ML20205L415

U.S. Nuclear Regulatory Commission Final Safety Evaluation for Oklo, Inc. Topical Report Oklo-2019-14-NP, Revision 1, Quality Assurance Program Description - Design and Construction,

ML20205L415
Person / Time
Site:	99902046, 05200049
Issue date:	08/11/2020
From:	Benjamin Beasley NRC/NRR/DANU/UARL
To:	Cochran C Oklo Inc
Mazza J, NRR/DANU/UARL, 415-0498
References
EPID: L-2019-TOP-0024
Download: ML20205L415 (24)

Text

August 11, 2020 Ms. Caroline Cochran Co-Founder, COO Oklo, Inc.

230 E. Caribbean Dr.

Sunnyvale, CA 94089

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION FINAL SAFETY EVALUATION FOR OKLO, INC. TOPICAL REPORT OKLO-2019-14-NP, REVISION 1, QUALITY ASSURANCE PROGRAM DESCRIPTION - DESIGN AND CONSTRUCTION (EPID NO. L-2019-TOP-0024)

Dear Ms. Cochran:

By letter dated June 30, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19178A068 (letter) and ML19178A069 [QAPD, Revision 0]), Oklo, Inc. (Oklo), submitted the topical report (TR), Quality Assurance Program Description Design and Construction, Revision 0 (Oklo QAPD). The TR was submitted for U.S. Nuclear Regulatory Commission (NRC) staff review in accordance with the guidance of NUREG-0800, Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants, Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants. On December 18, 2019, the NRC staff met with Oklo to discuss, Draft Request for Additional Information [RAI] Regarding Review of the Quality Assurance Program Description Topical Report, Oklo- 2019-14-NP, (ADAMS Accession No. ML19357A197), and formally transmitted those RAIs to Oklo via e-mail on December 19, 2019 (ADAMS Accession No. ML19357A189).

As a result, Oklo revised the QAPD and resubmitted Revision 1 of their QAPD in a letter from C.

Cochran, OKLO Inc., to the NRC Document Control Desk, Oklo Inc., Project 99902046, Responses to second round NRC RAIs on the Oklo Inc., Design and Construction Quality Assurance Plan Description, Rev. 0, dated January 24, 2020 (ADAMS Accession No. ML20027A004). By letter dated April 27, 2020 (ADAMS Accession No. ML20094G941 non-public), an NRC draft safety evaluation (SE) regarding our approval of OKLO-2019-14-NP, Revision 1 was provided for your comments on any factual errors or clarity concerns. By email dated July 13, 2020, Oklo communicated that there were no comments of substance on the draft SE and only minor edits were noted. Enclosed is a copy of the NRC staff's final SE for the TR. It should be noted that the final SE required a review by the NRC Office of General Counsel since the QAPD TR will be used for a combined license application (COL). Some minor edits and clarifications were made as part of the Office of General Counsel review.

On the basis of its review, the NRC staff concludes that the Oklo QAPD, OKLO-2019-14-NP, Revision 1, Quality Assurance Program Description, as documented in the referenced letters, adequately describes the Oklo Quality Assurance Program (QAP). Accordingly, the NRC staff finds that the Oklo QAP satisfies the quality assurance requirements of Appendix B to Title 10 of the Code of Federal Regulations Part 50. The NRC staff further emphasizes (as noted in the

C. Cochran final SE) that the exceptions that Oklo took in Part II Section 10, and Part IV Section 1 of the Oklo QAP are expected to be addressed during the review of the Oklo Aurora COL application.

The enclosed SE defines the basis for acceptance of the TR. Our acceptance applies only to material provided and we do not intend to repeat our review of the acceptable material described in the TR. When the TR appears as a reference in regulatory applications, our review will ensure that the material presented applies to the specific application involved. Licensing requests that deviate from this TR will be subject to a plant- or site-specific review in accordance with applicable review standards.

In accordance with the guidance provided on the NRC website, we request that Oklo publish the accepted version of this TR within 3 months of receipt of this letter. The accepted version shall incorporate this letter and the enclosed SE after the title page.

Also, the accepted version must contain historical review information, including NRC requests for additional information and your responses after the title page. The accepted versions shall include a "-A" (designating accepted) following the TR identification symbol.

As an alternative to including the RAIs and RAI responses behind the title page, if changes to the TR were provided to the NRC staff to support the resolution of RAI responses, and the NRC staff reviewed and approved those changes as described in the RAI responses, there are two ways that the accepted version can capture the RAIs:

1. The RAIs and RAI responses can be included as an Appendix to the accepted version.

2. The RAIs and RAI responses can be captured in the form of a table (inserted after the final SE) which summarizes the changes as shown in the approved version of the TR. The table should reference the specific RAIs and RAI responses which resulted in any changes, as shown in the accepted version of the TR.

If future changes to the NRC's regulatory requirements affect the acceptability of this TR, Oklo and/or licensees referencing it will be expected to revise the TR appropriately or justify its continued applicability for subsequent referencing.

C. Cochran If you have any questions, please contact Jan Mazza at (301) 415-0498 or jan.mazza@nrc.gov.

Sincerely,

/RA/

Benjamin Beasley, Chief Advanced Reactor Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Project No. 99902046 Docket No.52-049

Enclosure:

Final Safety Evaluation cc: Distribution via list serv

ML20205L415 *via -email NRC-002 OFFICE NRR/DANU/UARL/PM* NRR/DANU/UARL/LA* NRR/DRO/IQVB/TR*

NAME JMazza SLent GGalletti DATE 07/23/2020 7/24/2020 7/27/2020 OFFICE OGC/GCHA/AGCNRP* NRR/DRO/IQVB/BC* NRR/DANU/UARL/BC*

NAME MCarpentier NLO KKavanagh BBeasley DATE 8/03/2020 8/03/2020 8/11/2020 UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 FINAL SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION REGARDING THE OKLO, INC. TOPICAL REPORT OKLO-2019-14-NP, REVISION 1, QUALITY ASSURANCE PROGRAM DESCRIPTION PROJECT NO. 99902046 DOCKET NO.52-049

1.0 INTRODUCTION

By letter dated June 30, 2019 (Reference 1), Oklo, Inc. (Oklo, the applicant), submitted the topical report (TR) OKLO-2019-14-NP, Quality Assurance Program Description Design and Construction, Revision 0 (Oklo QAPD), for U.S. Nuclear Regulatory Commission (NRC) staff review in accordance with the guidance of NUREG-0800, Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants, Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants (Reference 2). By e-mail dated December 19, 2019 (Reference 3), the NRC staff provided a request for additional information (RAI) regarding the Oklo QAPD. The NRC staff and Oklo held a meeting on December 18, 2019, to discuss and further clarify the RAI. Oklo responded to the NRC staffs RAI in a letter dated January 24, 2020 (Reference 4), and also provided Revision 1 of TR OKLO-2019-14-NP, to address changes to the QAPD as a result of the RAIs.

The Oklo QAPD TR addresses the activities associated with the design and construction (D&C) of the Oklo power reactor. It should be noted that Oklo intends to use this Quality Assurance Program (QAP), in part, to support a custom combined license application (COL) for its Aurora reactor. The custom COL includes all siting and design information. The QAPD is based on the applicable portions of both Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations, Part 50 (10 CFR 50), Domestic Licensing of Production and Utilization Facilities, and the Nuclear Energy Institute (NEI) NEI 11-04A, Quality Assurance Program Description, revision 0, dated September 13, 2012 (Reference 5). Guidance document NEI 11-04A was approved by the NRC for applicants of 10 CFR Part 52 permits or licenses, as applicable, for establishing a quality assurance program that complies with the requirements of Appendix B to 10 CFR Part 50 and 10 CFR Parts 50 and 52. Guidance document NEI 11-04A is based on the American Society of Mechanical Engineers (ASME) NQA-1-2008, Quality Assurance Program Requirements for Nuclear Facilities, with NQA-1a-2009 Addenda (Reference 6).

Enclosure

Additionally, the Oklo QAPD incorporates the ASME NQA-1a-2011 Addenda (herein referred to as (NQA-1-2008/2009a with 2011b), as endorsed by NRC Regulatory Guide (RG) 1.28, Revision 5, Quality Assurance Program Criteria (Design and Construction) (Reference 7),

relevant to the Oklo power reactor project.

2.0 REGULATORY EVALUATION

The Commissions regulatory requirements related to quality assurance programs are set forth in 10 CFR 52.47(a)(19) for standard design certifications, 52.79(a)(25) for COL applications ,

52.17(a)(1)(xi) for early site permit applications, and Appendix B to 10 CFR 50 (Appendix B).

Regulations in 10 CFR 52.47(a) and 52.79(a) require that design certification and COL applications contain the technically relevant information in a final safety analysis report (FSAR) 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 (SSCs) and of the facility as a whole. Regulations in 10 CFR 52.47(a)(19) and 10 CFR 52.79(a)(25) state that the FSAR must include a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the safety-related SSCs of the facility. Regulations in 10 CFR 52.47(a)(19) and 52.79(a)(25) further require that the description of the quality assurance program for a nuclear power plant include a discussion of how the applicable requirements of Appendix B will be satisfied.

Appendix B establishes quality assurance requirements for the design, fabrication, construction, and testing of SSCs for the facility. The pertinent requirements of Appendix B apply to all activities affecting the safety-related functions of those SSCs and include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying SSCs.

3.0 EVALUATION In evaluating the adequacy of the Oklo QAPD, the NRC staff utilized the guidance contained in NUREG-0800 (SRP), Section 17.5, which provides an outline of an acceptable quality assurance program template for design certification, early site permit, combined license, construction permit, and operating license applicants. Section 17.5 of the SRP is based on ASME standard NQA-1-1994 Edition, as supplemented by additional regulatory and industry guidance for nuclear operating facilities. ASME standard NQA-1-2008/2009a with 2011b, upon which the Oklo QAPD is based, incorporates the supplemental guidance into a single document, and is therefore in alignment with Section 17.5 of the SRP. In addition, NQA-1-2008/2009a with 2011b is endorsed by NRC RG 1.28, Revision 5.

3.1 Quality Assurance Program Overview Report TR OKLO-2019-14-NP, Revision 1, provides for the control of Oklo activities affecting the quality and performance of SSCs related to the design and construction of the Oklo power reactor. The NRC understands that a supplement to this TR or a separate TR for the control of Oklo activities affecting quality and performance of SSCs during the operational phase on the Oklo power reactor will be submitted in the future. This safety evaluation (SE); therefore, is limited to only the design and construction phases for the Oklo power reactor.

3.1.1 Organization The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.A, for providing an organizational description that includes the organizational structure, functional responsibilities, levels of authority, and interfaces for establishing, executing, and verifying Oklo quality assurance program implementation. The Oklo QAPD establishes independence between the organization performing checking functions related to the QAPD and the organization responsible for performing the function. In addition, the Oklo QAPD provides for applicable management to be responsible to size the QA organization commensurate with the duties and responsibilities assigned. Finally, responsibility and authority for planning, establishing, and implementing an effective overall quality assurance program are clearly described and defined.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 1, Sections 100 through 300, without further clarifications or exceptions. The staffs review of the description of organizational controls finds that it is consistent with the quality requirements in NQA-1-2008/2009a/2011b and Section 17.5 of the SRP and is therefore acceptable.

3.1.2 Quality Assurance Program The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.B, for establishing the necessary measures to implement a QA program in order to ensure that the design of the Oklo power reactor is in accordance with governing regulations and license requirements. The QA program applies to those quality-related activities that involve the functions of safety-related SSCs associated with the design of the Oklo power reactor, and to the managerial and administrative controls to be used to assure the Oklo power reactor design complies with applicable regulatory requirements. Examples of design and construction program safety-related activities include, but are not limited to, basic, applied, and developmental research; determination of SSC safety class; design configuration management; and document control.

A list or system identifying the SSCs and activities to which the Oklo QAPD applies is maintained for the D&C project. Oklo may delegate all or part of the activities for which they are responsible to others; however, Oklo retains overall responsibility for quality assurance program effectiveness. The Oklo QAPD provides for measures to assess the adequacy of the quality assurance program and to ensure its effective implementation, at least once each year or at least once during the life of the activity, whichever is shorter. In addition, consistent with SRP Section 17.5, Paragraph II.B.8, the Oklo quality assurance program applies a grace period of 90 days to activities that must be performed on a periodic basis. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by performing the activity early.

The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraphs II.S and II.T, for describing the necessary measures to establish and maintain formal indoctrination and training programs for personnel performing, verifying, or maintaining activities within the scope of the quality assurance program to assure that suitable proficiency is achieved and maintained. The Oklo QAPD provides the minimum training requirements for all personnel responsible for implementation of the Oklo QA program.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008, Requirement 2, Sections 100 through 500, with the following clarifications or exceptions.

1. QA Program (NQA-1 Requirement 2)

a. Audit Participation (1) Prospective lead auditors, with comparable industry experience, may satisfy the lead auditor qualification requirement of participating in a minimum of five QA audits within a period of 3 years prior to the date of qualification by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results, and participate in at least one nuclear audit within the year preceding the date of qualification, subject to review and acceptance by the responsible QA organization.

The staffs review of lead auditor qualifications finds that NQA-1-2008, Requirement 2, Section 303.3 provides for participation in independent assessments as another means of satisfying the requisite number of quality assurance audits and supplies the acceptance criteria for use of these activities toward lead auditor qualification. Although there is no need for this exception in Oklo QAPD, it is consistent with the quality requirements in NQA-1-2008/2009a/2011b and Section 17.5 and is therefore acceptable.

3.1.3 Design Control The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.C.1, for establishing the necessary measures to control the design, design verification, and analysis activities of safety-related items and services that are subject to the provisions of the QAPD. The Oklo quality assurance program design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces. These provisions ensure that the design inputs (such as design bases, performance and regulatory requirements, and codes and standards) are correctly translated into design outputs (such as analyses, specifications, drawings, procedures, and instructions). In addition, the Oklo QAPD provides for design documents to be reviewed by individuals knowledgeable in QA to ensure that the documents contain the necessary quality assurance requirements.

Consistent with SRP Section 17.5, Paragraph II.C.2, the Oklo design processes provide for design verification to ensure that items and activities subject to the provisions of the quality assurance program are suitable for their intended application and consistent with their effect on safety. Design changes are subject to these controls, which include verification measures commensurate with those applied to original plant design. The extent of the design verification required is a function of the importance to safety of the item under consideration, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs. Verification methods may include, but are not limited to, design reviews, alternative calculations, and qualification testing.

The Oklo QAPD governs the development, procurement, testing, maintenance, and use of computer application and digital equipment software when used in safety-related applications and designated nonsafety-related applications. Oklo and its suppliers are responsible for developing, approving, and issuing procedures, as necessary, to control the use of such computer application and digital equipment software.

The QAPD states that the procedures shall require that the application software be assigned a proper quality classification and that the associated quality requirements be consistent with this classification.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 3, as well as the standards for computer software contained in NQA 2008/2009a with 2011b, Subparts 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications, and 2.14, Commercial-Grade Items and Services, without further clarifications or exceptions.

3.1.4 Procurement Document Control The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.D, for establishing the necessary administrative controls and processes to ensure that applicable regulatory, technical, and QA program requirements are included or referenced in procurement documents.

Applicable technical, regulatory, administrative, quality, and reporting requirements (such as specifications, codes, standards, tests, inspections, special processes, and 10 CFR Part 21, "Reporting of Defects and Noncompliance" (10 CFR 21)) are invoked for the procurement of items and services.

To the extent necessary, procurement documents shall require suppliers to have a documented QA program that is determined to meet the applicable requirements of Appendix B, as appropriate to the circumstances of procurement (or the supplier may work under the Oklo approved QA program).

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 4, Sections 100 through 400, with the following clarifications and exceptions:

1. As an alternative to Requirement 4 regarding services performed by a supplier, Oklo procurement documents may allow the supplier to work under the Oklo QAP, including implementing procedures, in lieu of the supplier having its own QAP. As an alternative to Section 300 and 400 of Requirement 4 which requires the review of technical and QAP requirements of procurement documents prior to award of a contract and for procurement document changes. Oklo may satisfy this requirement through the review of the procurement specification, when the specification contains the technical and quality assurance requirements of the procurement. Procurement documents for Commercial-Grade Items that will be procured by Oklo for use as safety-related items shall contain technical and quality requirements such that the procured item can be appropriately dedicated in accordance with the Oklo QAPD, Section 7, Control of Purchased Material, Equipment and Services.

The NRC staff evaluated these proposed alternatives and determined that they provide for adequate control of quality related activities and the QA review of procurement documents and the associated requirements before awarding the contract and after any change, which is consistent with the intent of NQA 2008/2009a with 2011b, Requirement 4, Section 300, and Criterion IV of Appendix B. Therefore, the NRC staff concluded that this alternative is acceptable.

3.1.5 Instructions, Procedures, and Drawings The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.E, for establishing the necessary measures and governing procedures to ensure that activities affecting quality are prescribed by, and performed in accordance with, documented instructions, procedures, or drawings of a type appropriate to the circumstances and which, where applicable, include quantitative or qualitative acceptance criteria to implement the QAPD.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 5, Section 100, without further clarifications or exceptions.

3.1.6 Document Control The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.F, for establishing the necessary measures and governing procedures to control the preparation, review, approval, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, are controlled. Measures are provided to assure that documents, including revisions or changes (other than those defined in implementing procedures as minor changes), are reviewed and approved by the same organization that performed the original review and approval, unless other organizations are specifically designated. A list of all controlled documents, identifying the current approved revision or date, is maintained so personnel can determine the appropriate document for use.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 6, Sections 100 through 300, without further clarifications or exceptions.

3.1.7 Control of Purchased Material, Equipment, and Services The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.G, for establishing the necessary measures and governing procedures to control the procurement of items and services to ensure conformance with specified requirements. The program provides measures for source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services. The QAPD establishes and implements measures to assess the quality of purchased items and services, whether purchased directly or through contractors, at intervals and to a depth consistent with the item's or service's importance to safety, complexity, quantity, and frequency of procurement.

The Oklo QAPD provides measures for evaluating prospective suppliers and selecting only qualified suppliers, as well as auditing and evaluating suppliers to ensure that qualified suppliers continue to provide acceptable products and services. The scope of procurement includes engineering, design and testing services, as well as the procurement of safety-related software.

The Oklo QAPD also outlines acceptance actions, such as source verification, receipt inspection, certificates of conformance, and review of documentation (e.g., Certified Material Test Reports/Certificates) to ensure that the procurement, inspection, and test requirements have been satisfied before relying on the item to perform its intended safety function.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 7, Sections 100 through 800, with the following clarifications and exceptions:

1. The Oklo QAPD proposes that other 10 CFR 50 licensees, authorized nuclear inspection agencies, the National Institute of Standards and Technology (NIST),

and other State and Federal agencies that may provide items or services to Oklo during the D&C phase are not required to be evaluated or audited.

The NRC staff acknowledges that 10 CFR Part 50 licensees, authorized nuclear inspection agencies, the NIST, and other State and Federal agencies perform work under acceptable quality programs, and no additional audit or evaluation is required. The NRC staff determined that this exception is acceptable as documented in a letter to the Edwin Hatch Nuclear Power Station on March 20, 2000 (Reference 8). In addition, this exception is also applicable to Oklo as a COL applicant as they will maintain an NRC approved QAPD consistent with the regulations.

However, Oklo is still responsible for ensuring that the items or services procured conform to the applicable Appendix B criteria, ASME Boiler and Pressure Vessel Code requirements, and other regulatory requirements and commitments. Oklo is also responsible for ensuring that procured items or services are suitable for the intended application, as well as for documenting the associated evaluation.

To this extent and on this basis, the NRC staff finds the proposed exception acceptable.

2. The Oklo QAPD includes provisions consistent with the regulatory guidance provided in SRP Section 17.5, Paragraph II.L.8, for the procurement of commercial-grade calibration services for safety-related applications from a calibration laboratory. The Oklo QAPD proposes not to require procurement source evaluation and selection measures provided each of the following conditions are met:

a. Purchase documents impose additional technical and administrative requirements as necessary, to comply with the Oklo quality assurance program and technical provisions. At a minimum, the purchase document shall require that the calibration certificate/report include identification of the laboratory equipment and standard used.

b. Purchase documents require reporting as-found calibration data when calibrated items are found to be out of tolerance.

c. A documented review of the suppliers accreditation will be performed and will include a verification of the following:

i. The calibration laboratory holds a domestic accreditation by an NRC-approved domestic (United States) accrediting body recognized by the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement ii. The accreditation is based on ANS/ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

iii. The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, range, and uncertainties.

In addition, the Oklo QAPD recognizes calibration and/or testing services may be procured from domestic and international laboratories accredited to ISO/IEC 17025:2017 in lieu of performing a survey as part of the commercial-grade dedication process in accordance with the NRCs SE of Revision 1 of NEI 14-05 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14322A535.

The NRC staff evaluated these proposed alternatives and determined that they provide for adequate control of calibration and testing services procured as part of commercial-grade dedication activities, which is consistent with the current regulatory position regarding the acceptability of procuring commercial-grade calibration and testing services from NRC-recognized ISO 17025-2017 accredited calibration and testing laboratories that are documented in SRP Section 17.5, Paragraph II.L.8, as well as the NRCs SE of Revision 1 of NEI 14-

05. On this basis, the NRC staff finds the proposed exception acceptable.

3. The Oklo QAPD commits to the requirements of the NQA-1a-2009 Addenda, Requirement 7, Section 501. Oklo considers documents that may be stored in approved electronic media under Oklo or vendor control, not physically located on the plant site, but accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site.

Following completion of the construction period, sufficient as-built documentation will be maintained and/or turned over to Oklo to support operations. As such, the NRC staff finds the proposed clarification acceptable.

4. The Oklo QAPD commits to the requirements of the NQA-1a-2009 Addenda, Requirement 7, Section 700, and Subpart 2.14, "Quality Assurance Requirements for Commercial-Grade Items and Services," for establishing commercial-grade item requirements. These sections implement controls for the selection, determination of suitability of intended use (critical characteristics),

evaluation, receipt, and acceptance of commercial-grade services or items to ensure they will perform satisfactorily in service. As such, the NRC staff finds the proposed clarification acceptable.

5. As an alternative to NQA-1a-2009 Addenda, Requirement 7, Section 700, the Oklo QAPD proposes that Oklo will assume 10 CFR 21 reporting responsibility for all commercial items and services that Oklo dedicates for use in safety-related applications.

The purpose of 10 CFR 21 states that any individual director or responsible officer of a firm constructing, owning, operating, or supplying the components of any licensed or regulated facility or activity, who obtains information reasonably indicating: (a) that the facility, activity or basic component supplied to such facility or activity 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 (b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could

create a substantial safety hazard, must immediately notify the Commission of such failure to comply or such defect, unless he has actual knowledge that the Commission has been adequately informed of such defect or failure to comply.

Therefore, the alternative proposed in the Oklo QAPD, which ensures that 10 CFR 21 reportability requirements encompass all items and services dedicated by Oklo for the Oklo power reactor D&C project, would continue to meet the intent of this requirement and is, therefore, acceptable to the NRC staff.

3.1.8 Identification and Control of Materials, Parts, and Components The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.H, for establishing the necessary measures and governing procedures to identify and control items to prevent the use of incorrect or defective items. This includes controls for consumable materials and items with limited shelf life. The identification of items is maintained throughout fabrication, erection, installation, and use so that the item can be traced to its documentation, consistent with the items effect on safety. Identification locations and methods are selected so as not to affect the function or quality of the item.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 8, without further clarifications or exceptions.

3.1.9 Control of Special Processes The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.I, for establishing the necessary measures and governing procedures to assure special processes are adequately controlled. These provisions include assuring that special processes are accomplished by qualified personnel using qualified procedures and equipment. Personnel are qualified and special processes are performed in accordance with applicable codes, standards, specifications, criteria or other specially established requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 9, without further clarifications or exceptions.

3.1.10 Inspection The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.J, for establishing the necessary measures and governing procedures to assure inspections are adequately controlled. These inspections ensure items, services, and activities affecting safety meet established requirements and conform to documented specifications, instructions, procedures, and design documents. The inspection program establishes requirements for planning inspections, determining applicable acceptance criteria, setting the frequency of inspection, and identifying special tools needed to perform the inspection. Qualified personnel perform the inspections and are independent of those who performed or directly supervised the work.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b Requirement 10, and Subparts 2.4, 2.5, and 2.8 for establishing appropriate inspection requirements with the following clarifications and exceptions:

1. Subpart 2.4 commits Oklo to Institute of Electrical and Electronic Engineers (IEEE) 336-1985 (Reference 9) which refers to IEEE 498-1985 (Reference 10). Both IEEE 336-1985 and IEEE 498-1985 use the definition of Safety Systems from IEEE 603-1980 (Reference 11). Oklo does not commit to this definition of Safety Systems because this definition is not exactly relevant to the Oklo reactor and does not commit to the balance of IEEE 603-1980.

2. An additional exception to Subpart 2.4 is addressed in Part II, Section 12 of the QAPD.

The NRC staff evaluated these proposed alternatives and determined that the subject of determining what encompasses safety-related SSCs and Safety Systems for the Oklo design is an issue beyond the QAPD and therefore will be addressed more holistically as part of the Oklo COL Submittal review. Therefore, the NRC staff identifies this as an issue to be addressed during the COL review phase of the OKLO design.

3.1.11 Test Control The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.K, for establishing the necessary measures and governing procedures to assure testing is adequately identified and controlled to demonstrate that performance of plant SSCs is in accordance with design. Tests are performed according to applicable procedures that include, consistent with the effect on safety (1) instructions and prerequisites to perform the tests, (2) use of proper test equipment, and (3) that the test is performed under suitable environmental conditions.

Test results are documented and evaluated by the organization performing the test, and reviewed by a responsible authority, to assure that the test requirements have been satisfied. If acceptance criteria are not met, re-testing is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.

In establishing provisions to ensure that the computer software used in applications affecting safety is prepared, documented, verified, tested, and used such that the expected outputs are obtained, and configuration control maintained, the Oklo QAPD commits to implement the quality standards described in the NQA-1-2008/2009a with 2011b, Subpart 2.7, without clarifications or exceptions.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 11, as they relate to establishing the provisions for testing, without further clarifications or exceptions.

3.1.12 Control of Measuring and Test Equipment (M&TE)

The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.L, for establishing the necessary measures and governing procedures to assure M&TE calibration, maintenance, and use is adequately controlled. Appropriate documentation will be maintained for these devices to indicate the control status, when the next calibration is due, and identify any limitations on use of the device.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 12, Sections 100 through 400 with the following clarifications or exceptions.

1. Oklo QAPD clarifies that NQA-1-2008, Subpart 2.4 refers to American National Standards Institute (ANSI)/IEEE Standard (Std). 336-1985 for the installation, inspection, and testing requirements for power, instrumentation, and control equipment at nuclear facilities. Where ANSI/IEEE Std. 336-1985, refers to the use of IEEE Std. 498-1985 for measuring and test equipment control, Oklo will implement the QA requirements of NQA-1-2008, Requirement 12.

The NRC staff finds that this alternative is consistent with the staff guidance provided in SRP Section 17.5, Paragraph II.L.3. Therefore, the NRC staff concluded that this alternative is acceptable.

2. Oklo QAPD clarifies that the out-of-calibration conditions described in NQA-1-2008, Requirement 12, Section 303.2, and the subsequent requirements to evaluate the validity of previous M&TE results, refer to cases where the M&TE is found to be out of the required accuracy limits (i.e., out of tolerance) during calibration versus simply overdue for calibration. The latter situation is addressed by NQA-1-2008, Requirement 12, Section 303, and assumes that an overdue calibration does not automatically equate to an inaccurate measurement or test.

The NRC staff determined that the clarification for out-of-calibration conditions is consistent with the overall objective of NQA-1-2008, Requirement 12, Section 303.2, and Criterion XII of Appendix B, which require that M&TE used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits. Therefore, the NRC staff concluded that this clarification is acceptable.

3. Measuring and test equipment are not required to be marked with the calibration status, as described in Section 303.6, where it is impossible or impractical due to equipment size or configuration (such as the label will interfere with operation of the device) provided the required information is maintained in suitable documentation traceable to the device. This exception also applies to the calibration labeling requirement stated in NQA-1-2008, Subpart 2.4 (See Section 7.2.1 of ANSI/IEEE Std. 336-1985).

The NRC staff determined that the clarification for calibration status is consistent with the overall objective of NQA-1-2008, Requirement 12, Section 303.6, and Criterion XII of Appendix B. Therefore, the NRC staff concluded that this clarification is acceptable.

3.1.13 Handling, Storage, and Shipping The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.M, for establishing the necessary measures and governing procedures to assure adequate handling, storage, packaging, shipping, cleaning and preservation of items to prevent inadvertent damage or loss, and to minimize deterioration. The Oklo QAPD establishes housekeeping practices to account for conditions or environments that could affect the quality of SSCs within the plant.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 13, with the following clarifications or exceptions.

1. NQA-1-2008, Subpart 2.2, Section 606, "Storage Records:" This section requires written records be prepared containing information on personnel access. As an alternative to this requirement, Oklo documents establish controls for storage areas that describe

those authorized to access areas and the requirements for recording access of personnel. However, these records of access are not considered quality records and will be retained in accordance with the administrative controls of the applicable plant.

The NRC staff determined that this proposed alternative is acceptable, on the basis that these records do not meet the classification of a quality record as defined in NQA 2008, Requirement 17.

3.1.14 Inspection, Test, and Operating Status The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.N, for establishing the necessary measures and governing procedures to control inspection, test, and operating status of items and components within the scope of the QAPD to maintain personnel and reactor safety and avert inadvertent operation of equipment.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 14, without the following clarifications or exceptions.

3.1.15 Nonconforming Materials, Parts, or Components The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.O, for establishing the necessary measures and governing procedures to control items, including services that do not conform to specified requirements, in order to prevent inadvertent use. Controls provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming items, and notification to affected organizations. Controls are also provided to address conditional release of nonconforming items for use on an at-risk basis prior to resolution and disposition of the nonconformance, including maintaining identification of the item and documenting the basis for such release.

In addition, the Oklo QAPD provides for establishing the appropriate interfaces between the quality assurance program for identification and control of nonconforming materials, parts, or components, and the non-QA reporting program in order to satisfy the requirements of 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants (10 CFR Part 52), 10 CFR 50.55, and 10 CFR 21 during COL D&C.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 15, Sections 100 through 400, without further clarifications or exceptions.

3.1.16 Corrective Action The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.P, for establishing the necessary measures and governing procedures to promptly identify, control, document, classify, and correct conditions adverse to quality. The QAPD provides for procedures to ensure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards.

Reports of conditions adverse to quality are analyzed to identify trends. Significant conditions adverse to quality and significant adverse trends are documented and reported to responsible management. In the case of a significant condition adverse to quality, the cause is determined and actions to preclude recurrence are taken. In the case of suppliers working on safety-related

activities, or other similar situations, Oklo may delegate specific responsibilities for corrective actions, but Oklo maintains overall responsibility for the effectiveness of corrective action measures and the corrective action program.

Oklo has established appropriate interfaces between the QAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55, and 10 CFR 21 during D&C.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 16, Section 100, without further clarifications or exceptions.

3.1.17 Quality Assurance Records The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.Q, for establishing the necessary measures to ensure that sufficient records of items and activities affecting quality are developed, reviewed, approved, issued, used, and revised to reflect completed work. The provisions of such procedures establish the scope of the records retention program for Oklo and include requirements for records administration including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user privileges, and final disposition.

The Oklo QAPD establishes measures to ensure that sufficient records of completed items and activities affecting quality are appropriately stored. The records and retention times are based on Regulatory Position C.1 of RG 1.28, Revision 5, as applicable for the Oklo power reactor D&C project. In all cases where State, local, or other agencies have more restrictive requirements for record retention, the Oklo QAP provides that those more restrictive requirements will be met.

When using electronic records storage and retrieval systems, the Oklo QAPD provides for compliance with the NRC guidance contained in NRC Generic Letter (GL) 88-18, Plant Record Storage on Optical Disks (Reference 12), Regulatory Issue Summary (RIS) 00-18, Guidance on Managing Quality Assurance Records in Electronic Media (Reference 13), and the associated Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guidelines (TG), including TG 11-2011, Authentication of Records and Media, TG 15-2011, Management of Electronic Records, TG 16-2011, Software Configuration Management and Quality Assurance, and TG 21-2011, Electronic Records Protection and Restoration.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 17, Sections 100 through 800, with further clarifications or exceptions.

1. Lifetime and Nonpermanent Records Paragraph 400, Classification, of Requirement 17, Quality Assurance Records, provides guidance on the retention of lifetime and nonpermanent records. Paragraph 401, Lifetime Records, discusses the scope and responsibilities related to these records. The owner or an authorized agent must maintain lifetime records for the life of the particular item while it is installed in the plant or stored for future use.

2. Paragraph 402, Nonpermanent Records, identifies nonpermanent records as those records that ...show evidence that an activity was performed in accordance with the applicable requirements... The owner or an authorized agent does not need to retain these records for the life of the item, because they do not meet the criteria for lifetime

records. However, Paragraph 700, Retention, specifies that document retention periods be documented, and records maintained for their retention period.

3. NQA-1 Part III, Nonmandatory Subpart 3.1-17.1, Guidance on Quality Assurance Records, Paragraph 200, List of Typical Lifetime Records, lists typical lifetime records containing information that meets Requirement 17 of Part I. The list of typical lifetime records in Nonmandatory Subpart 3.1-17.1 should be considered for guidance purposes only. Note that the particular names or terms of these records may vary. For records not listed in Subpart 3.1-17.1, the type of record that most nearly describes the record in question should be followed with respect to its retention classification. The applicant or licensee should be cognizant that the list is not considered to be all-inclusive. The applicant or licensee itself is responsible for ensuring, in accordance with Criterion XVII, Quality Assurance Records, of Appendix B to 10 CFR Part 50, that it maintains sufficient records to furnish evidence of activities affecting quality.

The NRC staff has determined that these proposed alternatives are acceptable, on the basis that Regulatory Position C.1.a of RG 1.28, Revision 5 provides record retention times for lifetime and nonpermanent records consistent with these descriptions. In establishing the retention time for records, the NRC staff will evaluate the adequacy of records retention times as site-specific information during the Oklo COL application review.

4. Managing Quality Assurance Records in Electronic Media For the management of electronic records, appropriate controls on quality assurance include the following:

a. No deletion or modification of records unless authorized pursuant to the record retention rule

b. Redundancy (system backup, dual storage, etc.) is provided

c. Legibility is required of each record

d. Records media are properly maintained

e. Inspections to ensure no degradation of records

f. Records are acceptably converted into any new system before the old system is taken out of service The NRC staff has determined that these proposed alternatives are acceptable, on the basis that Regulatory Position C.3.b of RG 1.28, Revision 5 provides electronic record management consistent with these controls and because the Oklo QAPD provides for compliance with the NRC guidance contained in NRC GL 88-18 and associated NIRMA Guidelines.

3.1.18 Audits The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.R, for establishing the necessary measures and governing procedures to implement audits in order to verify that activities covered by the quality assurance program are performed in conformance with the requirements established. The audit programs are also themselves reviewed for effectiveness as part of the overall Oklo audit process.

The Oklo QAPD provides for conducting periodic internal and external audits. Internal audits are conducted to determine the adequacy of program and procedures, as well as to determine if

they are meaningful and comply with the overall Oklo QA program. Internal audits are performed (1) with a frequency commensurate with the safety significance of the activity and in a manner which assures that audits of safety-related activities are completed; and/or (2) with a frequency that ensures that an audit of all applicable quality assurance program elements is completed within a period of once per calendar year or at least once during the life of the activity, whichever is shorter.

External audits determine the adequacy of supplier or contractor quality assurance programs.

The scope of the audit is determined by the quality status and safety importance of the activities being performed. These audits are conducted by trained personnel not having direct responsibility in the area being audited and in accordance with preplanned and approved audit plans or checklists, under the direction of a qualified lead auditor and the cognizance of the Oklo quality assurance director.

The Oklo QAPD provides for all audit results to be documented and reviewed by responsible management. Management responds to all audit findings and initiates corrective actions where indicated. In addition, where corrective action measures are determined necessary, documented follow-up of applicable areas through inspections, review, re-audits, or other appropriate means, is conducted to verify the implementation and effectiveness of the assigned corrective actions.

The Oklo QAPD commits to implement the quality standards described in NQA-1-2008/2009a with 2011b, Requirement 18, Sections 100 through 800, and RG 1.28, Rev. 5, without further clarifications or exceptions.

3.2 Nonsafety-Related SSC Quality Control 3.2.1 Nonsafety-Related SSCs - Significant Contributors to Plant Safety The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.V.1, for establishing specific program controls to be applied to nonsafety-related SSCs that are significant contributors to plant safety, but for which Appendix B is not applicable.

The Oklo QAPD applies specific controls to such items in a selected manner, targeted toward those characteristics or critical attributes that render the SSC a significant contributor to plant safety, consistent with applicable sections of the Oklo quality assurance program.

The NRC staff has determined that this approach, as described in the Oklo QAPD, is acceptable to maintain alignment with SRP Section 17.5, Paragraph II.V.1.

3.2.2 Nonsafety-Related SSCs Credited for Regulatory Events In establishing the quality requirements for nonsafety-related SSCs credited for regulatory events, the Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.V.2, and Oklo commits to implement the following regulatory guidance:

1. The quality requirements for the fire protection system in accordance with Regulatory Position 1.7, "Quality Assurance," in RG 1.189, Revision 2, "Fire Protection for Operating Nuclear Power Plants," dated October 2009 (Reference 14). RG 1.189, Section 8.5, provides guidance for non-LWRs (light-water reactors), and states, in part, that FPPs for proposed new non-LWR designs should meet the overall fire protection objectives and

guidance in the applicable regulations and this RG as they relate to safe shutdown and radiological release, as well as the specific fire protection requirements that apply. Fire hazards should be identified and evaluated, and an appropriate level of protection provided to meet these objectives. Design reviews and testing programs should confirm the safe shutdown capability. SSCs important to safe shutdown should be protected in accordance with the enhanced criteria described above for light-water reactors.

2. Oklo implements the quality requirements for anticipated transients without scram (ATWS) equipment in accordance with Part III, Section 1, to the extent that any equipment have been identified to be important to safety in case of ATWS.

3. Oklo implements the quality requirements for station blackout (SBO) equipment in accordance with Part III, Section 1, to the extent that any equipment has been identified to be important to safety in case of SBO.

While Oklo does not explicitly commit to GL 85-06, Quality Assurance Guidance for ATWS Equipment That Is Not Safety-Related, issued January 1985 (Reference 15), or Regulatory Position 3.5, Quality Assurance and Specific Guidance for SBO Equipment That Is Not Safety-Related, and RG 1.155, Station Blackout, issued August 1988, Appendix A, Quality Assurance Guidance for Non-Safety Systems and Equipment, (Reference 16), the QAPD explicitly states that programmatic controls consistent with applicable sections of the QAPD are applied to those items in a selected manner, targeted at those characteristics or critical attributes that render the SSC a significant contributor to plant safety. The NRC staff has determined that this approach, as described in the Oklo QAPD, is acceptable and meets the intent of the quality criteria applied to fire protection (10 CFR 50.48), ATWS (10 CFR 50.62),

and the SBO (10 CFR 50.63) SSCs that are not safety-related.

3.3 Regulatory Commitments The Oklo QAPD follows the guidance of SRP Section 17.5, Paragraph II.U, for establishing QA program commitments. Furthermore, Oklo commits to comply with the following NRC RGs and other quality assurance standards to supplement and support the quality assurance program with the following clarifications and exceptions:

1. RG 1.28, Revision 5, "Quality Assurance Program Requirements (Design and Construction)," dated June 2010. RG 1.28 describes a method acceptable to the NRC for complying with the provisions of Appendix B with regard to establishing and implementing the requisite QA program for the design of nuclear power

2. RG 1.164: Dedication of Commercial-Grade Items for Use in Nuclear Power Plants June 2017 (Reference 17). Oklo commits to RG 1.164 for dedication of commercial-grade items without clarifications or exceptions.

3. RG 1.231: Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants, Revision 0 January 2017 (Reference 18). Oklo commits to RG 1.231 without clarifications or exceptions.

4. ASME NQA-1-2008, and NQA-1a-2009 Addenda, "Quality Assurance Requirements for Nuclear Facility Applications," Parts I, II, and III as described above in Sections 3.1.1 through 3.1.18 of this SE.

5. Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guides, as described in Section 3.1.17 of this SE.

With respect to the following Regulatory Guidance;

1. RG 1.26, Revision 5, "Group Classification and Standards for Water, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants, dated February 2017 (Reference 19). RG 1.26 defines classification of systems and components.

2. RG 1.29, Revision 5, "Seismic Design Classification," dated March 2007 (Reference 20).

RG 1.29 defines systems required to withstand a safe shutdown earthquake.

Oklo has stated that because of the substantial differences between the Oklo plant design and LWR designs, direct commitment to these RGs cannot be made. Oklo is, however, dedicated to incorporate insights from this guidance and past designs. It is anticipated that the Oklo application will make use of International Atomic Energy Agency (IAEA) Safety Guide NS-G-1.6, Seismic Design and Qualification for Nuclear Power Plants to guide Seismic categories for SSCs according to their safety significance (Reference 21).

The NRC staff has reviewed Oklos position and believes this issue is much broader than the QAPD review, and therefore should be addressed in a more holistic manner as part of the COL application review. Therefore, the NRC staff identifies this as an issue to be addressed during the COL review phase of the OKLO design.

The NRC understands that a supplement to this TR or a separate TR for the control of Oklo activities affecting quality and performance of SSCs during the operational phase on the Oklo power reactor will be submitted in the future. The following should be addressed as part of that submittal.

1. RG 1.8, Revision 4, Qualification and Training of Personnel for Nuclear Power Plants (Reference 22), dated June 2019. RG 1.8 provides guidance regarding qualifications and training for nuclear power plant personnel.

2. RG 1.33, Revision 3, Quality Assurance Program Requirements (Operations), issued June 2013. (Reference 23)

3. RG 1.54, Revision 3, Service Level I, II, and III Protective Coatings Applied to Nuclear Power Plants, issued April 2017 (Reference 24).

4.0 CONCLUSION

The Oklo QAPD delineates the policies, processes, and controls established by Oklo and associated implementing documents relative to U.S. domestic licensing requirements for design and construction of nuclear power plants. Together, the QA program documents defined in the QAPD provide for control of Oklo activities that affect the quality of safety-related nuclear plant SSCs and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will be designed and constructed satisfactorily for service. The QAPD may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations, or where other NRC guidance establishes program requirements.

The Oklo QAPD follows the NRC guidance contained within, and conforms to the format of, SRP Section 17.5. The NRC staff used the acceptance criteria of SRP Section 17.5 as the basis for evaluating the acceptability of the Oklo quality assurance program in conformance with the provisions of 10 CFR 52.47(a)(19) and Appendix B to 10 CFR 50. On the basis of its review of the Oklo QAPD, the NRC staff concludes that:

1. The Oklo QAPD adequately describes the authority and responsibility of management and supervisory personnel, performance and verification personnel, and self-assessment personnel, in relation to activities to which the Oklo quality assurance program is applicable.

2. The Oklo QAPD adequately provides for organizations and personnel to perform verification and self-assessment functions related to Oklo activities that affect the quality of safety-related nuclear plant SSCs, as well as select nonsafety-related SSCs, with these organizations and personnel having the authority and independence to conduct activities without undue influence from those directly responsible for costs and schedules.

3. The Oklo QAPD adequately applies to activities and items that are important to safety.

4. The Oklo QAPD adequately establishes controls that, when properly implemented, comply with the requirements of 10 CFR 52, 10 CFR 50.55, Appendix B to 10 CFR 50, and 10 CFR 21, consistent with the criteria contained in SRP Section 17.5, as well as the relevant regulatory guidance, with the specific exceptions associated with the Oklo design not being a LWR, noted herein. These exceptions will need to be addressed as part of the COL application review.

On the basis of its review, the NRC staff determined that the Oklo QAPD adequately describes the Oklo quality assurance program. Accordingly, the NRC staff concludes that the Oklo QA program complies with the applicable NRC regulations and industry standards and can be used by Oklo for activities associated with the design and construction of the Oklo power reactor.

Principal Contributors: Greg Galletti Date: August 11, 2020

5.0 REFERENCES

1. Letter from Caroline Cochran, Co-Founder, COO, Oklo Inc., to the NRC Document Control Desk, OKLO Power Submittal of OKLO Quality Assurance Program Description (QAPD) for Design and Construction, dated June 30, 2019 ADAMS Accession No. ML19178A068 (letter) and ML19178A069 (QAPD, Revision 0)

2. NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants," Section 17.5, Quality Assurance Program Description - D&C, Early Site Permit and New License Applicants," dated March 2007 (ADAMS Accession No. ML063190019)

3. Email from J. Mazza, NRC, to C. Cochran, Oklo Inc., Request for Additional Information

- Quality Assurance Program Description Design and Construction Topical Report, Oklo-2019-14-NP, dated December 19, 2019 (ADAMS Accession No. ML19357A189)

4. Letter from C. Cochran, OKLO Inc., to the NRC Document Control Desk, Oklo Inc.,

Project 99902046 Responses to second round NRC RAIs on the Oklo Inc. Design and Construction Quality Assurance Plan Description, Rev. 0, dated January 24, 2020 (ADAMS Accession No. ML20027A004)

5. Nuclear Energy Institute (NEI) NEI 11-04A, Quality Assurance Program Description, Revision 0, dated August 2013 (ADAMS Accession No. ML13235A267)

6. American Society of Mechanical Engineers (ASME) NQA-1-2008, Quality Assurance Program Requirements for Nuclear Facilities (with 1a-2009a Addenda and 1b-2011 Addenda), New York, NY, dated March 14, 2008

7. Regulatory Guide (RG) 1.28, Revision 5, Quality Assurance Program Criteria (Design and Construction), dated October 2017 (ADAMS Accession No. ML17207A293)

8. Letter from NRC to Southern Nuclear Operating Company, Edwin I. Hatch Nuclear Power Station, Units 1 and 2, RE: Approval of Relief Request RR-27, Third 10-Year Interval Inservice Inspection Program (TAC NOS. MA6163 and MA6164), dated March 20, 2000 (ADAMS Accession No. ML003693241)

9. Institute of Electrical and Electronic Engineers (IEEE), 336-1985, IEEE Standard Installation, Inspection and Testing Requirements for Power, Instrumentation, and Control Equipment at Nuclear Facilities, dated April 1985

10. IEEE 498-1985, IEEE Standard Requirements for the Calibration and Control of Measuring and Test Equipment Used in Nuclear Facilities, dated June 1985

11. IEEE 603-1980, IEEE Standard Criteria for Safety Systems for Nuclear Power Generating Systems, dated November 1980

12. NRC GL 1988-18, Plant Record Storage on Optical Disks, dated October 20, 1988

13. Regulatory Issue Summary 00-18, Regulatory Issue Summary 00-18, Guidance on the Management of Quality Assurance Records on Electronic Media, dated October 17, 2011 (ADAMS Accession No. ML112690193)

14. RG 1.189, Revision 2, "Fire Protection for Operating Nuclear Power Plants," dated October 2009 (ADAMS Accession No. ML092580550)

15. GL 1985-06, "Quality Assurance Guidance for ATWS Equipment That Is Not Safety-Related," dated April 16, 1985

16. RG 1.155, "Station Blackout, dated August 1988 (ADAMS Accession No. ML003740034)

17. RG 1.164: Dedication of Commercial-Grade Items for Use in Nuclear Power Plants dated June 2017 (ADAMS Accession No. ML17041A206)

18. RG 1.231: Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants, Revision 0, dated April 2018 (ADAMS Accession No. ML17338A072)

19. RG 1.26, Quality Group Classifications for Water, Steam, and Radioactive-Waste-Containing Components of Nuclear Power Plants. Revision 5, dated February 2017 (ADAMS Accession No. ML16082A501)

20. RG 1.29, Seismic Design Classification for Nuclear Power Plants. Revision 5, dated July 2016 (ADAMS Accession No. ML16118A148)

21. IAEA NS-G-1.6, Seismic Design and Qualification for Nuclear Power Plants, Vienna, Austria, 2003

22. RG 1.8, Qualification and Training of Personnel for Nuclear Power Plants, Revision 4, dated June 2019 ADAMS Accession No. ML19101A395)

23. RG 1.33, Quality Assurance Program Requirements (Operations), Revision 3, dated June 2013 (ADAMS Accession No. ML13109A458)

24. RG 1.54, Revision 3, Service Level I, II, and III Protective Coatings Applied to Nuclear Power Plants, dated April 2017 (ADAMS Accession No. ML17031A288)