ML20254A355

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Shine Medical Technologies, LLC - Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 7-4
ML20254A355
Person / Time
Site: SHINE Medical Technologies
Issue date: 09/10/2020
From: Jim Costedio
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
2020-SMT-0087
Download: ML20254A355 (16)
v • d • e


Text

September 10, 2020 2020-SMT-0087 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

(2) NRC letter to SHINE Medical Technologies, LLC, Issuance of Request for Additional Information Related to the SHINE Medical Technologies, LLC Operating License Application (EPID No. L-2019-NEW-0004), dated May 26, 2020 (ML20148M278)

(3) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3, dated August 28, 2020 SHINE Medical Technologies, LLC Application for an Operating License Revision 1 of SHINE Response to Request for Additional Information 7-4 Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI (Reference 1). The NRC staff determined that additional information was required to enable the staffs continued review of Chapter 7 of the Final Safety Analysis Report (FSAR)

(Reference 2). SHINE provided the response to the NRC staffs request for additional information (RAI) associated with Chapter 7 of the FSAR via Reference (3).

SHINE has determined that the SHINE Response to RAI 7-4, provided via Reference (3),

contains an administrative error in that a table referenced in the response was not provided to support the response. provides Revision 1 of the SHINE Response to RAI 7 4. Revision 1 supersedes the previously provided SHINE Response to RAI 7-4, provided via Reference (3), in its entirety.

If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on September 10, 2020.

101 E. Milwaukee St., Suite 600 l Janesville, WI 53545 l P (608) 210-1060 l F (608) 210-2504 l www.shinemed.com

        

Document Control Desk Page 2 Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health

ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE REVISION 1 OF SHINE RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 7-4 The NRC staff determined that additional information was required to enable the staffs continued review of Chapter 7 of the SHINE Medical Technologies, LLC (SHINE) Final Safety Analysis Report (FSAR) (Reference 1). SHINE provided the response to the NRC staffs request for additional information (RAI) associated with Chapter 7 of the FSAR via Reference (2).

SHINE has determined that the SHINE Response to RAI 7-4, provided via Reference (2),

contains an administrative error in that a table referenced in the response was not provided to support the response. Revision 1 of the SHINE Response to RAI 7-4 is provided below.

Chapter 7 - Instrumentation and Control Systems RAI 7-4 Chapter 7 of the SHINE FSAR describes the highly integrated protection system (HIPS) platform for the TRPS and engineered safety features actuation system (ESFAS). However, the FSAR appears to contain inconsistent descriptions of the use of the HIPS platform and/or implies how the HIPS platform will be used to implement the design of the TRPS and ESFAS.

(1) Clarify how the TRPS and ESFAS use the generically approved HIPS platform. If the application intends to credit the NRC-approved HIPS platform, then:

(a) Describe how the Application Specific Action Items identified for the HIPS platform are dispositioned, including those that are not applicable for the SHINE TRPS and ESFAS.

(b) Describe the differences between the system architecture approved for HIPS platform and the architecture proposed for the TRPS and ESFAS and explain it is acceptability for the SHINE design.

(2) Provide a description of the SHINE system design, as well as the suitability and adequacy of the HIPS platform for performing SHINE design functions, including conformance with the SHINE design criteria and bases. This RAI is similar to RAI 7-1, but in this case, SHINE should indicate the specific design or attributes in the HIPS platform that will meet each of its applicable design criterion.

SHINE Response (1) SHINE has revised Chapter 7 of the FSAR to describe SHINE crediting the prior NRC approval of the Highly Integrated Protection System (HIPS) platform, described in Topical Report TR-1015-18653, Design of the Highly Integrated Protection System Platform (Reference 3), for use in the SHINE facility. This clarification has been added to Subsections 7.1.2 and 7.1.3 of the FSAR.

Page 1 of 14

(a) The Application-Specific Action Items (ASAIs) identified in the Safety Evaluation for the HIPS platform (Reference 4) are dispositioned as described in Table 7-4-1. The table identifies the sections of the FSAR that address ASAIs that are applicable to SHINE.

(b) The architecture described in Section 3.0 of the HIPS topical report (Reference 3) is a representative architecture provided for reference to help describe the attributes of the HIPS platform. As stated in Section 3.1.6 of the Safety Evaluation for the HIPS platform (Reference 4), This example architecture is intended to illustrate the capability of the HIPS platform to implement a prospective system architecture and does not define a proposed usage. The approval of the HIPS platform is independent of architecture; therefore, the architecture of the SHINE control systems does not represent a difference from the approved HIPS platform.

(2) Section 7.4.5 of the FSAR describes the system design, suitability, and adequacy of the HIPS platform for performing SHINE design functions. Conformance with the SHINE design criteria and design bases for applicable HIPS platform design attributes is described in Section 7.4.5 of the FSAR.

Additionally, as described in the SHINE Response to RAI 7-1 and RAI 7-2 (Reference 2),

Subsections 7.4.2 and 7.5.2 of the FSAR have been revised to state how the target solution vessel reactivity protection system (TRPS) and engineered safety features actuation system (ESFAS) meet or implement the applicable SHINE design criteria and system-specific design criteria.

A revision to the FSAR, incorporating the changes to Chapter 7 described above, was provided via Reference 2.

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Table 7-4-1: Disposition of Application-Specific Action Items SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 1 2.0 An applicant or licensee referencing this SE must establish full Partially applicable. Compliance to the NuScale DSRS and Not applicable compliance with the design criteria and regulations identified in 10 CFR 50.55a(h) is not applicable to SHINE. Chapter 7 of the NuScale DSRS Chapter 7, Table 7.1, or the appropriate plant FSAR describes the application of the HIPS platform to design criteria that are relevant to the specific application(s) of implement the TRPS and ESFAS design, consistent with the the HIPS platform as a safety-related I&C system in an NPP as requirements of 10 CFR 50.34(b)(2) and the guidance of defined in 10 CFR 50.55a(h). NUREG-1537.

2 2.0 An applicant or licensee referencing this SE must demonstrate Applicable. Evidence that the HIPS platform used to implement Not applicable 3.0 that the HIPS platform used to implement the application- the TRPS and ESFAS design is unchanged from the base specific or plant-specific system is unchanged from the base platform addressed in the Safety Evaluation for the HIPS platform addressed in this SE. Otherwise, the applicant or platform (Reference 4) is provided in Subsections 7.1 and 7.4.5 licensee must clearly and completely identify any modification of the FSAR.

or addition to the base HIPS platform as it is employed and provide evidence of compliance by the modified platform with all applicable regulations that are affected by the changes.

3 3.6 Although the staff determined that the HIPS platform supports Not applicable. Compliance to IEEE 603-1991, IEEE Standard Not applicable satisfying various sections and clauses of IEEE Std. 603-1991, Criteria for Safety Systems for Nuclear Power Generating an applicant or licensee referencing this SE must identify the Stations, is not applicable to SHINE. The TRPS and ESFAS approach taken to satisfy each applicable clause of IEEE design supports satisfying various sections and clauses of IEEE Std. 603-1991. Because this SE does not address a specific 603-1991 because the HIPS platform supports satisfying application, establish a definitive safety system or protective various sections and clauses of IEEE 603-1991; however, the action, or identify and analyze the impact of credible events SHINE basis for application of the HIPS platform to implement along with their direct and indirect consequences, an applicant the TRPS and ESFAS design is consistent with the guidance of or licensee should identify its plant-specific design basis for its NUREG-1537.

safety system application and the applicability of each IEEE Std. 603-1991 clause to its application-specific HIPS platform-based safety system or component. Furthermore, the applicant or licensee must demonstrate that the plant-specific and application-specific use of the HIPS platform satisfies the applicable IEEE Std. 603-1991 clauses in accordance with the plant-specific design basis and safety system application.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 4 3.7 Although the staff determined that the HIPS platform supports Partially applicable. Compliance to IEEE 7-4.3.2-2003, IEEE Not applicable satisfying various sections and clauses of IEEE Standard Criteria for Digital Computers in Safety Systems of Std. 7-4.3.2-2003, an applicant or licensee referencing this SE Nuclear Power Generating Stations, is not applicable to must identify the approach taken to satisfy each applicable SHINE. The TRPS and ESFAS design supports satisfying clause of IEEE Std. 7-4.3.2-2003. The applicant or licensee various sections and clauses of IEEE 7-4.3.2-2003 because the should consider its plant-specific design basis. This SE does HIPS platform supports satisfying various sections and clauses not address a specific application, establish a definitive safety of IEEE 7-4.3.2-2003; however, the SHINE basis for application system or protective action, or identify and analyze the impact of the HIPS platform to implement the TRPS and ESFAS design of credible events along with their direct and indirect is consistent with the guidance of NUREG-1537. The following consequences. The applicant or licensee should identify its Sections of the FSAR address various clauses of IEEE 7-4.3.2-plant-specific design basis for its safety system application and 2003:

the applicability of each IEEE Std. 7-4.3.2-2003 clause to its application-specific HIPS platform-based safety system or

  • 7.1.4 (Highly Integrated Protection System Design) component. Furthermore, the applicant or licensee must
  • 7.4.5.2.1 (Independence) demonstrate that the plant-specific and application-specific use
  • 7.4.5.2.2 (Redundancy) of the HIPS platform satisfies the applicable IEEE Std. 7-4.3.2-2003 clauses in accordance with the plant-specific
  • 7.4.5.2.3 (Predictability and Repeatability) design basis and safety system application.
  • 7.4.5.5 (HIPS Performance Analysis)
  • 7.4.3.13 and 7.5.3.12 (Design Codes and Standards)
  • 7.4.2.2.11 and 7.5.2.2.11 (Equipment Qualification)
  • 7.6 (Control Console and Display Instruments)
  • 7.4.3.7 and 7.5.3.6 (Human Factors)
  • 7.4.4.1 and 7.5.4.1 (Monitored Variables and Response)
  • 7.4.4.2 and 7.5.4.2 (Operational Bypass, Permissives, and Interlocks) 5 3.8 Although the staff determined that the HIPS platform includes Not applicable. Compliance to DI&C-ISG-04, Interim Staff Not applicable features to support satisfying various sections and clauses of Guidance on Highly-Integrated Control Rooms -

DI&C-ISG-04, an applicant or licensee referencing this SE must Communications Issues (HICRc), is not applicable to SHINE.

evaluate the HIPS platform-based system for full conformance The TRPS and ESFAS design supports satisfying various against this guidance. The applicant or licensee should consider sections and clauses of DI&C-ISG-04 because the HIPS its plant-specific design basis. This SE does not address a platform supports satisfying various sections and clauses of specific application, establish a definitive safety system or DI&C-ISG-04; however, the SHINE basis for application of the protective action, or identify and analyze the impact of credible HIPS platform to implement the TRPS and ESFAS design is events along with their direct and indirect consequences. consistent with the guidance of NUREG-1537.

6 3.9 Although the staff determined that the HIPS platform includes Not applicable. Compliance to the SRM to SECY-93-087, Not applicable features to support satisfying various sections of the SRM to Policy, Technical, and Licensing Issues Pertaining to SECY-93-087, an applicant or licensee referencing this SE Evolutionary and Advanced Light-Water Reactor (ALWR) must evaluate the HIPS platform-based system for full Designs, is not applicable to SHINE. The TRPS and ESFAS compliance against this requirement. The applicant or licensee design supports satisfying various sections and clauses of the should consider its plant-specific design basis. This SE does SRM to SECY-93-087 because the HIPS platform supports not address a specific application, establish a definitive safety satisfying various sections and clauses of the SRM to system or protective action, or identify and analyze the impact SECY-93-087; however, the SHINE basis for application of the of credible events along with their direct and indirect HIPS platform to implement the TRPS and ESFAS design is consequences. consistent with the guidance of NUREG-1537.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 7 3.1.4.3 An applicant or licensee referencing this SE must provide Applicable. Subsections 7.4.4.3 and 7.5.4.4 of the FSAR TRPS Criterion 33 and 37 administrative controls (e.g., procedures, technical describe how the HIPS-based TRPS and ESFAS equipment is ESFAS Criterion 34 and 38 specifications) to prevent an operator from placing the same used for maintenance bypasses. Limiting Conditions for SFM across more than one division into maintenance bypass Operation (LCOs) 3.2.3, 3.2.4, and 3.7.1 of the Technical concurrent with a single failure of a different division. Specifications provide the administrative controls related to placing a TRPS or ESFAS safety function module (SFM) into maintenance bypass.

8 3.2 An applicant or licensee referencing this SE should verify Partially applicable. Compliance to Regulatory Guide 1.75, TRPS Criterion 20 and 21 having appropriate physical independence between nonsafety- Power Reactor Criteria for Independence of Electrical Safety ESFAS Criterion 21 and 22 related and safety-related equipment to satisfy the Class 1E to Systems, is not applicable to SHINE. Subsection 7.4.5.2.1 of non-Class 1E separation requirements, consistent with the the FSAR describes how the HIPS-based TRPS and ESFAS guidelines of RG 1.75, Revision 3. equipment implements physical, electrical, communications, and functional independence between nonsafety-related and safety-related equipment, consistent with the guidance of NUREG-1537.

9 3.4 An applicant or licensee referencing this SE must provide the Not applicable. Compliance to 10 CFR 50.55a(h) or the SRM to Not applicable basis for the allocation of safety functions between the two SECY-93-087 is not applicable to SHINE. Implementation of diverse divisions to mitigate the effects of a postulated CCF diversity within the TRPS and the ESFAS is discussed in concurrent with Chapter 15 events of its final safety analysis Subsection 7.4.5.2.4 of the FSAR.

report.

10 3.4 An applicant or licensee referencing this SE must verify that all Not applicable. Compliance to 10 CFR 50.55a(h) or the SRM to Not applicable diversity attributes of a HIPS platform (i.e., equipment diversity, SECY-93-087 is not applicable to SHINE. Implementation of design diversity, and functional diversity) conform to the diversity within the TRPS and the ESFAS is discussed in diversity design details provided in the TR. Subsection 7.4.5.2.4.

11 3.4 An applicant or licensee referencing this SE must verify that the Not applicable. Compliance to 10 CFR 50.55a(h) or IEEE 603 is Not applicable diverse FPGA technologies have unique identification. not applicable to SHINE. Subsections 7.4.3.10 and 7.5.3.9 of the FSAR describe how the HIPS-based TRPS and ESFAS equipment designs address unique identification.

12 3.6.2.1 An applicant or licensee referencing this SE should perform a Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 16 and 17 3.6.2.5 system-level FMEA to demonstrate that the application-specific design criteria of NUREG-1537 for single failure. The TRPS and ESFAS Criterion 16, 17, and 18 3.6.2.6.3.1 use of the HIPS platform identifies each potential failure mode ESFAS designs include performance of a failure modes and 3.6.2.6.3.3 and determines the effects of each failure. The FMEA should effects analysis, which evaluates potential single failures and 3.8.1.18 demonstrate that single failures, including those with the determines the effects of each failure, to inform the designs of potential to cause a nonsafety system action (i.e., a control TRPS and ESFAS.

function) resulting in a condition requiring protective action (i.e., a protection function), cannot adversely affect the protection functions, as applicable.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 13 3.6.2.1 An applicant or licensee referencing this SE should Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 47 demonstrate that the application-specific diagnostic, self-test, design criteria of NUREG-1537 for single failure, redundancy, ESFAS Criterion 48 and manually initiated test and calibration features will not and independence. Subsections 7.4.5.2.1 and 7.4.5.2.2 of the adversely affect channel independence, system integrity, or the FSAR describe how the principles of independence and systems ability to meet the single-failure criterion. redundancy are incorporated into the design of the TRPS and ESFAS. The TRPS and ESFAS designs include performance of a failure modes and effects analysis, which evaluates potential single failures and determines the effects of each failure, to inform the designs of TRPS and ESFAS.

14 3.6.2.1 An applicant or licensee referencing this SE must review the Partially applicable. Compliance to 10 CFR 50.55a(h) or Not applicable actions to be taken when failures and errors are detected during IEEE 603 is not applicable to SHINE. The ESFAS and TRPS tests and self-tests and ensure that these actions are consistent designs conform to the design criteria of NUREG-1537 for self-with system requirements. In addition, the applicant or licensee testing and diagnostics. Subsections 7.4.4.4, 7.5.4.5, and should describe how errors and failures are indicated and 7.4.5.5 of the FSAR describe the self-testing and diagnostic managed after they are detected. Finally, the applicant or features of the TRPS and ESFAS design. The TRPS and licensee should confirm that this information is provided in the ESFAS designs include performance of a failure modes and single-failure analysis for the plant-specific application. effects analysis, which evaluates potential single failures and determines the effects of each failure, to inform the designs of TRPS and ESFAS.

15 3.6.2.2 An applicant or licensee referencing this SE must demonstrate Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 43, 44, and 45 3.6.4.3 that the application-specific logic satisfies the completion of design criteria of NUREG-1537 for completion of protective ESFAS Criterion 44, 45, and 46 protective action requirements. actions. Subsections 7.4.3.3 and 7.5.3.2 of the FSAR discuss how the TRPS and ESFAS designs ensure completion of protective actions.

16 3.6.2.3 An applicant or licensee referencing this SE must confirm that Partially applicable. Compliance to 10 CFR 50 Part B is not TRPS Criterion 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13 3.7.1.3 the HIPS platform manufacturer is currently on the Nuclear applicable to SHINE. The SHINE Quality Assurance Program ESFAS Criterion 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13 Procurement Issues Committee list or confirm that the HIPS Description (QAPD) is based upon ANSI/ANS-15.8-1995 and manufacturing quality processes conform to the applicants or complies with the requirements of 10 CFR 50.34 for a licensees program that is compliant with 10 CFR Part 50, production or utilization facility. The HIPS manufacturing quality Appendix B (i.e., vendor is included in the applicants Approved processes, including the HIPS software and associated Vendor List). The applicant or licensee will need to demonstrate development life cycle, conform to the SHINE QAPD that the HIPS software and associated development life cycle requirements.

conform to applicable regulatory requirements.

17 3.6.2.4 An applicant or licensee referencing this SE must confirm that Applicable. The SHINE QAPD is based upon ANSI/ANS 15.8- TRPS Criterion 54 and 55 3.6.2.6.2 the HIPS platform equipment is qualified to the applicable 1995 and complies with the requirements of 10 CFR 50.34 for a ESFAS Criterion 55 and 56 3.7.1.4 regulatory requirements. production or utilization facility. Subsections 7.4.3.13 and 3.8.1.17 7.5.3.12 of the FSAR identify the required codes and standards to be used in qualifying the TRPS and ESFAS equipment.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 18 3.6.2.5 An applicant or licensee referencing this SE must identify the Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 28 and 46 3.7.1.5.1 safe states for protective functions and the conditions that design criteria of NUREG-1537 for safe states. The safe states ESFAS Criterion 29 and 47 3.8.1.20 require the system to enter a fail-safe state. The applicant or for the TRPS and ESFAS are provided in Subsection 7.4.3.8 licensee must also demonstrate system qualification for and Table 7.5-2 of the FSAR and the conditions that require the installation and operation in mild environment locations. TRPS and ESFAS to enter a fail-safe state are provided in Subsections 7.4.3.1 and 7.5.3.1 of the FSAR. FSAR Subsections 7.4.3.13 and 7.5.3.12 identify the required codes and standards to be used in qualifying the TRPS and ESFAS equipment.

19 3.6.2.5 An applicant or licensee referencing this SE must confirm that Applicable. The ESFAS and TRPS designs conform to the SHINE Design Criterion 13 3.7.1.5.1 system real-time performance is adequate to ensure completion design criteria of NUREG-1537 for completion of protective TRPS Criterion 14 and 24 3.8.1.19 of protective actions within critical time frames required by the actions within critical time frames. Assumed maximum response ESFAS Criterion 14 and 25 3.8.1.20 plant safety analyses. time and response time analysis for the TRPS and ESFAS is discussed in Subsection 7.4.5.2.3 of the FSAR.

20 3.6.2.6.1 An applicant or licensee referencing this SE must demonstrate Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 18, 20, 21, 22, and 23 3.8.1.2 that the full system design, any use of a shared component, the design criteria of NUREG-1537 for independence. ESFAS Criterion 19, 21,22, 23, and 24 3.8.1.16 equipments installation, and the power distribution architecture Subsection 7.4.5.2.1 of the FSAR describes how the provide the required independence. HIPS-based TRPS and ESFAS equipment implements physical, electrical, communications, and functional independence.

21 3.6.2.6.1 An applicant or licensee referencing this SE must provide Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 17 3.8.1.2 redundant power sources to separately supply the redundant design criteria of NUREG-1537 for redundancy. ESFAS Criterion 17 3.8.1.16 power conversion features within the HIPS platform. Subsection 7.4.5.2.2 of the FSAR describes how the HIPS-based TRPS and ESFAS equipment implements redundancy.

22 3.2.2 An applicant or licensee referencing this SE must verify that the Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 20, 21 and 22 3.6.2.6.3.1 safety network provides electrical, physical, and design criteria of NUREG-1537 for independence. ESFAS Criterion 21, 22 and 23 3.8.1.1 communications independence and security requirements for Subsection 7.4.5.2.1 of the FSAR describes how the 3.8.1.2 communication from safety to nonsafety-related systems. HIPS-based TRPS and ESFAS equipment implements physical, 3.8.1.3 electrical, communications, and functional independence.

3.8.1.8 3.8.1.16 23 3.6.2.6.3.2 An applicant or licensee referencing this SE must perform Partially applicable. Compliance to 10 CFR 50.55a(h) or TRPS Criterion 19, 20, 21, and 22 3.6.2.6.4 isolation testing on the HIPS platform equipment to demonstrate IEEE 603 is not applicable to SHINE. The ESFAS and TRPS ESFAS Criterion 20, 21, 22, and 23 3.8.1.1 the capability to satisfy the Class 1E to non-Class 1E isolation designs conform to the design criteria of NUREG-1537 for 3.8.1.2 requirements, consistent with the guidelines of RG 1.75, independence. Subsection 7.4.5.2.1 of the FSAR describes how 3.8.1.16 Revision 3. the HIPS-based TRPS and ESFAS equipment implements physical, electrical, communications, and functional independence.

24 3.6.2.7 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 47 and 48 3.6.3.5 the HIPS platform equipment is used for testing and calibration design criteria of NUREG-1537 for testing and calibration. ESFAS Criterion 48 and 49 of safety-related features. Subsections 7.4.4.4, 7.5.4.5, and 7.4.5.5 of the FSAR describe the self-testing and calibration features of the TRPS and ESFAS design.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 25 3.6.2.7 An applicant or licensee referencing this SE must provide Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 48 and 49 3.6.3.5 additional diagnostics or testing functions (i.e., self-tests or design criteria of NUREG-1537 for test and calibration. ESFAS Criterion 49 and 50 periodic surveillance tests) to address any system-level failures Subsections 7.4.4.4, 7.5.4.5, and 7.4.5.5 of the FSAR describe that are identified as detectable only through periodic testing and calibration for the TRPS and the ESFAS.

surveillance. LCOs 3.2.1 and 3.2.2 of the Technical Specifications identify the periodic surveillance requirements for TRPS and ESFAS equipment.

26 3.6.2.7 An applicant or licensee referencing this SE must describe how Partially applicable. Compliance to 10 CFR 50.55a(h) or IEEE TRPS Criterion 47 3.6.3.5 the HIPS platform equipment is used for any automatic sensor 603 is not applicable to SHINE. The ESFAS and TRPS designs ESFAS Criterion 48 cross-check as a credited surveillance test function and the conform to the design criteria of NUREG-1537 for system tests provisions to confirm the continued execution of the automatic and surveillances. Automatic testing methods and use of TRPS tests during plant operations. and the ESFAS equipment for performing cross-checks is discussed in Subsections 7.4.4.4, 7.5.4.5, and 7.4.5.5 of the FSAR. Required channel checks are discussed in the Technical Specifications.

27 3.6.2.8.1 An applicant or licensee referencing this SE must describe any Not applicable. The SHINE design does not include manually Not applicable manual controls and associated displays used to support controlled safety actions for which no automatic control is manually controlled safety actions necessary to accomplish a provided.

safety function for which no automatic control is provided.

28 3.6.2.8.2 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the SHINE Design Criterion 6 the HIPS platform safety system status information is used in design criteria of NUREG-1537 for indication. A description of displays to provide unambiguous, accurate, complete, and how safety system status is used in displays is provided in timely status of safety system protective actions. Section 7.6 of the FSAR.

29 3.6.2.8.3 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 42 the HIPS platform bypass status information is used to design criteria of NUREG-1537 for indication of bypasses. A ESFAS Criterion 43 automatically actuate the bypass indication for bypassed or description of how safety system status is provided to the inoperable conditions, when required, and provide the capability operators is provided in Subsections 7.4.4.2 and 7.5.4.2 of the to manually activate the bypass indication from within the FSAR. Subsections 7.4.4.3 and 7.5.4.4 of the FSAR provide a control room. description of manual switches for placing HIPS modules in bypass.

30 3.6.2.8.4 An applicant or licensee referencing this SE must describe how Partially applicable. Compliance to 10 CFR 50.55a(h) or IEEE SHINE Design Criterion 6 the information displays are accessible to the operator and are 603 is not applicable to SHINE. TRPS and ESFAS equipment is visible from the location of any controls used to effect a not used to display information for the operator or to affect a manually controlled protective action provided by the front panel manually-controlled protective action provided by the front panel controls of a HIPS-based system. controls. A description of how safety system status is used in displays is provided in Section 7.6 of the FSAR.

31 3.6.2.9 An applicant or licensee referencing this SE must provide Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 1, 2, and 3 additional control of access features to address the system- design criteria of NUREG-1537 for access control. ESFAS Criterion 1, 2, and 3 level aspects for a safety system using the HIPS platform. Subsection 7.4.5.3 of the FSAR describes how the HIPS-based TRPS and ESFAS equipment design addresses the control of access.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 32 3.6.2.10 An applicant or licensee referencing this SE must provide Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 48 and 49 3.8.1.13 additional diagnostics or testing functions (self-tests or periodic design criteria of NUREG-1537 for test and calibration. ESFAS Criterion 49 and 50 surveillance tests) to address any system-level failures that are Subsections 7.4.4.4, 7.5.4.5, and 7.4.5.5 of the FSAR describe identified as detectable only through periodic surveillance. The testing and calibration for the TRPS and the ESFAS.

applicant or licensee must also ensure that failures detected by LCOs 3.2.1 and 3.2.2 of the Technical Specifications identify these additional diagnostics or testing functions are consistent the required surveillance tests for the TRPS and ESFAS with the assumed failure detection methods of the application- actuation priority logic. A TRPS and ESFAS failure modes and specific single-failure analysis. effects analysis identified no nondetectable system failures.

33 3.6.2.11 An applicant or licensee referencing this SE must establish the Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 50 identification and coding requirements for cabinets and cabling design criteria of NUREG-1537 for identification. Subsections ESFAS Criterion 51 for a safety system. 7.4.3.10 and 7.5.3.9 of the FSAR describe how TRPS and ESFAS equipment design addresses identification.

34 3.6.2.12 An applicant or licensee referencing this SE must demonstrate Not applicable. Compliance to 10 CFR 50.55a(h) or IEEE 603 is Not applicable that the application-specific system design implemented with not applicable to SHINE. The ESFAS and TRPS designs the HIPS platform meets the applicable regulatory requirements comply with the requirements of 10 CFR 50.34(b)(2), consistent for auxiliary features. with the guidance of NUREG 1537.

35 3.6.2.13 An applicant or licensee referencing this SE must demonstrate Applicable. The ESFAS and TRPS designs conform to the SHINE Design Criterion 5 that the application-specific system design implemented with design criteria of NUREG-1537 for shared systems.

the HIPS platform meets the applicable regulatory requirements Subsection 7.1.2 and Figure 7.1-1 of the FSAR describe the for shared systems. use of a separate TRPS subsystem for each IU Cell.

36 3.6.2.14 An applicant or licensee referencing this SE must confirm that Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 51 the HIPS platform equipment meets any specified human design criteria of NUREG-1537 for human factors. ESFAS Criterion 52 factors requirements. Subsections 7.4.3.7 and 7.5.3.6 of the FSAR describe how human factors are incorporated into the design of the TRPS and ESFAS.

37 3.6.2.15 An applicant or licensee referencing this SE must confirm that Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 23 and 24 3.7.1.15 the HIPS platform equipment meets any specified quantitative design criteria of NUREG-1537 for reliability. Reliability ESFAS Criterion 24 and 25 or qualitative reliability goals. characteristics of the TRPS and ESFAS designs are described in Subsection 7.4.5.2.3 of the FSAR.

38 3.6.3.1 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the SHINE Design Criterion 14 3.6.4.1 the HIPS platform equipment is used to provide automatic design criteria of NUREG-1537 for automatic sense and safety system sense and command features for required safety command features. Subsections 7.4.3.1 and 7.5.3.1 of the functions. FSAR describe the automatic sense and command features of the TRPS and ESFAS.

39 3.6.3.2 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 15 and 52 3.6.4.2 the HIPS platform equipment is used to provide manual safety design criteria of NUREG-1537 for manual sense and command ESFAS Criterion 15 and 53 system sense and command features for required safety features. Subsections 7.4.3.7 and 7.5.3.6 of the FSAR describe functions. the manual sense and command features of the TRPS and ESFAS.

40 3.6.3.3 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 27 the HIPS platform equipment is used for sense and command design criteria of NUREG-1537 for sense and command ESFAS Criterion 28 features to provide protection against the resulting condition of features. Subsections 7.4.3.12 and 7.5.3.11 of the FSAR a nonsafety system action that has been caused by a single describe the sense and command features of the TRPS and credible event, including its direct and indirect consequences. ESFAS.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 41 3.6.3.4 An applicant or licensee referencing this SE must describe how Applicable. The design basis for acquiring and conditioning SHINE Design Criterion 13 the HIPS platform equipment is used to acquire and condition inputs in the TRPS and ESFAS is provided in Subsection 7.4.5 field sensor measurements of the required variables. of the FSAR.

42 3.6.3.6 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 33, 34, 35, 36, 37, 38, 39, 40, and 42 3.6.4.4 the HIPS platform equipment is used for operating bypasses. design criteria of NUREG-1537 for operating bypasses. ESFAS Criterion 34, 35, 36, 37, 38, 39, 40, 41, and 43 Subsections 7.4.4.2 and 7.5.4.2 of the FSAR describe how the HIPS-based TRPS and ESFAS equipment is used for operating bypasses.

43 3.6.3.7 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 41 the HIPS platform equipment is used for maintenance bypasses design criteria of NUREG-1537 for maintenance bypasses. ESFAS Criterion 42 and provide the technical specification requirements. Subsections 7.4.4.3 and 7.5.4.4 of the FSAR describe how the HIPS-based TRPS and ESFAS equipment is used for maintenance bypasses. LCOs 3.2.3, 3.2.4 and 3.7.1 of the Technical Specifications provide the administrative controls related to placing a TRPS or ESFAS SFM into maintenance bypass.

44 3.6.3.8 An applicant or licensee referencing this SE must describe the Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 29, 30 and 32 setpoints, setpoint methodologies, or HIPS platform module design criteria of NUREG-1537 for setpoints. Subsection 7.2.1 ESFAS Criterion 30, 31 and 33 accuracies used for a safety system implemented with the HIPS of the FSAR discusses the setpoint methodology. Tables 7.4-1 platform equipment. and 7.5-1 of the FSAR provide the accuracies required for the TRPS and ESFAS monitored variables.

45 3.6.4.5 An applicant or licensee referencing this SE must describe how Applicable. The ESFAS and TRPS designs conform to the TRPS Criterion 37 and 41 the HIPS platform equipment is used for maintenance design criteria of NUREG-1537 for maintenance bypasses. ESFAS Criterion 38 and 42 bypasses. Subsections 7.4.4.3 and 7.5.4.4 of the FSAR describe how the HIPS-based TRPS and ESFAS equipment is used for maintenance bypasses.

46 3.6.5 An applicant or licensee referencing this SE must describe Applicable. The ESFAS and TRPS designs conform to the SHINE Design Criterion 27 power sources to the HIPS platform equipment and how they design criteria of NUREG-1537 for safety system power meet applicable regulatory requirements. sources. The description of the TRPS and ESFAS power source is provided in Subsection 8a2.2 of the FSAR.

47 3.7.1.5.2 An applicant or licensee referencing this SE must confirm that Applicable. The required quality and standards of TRPS and TRPS Criterion 4, 5, 6, 7, 8, 9, 10, 11, and 12 the manufacturer followed the same design, development, and ESFAS software development processes is described in ESFAS Criterion 4, 5, 6, 7, 8, 9, 10, 11, and 12 iV&V processes for test and calibration functions as for all other Subsection 7.4.5.4 of the FSAR.

HIPS platform functions.

48 3.7.1.5.2 An applicant or licensee referencing this SE that relies on a Not applicable. A separate computer is not relied upon for the Not applicable separate computer for the sole verification of test and sole verification of test and calibration data for the TRPS and calibration data should ensure adequate iV&V, configuration ESFAS.

management, and quality assurance for the test and calibration functions of the separate computer.

49 3.7.1.5.3 An applicant or licensee referencing this SE must confirm that Applicable. The required quality and standards of TRPS and TRPS Criterion 4, 5, 6, 7, 8, 9, 10, 11, and 12 the manufacturer followed the same design, development, and ESFAS software development processes is described in ESFAS Criterion 4, 5, 6, 7, 8, 9, 10, 11, and 12 iV&V processes for self-diagnostics functions as for all other Subsection 7.4.5.4 of the FSAR.

HIPS platform functions.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 50 3.7.1.5.3 An applicant or licensee referencing this SE must verify that the Applicable. The required quality and standards of TRPS and TRPS Criterion 4, 5, 6, 7, 8, 9, 10, 11, 12, and 47 manufacturer included the self-diagnostic functions within its ESFAS software development processes is described in ESFAS Criterion 4, 5, 6, 7, 8, 9, 10, 11, 12, and 48 type testing of the HIPS platform standardized circuit boards Subsection 7.4.5.4 of the FSAR. Subsections 7.4.2.2.11 and during EQ. 7.5.2.2.11 of the FSAR identify the equipment qualifications for applicable operating environments.

51 3.7.1.5.3 An applicant or licensee referencing this SE must demonstrate Applicable. Testing and calibration for the TRPS and the TRPS Criterion 47 that the combination of HIPS platform self-tests and system ESFAS is described in Subsections 7.4.4.4, 7.5.4.5, and 7.4.5.5 ESFAS Criterion 48 surveillance testing provide the necessary test coverage to of the FSAR. LCOs 3.2.1 and 3.2.2 of the Technical ensure that there are no undetectable failures that could Specifications identify the required surveillance testing for the adversely affect a required safety function. TRPS and ESFAS.

52 3.7.1.6 An applicant or licensee referencing this SE must demonstrate Applicable. Subsection 7.4.5.2.1 of the FSAR describes how the TRPS Criterion 18, 19, 20, 21, 22, 23, 24, 25, and 26 that the full system design, any use of a shared component, the HIPS-based TRPS and ESFAS equipment implements physical, ESFAS Criterion 19, 20, 21, 22, 23, 24, 25, 26, and 27 equipments installation, and the communication bus electrical, communications, and functional independence.

architecture provide the required independence.

53 3.7.1.6 An applicant or licensee referencing this SE must verify that the Applicable. Subsection 7.4.5.2.1 of the FSAR describes how the TRPS Criterion 20 and 22 safety network provides communications independence and HIPS-based TRPS and ESFAS equipment implements physical, ESFAS Criterion 21 and 23 security requirements for communication from safety- to electrical, communications, and functional independence.

nonsafety-related systems.

54 3.7.1.11 An applicant or licensee referencing this SE must establish the Applicable. Subsections 7.4.5.4.6.3, 7.4.3.10, and 7.5.3.9 of the TRPS Criterion 50 identification and coding requirements for cabinets and FSAR describe how the HIPS-based TRPS and ESFAS ESFAS Criterion 51 components for a safety system and the methods to verify that equipment design addresses identification.

the correct firmware or software is installed in the correct hardware component.

55 3.8.1.1 An applicant or licensee referencing this SE must demonstrate Applicable. Subsection 7.4.5.2.1 of the FSAR describes how the TRPS Criterion 18, 20, and 21 that a full system design does not, with the exception of division HIPS equipment implements divisional voting logic. Other than ESFAS Criterion 19, 21, and 22 voting logic, depend on any information or resource originating divisional voting logic, the TRPS and ESFAS do not depend on or residing outside its own safety division to accomplish its any information or resource originating or residing outside of safety function. each safety division to accomplish their safety functions.

56 3.8.1.5 An applicant or licensee referencing this SE must confirm that Applicable. A response time analysis for the TRPS and ESFAS TRPS Criterion 23 and 24 system real-time performance is adequate, assuming the is discussed in Subsection 7.4.5.2.3 of the FSAR. ESFAS Criterion 24 and 25 longest possible completion time to ensure the completion of protective actions within the critical time frames required by the plant safety analyses.

57 3.8.1.12 An applicant or licensee referencing this SE must configure the Applicable. The TRPS and ESFAS EIMs are configured to TRPS Criterion 48 slave modules (e.g., SFMs and EIMs) to alarm and assume a provide fault indication and assume the deenergized state as ESFAS Criterion 49 fail-safe state. identified in Subsection 7.4.3.8 of the FSAR for TRPS and Table 7.5-2 of the FSAR for ESFAS. The SFMs will also be configured to provide fault indications, and the specific fail-safe state for each TRPS and ESFAS SFM will be configured during the detailed programmable logic requirements and design phases.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 58 3.8.1.18 An applicant or licensee referencing this SE should verify Applicable. Subsections 7.4.5.3.1 and 7.4.5.4 of the FSAR TRPS Criterion 2, 5, and 6 having appropriate physical, logical, and programmatic controls describe the secure development environment requirements for ESFAS Criterion 2, 5, and 6 during the system development phases to ensure that TRPS and ESFAS system development.

unwanted, unneeded, and undocumented functionality is not introduced into digital safety systems.

59 3.8.1.19 An applicant or licensee referencing this SE must describe how Applicable. TRPS and ESFAS integrity characteristics which TRPS Criterion 24 3.8.1.20 the HIPS platform equipment is used to provide a deterministic support a deterministic communication structure are discussed ESFAS Criterion 25 communication structure for required safety functions. in Subsection 7.4.5.2.3 of the FSAR.

60 3.8.3.1.2 An applicant or licensee referencing this SE must demonstrate Applicable. Communications independence within the TRPS TRPS Criterion 21 and 22 that the full system design supports cross-divisional and and the ESFAS is discussed in Subsection 7.4.5.2.1 of the ESFAS Criterion 22 and 23 nonsafety communication with the appropriate independence FSAR.

and isolation.

61 3.8.3.1.3 An applicant or licensee referencing this SE must demonstrate Applicable. The use of an enable nonsafety switch and Not applicable that the application-specific use of an enable nonsafety switch associated priority logic within the TRPS and ESFAS is and its configuration details will not adversely affect the channel described in Subsections 7.4.3.3, 7.4.3.4, 7.5.3.2, and 7.5.3.3 of independence nor the operation of safety-related equipment the FSAR. Specific logic diagrams for how the enable nonsafety when the safety-related equipment is performing its safety switch is implemented in TRPS and ESFAS logic is provided in function. In addition, the applicant or licensee must demonstrate Figures 7.4-1 and 7.5-1 of the FSAR. Use of the enable that the application-specific use of an enable nonsafety switch nonsafety switch is also discussed in Section 7.6 of the FSAR.

should not be able to bring a safety function out of bypass condition unless the affected division has itself determined that such action would be acceptable.

62 3.9.1 An applicant or licensee referencing this SE must demonstrate Partially applicable. Compliance to 10 CFR 50.55a(h) is not TRPS Criterion 16 3.9.2 that the HIPS platform equipment is used to provide FPGA applicable to SHINE. Implementation of diversity within the ESFAS Criterion 16 diversity between redundant portions of the systems to TRPS and the ESFAS is discussed in Subsections 7.4.5.2.4 eliminate HIPS platform digital CCF vulnerabilities. and 7.4.5.2.5 of the FSAR. The diversity of equipment between the TRPS/ESFAS and the PICS is also relied upon to provide defense-in-depth and diversity against digital common cause failures (CCF) in the TRPS and ESFAS.

63 3.9.2 An applicant or licensee referencing this SE must address any Applicable. Implementation of diversity within the TRPS and the TRPS Criterion 16 3.9.3 other digital CCF vulnerabilities in the application-specific D3 ESFAS is discussed in Subsections 7.4.5.2.4 and 7.4.5.2.5 of ESFAS Criterion 16 analysis. the FSAR. The diversity of equipment between the TRPS/ESFAS and the PICS is also relied upon to provide defense-in-depth and diversity against digital CCF in the TRPS and ESFAS.

64 3.9.3 An applicant or licensee referencing this SE must demonstrate Partially applicable. Compliance to 10 CFR 50.55a(h) is not TRPS Criterion 16 that the HIPS platform equipment is used to provide FPGA applicable to SHINE. Implementation of diversity within the ESFAS Criterion 16 diversity between redundant portions of the system architecture TRPS and the ESFAS is discussed in Subsections 7.4.5.2.4 (e.g., in each of two redundancies in a four-fold redundant and 7.4.5.2.5 of the FSAR. The diversity of equipment between system or in one redundancy in a two-fold redundant system) to the TRPS/ESFAS and the PICS is also relied upon to provide ensure HIPS platform safety performance in the presence of a defense-in-depth and diversity against digital CCF in the TRPS digital CCF. and ESFAS.

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SER ASAI ASAI Applicability to SHINE and Description of How the Applicable Design Criteria Referenced ASAI Description No. TRPS and ESFAS Design Addresses the ASAI (As Stated in Subsections 7.4.2 and 7.5.2 of the FSAR)

Section(s) 65 3.9.4 An applicant or licensee referencing this SE must demonstrate Partially applicable. Compliance to 10 CFR 50.55a(h) is not TRPS Criterion 16 that the HIPS platform equipment is used to provide diversity for applicable to SHINE. Implementation of diversity within the ESFAS Criterion 16 indication and component control signals to ensure HIPS TRPS and the ESFAS is discussed in Subsections 7.4.5.2.4 platform monitoring and control performance in the presence of and 7.4.5.2.5 of the FSAR. The diversity of equipment between a digital CCF. the TRPS/ESFAS and the PICS is also relied upon to provide defense-in-depth and diversity against digital CCF in the TRPS and ESFAS.

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References (1) NRC letter to SHINE Medical Technologies, LLC, Issuance of Request for Additional Information Related to the SHINE Medical Technologies, LLC Operating License Application (EPID No. L-2019-NEW-0004), dated May 26, 2020 (ML20148M278)

(2) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3, dated August 28, 2020 (3) NuScale Power, LLC letter to NRC, NuScale Power, LLC Submittal of the Approved Version of NuScale Topical Report TR-1015-18653, Design of the Highly Integrated Protection System Platform, Revision 2 (CAC No. RQ6005), dated September 13, 2017 (ML17256A892)

(4) NRC letter to NuScale Power, LLC, Final Safety Evaluation for NuScale Power, LLC Licensing Topical Report: 1015-18653, Design of the Highly Integrated Protection System Platform, Revision 2, CAC No. RQ6005, dated June 6, 2017 (ML17116A097)

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