programs or processes are required to support further assessment of the issue.

6. The GIRP collects information to assess the proposed GI against the screening criteria, as appropriate. If needed, the RPM can contact the submitter to obtain additional information.

7. The screening evaluation typically includes a literature search and a review of previous related GIs, using the results of the RPMs efforts during the quick screening.

The NRC has various avenues to address generic issues that have evolved from nuclear reactor operating experience and regulatory initiatives. To gather the necessary information required to resolve generic issues, the NRC can leverage a Bulletin, Generic Letter, or 10 CFR 50.54(f) Letter to request information from licensees. If there is not enough information to issue a Bulletin, Generic Letter, or 50.54(f) Letter, then the GIRP should look at other avenues to gather enough information to determine whether or not to issue a Bulletin, Generic Letter, or 10 CFR 50.54(f) Letter.

8. The RPM tracks and documents the completion of any screening milestones.

The RPM monitors the GIRPs activities to ensure the focus remains on the issue and avoids scope creep.

9. The GIRP prepares a detailed screening analysis, and all members concur (any non-concurrence should be noted in the screening report).

RES OFFICE INSTRUCTION Page 9 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

10. The GIRP screening report should include the following, as applicable:

a. A detailed definition of the scope of the issue and affected facilitiesthe scope can include multiple facility types and should consider the implications for different types of reactors and other licensed facilities; the GIRP may create separate issues if deemed more appropriate

b. The basis for excluding any NRC-regulated facilities that the issue may or may not affect (e.g., fuel fabrication/enrichment facilities)

c. A limited scope evaluation of the potential safety or risk significance of the issue, based upon information and resources available; a best-estimate projective risk may be qualitatively or quantitatively assessed

d. If the GIRP recommends the proposed issue proceed to the Assessment Stage, the report should also include:

i.

Suggested milestones for completing the assessment in a time frame specified in MD 6.4 ii.

A justification that ongoing facility operations are safe to continue (e.g.,

JOO is still valid) while the GIRP completes the formal assessment.

iii.

If the staff can not provide adequate justification that the plants are safe to continue operating during the assessment, then the issue should be entered into the LIC-504 process.

11. The GIRP applies a graded approach, as defined in MD 6.4, to perform the screening analysis. For complex issues, the GIRP may request and use outside agency resources.

12. If the GIRP finds that there is insufficient information available and determines that extensive additional research is required to properly evaluate the proposed GI, the GIRP can recommend to the RES Office Director that the GI exit the GI process to allow additional research to be performed, as appropriate.

This proposed GI can be closed out; subsequently a work request will be submitted to evaluate the proposed issue in accordance with RES Office Instruction PRM-001, "Process for Responding to Work Requests: Informal Assistance, Research Assistance, User Needs, and Research Plans." After the additional research is performed, the safety issue is re-evaluated. If a safety issue still exists, then the issue should be re-submitted into the GI program for screening and assessment as a new GI.

13. If the GIRP concludes that the proposed GI does not satisfy all seven screening criteria, the GIRP informs the RES Office Director of its recommendation that the proposed GI should not proceed to the Assessment Stage and should exit the GI process.

RES OFFICE INSTRUCTION Page 10 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

a. The RPM assists the GIRP in preparing a memorandum to the RES Office Director, stating why the proposed GI does not meet the screening criteria.

b. The RPM coordinates with the RES Office Director to determine whether the Office Director requires a formal briefing from the GIRP.

c. Once the RES Office Director agrees with the GIRP recommendation, the GI Program Manager or the RES Office Director sends a closure memorandum to the submitter, summarizing the GIRPs evaluation and stating that the issue has exited the GI process.

d. The RPM will update the internal GI Program status and tracking database (GI Dashboard) to reflect the outcome of the Screening Stage.

e. The proposed GI does not proceed to the Assessment Stage, and it exits the GI process.

14. If the GIRP concludes that the proposed GI meets all seven screening criteria, the GIRP informs the RES Office Director of its recommendation that the proposed GI should continue to the Assessment Stage.

15. The RPM assists the GIRP in preparing a memorandum to the RES Office Director, stating why the proposed GI satisfies the screening criteria.

a. The memorandum should include a justification that adequate protection of safety is assured for ongoing facility operations while the GI is in the Assessment Stage.

b. The RPM coordinates with the RES Office Director to determine whether the Office Director desires a formal briefing from the GIRP.

c. The GIRP memorandum to the RES Office Director documenting the results of the screening analysis should include GI Program management concurrence to ensure consistency in the GI process. The memorandum should also document any additional views or non-concurrences from any GIRP member to inform the RES Office Director.

16. The RES Office Director reviews the GIRPs recommendation.

a. The RES Office Director can request a meeting with the GIRP to discuss its findings and conclusion.

b. If the RES Office Director does not agree with the screening evaluation or the GIRPs recommendations, the GIRP will reconvene to consider the RES Office Directors comments and revisit the screening evaluation.

c. If the RES Office Director agrees with the GIRPs screening evaluation and recommendations, the RPM issues the screening results as final on behalf of the GIRP and makes the screening results and associated documents

RES OFFICE INSTRUCTION Page 11 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues publicly available. The RPM forwards the GIRP report to the appropriate regulatory offices for regulatory review and potential action.

d. The RES Office Director can issue a memorandum acknowledging the results of the GIRP screening report. The RES Office Director may provide modifications or additional recommendations. The memorandum establishes expectations for the staff in RES and affected regulatory offices during the Assessment Stage, particularly the members of the GIRP. Depending on the extent of the assessment, the RES Office Director can request additional personnel and funding to accommodate the work required for the assessment.

17. The RPM updates the internal GI Program status and tracking database (GI Dashboard) to reflect the outcome of the screening.

18. The RPM is responsible for informing the submitter, the Advisory Committee on Reactor Safeguards (ACRS), and other stakeholders of the screening results. This is normally accomplished by including these individuals on the distribution list for the screening memorandum. For high-interest issues, the GI Program Manager or the RES Office Director may provide additional communications to various stakeholders.

5.2 Stage 2Assessment Stage (target for completion is typically 1 to 3 years)

The purpose of the Assessment Stage is to determine whether the proposed GI has enough safety and regulatory significance to merit an NRC staff effort to take regulatory action (e.g., new or revised regulations or guidance, order, or generic communication).

The assessment includes an evaluation of risk significance, safety significance, environmental significance (with respect to radiological health and safety), security significance, and regulatory compliance. A more in-depth evaluation will be performed by the program office in the Regulatory Office Implementation stage.

5.2.1 Actions during the Assessment Stage

1. The objective of the assessment is to provide a more detailed analysis of the risk significance, safety significance, environmental significance, security significance, and regulatory compliance of the proposed GI to determine whether the GI merits regulatory actions to address the proposed GI.

2. The RPM is responsible for forming an assessment team. An assessment team can consist of the existing GIRP members, or the RPM can request additional support staff as necessary.

3. The GIRP members from the Screening Stage typically continue to the Assessment Stage. However, panel members can change to accommodate factors such as individual workloads, organizational changes, and retirements.

4. The RPM arranges for any necessary contractor support, additional support staff from within RES, and staff from other program offices.

RES OFFICE INSTRUCTION Page 12 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

5. The GIRP directs the assessment team on the scope of the issue and any scope changes.

6. The first step for the RPM and the assessment team is to develop an assessment plan, identifying the actions necessary to complete the assessment. The objective of the assessment plan is to accumulate enough information to complete a formal assessment report, documenting the results of the teams investigation. The plan should contain include information from the Screening Report, e.g., detailed schedules, milestones, and responsibilities necessary to complete the assessment report. Appendix C, Assessment Plan Instructions, to this OI provides details of the contents of a typical assessment plan.

7. The assessment team may use a graded approach, as defined in MD 6.4. The key areas to be assessed are the safety/risk significance of the issue.

8. The assessment team is encouraged to use risk as a screening threshold. The team may use the figures and tables located in Appendix B, Risk Criteria, to this OI to determine whether the risk associated with the issue is significant enough to justify forwarding the GI to the regulatory office to pursue changes to nuclear facilities or other regulatory actions. For issues that are not amenable to quantification of the change in risk, the assessment team may use qualitative criteria to assess the safety/risk significance. The risk criteria are provided as guidance for determining the significance of a proposed GI.

The issue reviewer should also understand how risk significance is influenced by uncertainties and assumptions in the risk analysis. NRC guidance on risk is in Regulatory Guide 1.174, "An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis."

9.

The assessment team develops possible regulatory options to address the issue, which should also include the technical basis and a safety/risk assessment of the options.

On an annual basis, the GIRP will complete an annual evaluation of the proposed GI and document the results of the evaluation in a memorandum to the RES Office Director. Appendix F has a worksheet to be filled out in conjunction with the annual evaluation. The evaluation should be completed within one calendar year from the date that the proposed GI enters the Assessment Stage and every year there after. (For example: the proposed GI enters the Assessment Stage on October 1, 2024, then the first annual assessment should be completed by October 1, 2025, the second annual assessment on October 1, 2026, and the third annual assessment by October 1, 2027)

10. At the completion of its work the assessment team will prepare an assessment report that documents its analysis of the proposed GI. The assessment report should include the following key elements, as applicable:

a. environmental significance

RES OFFICE INSTRUCTION Page 13 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

b. security significance

c. safety and risk significance (Appendix B to this OI provides guidance and criteria for performing a risk assessment)

d. regulatory compliance (assess existing applicable regulations and licensees licensing bases to determine whether the GI may be backfit issue)

e. proposed regulatory path forward.

11. Once the assessment report is complete, the assessment team submits the report to the GIRP to determine whether the proposed GI warrants additional regulatory action.

12. If the GIRP concludes that no additional actions are required, the GIRP will inform the RES Office Director of its recommendation that the proposed GI should not proceed to the ROI stage and should exit the GI process.

a. The RPM assists the GIRP in preparing a memorandum to the RES Office Director, stating why the proposed GI should not proceed to ROI stage.

b. The RPM coordinates with the RES Office Director to determine whether the Office Director desires a formal briefing from the GIRP.

c. Once the RES Office Director acknowledges agreement with the GIRP recommendation, the GI Program Manager or the RES Office Director sends a closure memorandum to the submitter, summarizing the GIRPs evaluation and stating that the issue has exited the GI process.

13. If the GIRP concludes that additional actions are required, the GIRP will inform the RES Office Director of its recommendation that the proposed GI should proceed to the ROI stage.

a. The RPM assists the GIRP in preparing a memorandum to the RES Office Director, stating why the proposed GI should proceed to ROI stage.

b. The memorandum should include a justification that adequate protection of safety is assured for ongoing facility operations while the GI is in the ROI stage.

c. The RPM coordinates with the RES Office Director to determine whether the Office Director desires a formal briefing from the GIRP.

d. The RES Office Director sends a memorandum to the appropriate regulatory offices, notifying them of the GIRP's evaluation together with any modifications or additional recommendations, as described in Section 5.2.2.

RES OFFICE INSTRUCTION Page 14 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

14. The GIRP memorandum to the RES Office Director documenting the results of the assessment should include GI Program management concurrence to ensure consistency in the GI process. The memorandum should document any alternative views or non-concurrence from any GIRP member.

15. The RES Office Director may desire additional information as part of the Office Directors review of the GIRPs assessment report.

a. The RES Office Director can request a meeting with the GIRP to discuss its findings and conclusion.

b. If the RES Office Director agrees with the assessment report and the GIRPs recommendations, the RPM issues the assessment report as final on behalf of the GIRP and makes the assessment report and associated documents publicly available.

c. If the RES Office Director does not agree with the assessment report or the GIRPs recommendations, the GIRP will reconvene to consider the RES Office Directors comments and revisit the assessment report.

d. The RES Office Director may modify or make additional recommendations in the memorandum forwarding the results of the GIRPs report to the affected regulatory offices or other stakeholders, as described in Section 5.2.2.

16. The RPM updates the internal GI Program status and tracking database (GI Dashboard) to reflect the outcome of the assessment.

17. The RPM is responsible for informing the submitter, the ACRS, and other stakeholders of the assessment results. This is normally accomplished by including these individuals on the distribution list for the assessment report. For high-interest issues, the GI Program Manager or the RES Office Director may provide additional communications to various stakeholders.

5.2.2 Actions during Transition from Assessment to Regulatory Office Implementation

1. Once the assessment is complete, the RES Office Director sends a transfer memorandum to the Directors of the affected regulatory offices receiving the GI for regulatory office implementation.

2. The transfer memorandum transfers ownership of the GI from RES to the appropriate regulatory office for implementation. The memorandum also describes the role of a transition team in facilitating the transfer of ownership and knowledge of the issues to the regulatory office.

3. The transfer memorandum should include the following:

a. copy of the GIRP recommendation memorandum

RES OFFICE INSTRUCTION Page 15 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

b. evaluation of the environmental, security, safety, and risk significance

c. justification for ongoing safe operation while the GI is being addressed

d. assignment of a permanent GI identification number (GI-00#)

e. description of the transition team and its purpose

f. assessment of regulatory compliance

g. proposed regulatory action to address the issue

h. draft communication plan:

(1) As desired, the RPM prepares a draft communication plan in accordance with Guidance on Communication Tools & Plans, available on the website for the Office of the Executive Director for Operations (OEDO).

Section 5.4.9 of this OI provides additional guidance. The RPM should begin drafting the communication plan while the GIRP is completing the assessment recommendation. This early preparation will facilitate the approval and issuance of the communication plan before the recommendation is given to the RES Office Director for endorsement.

(2) The draft communication plan is intended to help ensure ongoing communications with public stakeholders and other regulatory offices. A final plan may be formal or informal, as determined by the transition team.

(3) The communication plan provides information on resource allocation, information flow, and decisions on transitioning to the regulatory office for regulatory action.

(4) The communication plan typically outlines the need for public meetings, as necessary, during the ROI stage.

4. The Director of the receiving regulatory office should issue an acknowledgment memorandum assuming responsibility for the GI for regulatory implementation.

The acknowledgment memorandum should include the following to ensure a smooth transition:

a. identification of the transition team lead

b. membership of the transition team

c. a transition team charter that includes knowledge transfer and a draft resolution plan for the ROI stage

5. The RPM submits the final assessment report, transition team documents, and regulatory office acceptance memorandum to the NRCs Agencywide Documents Access and Management System (ADAMS) and updates the GI

RES OFFICE INSTRUCTION Page 16 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Dashboard to reflect the transition from the Assessment Stage to the ROI stage.

6. The RPM is responsible for informing the submitter, the ACRS, regulatory office Directors, and other stakeholders of the assessment results, as described in the communication plan.

5.3 Stage 3Regulatory Office Implementation Stage (target for completion is typically 3 to 5 years)

The purpose of the ROI stage is to develop appropriate regulatory actions and implement resolution of the issue in a timely manner. The actions listed below describe and outline the intended GI process activities during the ROI stage. These actions are not intended to supersede existing regulatory office procedures.

The transition team assists the regulatory office in implementing the appropriate regulatory actions during the ROI stage. As stated in MD 6.4, the mission of a transition team is to ensure that an issue receives the necessary attention in the appropriate receiving regulatory office to ensure progress is maintained. The transition team supports the regulatory office in its decision as to the appropriate regulatory action to address the GI, and to facilitate the transition to the appropriate regulatory process. For example, the transition team could support actions 1-10 in Section 5.3.1. Regulatory office management may terminate the transition team when its purpose has been accomplished, at their discretion.

5.3.1 Actions during the Regulatory Office Implementation Stage

1. Activities associated with the ROI stage typically occur within the scope of existing regulatory programs (e.g., generic communications and rulemaking).

2. The responsible regulatory office assigns a new project manager to the GI.

This project manager is responsible for managing the resolution of the GI and periodically reporting to NRC managers and the RES RPM on the status of activities necessary to resolve the GI.

3. The RES RPM continues to track and report on the status of active GIs in the ROI stage until all required actions have been completed, at which time the RPM closes out the GI.

4. The responsible regulatory office performs a regulatory analysis, as appropriate, to determine the proper action within the regulatory process (e.g., rulemaking, backfit, orders, generic communication).

5. If the regulatory office determines that no new regulatory requirement is necessary, the responsible regulatory office will issue a memorandum to the RES Office Director or GI Program Manager describing the evaluation and the justification for reaching this determination. The RPM, GI Program Manager, or RES Office Director issues a closeout memorandum to the submitter, informing him or her of the decision to close the GI and any actions taken. The GI will then exit the GI process.

RES OFFICE INSTRUCTION Page 17 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

6. If the regulatory office determines that there is a need for a new regulatory action, the responsible regulatory office will initiate the appropriate regulatory process.

7. The assigned project manager establishes milestones to resolve the GI.

Typical milestones are dependent on the chosen regulatory process and should include the following:

a. regulatory basis and technical development (typically up to 30 months for rules and 6 months for generic letters, less time for orders)

b. communications with the ACRS and the Committee to Review Generic Requirements (CRGR), and conduct of public meetings, as appropriate (typically up to 3 months for rules and generic letters, less time for orders)

c. completion generic letters and orders (typically 9 months for generic letters, and less time for orders)

d. licensee implementation of facility modifications (typically up to 48 months)

e. NRC inspection and verification (typically up to 12 months following implementation)

8. The assigned project manager performs the following functions:

a. tracks and documents completion of ROI milestones

b. monitors for scope changes

c. updates the communication plan

d. organizes public meetings to gain stakeholder input, as appropriate; public meetings can be held to determine the appropriate regulatory action; public meetings may also be held as part of a regulatory process

9. The ACRS may request a meeting to support the development of the appropriate regulatory action. The ACRS may hold additional meetings as part of the regulatory process selected for the GI. The ACRS has the option to review actions taken as it deems necessary.

10. The responsible regulatory offices implement the new regulatory action (e.g.,

order, generic communication, etc.).

11. Licensees may be required to implement actions to comply with the new regulatory action. The regulatory offices track the status of implementation and provide status reports to the RPM. The RPM maintains the status of the GI on the GI Dashboard.

12. The NRC staff performs inspections to verify that licensees have completely implemented all required actions, as appropriate, for the regulatory action.

RES OFFICE INSTRUCTION Page 18 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

13. After all licensees have implemented the appropriate corrective actions and the NRC staff has verified that all the affected licensees have implemented all required actions, the project manager notifies the RPM that the GI can be closed.

14. The RPM, GI Program Manager, or RES Office Director issues a closeout memorandum to the submitter, notifying him or her that the GI has been closed and briefly describing the actions taken.

5.4 Generic Issue Tracking and Reporting The GI Program maintains a system to track GIs and report the status of issues to stakeholders. The GI Program uses the NRC public webpages, online GI Dashboard, NUREG-0933, and several periodic reports to communicate activities about GIs.

The GI Program is intended to be transparent and open to the public. The GI Program maintains a webpage on the NRC public website under the tab, About NRC, and under the heading, How We Regulate, under the topic, Operational Experiences.

The Generic Issues Program webpage contains the following links:

Policy and Procedure Documents (links to program documents, such as TEC-002 and MD 6.4)

Frequently Asked Questions (answers to commonly asked questions about the GI Program)

How to Propose a New Generic Issue (contains NRC Form 833, Form to Propose a Generic Issue (GI), to submit a new GI via mail and a link to an online form to send directly to the NRC mailbox, GIP.Resource@NRC.gov)

Generic Issues Program Status (GIMCS semi annual reports (formerly issued quarterly))

NUREG-0933, Resolution of Generic Safety Issues (link to historical data of all issues accepted into the GI Program)

Generic Issue Dashboard (database containing the status of active GIs within the three-stage GI process and proposed GIs that were screened out of the process before acceptance as GIs) 5.4.1 GI Tracking

1. When a GI is initially proposed, the RPM assigns a PRE-GI number and enters the information into the tracking database (GI Dashboard). The RPM has the option to enter the information into the GI Dashboard even if the proposed GI is not accepted. Such issues may be a source of knowledge for similar issues submitted in the future.

2. Once the GIRP completes its assessment and recommends that the GI

RES OFFICE INSTRUCTION Page 19 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues proceed to the ROI stage, the RPM assigns the proposed GI a new, permanent GI number.

3. The RPM tracks the GI as it proceeds through the three stages of the GI process, updating the status on the GI Dashboard.

5.4.2 GI Dashboard

1. The RPM uses the GI Dashboard as an issue management database to record proposed GIs, track their progress through the GI process, and document results of evaluations as required by the program guidelines.

2. The RPM updates the GI Dashboard to reflect important milestones, activities, documents, and notifications associated with GIs.

3. The RPM coordinates with the assigned regulatory office project managers for active GIs in the ROI stage to update the status on the GI Dashboard as progress is made toward resolution.

5.4.3 Generic Issues Management Control System (GIMCS) Report

1. The purpose of the GIMCS report is to periodically inform NRC Office Directors, stakeholders, and members of the public of activities associated with active GIs in the ROI stage that are being processed for regulatory actions.

2. The RPM issues a GIMCS report on a semiannual basis to NRC managers and makes it publicly available on the GI Program Web site to inform external stakeholders of progress in addressing active GIs.

3. The GIMCS report typically consists of the following elements:

a. identification of the open GIs currently in the ROI stage

b. description of significant activities that occurred during the previous reporting period

c. brief description and a summary of activities (similar, if not identical, to the semiannual report to Congress) 5.4.4 Semiannual Report to Congress

1. One purpose of the semiannual report to Congress is to inform members of Congress of activities associated with active GIs that are in the regulatory offices for implementation. The discussion may include significant PRE-GIs that have passed the screening criteria and are in the Assessment Stage.

2. The input is ticketed correspondence in the Office of the Executive Director of Operations (EDO) tracking system. The RPM prepares input for the RES Office Director to send to the EDO to report on activities associated with active

RES OFFICE INSTRUCTION Page 20 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues GIs. The regulatory office project managers provide information to the RPM for this report.

3. The input to the report should include the following items:

a. the number of active GIs in the ROI stage

b. a brief description of each active GI

c. recent significant activities and near-term future significant activities

d. actions required to close out the GIs

e. approximate date the GIs are expected to close 5.4.5 NUREG-0933

1. The RPM periodically updates information in NUREG-0933 through supplements.

2. The RPM adds a new GI to NUREG-0933 when a proposed GI is assigned a permanent GI number.

3. The NRC uses supplements to NUREG-0933 to add information about the description, screening, and assessment of all newly identified permanent GIs.

The supplements also document resolution of the GIs closed out since publication of the previous supplement.

4. NUREG-0933 is available on the NRC public website at http://nureg.nrc.gov/sr0933/.

5.4.6 NUREG-1925

1. The RPM provides revisions to NUREG-1925, Research Activities, describing the GI process.

2. The latest version of NUREG-1925 is available on the NRC public website at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1925/.

5.4.7 Convention on Nuclear Safety (CNS) Report

1. In support of U.S. participation in the Convention on Nuclear Safety (CNS), the RPM provides updates for the CNS report to the point of contact in NRR, as required.

2. The U.S. national reports are issued as NUREG-1650, The United States of America National Report for the Convention on Nuclear Safety. The NRC issues revisions to NUREG-1650 every 3 years.

RES OFFICE INSTRUCTION Page 21 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues 5.4.8 Advisory Committee on Reactor Safeguards

1. The RPM provides information to the ACRS on GI activities. The NRC staff notifies the ACRS when the following reports are issued:

a. GIRP final screening report

b. GIRP final assessment report

c. GI closeout memorandum

2. The staff normally notifies the ACRS by including the ACRS on distribution for the reports listed above. The staff may also notify the ACRS through a separate memorandum for issues of significant interest, such as GIs that are anticipated to transition to the ROI stage.

5.4.9 Communication Plans

1. A communication plan lays out how the NRC is going to communicate with stakeholders about a particular issue. It is not intended to communicate information about the issue. The communication plan can contain details about the GI, such as background, key message, audience, timeline, communication tools, and questions and answers.

2. Guidance on Communication Tools & Plans, available on the NRC internal website: https://intranet.nrc.gov/comm/32523.

3. The RPM or office project manager prepares a communication plan for those issues the GIRP recommends for screening into the GI Program.

4. The RPM or office project manager issues the initial communication plan along with the GIRPs screening recommendation and periodically updates the communication plan as major milestones (e.g., assessment plan, assessment report) are met to inform stakeholders of the progress of the GI.

5.4.10 External Stakeholder Involvement in the Generic Issues Program

1.

The GI Program Manager and the regulatory office consider the need for a public meeting with external stakeholders. A public meeting can be conducted for the following reasons:

a. to communicate the results of the Screening and Assessment Stages

b. to gain stakeholder input, as necessary

c. as part of developing the appropriate regulatory action

d. as the transition team transfers responsibility for the GI to the appropriate regulatory office, as necessary

RES OFFICE INSTRUCTION Page 22 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

e. during the regulatory process in the ROI stage, as often as necessary

2.

The GI Program Manager communicates any needs for external resources to the office level as necessary to resolve complex proposed GIs. This could include contracts, grants, and international collaboration.

5.4.11 Accounting for NRC Staff Resources

1. NRC staff working on issues in the GI process should record the time expended working on GIs to the appropriate cost activity codes (CACs) in the agency timekeeping system. This includes time spent on attendance at meetings, meeting preparation, and assessing the proposed GIs. CACs for GIs in the ROI stage should be established by the regulatory offices based on the regulatory process selected to resolve the GIs.

2. The RPM will notify the staff of the appropriate CACs for proposed GIs and will perform periodic reviews of the time charged to the GI program CACs to facilitate accurate accounting for NRC staff efforts on generic issues.

3. To monitor time charged to GI CACs, do the following:

Go to the NRC intranet home page.

Under NRC applications select CACs, click accept and continue.

This brings you to Search CAC.

Select Reports pull down.

Select CAC Labor.

Enter the Generic Issues CAC KF0058 and date range.

Run second report using EPID, R-2017-GIP-0000 and date range Run the report.

6. PERFORMANCE MEASURES None.

RES OFFICE INSTRUCTION Page 23 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

7. REFERENCES1 Federal Regulations U.S. Code of Federal Regulations (CFR), Domestic Licensing of Production and Utilization Facilities, Part 50, Chapter I, Title 10, Energy (https://www.nrc.gov/reading-rm/doc-collections/cfr/), Section 109, Backfitting.

CFR, Licenses, Certifications, and Approvals for Nuclear Power Plants, Part 52, Chapter I, Title 10, Energy, Section 63, Finality of Standard Design Certifications.

CFR, Domestic Licensing of Special Nuclear Material, Part 70, Chapter I, Title 10, Energy, Section 76, Backfitting.

CFR, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste, Title 72, Chapter I, Title10, Energy, Section 62, Backfitting.

CFR, Certification of Gaseous Diffusion Plants, Part 76, Chapter I, Title 10, Energy, Section 76, Material Status Reports.

Presidential Executive Orders Executive Order 12866, Regulatory Planning and Review, September 30, 1993, in Federal Register, Vol. 58, No. 190, October 4, 1993 (ADAMS Accession No. ML040070197).

NRC Documents U.S. Nuclear Regulatory Commission (NRC), Commissions Policy Statement, Principles of Good Regulation," 1991 (ADAMS Accession No. ML14135A076).

NRC, Commissions Policy Statement, Safety Goals for the Operation of Nuclear Power Plants, Federal Register, Vol. 51, No. 149, August 4, 1986, pp. 28044-28049, as corrected and republished in Federal Register, Vol. 51, No. 162, August 21, 1986, pp. 30028-30033 (https://www.nrc.gov/reading-rm/doc-collections/commission/policy/51fr30028.pdf). Staff proposed changes, Modifications to the Reactor Safety Goal Policy Statement, SECY-00-0077, dated March 30, 2000 (ML003684288), and resulting SRM, Staff Requirements - SECY-00-0077 - Modifications to the Reactor Safety Goal Policy Statement, dated June 27, 2000 (ML003684288).

NRC, Committee to Review Generic Requirements Charter (http://www.nrc.gov/about-nrc/regulatory/crgr.html).

1 Publicly available NRC published documents are available electronically through the NRC Library on the NRCs public website at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html. For problems with ADAMS, contact the Public Document Room staff at 301-415-4737 or (800) 397-4209, or email pdr.resource@nrc.gov. The NRC Public Document Room (PDR), where you may also examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to pdr.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

RES OFFICE INSTRUCTION Page 24 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues NRC, EMBARK Ventures Studio, Generic Issues Program: Report of Recommendations. December 2023 (ML23317A310).

NRC, Guidance on Communication Tools & Plans, available on the NRC internal website:

https://intranet.nrc.gov/comm/32523 NRC, Management Directive (MD) 6.4, Generic Issues Program.

NRC, MD 8.4, Management of Facility-Specific Backfitting and Information Collection, September 20, 2019 (ML18093B087).

NRC, NUREG-0933, Resolution of Generic Safety Issues, December 2011 (http://nureg.nrc.gov/sr0933/).

NRC, NUREG-0705, Identification of New Unresolved Safety Issues Relating to Nuclear Power Plants (ML072500161) (not available in public ADAMS).

NRC, NUREG-1650, The United States of America National Report for the Convention on Nuclear Safety: 8th National Report, August 2022 (ML22067A170).

NRC, NUREG-1409, Backfitting Guidelines (Initial Report), July 1990 (ML032230247).

NRC, NUREG-1409, Backfitting Guidelines, Revision 1, enclosed as part of SECY 21-0037, March 31, 2021 (ML21006A432).

NRC, NUREG-1530, Reassessment of NRCs Dollar per Person-Rem Conversion Factor Policy, Revision 1, February 2022 (ML22053A025).

NRC, NUREG-1925, Research Activities (https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1925/).

NRC, NUREG-1614, "NRCs Strategic Plan: Fiscal Years 2022-2026, Volume 8" (ML22067A170)

NRC, NRR Office Instruction LIC-504, Integrated Risk-Informed Decision-Making Process for Emergent Issues, Revision 5, March 9, 2020 (ML19253D401).

NRC, Guidance on Communication Tools & Plans, available on the NRC internal website:

https://intranet.nrc.gov/comm/32523 NRC, Office of Nuclear Material Safety and Safeguards (NMSS), NMSS Draft Policy and Procedure Letter 1-82, 10 CFR Part 70 Backfit Guidance, June 20, 2003 (ML031740722).

NRC, NMSS-LIC-253, "Backfit Guidance for the Office of Nuclear Material Safety and Safeguards," this OI was created to combine U.S. Nuclear Regulatory Commission (NRC) Policy and Procedure Letter (P&PL) 1-82, 10 CFR Part 70 Backfit Guidance; P&PL 1-84, 10 CFR Part 72 Backfit Guidance; and P&PL 1-53 GDP Plant Specific and Generic Backfit Management (ML15037A178).

RES OFFICE INSTRUCTION Page 25 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues NRC, Regulatory Guide (RG) 1.174, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, Revision 3, issued January 2018 (ML17317A256).

NRC, RG 1.175, An Approach for Plant-Specific, Risk-Informed Decisionmaking:

Inservice Testing, issued June 2021 (ML21140A055).

NRC, RG 1.177, An Approach for Plant-Specific, Risk-Informed Decisionmaking:

Technical Specifications, Revision 1, issued January 2021 (ML20164A034).

NRC, RG 1.178, An Approach for Plant-Specific Risk-Informed Decisionmaking for Inservice Inspection of Piping, Revision 2, issued April 2021 (ML20136A105).

NRC, RG 1.201 (for trial use), Guidelines for Categorizing Structures, Systems, and Components in Nuclear Power Plants According to Their Safety Significance, Revision 1, issued May 2006 (ADAMS Accession No. ML061090627).

NRC, Risk-Informed Decisionmaking for Nuclear Material and Waste Applications, Revision 1, February 28, 2008 (ADAMS Accession No. ML080720238).

RES OFFICE INSTRUCTION Page 26 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Appendix A Screening Criteria The Generic Issues (GI) Program addresses only those issues that meet all of the following seven criteria:

1. The issue affects public health and safety, the common defense and security, or the environment (with respect to radiological health and safety). For issues that are not amenable to quantification using risk assessment, qualitative factors may be developed and applied as necessary to assess safety/risk significance.

This criterion eliminates issues not directly involving or affecting safety or security (e.g., purely administrative matters, policy, regulatory process issues, or U.S. Nuclear Regulatory Commission (NRC) organizational issues).

The staff may use quantification methods for assessing the associated risk. Figures in Appendix B to this office instruction provide guidance on a threshold risk to determine whether a GI should continue to be evaluated in the GI process or exit the process. The staff may use the figures at any time during the GI process. These figures are derived from Figures 4 and 5 in Regulatory Guide 1.174, Revision 3, An Approach for using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, issued January 2018. These figures define the levels of acceptable risk associated with a change in a nuclear facility.

Draft revision 5 of NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission, Table 2-1, "PRA-Related Information for Use in Preliminary Screening Analyses," describes similar criteria that may be helpful to NRC staff to use in preliminary screening of the merit of proposed new regulatory requirements.

For GIs that are not amenable to risk assessment using quantification methods, reviewers may develop and apply qualitative criteria as necessary to assess the safety and risk significance.

For issues related to materials and waste, reviewers can use quantitative health guidelines (QHGs) to determine the applicability of this criterion. The Office of Nuclear Regulatory Research (RES) technical report, Risk-Informed Decisionmaking for Nuclear Material and Waste Applications, Revision 1, dated February 28, 2008, provides a more detailed discussion of QHGs.

2. The issue applies to two or more facilities and/or licensees/certificate holders, or holders of other regulatory approvals.

This criterion ensures that plant-specific issues are handled under other, more appropriate processes, such as the Reactor Oversight Process.

3. The issue is not being addressed using other regulatory programs and processes, existing regulations, policies, or guidance.

RES OFFICE INSTRUCTION Page 27 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues The intent of the GI Program is to direct or transfer the issue to the most suitable NRC regulatory office and for the staff to actively work through the issue. This criterion ensures that the GI Program staff is not addressing an issue that other NRC staff are already handling. It also facilitates the staffs identification of an efficient mechanism for addressing a regulatory issue. If an NRC regulatory office is using another mechanism (regulatory program or process) to address the issue, the issue exits the GI process. Examples of issues to be excluded from the GI process using this criterion include issues that are being processed through the Generic Communications process or the Reactor Oversight Process.

4. The issue can be resolved by new or revised regulation, policy, or guidance.

This criterion ensures that the staff has the ability to address the issue. It also assists in identifying and recommending a regulatory product to resolve the issue.

5. The issues risk or safety significance can be adequately determined in a timely manner (i.e., it does not involve phenomena or other uncertainties that would require long-term study and/or experimental research to establish the risk or safety significance).

This criterion eliminates those issues requiring a long-term research study before entry into the GI process, rather than using a prolonged evaluation under the GI process. The appropriate regulatory office should evaluate issues requiring long-term studies under a User Need Request or other request for RES support. Alternatively, RES may initiate and manage the issue. Upon completion of the long-term study, the issue may enter the GI process for evaluation.

6. The issue is well defined, discrete, and technical.

This criterion is intended to ensure that the initial scope of the proposed GI is manageable.

This will help prevent scope creep and exclude matters extraneous to the issue from evaluation. Reviewers may propose to address closely related issues or topics as a single GI. Likewise, reviewers may separate GIs for individual processing if necessary to expedite important issues through the GI process.

7. Resolution of the issue may involve review, analysis, or action by the affected licensees, certificate holders, or holders of other regulatory approvals.

This criterion identifies potential weaknesses and deficiencies in existing regulations and guidance that affect safety and security. If it becomes apparent that no action is needed by holders of licenses or other NRC approvals, then further assessment under the GI process is not needed, and the issue exits the GI process.

RES OFFICE INSTRUCTION Page 28 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Appendix B Risk Criteria The Generic Issues (GI) Program is designed to address only those issues that raise a question about the safety of a nuclear facility. In order to determine whether the proposed GI could potentially impact facility safety, the U.S. Nuclear Regulatory Commission (NRC) staff can perform a quantitative risk analysis using event probabilities. Issue reviewers can use the criteria in this appendix as guidance for determining whether a proposed GI poses a significant enough risk to warrant continuation in the GI process. In applying the risk criteria, the issue reviewer should understand how the risk significance is influenced by the uncertainties and assumptions in the risk analysis. If a proposed GI fails to meet the criteria, the staff can recommend that the issue exit the GI process.

The criteria are based on the same technical bases used for determining whether the risk associated with a specific facility design change is acceptable. The criteria are illustrated in Figure 4 of Regulatory Guide 1.174, Revision 3, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, issued January 2018, and reproduced below in Figure B-1. If a proposed facility change has a high risk, then the change should not be allowed, which is shown as Region I in Figure B-1.

Figure B-1. Acceptance guidelines for core damage frequency (Source: Regulatory Guide 1.174, Figure 4)

Figures B-2 and B-3 provide guidance on whether the generic issue should continue in the process. If either criteria is met to (e.g., continue in the process), then the generic issue should continue in the process.

Figure B-2 shows the criteria for core damage frequency (CDF) for the GI Program. The change in core damage frequency (CDF)/reactor-year represents the increase to the facilitys baseline CDF because of potential negative effects from the proposed GI. Analogous to RG 1.174, if a proposed GI has a high-risk impact, then it should continue in the GI process. Thus, Region I

RES OFFICE INSTRUCTION Page 29 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues in Figure B-1 corresponds to continue in process. The numerical values associated with defining the regions are to be interpreted as indicative values only. In the context of integrated decisionmaking, the boundaries between regions shown in gray, are not definitive. When in the gray area, the staff may use other factors to determine whether the generic issue should continue in the program.

Figure B-3 shows the criteria for large early release frequency (LERF) for the GI Program. The discussion for Figure B-2 applies similarly to Figure B-3.

Figure B-2. Core damage frequency (CDF) criteria for the GI Program

RES OFFICE INSTRUCTION Page 30 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Figure B-3. Large early release frequency (LERF) criteria for the GI Program Consistent with the discussion in RG 1.174, the staff has created thresholds for determining whether the GI should continue in the GI process based on risk.

If regulatory initiatives to address the proposed GI result in a substantial change, that is, if the CDF is equal to or greater than 1x10-5/reactor-year, then the staff should consider the proposed GI substantial and recommend that the proposed GI continue in the GI process.

If the proposed GI results in a small change, that is, CDF less than 1x10-6/reactor-year, then, generally, the proposed GI should not continue in the GI process unless management decides otherwise (based on strong engineering or qualitative justification, as well as consideration of uncertainties). One such circumstance may involve a class of accident sequences involving the potential for early containment failure or containment bypass, such as an estimated conditional containment failure probability of greater than 1x10-1/reactor-year.

If the CDF is between 1x10-5 and 1x10-6/reactor-year, then the staff should consider other factors, such as the probability of containment failure, before reaching a conclusion on whether the proposed GI should continue in the GI process. Management should make the final determination on whether to proceed.

RES OFFICE INSTRUCTION Page 31 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Appendix C Assessment Plan Instructions

1. The assessment is to provide a formal evaluation of the proposed generic issue (GI) in order to determine whether the issue should proceed to the appropriate U.S. Nuclear Regulatory Commission (NRC) regulatory office for implementation. An assessment typically consists of the following elements:

a. safety assessment A safety assessment should evaluate whether the fundamental safety principles on which the facility design was based are not compromised. It should include a discussion on how the facility maintains defense-in-depth principles and safety margins.

Appendix D, Safety Assessment, to this office instruction contains information a safety assessment.

b. risk assessment With respect to a change in the facility, a risk assessment should follow the guidance in Regulatory Guide 1.174, Revision 3, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, issued January 2018, to determine whether there is a significant change in the core damage frequency. Appendix B to this office instruction contains more information on completing a risk assessment.

c. technical assessment A technical assessment should provide an in-depth analysis of the problem, including an explanation of the phenomenon and the potential effects on the nuclear facility.

d. regulatory assessment A regulatory assessment should evaluate whether the NRC bases its decision on adequate information. This will ensure that agency decisions that impose regulatory burdens on licensees are based on adequate information about the pros and cons associated with a reasonable set of alternatives. Steps to Develop an Assessment Plan

a. The RPM develops and issues an assessment plan.

b. If the assessment plan requires support from other divisions in the Office of Nuclear Regulatory Research (RES), then it may be appropriate for the RPM to send a memorandum to the appropriate RES division directors and the RES Office Director requesting additional assistance.

c. The assessment plan should include guidance, milestones, and a schedule for the evaluation of the proposed GI.

RES OFFICE INSTRUCTION Page 32 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues

d. The assessment plan does not have to follow any explicit format or content. The only expectation is that the scope, work plan, resources, coordination points, and schedule are clear.

e. The assessment plan should include the following as appropriate:

i.

description of the proposed GI ii.

objective of the assessment plan iii.

members of the assessment team iv.

specific tasks required (which may include tests)

v.

schedule for implementation (including sufficient margin to facilitate timely completion of the schedule for major milestones)

f. The assessment plan should include the actions proposed for exploration during the assessment, as appropriate, e.g., industry initiatives, new risk tools or methods, etc.

g. The assessment plan should discuss the formulation of new regulations, policy positions, generic communications, Commission papers, or others regulatory actions.

h. The assessment plan should discuss milestones that include tests or research, public meetings, industry meetings, and major review and concurrence.

i.

The assessment plan should include estimates of resources required for direct technical staff and contractors as well as requests for assignment of a technical staff for preparing or reviewing safety/risk/regulatory assessments to the appropriate managerial level in the program office.

j.

The assessment plan should include a list of technical contacts, including their affiliations, titles, addresses, phone numbers, and e-mail addresses.

k. The assessment plan should include a list of appropriate documents specific to the current GI process stage, including those documents that provide the basis for the GI.

l.

The assessment plan should complement the issue-specific communication plan, if developed.

m. If the assessment plan proposes interactions with outside organizations (such as licensees), industry groups (such as the Nuclear Energy Institute Owners Groups, the Electric Power Research Institute, and nuclear steam supply system vendors), the Advisory Committee on Reactor Safeguards, and others, as appropriate, then the plan should address the planned coordination with such organizations.

n. The preferred approach is to conduct meetings that are open to the public and to place the meeting minutes, with enclosures, in the ADAMS.

o. The RPM places documents provided to, or received from, an outside organization into

RES OFFICE INSTRUCTION Page 33 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues the Agencywide Documents Access and Management System.

p. The NRC staff documents the results of tests outside agencies conduct in a NUREG report, as applicable. The RPM provides the responsible regulatory offices with a copy of the test report for information. The RPM considers whether a technical review is required and should formally request staffs participation in the technical review process.

q. Once an assessment plan has been drafted, the RPM provides a copy to the involved program offices, requesting comments to ensure that the proposed assessment approach identifies practical objectives, schedules, and staff resources.

r. The RPM should confirm assignment of a regulatory office lead contact. This contact does not need to review the detailed technical information RES develops but should be involved in the key decisions, such as which alternative assessment approaches are to be considered.

s. The RPM tracks appropriate assessment plan milestones. In the event of significant changes to milestones or timeliness, the RPM consults with the GIRP chairperson. If deemed necessary, the RPM updates the assessment plan and distributes to the responsible regulatory office or offices.

RES OFFICE INSTRUCTION Page 34 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues Appendix D Safety Assessment Evaluation of Defense-in-Depth Attributes and Safety Margins One aspect of the engineering evaluations is to show that the fundamental safety principles on which the facility design was based are not compromised. Design-basis accidents (DBAs) play a central role in nuclear facility design. DBAs are a combination of postulated challenges and failure events against which facilities are designed to ensure adequate and safe facility response. During the review, design engineers evaluate facility response and associated safety margins using conservative assumptions. National standards and other considerations, such as defense-in-depth attributes and the single-failure criterion, constitute additional engineering considerations that also influence facility design and operation. The proposed generic issue (GI) may also affect safety margins. Therefore, as part of the evaluation to determine the issues safety significance, the NRC staff should evaluate the impact of the issue on the functionality, reliability, and availability of affected equipment.

1. Defense in Depth The engineering evaluation should evaluate whether the impact of the proposed GI (individually and cumulatively) is consistent with the defense-in-depth philosophy. In this regard, the intent of this principle is to ensure that the licensee maintains the philosophy of defense in depth, not to prevent changes in the way defense in depth is achieved. The defense-in-depth philosophy has traditionally been applied in reactor design and operation to provide multiple means to accomplish safety functions and prevent the release of radioactive material. It has been and continues to be an effective way to account for uncertainties in equipment and human performance and, in particular, to account for the potential for unknown and unforeseen failure mechanisms or phenomena, which neither the probabilistic risk analyses nor traditional engineering analyses reflect (whether because they are unknown or unforeseen). If a comprehensive risk analysis is done, it can provide insights into whether the extent of defense in depth (e.g., balance among core damage prevention, containment failure, and consequence mitigation) is appropriate to assure protection of public health and safety. However, to address the unknown and unforeseen failure mechanisms or phenomena, the licensee should use and maintain traditional defense-in-depth considerations. The engineering evaluation should consider the purpose of the general design criteria in Title 10 of the Code of Federal Regulations Part 50, Domestic Licensing of Production and Utilization Facilities, Appendix A, General Design Criteria for Nuclear Power Plants; national standards; and engineering principles, such as the single-failure criterion. Further, the evaluation should consider the impact of the proposed GI on barriers (both preventive and mitigative) to core damage, containment failure or bypass, and the balance among defense-in-depth attributes.

The NRC staff should assess whether the proposed GI meets the defense-in-depth principle.

Defense in depth consists of a number of elements, and consistency with the defense-in-depth philosophy is maintained if the following occurs:

A reasonable balance among prevention of core damage, prevention of containment failure, and consequence mitigation is preserved.

Overreliance on programmatic activities as compensatory measures is avoided.

RES OFFICE INSTRUCTION Page 35 of 43 TEC-002, REVISION 4 Procedures for Processing Generic Issues System redundancy, independence, and diversity are preserved, commensurate with the expected frequency, consequences of challenges to the system, and uncertainties (e.g., no risk outliers).

Defenses against potential common cause failures are preserved, and the potential for the introduction of new common cause failure mechanisms is assessed.

The independence of barriers is not degraded.

Defenses against human errors are preserved.

The purpose of the facilitys design criteria is maintained.

2. Safety Margin The engineering evaluation should assess whether the impact of the proposed GI is consistent with the principle that sufficient safety margins are maintained. The bullets below summarize an acceptable set of guidelines for making that assessment. Other equivalent acceptance guidelines may also be used. With sufficient safety margins, the following are true:

Codes and standards or their alternatives approved for use by the NRC are met.

Safety analysis acceptance criteria in the licensing basis (e.g., final safety analysis report, supporting analyses) are met, or proposed revisions provide sufficient margin to account for analysis and data uncertainty.

The NRC has developed application specific guidelines reflecting this general guidance. The staff can refer to guidance provided in the latest revision of the following regulatory guides:

Regulatory Guide 1.174, An Approach For Using Probabilistic Risk Assessment In Risk-Informed Decisions On Plant-Specific Changes To The Licensing Basis Regulatory Guide 1.175, An Approach for Plant-Specific, Risk-Informed Decisionmaking: Inservice Testing Regulatory Guide 1.177, An Approach for Plant-Specific, Risk-Informed Decisionmaking: Technical Specifications Regulatory Guide 1.178, An Approach for Plant-Specific, Risk-Informed Decisionmaking for Inservice Inspection of Piping Regulatory Guide 1.201 (for trial use), Guidelines for Categorizing Structures, Systems, and Components in Nuclear Power Plants According to Their Safety Significance

RES OFFICE INSTRUCTION Page 36 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Appendix E Examples of Generic Issues Documents and Generic Issue-Related Websites The generic issue (GI) Program documents the status of GIs in correspondence that are issued when a GI reaches a designated point in the process. The GI staff has issued the following documents, which are available on the GI Program SharePoint site. These documents provide examples that the staff should use when drafting new program documents:

Examples of correspondence:

- GI submittal

- acceptance or nonacceptance into the GI process

- request for a regulatory office to perform an immediate safety determination

- response to an immediate safety concern determination

- GI staff initial review recommending screening issue out and exiting the GI process

- GI staff initial review recommending forming a Generic Issues Review Panel (GIRP)

- request to a regulatory office for members to form a GIRP

- identification of GIRP members or additional members to augment a GIRP

- results of a GIRP screening evaluation

- Office of Nuclear Regulatory Research (RES) Office Director acceptance of GIRP screening recommendation and continuance to Assessment Stage

- results of assessment

- formulation of a transition team

- recommendation from RES Office Director to transfer issue to regulatory office

- closeout documentation

- notification to Advisory Committee on Reactor Safeguards of GIs that screen out or transition to regulatory office or close out Examples of programmatic reports and input into other agency periodic reports:

- Generic Issues Management Control System (GIMCS) report

- input into the semiannual report to Congress

RES OFFICE INSTRUCTION Page 37 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues

- input into The United States of America National Report for the Convention on Nuclear Safety report

- input into NUREG-1925, Research Activities GI-related webpages:

- GI home page (public): https://www.nrc.gov/about-nrc/regulatory/gen-issues.html

- GI submittal form page (public): https://www.nrc.gov/about-nrc/regulatory/gen-issues/prop-new-gen-issue.html

- NUREG-0933, Resolution of Generic Safety Issues, page (public):

https://www.nrc.gov/sr0933/

- GIMCS report page (public): https://www.nrc.gov/reading-rm/doc-collections/generic-issues/quarterly/

- GI Dashboard page (public): https://www.nrc.gov/about-nrc/regulatory/gen-issues/dashboard.html

- GI Dashboard page (internal NRC): http://gid.nrc.gov/Planning

RES OFFICE INSTRUCTION Page 38 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Appendix F Assessment Stage Annual Evaluation Template Annual evaluations should be conducted once a year starting from the day that an issue enters Stage 2, Assessment.

Step #1: Fill out the table below to make a determination on whether the issue should or should not remain in the Generic Issues (GI) Program.

Worksheet to be completed as part of the annual evaluation Question Options Answer 1 Does the issue still affect public health and safety, the common defense and security, or the environment?

Yes or No How does it affect it or how does it not affect it?

2 Is continued operation okay?

Yes or No Why or Why not?

3 Can the research required to complete the assessment be completed in a timely manner?

Yes or No If no, should this issue be turned into a research project?

4 Are there clear goals and timelines for the resolution of the proposed GI?

Yes or No What are the goals and timelines?

Be specific on the dates, who is working on the goal, what the goal is, why you have this goal, any perceived challenges, and how you are going to resolve the proposed GI.

5 Is there another regulatory process better suited to address the issue without the need for further assessment?

Yes or No If yes, what is the regulatory process?

6 Should this issue remain in the Generic Issue Program?

Yes or No Why or why not?

Step #2: Using the evaluation results above, develop a memorandum to the Director of the Office of Nuclear Regulatory Research with the following information in the body:

RES OFFICE INSTRUCTION Page 39 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues The Generic Issues Review Panel (GIRP) has conducted an annual evaluation of the (insert issue) issue on (insert date here) and is recommending that the issue (stay or exit) the Generic Issues Program because (insert justification here using the results above):

1. Describe where the proposed GI is in the process (e.g., information gathering, research, or resolution).

2. Does the proposed GI still affect public health and safety, the common defense and security, or the environment? How does it affect it or how does it not affect it?

3. Is continued operation okay? Why or why not?

4. Can research required to complete the assessment be completed in a timely manner? If no, should the proposed GI be turned into a research project?

5. Are there clear goals and timelines for the resolution of the proposed GI? Be specific on the dates, who is working on the goal, what the goal is, any perceived challenges, and how you are going to resolve the proposed issue.

6. Is there another regulatory process better suited to address the proposed GI without the need for further assessment? If yes, what is it?

7. Is the proposed GI still fitting for the Generic Issue Program? Why or why not?

RES OFFICE INSTRUCTION Page 40 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Exhibit 1 - Generic Issues Process Overview

RES OFFICE INSTRUCTION Page 41 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Exhibit 2 Generic Issue (GI) Process - Stage 1

RES OFFICE INSTRUCTION Page 42 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Exhibit 3 - Assessment Stage (orange background) and Implementation Stage (green background)

RES OFFICE INSTRUCTION Page 43 of 43 TEC-002, REVISION 4 Procedure for Processing Generic Issues Exhibit 4 - Sources of new proposed Generic Issues (pre-GI)