ML24311A153

DPO Case File: DPO-2024-001 - Redacted-Public

ML24311A153
Person / Time
Issue date:	11/06/2024
From:	Figueroa-Toledo G, Jordan Hoellman, Mark King Office of Nuclear Reactor Regulation
To:
References
DPO-2024-001
Download: ML24311A153 (1)

Text

DPO Case File for DPO-2024-001 The following pdf represents a collection of documents associated with the submittal and disposition of a differing professional opinion (DPO) from NRC employees involving NRCs authorization of Entergy requests to change quality assurance program for use of ASME code case N-752 at Arkansas Nuclear One.

Management Directive (MD) 10.159, NRC Differing Professional Opinions Program, describes the DPO Program. https://www.nrc.gov/docs/ML2312/ML23123A099.pdf The DPO Program is a formal process that allows employees and NRC contractors to have their differing views on established, mission-related issues considered by the highest-level managers in their organizations, i.e., Office Directors and Regional Administrators. The process also provides managers with an independent, three-person review of the issue (one person chosen by the employee).

Because the disposition of a DPO represents a multi-step process, readers should view the records as a collection. In other words, reading a document in isolation will not provide the correct context for how this issue was reviewed and considered by the NRC.

It is important to note that the DPO submittal includes the personal opinions, views, and concerns of several NRC employees. The NRCs evaluation of the concerns and the NRCs final position are included in the DPO Decision.

The records in this collection have been reviewed and approved for public dissemination.

Document 1: DPO Submittal Document 2: Memo Establishing DPO Panel Document 3: DPO Panel Report Document 4: DPO Decision

Document 1: DPO Submittal

NRC FORM 680 (09-2019)

NRC MD 10.159

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U.S. NUCLEAR REGULATORY COMMISSION DPO Case Number DPO-2024-001 DIFFERING PROFESSIONAL OPINION Date Received 11/01/2023 Name(s) and Title(s) of Submitter(s)

Co-submitters: Jay Collins, Organization Work Email Thomas Scarbrough. SENIOR MECHANICAL ENGINEER and John Honcharik NRR/DEX/EMIB Thomas.Scarbrough@nrc.gov Name and Title of Supervisor Organization Work Email Stewart Bailey -

NRR/DEX/EMIB Stewart.Bailey@nrc.gov When was the prevailing staff view, existing decision, or stated position Where (i.e., ADAMS Ml#, if applicable):

established?

ML21118B039 and ML21132A279 05/19/2021 Subject of DPO NRC authorization of Entergy requests to change Quality Assurance Program for use of ASME Code Case N-752 at Arkansas Nuclear One Summary of prevailing staff view, existing decision, or stated position; Reason for DPO, potential impact on mission, and proposed alternatives.

See attachment.

Describe the (a) importance of prompt action on the issue, (b) safety significance of the issue, and (c) the complexity of the issue.

See attachment.

Do you believe the issue represents an immediate public health and safety concern?

Yes Is the issue directly relevant to a decision pending before the Commission?

If 'Yes'. Reference Document (i.e., ADAMS Ml#):

Yes NRC staff are currently reviewing a request by Duke Energy to use ASM E Code Case N-752 with the same QA program changes at Oconee.

Did informal discussions take place?

If 'Yes'. with whom and during what time frame?

Yes Numerous informal discussions including NRR staff and management from Branch Chief up to NRR Office Director since August 2023.

Proposed panel members are:

Stewart Bailey; Matthew Mitchell; Jay Collins List of area(s) of technical expertise needed to property assess the issue (e.g., electrical engineering, operator licensing).

lnservice Testing, lnservice Inspection, Quality Assurance When the process is complete, I would like management to determine whether public release of the DPO case file (with or without redactions) is appropriate (Select "No" if you would like the DPO case file to be non-public):

Yes Please note that your DPO submittal may be shared on a need-to-know basis in an effort to resolve the concern, determine the most appropriate regulatory action.s in response to the concern, and identify key agency resources to evaluate the concern.

DPO Accepted:

DPO Accepted / Rejected By I

DPO Accepted / Rejected On Gladys Figueroa-Toledo 2/20/2024 Page 1 of 1 NRC FORM 680 (09-2019)

THOMAS G. SCARBROUGH DIFFERING PROFESSIONAL OPINION NRC AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM FOR USE OF ASME CODE CASE N-752 AT ARKANSAS NUCLEAR ONE Background on Completed Licensing Activities On May 27, 2020 (ML20148M343), with a supplement dated November 17, 2020 (ML20322A141), Entergy Operations, Inc. (Entergy) submitted a request to implement ASME Code Case N-752, Risk-Informed Categorization and Treatment for Repair/Replacement Activities in Class 2 and 3 SystemsSection XI, Division 1, at Arkansas Nuclear One, Units 1 and 2 (ANO) as an alternative to specific requirements in the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (BPV Code),Section XI, under Title 10 of the Code of Federal Regulations (10 CFR) in Section 50.55a, Codes and Standards, paragraph (z)(1), as providing an acceptable level of quality and safety. On October 26, 2020 (ML20300A324), with supplements dated April 5, 2021 (ML21095A244), and April 30, 2021 (ML21120A326), Entergy submitted a request to reduce its commitments in the Quality Assurance Program Manual (QAPM) at ANO during implementation of Code Case N-752 under 10 CFR 50.54, Conditions of licenses. On May 19, 2021 (ML21118B039), the NRC staff issued a safety evaluation (SE) authorizing the use of Code Case N-752 at ANO as an alternative to the specified ASME BPV Code,Section XI, requirements under 10 CFR 50.55a(z)(1). On the same date of May 19, 2021 (ML21132A279), the NRC staff issued an SE approving the proposed change to the QAPM at ANO under 10 CFR 50.54 with specific treatment controls (although less rigorous than previously applied) for safety-related Class 2 and Class 3 components categorized as low safety significant (LSS) when implementing Code Case N-752.

Concerns According to its statements, Entergy considers those NRC SEs to have granted an exemption from the quality assurance (QA) requirements in 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 items1 categorized as LSS when implementing Code Case N-752 at ANO.

This incorrect position by Entergy might result in an unacceptable level of quality and safety when Entergy implements Code Case N-752 at ANO. With the exemption from 10 CFR Part 50, Appendix B, assumed by Entergy as reflected in changes to its QAPM and updated Safety Analysis Report (SAR), there are no regulatory QA requirements to provide assurance that Entergy will implement adequate controls for such activities as design, procurement, procedures, material selection, installation, welding, examination, pressure testing, corrective action, and documentation for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO. Although determined by Entergy to be individually less important than other items at ANO, all of the safety-related Class 2 and Class 3 items categorized as LSS under Code Case N-752 perform active or passive safety-related functions to provide reasonable assurance of public health and safety during the operation of the nuclear power plant. The scope of Code Case N-752 includes a multitude of safety-related 1 ASME Code Case N-752 does not define items but provides a parenthetical phrase indicating, for example, that items include piping, components, and tanks. Industry representatives have indicated that items using Code Case N-752 might include internal piece-parts of active or passive components. The use of the term items including internal piece-parts is one of several concerns with Code Case N-752 related to its generic use at nuclear power plants.

Class 2 and Class 3 items categorized as LSS that could receive reduced QA treatment under Code Case N-752 with the QAPM changes over the remaining life of ANO. Such reduced QA treatment over an extended time could lead to common cause failure of two or more of these items to perform their active or passive safety-related functions that might result in a significant impact on the safe operation of ANO. As indicated by changes to its QAPM and SAR, Entergy assumes that the licensing bases and enforcement actions related to safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO are outside the scope of 10 CFR Part 50, Appendix B.

Beyond the concerns regarding the basis for NRC staff acceptance of the QAPM changes at ANO requested by Entergy under 10 CFR 50.54(a)(4), this is a generic issue because other nuclear power plant licensees might rely on 10 CFR 50.54(a)(3)(ii) to implement the same QAPM changes as Entergy made at ANO to achieve an exemption from 10 CFR Part 50, Appendix B, without a requirement to submit those changes for NRC review. For example, Duke Energy referenced the ANO submittals in its request to use Code Case N-752 at the Oconee Nuclear Station (ONS). Duke Energy might take the position that it will also receive an exemption from the QA requirements of 10 CFR Part 50, Appendix B, when implementing Code Case N-752 at ONS. As a further generic issue, the SEs prepared by the NRC staff in response to the Entergy requests to use Code Case N-752 and to change its QAPM at ANO did not follow the required regulatory process for allowing a licensee to not comply with NRC regulations, such as 10 CFR Part 50, Appendix B.

Suggested Resolution Inform Entergy that the licensing basis and enforcement actions related to 10 CFR Part 50, Appendix B, continue to apply to safety-related Class 2 and Class 3 structures, systems, and components (SSCs) categorized as LSS when implementing Code Case N-752 at ANO.

Correct the NRC SEs on the use of Code Case N-752 and reduction in QA program requirements at ANO to clarify that 10 CFR Part 50, Appendix B, continues to apply.

Implement these actions to avoid allowing a licensee to not comply with NRC regulations contrary to the NRC rules and federal rulemaking process for preparing, issuing, and enforcing NRC regulations.

Supporting Information Anecdotal Statements by Industry General statements by industry representatives indicate that licensees do not understand that 10 CFR Part 50, Appendix B, continues to apply to safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752.

Entergy Statements regarding 10 CFR Part 50, Appendix B, when implementing N-752 With respect to its request to use Code Case N-752 and to reduce QA treatment requirements in its QAPM at ANO, Entergy has made numerous statements directly in its submittals, by reference to Code Case N-752, or during interactions with NRC staff, that safety-related Class 2 and Class 3 SSCs categorized as LSS will not be within the scope of 10 CFR Part 50, Appendix B, when implementing Code Case N-752 at ANO.

A few examples of those statements, along with an assessment of those statements, are provided as follows:

(1) Code Case N-752, paragraph -1420, LSS Items, states, in part, that LSS items are exempt from the requirements of ASME BPV Code,Section XI, IWA-1400(o). Paragraph IWA-

1400(o) in the ASME BPV Code,Section XI, refers to the documentation requirements for the QA program in 10 CFR Part 50, Appendix B, and NQA-1. ASME included this paragraph in Code Case N-752 because the BPV Code is an international code with users outside the jurisdiction of the NRC. The Code Case N-752 reference to QA requirements in Section XI of the ASME BPV Code is a reminder that the requirements in 10 CFR 50.55a, which incorporates by reference the ASME BPV Code, and the requirements in 10 CFR Part 50, Appendix B, are independent regulations for NRC licensees. Consistent with the independence of those NRC regulations, Footnote 1 in Code Case N-752 states: If compliance with 10 CFR 50 Appendix B or NQA-1 is required at the Owners facility, IWA-1400(o) is not exempt. In its submittal dated October 26, 2020, Entergy states ASME Code Case N-752 includes provisions for exempting Class 2 or Class 3 items categorized as LSS from the QA requirements of the 2007 Edition/2008 Addenda of ASME Section XI, paragraph IWA-1400(n), which invokes the requirement for a QA Program in accordance with either 10 CFR 50, Appendix B, or ASME NQA-1.

This statement by Entergy is incorrect in several respects. First, ASME BPV Code,Section XI, does not control the requirements to meet 10 CFR Part 50, Appendix B. Second, licensees are required to meet the NRC regulations in 10 CFR Part 50, Appendix B, by their licensing basis, and the provisions in 10 CFR 50.55a cannot change those requirements.

Third, a Code Case under 10 CFR 50.55a cannot exempt an NRC licensee from the QA requirements in 10 CFR Part 50, Appendix B.

(2) In its submittal dated October 26, 2020, regarding its request to change the QAPM at ANO, Entergy stated that Code Case N-752 allows exemption of the associated QA requirements

[i.e., IWA-1400(n)] provided 10 CFR 50 Appendix B or NQA-1 is not required at the nuclear site. Further, Entergy stated that [a]doption of ASME Code Case N-752 exemption of IWA-1400(n) will represent a reduction in commitment with respect to the previously approved Entergy QAPM. Entergy then proposed that treatment of safety-related Class 2 and 3 SSCs identified as LSS in accordance with ASME Code Case N-752 not be required to meet the requirements of the QAPM. With the planned removal of those SSCs from the QAPM, Entergy stated that it had verified that the Entergy QAPM will continue to comply with 10 CFR Part 50 Appendix B, Standard Review Plan 17.3, NUREG-0800 and 10 CFR 50.54(a)(3). In other words, Entergy indicated that safety-related Class 2 and Class 3 SSCs identified as LSS at ANO will not meet 10 CFR Part 50, Appendix B, when implementing Code Case N-752, because those SSCs will not be included within the scope of the QAPM at ANO.

(3) In the Entergy submittal dated October 26, 2020, the licensee clearly states that 10 CFR Part 50, Appendix B, does not apply to Code Case N-752 repair/replacement activities.

Table 1, Entergy Procedures Applicability for Repair/Replacement Activities, in the Entergy submittal includes a column titled Proposed Code Case N-752 Repair/Replacement Program (Class 2 and 3 LSS Items), Appendix B QA Program Applies, which specifies No with a reference to Note 5 for (a) Design Control, (b) Configuration Control, (c) Procurement, (d) Work Management Planning/Instructions, (e) Control of Materials, Parts, Components, (f)

Installation, (g) Control of Welding and Post-Weld Heat Treatment (PWHT), (h) Control of Nondestructive Examination (NDE), (i) Pressure Testing, and (j) Corrective Action/Nonconformances. In Note 5 of Table 1, Entergy states the following:

Treatment (e.g., design control, configuration control, procurement, installation) of Class 2 and 3 LSS items will not be required to comply with the quality assurance provisions of 10 CFR 50, Appendix B. However, the procedures

governing these treatment activities will be classified as safety-related and therefore, under the jurisdiction of 10 CFR 50, Appendix B.

These statements by Entergy reflect its incorrect assumption that 10 CFR Part 50, Appendix B, will not apply to safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO.

(4) Recently, Entergy submitted its plan to modify the Safety Analysis Report (SAR) for ANO (forwarded by NRC Project Manager on September 29, 2023) to reflect the NRC authorization to use ASME Code Case N-752 at ANO. The SAR change states the following:

Code Case N-752 provides a process for determining the risk-informed categorization and treatment for repair/replacement activities on pressure retaining Class 2 and 3 components and their associated supports. Components are categorized as either High Safety Significant (HSS) or Low Safety Significant (LSS).

Repair/replacement activities on Class 2 and 3 pressure retaining components and supports categorized as HSS shall continue to comply with the ASME XI Code and Entergy QAPM. Alternatively, Class 2 and 3 pressure retaining components and supports determined to be LSS in accordance with Code Case N-752 may comply with the alternative treatment requirements of Code Case N-752 including those specified below.

1. Compliance with the repair/replacement requirements of ASME Section XI (e.g., IWA-4000) is not required.

2. Compliance with the Entergy QAPM is not required.

In implementing Code Case N-752, the fracture toughness requirements specified in Owners Requirements and the original construction Code applicable to LSS components shall be met. Additionally, Inservice Inspections (ISI) and Inservice Testing (IST) of LSS components shall continue to be performed in accordance with the sites ISI and IST programs.

Class 2 and 3 pressure retaining components and supports that have been categorized as LSS in accordance with Code Case N-752 are identified as LSS in the Enterprise Asset Management (EAM) application. Alternative treatment requirements for LSS components and supports are specified in applicable risk-informed repair/replacement program procedures.

By this revision to the SAR, Entergy has removed all references to the regulatory QA requirements for the treatment of safety-related Class 2 and Class 3 components that are categorized as LSS when implementing Code Case N-752 at ANO. Therefore, NRC reviewers and inspectors will be unaware that (a) those components remain within the scope of 10 CFR Part 50, Appendix B, with respect to their licensing basis and enforcement actions; and (b) there are specific treatment requirements for safety-related Class 2 and Class 3 SSCs that are categorized at LSS when implementing Code Case N-752, which were the basis for the NRC staff authorizing the use of Code Case N-752 at ANO.

NRC SE Statements regarding 10 CFR Part 50, Appendix B, when authorizing N-752 The NRC SEs authorizing the use of ASME Code Case N-752 at ANO under 10 CFR 50.55a and allowing the QAPM changes at ANO under 10 CFR 50.54 (both dated May 19, 2021) have

resulted in Entergy incorrectly concluding that the NRC granted an exemption from 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO. The NRC SEs will result in licensing basis and enforcement issues because NRC reviewers and inspectors might not be aware that, despite statements by Entergy and ambiguous statements by the NRC staff, 10 CFR Part 50, Appendix B, continues to apply to safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752, with specific treatment requirements that were the basis for the NRC staff authorizing the use of that code case at ANO.

A few examples where the language in the SEs has allowed the incorrect conclusion by Entergy, and an assessment of the language, are as follows:

(1) In the SE approving the changes to the QAPM at ANO, the NRC staff stated the following in Section 4.0, Conclusion, of the SE:

The NRC staff reviewed the licensees application for the implementation of ASME Code Case N-752 in its QAPM. The NRC staff concludes that there is reasonable assurance that the licensees QAPM will continue to meet the requirements of Appendix B to 10 CFR Part 50 while implementing ASME Code Case N-752 for the treatment of safety-related SSCs identified as LSS. Therefore, the NRC staff finds that the licensees proposed changes in the Entergy QAPM, Revision 39, are acceptable.

Contrary to the first sentence of this SE conclusion, the licensee is not implementing Code Case N-752 in its QAPM. In its request (April 30, 2021, supplemental letter), Entergy stated that the QAPM will be modified to state that the treatment of safety-related Class 2 and Class 3 items that are categorized as LSS in accordance with Code Case N-752 is not required to meet the requirements of this manual. Therefore, any item that is characterized as LSS is not required to follow, or is not included in, the QAPM. As a result, Entergy removed these LSS components from the QAPM at ANO.

The second sentence of the SE conclusion states that there is reasonable assurance that the licensees QAPM will continue to meet the requirements of Appendix B to 10 CFR Part 50 while implementing ASME Code Case N-752 for the treatment of safety-related SSCs identified as LSS. This sentence in the SE simply indicates that the licensees QAPM will continue to meet the requirements of 10 CFR Part 50, Appendix B, for SSCs within the new scope of the QAPM at ANO. However, the sentence in the SE fails to recognize that Entergy has removed from the QAPM the QA requirements for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO. So, the QAPM continues to be acceptable for those components that are not LSS, but there is inadequate discussion of the continued treatment of the LSS items.

The third sentence of the SE conclusion states that the NRC staff finds that the licensees proposed changes in the Entergy QAPM, Revision 39, are acceptable. In its submittals, Entergy refers to the QAPM for meeting the QA requirements of 10 CFR Part 50, Appendix B, at ANO. The SE sentence omits the fact that the treatment requirements for safety-related Class 2 and Class 3 SSCs categorized as LSS have been removed from the QAPM at ANO.

The SE, as written, has allowed Entergy to incorrectly conclude that the NRC staff granted an exemption from 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO. The SE conclusion should have stated that safety-related Class 2 and Class 3 SSCs categorized as LSS are required to continue to meet 10 CFR Part 50, Appendix B, when implementing Code Case N-752. The SE conclusion should have stated that the NRC staff accepted a

reduced level of treatment for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752, based on its review of the alternative treatment requirements for those SSCs specified in the Entergy submittals. The SE conclusion should have specified that the alternative treatment requirements for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 are within the scope of 10 CFR Part 50, Appendix B, with respect to the licensing basis and regulatory enforcement at ANO.

(2) In the SE approving the changes to the QAPM at ANO, the NRC staff in Section 2.0, Regulatory Evaluation, summarizes the requirements in 10 CFR 50.54(a)(4) regarding changes to a QA program description. In particular, the SE states that the submittal of a change to the QA program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, and the QA program description commitments previously accepted by the NRC. Contrary to the 10 CFR 50.54(a)(4) requirement that the revised QA program will continue to satisfy the criteria of 10 CFR Part 50, Appendix B, the SE allowed Entergy to remove from the QAPM the treatment requirements for safety-related Class 2 and Class 3 SSCs categorized as LSS for implementing Code Case N-752 at ANO. In approving the QAPM changes, the SE supported an incorrect conclusion by Entergy that the NRC staff granted an exemption from 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO.

(3) In the SE on the use of Code Case N-752, the NRC staff relies on 10 CFR 50.69, Risk-informed categorization and treatment of structures, systems and components for nuclear power reactors, in authorizing the alternative request by Entergy under 10 CFR 50.55a(z)(1) to implement Code Case N-752 at ANO. This reliance on 10 CFR 50.69 circumvents the regulatory requirement that licensees must request and receive a license amendment per 10 CFR 50.92, Issuance of amendment, to apply the alternative treatment requirements specified in 10 CFR 50.69. For example, 10 CFR Part 50, Appendix B, is one of the regulations that is relaxed for RISC-3 components (analogous to LSS under Code Case N-752) under 10 CFR 50.69. The reliance on 10 CFR 50.69 in the SE allowed Entergy to incorrectly conclude that the NRC staff granted an exemption from 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO.

(4) In the SE authorizing the use of Code Case N-752 at ANO, the NRC staff states that Code Case N-752 would allow LSS items to be exempt from ASME Code,Section XI, IWA-1400(o), which requires the licensee to document a Quality Assurance Program in accordance with 10 CFR Part 50 or ASME NQA-1. While a Code Case under 10 CFR 50.55a can change the documentation requirements that are specified in the ASME Code, it cannot exempt a licensee from the QA requirements of 10 CFR Part 50, Appendix B. The statement in the SE allowed Entergy to incorrectly conclude that Code Case N-752 allowed an exemption from 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing the code case at ANO.

These statements in the NRC SEs on the use of Code Case N-752 and QAPM changes at ANO imply that safety-related Class 2 and Class 3 SSCs categorized as LSS are exempt from the QA requirements of 10 CFR Part 50, Appendix B, when implementing Code Case N-752 at ANO.

These SEs undermine the ability of the NRC staff to evaluate licensee actions to meet the regulatory requirements in 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3

SSCs categorized as LSS when implementing Code Case N-752 at ANO. For example, the NRC staff would be unable to evaluate licensee changes under their licensing basis or take enforcement action regarding the treatment of these SSCs if removed from the scope of 10 CFR Part 50, Appendix B.

Conclusion ASME Code Cases under the scope of 10 CFR 50.55a cannot exempt an NRC licensee from the QA requirements of 10 CFR Part 50, Appendix B. The NRC staff cannot grant an exemption from the QA requirements of 10 CFR Part 50, Appendix B, when authorizing an alternative request under 10 CFR 50.55a(z), or when approving a change to a QA Manual under 10 CFR 50.54. Such an action by the NRC staff would be contrary to the federal administrative process for preparing, issuing, and enforcing NRC regulations. The NRC SEs authorizing the use of Code Case N-752 and the QAPM changes at ANO need to be corrected to specify that the NRC staff did not grant an exemption from the QA requirements in 10 CFR Part 50, Appendix B, with respect to the licensing basis and enforcement actions for those SSCs. The NRC SEs need to be revised to clarify that the NRC staff authorized a reduced level of treatment for those SSCs as allowed by 10 CFR Part 50, Appendix B, in response to the Entergy alternative request under 10 CFR 50.55a(z)(1), based on the specific alternative treatment requirements in the Entergy submittals.

As a conforming change, the licensee should be encouraged to revise its QAPM and SAR to specify that the safety-related Class 2 and Class 3 SSCs categorized as LSS when implementing Code Case N-752 at ANO remain within the scope of 10 CFR Part 50, Appendix B, and to reflect the specific alternative treatment requirements that provided the basis for the NRC authorization of the use of Code Case N-752 under 10 CFR 50.55a(z)(1), and the approval of the QAPM changes under 10 CFR 50.54.

Lesson Learned The lesson learned from this issue is that these requests by Entergy should have been provided to the NRC Office of the General Counsel (OGC) for legal review prior to issuance because of the unique and special circumstances related to those licensee requests, as indicated in NRR Office Instruction LIC-102, Revision 3, Review of Relief Requests, Proposed Alternatives, and Requests to Use Later Code Editions and Addenda.

Document 2: Memo Establishing DPO Panel

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 5, 2024 MEMORANDUM TO:

Sabrina D. Atack, Panel Chair Office of Office of International Programs David E. Roth, Panel Member Office of the General Counsel Geoffrey K. Ottenberg, Panel Member Region II THRU:

David L. Pelton, Director Office of Enforcement FROM:

Gladys Figueroa-Toledo, Sr Differing Views Program Manager Office of Enforcement

SUBJECT:

AD HOC REVIEW PANEL - DIFFERING PROFESSIONAL OPINION ASSOCIATED WITH NRC AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM FOR USE OF ASME CODE CASE N-752 AT ARKANSAS NUCLEAR ONE (DPO-2024-001)

In accordance with Management Directive (MD) 10.159, The NRC Differing Professional Opinion Program; and in my capacity as the Senior Differing Views Program Manager (DVP PM); and in coordination with David L. Pelton, Director, Office of Enforcement, Andrea Veil, Director, Office of Nuclear Reactor Regulation, and the Differing Professional Opinion (DPO) submitter; you are appointed as members of a DPO Ad Hoc Review Panel (DPO Panel) to review a DPO submitted by an U.S. Nuclear Regulatory Commission (NRC) employee.

The DPO (Enclosure 1) involves NRC authorization of Entergy requests to change quality assurance program for use of ASME Code Case N-752 at Arkansas Nuclear One. The DPO has been forwarded to Ms. Veil for consideration and issuance of a DPO Decision.

The DPO Panel plays a critical role in the success of the DPO Program. Your responsibilities for conducting the independent review and documenting your conclusions in a report are addressed in the handbook for MD 10.159 in Section II.G and Section II.H, respectively. The DPO Web site also includes helpful information, such as a Differing Views Best Practices Guide, tables with status information and timeliness goals for open DPO cases, and closed DPO case files (which include previous DPO panel reports). We will also send you additional information that should help you implement the DPO process.

CONTACT:

Gladys Figueroa-Toledo, OE (301) 287-9497

Timeliness is an important DPO Program objective. Thus, the disposition of this DPO should be considered an important and time sensitive activity. Although MD 10.159 identifies a timeliness goal of 75 business days for the DPO panel review and report and 30 additional business days for the issuance of a DPO Decision, the DPO Program also sets out to ensure that issues receive a thorough and independent review. Therefore, the overall timeliness goal will be based on the significance and complexity of the issues, schedule challenges, and the priority of other agency work. Process milestones and timeliness goals specific to this DPO will be discussed and established at a kick-off meeting.

Communication of expected timelines and status updates are important in the effectiveness and overall satisfaction with the Differing Views Program. If you need an extension beyond the timeliness goal, please send an e-mail to Mr. Pelton, Ms. Veil, the DPO submitter, and DPOPM.Resource@nrc.gov that includes the reason for the extension request and a proposed completion date.

An important aspect of our organizational culture includes maintaining an environment that encourages, supports, and respects differing views. As such, you should exercise discretion and treat this matter appropriately. To preserve privacy, minimize the effect on the work unit, and keep the focus on the issues, you should simply refer to the employees as the DPO submitters. Avoid conversations that could be perceived as hallway talk on the issue and refrain from behaviors that could be perceived as retaliatory or chilling to the DPO submitters or that could potentially create a chilled environment for others. It is appropriate for employees to discuss the details of the DPO with their co-workers as part of the evaluation; however, as with other predecisional processes, employees should not discuss details of the DPO outside the agency. If you have observed inappropriate behaviors, heard allegations of retaliation or harassment, or receive outside inquiries or requests for information, please notify the Office of Enforcement.

On an administrative note, please ensure that all DPO-related activities conducted by staff are charged to Activity Code ZG0007. Managers should report time to their Management/Supervisor Activity Code. Administrative Assistants should report time to their Secretary/Clerical Activity Code.

We appreciate your willingness to serve on the DPO Panel and your dedication to completing a thorough and objective review of this DPO. Successful resolution of the issues is important for the NRC and its stakeholders. If you have any questions or concerns, please feel free to contact me. We look forward to receiving your conclusions and recommendations.

Enclosures:

1. DPO-2024-001 Submittal (ML24064A235)

2. Process Milestones and Timeliness Goals (ML24064A236) cc: A. Veil, NRR M. King, NRR T. Scarbrough, NRR J. Collins, NRR J. Honcharik, NRR D. Pelton, OE J. Cai, OE D. Solorio, OE G. Figueroa-Toledo, OE N. Khan, OE

SUBJECT:

AD HOC REVIEW PANEL - DIFFERING PROFESSIONAL OPINION ASSOCIATED WITH NRC AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM FOR USE OF ASME CODE CASE N-752 AT ARKANSAS NUCLEAR ONE (DPO-2024-001) DATE: 3/4/2024 ADAMS Package: ML24064A218 MEMO: ML24064A230 - ML24064A235 Attachment - ML24065A041 - ML24064A236 OE-011 OFFICE OE: DPO/PM OE: D NAME GFigueroaToledo DPelton DATE 3/4/2024 3/5/2024 OFFICIAL RECORD COPY

Document 3: DPO Panel Report

August 16, 2024 MEMORANDUM TO:

Michael King Special Assistant for Advance Act Office of the Executive Director for Operations FROM:

Sabrina D. Atack, Panel Chair /RA/

Office of Office of International Programs David E. Roth, Panel Member /RA/

Office of the General Counsel Geoffrey K. Ottenberg, Panel Member /RA/

Region II

SUBJECT:

DIFFERING PROFESSIONAL OPINION PANEL REPORT ON NRC AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM FOR USE OF ASME CODE CASE N-752 AT ARKANSAS NUCLEAR ONE (DPO-2024-001)

In a memorandum dated March 5, 2024, we were appointed as members of a Differing Professional Opinion (DPO) Ad Hoc Review Panel (DPO Panel) to review a DPO regarding the U.S. Nuclear Regulatory Commission (NRC) Authorization of Entergy Requests to Change Quality Assurance Program for Use of ASME Code Case N-752 at Arkansas Nuclear One (DPO-2024-001).The DPO Panel has reviewed the DPO in accordance with the guidance in Management Directive 10.159, The NRC Differing Professional Opinion Program. The DPO Panel Report is enclosed for your consideration.

Please do not hesitate to contact us if you have any questions regarding the enclosed report.

CONTACT:

Sabrina Atack, OIP 301-287-9057

Enclosure:

DPO Panel Report

ML24229A237 (pkg) ML24229A242 (memo)

Office OGC REG II OIP Name DRoth GOttenberg SAtack Date 08/16/2024 08/16/2024 08/16/2024

Differing Professional Opinion (DPO)

NRC Authorization of Entergy Requests to Change Quality Assurance Program for Use of ASME Code Case N-752 at Arkansas Nuclear One (DPO-2024-001)

DPO Panel Report

________________________/RA/_______________________

Sabrina D. Atack

/RA/

David E. Roth

________________________/RA/_______________________

Geoffrey K. Ottenberg August 16, 2024

Executive Summary...................................................................................................................... 1

1. Introduction............................................................................................................................... 3

2. Background and Relevant Regulations and Guidance........................................................ 3 License Amendments in 10 CFR Part 50................................................................................ 3 10 CFR 50.69 Amendments...................................................................................................... 4 Exemptions from Requirements in Regulations................................................................... 4 50.55a Codes and Standards, and 50.55a(z) Alternatives.................................................... 5 Requirements in 10 CFR Part 21............................................................................................. 6 Requirements Addressing Quality Assurance...................................................................... 7

3. Regulatory Actions Associated with the DPO...................................................................... 9 3.1. Unit 2 Alternative Request for Risk-Informed Safety Classification and Treatment for Repair/Replacement Activities (ANO2-R&R-004)...........................................................11 3.2 ANO Unit 2 Alternative Request to Use Code Case N-716 for RI-ISI Program (AN02-ISI-006)...................................................................................................................................... 12 3.3. ANO Units 1 & 2 Exemption Request (Withdrawn) to Support Use of Code Case N-752............................................................................................................................................. 13 3.4 ANO Units 1 & 2 Code Case N-752 Alternative Request (EN-20-RR-001)................... 14 3.5 ANO Units 1 & 2 QAPD Commitment Reduction........................................................... 14 3.6 ANO Unit 1 & 2 Application to Adopt 10 CFR 50.69...................................................... 16 3.7 Entergy Request for Confirmation of Information........................................................ 17 3.8 Differing Professional Opinion........................................................................................ 18

4. Results of Panel Review........................................................................................................ 20 4.1. Acceptance of Entergys QAPM change for review as a reduction in commitment 21 4.1.1. Concern 1 Evaluation................................................................................................ 21 4.1.2. Concern 1 Findings and Conclusions.................................................................... 23 4.1.3. Concern 1 Recommendations................................................................................. 24 4.2. Concern 2: Approval of Entergys QAPM commitment reduction............................. 24 4.2.1. Concern 2 Evaluation................................................................................................ 24 4.2.1.1 Entergy Evaluation.............................................................................................. 31 4.2.1.2 Duke Evaluation................................................................................................... 39 4.2.2. Concern 2 Findings and Conclusions.................................................................... 40 4.2.3. Concern 2 Recommendations................................................................................. 41 4.3. Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 10 CFR 50, Appendix B applicability.................................................................... 43 4.3.1. Concern 3 Evaluation................................................................................................ 43 4.3.2. Concern 3 Findings and Conclusions.................................................................... 47

4.3.3. Concern 3 Recommendations................................................................................. 48 4.4. Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergys QA Program......................................................................................... 48 4.4.1. Concern 4 Evaluation................................................................................................ 48 4.4.2. Concern 4 Findings and Conclusions.................................................................... 50 4.4.3. Concern 4 Recommendations................................................................................. 51

5. Conclusion and Recommendations..................................................................................... 51 References................................................................................................................................... 53

Executive Summary On November 1, 2023, staff of the U.S. Nuclear Regulatory Commission submitted differing professional opinion, DPO-2024-001, related to the recent granting of an American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (BPVC)Section XI Code Alternative under Title 10 of the Code of Federal Regulations (10 CFR) 50.55a(z) to use Code Case N-752 and related acceptance of a Quality Assurance Program Description (QAPD)

Commitment Reduction under 10 CFR 50.54(a)(4) for Arkansas Nuclear One (ANO), Units 1 and 2 (Note that Entergys QAPD is referred to as the Quality Assurance Program Manual, or QAPM). These approvals allow treatment of low safety significant (LSS) safety-related ASME Code Class 2 and 3 components that differs from their prior special treatment under the licensees Quality Assurance (QA) Program implementing the 10 CFR 50, Appendix B requirements.

On March 5, 2024, a review panel was established to review the issues raised by the submitters. The panel members work in other offices than the submitters and were not involved in the review of the ANO regulatory actions.

The issues raised by the submitters are summarized in Section 2 of this report. Section 3 of this report provides background on related regulatory history of risk-informed initiatives undertaken at ANO and the issues discussed in this report. Section 4 of this report presents the results of the panels review of the issues raised by the submitters. Of the four concerns agreed upon by the DPO submitters and the DPO panel, the panel agreed with Concerns 2, 3 (in part), and 4 and disagreed with Concern 1 and Concern 3 (in part), as summarized in Section 5 of this report and expanded upon in each subsection titled Findings. These conclusions resulted in several recommendations, as enumerated below and expanded in each subsection titled Recommendations.

The bullets below summarize the DPO report outcomes:

Concern 1: Acceptance of Entergys QAPM change for review as a reduction in commitment o DPO Panel Opinion: Disagree that staff should have not accepted the request o DPO Panel Recommendations: None Concern 2: Approval of Entergys QAPM reduction in commitment request o DPO Panel Opinion: Agree that the approval resulted in unclear expectations for how Appendix B would be met for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO o DPO Panel Recommendations: The panels recommendations include:

Taking action to achieve clarity on: (1) the level of detail required to be included in the QAPD describing alternate treatments used to satisfy Appendix B, and (2) whether a statement within the QA Program Description that SSCs were removed from treatment under QAPM/QAPD equates to removal of the items from treatment

under the Appendix B QA Program and whether this removal could, under any circumstances, satisfy Criterion II of Appendix B.

Leveraging baselining inspection activities, as appropriate, to validate that licensees that are approved for use of N-752 continue to satisfy the requirements of 10 CFR 50, Appendix B and 10 CFR Part 21.

Considering use of a generic communication Reviewing NUREG-0800 guidance in section 17.3, Quality Assurance Program Description, to consider if updates are warranted based on lessons learned from this DPO.

Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 10 CFR 50, Appendix B applicability o DPO Panel Opinion: Agree and Disagree (Agree) The DPO panel agreed that Code Case N-752 should not be approved without a clear record and common understanding that Appendix B requirements apply. The DPO panel also found it unclear how the IWA-1400(n) exemption (when applying it to the Entergy Section XI Code of record) of Code Case N-752 can be used without exemption of 10 CFR 50, Appendix B.

(Disagree) The licensee did not request and, the staff did not approve an exemption to 10 CFR 50, Appendix B, so the licensee must still comply with its requirements.

Thus, it is the DPO panels view that Appendix B requirements still apply. It is clear that this was the staffs expectation based on the language in its approval.

o DPO Panel Recommendations:

Consider issuing a second RCI to clarify Entergys understanding of the regulatory commitment contained in the November 17, 2020, revision to the Proposed Alternative to Use ASME Code Case N-752 at ANO (ML20322A141).

Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergys QA Program o DPO Panel Opinion: Agree. As noted in the response to other concerns, moving the description of how QA provisions will be applied to Class 2 and 3 LSS SSC when removed from out of a licensees QAPD creates potential challenges in confirming compliance and ensuring that changes receive review and approval, as appropriate.

Given the ability of other plants to use the model established in the staffs approval of ANOs QAPM change, it is reasonable to believe that varied approaches to QA processes and procedures may be used.

o DPO Panel Recommendations:

NRR should consider briefing reviewers who would receive and perform an acceptance review of requests to use Code Case N-752 to identify the recognized concerns with the use of the Code Case, and consider pausing acceptance and review of such requests until clarity is received on the viability of the Code Case.

Any action taken in response to the other concerns should also be communicated to or otherwise carried out on the other affected plants.

1. Introduction The DPO fundamentally concerns a situation where there is a mismatch between what the staff believes it approved and what the licensees think was approved concerning whether licensees who were approved by the NRC to use ASME Code Case N-752 as an alternative under 10 CFR 50.55a(z) and also approved for a reduction in quality assurance program commitments under 10 CFR 50.54(a)(4) must continue to comply with 10 CFR Appendix B for certain structures, systems, and components.

The four concerns were summarized as:

Concern 1: Acceptance of Entergys QAPM change for review as a reduction in commitment Concern 2: Approval of Entergys QAPM reduction in commitment request Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 10 CFR 50, Appendix B applicability Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergys QA Program When the issue was first raised it was raised as speculation based in part from statements by a licensees employee during a public meeting. But routine information subsequently provided on the docket by licenses, targeted information provided on the docket in response to the NRCs specific inquiry, and information reviewed by inspectors during routine planned inspections have confirmed that the licensees read the NRCs approval differently than what the NRC intended.

The set of licensees for whom the NRC approved ASME Code Case N-752 is known to the NRC, but because of the existing permission provided in 10 CFR 50.54(a)(3) for a licensee make changes to its quality assurance program without prior NRC approval under 10 CFR 50.54(a)(4) in situations where the NRC had already approved the reduction for another licensee, inspection, requests for confirmatory information, or waiting until receipt of periodic required records updates must be used to determine the full extent of condition. Concerning safety, the DPO opined that with the exemption from 10 CFR Part 50, Appendix B, assumed by Entergy as reflected in changes to its QAPM and updated Safety Analysis Report (SAR), there are no regulatory QA requirements to provide assurance that Entergy will implement adequate controls for such activities as design, procurement, procedures, material selection, installation, welding, examination, pressure testing, corrective action, and documentation for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO.

However, the DPO submitter and the involved technical staff who performed the approvals have not suggested that an immediate order or other regulatory action is needed at this time to address safety.

In the report, the DPO Panel addresses the specific issues raised in the DPO and examines how the facts and regulations support the concerns. Last, the DPO Panel provides recommendations.

2. Background and Relevant Regulations and Guidance License Amendments in 10 CFR Part 50 Title 10 of the Code of Federal Regulations (10 CFR) Part 50 provides the general provisions for Domestic Licensing of Production and Utilization Facilities. Under 10 CFR 50.90, whenever a holder of a license wishes to amend the license, including technical specifications in the license, an application for amendment must be filed, fully describing the changes desired. Under 10

CFR 50.92(a), determinations on whether to grant an applied-for license amendment are to be guided by the considerations that govern the issuance of initial licenses or construction permits to the extent applicable and appropriate. Both the common standards in 10 CFR 50.40(a), and those specifically for issuance of operating licenses in 10 CFR 50.57(a)(3), provide that there must be reasonable assurance that the activities at issue will not endanger the health and safety of the public.

10 CFR 50.69 Amendments In 2004, the Nuclear Regulatory Commission (NRC) amended its regulations to provide in 10 CFR 50.69 an alternative approach for establishing the requirements for treatment of structures, systems and components (SSCs) for nuclear power reactors using a risk-informed method of categorizing SSCs according to their safety significance.i The 10 CFR 50.69 regulation provides optional requirements with respect to special treatment, that is, those requirements that provide increased assurance (beyond normal industrial practices) that SSCs perform their design basis functions.ii For SSCs that do not significantly contribute to plant safety on an individual basis, this approach should allow an acceptable, though reduced, level of confidence (i.e., reasonable confidence) that these SSCs will satisfy functional requirements.iii The Commission concluded that the 10 CFR 50.69 process provides reasonable assurance of adequate protection of public health and safety because the following four principles were used in the development of 10 CFR 50.69 will continue to be employed in the NRC's continuing regulatory oversight of 10 CFR 50.69 implementation: (1) reasonable confidence that the net increase in plant risk is small; (2) defense-in-depth is maintained; (3) reasonable confidence that safety margins are maintained; and (4) monitoring and performance assessment strategies are used.iv The NRCs approval of a request to use the 10 CFR 50.69 process permits licensees (and applicants for licenses) to remove SSCs of low safety significance from the scope of certain identified special treatment requirements and revise requirements for SSCs of greater safety significance.v The requirements for which 10 CFR 50.69 permits alternatives include: 10 CFR part 21 (reporting of defects and noncompliance); the inservice inspection and repair and replacement (with the exception of fracture toughness) requirements for ASME Class 2 and Class 3 SSCs in 10 CFR 50.55a(g); and Appendix B to 10 CFR part 50.vi A licensee voluntarily choosing to implement 10 CFR 50.69 shall submit an application for license amendment under 10 CFR 50.90.vii When promulgating the rule in 2004, the Commission explained why the Commission concluded that prior NRC approval via approval of a license amendment request was required.viii The Commission concluded that the review of the license amendment request will involve substantial engineering judgment on the part of NRC reviewers, inasmuch as the rule does not contain objective, non-discretionary criteria for assessing the adequacy of the probabilistic risk assessment (PRA) process, PRA review results and sensitivity studies.ix In Section III.6.0 Implementation Process Requirements of the final rule the Commission elaborated further on the reasons why a LAR was needed for existing licensees and what the NRC would review while considering the LAR.x Exemptions from Requirements in Regulations The Commission expects the intent of its regulations to be met and normally this requires conforming to the regulations as stated.xi There are circumstances, however, where on balance it would not be equitable or in the public interest to require literal adherence to regulations particularly where a particular requirement applied to a specific plant would not result in an improvement in overall safety or a reduction in risk to the public.xii The Commission will exercise its discretion to limit exemptions in any particular area if the usage of exemptions threatens to erode the rule itself.xiii The Commission is also aware that exemptions can serve

as warning signals that a particular rule may need to be revised and can serve as a supplement to traditional evaluation mechanisms in identifying areas in need of revision.xiv Concerning the relationship between the exemption criteria in 10 CFR 50.12(a) and other provisions in Part 50 that contain specific exemption criteria or alternative methods of compliance, the Commission emphasized that 10 CFR 50.12(a) is the exemption provision that applies generally to the provisions of 10 CFR Part 50.

xviii xv The Commission explained that if another regulation in Part 50 provides for specific exemption relief, or for alternative methods of compliance, the criteria of the specific regulation are the appropriate considerations.xvi The Commission noted that if the exemption criteria in the specific regulation are met, the rule has been complied with, and no exemption under 10 CFR 50.12(a) is necessary.xvii Further, the Commission stated that it is only in those cases where the specific exemption or alternative compliance criteria cannot be satisfied, that the application of the criteria in 10 CFR 50.12(a) will be appropriate.

Last, the Commission stated that if the specific exemption criteria, or the alternative methods of compliance, can be satisfied, there is no need also to satisfy the criteria of 10 CFR 50.12(a).xix Concerning relief from regulations in 10 CFR part 50 for which the regulations do not provide a specific mechanism of relief, 10 CFR 50.12(a)(1) & (2) allows the Commission to, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of 10 CFR part 50, which are authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security, but the Commission will not consider granting an exemption unless special circumstances are present. Concerning exemptions of part 52 regulations, 10 CFR 52.7 directs usage 10 CFR 50.12 unless there are other specific exemption criteria applicable to the situation.

50.55a Codes and Standards, and 50.55a(z) Alternatives In 1984, the Commission observed that 10 CFR 50.55a requires that certain nuclear power plant components be constructed to the nuclear section of the ASME Boiler and Pressure Vessel Code, the standard used by the nuclear industry to comply with the NRC General Design Criteria and Quality Assurance Criteria.xx The Commission also observed that Appendices A and B of 10 CFR Part 50 already require quality standards and a quality assurance program that parallels the ASME Code requirements, and in fact, the ASME Code has become the NRC and industry standard for compliance with these Appendices A and B of 10 CFR Part 50.xxi As described in 10 CFR 50.55a(a), the standards listed in 10 CFR 50.55a(a) have been approved for incorporation by reference. Per 10 CFR 50.55a(b), systems and components of boiling and pressurized water-cooled nuclear power reactors must meet the requirements of the ASME BPV Code and the ASME OM Code as specified in this 10 CFR 50.55a(b). The paragraphs of 10 CFR 50.55a address multiple requirements including, for example, inservice testing as stated in 10 CFR 50.55a(g). 10 CFR 50.55a(z) permits authorization of alternatives to requirements in specific paragraphs in § 50.55a after demonstration by the applicant that the proposed alternative would provide an acceptable level of quality and safety. By way of background, in 1984, the Commission made changes to 10 CFR 50.55a that, among other things, simplified the procedure for authorizing alternatives to certain NRC requirements.

xxiii xxii The change clarified and moved the then-existing regulation from 50.55a(a)(3) to newly-created paragraph 50.55a(z).xxiv 10 CFR 50.55a(z) currently states:

Alternatives to codes and standards requirements. Alternatives to the requirements of paragraphs (b) through (h) of this section or portions thereof may be used when authorized by the Director, Office of Nuclear Reactor Regulation. A proposed alternative

must be submitted and authorized prior to implementation. The applicant or licensee must demonstrate that:

(1) Acceptable level of quality and safety. The proposed alternative would provide an acceptable level of quality and safety; or (2) Hardship without a compensating increase in quality and safety. Compliance with the specified requirements of this section would result in hardship or unusual difficulty without a compensating increase in the level of quality and safety.

By its own words, 50.55a(z) concerns only alternatives to the requirements of 10 CFR 50.55a(b) through (h).

ASME Code Case N-752 As described by ASME, in the event of an urgent need for alternative rules concerning materials, construction, or in-service inspection activities not covered by existing Boiler and Pressure Vessel Code (BPVC) rules, or need for early implementation of an approved code revision, ASME may issue a code case.xxv The NRC places approved code cases into 10 CFR 50.55a and documents discussed therein. See, for example 10 CFR 50.55a(a)(3), which states:

The use of code cases listed in the NRC regulatory guides in paragraphs (a)(3)(i) through (iii) of this section is acceptable with the specified conditions in those guides when implementing the editions and addenda of the ASME BPV Code and ASME OM Code incorporated by reference in paragraph (a)(1) of this section. The NRC report in paragraph (a)(3)(iv) of this section is acceptable as specified in the conditions when implementing code cases listed in the NRC regulatory guides in paragraphs (a)(3)(i) through (iii) of this section.

ASME Code Case N-752 and N-752 Rev. 1 address risk-informed categorization and treatment for repair/replacement Activities in Class 2 and 3 Systems.xxvi The NRC has not approved Code Case N-752 (either version) and has not incorporated the code case directly or by reference into 10 CFR 50.55a.

Requirements in 10 CFR Part 21 The 10 CFR 50.69 process allows for voluntarily compliance with the requirements 50.69 as an alternative to compliance with, among other things, 10 CFR part 21. As described in 10 CFR 21.1, the Commission sets forth requirements to notify the Commission about, among other things, when a basic component supplied to a facility fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards, or when a basic component supplied to such facility could create a substantial safety hazard. As shown in 10 CFR 21.3, the term basic component is a defined term, and the definition includes: Basic components are items designed and manufactured under a quality assurance program complying with appendix B to part 50 of this chapter, or commercial grade items which have successfully completed the dedication process.

Concerning relief from requirements in 10 CFR part 21, the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.xxvii xxviii Related, suppliers of commercial grade items are exempt from the provisions of 10 CFR part 21 to the extent that they supply commercial grade items.

Requirements Addressing Quality Assurance 10 CFR 50.34(b)(6)(ii) requires the final safety analysis report included with each application for an operating license to include the following information concerning facility operation:

Managerial and administrative controls to be used to assure safe operation. Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, sets forth the requirements for such controls for nuclear power plants and fuel reprocessing plants. The information on the controls to be used for a nuclear power plant or a fuel reprocessing plant shall include a discussion of how the applicable requirements of appendix B will be satisfied.

10 CFR 50.10(b) states that, with certain exceptions not relevant here, no person shall use any utilization facility except as authorized by a license issued by the Commission. 10 CFR 50.54 specifies conditions in every nuclear plant operating license issued under 10 CFR part 50 and similarly specifies conditions in every combined license issued under 10 CFR part 52.

Concerning meeting Appendix B to 10 CFR part 50, 10 CFR 50.54(a) states in part:

(1) Each nuclear power plant... licensee subject to the quality assurance criteria in appendix B of this part shall implement, under § 50.34(b)(6)(ii) or § 52.79 of this chapter, the quality assurance program described or referenced in the safety analysis report, including changes to that report.....

(3) Each licensee described in paragraph (a)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report without prior NRC approval, provided the change does not reduce the commitments in the program description as accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to the NRC in accordance with the requirements of Sec. 50.71(e). In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered to be reductions in commitment:

(ii) The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility; (4) Changes to the quality assurance program description that do reduce the commitments must be submitted to the NRC and receive NRC approval prior to implementation, as follows:

(i) Changes made to the quality assurance program description as presented in the Safety Analysis Report or in a topical report must be submitted as specified in Sec. 50.4.

(ii) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance

program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).

In 1983, the Commission amended its rules to assure that when licensees and construction permit holders reduce their commitments in their quality assurance program descriptions previously accepted by the Commission, they submit the changes to the Commission and receive Commission-approval before implementing the changes.xxix The Commission wrote in part:

Because of the importance of the QA program as a management tool to attain objectives important to nuclear safety, the NRC staff conducts extensive reviews during the licensing process to ensure that the applicants QA program description satisfies 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. Once the NRC staff has accepted it, the QA program description becomes a principal inspection and enforcement tool in ensuring that the permit holder or licensee is in compliance with all NRC quality assurance requirements for protecting the public health and safety.xxx When explaining the 1983 rule change, the Commission wrote that the requirements of Appendix B of 10 CFR Part 50 clearly state that the licensee or permit holder has responsibility for the establishment and execution of the QA program.

xxxii xxxiii xxxiv xxxi Further, in all cases, licensees and permit holders making changes to the QA program description that do reduce the commitments must submit the changes to NRC and receive NRC approval before implementing the changes.

The Commission will evaluate submitted changes to determine if the revised QA program description is in accord with the Commission's QA requirements in Appendix B of 10 CFR Part 50 and Safety Analysis Report QA program description commitments previously accepted by the NRC.

Last concerning the 1983 rule change, the Commission explained that when there is a change involving a change to the QA program as described in the Safety Analysis Report, then the NRC has to be notified and provided with a letter providing the basis for a Commission determination concerning compliance with the criteria in Appendix B of 10 CFR Part 50.

Thus, the 1983 versions of 10 CFR 50.54(a)(3)(ii) and 10 CFR 50.55(f)(3)(ii) conditioned licenses and construction permits, respectively, requiring changes to QA programs submitted to the NRC to include the bases for concluding that the revised programs incorporating the changes continue to satisfy the criteria of Appendix B and the relevant Safety Analysis Report quality assurance program description commitments previously accepted by the NRC. xxxv 10 CFR 50.54(a) Other Licensee Adoption of Alternatives or Exceptions Without Prior Approval.

On February 23, 1999, the NRC published a direct final rule to modify 10 CFR 50.54(a) by providing six quality assurance (QA) programmatic areas within which changes to the QA program will not be considered reductions in commitments and accordingly not subject to prior NRC approval.xxxvi The Commission made clear that the permission given to make changes to the QA programs without prior NRC did not relieve licensees of the requirement to meet Appendix B and other related regulations by writing:

Licensees shall continue to conform to the requirements in appendix B to 10 CFR Part 50 and 10 CFR 50.34(b)(6)(ii) and to notify the NRC of these changes as required by 10 CFR 50.71(e). The Direct Final Rule will provide some immediate relief to licensees by minimizing the need for debate with the NRC on changes that currently would constitute reductions in commitment which need prior NRC approval, but which are of minor safety significance.xxxvii

The Commission provided a section-by-section analysis of the new rule wherein the Commission described how the regulation works, stating:

Paragraph (a)(3)(ii) of § 50.54 specifies that licensees may use a QA alternative or exception previously approved by the NRC in a safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility. The licensee must demonstrate, however, that the plant conditions under which the previously endorsed alternative or exception was granted apply to its plant as well. That is to say that the NRC safety evaluation performed to grant the previous alternative or exception is relevant to the licensee's plant and that any QA elements credited by the original licensee or the NRC staff are applied as part of the implementation of the position.

Licensee QA programs typically contain an array of alternate positions and exceptions to NRC QA regulatory guides and QA standards. This provision would allow licensees to use other alternatives and exceptions that have an accompanying NRC safety evaluation. In the event that QA alternatives or exceptions have been approved without a safety evaluation (e.g., prior to 1997, the NRC approval letters for QA program changes did not elaborate on the rationale for accepting the change), the NRC is willing to perform the evaluations for the incorporation of these changes by other licensees, if licensees request such actions.xxxviii Thus section 50.54(a)(3)(ii) allows licensees to adopt any QA alternative or exception approved by an NRC safety evaluation report (SER), provided that the bases of the NRC approval are applicable to the licensee's facility.xxxix Alternatives and exceptions approved in SERs were approved in the context of the entire QA program.xl In all cases, it is the licensee's responsibility to ensure that the QA program as revised contains all elements that formed the bases of the NRC approval of alternatives or exceptions so that compliance with Appendix B to 10 CFR Part 50 is maintained.xli

3. Regulatory Actions Associated with the DPO The related regulatory actions that took place over the course of several years are described below. The timeline below shows the evolution of several regulatory actions taken and requested at the ANO facility related to risk informed activities. The descriptive sections that follow the timeline are presented in chronological order.

April 17, 2007, (ML071150108) Reest for AlternativeANO2-R&R-004, Revision 1 Request to Use Risk-Informed Safety Classification and Treatment for Repair /Replacement Activities in Class 2 and 3 Moderate Fnf',g,' Sy:itf:ms August 6, 2007, February 20, 2008 January 12, 2009 (ML072220160) RAJ Response (ML080520186) RAJ Response (ML090120620)Supplernental Information (M L090930246) APPROVAL OF REQUEST FOR ALTERNATIVE AN02-R&R-004, REVISION 1 January 20,201O(ML100210161) Request for Alternative-Implementation of a Risk-Informed lnservice Inspection Program Based on ASME Code Case N-716 Arkansas Nuclear One, Unit 2 January 28,201O(M..100200753)

Supplement to Request for Alternatiw August 24, 2010 (ML102380446) RAJ

Response

January 5, 2011, NRC SE (M..103500532)

-REQUEST FOR ALTERNATIVE AN02-ISI-006 May 27, 2020 (ML20148M344) Request for Exemption from 10 CFR50, Appendix B Requ1rernents toSupportApplication of ASME Code Case N-752, "Risk-Informed categorization and Treatment_for _Repair/Replacement Activities in Class 2 and 3 Systems, (ML20197A186)ANO-1/AN0-2 Acceptance Relliew Draft Supplemental Information Request July 7, 2020, Enterg,, conference ca a with the NRC to clarify the requested supplemental information July 15, 2020 (ML20197.A056) IMthdrawal of Request for Exemption May 27, 2020 (ML20148M343) Relief Request Number EN-20-RR-001-Proposed Alternative to Use ASME Code Case N-752 November 17, 2020 (M..20322A141) Relief Request Number EN-20-RR-001, Revision 1-revised relief requestand RAJ response May 19, 2021 NRCSE (ML21118B039)ARKANSAS NUCLEAR ONE, UNITS 1 AND 2-APPROVALOF REQUEST FOR ALTERNATIVE October 26, 2020(ML20300A324) Reduction of Commitment to the Entergy Operation's QuaUty Assurance Program Manual Description April 5, 2021 (ML21095A244) RAJ

Response

April 30, 2021 (ML2112M326)

Supplement to RAJ Response ARKANSAS NUCLEAR ONE, UNITS 1 AND 2 - REQUEST FOR APPROVAL OF CHANGE TO THE ENTERGY QUALITY ASSURANCE PROGRAM MANUAL May 26, 2021 (ML21147A234) [Unit 1], (ML21147A264) [Unit 2] Application to Adopt 10CFR50.00 March 9, 2022 (ML22068A170)

May 18, 2022 (ML22138A380)

RAJ Response (Units 1 and 2)

RAJ Response (Units 1 and 2)

June 23, 2022 (ML22138A431)

NRC SE 50.69 Amendment Unit 1 July 19, 2022 (ML2216!iA244 N RC SE 50.69 Amendrnent Unit 2 March 27, 2024 (ML24088A009) e-mail

Subject:

Entergy Fleet -Final Request for Confirmation of Information (RCI) RE: Alternative Request EN-RR-22-001 Concerning ASME Code Case N-752 (L-2022-LLR-0054)

April 1 0, 2024 (ML24101A388) RCI Response

3.1. Unit 2 Alternative Request for Risk-Informed Safety Classification and Treatment for Repair/Replacement Activities (ANO2-R&R-004)

On April 17, 2007, xliii xlii Entergy requested the approval of a Code Alternative to use a risk-informed safety classification and treatment for repair/replacement activities in Class 2 and 3 moderate energy systems at Arkansas Nuclear One, Unit 2 (ANO-2). The request was later modified on January 12, 2009, to include high-energy systems. The licensees request was approved on April 22, 2009,xliv and applied to the remainder of the licensees 3rd and 4th ISI Intervals for ANO Unit 2. The NRC SER for this approval provided as background that the licensee had previously received acceptance of its RI-ISI methodology on December 29, 1998,xlv upon which the SSC categorization (LSS vs HSS) would be based. The NRC SER further mentioned that the licensee clarified that the method would be supplemented with the "additional considerations" contained in Nuclear Energy Institute (NEI) 00-04, "10 CFR 50.69 SSC Categorization Guideline."xlvi The alternative requested the use of a risk-informed safety classification and treatment for repair/replacement activities which was defined in the attachment to its request. The request did not directly use any singular document but was rather a combination of approaches defined in Code Case N-660, EPRI TR-112657, the risk informed ISI program previously approved for ANO-2, and NEI 00-04.

Notably, the ANO2-R&R-004 alternative request included a statement that Those components that are LSS will be exempt from ASME Section XI repair/replacement requirements. It did not make any statement that the LSS components would be exempt from Appendix B requirements.

Other sites have used this prior NRC review and acceptance as part of their requests to adopt 10 CFR 50.69. For example, the H. B. Robinson Steam Electric Plant Unit 2 (HBR2) UFSAR states that HBR 2 has implemented 10 CFR 50.69 using the processes for categorization of Risk-Informed Safety Class (RISC)-1, RISC-2, RISC-3, and RISC-4 structures, systems, and components (SSCs) using... The Arkansas Nuclear One, Unit 2 passive categorization method to assess passive component risk for Class 2 and Class 3 SSCs and their associated supports (Reference 13.7.1-1), where reference 13.7.1-1 is the NRC authorization for ANO Unit 2 to use the ANO2-R&R-004 proposed alternative and its associated safety evaluation (ML090930246).

This ANO Unit 2 passive categorization method to assess passive component risk for Class 2 and Class 3 SSCs was confirmed as having been used to classify the HBR2 Containment Air Recirculation Cooling System during review of an item procured under the 10 CFR 50.69 provisions during the 2024 Robinson Commercial Grade Dedication Inspection.

Entergy referred to the NRC approval of ANO2-R&R-004 as precedent in their May 27, 2020, request to adopt Code Case N-752 as a Code alternative.

DPO Panel Observations about this regulatory action The DPO panel noted that the NRC SER (ML090930246) associated with the approval of ANO2-R&R-004 included the following statements:

RISC-1 SSCs (safety-related HSS) and RISC-3 (safety-related LSS) are subject to the regulatory requirements for safety-related equipment specified in 10 CFR Part 50.

And The licensees proposed alternative has not requested any changes to these requirements.

The panel further noted that the NRCs approval relied on the application of the LSS treatment requirements being consistent with 10 CFR 50.69:

The NRC staff evaluated the acceptability of these alternative requirements based on consistency with the requirements in 10 CFR 50.69.

A similar reasonable confidence threshold was also acknowledged in the NRC SER:

Entergy will replace the existing Section XI repair/replacement requirements with owner-defined activities to confirm with reasonable confidence that each LSS item remains capable of performing its safety function(s) under design-basis conditions.

Also similar to Entergys request to adopt Code Case N-752 as a Code alternative, the NRC SER approving ANO2-R&R-004 makes note that:

... Entergy states that the guidance for the treatment of repair/replacement activities will be maintained in a high-level corporate document or procedure. The treatment will include guidance such as, but not limited to, design controls, procurement, installation, inspection, and configuration control.

3.2 ANO Unit 2 Alternative Request to Use Code Case N-716 for RI-ISI Program (AN02-ISI-006)

On January 20, 2010, Entergy requested a Code alternative to allow the use of Code Case N-716 to implement a Risk Informed Inservice Inspection (RI-ISI) program at ANO-2.xlvii In its request, the licensee stated that As a risk-informed application, this submittal meets the intent and principles of Regulatory Guide (RG) 1.174, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions On Plant-Specific Changes to the Licensing Basis, and RG 1.178, An Approach for Plant-Specific Risk-Informed Decisionmaking Inservice Inspection of Piping.

Code Case N-716-2 is currently considered acceptable for use as listed in RG 1.147, Inservice Inspection Code Case Acceptability, ASME Section XI, Division 1, Revision 20. Similarly, Code Case N-716-1 was unconditionally accepted for use in RG 1.147, Revision 17. The Code Case N-716 generally provides alternative examination requirements for inservice inspection of Class 1 piping welds or Class 2 components, and for preservice inspection of Class 1 piping welds or Class 2 components, or as additional requirements for Class 3 or Non-Class components.

Components within the scope of the Code Case are assigned a risk category (HSS or LSS) that is used to determine the treatment requirements of the Code Case.

To implement the Code Case, the owners responsibilities include ensuring that the technical adequacy of the PRA is reviewed to confirm that it meets the requirements of Mandatory Appendix II of this Case, or that the Owner has met PRA technical adequacy requirements for RI-ISI applications accepted by the regulatory authority having jurisdiction at the plant site.

Mandatory Appendix II of the Code Case contains the PRA technical adequacy requirements and states that the Owner shall ensure that the technical adequacy of the PRA is reviewed to confirm that it meets the requirements of Table II-1 or that the Owner has met PRA technical adequacy requirements for RI-ISI applications accepted by the regulatory authority having jurisdiction at the plant site. The NRC ultimately approved Entergys request to implement the RI-ISI program at ANO on January 5, 2011.xlviii

3.3. ANO Units 1 & 2 Exemption Request (Withdrawn) to Support Use of Code Case N-752 On the same day the Code Case N-752 Alternative Request was submitted, May 27, 2020, Entergy submitted a request for an exemption to the requirements of 10 CFR 50, Appendix B, for the ASME Section XI, Repair/Replacement Programs that are in the scope of the request to use Code Case N-752 in accordance with 10 CFR 50.12, "Specific exemptions." At the time of the exemption request, Entergy believed, as stated in their submittal, that the 10 CFR 50, Appendix B requirements were unduly burdensome for components of Low Safety Significance (LSS) and that alternative practices, supplemented as appropriate, are adequate to provide reasonable confidence that the LSS components will perform their safety related functions under design basis condition. Accordingly, the request detailed that the exemption was only to apply to the safety-related, Code Class 2 or 3 items which were classified as LSS in accordance with the method described in Code Case N-752. Recognizing that the direct provisions of Code Case N-752 did not, by itself, allow for exemption from CFR requirements, Entergy made the following statement explaining why the exemption request was submitted for NRC consideration:

ASME Code Case N-752 includes provisions for exempting Class 2 or Class 3 items categorized as LSS from the QA requirements of the 2007 Edition/ 2008 Addenda of ASME Section XI, paragraph IWA-1400(n), which invokes the requirement for a QA Program in accordance with either 10 CFR 50, Appendix B, or ASME NQA-1. However, approval to implement this Code Case cannot waive the 10 CFR 50, Appendix B, licensing basis requirement. The purpose for this request is to obtain approval for exempting ANO-1 and ANO-2, from the requirements of 10 CFR 50, Appendix B, for those safety-related Class 2 or Class 3 items categorized as LSS using the risk-informed methodology found in Code Case N-752.xlix Further, in their submittal requesting the exemption from 10 CFR 50, Appendix B, under 10 CFR 50.12, Entergy compared the provisions of Code Case N-752 to those of 10 CFR 50.69 in the following statement:

The provisions of Code Case N-752 are similar to those of 10 CFR 50.69, "Risk-Informed Categorization and Treatment of Structures, Systems, and Components (SSCs) for Nuclear Power Plants" (Reference 4), in that the provisions allow adjustment of the scope of items subject to special treatment controls (e.g., quality assurance, testing, inspection, condition monitoring, assessment, and evaluation). For items determined to be of LSS, alternative treatment requirements may be implemented in accordance with this Code Case. For equipment determined to be of High Safety Significance (HSS), requirements will not be changed.l Entergy ultimately withdrew their request for the Appendix B exemption under 50.12 in a letter dated July 15, 2020li. The letter stated that on July 7, 2020, Entergy conducted a conference call with the NRC to clarify the requested supplemental information and that based on the discussions during the conference call, Entergy desires to withdraw the exemption request.

While a specific record of the conference call could not be located, the Entergy request to reduce the QAPD commitment (ML20300A324, discussed below) stated that, While Entergy withdrew the exemption request and the NRC did not finalize the Requests for Additional Information (RAIs), they were discussed during the July 7, 2020, conference call. Enclosure 2 provides additional information in response to the draft RAIs.

3.4 ANO Units 1 & 2 Code Case N-752 Alternative Request (EN-20-RR-001)

On May 27, 2020, Entergy requested an ASME BPVC Section XI Code Alternative to be granted which would allow the use of Code Case N-752 [Entergy Relief Request Number EN-20-RR-001 - Proposed Alternative to Use ASME Code Case N-752, Risk-Informed Categorization and Treatment for Repair/ Replacement Activities in Class 2 and 3 Systems,Section XI, Division 1, for ANO Units 1 and 2, dated May 27, 2020lii]. On page 2 of 12 of the requests Enclosure, Entergy discussed that NRC had incorporated section 50.69 into the CFR and stated that the categorization and treatment requirements of Code Case N-752 are consistent with those in 10 CFR 50.69. Entergy further pointed out that RG 1.201 had been issued which endorsed a categorization method, with conditions, for categorizing active SSCs described in Nuclear Energy Institute (NEI) 00-04, "10 CFR 50.69 SSC Categorization Guideline."

Entergy did not request the adoption of 10 CFR 50.69 nor commit to using the guidance in RG 1.201 when implementing Code Case N-752 in its Code Alternative request. Instead, in section 5.2, Basis for Use, of its alternative request to use Code Case N-752, Entergy made the statement that the categorization process in Code Case N-752 was technically identical to the process approved by the NRC under Relief Request ANO2-R&R-004, Revision 1 (Reference 4),

which, in turn, is based on founding principles in EPRI Report TR-112657, Revision B-A, Revised Risk-Informed Inservice Inspection Evaluation Procedure, and the categorization process of Code Case N-660, but with improvements and lessons learned from trial applications. The ANO Unit 2 alternative request, ANO2-R&R-004, is described above.

3.5 ANO Units 1 & 2 QAPD Commitment Reduction On October 26, 2020, Entergy requested a Reduction of Commitment to the Entergy Operations Quality Assurance Program Manual (QAPM) Description applicable to ANO Units 1 and 2 under the provisions of 10 CFR 50.54(a)(4). This request superseded the Appendix B exemption request that was withdrawn by Entergy on July 15, 2020. In the request, Entergy described that adoption of the ASME Code Case N-752 exemption on IWA-1400(n) represented a reduction in commitment with respect to the previously approved Entergy QAPM.

The request acknowledges that Code Case N-752 exempts Class 2 and 3 LSS SSCs from the repair/replacement requirements of ASME Section XI, and stated that it also allows exemption of the associated QA requirements [i.e., IWA-1400(n)] provided 10 CFR 50 Appendix B or NQA-1 is not required at the nuclear site. Entergy proposed that LSS safety-related Class 2 and 3 items that were covered by ASME Code Case N-752 not be required to meet the requirements of the QAPM. Instead, Entergy stated they would develop program elements describing treatment of these LSS SSCs to ensure continued capability and reliability of the design basis function. This statement was modified by later submittals, eventually stating: Instead, treatment of these LSS SCCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function. Further in the October 26, 2020, request, Entergy stated that, The QAPM, as revised and noted, continues to satisfy the requirements of 10 CFR 50, Appendix B and the Regulatory Guides and ANSI Standards referenced in the QAPM Table of Contents and QAPM Table 1. Notably, per the previous statement, the LSS safety-related Class 2 and 3 items would not be required to meet the requirements of the QAPM.

According to Entergys statements in the QAPD Commitment Reduction request, while Entergy withdrew the earlier Appendix B exemption request, and the NRC did not finalize the Requests for Additional Information (RAIs) related to the Appendix B exemption request, the RAIs were

discussed during a July 7, 2020, conference call. Enclosure 2, Response to NRC Feedback, to Entergys QAPD Commitment Reduction request provides additional information in response to those draft RAIs. The Enclosure 2 requests included inquiries such as:

Provide a markup of the proposed changes that the licensee will make to the ANO-1 and ANO-2 QA Program description based on the scope of the SSCs exempted from 10 CFR Part 50 Appendix B, the basis for this exemption request, and a detailed description of the proposed changes to the program elements. The descriptions should address, at a minimum:

A description of those portions of QA Program that remain applicable to the exempted SSCs (e.g., design control, procurement, installation, configuration control, A description of the administrative controls for repair/replacement activities.

A description of the methodology for evaluating changes in configuration, design, fabrication, examination, and pressure-testing requirements used in repair/replacement activities that will ensure structural integrity and leak tightness of the system are sufficient to support design bases functional requirements of the system.

A detailed description of what constitutes the Owners requirements or modified Owners requirements as permitted by the licensing basis.

A detailed description of the program or process that will provide confidence that the items used for repair/replacement activities meet the Construction Code to which the original item was constructed.

A detailed test program to assure all testing activities required to demonstrate pressure testing of repair/replacement activities be performed in accordance with the requirements of Code of Construction selected for the repair/replacement activity.

A detailed methodology for performance of repair/replacement activities and associated non-destructive examination (NDE), nonconformance, and corrective action).

DPO Panel Observation One can observe that, in accordance with the original intent of clarifying the licensees stance on the Appendix B exemption request, the draft RAI language included scope of the SSCs exempted from 10 CFR Part 50 Appendix B, as opposed to scope of the SSCs not required to meet the QAPM as proposed by Entergy in the QAPD Commitment Reduction request.

Additionally, Entergys response to this request included that Table 1 describes Entergy process procedures and QA Program applicability for performing repair/replacement activities.

Review of Table 1 contained in Enclosure 2 to the QAPD Commitment Reduction request reveled that Entergy communicated that although in many cases, a process procedure would apply, they considered that the Appendix B QA Program was either not applicable or would not apply directly to the Class 2 & 3 LSS items. Instances where the QA Program would not apply were modified by Note 5, which stated:

Treatment (e.g., design control, configuration control, procurement, installation) of Class 2 and 3 LSS items will not be required to comply with the quality assurance provisions of 10 CFR 50, Appendix B. However, the procedures governing these treatment activities will be classified as safety-related and therefore, under the jurisdiction of 10 CFR 50, Appendix B.liii

It is noted that the licensee makes a direct statement in Note 5 that the Class 2 and 3 LSS items will not be required to comply with the quality assurance provisions of 10 CFR 50, Appendix B.

Additionally, the procurement line item in Table 1 is also modified by Note 6, which states:

Although procurement will be performed in accordance with Entergy safety related procedures, Class 2 and 3 LSS items used in repair/replacement activities will be procured and controlled as nonsafety-related. Supplemental procurement requirements and controls will be specified, as appropriate, to confirm with reasonable confidence that Class 2 and 3 LSS items remain capable of performing their safety related functions under design-basis conditions.

The licensee stated that the Class 2 and 3 LSS items would be procured and controlled as nonsafety-related, potentially affecting how they would be treated under 10 CFR Part 21 and 10 CFR 50, Appendix B. The licensees statement that the item would be controlled as a nonsafety-related item appear to conflict with later details they provided in their April 30, 2021, response to an RAI, leaving it unclear if the items would undergo a dedication process to become basic components as defined in 10 CFR 21.3. While the NRC, in an RAI dated February 17, 2021 liv, requested that Entergy Provide a detailed description of the supplemental procurement requirements and controls that will be specified by Entergy Engineering to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions, it did not directly confirm that the licensee would be performing commercial grade dedication activities or specifying that Part 21 requirements would be applied to the newly procured LSS Class 2 and 3 items. During a conference call between the NRC and Entergy, on April 15, 2021, per an Entergy RAI response supplement dated April 30, 2021lv, the NRC requested detailed description of the supplemental procurement requirements and controls that will be specified by Entergy to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions. Entergy responded by providing a description of the supplemental procurement requirements and controls they would be applying to the LSS Class 2 and 3 SSCs. Among the supplemental control requirements described in ML21120A326, the licensee included in its response that its QC Receiving Attributes include Dedication activities were adequately documented.

3.6 ANO Unit 1 & 2 Application to Adopt 10 CFR 50.69 Entergy made a separate request to adopt the use of 10 CFR 50.69, "Risk-informed Categorization and Treatment of Structures, Systems, and Components for Nuclear Power Reactors" dated May 26, 2021, for ANO Units 1 & 2 on May 26, 2021, seven days after the NRC accepted their reduction in QAPD commitment and granted their alternative request to use Code Case N-752 (both were approved on the same day, May 19, 2021).lvi The ANO Units 1 &

2 applications to adopt 10 CFR 50.69, "Risk-informed Categorization and Treatment of Structures, Systems, and Components for Nuclear Power Reactors" dated May 26, 2021, referenced the use of RG 1.174 in multiple places.lvii They also reference in multiple places RG 1.200, "An Approach for Determining the Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed Activities," whose stated purpose is to describe an approach that is acceptable to the staff of the U.S. Nuclear Regulatory Commission (NRC) for developing risk-informed applications for a licensing basis change that considers engineering issues and applies risk insights. It provides general guidance concerning analysis of the risk associated with proposed changes in plant design and operation. RG 1.174 was not committed to in either the request to reduce the QAPD commitment or the Code Alternative request to use Code Case

N-752. It was however used in Entergys request to use Code Case N-716 (ML100210161) to implement a risk-informed ISI program.

Relevant to the subject DPO, although Entergy invoked reference to consistency with 50.69 methods in its request for the Code Alternative to adopt Code Case N-752, Entergy did not request that the acceptance of either the QAPD reduction in commitment under the provisions of 10 CFR 50.54(a)(3) or a 50.55a(z) alternative to the requirements of ASME BPVC Section XI, required by 10 CFR 50.55a(g) be contingent on the NRCs acceptance of Entergys request to adopt 10 CFR 50.69. Of note, Entergy did separately request to adopt the use of 10 CFR 50.69 for ANO Units 1 & 2 on May 26, 2021, seven days after the NRC accepted their reduction in QAPD commitment and granted their alternative request to use Code Case N-752 (both were approved on the same day, May 19, 2021).Entergys request to adopt 10 CFR 50.69 at ANO was approved on June 23, 2022, for Unit 1, and July 19, 2022, for Unit 2. Approval of 10 CFR 50.69 exempts 10 CFR 50, Appendix B, and allows for treatment under 10 CFR 50.69 provisions provided the required classification and alternative processes are followed. See 10 CFR 50.69 discussion above.

3.7 Entergy Request for Confirmation of Information On March 22, 2024, the NRC sent a Request for Confirmation of Information (RCI)

(ML24088A009) to Entergy regarding their Relief Request No. EN-RR-22-001, which requested the use of ASME Code Case N-752 at Grand Gulf Nuclear Station, Unit 1, River Bend Station, Unit 1, and Waterford Steam Electric Station, Unit 3. The RCI reinforced that Appendix B to 10 CFR Part 50 establishes quality assurance (QA) requirements for the design, fabrication, construction, and testing of SSCs.

The RCI noted that the revisions to the Safety Analysis Reports (SARs) for ANO Units 1 (Amendment 31) and 2 (Amendment 30) (ML23180A110 and ML22124A153, respectively),

stated that 1. Compliance with the repair/replacement requirements of ASME Section XI (e.g.,

IWA-4000) is not required. 2. Compliance with the Entergy QAPM is not required. The RCI stated that these revisions were not consistent with the changes the staff approved to the Entergy QAPM and could imply that the requirements of Appendix B to 10 CFR Part 50 no longer apply to safety-related Class 2 and Class 3 LSS SSCs.

The RCI requested that Entergy confirm that the repair/replacement items would be:

treated in accordance with existing QAP procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50 and that additional supplemental requirements and controls, as described in the Entergy letter dated April 30, 2021, used to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions, are currently being implemented and have been incorporated into the existing ANO QAP procedures used for the procurement of safety-related Class 2 and 3 LSS SSCs and will also be incorporated into the Grand Gulf, River Bend, and Waterford 3 QAP procedures, if the NRC staff authorizes the requested alternative.

On April 10, 2024, Entergy responded to the RCI, confirming that the repair/replacement items:

are being treated in accordance with existing Quality Assurance Program (QAP) procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50 and

that the additional supplemental requirements and controls, as described in the Entergy letter dated April 30, 2021 (Reference 1), used to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions, are currently implemented and have been incorporated into the existing QAP procedures used for the procurement of safety-related Class 2 and 3 LSS SSCs for ANO. The existing QAP procedures will be used for the procurement of safety-related Class 2 and 3 LSS SSCs for GGNS, RBS, and WF3 following authorization.

3.8 Differing Professional Opinion Aware of the series of regulatory actions above, the DPO increased the awareness of NRC staff that Entergy considers the net effect of the regulatory actions to have granted an exemption from the quality assurance (QA) requirements in 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO.

The DPO asserted that the incorrect position by Entergy might result in an unacceptable level of quality and safety when Entergy implements Code Case N-752 at ANO. The DPO opined that with the exemption from 10 CFR Part 50, Appendix B, assumed by Entergy as reflected in changes to its QAPM and updated Safety Analysis Report (SAR), there are no regulatory QA requirements to provide assurance that Entergy will implement adequate controls for such activities as design, procurement, procedures, material selection, installation, welding, examination, pressure testing, corrective action, and documentation for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO. Although determined by Entergy to be individually less important than other items at ANO, all of the safety-related Class 2 and Class 3 items categorized as LSS under Code Case N-752 perform active or passive safety-related functions to provide reasonable assurance of public health and safety during the operation of the nuclear power plant. The scope of Code Case N-752 includes a multitude of safety-related Class 2 and Class 3 items categorized as LSS that could receive reduced QA treatment under Code Case N-752 with the QAPM changes over the remaining life of ANO. Such reduced QA treatment over an extended time could lead to common cause failure of two or more of these items to perform their active or passive safety-related functions that might result in a significant impact on the safe operation of ANO. As indicated by changes to its QAPM and SAR, Entergy assumes that the licensing bases and enforcement actions related to safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO are outside the scope of 10 CFR Part 50, Appendix B.

The DPO also stated that, beyond the concerns regarding the basis for NRC staff acceptance of the QAPM changes at ANO requested by Entergy under 10 CFR 50.54(a)(4), this is a generic issue because other nuclear power plant licensees might rely on 10 CFR 50.54(a)(3)(ii) to implement the same QAPM changes as Entergy made at ANO to achieve an exemption from 10 CFR Part 50, Appendix B, without a requirement to submit those changes for NRC review. For example, Duke Energy referenced the ANO submittals in its request to use Code Case N-752 at the Oconee Nuclear Station (ONS). Duke Energy might take the position that it will also receive an exemption from the QA requirements of 10 CFR Part 50, Appendix B, when implementing Code Case N-752 at ONS. As a further generic issue, the SEs prepared by the NRC staff in response to the Entergy requests to use Code Case N-752 and to change its QAPM at ANO did not follow the required regulatory process for allowing a licensee to not comply with NRC regulations, such as 10 CFR Part 50, Appendix B.

From the DPO Panels meetings and interactions with the submitters, the above concerns were binned into four overarching concerns described below.

Concern 1: Acceptance of Entergys QAPM change as a reduction in commitment Action Related to Concern: Instead of considering application of the IWA-1400(n) exemption (allowed under Code Case N-752 for sites not required to comply with 10 CFR 50, Appendix B, or NQA-1) as a reduction in QAPM commitment, the NRC should have considered it an exemption from Appendix B requirements and reviewed it as a specific exemption request per 10 CFR 50.12 requirements.

Related Agency Decision: In its May 19, 2021, SE regarding Entergys request for approval of a QAPD reduction in commitment, the NRC accepted that the Code Case N-752 provisions for exempting Class 2 or 3 items categorized as LSS from the QA requirements of paragraph IWA-1400(n) of the 2007 Edition and 2008 Addenda of ASME Code Section XI, represented a reduction in commitment to the previously approved Entergy QAPM.

Concern 2: Approval of Entergys QAPM reduction in commitment request Action Related to Concern: Absent an exemption being previously granted under 10 CFR 50.12, the NRC should not have approved Entergys request for a QAPD commitment reduction because the licensees submittals stated that the quality assurance (QA) requirements in 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 items categorized as low safety significant (LSS) do not apply when implementing Code Case N-752 at ANO. Further, the language in the May 19, 2021, NRC SE makes it sound like Appendix B compliance is voluntary.

In order to have concluded the QAPD reduction in commitment was acceptable, the Appendix B treatment provisions described in the licensee's submittals should have been incorporated into the Entergy QAPD, rather than the LSS Class 2 & 3 items being removed from treatment under the QAPD. Absent such an approach, it is possible that the only aspect of these SSCs that will be subject to Appendix B criteria are the handling of procedures associated with their control.

The discussion in the NRC SE did not establish a durable licensing basis.1 Related Agency Decision: The NRC found acceptable Entergys request for approval of a reduction in commitment to the previously accepted Quality Assurance Program for ANO dated October 26, 2020 (ML20300A324), as supplemented by letters dated April 5, 2021, and April 30, 2021 (ML21095A244 and ML21120A326, respectively), and issued a safety evaluation on May 19, 2021 (ML21132A279) which concluded that there is reasonable assurance that the licensees QAPM will continue to meet the requirements of Appendix B to 10 CFR Part 50 while implementing ASME Code Case N-752 for the treatment of safety-related SSCs identified as LSS.

1 The DPO submitters provided the following information supporting this opinion:

Entergy has not obtained an exemption from 10 CFR Part 50, Appendix B, under 10 CFR 50.12 when applying ASME Code Case N-752 at ANO.

Other nuclear power plant licensees may rely on 10 CFR 50.54(a)(3)(ii) to implement the same QAPM changes as Entergy made at ANO, without a requirement to submit those changes for NRC review.

Licensees are currently implementing this change to their QAPMs through this process.

The SEs accepting the QAPM changes at ANO under 10 CFR 50.54, and authorizing the use of ASME Code Case N-752 under 10 CFR 50.55a(z) at ANO, are contrary to the NRC rules for granting exemptions from the NRC regulations by allowing Entergy to not meet 10 CFR Part 50, Appendix B, for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

The SEs cause uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 10 CFR 50, Appendix B applicability Action Related to Concern: Absent a clear record that Appendix B requirements would still apply to the safety-related, ASME Class 2 and 3, low-safety significant (LSS) items to which the Code Case N-752 provisions would be applied, the NRC should not have approved the licensees request to apply the alternative requirements of Code Case N-752 because it explicitly states that one of the Owners responsibilities is documentation of a Quality Assurance Program in accordance with Title 10, Code of Federal Regulations, Part 50 if compliance with 10 CFR 50 Appendix B is required at the Owner's facility. The NRCs approval of Entergys request for a QAPD reduction of commitment (ML21132A279) does not provide this clear record.2 Related Agency Decision: The NRC issued an approval on May 19, 2021 (ML21118B039) of Entergys request dated May 27, 2020 (ML20148M343) as supplemented by letter dated November 17, 2020 (ML20322A141) to apply an ASME BPVC Section XI Code alternative to implement ASME Code Case N-752.

Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergys QA Program Action Related to Concern: Procedures will be enforceable under Appendix B, but how enforcement of the Appendix B criteria will be applied to the Class 2 and 3 LSS repair/replacement components (not procedures) is unknown. Procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50 will be controlled under Entergys QAPD, but the repair/replacement items will not. Rather than incorporate modified treatment of the LSS Class 2 & 3 repair/replacement items into their QAPD, the alternate controls are unknown.

Related Agency Decision: The NRC requested confirmation of information (RCI) and received a response from Entergy for Grand Gulf Unit 1, River Bend Unit 1, and Waterford Unit 3 that confirmed that safety-related Class 2 and 3 SSCs categorized as LSS when implementing Code Case N-752 will be treated in accordance with existing QAP procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50.

4. Results of Panel Review The following subsections provide the results of the panels review of the four concerns identified by the submitters. The subsection titles below identify which of the submitters concerns is being addressed in that subsection.

2 The DPO submitters provided the following information supporting this opinion:

The SEs accepting the QAPM changes at ANO under 10 CFR 50.54, and authorizing the use of ASME Code Case N-752 under 10 CFR 50.55a(z) at ANO, are contrary to the NRC rules for granting exemptions from the NRC regulations by allowing Entergy to not meet 10 CFR Part 50, Appendix B, for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

The SEs cause uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

Since the scope of Code Case N-752 applies to all pressure-retaining items and their associated supports categorized as low-safety significant, and since some pressure retaining items also perform active functions (e.g., pumps and valves), certain replacement and repair activities could affect the active functions absent appropriate Appendix B controls.

4.1. Acceptance of Entergys QAPM change for review as a reduction in commitment The submitters were concerned that by accepting Entergy/ANOs request to reduce the Quality Assurance Program Description, as described in the licensees submittal, the NRC has accepted a request that was instead an exemption of the regulatory requirements in 10 CFR 50, Appendix B, and should have been processed as such.

4.1.1. Concern 1 Evaluation The submitters were concerned that by accepting Entergy/ANOs request to reduce the Quality Assurance Program Description, as described in the licensees submittal, the NRC has accepted a condition that is instead an exemption of the regulatory requirements in 10 CFR 50, Appendix B.

The panel noted that the licensing basis change being requested by Entergy was twofold, submitted separately; a reduction in QAPD commitment and the adoption of Code Case N-752 as an ASME Section XI Code alternative. The Code alternative request has risk informed aspects to it and involves use of PRA techniques to classify the piping system components according to their risk. The QAPD reduction in commitment was intended to support the Code alternative request. RG 1.174 describes an acceptable method for assessing the nature and impact of LB licensing basis changes by a licensee when the licensee chooses to support (or is requested by the staff to support) these changes with risk information. The RG contains Principle 1, which states, The proposed licensing basis change meets the current regulations unless it is explicitly related to a requested exemption (i.e., a specific exemption under 10 CFR 50.12).

To evaluate this concern/assertion, the panel interviewed NRR staff involved in the approval process, reviewed background information discussed in this report above and considered agency requirements located in 10 CFR Part 2, Agency Rules of Practice and Procedure, and policy in LIC-109, Acceptance Review Procedures for Licensing Basis Changes. The evaluation involved review of the acceptance review criteria for requests for licensing actions (RLAs).

LIC-109, Acceptance Review Procedures for Licensing Basis Changes Per the Policy section of LIC-109, revision 3:

It is the policy of the Office of Nuclear Reactor Regulation (NRR) to review an application to amend a license for completeness and acceptability for docketing. The regulations in Title 10 of the Code of Federal Regulations (10 CFR), Part 2, Agency Rules of Practice and Procedure, prescribe the procedure for: issuance of a license; amendment of a license at the request of the licensee; and transfer and renewal of a license. Activities covered by this Office Instruction (OI) are those changes to a plants licensing basis that require U.S. Nuclear Regulatory Commission (NRC) approval prior to implementation (e.g., license amendments, relief requests, exemptions, etc.).

The regulations that are applicable to this OI are contained in 10 CFR 2.101, Filing of Application, 10 CFR 2.102, Administrative Review of Application, 10 CFR 2.107, Withdrawal of Application, and 10 CFR 2.108, Denial of Application for Failure to Supply Information.

Section 2.101 of 10 CFR allows the NRC staff to determine whether a request for licensing action (RLA) is complete and acceptable for docketing. Additionally, the NRC

staff may return an application found to be incomplete, and therefore not acceptable for review, to a licensee to address any identified insufficiencies.

Section 2.101 of 10 CFR requires that:

(a)(1) An application for a permit, a license, a license transfer, a license amendment, a license renewal, or a standard design approval, shall be filed with the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as prescribed by the applicable provisions of this chapter. A prospective applicant may confer informally with the NRC staff before filing an application and that, (a)(4) If it is determined that all or any part of the tendered application and/or environmental report is incomplete and therefore not acceptable for processing, the applicant will be informed of this determination, and the respects in which the document is deficient.

LIC-109 provides the guidance for making this determination. LIC-109 accordingly provides Acceptance Review Criteria that includes, but is not limited to:

Use of Approved Guidance: Determine whether the RLA cites any unapproved guidance such as draft TRs, TRs not yet approved by the NRC, TSTF travelers not yet approved, or draft ASME Code cases. Unapproved guidance may be used as the basis for a proposed change; however, the licensee must supply all information necessary (i.e.,

plant-specific justification and technical basis) to support the change.

Additional Criteria: For certain RLAs, ensure that the licensee or industry addresses any specific criteria associated with a particular action. These criteria are typically identified either in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, 10 CFR Part 73, Physical Protection of Plants and Materials, or in the associated guidance document. An example is an exemption request in which the licensee must not only justify the acceptability of the proposed action but must demonstrate that there are special circumstances present that justify the issuance of an exemption.

Linked RLAs: Determine whether the approval of the RLA is contingent upon the approval of other RLAs or TRs currently under review. It is important to note that multiple RLAs can affect the same systems or technical specifications (TSs) without being linked.

As such, it may be possible to issue RLAs in any order and without regard to the results of the review of the others. An RLA should not be accepted for NRC review and approval until all requisite RLAs have been reviewed and approved by the NRC.

Need for an Exemption: Determine whether any exemptions are needed to support the RLA. Generally, the licensee will submit the exemption request with the associated RLA.

If submitted separately, the NRC staff should ensure that the licensee understands that an exemption is necessary for acceptance of the associated RLA and agrees to submit the exemption request in parallel with the associated RLA.

Sufficiency of Information: Determine if there are significant, obvious problems with the information and analyses provided. Technical staff may use various measures for this criterion, such as the volume and magnitude of questions that could be generated based simply on the initial reading of the application. The information provided should support a comparison of the RLA to the licensees existing processes or programs, if applicable, with justification for the change. If significant, obvious problems are identified, the RLA should be considered unacceptable.

Regulatory Basis: Determine whether the applicable regulations and criteria are properly applied. The licensee should identify the regulatory criteria used to determine that the RLA is acceptable. The NRC staff may utilize guidance documents such as the standard review plan or any specific review standards for specific RLAs (e.g., EPUs). When the licensee proposes an alternative to an approved approach described in a guidance document, the NRC staff should verify the completeness of the scope and logic of the alternate methodology. From the information contained in the application, the NRC staff should be able to identify the applicable criteria by which to evaluate the proposed action.

Use of Precedent: Determine whether cited precedents are justified and used appropriately and whether any deviations from the precedent appear to be justified. A previous precedent of approval itself is not a justification for a proposed change but can facilitate a resource savings by allowing the technical staff to make appropriate use of information from previously-approved reviews.

The staff found the Entergy request for approval of their October 26, 2020, Reduction of Commitment to the Entergy Operations Quality Assurance Program Manual Description acceptable for review as described in an email dated December 21, 2020 (ML20337A155). LIC-109 describes acceptable for review as:

Acceptable for Review If the RLA is found to be acceptable for review, or if it is determined that the information needs identified during the acceptance review are not significant enough to fail the acceptance review criteria and should be addressed in the technical review process (i.e.,

via the RAI process), the acceptance of the RLA for review should be communicated to the licensee per Section 6.0, Documentation of an Application Found Acceptable for NRC Staffs Review, of this enclosure.

The acceptance review concluded (ML20337A155) that any information needs could be addressed by RAIs and was not significant enough to fail the acceptance criteria.:

The NRC staff has reviewed your application and concluded that it does provide technical information in sufficient detail to enable the NRC staff to complete its detailed technical review and make an independent assessment regarding the acceptability of the proposed request in terms of regulatory requirements and the protection of public health and safety and the environment. Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which issues that impact the NRC staffs ability to complete the detailed technical review are identified despite completion of an adequate acceptance review. You will be advised of any further information needed to support the NRC staffs detailed technical review by separate correspondence.

4.1.2. Concern 1 Findings and Conclusions The panel disagrees that the licensees request should have been reviewed as an exemption request.

Reviewing the requested reduction in QA Program commitment in accordance with 10 CFR 50.54(a) is appropriate to the circumstances, which included withdrawal of Entergys prior exemption request.

The panel did not disagree with the results of the acceptance review because specifically that the licensee was requesting a reduction in QA program commitment under 10 CFR 50.54(a) and referenced the withdrawal of the prior exemption request. Generally, the NRCs acceptance review process is used to validate that the NRC has enough information to conduct its review.

Following this premise, it is reasonable that the staff accepted the request for review, especially given the familiarity with the previous request. (Note: Additionally, Enclosure 2 of Entergys October 26, 2020, submittal was prepared by the licensee in response to a request for additional information related to the prior exemption request, and that was made known to staff in the licensees October 26, 2020, submittal.)

The DPO panel noted however, that some of the Acceptance Review Criteria that could have been challenged during the acceptance review process were not later addressed via RAIs. In particular, statements in Enclosure 2 to the October 26, 2020, submittal stated that the treatment of the LSS SSCs under Code Case N-752 would not be required to comply with 10 CFR 50, Appendix B. Reviewers could have also questioned this approach. However, the revised regulatory commitment in Entergys related November 17, 2020, ASME Code alternative request submittal (ML20322A141) proposed the treatment of safety-related Class 2 and 3 SSCs identified as LSS in accordance with ASME Code Case N-752 would not be required to meet the requirements of the QAPM as opposed to the treatment not being required to comply with 10 CFR 50, Appendix B.

4.1.3. Concern 1 Recommendations None.

4.2. Concern 2: Approval of Entergys QAPM commitment reduction This item pertains to the concern that the NRC should not have approved the Entergy QAPM reduction in commitment because of the lack of clarity that 10 CFR 50, Appendix B requirements continue to apply.

4.2.1. Concern 2 Evaluation The submitters were concerned that the May 19, 2021, NRC SE accepting Entergys proposed QAPD commitment reduction was worded in a way that conveys that the NRCs position is that compliance with 10 CFR 50, Appendix B is voluntary for Class 2 and 3 LSS items.

To evaluate this concern/assertion the panel interviewed NRR staff involved in the approval process, reviewed background information referenced in section 3 above, and considered agency position in statements of considerations of appliable rules. The evaluation involved communication with the NRC inspectors performing two separate inspection activities: (1) inspection of the ANO facility during a Comprehensive Engineering Team Inspection (CETI) to ascertain the classification of and applicability of Appendix B processes to LSS Class 2 and 3 repair/replacement items and (2) inspection of the Oconee facility during an Age-Related Degradation Focused Engineering Inspection (FEI) to gather information regarding interpretation of the allowances of the QAPD commitment reduction accepted for ANO but used by other licensees under 10 CFR 50.54(a).

The panel considered the sequence of Entergys requests when evaluating this concern.

Originally, the request to adopt Code Case N-752 was submitted along with an exemption request under 50.12 to exclude the 10 CFR 50, Appendix B requirements.

Entergys October 26, 2020, QAPD commitment reduction request came after the original request to adopt Code Case N-752 and Entergys withdrawal of the exemption request. The QAPD commitment reduction request included the following statements:

Code Case N-752 allows a distinction in treatment of HSS and LSS safety-related SSCs.

However, the provisions of Code Case N-752 are similar to those of 10 CFR 50.69, "Risk-Informed Categorization and Treatment of Structures, Systems, and Components (SSCs) for Nuclear Power Plants," in that the provisions allow adjustment of the scope of items subject to special treatment controls (e.g., quality assurance, testing, inspection, condition monitoring, assessment, and evaluation) based on safety significance.

Similarly, for Code Case N-752 items determined to be of LSS, alternative treatment requirements may be implemented. For equipment determined to be of HSS, requirements will not be changed. Code Case N-752 exempts Class 2 and 3 LSS SSCs from the repair/replacement requirements of ASME Section XI; it also allows exemption of the associated QA requirements [i.e., IWA-1400(n)] provided 10 CFR 50 Appendix B or NQA-1 is not required at the nuclear site.

While Entergys statement that 10 CFR 50.69 allows for adjustment of the scope of the items subject to special treatment controls based on safety significance and that the provisions of N-752 are similar to those in 50.69 is true, this statement fails to acknowledge that when implementing the provisions of 10 CFR 50.69, the requirements of Appendix B to 10 CFR 50, 10 CFR 21, and the inservice inspection, and repair and replacement (with the exception of fracture toughness) requirements for ASME Class 2 and Class 3 SSCs in 10 CFR 50.55a(g), among others, are exempted by rule after receipt of NRC approval.

As explained in the statements of considerations for the 10 CFR 50.69 rule, 69 FR 68047, there were regulatory obstacles in implementing a graded QA program without obtaining other exemptions:

In March 1996, STP Nuclear Operating Company (STPNOC) requested that the NRC approve a revised Operations Quality Assurance Program (OQAP) that incorporated the methodology for grading quality assurance (QA) based on PRA insights. The STP graded QA proposal was an extension of the existing regulatory framework. Specifically, the STP approach continued to use the traditional safety-related categorization, but allowed for gradation of safety significance within the safety-related categorization (consistent with 10 CFR part 50 appendix B) through use of a risk-informed process.

Following extensive discussions with the licensee and substantial review, the NRC staff approved the proposed revision to the OQAP on November 6, 1997. Subsequent to NRC's approval, STPNOC identified implementation difficulties associated with the graded QA program. Despite the reduced QA requirement applied for a large number of SSCs in which the licensee judged to be of low safety significance, other regulatory requirements such as environmental qualification, the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (BPV), or seismic requirements, continued to impose substantial burdens. As a result, the replacement of a low safety significant component needed to satisfy other special requirements during a procurement process. These requirements prevented STPNOC from realizing the full potential reduction in unnecessary regulatory burden for SSCs judged to have little or no safety importance. In an effort to achieve the full benefit of the graded QA program (and in fact to go beyond the staff's previous approval of graded QA), STPNOC submitted a

request, dated July 13, 1999, asking for an exemption from the scope of numerous special treatment regulations (including 10 CFR part 50 appendix B) for SSCs categorized as low safety significant or as non-risk significant. STPNOC's exemption was ultimately approved by the staff in August 2001 (further discussion on this exemption request is provided in Section IV.2)...

Entergys implementation (i.e., revision of its process procedures) of the reduction in QAPM commitment is inconsistent with both STPs graded QA approach and STPs 10 CFR 50.69 proof-of-concept approach. STPs graded QA approach involved description of the graded treatments directly in their QA Program Plan Description. The STP exemption request (ML20209G724) associated with the proof of concept program included exemption from the quality assurance requirements in GDC-1, 10 CFR Part 50, Appendix B, and 10 CFR 21.

In its submittal requesting the authorization to use Code Case N-752 as a Code alternative (ML20148M343), Entergy included as precedent the NRCs approval of ANO2-R&R-004 (ML090930246), discussed in detail in this report above. One key difference in the NRC SER for ANO2-R&R-004 and the SER approving the use of Code Case N-752, EN-20-RR-001, revision 1 (ML21118B039) is that the NRC SER for ANO2-R&R-004 acknowledges that the Part 50 regulatory requirements applicable to safety-related equipment apply to LSS items and that Entergy had not requested a change to those requirements, whereas, the NRC SER for EN RR-001 instead states that:

The applicable quality controls that will be implemented for the treatment of the LSS SCCs are described in the NRC staffs safety evaluation approving Entergys QAPM change, dated May 19, 2021 (ADAMS Accession No. ML21132A279).

The applicable quality controls described in the May 19, 2021, SE included that:

the licensee plans to use current processes and procedures with additional controls for the treatment of Class 2 and 3 LSS SSCs to ensure continued capability and reliability of the design-basis function. For example, changes to the configuration, design, materials, fabrication, examination, and pressure testing requirements used to support repair/replacement activities on Class 2 and 3 LSS SSCs will be performed in accordance with the licensees existing design change process. Further, any conditions that may prevent an LSS SSC from performing its safety-related function under design-basis conditions will be identified and addressed in accordance with the licensees corrective action program.

The licensee is also proposing to procure Class 2 and 3 LSS SSCs as nonsafety-related when used in repair/replacement activities performed in accordance with ASMEs Code Case N-752.

Appendix B in General The requirement to document a quality assurance program in the final safety analysis report for the facility comes from 10 CFR 50.34, Contents of applications; technical information.

Specifically:

(b) Final safety analysis report. Each application for an operating license shall include a final safety analysis report. The final safety analysis report shall include information that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the structures, systems, and components and of the facility as a whole, and shall include the following:...

(6) The following information concerning facility operation:

(i) The applicant's organizational structure, allocations or responsibilities and authorities, and personnel qualifications requirements.

(ii) Managerial and administrative controls to be used to assure safe operation. Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, sets forth the requirements for such controls for nuclear power plants and fuel reprocessing plants. The information on the controls to be used for a nuclear power plant or a fuel reprocessing plant shall include a discussion of how the applicable requirements of appendix B will be satisfied.

(iii) Plans for preoperational testing and initial operations.

(iv) Plans for conduct of normal operations, including maintenance, surveillance, and periodic testing of structures, systems, and components....

And 10 CFR 50, Appendix B, states in part that:

Introduction. Every applicant for a construction permit is required by the provisions of § 50.34 to include in its preliminary safety analysis report a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. Nuclear power plants and fuel reprocessing plants include structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. This appendix establishes quality assurance requirements for the design, manufacture, construction, and operation of those structures, systems, and components.

II. Quality Assurance Program The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations..

In the Preliminary Safety Evaluation associated with SECY-01-0103, STP Nuclear Operating Company Exemption Requests: Proof-Of-Concept For Risk-Informing 10 CFR Part 50 Option 2 (ADAMS ML011510272), the NRC acknowledges that Although 10 CFR Part 50, Appendix B, provides flexibility to apply QA controls in a graded manner that is commensurate with the safety importance of SSCs, other regulations require that the explicit criteria of 10 CFR Part 50, Appendix B, still apply.

The Quality Assurance Program for ANO is described in section 1.6.1 (Unit 1) and Chapter 17 (Unit 2) of the ANO UFSARs. The ANO UFSARs do not go into the details of how Appendix B is satisfied, but rather refers the reader to the Entergy Operations, Inc. (EOI) QA Program Manual (QAPM), as discussed in this report above.

The exemptions that South Texas Project requested as part of the 50.69 proof of concept program included exemption from 10 CFR 50.34(b)(6)(ii). The NRC denied this exemption request, explaining that:

The underlying purpose of the requirement is for the licensee to document how the QA requirements of 10 CFR Part 50, Appendix B, will be satisfied for safety-related SSCs.

The application of a risk-informed categorization process or changes to special treatment requirements applied to safety-related SSCs does not affect the underlying purpose of the requirement of 10 CFR 50.34(b)(6)(ii) related to the documentation describing the licensee's OQAP. Should the licensee be granted exemptions from any of the requirements of 10 CFR Part 50, Appendix B, for LSS and NRS SSCs, the documentation describing its OQAP should note that exemptions have been granted for LSS and NRS SSCs from those requirements....

Based on the above findings, the staff has determined that the OQAP description should include a discussion of the scope of the SSCs exempted from 10 CFR Part 50, Appendix B, requirements, the basis for this exemption (e.g., by referencing the staffs SE), and also reference the document where the alternate treatment processes are described (i.e., proposed FSAR, Section 13.7). Further, the staff determined that the OQAP description should identify any portion of the OQAP that remains applicable to the exempted SSCs (i.e., those sections related to design control, corrective action, and nonconforming items).

As a result of the approval of the QAPD commitment reduction, Entergy updated their QAPM to reflect that treatment of the LSS SSCs are not covered under the QAPM and Instead, treatment of these LSS SSCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function.

Entergys change to the QAPM raises a question regarding whether the description of the QA program, which is required by Criterion II of Appendix B to be documented by written policies, procedures, or instructions could extend to the processes and procedures that implement the program but are not included directly in the QAPM description document. If interpreted in this manner, the 10 CFR 50, Appendix B, Criterion II, requirement that the licensee shall identify the structures, systems, and components to be covered by the quality assurance program is satisfied if the QA Program treatment includes the LSS items.

The challenge to accepting the philosophy above, as it applies to the Entergy requested QAPD commitment reduction is that Entergy, in Table 1 of Enclosure 2 of their October 26, 2020, submittal (ML20300A324) reflected that the 10 CFR 50, Appendix B QA Program would not apply to the Class 2 and 3 LSS items, but the process procedure, would continue to apply. If accepted, this could represent a non-compliance because the SSCs to be covered by the QA program are required to be identified by Criterion II of Appendix B, the Appendix B introduction section is clear that the Appendix B requirements apply to safety-related components, and these LSS SSCs are explicitly identified as not covered by the Appendix B program in Entergys October 26, 2020, submittal. The NRC issued an RCI to seek confirmation regarding the treatment of these SSCs; however, it is the opinion of the DPO panel that the response to the RCI still allows for uncertainty since it did not explicitly confirm that Appendix B requirements would be applied to the SSCs.

The Commissions SOCs associated with 10 CFR Part 50 state the following (Reporting of Changes to the Quality Assurance Program, 48 FR 1026 (January 10, 1983) (available at https://archives.federalregister.gov/issue_slice/1983/1/10/1021-1029.pdf#page=6)):

Because of the importance of the QA program as a management tool to attain objectives important to nuclear safety, the NRC staff conducts extensive reviews during the licensing process to ensure that the applicants QA program description satisfies 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. Once the NRC staff has accepted it, the QA program description becomes a principal inspection and enforcement tool in ensuring that the permit holder or licensee is in compliance with all NRC quality assurance requirements for protecting the public health and safety.

As such, the staffs approval of this treatment (removal from treatment under the QAPM) could affect the staffs ability to use the QAPD as the principal inspection and enforcement tool in ensuring compliance consistent with the above.

QAPM/QAPD Comparison In order to assess potential licensee interpretation of the allowances afforded by the NRCs acceptance of the Entergy QAPD commitment reduction, the Entergy and Duke QAPD updates were reviewed and compared. The language in section 17.3, Quality Assurance Program Description, of the Standard Review Plan (SRP) in NUREG-0800 was also considered.

The panel compared the language of the Entergy and Duke QAPD updates:

Entergy Duke QAPM, paragraph A.7. Regulatory Commitments

c. For those sites who have received NRC authorization to use the alternative repair/replacement categorization and treatment requirements of Code Case N-752 in lieu of the corresponding sections of ASME Section XI, as referenced in 10 CFR 50.55a Codes and Standards, treatment of safety-related structures, systems, and components (SSCs) identified as low safety significant (LSS) Class 2 and 3 SSCs in accordance with ASME Code Case N-752 is not required to meet the requirements of this manual. Instead, treatment of these LSS SSCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function.

17.3.1.1.1 Quality Assurance Program Alternatives As authorized by regulation or NRC approval, some alternatives to 10 CFR 50 Appendix B and this Quality Assurance Program may be in effect at specific sites within the Duke Energy Fleet. The following alternatives are allowed through NRC authorization and / or approval:

• For those sites who have received NRC authorization to use the alternative repair/replacement categorization and treatment requirements of ASME Code Case N-752 in lieu of the corresponding sections of ASME Section XI, as referenced in 10 CFR 50.55a Codes and Standards:

o Safety-related SSCs identified as low safety significant (LSS) Class 2 and 3 in accordance with ASME Code Case N-752 are authorized for alternate treatment from the requirements of 10 CFR 50 Appendix B and the associated QA aspects of this document. Treatment of these LSS SSCs is performed in accordance with existing QAP procedures and processes which include additional controls to ensure the capability and reliability of the SSCs design basis function.

The panel noted a difference in the language between the two utilities, in that the Entergy QAPD update indicates that the alternate treatment is not required to meet the requirements of this manual (referring to the QA Program manual/QAPD), whereas the Duke QAPD update indicates the belief that they are authorized for alternate treatment from the requirements of 10 CFR 50 Appendix B and the associated QA aspects of this document. Dukes main administrative control procedure for the Code Case N-752 process, AD-EG-ALL-1221, Alternate Treatment Implementation Process Per 10 CFR 50.69 and Risk-Informed Code Cases, revision 1 (described in further detail below), when it makes statements regarding removal of the regulatory requirements from controlling programs and processes and that ASME Code Case N-752 LSS items are also exempt from the requirements of the Duke Energy QA Topical Report (i.e., Appendix B requirements). The Entergy implementing procedure, CEP-RR-006, Risk-Informed Categorization and Treatment for Repair/Replacement Activities in Class 2 and 3 Systems, revision 0 (described in further detail below), makes similar statements that LSS systems, components, and supports are not required to comply with the quality assurance requirements of 10CFR50, Appendix B.

The panel reviewed the NRC guidance for review of QAPD changes contained in the Standard Review Plan (SRP). One notable observation was that the licensees approach to requesting the NRCs acceptance of their reduction in QAPD commitment was likely an approach not envisioned when the SRP guidance was written. Specifically, the expected conclusion of the review performed using section 17.3, Quality Assurance Program Description, is that the applicant's QAPD complies with the applicable NRC regulations and industry standards. In this case, that conclusion is irrelevant because Entergy requested to exclude these safety-related,

LSS ASME Class 2 and 3 repair/replacement items from treatment under the Entergy QAPD. It appears to the panel that the SRP guidance in section 17.3 presupposes that the reduction in commitment being requested will be a change to the language in the QAPD describing the processes and activities to be applied to items within the scope of 10 CFR 50, Appendix B, as opposed to removal of safety related items from treatment under the QAPD.

The SRP section 17.3 guidance further presupposes that all important to safety items are covered under the scope of a licensees QAPD-this doesnt align with what was requested by Entergy. To illustrate this, the Evaluation Findings portion of SRP section 17.3 states that The QA program applies to activities and items that are important to safety.

The language in the Acceptance Criteria portion of SRP section 17.3 allows for: Except when acceptable alternatives are provided. Discussions with the NRR staff involved in the approval of the licensees request revealed that the focus of the review is whether or not the licensees proposed activities would still be in compliance with the QA program requirements of 10 CFR 50, Appendix B, rather than focusing on whether the individual statements of the SRP would be satisfied. The language in the licensees submittal was understood by the reviewers to mean that the existing QA procedures and processes would be applied to the LSS items to which the Code Case would be applied and that supplemental procedures would be developed which were specific to the LSS Class 2 and 3 items classified by the Code Case approach. That understanding formed the bases of the NRC acceptance.

The NRC SRP section 17.3, Review Procedures allows for a request that an inspection be performed by NRR or Regional personnel as appropriate to assess the applicants interpretation and translation of the QAPD commitments into its procedures and processes. In this case, a confirmatory inspection or audit of the planned process implementation would have likely been beneficial, had one been requested. The panel performed a limited review of the translation of the modified treatment of the LSS ASME Class 2 and 3 items into Entergy and Duke procedures and assessed the licensees interpretation of the new QAPD commitments as described below.

4.2.1.1 Entergy Evaluation 10 CFR 50.54(a)(4)(ii) required requires that the licensee include in their submittal requesting the QAPD commitment reduction the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance program description commitments previously accepted by the NRC.. The conclusion of the NRC SE approving the QAPD commitment reduction was that:

reasonable assurance that the licensees QAPM will continue to meet the requirements of Appendix B to 10 CFR Part 50 while implementing ASME Code Case N-752 for the treatment of safety-related SSCs identified as LSS. Therefore, the NRC staff finds that the licensees proposed changes in the Entergy QAPM, Revision 39, are acceptable.

This conclusion is valid for the items still under QAPD treatment, as they were unaffected by the change.

This conclusion was based at least in part on "the licensee plans to use current processes and procedures with additional controls for the treatment of Class 2 and 3 LSS SSCs to ensure continued capability and reliability of the design-basis function as described in the Technical Evaluation section of the May 19, 2021, NRC Safety Evaluation of the licensees submittals (ML21132A279). However, the licensee also stated in their submittals that the LSS items would

be removed from treatment under the Entergy QAPD. This left it uncertain what was meant by the approval of the submittals.

The licensee communicated in Table 1 of Enclosure 2 of their October 26, 2020, submittal that:

the Appendix B QA Program would not apply to the Class 2 and 3 LSS Items under their Proposed Code Case N-752 Repair/Replacement Program. The following requirements in Criterion II of 10 CFR 50, Appendix B, apply to these statements:

The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations. The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety.

The panel noted that Entergy stated, that treatment of safety-related Class 2 and 3 SSCs identified as LSS in accordance with ASME Code Case N-752 will not be required to meet the requirements of the QAPM, and that (according to Table 1 of Enclosure 2 of the October 26, 2020, submittal) the Appendix B QA Program would not apply to the Class 2 and 3 LSS Items under their Proposed Code Case N-752 Repair/Replacement Program.

Entergys description in its October 26, 2020, request also reflected a potential understanding that Appendix B is exempted for the SSCs through use of the IWA-1400(n) exemption in Code Case N-752:

ASME Code Case N-752 includes provisions for exempting Class 2 or Class 3 items categorized as LSS from the QA requirements of the 2007 Edition/ 2008 Addenda of ASME Section XI, paragraph IWA-1400(n), which invokes the requirement for a QA Program in accordance with either 10 CFR 50, Appendix B, or ASME NQA-1.

Further, the licensee stated in its October 26, 2020, submittal that it intended to use the IWA-1400(n) exemption provision of Code Case N-752, and that adoption of this provision is what constitutes the reduction in commitment.:

Adoption of the ASME Code Case N-752 exemption on IWA-1400(n) will represent a reduction in commitment with respect to the previously approved Entergy QAPM.

Appendix B Applicability in Entergy Implementing Procedures The Entergy review included feedback received from inspection of the ANO facility during the 2024 Comprehensive Engineering Team Inspection (CETI) and included reviews of the procedures controlling the repair/replacement activities and associated design/procurement processes. The controlling procedure for ASME Section XI repair/replacement activities was contained in CEP-RR-001, ASME Section XI Repair/Replacement Program, revision 320, and redirects the procedure user to CEP-RR-006 when dealing with LSS items:

5.1.1.6 If Class 2 or 3 items have been categorized as Low Safety Significant (LSS) in accordance with Code Case N-752, then repair/replacement activities including

associated design and procurement may be performed in accordance with the alternative treatment requirements of program section CEP-RR-006 in lieu of this program section.

The controlling procedure for Entergys Code Case N-752 program, CEP-RR-006, Risk-Informed Categorization and Treatment for Repair/Replacement Activities in Class 2 and 3 Systems, revision 0, indicated Entergys belief that 10 CFR 50, Appendix B requirements do not apply to Section XI repair/replacement activities for LSS items. Specifically, the Purpose section states:

The ASME Section XI Code Case N-752 categorization and treatment requirements for performing repair/replacement activities, as delineated in this program section, are exempt from 10 CFR 50, Appendix B as documented in the Entergy Quality Assurance Program Manual (QAPM).

Further, the definition of Code Case N-752 Risk Informed Categories in CEP-RR-006, revision 0, included the following:

Low Safety Significant (LSS) - A function not determined to be safety significant from the plant probabilistic risk assessment or from other relevant information (e.g., defense in depth considerations). LSS systems, components, and supports are not required to comply with the quality assurance requirements of 10CFR50, Appendix B.

Section 5.3, Treatment Requirements for HSS and LSS Items, of CEP-RR-006, also stated the following for LSS Items:

Based on Code Case N-752, repair/replacement activities performed in accordance with this program section are exempt from all requirements of IWA-4000 of the ASME Section XI Code including the following:... (c) Compliance with 10 CFR 50, Appendix B as documented in the Entergy QAPM.

Control of Specifications/Applicable Standard Section 5.2 of CEP-RR-006 explains that:

Design specifications, drawings, licensing basis documents, procedures, and other affected documents shall be revised, as appropriate, to [facilitate] implementation of the alternative treatments of Code Case N-752 on Class 2 and 3 LSS items.

The Entergy evaluation involved a cursory review of a modification to the ANO Unit 2 turbine-driven emergency feedwater (TDEFW) governor control system (EC 77577), which involved a modification to the governor valve, 2CV-0332, which was previously classified as an ASME Section III, Class 3 component as reflected in ANO Unit 2 UFSAR Table 3.2-3, but the vendor was only able to supply the bonnet in accordance with ANSI B31.1, Power Piping. The modification ended up using a bonnet obtained from a similar valve from Unit 1 also designed and built to ANSI B31.1 due to timing of the receipt of the new part. Much of the discussion in the modification package regarding the need to use the provisions of N-752 had to do with taking exception to the original ASME Section III Code to allow the ANSI B31.1 component in its place. Both ASME BPVC Section III and ANSI B31.1 have been considered acceptable for safety-related, Class 3 applications at various nuclear facilities (ref. Generic Letter 89-09), so there does not appear to be a technical concern for this particular change.

Entergy, in EC 77577, described the change to the governor valve bonnet as an ASME Code exception, as opposed to a QA exemption or a utilization of alternate treatment to satisfy

Appendix B, in their design evaluation. Specifically, Entergy justified the Code exception simply by justifying the component was considered LSS per the Code Case N-752 process:

In order to justify this ASME Code exception, Electric Power Research Institute (EPRI) report IR-2021-0834 (CALC-ANO2-EP-21-00002) is issued in accordance with EN-DC-149 to perform a risk-informed evaluation of 2CV-0332 using ASME Code Case N-752.

The results of the evaluation show EFW governor valve 2CV-0332 to be low safety significant. Therefore, the code exception is acceptable. Refer to CALC-ANO2-EP 00002 for details.

This Code exception was reflected in the ANO Unit 2 UFSAR in Table 3.2-3, Equipment Code Group Classification, which identifies that, in general, the emergency feedwater control valves were ASME Section III, Class 3 valves. The ANO UFSAR Table 3.2-3 also says to refer to Table 3.2-5 for code exception applicable to EFW governor valve 2CV-0332". Accordingly, ANO Unit 2 UFSAR Table 3.2-5, Components Built Toto Codes Other Than Those Specified in Regulatory Guide 1.26, was updated to reflect that for the emergency feedwater system:

Governor Valve 2CV-0332 - Quality Group D [emphasis added]; ASME B31.1.0. Code exception evaluated per EPRI Report IR-2021-0834 (CALC-ANO2-EP-00002) which performs a risk-informed evaluation of 2CV-0332 using ASME Code Case N-752. Refer to EC-77577 for details.

This update to the ANO UFSAR reflected a reclassification of the TDEFW Governor Valve, 2CV-0332, to be Quality Group D. Quality Group D is described in UFSAR Table 3.2-1 as:

Category 2 fluid system components which are not essential for safe shut down of the nuclear systems and equipment. Failure of such equipment could cause loss of power generation but would not endanger public safety. This group includes systems which contain radioactive material but whose failure could not release quantities of radioactive material sufficient to endanger public safety.

And UFSAR Table 3.2-1 further describes Category 2 as:

A. Plant features not required to assure (1) the integrity of the reactor coolant pressure boundary, (2) the capability to shut down the reactor and maintain it in a safe shutdown condition, or (3) the capability to prevent or mitigate the consequences of accidents which could result in exposures comparable to the guideline exposures of 10 CFR Part 100.

B. Plant features not required to meet AEC GDC-1 of Appendix A to 10 CFR Part 50 and Appendix B to 10 CFR Part 50.

C. Plant features not required to meet AEC GDC-2 of Appendix A to 10 CFR Part 50 and proposed Appendix A to10 CFR Part 100. Plant features not designed to withstand the effects of the Design Basis Earthquake.

Item B in the UFSAR Table 3.2-1 definition of Category 2 directly deals with the submitters concern that Entergy is considering the QAPD reduction in commitment to be an exemption to 10 CFR 50, Appendix B.

Communication with the ANO CETI team regarding their review of the Electric Power Research Institute (EPRI) report IR-2021-0834 (CALC-ANO2-EP-21-00002) revealed that its purpose was only to evaluate and determine the risk classification (HSS or LSS) of the 2CV-0332 valve. The panel wanted to explore whether Entergy based a change in quality group (from C to D) of the TDEFW governor valve on its determination that the component was considered LSS rather

than on its determination of the components safety function. Following discussion with the ANO CETI team regarding the issue, Entergy entered this issue into its corrective action program during the CETI inspection at ANO.

Inspection revealed that the valve is still considered to be Q in the licensees tracking system which is synonymous with safety-related for seismic qualification purposes. The replacement valve bonnet was analyzed in FCR 91062 to have maintained its seismic qualification.

The quality group reclassification is related to the Code or Standard being applied to the TDEFW governor valve, in that ANOs UFSAR Table 3.2-4, Summary of Codes and Standards for Nuclear Components, indicates that ANSI B31.1.0 is applicable to Quality Group D piping, pumps, and valves, but is not applicable to Quality Group C. However, application of ANSI B31.1 to Class 3 components purchased after July 1971 does not conform to the ANO Unit 2 UFSAR section 3.2 description of classification of SSCs:

For components purchased after July, 1971 the codes used are those specified by 10 CFR 50 and Regulatory Guide 1.26.

As explained above, it has been recognized that ANSI B31.1.0 has been applied to the design of Class 3 applications at various nuclear facilities, so if implemented correctly, it would not appear to present a safety hazard. However, if the licensee also controls the item as non-safety related, as described in their Enclosure 2 to the October 26, 2020, submittal, and began treating the item as seismic Category 2, the licensee may no longer be in compliance.

Part 21 Applicability/Basic Component Because Entergy included language regarding the exclusion of the items from the Appendix B QA Program, but not the QA process procedures from 10 CFR 50, Appendix B, in Enclosure 2 to their October 26, 2020, submittal, the panel considered how the safety-related items would have previously been treated under Appendix B processes. Dedication of a commercial grade item must be done in accordance with 10 CFR 50, Appendix B, per 10 CFR 21 requirements. Since dedication is a process that is particular to the item itself, it is a good indicator to use to ascertain what the licensee intended in their submittal with regard to whether the 10 CFR 50, Appendix B requirements were exempted or not.

The panel observed that the language in Enclosure 2 to Entergys October 26, 2020, submittal is inconsistent with that in Entergys supplemental response dated April 30, 2021. The February 17, 2021, NRC RAI (ML21071A217) addressed statements in Enclosure 2 of Entergys October 26, 2020, regarding procurement and treatment of the LSS items as non-safety related but converted Entergys use of the reasonable confidence term to reasonable assurance when the following was requested:

Provide a detailed description of the supplemental procurement requirements and controls that will be specified by Entergy Engineering to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions.

In Entergys RAI response dated April 30, 2021, it also used the reasonable assurance terminology, and further included that Entergys supplemental procurement requirements for QC Receiving Attributes would include that Dedication activities were adequately documented. These statements likely led to confusion regarding the licensees intent.

The use of the terms reasonable assurance and dedication aligns with the definitions in 10 CFR 21.3 applicable to dedication, critical characteristics, and basic component, and could have been taken to represent the licensees intent to convert the nonsafety related items procured for the N-752 repair/replacement activities into basic components for safety-related service. As explained below, Entergy redefined the term basic component in procedure EN-DC-313, Procurement Engineering Process, revision 22. This redefinition of basic component appears to allow the LSS item to not undergo commercial grade dedication. Through discussions with ANO staff, the CETI team revealed that the licensee does not intend to perform commercial grade dedication of the N-752 SSCs.

However, the ANO CETI inspection of an item evaluated as LSS in accordance with N-752 revealed that the procurement of a replacement bonnet for a Unit 2 Turbine Driven Emergency Feedwater (TDEFW) governor valve invoked Appendix B and Part 21 in its requirements to its supplier. Although the licensees redefinition of basic component allows them to not perform dedication, the licensee did not use that allowance for the item inspected during the CETI.

Entergy procedure EN-DC-313, Procurement Engineering Process, revision 22, defined basic component as: Basic components are items designed and manufactured under a quality assurance program complying with 10 CFR Part 50, Appendix B, or commercial-grade items which have successfully completed the dedication process, or safety related items which are classified as Quality Level QL for use in systems or components determined to be LSS in accordance with Code Case N-752. Notably Entergys redefinition of basic component was not included in either the request to reduce the QAPD or the request to adopt N-752 as a Code alternative. The panel also observed that this differed from STPs 50.69 proof of concept approach which obtained an exemption from the definition of basic component.

Similarly, the definition of Code Case N-752 Risk-Informed Categories in Entergy procedure EN-DC-313 states that LSS items are not required to satisfy 10 CFR 50, Appendix B:

Low Safety Significant (LSS) - A function not determined to be safety significant from the plant probabilistic risk assessment or from other relevant information (e.g., defense in depth considerations). LSS systems, components, and supports are not required to comply with the quality assurance requirements of 10CFR50, Appendix B. [Reference -

QAPM Section A.7.c]

Another example of Entergys implementation of the procurement process is in EN-DC-313, section 5.3 where safety-related item is defined:

5.3 SAFETY RELATED PROCUREMENT METHODS

1. A safety related item is:

a. Subject to 10CFR50, Appendix B Quality Assurance program requirements which mandates planned and systematic actions to control the quality of 10CFR50 Safety Related items, OR

b. Subject to 10CFR72 Quality Assurance program requirements which mandates actions to control the quality of 1 0CFR72, Dry Fuel Storage (DFS) Classification Level ITS-B items, OR

c. Subject to Code Case N-752 but the 10CFR50, Appendix B Quality Assurance program requirements do not apply to items categorized as LSS

2. A safety related item can be procured utilizing either of the following methods:

a. Procured safety related from a qualified supplier that maintains an acceptable Quality Assurance program meeting the requirements of 10CFR50, Appendix B with 10CFR21 item defect reporting requirements applied to the Purchase Order, OR

b. Procured as a commercial-grade item and dedicated under Entergy's (or a third party dedicator's) Quality Assurance program meeting the requirements of 10CFR50, Appendix B with Entergy (or the third party dedicator) assuming the responsibility of 10CFR21 item defect reporting requirements, OR

c. DFS Classification Level ITS-B items will be procured as "Safety Related" ensuring the appropriate 10CFR50 programs and processes are invoked with the exception of fabrication and procurement. ITS-B items will be fabricated and procured per 10CFR72, not 10CFR50 (i.e., not 10CFR50 Appendix B), OR

d. Procured as a Quality Level QL item when categorized as LSS in accordance with Code Case N-752.

3. Suppliers of commercial-grade items are not subject to defect reporting requirements of 10CFR21, therefore Entergy (or the dedicating entity) assumes this responsibility via Commercial-Grade Dedication (reference EN-DC-306).

Notably, the above procurement method description does not include that the items procured as Quality Level QL would be dedicated, but the provision to perform dedication is made for those items procured as commercial grade. In discussing Quality Level, EN-DC-313 states the following:

Quality Level QL is assigned to Safety-Related items which are categorized as LSS in accordance with Code Case N-752. These items may be procured as Non-Safety Related and the requirements of 10 CFR 50 Appendix B do not apply.

This appears to carry over the proposal from Entergys October 26, 2020, QAPD Commitment reduction submittal that the LSS N-752 items were to be procured as non-safety related:

Based on Code Case N-752, Entergy is proposing to procure Class 2 and 3 LSS items as nonsafety-related when used in repair/replacement activities performed in accordance with Entergys Code Case N-752 Risk-Informed Repair/Replacement Program.

However, this language originated from Entergys planned response to the NRC RAIs that related to Entergys exemption request of May 27, 2020, which was later withdrawn. While the language regarding procuring the LSS items as non-safety related was repeated back in the NRC SER approving the QAPD reduction, it also used the reasonable assurance terminology.

It also gave examples of some of the controls to be applied but was non-exhaustive:

The licensee is also proposing to procure Class 2 and 3 LSS SSCs as nonsafety-related when used in repair/replacement activities performed in accordance with ASMEs Code Case N-752. When procuring Class 2 and 3 LSS SSCs as nonsafety-related, the licensees engineering staff will specify supplemental procurement requirements and implement additional controls, as appropriate, to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design-basis conditions. For example, the licensee will not allow the supplier to make any changes in design (e.g., form, fit, function, or material), and any changes to the procurement order need to be first approved by the licensee. Further, additional controls will include performing receipt inspections using qualified inspection

personnel similar to the licensees requirements used for procuring augmented quality SSCs.

Indeed, Entergys EN-DC-313 procedure makes a distinction between reasonable assurance and reasonable confidence, at least as applicable to their 50.69 process, in Attachment 4, 10 CFR 50.69 RISC-3 Procurement Process, where it defines reasonable assurance and reasonable confidence:

Reasonable Assurance - A justifiable level of confidence based on objective and measurable facts, actions, or observations which infer adequacy (Reference EPRI TR-102260). Denotes appropriate qualitative level necessary for safety-related, safety-significant (RISC-1) equipment performance. This is consistent with its use in 10 CFR 50 Appendix B, ANSI N45.2 implementing standards, and guidance cited in EPRI report 1011234.

Reasonable Confidence - Reasonable confidence under 10 CFR 50.69 is a somewhat reduced level of confidence, consistent with the individual low safety significance of RISC-3 SSCs, as compared with the relatively high level of confidence provided by the current special treatment requirements. Reasonable confidence is established through implementation of the sum-total of all Alternative Treatment requirements a utility applies to RISC-3 SSCs and is NOT solely reliant on the procurement process. Reasonable confidence is established based on facts, actions, knowledge, experience, and/or observations, which are deemed to be adequate (Reference EPRI 1011234]). The term "actions" with respect to 10 CFR 50.69 include Alternative Treatment requirements developed and implemented by the licensee pursuant to the 10 CFR 50.69 rule.

In summary, Entergy procedures indicated that reasonable assurance is the standard applicable to 10 CFR 50 Appendix B, whereas reasonable confidence is the standard applicable to 10 CFR 50.69 (but is invoked in Code Case N-752). The reasonable confidence standard may be used when approved to apply the alternative treatment allowed by 10 CFR 50.69, approval for which the licensee did not have at the time of the approval of the QAPD commitment reduction occurred.

Particularly with respect to procurement, Part 21 only provides two options to consider an item a basic component: (1) Basic components are items designed and manufactured under a quality assurance program complying with appendix B to part 50, or (2) commercial grade items which have successfully completed the dedication process. Using Entergys third option specific to LSS items procured as QL, provided in their revised definition of basic component in EN-DC-313 (discussed above) would require modification of the term in Part 21, which would require exemption under 10 CFR 21.7. Utilizing the Entergy revised definition without exemption would also be contrary to principle 1 for risk informed decision making for licensing basis changes in RG 1.174, that The proposed licensing basis change meets the current regulations unless it is explicitly related to a requested exemption (i.e., a specific exemption under 10 CFR 50.12).

Entergy also used the term augmented quality in its submittal. This term also shows up in EPRI 3002002982 and is defined as: As used in this report, augmented quality is an optional subset of the classification category non-safety-related. It may be applied to any item that is subject to non-safety-related regulatory requirements or special requirements imposed by the customer. This could be interpreted to mean that Entergy intended to treat the item as non-safety related and therefore subject to non-safety related regulatory requirements, but not the safety related requirements for these items. An example of this is the dedication process defined in 10 CFR 21.3.

4.2.1.2 Duke Evaluation At the time of the panels review, Oconee was the only Duke Energy facility to have received approval to use Code Case N-752 as a Section XI alternative. Inspection of the Oconee facility during the 2024 Age-Related Degradation (ARD) Focused Engineering Inspection (FEI) resulted in the following observations.

Appendix B Applicability in Duke Implementing Procedures Duke fleet procedure, AD-EG-ALL-1703, ASME Section XI Repair/Replacement Program Administration, revision 6, which was a controlling process for Section XI repair and replacement activities, was revised, as expected, to refer the user to AD-EG-ALL-1221, Alternative Treatment Implementation Process Per 10 CFR 50.69 and Risk-Informed Code Cases (described above):

The requirements of this procedure do NOT apply to Class 2 or 3 items that have been classified as RISC-3 per 10 CFR 50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components For Nuclear Power Reactors, or as Low Safety Significant (LSS) per ASME Code Case N-752, Risk-Informed Safety Classification and Treatment for Repair/Replacement Activities in Class 2 and 3 Moderate Energy Systems.

Refer to AD-EG-ALL-1221, Alternative Treatment Implementation Process Per 10 CFR 50.69 and Risk-Informed Code Cases, for additional information on risk-informed categorization and treatment implementation.

Duke fleet procedure, AD-EG-ALL-1221, Alternative Treatment Implementation Process Per 10 CFR 50.69 and Risk-Informed Code Cases, revision 1, section 5.9, ASME Code Case N-752 Low Safety Significant (LSS) Allowances and Requirements, contains a direct statement regarding Appendix B requirements being exempted when applying Code Case N-752. It states:

ASME Code Case N-752 LSS items are also exempt from the requirements of the Duke Energy QA Topical Report (i.e., Appendix B requirements).

Duke fleet procedure AD-EG-ALL-1221, revision 1, section 5.10, ASME Code Case N-752 Low Safety Significant (LSS) Alternative Treatment Process, contains a statement regarding removal of the regulatory requirements:

For ASME Code Case N-752 LSS SSCs, revise controlling programs and processes to document removal of the regulatory requirements, as allowed by ASME Code Case N-752, to permit the implementation of Alternative Treatment in a controlled and deliberate manner.

Control of Specifications/Applicable Standard Due to planned future modification involving the use of spray in place structural pipe liner to replace the safety-related Oconee condenser circulating water (CCW) piping pressure boundary using the Code Case provisions, the CCW system, which performs safety-related (QA-1) functions at the Oconee facility, had been evaluated by the licensee prior to the ARD FEI inspection to classify components within the system for their risk-informed classification. No modification or other implementation documentation was available at the time of the Oconee ARD FEI inspection since the CCW piping activity was being reviewed for feasibility at the time

of the inspection. No quality or risk-informed safety classification or reclassification had been performed at the time of the Oconee inspection since the calculation that evaluated the risk-informed classification of the system components is not considered a design output.

Duke fleet procedure, AD-EG-ALL-1107, Quality Classifications, revision 7, section 5.2, Classification Criteria Changes, states that, Adding the Risk-Informed Safety Classification does NOT constitute a Classification Change. This means that an item performing a safety function which has been previously classified as QA-1, does not change its required safety function, but it does add an additional identifier showing its risk informed classification. The procedure further clarifies in Attachment 9 that the Code Case N-752 designations only apply to safety related SSCs. In the terminology used at Oconee, the safety-related items are considered quality assurance level 1 (QA-1), and the Code Case N-752 designations are either considered 1-H or 1-L to designate high or low risk significance, respectively.

Part 21 Applicability/Basic Component Duke fleet procedure AD-EG-ALL-1221, revision 1, section 5.9.4 contains a statement that does not align with Entergys supplemental submittal dated April 30, 2021, which describes supplemental procurement requirements that will be applied to provide reasonable assurance that the safety function will be accomplished. Specifically, the Duke procedure invokes reasonable confidence instead when it states:

ASME Code Case N-752 LSS SSCs shall have requirements defined (e.g., design control, procurement, installation, configuration control and corrective action) to confirm with Reasonable Confidence that each LSS item remains capable of performing its safety-related functions under design basis conditions, including the following...

4.2.2. Concern 2 Findings and Conclusions The panel agrees that (from the DPO submittal) the SEs cause uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

The panel concludes licensees could, and have, interpreted the NRCs approval of the ANO QA Program commitment reduction to include that 10 CFR 50, Appendix B, did not apply to the LSS Class 2 and 3 SSCs classified and treated under Code Case N-752. The NRC SE approving the QAPD commitment reduction concluded that there is reasonable assurance that the licensees QAPM will continue to meet the requirements of Appendix B to 10 CFR Part 50 while implementing ASME Code Case N-752 for the treatment of safety-related SSCs identified as LSS. This conclusion endorsed the removal of these items from treatment under the QAPM was "based on the licensees plans to continue using current processes and procedures, as supplemented, for the treatment of Class 2 and 3 LSS SSCs.

The panel is in agreement that the staffs conclusion in the SE does not constitute an exemption from any regulatory requirements. Notwithstanding, the staffs determination that the QAPM will continue to meet Appendix B after removal of the Class 2 and 3 LSS SSCs from the QAPM leaves uncertainty regarding both the expected treatment of the items with respect to QA provisions, and the enforceability of any such QA provisions. Given that the docket associated with the evaluation of the request included the treatment descriptions in the October 26, 2020, submittal, Enclosure 2, Table 1, which indicated that the Appendix B QA Program would not apply to the Class 2 and 3 LSS SSCs classified under Code Case N-752, the NRC staffs

expectation for QA program implementation is not clear. Removal of the Class 2 and 3 items from treatment under the Appendix B QA program could potentially be viewed as out of sync with Criterion II of 10 CFR 50, Appendix B, which requires that, The applicant shall identify the structures, systems, and components to be covered by the quality assurance program. In this case, the licensee has explicitly identified safety-related SSCs within the scope of Appendix B to NOT be covered by the Entergy Appendix B quality assurance program. However, the DPO team recognizes that it is possible that policies and procedures could conceivably be used to form the quality assurance program in conjunction with the QAPM content.

Additionally, Code Case N-752 includes provisions for exempting IWA-4142 which required that the repair/replacement organization establish a Quality Assurance Program for control of their activities in accordance with the Repair /Replacement Program and Plans and that the QA Program shall comply with IWA-1400(n), [when the Owner is the Repair/Replacement Organization]; or 10CFR50 Appendix B supplemented as necessary to be consistent with the Owners Quality Assurance Program; NQA-1, Parts II and III, Basic Requirements and Supplements; or NCA-4000 [if the repair/replacement organization is other than the Owner].

Paragraph IWA-1400(n) of Section XI requires documentation of a Quality Assurance Program in accordance with either Title 10, Code of Federal Regulations, Part 50 or ASME NQA-1, Parts II and III, Basic Requirements and Supplements. Entergy described the IWA-1400(n) exemption in their October 26, 2020, request as allowing for exemption of the associated QA requirements

[i.e., IWA-1400(n)] provided 10 CFR 50 Appendix B or NQA-1 is not required at the nuclear site.

In order to utilize the exemption in IWA-1400(n), Entergy proposed the removal of the LSS SSCs from treatment under the QAPM as a reduction in QA Program commitment. It is unclear how a reduction in QA Program commitment would allow use of the Code Case N-752 exemption in the absence of an exemption from Appendix B. Specifically, if the removal of the LSS SSCs from treatment under the QAPM allowed Entergy to take advantage of the IWA-1400(n) exemption, it seems contrary to conclude that using current processes and procedures rather than the QAPM would satisfy Appendix B.

Further, if the use of processes and procedures for treatment of the LSS SSCs was intended to satisfy Appendix B, the lack of a high level description of the alternate treatment within the QAPM seems to be inconsistent with Commissions statements (48 FR 1026) on the use of the QAPD as a tool for ensuring that Appendix B requirements are met.

Notwithstanding the above, removal from treatment under the QA program, not just the QAPM description, was communicated in Table 1 of Enclosure 2 of the October 26, 2020, submittal. If a position later developed by the staff determines that removal of the item from treatment under the QA Program is not compliant with Appendix B, including Criterion II, then it should be reviewed as a potential change in NRC position.

4.2.3. Concern 2 Recommendations The panel recommends the following actions:

Short Term:

1) Panel members agreed that staff should achieve clarity on two fundamental principles associated with the staffs SE determination supporting use of the Code Case:

a. the level of detail required to be included in the QAPD describing alternate treatments used to satisfy Appendix B (e.g., to what extent does procedural guidance need to be discussed in the QAPD)

b. whether a statement within the QA Program Description that SSCs were removed from treatment under QAPM/QAPD, equates to removal of the items from treatment under the Appendix B QA Program and whether this removal could, under any circumstances, satisfy Criterion II of Appendix B.

Panel members found multiple options on how best to achieve this clarity.

The staff could develop a written position regarding the fundamental principles identified in 1a and 1b, with input from relevant NRC offices, to inform next steps.

This written position could be provided to the Backfit Community of Practice (CoP) to help ascertain both the enforceability of existing approvals for use of the Code Case N-752 and any actions needed to support clarity for future NRC use.

The staff could provide the NRC Backfit CoP with the available records related to this case (e.g., this panel report, QAPM commitment reduction information, Code Case N-752 alternative authorization, and inspection results), to assist in determining if future enforcement of the 10 CFR 50, Appendix B and 10 CFR 21 requirements would represent a position that diverges from the recent acceptance of the ANO QAPD commitment reduction and authorization to adopt Code Case N-752, including its exemption of IWA-1400(n).

2) Leverage baseline inspection activities, as appropriate, to validate that licensees that are approved for use of N-752 continue to satisfy the requirements of 10 CFR 50, Appendix B and 10 CFR Part 21.

3) Consider use of a generic communication. For example, a RIS could be used to clarify the staffs position. In addition, if concerns based on initial inspections indicate a trend in misinterpretation of what was accepted, an Information Notice can be drafted explaining the negative trend in enforcement matters.

Long Term:

4) The panel recommends that the NRCs guidance for review of requested QAPD changes contained in NUREG-0800, section 17.3, Quality Assurance Program Description, be reviewed and potentially revised to preclude future confusion of what is being accepted related to the review of QA reductions in commitment. This approach can ensure the staffs position in Recommendation 1, is widely understood.

a) While the guidance in this section of the SRP outlines and specifies the NRC's acceptance criteria for QAPDs, it also states that Except when acceptable alternatives are provided, the acceptance criteria that follow provide attributes to be addressed for a QAPD to be found acceptable. It does not provide acceptance criteria for instances when a licensee has requested to remove items from treatment under the station QAPD.

b) It further is not explicit that where an alternative QA treatment program is being requested for items that will be removed from the QAPD, the 10 CFR 50, Appendix B requirements still apply to the alternative program and will each need to be verified as acceptable, absent a prior exemption from those Appendix B requirements being granted.

4.3. Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 10 CFR 50, Appendix B applicability This issue pertains to the concern that by accepting Entergys approach of removing the LSS Class 2 and 3 items from treatment under the Entergy QAPD, Entergy and other licensees using the Entergy approval under 10 CFR 50.54(a)(3) will not have documentation of a QA program in accordance with 10 CFR 50, Appendix B. Specifically, the submitters were concerned that the NRC safety evaluation along with the statements in Entergys submittal related to their QAPD commitment reduction dated October 26, 2020, cause uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

4.3.1. Concern 3 Evaluation The submitters were concerned that by accepting Entergys approach of removing the LSS Class 2 and 3 items from treatment under the Entergy QAPD, Entergy and other licensees using the Entergy approval under 10 CFR 50.54(a)(3) will not have documentation of a QA program in accordance with 10 CFR 50, Appendix B. Specifically, the submitters were concerned that the NRC safety evaluation along with the statements in Entergys submittal related to their QAPD commitment reduction dated October 26, 2020, cause uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO.

To evaluate this concern/assertion the panel interviewed NRR staff involved in the approval process, reviewed background information referenced above, considered relevant Statements of Considerations and considered agency policy. The evaluation further involved consideration of similar approvals as precedent.

The Code Case N-752 paragraph -1420 provisions allow for exemption of IWA-1400(n), as applicable to ANO, and article IWA-4000 (which includes IWA-4142 specifically). The Code Case makes it a point that if compliance with 10 CFR 50 Appendix B or NQA-1 is required at the Owner's facility, IWA-1400(n) is not exempt. The combination of both provisions being exempted at a facility where compliance with 10 CFR 50 Appendix B is required gives a perception that the repair/replacement organization does not have to establish an Appendix B program that applies to the Section XI repair/replacement activity. This creates a conflict with the continued application of Appendix B requirements. It also creates a potential gap in QA treatment since the Code Case says the owner will, in lieu of those requirements, define requirements (e.g., design control, procurement, installation, configuration control, and corrective action) to confirm with reasonable confidence that each LSS item remains capable of performing its safety-related functions under design-basis conditions. The example list of requirements to be defined may indicate that not all of the Appendix B requirements continue to apply or require alternate treatments to be defined.

Additionally, the NRCs authorization of Entergy to use N-752 as a Section XI Code alternative included in its technical evaluation a statement from Entergys original October 26, 2020, QAPD commitment reduction request that was later superseded. Specifically, it stated that:

By letter dated October 26, 2020 (ADAMS Accession No. ML20300A324), the licensee submitted a proposed revision to the Entergy Quality Assurance Program Manual

(QAPM), which stated, in part, that program elements would be developed for repair/replacement of LSS items to ensure continued capability and reliability of the design basis function.

However, this statement was superseded in Entergys April 5, 2021, submittal which changed the statement that program elements would be developed to state that Instead, program elements describing treatment of these LSS SSCs are specified by Engineering to ensure the continued capability and reliability of the SSCs design basis function. The April 5, 2021, language was again later changed, and was ultimately approved, to state Instead, treatment of these LSS SCCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function.

As it related to the N-752 authorization, the NRC technical evaluation stated that The applicable quality controls that will be implemented for the treatment of the LSS [SSCs] are described in the NRC staffs safety evaluation approving Entergys QAPM change, dated May 19, 2021 (ADAMS Accession No. ML21132A279).

The In lieu of these requirements, the Owner shall define the requirements ( e.g., design control, procurement, installation, configuration control, and corrective action) language in paragraph -1420 of Code Case N-752 communicates an intent to implement the QA requirements for the repair/replacement items and the repair/replacement activities per those defined by the Owner specific to the implementation of the Code Case activities instead of the Owners previously established QA program. The licensee would have the flexibility to change these owner-defined QA requirements at will since these defined QA controls are no longer subjected to the 10 CFR 50.54 controls placed on revisions to licensees QA program descriptions.

Based on the above, the DPO Panel concluded that Concern 3 above is confirmed, in that of there is not a clear record of 10 CFR 50, Appendix B applicability. However, as described above, the licensees records make clear that the licensees view is that Appendix B does not apply.

Dual Function Components (Active and passive) The submitters included a concern regarding application of the QAPD reduction and the Code Case provisions to items that have both passive and active functions, such as pumps and valves. The potential for less rigorous Codes or standards to be applied is expected, given the language in Code Case N-752 (2019 edition) paragraph -1420 (e) which states:

Items used for repair/replacement activities shall meet the Construction Code to which the original item was constructed. Alternatively, items used for repair /replacement activities shall meet the technical requirements4 of a nationally recognized code, standard, or specification applicable to that item (e.g., ASME, ANSI, AWS, AISC, AWWA, API 650, API 620, MSS SPs, or TEMA), as permitted by the licensing basis.

However, (2019 edition) paragraph -1420 (j) states that: These provisions do not negate or affect Owner commitments to regulatory and enforcement authorities having jurisdiction at the plant site.

The provision of Code Case N-752 paragraph -1420 (j), above, ensures that important considerations for active components in the systems to which Code Case N-752 is being applied are not overlooked. An example of this would be the continued application of structural commitments made to the AEC/NRC during licensing of the facilities, such as a commitment to

follow Regulatory Guide 1.48, "Design Limit and Loading Combinations for Seismic Category I Fluid System Components. This regulatory guide specifies that:

for the particular case of active pumps and valves (i.e., pumps and valves that must performs a mechanical motion during' the course of accomplishing a system safety function), special design limits and supplemental requirements are specified to provide assurance of operability. These special design limits and supplemental requirements are provided for active pumps and valves because the rules for construction of Section III apply to the assurance of pressure-retaining integrity but do not assure that pumps and valves designated to perform a system safety function will operate when required.

While not all licensees are committed to using this Regulatory Guide, those that are would still have to ensure the same special design limits and supplemental requirements continue to be applied for those items classified in accordance with Code Case N-752. As described in RG 1.48, these special design limits and supplemental requirements would be contained in the owners design specification for the item. In this way, a similar level of quality to that previously applied to the active components is maintained under the provisions of paragraph -1420(j) of Code Case N-752. Further, the inservice testing requirements continue to also be applied, regardless of the Owners selected Code or standard applied to the design and construction of the items.

The panel reviewed Entergys and Dukes procedures for control of specifications to evaluate whether the application of the Code Case N-752 provisions allowed for modification of the existing design specifications for removal or modification of the previously approved design specifications. This review is described below in sections 4.3.1.1 and 4.3.1.2.

With respect to procurement of items which have both an active and a passive function, Entergy procedure EN-DC-308, Safety and Quality Classification of Replacement Parts, revision 8, was reviewed. It has a vulnerability in it regarding the potential to inappropriately procure an active subcomponent under the alternate treatment provisions, rather than the full special treatment under the Entergy QAPD. Specifically, section 5.2, General Guidelines, states:

For safety related (SR) parent components that were originally supplied as an assembly, the individual parts can be evaluated and analyzed to make one of the following determinations:...(e) The intended function of the part is relied upon for the accomplishment of the safety related function(s) of the parent component. However, the parent component has been categorized as LSS in accordance with Code Case N-752.

In this case, parts which comprise the LSS parent component are also LSS and may be procured as Procurement Class/ Quality Level QL as defined in EN-DC-313.

An example of this is valves which have an active function which is high risk, but the pressure boundary of the valve has been determined to be LSS in accordance with the N-752 categorization. This step in the procedure may allow the stem/disc or other active parts as applicable, to be procured as QL rather than a more appropriate procurement classification.

However, even given this potential, active components such as the stem assembly on the replaced TDEFW governor valve (see ANO EC 77577) were qualified and treated under an Appendix B program just as any other safety related active component would have been. The CETI inspection revealed that neither the valve (parent component) nor its sub-components were officially reclassified to QL in the station database.

In summary, while the procedure has a vulnerability, the vulnerability does not appear to be utilized in practice.

In assessing Concerns with the review of the Code Alternative, the DPO panel noted the use of reasonable confidence language in lieu of the standard reasonable assurance language associated with Appendix B:

The NRC staff finds that the licensees adherence to the above elements covered in Code Case N-752 for repair/replacement activities provides reasonable confidence that each LSS item will remain capable of performing its safety-related function.

The term reasonable confidence is invoked for RISC-3 components applicable to 10 CFR 50.69, however, at the time of the review and acceptance, ANO was not approved to use 10 CFR 50.69. The NRC SE further states that:

Therefore, the NRC staff finds the licensees alternative treatment requirements are consistent with the requirements in 10 CFR 50.69(d)(2)(ii), Corrective action, and therefore acceptable.

Using 10 CFR 50.69 as a comparison for consistency for a facility that has not been approved to use the provisions of 10 CFR 50.69 does not take into consideration 10 CFR 50.69 as whole, including its voluntary compliance provisions with 50.69 in lieu of the special treatment requirements (e.g., 10 CFR 50, Appendix B).

One example of this is 10 CFR Part 21, which requires the dedication process to be conducted in accordance with the applicable provisions of 10 CFR Part 50, appendix B, and that it provides reasonable assurance. Code Case N-752 paragraph -1420 invokes reasonable confidence instead and allows definition of alternate procurement controls:

In lieu of these requirements, the Owner shall define the requirements (e.g., design control, procurement, installation, configuration control, and corrective action) to confirm with reasonable confidence that each LSS item remains capable of performing its safety-related functions under design-basis conditions. Entergy has defined reasonable confidence in their EN-DC-313 procedure, and states that reasonable confidence is established through implementation of the sum-total of all Alternative Treatment requirements a utility applies to RISC-3 SSCs and is NOT solely reliant on the procurement process.

Nevertheless, per 10 CFR 50.55a(z), the intent of the staff review of the proposed alternative is to ensure that the licensee has demonstrated that the proposed alternative would provide an acceptable level of quality and safety. The NRC has also determined that implementation of 10 CFR 50.69 also provides an acceptable level of confidence that the safety function will be accomplished. Further, the precedent cited by Entergy in their May 27, 2020, request to adopt Code Case N-752 as a Code alternative, included the NRCs approval of Entergy Relief Request ANO2-R&R-004, Revision 1, described in section 3.1 of this report. When approving this prior Code alternative, the NRC staff evaluated the acceptability of these alternative requirements based on consistency with the requirements in 10 CFR 50.69. A similar reasonable confidence threshold was also acknowledged in the NRC SER approving the prior Code alternative:

Entergy will replace the existing Section XI repair/replacement requirements with owner-defined activities to confirm with reasonable confidence that each LSS item remains capable of performing its safety function(s) under design-basis conditions.

However, the NRC SE for this prior alternative acknowledged directly that the proposed alternative did not request any change to the requirements in 10 CFR Part 50.

4.3.2. Concern 3 Findings and Conclusions The panel agrees and disagrees as follows:

(Agree) The DPO panel agrees that Code Case N-752 should not be approved without a clear record and common understanding that Appendix B requirements apply. The DPO panel also believes that it is unclear how the IWA-1400(n) exemption (when applying it to the Entergy Section XI Code of record) of Code Case N-752 can be used without exemption of 10 CFR 50, Appendix B.

(Disagree) No exemption to 10 CFR 50, Appendix B was requested or granted, so the licensee must still comply with its requirements. It is clear that this was the staffs expectation based on the language in its approval. As stated in the discussion and findings associated with Concern 2, there remains a question of whether procedures can be used for compliance without having the overarching controls included in the QAPM.

Discussion: The approval to reduce the Entergy QAPM commitment appears to involve a difference in philosophy between the NRC reviewers and the licensee over what constitutes the QA Program required to be used during repair/replacement activities. The licensee appears to be of the belief that that once the Class 2 and 3 LSS SSCs were removed from treatment under the description in the QA Program Manual, it was no longer subjected to Appendix B requirements. The licensees reason for removing the SSCs from treatment under the QAPM was to utilize the exemption of IWA-1400(n) allowed by Code Case N-752 for plants not required to meet 10 CFR 50, Appendix B. The reviewers appear to have been of the understanding that the use of existing QA program processes and procedures containing description of alternate controls, akin to using a graded QA approach which was previously considered by the NRC to be an option to satisfy Appendix B, would be acceptable to satisfy the requirements of Appendix B.

However, in practice, Entergy has updated many of these processes and procedures to reflect that the Class 2 and 3 LSS items classified under N-752 do not have to satisfy Appendix B.

This is likely because the statements from Entergys October 26, 2020, submittal stated that the Appendix B QA Program does not apply, and those statements were not directly addressed in subsequent RAIs as not satisfactory to meet the requirements in Appendix B. The revisions made to the procedures as a result of Code Case N-752 implementation give the appearance that Entergy and Duke have considered the combined effect of the QAPD commitment reduction and the 50.55a(z) Code Alternative to be an exemption from the requirements of 10 CFR 50, Appendix B and 10 CFR Part 21 for the safety related items to which the Code Case applies.

Additionally, the Code Case uses terminology which aligns with 10 CFR 50.69, specifically reasonable confidence, which Entergy has defined in their EN-DC-313 procedure as inclusive of the sum-total of all Alternative Treatment requirements a utility applies to RISC-3 SSCs and is NOT solely reliant on the procurement process. Use of the more holistic approach per Energys definition presents a challenge to satisfying 10 CFR Part 21, which requires the dedication activity, not a holistic view of alternate treatments, to provide the reasonable assurance that the item will perform its intended function. Although Entergy used the reasonable confidence term in its April 5, 2021, response to an RAI regarding procurement controls to be put in place, the reasonable assurance language was repeated in Entergys April 30, 2021, submittal. The procedures reviewed by the ANO CETI team indicate that the

licensee does not require commercial grade dedication activities to be performed for the Class 2 and 3 LSS SSCs under Code Case N-752 treatment.

4.3.3. Concern 3 Recommendations The DPO Panel suggests the following in addition to the recommendations for Concern 2, which are also responsive to this concern:

5)

Consider issuing a second RCI to clarify Entergys understanding of the regulatory commitment contained in the November 17, 2020, revision to the Proposed Alternative to Use ASME Code Case N-752 (ML20322A141) (i.e., if it represented Entergys intent to not treat the Class 2 and 3 LSS safety-related items in accordance with Appendix B requirements).

4.4. Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergys QA Program This concern pertains to the potential lack of NRCs ability to review QA program changes and take enforcement action due to the use of QA procedures and processes that are outside the QAPM for Class 2 and 3 LSS repair/replacement components.

4.4.1. Concern 4 Evaluation This concern is effectively the same as those above, except it applies to the other Entergy facilities as well. The same discussion points above regarding the ambiguity in Entergys ANO submittals and the NRC SE apply to this concern as well.

To evaluate this concern/assertion the panel followed up on actions the licensee took in response to the receipt of the RCI involving review of the condition report written following receipt of the RCI and reviewing the corrective actions taken.

The RCI was provided to address omissions in the ANO UFSAR when compared to the staffs approval of the licensees QAPM change. The RCI was provided to Entergy on March 22, 2024, and stated:

Specifically, the SAR updates omit the approved alternative treatment, that... treatment of these LSS SSCs is performed in accordance with existing QAP procedures and processes which include supplemental controls to ensure the capability and reliability of the SSCs design basis function. As written, the revised SAR language is not clear that:

(a) those components remain within the scope of 10 CFR Part 50, Appendix B, with respect to their licensing basis and enforcement actions, and (b) there are specific treatment requirements for safety-related Class 2 and Class 3 SSCs that are categorized as LSS when implementing Code Case N-752, which were the basis for the NRC staff authorizing the use of Code Case N-752 at ANO, Units 1 and 2.

Specifically, the ANO UFSAR stated:

Code Case N-752 provides a process for determining the risk-informed categorization and treatment for repair/replacement activities on pressure retaining Class 2 and 3 components and their associated supports. Components are categorized as either High Safety Significant (HSS) or Low Safety Significant (LSS).

Repair/replacement activities on Class 2 and 3 pressure retaining components and supports categorized as HSS shall continue to comply with the ASME Section XI Code and the Entergy QAPM. Alternatively, Class 2 and 3 pressure retaining components and supports determined to be LSS in accordance with Code Case N-752 may comply with the alternative treatments of Code Case N-752 including those specified below:

1. Compliance with ASME Section XI, IWA-4000 is not required.

2. Compliance with the Entergy QAPM is not required.

The RCI response was received from Entergy on April 10, 2024 (ML24101A388), which stated that Entergy confirms that safety-related Class 2 and 3 structures, systems, and components (SSCs) categorized as Low Safety Significance (LSS) when implementing Code Case N-752 at Arkansas Nuclear One Units 1 and 2 (ANO) are being treated in accordance with existing Quality Assurance Program (QAP) procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50. The panel observed that on April 10, 2024, Entergy procedure CEP-RR-006, rev 0, described above was active and contained language that indicated the belief that Appendix B was exempted.

The DPO panel noted that at the time of the panels review, the UFSAR stated the same as the above. When the RCI was received by Entergy, CR-ANO-C-2024-00693, was initiated on April 11, 2024. The CR description stated, in part, that:

The NRC staff noted during their review of the 2023 Entergy fleet submittal that the revisions to the ANO-1 and 2 SARs, following implementation of Code Case N-752, are not consistent with the changes the staff approved to the Entergy QAPM and could imply that the requirements of Appendix B to 10 CFR Part 50 no longer apply to safety-related Class 2 and Class 3 LSS SSCs.

The NRC issued a Request to Confirmation of Information (RCI) on March 27, 2024, to Entergy to confirm that:

• Safety-related Class 2 and 3 SSCs categorized as LSS when implementing Code Case N 752 at ANO (and thus Grand Gulf, River Bend, and Waterford 3 if the NRC staff authorizes the requested alternative) are being treated in accordance with existing QAP procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50.

• The additional supplemental requirements and controls, as described in the Entergy letter dated April 30, 2021, used to confirm with reasonable assurance that Class 2 and 3 LSS SSCs will remain capable of performing their intended safety-related functions under design basis conditions, are currently being implemented and have been incorporated into the existing ANO QAP procedures used for the procurement of safety-related Class 2 and 3 LSS SSCs and will also be incorporated into the Grand Gulf, River Bend, and Waterford 3 QAP procedures, if the NRC staff authorizes the requested alternative.

Headquarters initiated CR-HQN-2024-00451 due to the issuance of the RCI. This CR is being initiated due of the wording in the ANO-1 and ANO-2 SARs led to the need for the NRC to issue the RCI, thereby adding time and resources of Entergy and the NRC unnecessarily.

This CR does not impact the operations of any SSC.

The immediate actions taken were:

Initiated CR-HQN-2024-00451 for the issuance of the RCI.

Confirmed the affected groups' (e.g., Procurement, QA) procedures for Class 2 and 3 LSS SSCs complied with the requirements with the QAPM for ANO.

A corrective action, CR-ANO-C-2024-00693-00002, was assigned on May 15, 2024, with a due date of August 29, 2024, to Revise the Unit 1 and Unit 2 SAR per the input provided in CA-1 to ensure these documents are consistent with the verbiage in the QAPM related to Code Case N-752.

The input in CA-1 included, The proposed action is to revise the ANO-1 and 2 SARs to be consistent with the NRC approved [Q]APM change.

An additional corrective action was assigned to CR-ANO-C-2024-00693 during the ANO CETI inspection in response to the teams inquiries related to their inspection sample. Specifically, CR-ANO-C-2024-00693-00003 was assigned on July 18, 2024, with a due date of August 30, 2024, with a description of:

The definition of Low Safety Significant (LSS) in EN-DC-308 also contains misleading wording as identified in this condition report. Revise EN-DC-308 to match the wording in the Entergy QAPM regarding the treatment of Category 2 and 3 SSCs IAW existing QAP procedures and processes.

Both of these corrective actions had not been completed at the time of the review, so the resolution is unknown at this point. However, it is noted that the proposed resolutions are not to directly reflect that Appendix B applies to the SSCs in either the FSAR revisions or the revision to procedure EN-DC-308. The corrective action proposals are instead to match the wording in the Entergy QAPM.

As described in the evaluation above, several of Entergys existing QAP procedures and processes were revised after receiving approval for the QAPM commitment reduction to include statements that LSS systems, components, and supports are not required to comply with the quality assurance requirements of 10CFR50, Appendix B. In one case (EN-DC-313), the procedural statement which excluded the applicability of Appendix B refers back to the QAPM:

Low Safety Significant (LSS) - A function not determined to be safety significant from the plant probabilistic risk assessment or from other relevant information (e.g., defense in depth considerations). LSS systems, components, and supports are not required to comply with the quality assurance requirements of 10CFR50, Appendix B. [Reference - QAPM Section A.7.c]

4.4.2. Concern 4 Findings and Conclusions The panel agrees that NRCs ability to review QA program changes and take enforcement action may be limited due to the use of QA procedures and processes that are outside the QAPM for Class 2 and 3 LSS repair/replacement components.

The panel assesses that there is evidence, as noted above, that Entergy plans to treat the Class 2 & 3 LSS SSCs in accordance with existing QAP procedures and processes that fall under the jurisdiction of Appendix B to 10 CFR Part 50. This language does not clearly indicate that the treatment of the SSCs will be in accordance with the Appendix B QA Program. This is evident in the proposed corrective action to revise the ANO-1 and 2 SARs to be consistent with the NRC approved [Q]APM change, which would appear to not address the licensees perception that

the QAPM change allows for an exemption to 10 CFR 50, Appendix B, for the Class 2 and 3 LSS SSCs under N-752 treatment.

4.4.3. Concern 4 Recommendations As this concern is closely tied to the above concerns, the panel recommends that:

6) NRR should consider briefing reviewers who would receive and perform an acceptance review of requests to use Code Case N-752 to identify the recognized concerns with the use of the Code Case, and consider pausing acceptance and review of such requests until clarity is received on the viability of the Code Case.

7) Any action taken in response to the other concerns should also be communicated to or otherwise carried out on the other affected plants.

5. Conclusion and Recommendations The DPO Panel found the DPO submitters concerns to be valid and well-described. Based on the DPO panels research, interviews, and analysis, it submits the following recommendations to NRR for consideration:

1.

Panel members agreed that staff should achieve clarity on two fundamental principles associated with the staffs SE determination supporting use of the Code Case:

a. the level of detail required to be included in the QAPD describing alternate treatments used to satisfy Appendix B (e.g., to what extent does procedural guidance need to be discussed in the QAPD)

b. whether a statement within the QA Program Description that SSCs were removed from treatment under QAPM/QAPD, equates to removal of the items from treatment under the Appendix B QA Program and whether this removal could, under any circumstances, satisfy Criterion II of Appendix B.

Panel members found multiple options on how best to achieve this clarity.

The staff could develop a written position regarding the fundamental principles identified in 1a and 1b, with input from relevant NRC offices, to inform next steps.

This written position could be provided to the Backfit Community of Practice (CoP) to help ascertain both the enforceability of existing approvals for use of the Code Case N-752 and any actions needed to support clarity for future NRC use.

The staff could provide the NRC Backfit CoP with the available records related to this case (e.g., this panel report, QAPM commitment reduction information, Code Case N-752 alternative authorization, and inspection results), to assist in determining if future enforcement of the 10 CFR 50, Appendix B and 10 CFR 21 requirements would represent a position that diverges from the recent acceptance of the ANO QAPD commitment reduction and authorization to adopt Code Case N-752, including its exemption of IWA-1400(n).

2. Leverage baseline inspection activities, as appropriate, to validate that licensees that are approved for use of N-752 continue to satisfy the requirements of 10 CFR 50, Appendix B and 10 CFR Part 21.

3. Consider use of a generic communication. For example, a RIS could be used to clarify the staffs position. In addition, if concerns based on initial inspections indicate a trend in misinterpretation of what was accepted, an Information Notice can be drafted explaining the negative trend in enforcement matters.

4. The panel recommends that the NRCs guidance for review of requested QAPD changes contained in NUREG-0800, section 17.3, Quality Assurance Program Description, be reviewed and potentially revised to preclude future confusion of what is being accepted related to the review of QA reductions in commitment. This approach can ensure the staffs position in Recommendation 1, is widely understood.

While the guidance in this section of the SRP outlines and specifies the NRC's acceptance criteria for QAPDs, it also states that Except when acceptable alternatives are provided, the acceptance criteria that follow provide attributes to be addressed for a QAPD to be found acceptable. It does not provide acceptance criteria for instances when a licensee has requested to remove items from treatment under the station QAPD.

It further is not explicit that where an alternative QA treatment program is being requested for items that will be removed from the QAPD, the 10 CFR 50, Appendix B requirements still apply to the alternative program and will each need to be verified as acceptable, absent a prior exemption from those Appendix B requirements being granted.

5. Consider issuing a second RCI to clarify Entergys understanding of the regulatory commitment contained in the November 17, 2020, revision to the Proposed Alternative to Use ASME Code Case N-752 (ML20322A141) (i.e., if it represented Entergys intent to not treat the Class 2 and 3 LSS safety-related items in accordance with Appendix B requirements).

6. NRR should consider briefing reviewers who would receive and perform an acceptance review of requests to use Code Case N-752 to identify the recognized concerns with the use of the Code Case, and consider pausing acceptance and review of such requests until clarity is received on the viability of the Code Case.

7. Any action taken in response to the other concerns should also be communicated to or otherwise carried out on the other affected plants.

References Endnotes i Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, 69 FR 68008 (Nov. 22, 2004) (available at https://www.federalregister.gov/d/04-25665/p-3).

ii ibid iii ibid iv ibid v ibid vi 10 CFR 50.69(b)(1)(i), (v), and (ix).

vii 10 CFR 50.69(b)(2).

viii Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, 69 FR 68008, 68015-16 (Nov. 22, 2004) (available at https://www.federalregister.gov/d/04-25665/p-98).

ix ibid x ibid xi Specific Exemptions; Clarification of Standards, 50 Fed. Reg. 50764, 50765 (Dec. 12, 1985) (available at https://archives.federalregister.gov/issue slice/1985/12/12/50761-50778.pdf#page=4).

xii ibid xiii ibid xiv ibid xv ibid xvi ibid xvii ibid xviii ibid xix ibid xx Codes and Standards for Nuclear Power Plants, 49 FR 9711, 9713 (March 15, 1984) (available at https://archives.federalregister.gov/issue_slice/1984/3/15/9708-9714.pdf#page=4).

xxi ibid xxii ibid xxiii ibid xxiv Final Rule, Approval of American Society of Mechanical Engineers' Code Cases, 79 Fed. Reg. 65,776, 65792 (November 5, 2014) (available at https://www.federalregister.gov/d/2014-25491).

xxv https://www.asme.org/codes-standards/publications-information/code-cases (last visited August 15, 2024) xxvi https://cstools.asme.org/csconnect/CodeCaseForm.cfm?Action=View&CaseNumber=3037&NoToolbar=y es (showing that Code Case N-752-1 was approved by ASME on April 12, 2021).

xxvii 10 CFR 21.7.

xxviii ibid xxix Reporting of Changes to the Quality Assurance Program, 48 FR 1026 (January 10, 1983) (available at https://archives.federalregister.gov/issue_slice/1983/1/10/1021-1029.pdf#page=6).

xxx ibid xxxi ibid xxxii ibid xxxiii ibid xxxiv ibid xxxv ibid xxxvi Changes to Quality Assurance Programs, 64 FR 9030 (February 23, 1999) (available at https://www.federalregister.gov/d/99-4395).

xxxvii ibid xxxviii ibid

xxxix Changes to Quality Assurance Programs: Responses to Comments, 64 FR 42823, 42824 (August 6, 1999) (available at https://www.federalregister.gov/d/99-20267).

xl ibid xli ibid xlii ML071150108 xliii ML090120620 xliv ML090930246 xlv ADAMS Legacy Library Accession Number 9901050347 xlvi ML052900163 xlvii ML100210161, Request for Alternative - Implementation of a Risk-Informed Inservice Inspection Program Based on ASME Code Case N-716 Arkansas Nuclear One, Unit 2 Docket No. 50-368 License No. NPF-6 xlviii ML103500532 xlix ibid l ibid li ML20197A056 lii ML20148M343 liii ML20300A324, Reduction of Commitment to the Entergy Operations Quality Assurance Program Manual Description, dated October 26, 2020 liv NRC email to Riley Keele (Entergy), "ANO-1 and ANO Final RAI RE: Proposed Change to Quality Assurance Program Manual" (EPID L-2020-LLQ-0005) lv ML21120A326 lvi ML21147A234 and ML21147A264 lvii ibid

Document 4: DPO Decision

September 5, 2024 MEMORANDUM TO:

Thomas G. Scarbrough, Senior Mechanical Engineer Mechanical Engineering and Inservice Testing Branch Division of Engineering and External Hazards Office of Nuclear Reactor Regulation Jay Collins, Senior Materials Engineer Piping and Head Penetrations Branch Division of New and Renewed Licenses Office of Nuclear Reactor Regulation John Honcharik, Senior Materials Engineer Piping and Head Penetrations Branch Division of New and Renewed Licenses Office of Nuclear Reactor Regulation FROM:

Michael F. King, Deputy Director

/RA/

Office of Nuclear Reactor Regulation

SUBJECT:

DIFFERING PROFESSIONAL OPINION DECISION ON THE U.S.

NUCLEAR REGULATORY COMMISSION (NRC)

AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM (QAP) FOR USE OF AMERICAN SOCIETY OF MECHANICAL ENGINEERS (ASME)

CODE CASE N-752 AT ARKANSAS NUCLEAR ONE (DPO-2024-001)

The purpose of this memorandum is to respond to your differing professional opinion (DPO) submitted on November 1, 2023, in accordance with Management Directive 10.159, The Nuclear Regulatory Commission Differing Professional Opinions Program (Agencywide Documents Access and Management System Accession No. ML23123A099). Your DPO titled, NRC authorization of Entergy requests to change Quality Assurance Program for use of ASME Code Case N-752 at Arkansas Nuclear One (ML24064A235), concerns a situation where there is an apparent mismatch between what the staff approved and what the licensees have implemented in the use of ASME Code Case N-752 as an alternative under Title 10 of the Code of Federal Regulations (10 CFR) 50.55a(z) and the reduction in quality assurance program commitments under 10 CFR 50.54(a)(4) to comply with 10 CFR Appendix B for certain structures, systems, and components.

CONTACT: Jordan Hoellman, NRR 301-415-5481

Specifically, you raised concerns related to Entergys interpretation of the NRC safety evaluations (SEs) issued on May 19, 2021, (1) authorizing the use of Code Case N-752 at Arkansas Nuclear One (ANO) as an alternative to the specified ASME BPV Code,Section XI, requirements under 10 CFR 50.55a(z)(1) (ML21118B039) and (2) approving the proposed change to the QAPM at ANO under 10 CFR 50.54 with specific treatment controls (although less rigorous than previously applied) for safety-related Class 2 and Class 3 components categorized as low safety significant (LSS) when implementing Code Case N-752 (ML21132A279). With these approvals, you raised concern that according to its statements, Entergy considers those NRC SEs to have granted an exemption from the quality assurance (QA) requirements in 10 CFR Part 50, Appendix B, for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO. You contend that this incorrect position by Entergy might result in an unacceptable level of quality and safety when Entergy implements Code Case N-752 at ANO.

I found your DPO to be carefully researched and of extremely high quality. I commend you for your commitment and dedication to the NRCs mission. Your willingness to raise concerns with your colleagues and managers and ensure that your concerns are heard and understood is admirable and vital to ensuring a healthy safety culture within the agency.

My response to the DPO is described in the enclosure and was informed by the DPO Panel report and their recommendations (ML24229A242).

Enclosure:

Directors Decision for Differing Professional Opinion

Package: ML24250A061 Memorandum: ML24250A067 Director's Decision: ML24250A074 OFFICE NRR/DD NAME MKing DATE 09/05/2024 JHoellman, NRR ARamirez, NRR BPham, NRR RFelts, NRR GFigueroaToledo, OE DSolorio, OE DPelton, OE

• via email

DIRECTORS DECISION FOR DIFFERING PROFESSIONAL OPINION ON THE U.S.

NUCLEAR REGULATORY COMMISSION (NRC) AUTHORIZATION OF ENTERGY REQUESTS TO CHANGE QUALITY ASSURANCE PROGRAM (QAP) FOR USE OF AMERICAN SOCIETY OF MECHANICAL ENGINEERS (ASME) CODE CASE N-752 AT ARKANSAS NUCLEAR ONE (DPO-2024-001)

Background

In DPO-2024-001, titled, NRC authorization of Entergy requests to change Quality Assurance Program for use of ASME Code Case N-752 at Arkansas Nuclear One (Agencywide Documents Access and Management System Accession No. ML24064A235), concerns were raised regarding a situation where there is an apparent mismatch between what the staff approved and what the licensees have implemented in the use of ASME Code Case N-752 as an alternative under Title 10 of the Code of Federal Regulations (10 CFR) 50.55a(z) and the reduction in quality assurance program commitments under 10 CFR 50.54(a)(4) to comply with 10 CFR 50, Appendix B for certain structures, systems, and components. Specifically, the DPO raised concerns related to Entergys interpretation of the NRC safety evaluations (SEs) issued on May 19, 2021, (1) authorizing the use of Code Case N-752 at Arkansas Nuclear One (ANO) as an alternative to the specified ASME Boiler and Pressure Vessel (BPV) Code,Section XI, requirements under 10 CFR 50.55a(z)(1) (ML21118B039) and (2) approving the proposed change to the QAPM at ANO under 10 CFR 50.54 with specific treatment controls (although less rigorous than previously applied) for safety-related Class 2 and Class 3 components categorized as low safety significant (LSS) when implementing Code Case N-752 (ML21132A279). With these approvals, the DPO raised concerns that according to its statements, Entergy considers those NRC SEs have granted an exemption from the quality assurance (QA) requirements in 10 CFR 50, Appendix B, for safety-related Class 2 and Class 3 items categorized as LSS when implementing Code Case N-752 at ANO. You contend that this incorrect position by Entergy might result in an unacceptable level of quality and safety when Entergy implements Code Case N-752 at ANO.

The DPO Ad Hoc Review Panel (the Panel) issued their report to me on August 16, 2024, after reviewing the applicable documents, conducting internal interviews with relevant individuals, and completing their deliberations (ML24229A242).

To inform my decision regarding this DPO, I reviewed the DPO submittal, the Panels report, and applicable documents. I also considered the discussions we had with the DPO submitters and relevant individuals during the Rapid Resolution phase of the DPO process. Further, I discussed specific aspects of the Panels recommendations with appropriate subject matter experts.

Summary of Issues The Panel agreed on a summary of issues identified in the DPO that accurately addressed the DPO submitters concerns. This summary of issues can be found on pages 1 and 2 of the Panels report. The Panel identified four concerns agreed upon by the DPO submitters. My assessment of the Panel conclusions will follow the format delineated by the Panel.

My Assessment of the Panel Conclusions The Panel performed a thorough review of the DPO and related technical areas. Their report provided substantial background regarding the origin of the ANO requested licensing actions and the NRC staffs technical evaluation, including subsequent related licensing actions requested by other licensees. The report was well written and provided conclusions from the Panel. I appreciate the Panels thoughtful assessment of the concerns raised in the DPO.

Before detailing my decisions related to the specific conclusions in the Panels report, it is important to address the risk-and safety-significance aspects of the issues raised. This is important given Commissions direction in SRM-SECY-19-0036, application of the single failure criterion to NuScale actuation block valves, which directs the staff to apply risk-informed principles when strict, prescriptive application of deterministic criteria such as the single failure criterion is unnecessary to provide for reasonable assurance of adequate protection of public health and safety as part of any licensing review or other regulatory decision. The decision is also informed by recently passed Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy (ADVANCE) Act legislation that requires the agency to assess potential updates to the Differing Professional Views or Opinions process to ensure any impacts on agency decisions and schedules are commensurate with the safety significance of the differing opinion.

Code Case N-752 provides for risk-informed categorization as high safety significance (HSS) or low safety significance (LSS) consistent with the guidance in Regulatory Guide (RG) 1.174, Revision 3, An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis, dated January 2018 (ML17317A256). Code Case N-752 requires the Owner to define alternative treatment requirements, which will confirm with reasonable confidence that each LSS item remains capable of performing its safety-related function. Code Case N-752 applies to components having only a pressure retaining function (i.e., passive function). It also applies to the passive function of components that have both active and passive functions (e.g., valves and pumps). Code Case N-752 does not change treatment on the active functions of components.

During the internal discussions of the Oconee Code Case N-752 review, NRC staff in the Division of Risk Assessment (DRA) performed an independent Standardized Plant Analysis Risk (SPAR) evaluation to develop a conservative upper bound to quantify the risk of the staff concerns over application of Code Case N-752. Multiple cases were developed and modeled to quantify the impact to internal events core damage frequency (CDF), including an across the board threefold, fivefold, and tenfold increase in failure rate frequency to account for uncertainty in relaxed treatment requirements. The staff included Class 1, 2, and 3 pressure retaining structures, systems and components (SSCs) in its bounding assessment. Although Code Case N-752 only includes Class 2 and 3 pressure retaining SSCs, DRA conservatively included Class 1 pressure retaining SSCs; and, even with this conservatism, the analysis showed that the increase in CDF for each of those increased failure frequencies fell below the RG 1.174 change threshold of 1E-5/yr.

Although failure rates of passive components are typically three to four orders of magnitude lower than active components, the methodology assumes 100% failure of the passive component and assesses categorization conservatively based on consequence alone. Furthermore, the difference between active and passive components is greater for active common cause failure rates because the likelihood of multiple passive components failing simultaneously is very low. The consequence evaluation addresses both direct and indirect impacts to the plant, including upstream and downstream components, as well as surrounding components outside the system that are affected by spatial effects, such as pipe whip or flooding. The sum total of the resulting failures is analyzed against quantitative indices as well as deterministic considerations. Since alternative treatment requirements, among other stipulations, must confirm that each LSS item remains capable of performing its safety-related function under design basis conditions, the failure rates of passive components are not expected to drastically increase and challenge the LSS categorization determination. It should also be noted that Code Case N-752 provides an additional layer of defense in depth compared to the handling of LSS components for licensees who voluntarily adopt 10 CFR 50.69. Different than 10 CFR 50.69, it does not provide an exemption from other requirements, including 10 CFR 50, Appendix B. It only approves alternative treatments for demonstrating compliance, does not relieve licensees of certain special treatments for Class 2 and 3 passive components, and requires the implementation of alternative treatment utilizing the existing QA processes and procedures. Therefore, the NRC staff has confirmed that the LSS items within the scope of the DPO concerns have appropriately and adequately been determined to be of low risk-and safety-significance and with defense in depth to address the additional uncertainties associated with implementation of Code Case N-752 compared to 10 CFR 50.69. Further, the Panels report recognizes that the DPO submitters and the involved technical staff who performed the approvals have not suggested that an immediate order or other regulatory action is needed to address safety.

However, the Panels assessment confirms that licensees interpret the NRCs approval differently than what the NRC intended. Therefore, providing clarity on what the staff approved is both warranted and appropriate, consistent with the NRCs Principles of Good Regulation.

The next several paragraphs outline the basis for my decisions and delineate where my conclusions support or differ from the Panels findings.

Concern 1: Acceptance of Entergys QAPM change for review as a reduction in commitment As expressed by the Panel, this concern associates the NRCs acceptance of Entergy/ANOs request to reduce the Quality Assurance Program Description (QAPD) (Note that Entergys QAPD is referred to as the Quality Assurance Program Manual (QAPM)), as described in the licensees submittal, as the NRC granting an exemption from the regulatory requirements in 10 CFR 50, Appendix B, and suggests that the request should have been processed as an exemption. In their report, the Panel disagreed with the DPO submitters and concluded that reviewing the requested reduction in QA Program commitment in accordance with 10 CFR 50.54(a) is appropriate to the circumstances, which included withdrawal of Entergys prior exemption request.

I agree with the Panels conclusion that reviewing the requested reduction in QA Program commitment in accordance with 10 CFR 50.54(a) was appropriate to the circumstances, which included withdrawal of Entergys prior exemption request. I also agree that this conclusion is strengthened given Enclosure 2 of Entergys October 26, 2020 submittal (ML20300A324) was prepared by the licensee in response to a request for additional information (RAI) related to the prior exemption request. I agree with the Panels citation to RG 1.174, which describes an acceptable method for assessing the nature and impact of licensing basis changes by a licensee when the licensee chooses to support (or is requested by the staff to support) changes with risk information. RG 1.174 contains Principle 1, which states, The proposed licensing basis change meets the current regulations unless it is explicitly related to a requested exemption (i.e., a specific exemption under 10 CFR 50.12). Therefore, I agree that the NRC could not grant an exemption from 10 CFR 50, Appendix B, without a request for an exemption.

I also agree with the Panels observation that Enclosure 2 to the October 26, 2020, submittal included statements to the effect that the treatment of the LSS SSCs under Code Case N-752 would not be required to comply with 10 CFR 50, Appendix B. These statements could and should have been questioned by the NRC staff. The revised regulatory commitment in Entergys related November 17, 2020, ASME Code alternative request submittal (ML20322A141) proposed that the treatment of safety-related Class 2 and 3 SSCs identified as LSS in accordance with ASME Code Case N-752 would not be required to meet the requirements of the QAPM. Based on the Panels report, licensees may have misinterpreted this as an exemption to 10 CFR 50, Appendix B, rather than an acknowledgement that the reduction in commitment that we approved in accordance with approved use of Code Case N-752 is acceptable to satisfy the requirements of 10 CFR 50, Appendix B. The lack of NRC questioning of the statements in the October 26, 2020, submittal likely contributed to misinterpretation of what the NRC staff approved.

Concern 2: Approval of Entergys QAPM commitment reduction As expressed by the Panel, this concern asserts that the NRC should not have approved the Entergy QAPM reduction in commitment because of the lack of clarity that 10 CFR 50, Appendix B requirements continue to apply. In their report, the Panel agreed with the DPO submitters that inconsistent language and terminology in the SEs have contributed to uncertainty regarding the regulatory requirements of the applicability of 10 CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO. The Panel concluded that licensees could, and have, interpreted the NRCs approval of the ANO QA Program commitment reduction to include that 10 CFR 50, Appendix B, did not apply to the LSS Class 2 and 3 SSCs classified and treated under Code Case N-752. The Panel agreed that the staffs conclusion in the SE does not constitute an exemption from any regulatory requirements.

I agree with the Panels conclusion that the SEs have contributed to uncertainty regarding the regulatory requirements of the applicability of 10 CFR 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO. However, as previously discussed, the NRC cannot grant an exemption from regulatory requirements without a request for an exemption. The NRCs conclusion in its SE approving the QAPM commitment reduction was therefore predicated on the basis that 10 CFR 50, Appendix B and Part 21 were not exempted. The NRCs SE could and should have been clearer in stating that the licensees QAPM, including implementing the ASME Code Case N-752 alternative treatment requirements for safety-related SSCs identified as LSS, is acceptable to satisfy the requirements of 10 CFR 50, Appendix B.

In addition, I agree with the Panels observation that the QA processes and procedures in conjunction with the QAPM content form the QA program and historically, the NRC has taken this position. It is important to consider the sequence of events undertaken in this licensing action, including but not limited to the licensees withdrawal of a request for an exemption from 10 CFR 50, Appendix B and the subsequent clarification on the record in response to requests for additional information as the staff discovered additional details. The NRC staff also included additional details related to the applicability of 10 CFR 50, Appendix B in similar requests from other licensees requesting to implement Code Case N-752 at their facilities, which have resulted in improved clarity of what was approved.

Concern 3: Approval of using ASME Section XI Code Case N-752 without a clear record of 1 O CFR 50, Appendix B applicability As expressed by the Panel, the concern is that by accepting Entergy's approach of removing the LSS Class 2 and 3 items from treatment under the Entergy QAPM, Entergy and other licensees using the Entergy approval under 10 CFR 50.54(a)(3) will not have documentation of a QA program in accordance with 10 CFR 50, Appendix B. The Panel's report specifies that the concern is that the NRC SE along with the statements in Entergy's submittal related to their QAPM commitment reduction cause uncertainty regarding the regulatory requirements and applicability of 1 O CFR Part 50, Appendix B, related to design, licensing basis, and enforcement for safety-related Class 2 and 3 LSS components when implementing Code Case N-752 at ANO. In their report, the Panel agreed and disagreed with this concern. The Panel agreed that Code Case N-752 should not be approved without a clear record and common understanding that Appendix B requirements apply; however, the Panel observed that no exemption to 10 CFR 50, Appendix B was requested or granted, so the licensee must still comply with its requirements.

I agree with the Panel's conclusion that inconsistent language and terminology in the licensee's submittals and the NRC's SEs have contributed to a misunderstanding regarding the applicability of 10 CFR 50, Appendix B. With respect to the use of the IWA-1400(n) exemption of Code Case N-752, I agree that the reviewers were of the understanding that the use of existing QA program processes and procedures containing description of alternate controls in accordance with Code Case N-752 would be acceptable to satisfy the requirements of 10 CFR 50, Appendix B. I believe this reduction in commitment is appropriate for the LSS items covered in Code Case N-752 based on the very low risk-and safety-significance confirmed by the NRC staff during its review while maintaining a level of defense in depth to address additional uncertainties of implementing Code Case N-752, when compared to 10 CFR 50.69.

I also agree with the Panel's conclusion that it is clear that it was the NRC staffs expectation that 10 CFR 50, Appendix B remained applicable based on the language in its approval and the subsequent clarification on the record. No exemption from 10 CFR 50, Appendix B was requested or granted, and the subsequent clarity should have made what the NRC intended to approve clearer. In practice, Entergy has updated QA processes and procedures to reflect that the Class 2 and 3 LSS items classified under Code Case N-752 do not have to satis 10 CFR 50, A endix B.

ree dures and processes controlled by the licensee is acceptable to satisfy the requirements of 10 CFR 50, Appendix B, consistent with the NRC staffs intent.

Concern 4: Alternate controls and enforcement of the LSS Class 2 and 3 items are outside of Entergy's QA Program As expressed by the Panel, this concern pertains to the potential lack of NRC's ability to review QA program changes and take enforcement action due to the use of QA procedures and processes that are outside the QAPM for Class 2 and 3 LSS repair/replacement components.

The concern is effectively the same as those above, except it applies to the other Entergy facilities as well. The same discussion points above regarding the ambiguity in Entergy's ANO submittals and the NRC SE apply to this concern. In its report, the Panel agreed that NRC's ability to review QA program changes and take enforcement action may be limited due to the use of QA procedures and processes that are outside the QAPM for Class 2 and 3 LSS repair/replacement components. I agree with the Panel's conclusion that this concern is effectively the same as the other concerns and relates to the ambiguity in Entergy's ANO submittals and the NRC SE. The Panel's report confirmed that corrective actions have been initiated at ANO based on the NRC's RCI issued as part of the Entergy fleet request. The Panel's report also confirmed that NRC inspectors have inquired about the changes Entergy implemented in the Updated Final Safety Analysis Report (UFSAR) and QA procedures at ANO.

These corrective actions have been appropriately initiated and should result in revisions to the UFSAR and QA procedures that reflect what the NRC approved. I also agree that the Panel's conclusion confirm that NRC inspectors can inspect this aspect of the licensees' QA program.

As discussed above, I believe the NRC position is clear (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 1 O CFR 50, Appendix B), but as discussed in the Panel's report, we have evidence that what we approved has been misinterpreted by the licensees due to inconsistent Ian ua e and terminolo in the ori inal Enter ANO licensin actions.

Response to Recommendations Panel Recommendation 1: Panel members agreed that staff should achieve clar;ty on two fundamental principles associated with the staff's SE determination supporting use of the Code Case:

a.

the level of detail required to be included in the QAPD describing alternate treatments used to satisfy Appendix B (e.g., to what extent does procedural guidance need to be discussed in the QAPD) b.

whether a statement within the QA Program Description that SSCs were removed from treatment under QAPMIQAPD, equates to removal of the items from treatment under the Appendix B QA Program and whether this removal could, under any circumstances, satisfy Criterion II of Appendix B.

Panel members found multiple options on how best to achieve this clarity.

The staff could develop a wrmen position regarding the fundamental principles identified in 1a and 1b, with input from relevant NRG offices, to inform next steps. This written position could be provided to the Backfit Community of Practice (CoP) to help ascertain both the enforceabiHty of existing approvals for use of the Code Case N-752 and any actions needed to support clarity for future NRG use.

The staff could provide the NRG Backfit CoP with the available records related to this case (e.g., this panel report, QAPM commitment reduction information, Code Case N-752 alternative authorization, and inspection results}, to assist in determining if future enforcement of the 1 O CFR 50, Appendix B and 1 O CFR 21 requirements would represent a position that diverges from the recent acceptance of the ANO QAPD commitment reduction and authorization to adopt Code Case N-752, including its exemption of IWA-1400(n).

I disagree with Recommendation 1. As outlined in my evaluation of the concerns, I believe the NRC position is clear (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B). However, as discussed in the Panel's report, we have evidence that the first licensees approved to implement this new program have misinterpreted what we

a roved. I believe it is appropriate for the licensee to address the inconsistency-either as a result of the CRs initiated as a result of the RCI andinspection inqumes n ergy, ANO) or once we bring it to their attention (Duke, Oconee). Further, as discussed in my evaluation, the NRC staff asked for subsequent clarification on the record as the staff discovered additional details, and the subsequent clarity should have made what the NRC intended to approve clearer. The NRC staff also included additional details related to the applicability of 1 O CFR 50, Appendix B in similar requests from other licensees requesting to implementing Code Case N-752 at their facilities. Most recently, in the NRC's SE approving the Entergy fleet Code Case N-752 Alternative request (ML24060A219), the NRC states [emphasis added]:

3.5.3 Quality Assurance The proposed alternative would allow LSS items to be exempt from ASME Code,Section XI, IWA-1400(n), which requires the licensee to document repair and replacement activities via a Quality Assurance Program (QAP) in accordance with Appendix B to 10 CFR Part 50 or ASME NQA-1. In Entergy's submittal dated June 30, 2022, the licensee mentions footnote (1) in Code Case N-752, which states, "If compliance with 10 CFR 50 Appendix B or NQA-1 is required at the Owner's facility, IWA-1400(0) is not exempt."4 For clarity, while the term "exempt" is used in the cited footnote, the proposed alternative does not exempt the LSS components from the requirements of Appendix B to 1 0 CFR Part 50, as any exemption from an NRC regulatory requirement in 10 CFR Part 50 would need to be requested and considered under 10 CFR 50.12, "Specific exemptions," or other more specific provisions, as appropriate.

4 The NRC staff notes that the reference of IWA-1400(0) vs. IWA-1400(n) is due to different editions and addenda of the ASME Code, but that the content is the same.

The NRC should engage the licensees to highlight what appears to be a misinterpretation of what we approved (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B). For this reason, I am tasking DORL to coordinate with the Regions to ensure licensees are made aware of the observed implementing procedures, which indicate potential misunderstanding of what the NRC approved and that the have not been ranted an exem tion from 1 O CFR 50, A endix B.

Panel Recommendation 2: Leverage baseline inspection activities, as appropriate, to validate that licensees that are approved for use of N-752 continue to satisfy the requirements of 10 CFR 50, Appendix B and 10 CFR Part 21.

I agree with Recommendation 2. The NRC should continue to leverage existing baseline inspection activities to monitor corrective actions taken to correct QA processes and procedures that were revised inappropriately based on the misunderstanding. Any sampling of corrective actions taken under the baseline inspection program should remain risk informed with regards to other inspection priorities.

Panel Recommendation 3: Consider use of a generic communication. For example, a RIS could be used to clarify the staffs position. In addition, if concerns based on initial inspections indicate a trend in misinterpretation of what was accepted, an Information Notice can be drafted explaining the negative trend in enforcement matters.

I agree with Recommendation 3. The NRC should follow-up with an Information Notice documenting the examples of inconsistencies in the licensees implementation compared to what was approved by the NRC. The Information Notice would provide the necessary clarity to all licensees who have either already been approved to implement Code Case N-752 or are considering requesting NRC approval to implement Code Case N-752 at their facilities, but with fewer resources than what would be necessary for a RIS. Information Notices are an efficient means of communicating experiences gained implementing a new program such a Code Case N-725. For this reason, I am tasking DRO to develop an Information Notice to provide the necessary clarity. The Information Notice would identify that based on NRC observations during inspections and in response to the NRC RCI, the NRC staff noted that some revisions to SARs and QA procedures at facilities that received NRC approval for a code alternative to implement Code Case N-752, are not consistent with the changes the staff approved to the precedent-setting ANO QAPM. These SAR and QA revisions could be interpreted to imply that the requirements of 10 CFR 50, Appendix B no longer apply to safety-related Class 2 and Class 3 LSS SSCs. The Information Notice would cite the evidence identified in the Panels report about the misinterpretations being implemented at ANO and Duke with respect to the language in the SARs and QA procedures stating LSS SSCs classified under Code Case N-752 are exempt from 10 CFR 50, Appendix B or are not required to comply with the quality assurance requirements of 10 CFR 50, Appendix B. As such, I would expect the Information Notice to (1) identify the inconsistencies in the licensing basis documentation that have been observed, (2) clarify that the NRC did not and cannot grant an exemption from NRC regulations (including 10 CFR 50, Appendix B) without a specific request for an exemption, regardless of the language used in the Code Case or NRC SEs, and (3) state that the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B. This Information notice is intended to communicate to industry the examples identified for industry awareness and consideration during implementation of Code Case N-752. The Information Notice should not include a technical evaluation of how Code Case N-752 should be implemented at a licensees facility or to detail specifics about how certain regulations should be met. The reduction in commitment approved by the NRC appropriately provides the licensees with alternative procedures to satisfy 10 CFR 50, Appendix B requirements, and the relief provided is appropriate given the low risk-and safety-significance of the items covered under Code Case N-752. The Information Notice would not be issued until the actions in response to Recommendation 1 are complete.

Panel Recommendation 4: The Panel recommends that the NRCs guidance for review of requested QAPD changes contained in NUREG-0800, section 17.3, Quality Assurance Program Description, be reviewed and potentially revised to preclude future confusion of what is being accepted related to the review of QA reductions in commitment. This approach can ensure the staffs position in Recommendation 1, is widely understood.

While the guidance in this section of the SRP outlines and specifies the NRC's acceptance criteria for QAPDs, it also states that Except when acceptable alternatives are provided, the acceptance criteria that follow provide attributes to be addressed for a QAPD to be found acceptable. It does not provide acceptance criteria for instances when a licensee has requested to remove items from treatment under the station QAPD.

It further is not explicit that where an alternative QA treatment program is being requested for items that will be removed from the QAPD, the 10 CFR 50, Appendix B requirements still apply to the alternative program and will each need to be verified as acceptable, absent I agree with Recommendation 4 in that the NRC should ensure that the staffs position in Recommendation 1 is widely understood. I agree that appropriate NRC guidance should be reviewed and potentially revised to preclude future confusion of what is being accepted related to the review of QA reductions in commitment. For this reason, I am tasking DORL and DRO to initiate a revision to appropriate guidance to specifically address QA reductions in commitment.

This would be done after communicating with the licensees and developing the Information Notice as discussed in the response to Recommendations 1 and 3. The Information Notice could then be referenced in the revisions.

Panel Recommendation 5: Consider issuing a second RCI to clarify Entergys understanding of the regulatory commitment contained in the November 17, 2020, revision to the Proposed Alternative to Use ASME Code Case N-752 (ML20322A141) (i.e., if it represented Entergys intent to not treat the Class 2 and 3 LSS safety-related items in accordance with Appendix B requirements).

I disagree with Recommendation 5. Issuing a second RCI to Entergy in not necessary. Instead, consistent with my response to Recommendation 1, the NRC should engage the licensees to highlight what appears to be a misunderstanding in what we approved (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B) and allow the corrective action program to guide appropriate action commensurate with the low risk-and safety-significance of this issue.

Panel Recommendation 6: NRR should consider briefing reviewers who would receive and perform an acceptance review of requests to use Code Case N-752 to identify the recognized concerns with the use of the Code Case, and consider pausing acceptance and review of such requests until clarity is received on the viability of the Code Case.

I disagree with Recommendation 6. Based on the results of the Panels report, I believe the NRC position is clear (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B). However, as discussed in the Panels report, we have evidence that what we approved has been misinterpreted by the licensees. NRC can provide direction to reviewers who would receive and perform an acceptance review of requests to use Code Case N-752 to be very explicit about that in subsequent reviews. As discussed above, NRCs SE approving the Entergy fleet Code Case N-752 Alternative request (ML24060A219) already explicitly provided our position. NRC does not need to pause acceptance and review of such requests.

Panel Recommendation 7: Any action taken in response to the other concerns should also be communicated to or otherwise carried out on the other affected plants.

I agree with Recommendation 7. The NRC should follow-up with an Information Notice to provide the necessary clarity to all licensees who are either already approved to implement Code Case N-752 or are considering requesting NRC approval to implement Code Case N-752 at their facilities.

Concluding Remarks The DPO submitters positions were of notable technical merit and well documented in the submittal. I commend all of you for your commitment and dedication to the NRC's mission. I want to thank the DPO submitters for raising this DPO and for their active participation throughout the process. Their willingness to raise concerns is admirable and vital to ensuring a healthy safety culture within our agency. The discussions early in the process were incredibly valuable in ensuring that the issues and the safety implications were appropriately understood. I also want to thank the Panel for their thoughtful assessment of the concerns raised by the DPO submitters.

While I believe the NRC position is clear (i.e., we did not grant an exemption from 10 CFR 50, Appendix B, and the reduction in commitment that we approved is acceptable to satisfy the requirements of 10 CFR 50, Appendix B), I agree with the DPO submitters that the inconsistent language and terminology in licensee's submittals and the NRC's SEs have contributed to a misunderstanding regarding the applicability of 1 O CFR 50, Appendix B to the Class 2 and 3 LSS items classified under Code Case N-752 as licensees have begun implementing this new program. Providing further clarity to all licensees who are either already approved to implement Code Case N-752 or are considering requesting NRC approval to implement Code Case N-752 at their facilities on what the NRC staff approved is both appropriate and warranted. The only question is how best to provide the clarity and how robust a solution is appropriate given the low risk-and safety-significance of the issue in question. As discussed earlier in my assessment, my decision is informed by Commission direction to apply risk-informed principles for any licensing or regulatory decision, ADVANCE Act direction to ensure impacts on agency decisions are commensurate with the safety significance of the differing opinion, and the NRC Principles of Good Regulation. My decision to ursue resolution throu h a combination of re ulato en a ement with licensees an roug e eas resource m ensIve orm o generic commurnca,on, an n orma,on otice, provide for an efficient means to address this issue in a manner that provides for reasonable assurance of adequate protection. It strikes an appropriate balance of regulatory clarity, reliability, and efficiency by providing the clarity needed for reliable implementation of the new Code Case N-752 using agency and stakeholder resources commensurate with the degree of risk reduction the additional clarity would achieve. The NRC will continue to monitor industry implementation of this new program through our routine baseline inspection program.

A summary of the DPO will be included in the Weekly Information Report (when the case is closed) to advise employees of the outcome.