Text

LLC Reply to a Notice of Violation Noted in IR 05200050/2024-201
	ML24131A153
Person / Time
Site:	05200050
Issue date:	05/10/2024
From:	Fosaaen C; NuScale
To:	; Office of Nuclear Reactor Regulation, Document Control Desk
References
	LO-168287 IR 2024201
	Download: ML24131A153 (1)
	v • d • e

LO-168287

May 10, 2024 Docket No. 052-050

U.S. Nuclear Regulatory Commission ATTN: Document Control Desk One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738

SUBJECT:

NuScale Power, LLC Reply to a Notice of Violation

REFERENCE:

1. NRC Letter to NuScale NUCLEAR REGULATORY COMMISSION INSPECTION REPORT OF NUSCALE POWER LLC., NO.

05200050/2024-201, AND NOTICE OF VIOLATION dated April 12, 2024 (ML24099A129)

In a letter dated April 12, 2024, the U.S. Nuclear Regulatory Commission (NRC) issued Inspection Report 05200050/2024-201 and Notice of Violation (NOV) 05200050/2024-201-01 (Reference 1), which was identified during a U.S. Nuclear Regulatory Commission (NRC) hybrid inspection conducted at the NuScale Power facility in Corvallis, Oregon and the NRC headquarters facility in Rockville, Maryland on February 26, 2024 through March 1, 2024.

Reference 1 requires that NuScale Power, LLC (NuScale) submit a written response to the NOV following the instructions specified, and that NuScale should document the results of the extent of condition review for the finding and determine if there are any effects on design activities associated with the Standard Design Approval Application.

NuScale contests NOV 05200050/2024-201-01. NuScales basis for disputing the NOV and its severity level are provided in Attachment 1. Although NuScale contests the NOV, Attachments 2 and 3 provide additional information in response to each of the NRCs two findings.

This letter makes no regulatory commitments and no revisions to any existing regulatory commitments.

If you have any questions, please contact Mark W Shaver at 541-360-0630 or at mshaver@nuscalepower.com.

SiSincerely, ncerely,

CCarrie Fosaaen arrie Fosaaen Vice President, Regulatory Affairs NuScale Power, LLC

NuScale Power, LLC 1100 NE Circle Blvd., Suite 200 Corvallis, Oregon 97330 Office 541.360.0500 Fax 541.207.3928 www.nuscalepower.com LO-168287 Page 2 of 2 05/10/24

Attachment 1: Basis for Disputing the Apparent Violation and Severity Level Attachment 2: Additional Information Regarding Finding One, Failure to Appropriately Classify Engineering Calculation (EC) EC-101197 Attachment 3: Additional Information Regarding Finding Two, Failure to Adhere to 10 CFR 50.46 Screening Process

Distribution: Director, Office of Enforcement, NRC Kerri Kavanagh, NRC Mahmoud Jardaneh, NRC Getachew Tesfaye, NRC Prosanta Chowdhury, NRC

NuScale Power, LLC 1100 NE Circle Blvd., Suite 200 Corvallis, Or egon 97330 Office 541.360.0500 Fax 541.207.3928 www.nuscalepower.com LO-168287 Attachment 1 Page 1 of 8

Attachment 1: Basis for Disputing the Apparent Violation and Severity Level

1.0 Introduction

1.1 Summary Based on the results of a U.S. NRC inspection conducted at NuScale Power, LLC from February 26 through March 1, 2024, documented in Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No. 05200050/2024-201, and Notice of Violation, (Reference 4.1), one alleged violation of NRC requirements was identified associated with Criterion V, Instructions, Procedures, and Drawings of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) part 50, Domestic Licensing of Production and Utilization Facilities, and Section 2.5, Instructions, Procedures, and Drawings, of the NuScale Power, LLC Quality Assurance Program Description, MN-122626-A (Reference 4.2). The alleged violation is based on two instances of failing to adhere to prescribed procedures.

NuScale hereby contests the violation. NuScale disputes factual and legal issues underpinning the apparent violation and further disputes the severity level assigned to the violation. As provided herein, the first alleged instance relies on facts not yet established and should be recharacterized. The second alleged instance does not violate 10 CFR 50 Appendix B Criterion V because it is not related to an activity affecting quality. With respect to severity, the first instance constitutes a minor violation pursuant to NRC guidance. The second instance, even if upheld, would also constitute a minor violation. Finally, even if not minor, the apparent violation should have been dispositioned as a noncited violation.

1.2 Statement of Apparent Violation

Violation 05200050/2024-201-01 alleges the following apparent violation, excerpted in pertinent part and with emphasis added:

Criterion V, Instruction, Procedures, and Drawings, of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, states that Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings.

NuScale Nonproprietary

Contrary to the above, as of March 1, 2024, NuScale failed to perform activities affecting quality in accordance with prescribed instructions, procedures, or drawings. Specifically, NuScale did not adequately adhere to prescribed procedures, EP-0303-2109 and LP-102185, in the following instances:

[Hereafter, Instance One:] NuScale failed to appropriately classify engineering calculation (EC) 101197, DHRS Thermal Hydraulic Calculation for the NPM-20, in accordance with EP-0303-2109. EP-0303-2109 defines safety-related SSCs as those structures, systems and components that are relied upon to remain functional during and following design-basis events to assurethe capability to shut down the reactor and maintain it in a safe shutdown condition. EC-101197 was classified as Non-Safety Related and treated as nonsafety-related calculation during NuScales design verification process when its stated scope is, in part, to assess the decay heat removal systems ability to perform its safety-related function to achieve and maintain safe shutdown.

[Hereafter, Instance Two:] NuScale failed to adhere to the process defined in LP-102185 to perform a screening under 10 CFR 50.46, Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors, of an error in accordance with LP-102185. NuScale did not assess whether combustible gas control accumulation in the reactor coolant system may be an error in the NuScale Design Certification ECCS evaluation model, which must be evaluated against reporting thresholds, as required by 10 CFR 50.46(a)(3).

2.0 Basis for Disputing the Violation

2.1 Instance One presumes facts not established because the appropriate classification of EC-101197 is not yet known.

The NRC first alleges NuScale failed to perform activities affecting quality in accordance with prescribed instructions, procedures, or drawings in the instance that NuScale failed to appropriately classify engineering calculation (EC) 101197, DHRS Thermal Hydraulic Calculation for the NPM-20, in accordance with EP-0303-2109. This first instance is predicated on EC-101197 (Reference 4.3) being incorrectly classified as nonsafety-related, but that presupposition may not be true.

NuScale does not dispute that the DHRS system is safety-related, and it is consistently and correctly classified as such within NuScale records. However, it does not necessarily follow that a calculation pertaining to DHRS is also safety-related. The DHRS also has nonsafety-related functions.

NuScale does not dispute that procedural errors pertaining to the classification of EC-101197 occurred. However, as discussed in Attachment 2, those errors occurred with respect to a different procedure than that cited by the NOV. Classification of NuScale Nonproprietary

Structures, Systems, and Components (SSC), EP-0303-2109 (Reference 4.4) does not directly address a design deliverables safety classification. EP-0303-2109 is the process to define SSC classification, and those classifications are used in the design control process (via Preparation and Approval of Engineering Calculations, EP-0303-303, (Reference 4.5)) to determine safety classifications of engineering deliverables. As noted above, SSC classification is not determinative of deliverable classification.

The errors made with respect to EP-0303-303 yielded an insufficient justification for the safety classification of EC-101197 and that justification was provided in the wrong portion of the calculation. However, it is not yet known whether the classification of EC-101197 was incorrect, as alleged. NuScale has initiated a corrective action to determine the correct classification (see Attachment 2, Section 2.3).

For the immediate purpose of considering this response, the first alleged instance of noncompliance should be understood as a failure to adhere to EP-0303-303, with unknown effect on the classification of EC-101197.

2.2 The process error alleged in Instance Two is not an activity affecting quality.

The NRC next alleges NuScale failed to perform activities affecting quality in accordance with prescribed instructions, procedures, or drawings in the instance that NuScale failed to adhere to the process defined in LP-102185 to perform a screening under 10 CFR 50.46. Inspection Report No. 05200050/2024-201 further notes that In both [of the findings], NuScale failed to follow established instructions, procedures, or drawings, for activities affecting quality. However, this alleged instance incorrectly assumes that screening under 10 CFR 50.46 is an activity affecting quality.

As regulatory basis for the apparent violation, 10 CFR 50 Appendix B Criterion V requires that activities affecting quality shall be prescribed by documented instructions, procedures, or drawings and shall be accomplished in accordance with these instructions, procedures, or drawings. Thus, any violation of Criterion V must entail (1) an activity affecting quality, and (2) either (a) performing that activity without documented instructions, procedures, or drawings, or (b) accomplishing that activity not in accordance with the documented instructions, procedures, or drawings.

NuScale does not dispute Condition Report 152940 failed to assess, for potential reportability under 10 CFR 50.46(a)(3)(iii), the issue of combustible gas control in the reactor coolant system for the US600 design. However, assessing 10 CFR 50.46 reportability is not an activity affecting quality.

Assessing 50.46 reportability is performed under Licensing Procedure (LP) 102185. In general, licensing activities do not affect nuclear quality because they are downstream (an output) of NuScales quality-related design activities, not an input to the design.

Specifically, LP-102185 states this procedure does not implement any section of NuScales Quality Assurance Program Description (QAPD). The procedure describes the process for evaluating and reporting to the NRC changes or errors in the emergency NuScale Nonproprietary

core cooling system evaluation model (ECCS EM). LP-102185 does not identify errors or yield changes to the design or the ECCS EM; its use only determines whether changes or errors identified elsewhere need to be reported to the NRC under 10 CFR 50.46.

Consistent with the declaration that LP-102185 does not implement any section of NuScales QAPD, 10 CFR 50.43(a)(3) and its history make no connection to quality. As stated in NRCs recent grant to NuScale of an exemption from 50.46 reporting for the US600 design (Reference 4.6), the purpose of 50.46 reporting is to provide timely reporting to the NRC regarding the nature and estimated effect of any change or error in the limiting ECCS analysis. In other words, 50.46 reporting supports NRCs regulatory oversight function. NuScale does not rely on 50.46 reporting to ensure the quality of the ECCS EM.

NuScale acknowledges that 50.46 reporting is part of the overall Corrective Action Program (CAP), and the CAP as a whole affects quality. However, that does not make every aspect of the CAP, including 50.46 reportability assessment, an activity affecting quality. Furthermore, NRC reviewed NuScales policies and implementing procedures that govern the implementation of its corrective action program to verify compliance with the regulatory requirements of Criterion XVI, Corrective Action, of Appendix B.No findings of significance were identified.

While Instance Two documents an activity performed not in accordance with procedure, that activity was not affecting quality. Therefore, Instance Two supporting the apparent violation should be withdrawn.

3.0 Basis for Disputing the Severity Level of the Violation

3.1 Instance One constitutes a minor violation under the Enforcement Policy.

The NOV provides minimal rationale for dispositioning the apparent violation as Severity Level IV, simply citing section 6.9.d of the Enforcement Policy (EP) as the basis. Section 6.9 of the EP addresses inaccurate and incomplete information or failure to make a required report. Every reactor licensee-related example in 6.9.d involves an actual failure to make a required report, a licensee submitting inaccurate or incomplete information, or a failure to implement adequate Part 21 processes.

While exemplary in nature, Instance One is none of these examples:

x The alleged error in EC-101197 was not a failure to make a required report. NRC stated The failure to correctly classify the functions of the DHRS contributed to failing to perform required screening per Section 5.1 of LP-102185. While NuScale does not concur in that assessment, even if assumed as true a screening failure is not a reporting failureSection 3.2 explains that no reporting failure occurred.

x Even if it was inaccurate (which, per Section 2.1, has not been established),

EC-101197 was not submitted to the NRC.

x The error alleged in Instance One is unrelated to NuScales Part 21 Process.

NuScale Nonproprietary

On the other hand, Instance One fits well within the guidance for and examples of minor violations. A minor violation is one of minor safety or security concern. Enforcement Manual (EM) section 2.1 states Issues that represent isolated failures to implement a requirement and have insignificant safety or regulatory impact should normally be categorized as minor violations. Isolated means based on a reasonable effort, the staff determines that the issue is not recurring nor is it indicative of a programmatic issue such as inadequate supervision, resources, etc. Potential minor violations, per EM Appendix E, include record keeping issues that do not preclude the licensee from being able to take appropriate action on safety-related matters. Although applicable to vendor inspection, Inspection Manual Chapter 0617 Appendix E includes the helpful example of a design-control-related violation being Minor because: Not establishing the measures necessary for the identification and control of design interfaces did not negatively affect the ability of the SSC to perform its intended safety function.

Instance One is of minor safety concern. As discussed in Section 2.1, for the purpose of this response NuScale acknowledges only that a procedure error yielded an inadequate and mislocated justification for the calculations safety classification. But even if EC-101197 was misclassified, the DHRS itself is properly classified as safety-related, and no problem with its design basis has been identified. There is no indication of a recurring or programmatic issue with document misclassification. As with the examples cited, Instance One did not have an actual safety-related impact; the DHRS is designed to perform its intended safety functions.

Instance One is unlike the examples in EM section 6.9.d, and similar to examples of other minor violations. Whether EC-101197 is ultimately determined to be misclassified or not, the procedural error at issue was of minor safety concern and isolated. Therefore, Instance One should be considered a minor violation.

3.2 Even if Instance Two is a violation, it constitutes a minor violation under the Enforcement Policy.

Pursuant to Section 2.2 above, NuScale disputes Instance Two violated 10 CFR 50 Appendix B Criterion V as alleged. However, even if it stands as a violation, it, too, should be a minor violation. Again, the NOV simply cites section 6.9.d of the EP as the basis for a Severity Level IV disposition. Section 6.9 of the EP addresses inaccurate and incomplete information or failure to make a required report. Section 6.9.d lists several examples of actual failures to make a required report, which presumably is NRCs basis for treating Instance Two as part of a Severity Level IV violation.

Unlike the examples in EP section 6.9.d, Instance Two does not allege a reporting failure. NRC only identified a failure to evaluate 50.46 reportability, not a failure to report.

Thus, Instance Two as alleged does not support a Severity Level IV disposition. NuScale has subsequently determined that the condition at issue was not reportable under 10 CFR 50.46. Therefore, an actual reporting failure in fact did not occur.

NuScale Nonproprietary

On the other hand, even if Instance Two constitutes a violation, it fits well within the guidance for and examples of minor violations. A minor violation is one of minor safety or security concern. Enforcement Manual (EM) section 2.1 states Issues that represent isolated failures to implement a requirement and have insignificant safety or regulatory impact should normally be categorized as minor violations. A potential minor violation, per EM Appendix E, includes an isolated procedural error and there were no safety consequences.

Instance Two is of minor safety concern and had no safety consequences. The 50.46 assessment error concerns NuScales US600 design certification. Prior to the error, NuScale requested an exemption from 50.46 reporting for the US600 design on the basis that no facility applicants reference the ECCS EM or the US600 design and none are expected, such that NRC and licensee cognizance of a potential ECCS EM change or error is not needed unless and until the design is referenced. That exemption was subsequently granted (Reference 4.6). Because no facility references the US600 design, there were no safety consequences associated with the 50.46 screening error.

Moreover, NuScale has subsequently determined that the condition at issue was in fact not reportable under 10 CFR 50.46. Thus, there was no safety consequence in failing to assess the issue for reportability.

Instance Two does not allege an actual failure to report and is thus unlike the examples in EM 6.9.d. Rather, Instance Two is an isolated procedural error of no safety consequence both because 50.46 reporting for the US600 design would have no foreseeable effect on safety and because 50.46 reporting was not required in this instance. Therefore, while NuScale disputes Instance Two is a violation, it should be considered a minor violation if upheld.

3.3 If not a minor violation, the NOV should be a noncited violation.

Pursuant to Section 2.3.2 of the EP, If a licensee or nonlicensee has implemented a corrective action program that is determined to be adequate by the NRC, the NRC will normally disposition SL IV violations as noncitied violations (NCVs) if all the criteria in Paragraph 2.3.2.a are met. Paragraph 2.3.2.a provides:

1. The licensee or nonlicensee must place the violation into a corrective action program to restore compliance and address recurrence.

2. The licensee or nonlicensee must restore compliance (or demonstrate objective evidence of plans to restore compliance) within a reasonable period of time (i.e. in a timeframe commensurate with the significance of the violation) after a violation is identified.

3. For traditional enforcement, the violation must either not be repetitive as a result of inadequate corrective action, or, if repetitive, the repetitive violation must not have been identified by the NRC.

NuScale Nonproprietary

4. The violation must not be willful.

With respect to the NCV criteria of Section 2.3.2.a:

x NuScale has implemented a CAP determined to be adequate by the NRC.

x The alleged violation was placed into the corrective action program, as identified in the inspection report under CR-157948 submitted by Carolyn Monaco, Vice President, Quality Assurance on March 1, 2024.

x Attachment 2 addresses restoration of compliance regarding Instance 1. NuScale disputes that Instance 2 constitutes noncompliance with Appendix B Criterion V, however Attachment 3 addresses corrective actions associated with the identified procedural violation.

x The alleged violation was not repetitive as defined by the NRC enforcement policy. This is NuScales first violation concerning Appendix B Criterion V.

x The alleged violation was not willful.

In sum, the apparent violation clearly meets the criteria for an NCV. While the apparent violation fits well with NRC policy and guidance for a minor violation, at most it should be dispositioned as an NCV.

3.4 Conclusion On the basis presented above, NuScale disputes factual and legal issues underpinning NOV 05200050/2024-201-01 and further disputes the severity level assigned to the violation.

NuScale Nonproprietary

4.0 References

4.1 Letter from Kerri Kavanagh (NRC) to Carrie Fosaaen (NuScale), Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No.

05200050/2024-201, and Notice of Violation, April 12, 2024 (ML24099A129)

4.2 NuScale Power, LLC, NuScale Power, LLC Quality Assurance Program Description, MN-122626-A, Revision 1.

4.3 NuScale Power, LLC DHRS Thermal Hydraulic Calculation for the NPM-20 EC-101197, Revision 2

4.4 NuScale Power, LLC Classification of Structures, Systems, and Components, EP-0303-2109, Revision 11.

4.5 NuScale Power, LLC Preparation and Approval of Engineering Calculations, EP-0303-303, Revision 19.

4.6 NRC Letter to NuScale, US600 Design Certification and Standard Design Approval Exemption From Reporting Requirements of Title 10 Code of Federal Regulations 50.46 (a)(3)(iii) March 28, 2024 (ML23234A122).

NuScale Nonproprietary

Attachment 2: Additional Information Regarding Finding One, Failure to Appropriately Classify Engineering Calculation (EC) EC-101197

1.0 Introduction and Background

1.1 Background

Based on the results of a U.S. NRC inspection conducted at NuScale Power, LLC from February 26 through March 1, 2024, documented in Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No. 05200050/2024-201, and Notice of Violation, (Reference 4.1), one alleged violation of NRC requirements was identified.

The issue was associated with Criterion V, Instructions, Procedures, and Drawings of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) part 50, Domestic Licensing of Production and Utilization Facilities, and Section 2.5, Instructions, Procedures, and Drawings, of the NuScale Power, LLC Quality Assurance Program Description, MN-122626-A (Reference 4.2).

Condition Report (CR) 157948, Failure to fully satisfy Appendix B Criterion V requirements, was entered into the NuScale Corrective Action Program (CAP) on March 1, 2024. The issue description, based on information available from the inspection exit meeting, is:

NRC inspection performed the week of February 26, 2024 identified a potential violation associated with NuScale compliance with Criterion V. Two examples of failure to perform activities affecting quality in accordance with implementing procedures were identified.

- Classification of safety-related functions of the decay heat removal system (DHRS)

- Performance of 50.46 screening associated with CR 1529040 [sic] for applicability to DCA. [Note that the correct CR number is 152940.]

The Notice of Violation was posted in NuScale offices and also made available electronically to all employees.

1.2 NRC Finding Section 5.2.2 of Engineering Procedure (EP) EP-0303-2109, Classification of Structures, Systems, and Components, Revision 11 states that the subject matter expert will review the systems functions, design basis events, and functional categorization that have been identified for the SSCs systems and documented in the system function report.

NuScale Nonproprietary

LO-168287 Attachment 2 Page 2 of 4

Contrary to this, the inspection team noted that NuScale failed to appropriately classify engineering calculation (EC) EC-101197, DHRS Thermal Hydraulic Calculation for the NPM-20, in accordance with EP-0303-2109, which defines safety-related SSCs as those structures, systems and components that are relied up on to remain functional during and following design-basis events to assurethe capability to shut down the reactor and maintain it in a safe shutdown condition. EC-101197 was classified as Non-Safety Related and treated as a non-safety related calculation during NuScales design verification process when its stated scope is, in part, to assess the decay heat removal systems ability to perform its safety-related function to achieve and maintain safe shutdown.

2.0 Actions Performed in Response to CR 164140

2.1 Summary

Following the initiation of CR 157948, which was classified as an adverse condition in the NuScale CAP, NuScale separated the two findings and CR 164140 was created to evaluate the condition identified as Classification of safety-related Functions of the DHRS. CR 164140 was also classified as an adverse condition.

The detailed causal evaluation for CR 164140 concluded a minor procedural noncompliance involving EC-101197 (Reference 4.3) occurred, however, the noncompliance is associated with implementation of Design Control Process, QP-0303-10267 (Reference 4.4) rather than with Classification of Structures, Systems, and Components, EP-0303-2109 (Reference 4.5) as identified in the inspection report and NOV. In summary, while the intent of Section 5.1.5 of QP-0303-10267 was met, EC-101197 did not have the statement explaining the safety classification of the calculation in the right section of the document. Section 5.1.6 of QP-0303-10267 requires identification of the safety classification of the design deliverable, based on the functionality categorized through EP-0303-2109, and this step was not satisfied. There is no clear link established between the relevant system function and the statement in EC-101197 that identifies the calculation as nonsafety-related.

The correct classification of EC-101197 has not yet been determined. A corrective action has been assigned to do so.

2.2 Reason for Alleged Violation

The apparent cause was determined to be human error associated with a poor assumption that the process would not or had not changed. Procedural guidance was modified after the release of EC-101197, Revision A and prior to the release of EC-101197, Revision 2. It was assumed EC-101197, Revision 2 still met procedural requirements, but a review of the applicable procedures would have identified that a statement from the purpose section should have been moved to the scope section, and that a more direct and clear tie to the system function(s) being analyzed was necessary.

NuScale Nonproprietary

LO-168287 Attachment 2 Page 3 of 4

2.3 Corrective Actions

Three actions were assigned to resolve the condition.

NuScale ID # Action Description CR 164140-CA-3 Move the safety classification statement in EC-101197 from the purpose to the scope section, to align with guidance in EP-0303-303 and EP-0303-303-F01.

Ensure the safety classification relates to a categorized system function from the DHRS system function report.

CR 164140-CA-4 Determine the safety classification of EC-101197: Review the purpose and scope of EC-101197 to identify the functionality the calculation is analyzing, and determine if this functionality is identified in the DHRS system function report.

Create follow-on actions as necessary to revise the system function report and/or EC-101197, and other impacted documents (if any).

CR 164140-CA-5 Communicate and reinforce procedure use and adherence requirements, and specific process requirements related to safety classification of engineering documents to the engineering organization.

2.4 Actions to Avoid Further Violations

Based on the causal evaluation, no procedural changes are required. Actions to address the identified issue are provided above. Communication detailing the importance of procedure use and adherence, and the purpose of process requirements related to safety classification will be provided to the engineering organization during an all-hands meeting.

There is no indication of a recurring or programmatic issue with document misclassification. Suspected procedure noncompliance issues are promptly entered into the NuScale CAP and addressed. Consideration is given on a case-by-case basis with respect to determining if there is any impact on design activities.

3.0 Conclusion

On the basis of the information presented, NuScale requests that the NRC review the content within Attachment 1.

4.0 References

4.1 NRC Letter to NuScale, Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No. 05200050/2024-201, and Notice of Violation, April 12, 2024 (ML24099A129).

4.2 NuScale Power, LLC, NuScale Power, LLC Quality Assurance Program Description, MN-122626-A, Revision 1.

4.3 NuScale Power, LLC, DHRS Thermal Hydraulic Calculation for the NPM-20, EC-101197, Revision 2.

4.4 NuScale Power, LLC, Design Control Process, QP-0303-10267, Revision 20.

NuScale Nonproprietary

LO-168287 Attachment 2 Page 4 of 4

4.5 NuScale Power, LLC, Classification of Structures, Systems, and Components, EP-0303-2109, Revision 11.

NuScale Nonproprietary

LO-168287

Attachment 3 Page 1 of 3

: Additional Information Regarding Finding Two, Failure to Adhere to 10 CFR 50.46 Screening Process

1.0 Introduction and Background

1.1 Background

Based on the results of a U.S. NRC inspection conducted at NuScale Power, LLC from February 26 through March 1, 2024, documented in Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No. 05200050/2024-201, and Notice of Violation, (Reference 4.1), one alleged violation of NRC requirements was identified.

The issue was associated with Criterion V, Instructions, Procedures, and Drawings of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) part 50, Domestic Licensing of Production and Utilization Facilities, and Section 2.5, Instructions, Procedures, and Drawings, of the NuScale Power, LLC Quality Assurance Program Description, MN-122626-A (Reference 4.2).

Condition Report (CR) 157948, Failure to fully satisfy Appendix B Criterion V requirements, was entered into the NuScale Corrective Action Program (CAP) on March 1, 2024. The issue description, based on information available from the inspection exit meeting, is:

NRC inspection performed the week of February 26, 2024 identified a potential violation associated with NuScale compliance with Criterion V. Two examples of failure to perform activities affecting quality in accordance with implementing procedures were identified.

- Classification of safety-related functions of the decay heat removal system (DHRS)

- Performance of 50.46 screening associated with CR 1529040 [sic] for applicability to DCA. [Note that the correct CR number is 152940.]

The Notice of Violation was posted in NuScale offices and also made available electronically to all employees.

1.2 NRC Finding

Section 5.1 of LP-102185, 10 CFR 50.46 Reporting, Revision 1, requires the screening of any change to or error in the Emergency Core Cooling System (ECCS) evaluation model or in the application of the model using 10 CFR 50.46 Screening Form, FM-102395 and report the results to the RM (Responsible Manager). Instruction for Form FM-102395 are included in Appendix A of this procedures (sic).

Contrary to this, the inspection team noted that NuScale failed to adhere to the process defined in LP-102185 to perform a screening under 10 CFR 50.46, Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors, of an error in accordance with LP-102185. NuScale did not assess whether combustible gas NuScale Nonproprietary

LO-168287

Attachment 3 Page 2 of 3

control accumulation in the reactor coolant system may be an error in the NuScale Design Certification ECCS evaluation model, which must be evaluated against reporting thresholds, as required by 10 CFR 50.46(a)(3).

2.0 Actions Performed in Response to CR 157948 2.1 Summary

Per Attachment 1, NuScale contests that this finding constitutes a violation of 10 CFR Appendix B Criterion V because LP-102185, 10 CFR 50.46 Reporting, (Reference 4.3) does not address an activity affecting quality.

In order to address the condition identified in the finding, CR 157948, classified as an adverse condition, was used to evaluate the condition and NuScale has proceeded with implementing corrective actions as identified in the causal evaluation.

2.2 Reason for Alleged Violation NuScale contests that this finding constitutes a violation of 10 CFR Appendix B Criterion V. The apparent cause of the error was determined to be that the procedure did not identify all applicable requirements to comply with 10 CFR 50.46.

2.3 Corrective Actions

Three actions were assigned to resolve the condition.

NuScale ID # Description CR 157948-CA-3 Revise LP-102815, 10 CFR 50.46 Reporting, correcting the apparent cause, to include instructions/guidance on evaluating other impacted designs/applications.

CR 157948-CA-4 Correct 10 CFR 50.46 evaluation performed for CR 152940, correcting the identified condition to identify applicability to the SDA and DCA.

CR 157948-PR-6 Perform 10 CFR 50 Part 21 Reportability Screening in accordance with LP-1503-9815, 10 CFR Part 21 Reporting

CR 157948-CA-4 Corrective Action is complete and determined with regard to the US600 design that the condition was not reportable.

2.4 Actions to Avoid Further Violations

NuScale contests that this finding constitutes a violation of 10 CFR Appendix B Criterion V. In the situation that the need for 10 CFR 50.46 reporting by NuScale is required in the future, revision of LP-102185, 10 CFR 50.46 Reporting will prevent recurrence.

NuScale Nonproprietary

LO-168287

Attachment 3 Page 3 of 3

Of note, subsequent to the occurrence identified in the finding (the erroneous 10 CFR 50.46 screening of CR 152940), NuScale received an exemption from the reporting requirements of 10 CFR 50.46 for the NuScale US600 Design Certification and Standard Design Approval (Reference 4.5).

The finding identified a deficiency related to 10 CFR 50.46 reporting for the DCA; there has been no impact to reporting with respect to the US460 Standard Design Approval Application (SDAA).

3.0 Conclusion

On the basis of the information presented, NuScale requests that the NRC review the content within Attachment 1. This instance was isolated, and as discussed in Attachment 1, there are no impacts on design activities associated with the SDAA.

4.0 References

4.1 NRC Letter to NuScale, Nuclear Regulatory Commission Inspection Report of NuScale Power LLC., No. 05200050/2024-201, and Notice of Violation, April 12, 2024 (ML24099A129).

4.2 NuScale Power, LLC, NuScale Power, LLC Quality Assurance Program Description, MN-122626-A, Revision 1.

4.3 NuScale Power, LLC, 10 CFR 50.46 Reporting, LP-102185, Revision 1.

4.4 NuScale Power, LLC, 10 CFR 50.46 Screening Form, FM-102395, Revision 2.

4.5 NRC Letter to NuScale, US600 Design Certification and Standard Design Approval Exemption From Reporting Requirements of Title 10 Code of Federal Regulations 50.46 (a)(3)(iii) March 28, 2024 (ML23234A122).

NuScale Nonproprietary

ML24131A153

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