ML22073A208

Shine OL SER Chapter 6 with No Open Items

ML22073A208
Person / Time
Site:	SHINE Medical Technologies
Issue date:	03/14/2022
From:	Gavello M NRC/NRR/DANU/UNPL
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Gavello M
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ENGINEERED SAFETY FEATURES Engineered safety features (ESFs) are active or passive features designed to mitigate the consequences of accidents and to keep radiological exposures to the public, the facility staff, and the environment within acceptable values at the SHINE Medical Technologies, LLC (SHINE, the applicant) irradiation facility (IF) and radioisotope production facility (RPF). The concept of ESFs evolved from the defense-in-depth philosophy of multiple layers of design features to prevent or mitigate the release of radioactive materials to the environment during accident conditions. The need for ESFs is determined by SHINEs accident analysis.

This chapter of the SHINE operating license application safety evaluation report (SER) describes the review and evaluation of the U.S. Nuclear Regulatory Commission (NRC, the Commission) staff of the final design of the SHINE IF and RPF ESFs as presented in Chapter 6, Engineered Safety Features, of the SHINE Final Safety Analysis Report (FSAR), as supplemented by the applicants responses to NRC requests for additional information (RAIs).

6a Irradiation Facility Engineered Safety Features SER Section 6a, Irradiation Facility Engineered Safety Features, provides an evaluation of the final design of SHINEs IF ESFs, as presented in SHINE FSAR Section 6a2, Irradiation Facility Engineered Safety Features, within which SHINE describes features designed to mitigate consequences of accidents and events in order to keep radiological exposures within acceptable values.

6a.1 Areas of Review The NRC staff reviewed SHINE FSAR Section 6a2 against applicable regulatory requirements, using appropriate regulatory guidance and acceptance criteria, to assess the sufficiency of the final design and performance of the SHINE IF ESFs. The final design bases of the SHINE IF ESFs were evaluated to ensure that the design bases and functions of the structures, systems, and components (SSCs) are presented in sufficient detail to allow a clear understanding of the facility and to ensure that the facility can be operated for its intended purpose and within regulatory limits for ensuring the health and safety of the operating staff and the public.

Drawings and diagrams were evaluated to determine if they present a clear and general understanding of the physical facility features and of the processes involved. In addition, the staff evaluated the sufficiency of SHINEs proposed technical specifications for the facility.

Areas of review for this section include a summary description of the IF ESFs, as well as a detailed description of the IF confinement. Within these review areas, the NRC staff assessed, in part, the design bases and functional descriptions of the required mitigative features of the confinement ESFs; drawings, schematic drawings and tables of important design and operating parameters, and specifications for confinement ESFs; necessary ESF equipment included as part of the confinement fabrication specifications; description of control and safety instrumentation, including locations and functions of sensors, readout devices, monitors and isolation components, as applicable; and the required limitations on the release of confined effluents to the environment.

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The ESFs described in SHINE FSAR Sections 6a2 are achieved through a combination of passive and active features of many SSCs. A detailed description of many of the SSCs are in their applicable portions of the FSAR and referenced in this SER.

6a.2 Summary of Application SHINE FSAR Section 6a.2 includes a summary of the ESFs installed in the IF, including references to FSAR Tables and Sections, which address accidents considered in the design.

Additionally, FSAR Table 6a2.1-1, Summary of Engineered Safety Features and Design Basis Accidents Mitigated, summarizes seven design-basis accidents (DBAs) mitigated by the confinement ESF, including a list of SSCs that provide an ESF.

6a.3 Regulatory Requirements and Guidance and Acceptance Criteria The NRC staff reviewed SHINE FSAR Section 6a2 against the applicable regulatory requirements, using appropriate regulatory guidance and acceptance criteria, to assess the sufficiency of the final design and performance of the SHINE IF ESFs for the issuance of an operating license.

6a.3.1 Applicable Regulatory Requirements The applicable regulatory requirements for the evaluation of SHINEs IF ESFs are as follows:

10 CFR 50.34, Contents of applications; technical information, paragraph (b), Final safety analysis report.

10 CFR 50.36, Technical Specifications.

10 CFR 50.40, Common Standards.

10 CFR 50.57, Issuance of operating license.

10 CFR 20.1201, Occupational dose limits for adults.

10 CFR 20.1301, Dose limits for individual members of the public.

6a.3.2 Applicable Regulatory Guidance and Acceptance Criteria In determining the regulatory guidance and acceptance criteria to apply, the NRC staff used its judgment, as the available guidance and acceptance criteria were typically developed for nuclear reactors. Given the similarities between the SHINE facility and non-power research reactors, the staff determined to use the following regulatory guidance and acceptance criteria:

NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (Reference 4).

NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (Reference 5).

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Final Interim Staff Guidance Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (Reference 6).

Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors:

Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (Reference 7).

As stated in the interim staff guidance (ISG) augmenting NUREG-1537, the NRC staff determined that certain guidance originally developed for heterogeneous non-power research and test reactors is applicable to aqueous homogenous facilities and production facilities.

SHINE used this guidance to inform the design of its facility and to prepare its FSAR. The staffs use of reactor-based guidance in its evaluation of the SHINE FSAR is consistent with the ISG augmenting NUREG-1537.

As appropriate, the NRC staff used additional guidance (e.g., NRC regulatory guides, Institute of Electrical and Electronics Engineers (IEEE) standards, American National Standards Institute/American Nuclear Society (ANSI/ANS) standards, etc.) in the review of the SHINE FSAR. The additional guidance was used based on the technical judgment of the reviewer, as well as references in NUREG-1537, Parts 1 and 2; the ISG augmenting NUREG-1537, Parts 1 and 2; and the SHINE FSAR. Additional guidance documents used to evaluate the SHINE FSAR are provided as references in Appendix B, References, of this SER.

In addition, the following SHINE design criteria in FSAR Chapter 3 are applicable to the confinement part of the ESFs:

Criterion 29 - Confinement design Confinement boundaries are provided to establish a low-leakage barrier against the uncontrolled release of radioactivity to the environment and to assure that confinement design leakage rates are not exceeded for as long as postulated accident conditions require. Four classes of confinement boundaries are established:

1) the primary confinement boundary,

2) the process confinement boundary,

3) hot cells and gloveboxes, and

4) radiologically-controlled area ventilation isolations.

Criterion 32 - Provisions for confinement testing and inspection Each confinement boundary is designed to permit:

1) appropriate periodic inspection of important areas, such as penetrations;

2) an appropriate surveillance program; and

3) periodic testing of confinement leakage rates.

Criterion 33 - Piping systems penetrating confinement 6-3

Piping systems penetrating confinement boundaries that have the potential for excessive leakage are provided with isolation capabilities appropriate to the potential for excessive leakage.

Piping systems that pass between confinement boundaries are equipped with either:

1) a locked closed manual isolation valve, or

2) an automatic isolation valve that takes the position that provides greater safety upon loss of actuating power.

Manual isolation valves are maintained locked-shut for any conditions requiring confinement boundary integrity.

Criterion 34 - Confinement isolation Lines from outside confinement that penetrate the primary confinement boundary and are connected directly to the primary system boundary are provided with redundant isolation capabilities.

Ventilation, monitoring, and other systems that penetrate the primary, process, glovebox, or hot cell confinement boundaries, are connected directly to the confinement atmosphere and are not normally locked closed, have redundant isolation capabilities or are otherwise directed to structures, systems, and components capable of handling any leakage.

Isolation valves outside confinement boundaries are located as close to the confinement as practical and upon loss of actuating power, automatic isolation valves are designed to take the position that provides greater safety. Manual isolation valves are maintained locked-shut for any conditions requiring confinement boundary integrity.

All electrical connections from equipment external to the confinement boundaries are sealed to minimize air leakage.

Criterion 35 - Control of releases of radioactive materials to the environment The facility is designed to include means to suitably control the release of radioactive materials in gaseous and liquid effluents and to handle radioactive solid wastes produced during normal operation, including anticipated transients. Sufficient holdup capacity is provided for retention of radioactive gases.

Criterion 39 - Hydrogen mitigation Systems to control the buildup of hydrogen that is released into the primary system boundary and tanks or other volumes that contain fission products and produce significant quantities of hydrogen are provided to ensure that the integrity of the system and confinement boundaries are maintained.

6a.4 Review Procedures, Technical Evaluation, and Evaluation Findings 6-4

The NRC staff performed a review of the technical information presented in SHINE FSAR Section 6a2, as supplemented, to assess the sufficiency of the final design and performance of SHINEs IF ESFs for the issuance of an operating license. The sufficiency of the final design and performance of SHINEs IF ESFs is determined by ensuring that it meets applicable regulatory requirements, guidance, and acceptance criteria, as discussed in Section 6a.3, Regulatory Requirements and Guidance and Acceptance Criteria, of this SER. The findings of the staff review are described in SER Section 6a.5, Review Findings.

6a.4.1 Summary Description The staff evaluated the SHINEs summary description of its IF ESFs, as described in SHINE FSAR Section 6a2.1, Summary Description, which references FSAR Tables and Sections.

SHINE FSAR Table 6a2.1-1 contains a summary of ESFs and design basis accidents they are designed to mitigate. The credited ESFs include primary confinement boundary, tritium confinement boundary, and combustible gas management.

SHINE FSAR figure 6a.2.1-1 provides a block diagram for the IF ESFs which shows the location and basic function of the SSCs providing ESFs in the IF portion of the main production facility.

The diagram indicates the passive components for which credit is taken for the three ESFs (i.e.

primary confinement boundary, tritium confinement boundary, and combustible gas management). The bock diagram also provides the active components in the three ESFs that respond to confinement isolation system signals from the engineered safety features actuation system (ESFAS) and target solution vessel (TSV) reactivity protection system (TRPS). SHINE stated the active components that respond to ESFAS and TRPS are listed in SHINE FSAR Chapter 7, Instrumentation and Controls, Section 7.4, Target Solution Reactivity Protection System and Section 7.5, Engineered Safety Features Actuation System.

6a.4.2 Confinement The NRC staff evaluated the sufficiency of the final design of the SHINE confinement and related systems as described in SHINE FSAR 6a.2.2.1, Confinement, in part, by reviewing confinement mitigation requirements, the defined confinement envelope, and detailed descriptions of the ESFs associated with confinement. Additionally, the staff evaluated the passive and active ESF components, under normal and upset operational conditions. The functional requirements, design bases, proposed technical specifications, and testing requirements were also evaluated for sufficiency.

Primary Confinement Boundary The primary confinement boundary contains the primary system boundary which contains the fission products. The primary confinement boundary is primarily passive and consists predominantly of the irradiation unit (IU) cell, the TOGS shielded cell, and a cell enclosing the two heating, ventilation, and air conditioning system (HVAC) units (RVZ1r) serving the IU and TOGS cells. The boundary of each IU is independent from the others. The IU cell portion of the primary confinement boundary holds the TSV, TSV dump tank, portions of the TOGS, portions of the primary closed loop cooling system (PCLS), associated primary system boundary (PSB) piping, the light water pool, and the neutron driver. The primary confinement boundary is operated within a normally-closed atmosphere except through the PCLS expansion tank. The PCLS expansion tank connection to radiological ventilation zone 1 exhaust subsystem (RVZ1e) provides a vent path for radiolysis gases produced in the PCLS and light 6-5

water pool, to avoid the buildup of hydrogen gas. The connection to RVZ1e is equipped with redundant dampers or valves that close on a confinement actuation signal, isolating the cells from Radiological Ventilation Zone (RVZ1). SHINE FSAR Section 9a2, Irradiation Facility Auxiliary Systems, Subsection 9a2.1.1.2, System Description, provides a detailed description of RVZ1 including the associated exhaust system RVZ1e.

Each piping system capable of excessive leakage that penetrates the primary confinement boundary, as described in SHINE FSAR Figure 6a2.2-1, Primary Confinement Boundary, is equipped with one or more isolation valves which serve as active confinement components, except for the nitrogen purge system (N2PS) supply and process vessel vent system (PVVS) connections, which may remain open to provide combustible gas mitigation. Actuation of the isolation valves is controlled by the TRPS.

SHINE FSAR Section 7.4.3.1, Safety Functions, provides a listing of TRPS monitored variables that can cause the initiation of an IU Cell Safety Actuation. Following an actuation, PSB and primary confinement boundary isolation valves transition to their deenergized states, closing valves to safely isolate the corresponding system.

Tritium Confinement Boundary Portions of the tritium purification system (TPS) serve as the tritium confinement boundary as depicted in the functional block diagram provided in SHINE FSAR Figure 6a2.2-2, Tritium Confinement Boundary.

Tritium in the IF is confined using active and passive features of the TPS. The TPS gloveboxes and secondary enclosure cleanup subsystems are credited as passive confinement barriers.

The TPS gloveboxes enclose TPS process equipment, thus allowing credit as a passive confinement barrier. TPS gloveboxes are maintained at negative pressure relative to the TPS room and have a helium atmosphere. The TPS gloveboxes provide confinement in the event of a breach in the TPS process equipment that results in a release of tritium from the isotope separation process equipment.

The TPS gloveboxes include isolation valves on the helium supply, the glovebox pressure control exhaust, and the vacuum/impurity treatment subsystem process vents.

The TPS has isolation valves on the process connections to the neutron driver assembly system (NDAS) target chamber supply and exhaust lines. The TPS-NDAS interface lines themselves are part of the credited tritium confinement boundary up to the interface with the primary confinement boundary.

When the isolation valves for a process line or glovebox close, the spread of radioactive material is limited to the glovebox plus the small amount in the lines between the glovebox and its isolation valves. The liquid nitrogen supply and exhaust lines and the gaseous nitrogen pneumatic lines for the TPS equipment are credited to remain intact during a DBA and the internal interface between the gloveboxes and nitrogen lines serves as a passive section of the tritium confinement boundary.

Upon detection of TPS exhaust to facility stack high tritium concentration or TPS glovebox high tritium concentration, the ESFAS automatically initiates a TPS isolation. Upon ESFAS initiation, required active components maintaining confinement are transitioned to their deenergized (safe) 6-6

state. A description of the ESFAS and a complete listing of the active components that transition to a safe state upon a TPS isolation are provided in SHINE FSAR Section 7.5. The evaluated accident sequences for which the tritium confinement boundary is necessary are listed in Table 6a2.1-1, Summary of Engineering Safety Features and Design Basis Accidents Mitigated, and further discussed in SHINE FSAR Chapter 13a2, Irradiation Facility Accident Analysis. SHINE FSAR Section 9a2.7, Tritium Purification System, contains a detailed description of tritium purification and the interfaces that function for tritium confinement.

Combustible Gas Management Hydrogen gas is produced by radiolysis in the target solution during and after irradiation. During normal operation the concentration of hydrogen gas is monitored and maintained below the lower flammability limit (LFL) using the TOGS. If TOGS becomes unavailable, the buildup of hydrogen gas is limited using the combustible gas management system, which uses the N2PS, PSB piping, and portions of the PVVS to establish an inert gas flow through the IUs. The objective of the combustible gas management system is to prevent conditions that could lead to a hydrogen deflagration within the PSB.

The N2PS provides back-up nitrogen sweep gas to each IU upon a loss of power or loss of normal sweep gas flow to maintain hydrogen concentrations in these systems below acceptable values. The combustible gas management system is provided in SHINE FSAR Figure 6a.2.2-3, Irradiation Facility Combustible Gas Management Functional Block Diagram. A detailed description of PVVS and N2PS are provided in SHINE FSAR Section 9b.6.1, Process Vessel Vent System, and Section 9b.6.2, Nitrogen Purge System, respectively.

On a loss of power or receipt of an appropriate TRPS or ESFAS actuation signal, solenoid-operated isolation valves on the nitrogen discharge manifold open and supply nitrogen to the IU cell supply header. The nitrogen is supplied to each TSV dump tank and flows through the TSV dump tank, the TSV, and the TOGS equipment and piping, and then directed to the PVVS guard beds, delay beds, and HEPA filter before being discharged to the environment via a safety-related vent path.

The complete listing of variables within the TRPS that can cause the initiation of an IU Cell Nitrogen Purge is provided in SHINE FSAR Section 7.4.3.1. These variables indicate a loss of flow or ability to recombine hydrogen by the TOGS. Upon initiation of an IU Cell Nitrogen Purge, active components required to function to establish and maintain the N2PS flow path are transitioned to their deenergized state by the TRPS and the ESFAS. Descriptions of the TRPS and ESFAS are provided in SHINE FSAR Sections 7.4 and 7.5, respectively.

Failure of the TOGS to manage the combustible gases generated by the subcritical assembly can potentially result in a deflagration within the PSB. Hydrogen deflagration within the PSB is an initiating event and accident analyzed in SHINE FSAR Chapter 13a2. The accident sequences for which the combustible gas management system is necessary are listed in SHINE FSAR Table 6a2.1-1, Summary of Engineered Safety Features and Design Basis Accidents Mitigates, and discussed in FSAR Chapter 13a2.

Dose Consequences SHINE FSAR Tables 6a2.1-2, Comparison of Unmitigated and Mitigated Radiological Doses for Select Irradiation Facility DBAs, provide unmitigated and mitigated doses for select DBAs in the IF. The maximum dose in FSAR Table 6a2.1-2 is 0.8 rem total effective dose equivalent (TEDE) 6-7

to the public and 1.9 rem TEDE to the worker. SHINE proposed an accident dose criterion of 1 rem TEDE based on the proposed rule described in 82 FR 15643. In SHINE FSAR Section 13a2.2, Accident Analysis and Determination of Consequences, SHINE proposed the following accident dose criteria as follows:

• Radiological consequences to an individual located in the unrestricted area following the onset of a postulated accidental release of licensed material would not exceed 1 rem TEDE for the duration of the accident; and,

• Radiological consequences to workers do not exceed 5 rem TEDE during the accident.

The NRC staff finds that dose consequences, in some cases, would be unacceptable without mitigation by ESFs. As described in SHINE FSAR Chapter 13b, specific postulated accident scenarios indicate the need for the confinement ESFs. The NRC staff finds that there is reasonable assurance that the ESF is designed to ensure that the radiological consequences to a member of the public and worker would remain below 1 rem and 5 rem, respectively, and therefore is acceptable.

Design Criteria Section 6b4.2 of the SE describes the staffs evaluation of the design criteria as it applies to both the IF and RPF.

Conclusion Based on its review, the NRC staff finds the level of detail provided on the Engineered Safety Features for SHINE demonstrates an adequate description for their design and concludes that SHINEs operating license application sufficiently defines systems operation in accordance with 10 CFR 50.34(b)(2).

The NRC staff evaluated the descriptions and discussions of SHINEs IF and RPF ESFs, including proposed technical specifications (TS), as described in SHINE FSAR Section 6a2 and finds that the final design of SHINEs IF and RPF ESFs, including the principal design criterion; design bases; and information relative to confinement provides reasonable assurance that the final design will conform to the design basis, and meets all applicable regulatory requirements and acceptance criteria in NUREG-1537.

6a.4.5 Proposed Technical Specifications In accordance with 10 CFR 50.36(a)(1), the NRC staff evaluated the sufficiency of the applicants proposed technical specifications for the SHINE facility.

The proposed TS 3.4, Containment, LCO 3.4.1, states the following:

Each primary Confinement boundary or PSB isolation valve listed in Table LCO 3.4.1 3.4.1-a shall be Operable. A valve is considered Operable if:

1. The valve is capable of opening or closing on demand from TRPS Note - A single isolation valve in a flow path may be inoperable for up to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> during the performance of required surveillances.

Note - This LCO is applied to each IU independently; actions are only 6-8

applicable to the IU(s) that fail to meet the LCO during the associated condition(s) of applicability.

Applicability Associated IU in Mode 1, 2, 3, or 4 Action According to Table 3.4.1 SR 3.4.1 Valves and dampers listed in Table 3.4.1-a shall be stroke tested quarterly.

The table 3.4.1, Confinement Boundary and Isolation Actions, states:

Action Completion Time (per IU)

1. If one or more flow path(s) with one or more isolation valve(s) is inoperable, Close at least one valve in the affected flow path 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> OR Place the associated IU in Mode 3 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> AND Place the associated IU in Mode 0. ((PROP/ECI))

2. If one or more flow path(s) with one or more isolation valve(s) is inoperable, Place the associated IU in Mode 3 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> AND Place the associated IU in Mode 0.

((PROP/ECI))

LCO 3.4.1 specifies that each confinement boundary and PSB isolation valve in Table 3.4.1-a, Isolation Valves, shall be operable from TRPS in all IU Modes of operation and provides actions to be taken if they are inoperable. The NRC staff finds that this condition would ensure that TRPS automatically isolates the confinement system and PSB to prevent the inadvertent release of radioactive material. The staff also finds that if the valves listed in Table 3.4.1-a are inoperable, the flow path is isolated by closing at least one valve or the target solution would be transferred to the TSV dump tank and then to the RPF. The staff finds for systems that do not have an option to close one valve in the flow path, the target solution would be transferred to the TSV dump tank and then to the RPF. The staff finds that the completion time allows for investigation and the performance of minor repairs and is based on the continued availability of the redundant actuation valve or redundant check valve in the flow path. Therefore, the staff finds the limiting condition for operation acceptable.

SR 3.4.1 requires that the valves in Table 3.4.1-a to be stroke test quarterly. Section 4.4.2, Confinement, of ANSI/ANS 15.1-2007 states that a functional test should be performed quarterly. The NRC staff finds that this frequency is in accordance with guidance in ANSI/ANS 15.1-2007. Therefore, the staff finds the surveillance requirement acceptable.

The proposed TS 3.4, LCO 3.4.2, states the following:

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The Confinement check valves listed in Table 3.4.2-a shall be Operable LCO 3.4.2 Note - This LCO is applied to each IU or TPS train independently; actions are only applicable to the IU(s) or TPS train(s) that fail to meet the LCO during the associated condition(s) of applicability.

Applicability According to Table 3.4.2-a Action According to Table 3.4.2 SR 3.4.2 The check valves listed in Table 3.4.2-a shall be inspected annually.

The table 3.4.2, Confinement Check Valve Actions, states:

Action Completion (per IU or per TPS train) Time

1. If the check valve is inoperable, Place the associated IU in Mode 3 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> AND Place the associated IU in Mode 0. ((PROP/ECI))

2. If the check valve is inoperable, Place the associated IU in Mode 3 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> AND Close the PCLS supply isolation valve. 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />

3. If the check valve is inoperable, Close the TPS isolation valve in the affected flow path. 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> LCO 3.4.2 specifies that each confinement check valve in Table 3.4.2-a, Confinement Check Valves, shall be operable in all IU Modes of operation, with tritium not in storage for TPS, and provides actions to be taken if they are inoperable. The NRC staff finds that this condition would ensure redundant isolation of the confinement system to prevent the inadvertent release of radioactive material. The staff also finds that if the TOGS radioisotope process facility cooling system (RPCS), subcritical assembly system (SCAS) nitrogen purge, and PCLS supply check valves are inoperable, the target solution would be transferred to the TSV dump tank and to the RPF, if required. For the PCLS and TPS check valves, the staff finds that the flow path for the system is also isolated. For the PCLS and TPS, the staff finds that the completion time allows for investigation and the performance of minor repairs and is based on the continued availability of the redundant isolation valve in the flow path. For the TOGS RPCS and SCAS nitrogen purge check valves, the staff finds that the completion time is based on the orderly shutdown of the IU and continued availability of redundant components. Therefore, the staff finds the limiting condition for operation acceptable.

SR 3.4.2 requires that the valves in table 3.4.2-a are inspected annually. The NRC staff finds that this surveillance would ensure the check valves maintain operability to isolate the system to 6-10

prevent the inadvertent release of radioactive material from the system. Therefore, the staff finds the surveillance requirement acceptable.

The proposed TS 3.4, LCO 3.4.5, states the following:

Primary Confinement boundary shield plugs shall be Operable. Primary LCO 3.4.5 Confinement boundary shield plugs are Operable if:

1. The shield plug seating surfaces have a proven satisfactory leak rate.

Note - This LCO is applied to each IU independently; actions are only applicable to the IU(s) that fail to meet the LCO during the associated condition(s) of applicability.

Applicability Associated IU in Mode 1, 2, 3, or 4 Action According to Table 3.4.5

1. IU cell primary Confinement boundary shall be verified to be Operable by SR 3.4.5 measuring leak rate past shield plug seating surfaces upon each reinstallation of the IU cell confinement boundary shield plug or inspection port. The IU cell shield plug leak rate must be less than 2.10E+06 sccm at 3.9 psi.

2. TOGS cell primary Confinement boundary shall be verified to be Operable by measuring leak rate past shield plug seating surfaces upon each reinstallation of the TOGS cell confinement boundary shield plug or inspection port. TOGS cell shield plug leak rate must be less than 1.16E+05 sccm at 3.9 psi.

The table 3.4.5, Primary Confinement Boundary Shield Plug Actions, states:

Action Completion (per IU) Time

1. If a primary Confinement boundary shield plug is not Operable Place the associated IU in Mode 3 Immediately AND ((PROP/ECI)).

Place the associated IU in Mode 0.

LCO 3.4.5 specifies that each primary confinement shield plug shall be operable by the seating surfaces having a proven satisfactory leak rate for all modes of operations and provides actions to be taken if they are inoperable. The NRC staff finds that this condition would ensure that primary confinement boundary is maintained after maintenance activities that results in the reinstallation of the shield plugs in the IU and TOGS primary confinement boundary. The staff also finds that if the shield plug seals are inoperable, the target solution would be transferred to the TSV dump tank immediately and then to the RPF. The staff finds that the completion time to drain the TSV to the TSV dump tanks immediately secures operations to limit the generation of radioactive material available for potential release during a design basis event. Therefore, the staff finds the limiting condition for operation acceptable.

SR 3.4.5 requires that each IU and TOGS shield plug seating surface leak rate be measured after reinstallation of the shield plug or inspection port, be closure tested quarterly, and be 6-11

leaked-tested every two years. Section 4.4.1, Containment, of ANSI/ANS 15.1-2007 states that a leak-tightness test should be performed following modifications or repair. The NRC staff finds that this frequency to perform a leak-tightness test of the shield plug or inspection port after reinstallation is in accordance with guidance in ANSI/ANS 15.1-2007. In response to RAI 13-16 (ADAMS Accession No. ML21243A268), SHINE stated the analytical leak rate out of the IU is 6E+04 standard cubic feet per minute (SCCM) at 0.5 Kilopascal (0.072 psi) and that the TOGS cell is 4E+04 sccm at 6 Kpa (0.87 psi). Because the TS leak rates provide margin to the analytical leak rates, the staff finds the TS leak rates acceptable. Therefore, the staff finds the surveillance requirement acceptable.

The proposed TS 5.5.5, Maintenance of Safety-Related SSCs, states, in part, the following:

The SHINE maintenance program, which includes inspection, testing, and maintenance, ensures that the safety-related SSCs are available and reliable when needed. The maintenance program includes corrective maintenance, preventative maintenance, surveillance and monitoring, and testing. The maintenance program includes the following activities to ensure that safety-related SSCs can perform their functions as required by the accident analysis:

1. Inspection and maintenance of Confinement boundaries; TS 5.5.5 specifies that SHINEs maintenance program ensures that safety-related SSCs, such as the confinement boundaries, are available and reliable to perform their safety function during a postulated accident. The NRC staff finds that the TS is an administrative control to implement a maintenance program which would help ensure that the confinement boundaries are reliable and available to perform their safety function. Therefore, the staff finds the administrative control acceptable.

6a.5 Review Findings The NRC staff reviewed the descriptions and discussions of SHINEs IF ESFs, as described in SHINE FSAR Section 6a2, as supplemented, against the applicable regulatory requirements and using appropriate regulatory guidance and acceptance criteria. Based on its review of the information in the FSAR and independent confirmatory review, the staff determined that:

(1) SHINE described the design of the IF and identified the major features or components incorporated therein for the protection of the health and safety of the public.

(2) The processes to be performed, the operating procedures, the facility and equipment, the use of the facility, and other TSs, provide reasonable assurance that the applicant will comply with the regulations in 10 CFR Part 50 and 10 CFR Part 20 and that the health and safety of the public will be protected.

(3) The issuance of an operating license for the facility would not be inimical to the common defense and security or to the health and safety of the public.

Based on the above determinations, the NRC staff finds that the descriptions and discussions of SHINEs IF ESFs are sufficient and meet the applicable regulatory requirements and guidance and acceptance criteria for the issuance of an operating license.

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6b Radioisotope Production Facility Engineered Safety Features SER Section 6b, Radioisotope Production Facility Engineered Safety Features, provides an evaluation of the final design of SHINEs RPF ESFs, as presented in SHINE FSAR Section 6b, Radioisotope Production Facility Engineered Safety Features, within which SHINE describes RPF ESFs and nuclear criticality control.

6b.1 Areas of Review The NRC staff reviewed SHINE FSAR Section 6b against applicable regulatory requirements, using appropriate regulatory guidance and acceptance criteria, to assess the sufficiency of the final design and performance of SHINEs RPF ESFs. The final design bases of the SHINE RPF ESFs were evaluated to ensure that the design bases and functions of the SSCs are presented in sufficient detail to allow a clear understanding of the facility and to ensure that the facility can be operated for its intended purpose and within regulatory limits for ensuring the health and safety of the operating staff and the public. In addition, the staff evaluated the sufficiency of SHINEs proposed technical specifications for the facility.

Areas of review for this section include a summary description of the RPF ESFs, as well as a description of the RPF confinement and nuclear criticality safety analysis. Within these review areas, the NRC staff assessed, in part, the confinement system and components, functional requirements of confinement, management of the nuclear criticality safety program, planned responses to criticality accidents, criticality-safety controls, nuclear criticality safety evaluations, and the criticality accident alarm system (CAAS).

6b.2 Summary of Application SHINE FSAR Section 6b.1 describes the SSCs that constitute the confinement ESFs in the RPF design and summarizes the postulated accidents whose consequences could be unacceptable without mitigation. As described in greater detail in FSAR Chapter 13b, specific postulated accident scenarios indicate the need for the confinement ESFs.

6b.3 Regulatory Requirements and Guidance and Acceptance Criteria The NRC staff reviewed SHINE FSAR Section 6b against the applicable regulatory requirements, using regulatory guidance and acceptance criteria, to assess the sufficiency of the final design and performance of SHINEs RPF ESFs for the issuance of an operating license.

6b.3.1 Applicable Regulatory Requirements The applicable regulatory requirements for the evaluation of SHINEs RPF ESFs are as follows:

10 CFR 50.34, Contents of applications; technical information, paragraph (b), Final safety analysis report.

10 CFR 50.36, Technical specifications.

10 CFR 50.40, Common Standards.

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10 CFR 50.57, Issuance of operating license.

10 CFR 20.1201, Occupational dose limits for adults.

10 CFR 20.1301, Dose limits for individual members of the public.

In addition to any radiological hazards associated with operations in a production facility, 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, Subpart H, Additional Requirements for Certain Licensees Authorized to Possess a Critical Mass of Special Nuclear Material, specifies limits regarding exposure to hazardous chemicals. Although not a requirement for 10 CFR Part 50 licenses, these limits were considered when reviewing this section of the SHINE FSAR.

6b.3.2 Applicable Regulatory Guidance and Acceptance Criteria In determining the regulatory guidance and acceptance criteria to apply, the NRC staff used its judgment, as the available guidance and acceptance criteria were typically developed for nuclear reactors. Given the similarities between the SHINE facility and non-power research reactors, the staff determined to use the following regulatory guidance and acceptance criteria:

NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (Reference x).

NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (Reference x).

Final Interim Staff Guidance Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (Reference x).

Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors:

Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (Reference x).

As stated in the interim staff guidance (ISG) augmenting NUREG-1537, the NRC staff determined that certain guidance originally developed for heterogeneous non-power research and test reactors is applicable to aqueous homogenous facilities and production facilities.

SHINE used this guidance to inform the design of its facility and to prepare its FSAR. The staffs use of reactor-based guidance in its evaluation of the SHINE FSAR is consistent with the ISG augmenting NUREG-1537.

As appropriate, the NRC staff used additional guidance (e.g., NRC regulatory guides, IEEE standards, ANSI/ANS standards, etc.) in the review of the SHINE FSAR. The additional guidance was used based on the technical judgment of the reviewer, as well as references in NUREG-1537, Parts 1 and 2; the ISG augmenting NUREG-1537, Parts 1 and 2; and the SHINE FSAR. Additional guidance documents used to evaluate the SHINE FSAR are provided as references in Appendix B, References, of this SER.

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6b.4 Review Procedures, Technical Evaluation, and Evaluation Findings The NRC staff performed a review of the technical information presented in SHINE FSAR Section 6b, as supplemented, to assess the sufficiency of the final design and performance of SHINEs RPF ESFs for the issuance of an operating license. Sufficiency of the final design and performance of SHINEs RPF ESFs is determined by ensuring that it meets applicable regulatory requirements, guidance, and acceptance criteria, as discussed in Section 6b.3, Regulatory Requirements and Guidance and Acceptance Criteria, of this SER. While the technical evaluation of these systems provided in this section is specific to the SHINE RPF, the staffs review considers the interface of these systems between the IF and RPF as part of a comprehensive technical evaluation. The findings of the staff review are described in SER Section 6b.5, Review Findings.

6b.4.1 Summary Description The staff evaluated the sufficiency of SHINEs summary description of its RPF ESFs, as described in SHINE FSAR Section 6b.1, Summary Description, using the guidance from Section 6.1, Summary Description, of NUREG-1537, Parts 1 and 2.

FSAR Table 6b.1-1, Summary of Engineered Safety Features and Design Basis Accidents, contains a summary of ESFs and design basis accidents they are designed to mitigate. The credited ESFs are the supercell confinement including below grade confinement, PVVS, and combustible gas management.

FSAR Figure 6b.1-1, Radioisotope Production Facility Engineered Safety Features Block Diagram, provides a block diagram for the IF ESFs, which shows the location and basic function of the SSCs providing ESFs in the RPF portion of the facility. The diagram indicates the passive components for which credit is taken for the three ESFs (i.e. process containment boundary, PVVS process isolation, and combustible gas management). The block diagram also provides the active components in the three ESFs that respond to confinement isolation system signals from ESFAS. The active components that respond to ESFAS are listed in FSAR Section 7.5, Engineered Safety Features Actuation System.

6b.4.2 Confinement The staff evaluated the sufficiency of the final design of the SHINE confinement and related systems as described in SHINE FSAR 6b.2.1, Confinement, in part, by reviewing confinement mitigation requirements, the defined confinement envelope, and detailed descriptions of the ESFs associated with confinement. Additionally, the staff evaluated the passive and active ESF components, under normal and upset operational conditions. The functional requirements, design bases, probable subjects of technical specifications, and testing requirements were also evaluated for sufficiency.

Super Cell Confinement The supercell is a set of hot cells in which isotope extraction, purification, and packaging is performed, and gaseous waste is handled. The supercell provides shielding and confinement to protect the workers, members of the public, and the environment by confining the airborne radioactive materials during normal operation and in the event of a release. SHINE FSAR Figure 6b.2-1, Supercell Confinement Boundary, provides a block diagram of the supercell 6-15

confinement boundary. The RVZ1e draws air through each individual confinement box, to maintain negative pressure inside the confinement, minimizing release of radiological material to the facility. Filters and carbon adsorbers are provided on the ventilation inlets and outlets, radiation monitoring on the outlet side to detect off-normal releases will isolate the hot cells by closing both inlet and outlet dampers or valves. Additionally, the actuation signal closes isolation valves on the molybdenum extraction and purification system (MEPS) heating loops and conducts a vacuum transfer system (VTS) safety actuation. As part of VTS safety actuation, connections to the supercell from the facility chemical reagent system (FCRS) skid isolate, closing the MEPS and iodine and xenon purification and packaging (IXP) supply valves as described in SHINE FSAR Subsection 7.5.3.1.17, VTS Safety Actuation. The active components required to function to maintain the confinement barrier are actuated by the ESFAS, as described in SHINE FSAR Section 7.5, Engineered Safety Features Actuation System. If sufficient radioactive material reaches the radiation monitors in the RVZ1e exhaust duct, ESFAS will isolate the RVZ building supply and exhaust. The evaluated accident sequence for which the supercell is necessary is listed in Table 6b.1-1 and discussed further in SHINE FSAR Section 13b.2.

Below Grade Confinement RPF tank vaults, valve pits, pipe trench, and carbon delay bed vault are part of below grade confinement. SHINE FSAR Figure 6b.2-2 provides a block diagram of the below grade confinement. Radioactive material is confined primarily by the structural components, including gaskets and other non-structural features are used, as necessary, to provide sealing. Each vault is equipped with a concrete cover plug fabricated in multiple sections with inspection ports to facilitate remote inspection of the confined areas. The pipe trench, vaults, and valve pits with equipment containing fissile material are equipped with drip pans and drains to the radioactive drain system (RDS). The below grade confinement is primarily passive. Process piping for auxiliary systems entering the boundary from outside confinement is provided with appropriate manual or automatic isolation capabilities. Contaminated air is confined to the vaults, valve pits, and pipe trench. The facility accident analysis considers the effect of air exchange from the confinement to the general areas in its evaluation of radiological consequences. Three mechanisms by which the process confinement boundary exchanges air with the RPF are considered: pressure-driven flow, counter-current flow, and barometric breathing. The combined effect of these mechanisms is a minor outflow of radioactive material from the confined area to the RPF and the environment under accident conditions. If sufficient radioactive material reaches the radiation monitors in the RVZ1 exhaust duct, ESFAS will isolate the RVZ building supply and exhaust. The evaluated accident sequence for which the process confinement boundary is necessary is listed in SHINE FSAR Table 6b.1-1 and discussed further in SHINE FSAR Section 13b.2, Analyses of Accidents with Radiological Consequences.

Process Vessel Ventilation System The PVVS captures or provides holdup for radioactive particulates, iodine, and noble gases generated within the RPF and primary system boundary. The system draws air from the process vessels through a series of processing components which remove the radioactive components by condensation, acid adsorption, mechanical filtration with high-efficiency particulate air (HEPA) filters, and adsorption in carbon beds. The PVVS guard and delay beds are equipped with isolation valves to isolate affected guard bed or group of delay beds from the system. The isolation valves serve a dual purpose, prevent release of radioactive material to the environment and isolate fire impacted beds from unimpacted beds. The delay beds are 6-16

equipped with sensors to detect fires which provide indication to ESFAS. The redundancy in the beds and the ability to isolate individual beds allows the PVVS to continue to operate following an isolation. The evaluated accident sequence for which the PVVS isolation is necessary is listed in SHINE FSAR Table 6b.1-1 and discussed further in SHINE FSAR Section 13b.2.

Combustible Gas Management Hydrogen gas is produced by radiolysis in the target solution during and after irradiation. During normal operation, the PVVS removes radiolytic hydrogen and radioactive gases generated within the RPF and primary system boundary. If PVVS becomes unavailable, the buildup of hydrogen gas is limited using the combustible gas management system, which uses the nitrogen purge system (N2PS), process system piping, and the parts of PVVS to establish an inert gas flow through the process vessels. The principal objective of the combustible gas management system is to prevent the conditions that could lead to a hydrogen deflagration in the gas spaces in the RPF process tanks.

The N2PS provides a backup supply of sweep gas following a loss of electrical power or loss of sweep gas flow to the RPF tanks normally ventilated by PVVS. SHINE FSAR Figure 6b.2-3, Combustible Gas Management, provides a functional block diagram of the combustible gas management system. The source of nitrogen is high pressure nitrogen gas stored in pressurized vessels. On a loss of power or receipt of an ESFAS actuation signal, isolation valves on the radiological ventilation zone 2 (RVZ2) air supply to PVVS shut and isolation valves on the N2PS discharge manifold open, releasing nitrogen into the RPF N2PS distribution piping. The nitrogen gas flows through the RPF equipment and into the PVVS process piping and the PVVS passive filtration equipment before being discharged out in an alternate vent path in the PVVS. The complete listing of variables within the ESFAS that can cause the initiation of an RPF Nitrogen Purge is provided in FSAR Subsection 7.5.31. These variables include a loss of flow. The active components required to function to initiate the RPF Nitrogen Purge are actuated by the ESFAS. A detailed description of the ESFAS is provided in FSAR Section 7.5.

The combustible gas management system prevents deflagrations and detonations in RPF process tanks which could lead to a tank or pipe failure and cause a target solution spill inside the process confinement boundary. The accident sequences for which the combustible gas management system is necessary are listed in FSAR Table 6b.1-1 and discussed in FSAR Charter 13a2.

Dose Consequences SHINE FSAR Tables 6b2.1-2, Comparison of Unmitigated and Mitigated Radiological Doses for Select Radioisotope Production Facility DBAs, provide unmitigated and mitigated doses for select DBAs in the RPF. The maximum dose in FSAR Table 6b2.1-2 is 0.042 rem total effective dose equivalent (TEDE) to the public and 0.076 rem TEDE to the worker.

The NRC staff finds that dose consequences, in some cases, would be unacceptable without mitigation by ESFs. As described in SHINE FSAR Chapter 13b, specific postulated accident scenarios indicate the need for the confinement ESFs. The NRC staff finds that there is reasonable assurance that the ESF is designed to ensure that the radiological consequences to a member of the public and worker would remain below 1 rem and 5 rem, respectively, and therefore is acceptable.

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Design Criteria As stated in SHINE FSAR Section 3.1, Design Criteria, the nuclear safety classification of safety-related SSCs at SHINE are those physical SSCs whose intended functions are to prevent accidents that could cause undue risk to health and safety of workers and the public; and to control or mitigate the consequences of such accidents. SHINE FSAR Table 3.1-1, Safety-Related Structures, Systems, and Components, identifies the SSCs at SHINE that are classified as safety-related. The list includes the confinement features and all its supporting structures and systems. SHINE FSAR Table 3.1-3, SHINE Design Criteria, provides the generically applicable design criteria to the SHINE facility. The NRC staff focused on the design criteria applicable to confinement, namely criterion 29, 32, 33, 34, 35, and 39. The criteria are described in section 6a.3.2 of this SE.

For Criterion 29, the NRC staff finds that SHINE appropriately identified passive confinement boundaries and active components for the establishment of the four classes of confinement boundaries. Specifically, the primary confinement boundary, the process confinement boundary, the hot cells and gloveboxes, and the radiologically-controlled area ventilation zones are addressed in sufficient detail in SHINE FSAR Sections 6a2.2.1, Confinement, and 6b2.1, Confinement, and SHINE FSAR Figures 6a2.2-1, 6a2.2-2, Tritium Confinement Boundary; 6b.2-1, Supercell Confinement Boundary; and 6b.2-2, Below Grade Confinement Boundary.

For criterion 32, the NRC staff finds that periodic inspection, surveillance, and periodic testing are satisfied by the proposed technical specifications.

For criterion 33, the NRC staff finds that the piping systems penetrating confinement have been provided with automatic isolation capabilities, manual valve positions, and isolation valves in close proximity of the outside of confinement to the extent reasonably achievable based on descriptions in SHINE FSAR Sections 6a2 and 6b and FSAR Figures 6a2.2.1, 6a2.2-2, 6a2.2-2, 6b.2.2-1 and 6b.2-1.

For criterion 34, the NRC staff finds that based on the descriptions in SHINE FSAR Sections 6a2 and 6b along with FSAR Figures 4a2.8.1, 6a2.2-1, 6a2.2-2, 9a2.1-3, Radiological Ventilation Zone 1 Exhaust Subsystem (RVZ1e) Flow Diagram, 9a2.7-1, TPS Process Flow Diagram, the criteria described for confinement isolation of process piping and ventilations system are sufficiently described and depicted in the FSAR.

For criterion 35, the NRC staff finds that the facility is equipped with isolation provisions in the ventilation system at the RCA boundary and that the PVVS exhaust beds are designed for holdup capacity for retention of radioactive gases.

For criterion 39, the NRC staff finds that the applicant has described systems to control the buildup of hydrogen that is released into the primary system boundary and tanks or other volumes that contain fission products to ensure that the integrity of the system and confinement boundaries are maintained.

Based on the foregoing, the NRC staff concludes that the licensee has provided final analysis and evaluation of the design and performance of structures, systems, and components as it relates to confinement and satisfied 50.34(b)(4).

Conclusion 6-18

Based on its review, the NRC staff finds the level of detail provided on the Engineered Safety Features for SHINE demonstrates an adequate description for the design and concludes that the application sufficiently defines each systems operation in accordance with 10 CFR 50.34(b)(2).

The NRC staff evaluated the descriptions and discussions of SHINEs IF and RPF ESFs, including subjects of technical specifications, as described in SHINE FSAR Section 6b and finds that the final design of SHINEs IF and RPF ESFs, including the principal design criterion; design bases; and information relative to confinement provides reasonable assurance that the final design will conform to the design basis, and meets all applicable regulatory requirements and acceptance criteria in NUREG-1537.

6b.4.5 Nuclear Criticality Safety The NRC staff evaluated the sufficiency of SHINEs nuclear criticality safety design criteria and methods, as described in SHINE FSAR Section 6b.3, Nuclear Criticality Safety, and supplemented by the applicants responses to RAIs, and the applicants Nuclear Criticality Safety (NCS) Manual, computer code validation report, and a sampling of final NCS calculations and evaluations using the guidance and acceptance criteria from Section 6b.3 of the ISG augmenting NUREG-1537, Part 2, which is based on Chapter 5, Nuclear Criticality Safety, of NUREG-1520 (Reference 60). Specifically, the pertinent sections of Section 6b.3 of the ISG augmenting NUREG-1537, Part 2, are drawn from Section 5.4.3, Regulatory Acceptance Criteria, of NUREG-1520, Rev. 1.

6b.4.6 Proposed Technical Specifications In accordance with 10 CFR 50.36(a)(1), the NRC staff evaluated the sufficiency of the applicants proposed technical specifications for the SHINE facility.

The proposed TS 3.4, LCO 3.4.3, states the following:

Each tritium Confinement boundary valve for each TPS glovebox listed in LCO 3.4.3 Table 3.4.3-a shall be Operable. A valve is considered Operable if:

1. The valve is capable of closing on demand from ESFAS Note - A single valve in a flow path may be inoperable for up to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> during the performance of required surveillances.

Note - This LCO is applied to each TPS train independently; actions are only applicable to the TPS train(s) that fail to meet the LCO during the associated condition(s) of applicability.

Applicability Tritium in associated TPS process equipment not in storage Action According to Table 3.4.3 SR 3.4.3 1. Valves listed in Table 3.4.3-a shall be closure tested quarterly.

2. Each TPS glovebox shall be leak-tested every two years.

The table 3.4.3, TPS Glovebox Confinement Boundary Valve Actions, states:

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Action Completion (per TPS Train) Time

1. If one or more flow path(s) with one or more isolation valve(s) is inoperable, Place tritium in the associated train of TPS process 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> equipment in its storage location OR 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> Close at least one valve in the affected flow path.

LCO 3.4.3 specifies that each confinement boundary valve in Table 3.4.3-a, TPS Glovebox Confinement Valves, shall be operable when it closes on demand from ESFAS and provides actions to be taken if they are inoperable. The NRC staff finds that this condition would ensure that ESFAS automatically isolates the TPS glovebox system to prevent the inadvertent release of tritium, a radioactive gas. The staff also finds that if the valves listed in Table 3.4.1-a are inoperable, the tritium is placed in storage or at least one valve is closed to isolate the flow path.

The staff finds that the completion time allows for investigation and the performance of minor repairs and adequate time to place the tritium in its storage location, and is based on the continued availability of the redundant actuation valve or redundant check valve in the flow path.

Therefore, the staff finds the limiting condition for operation acceptable.

SR 3.4.3 requires that the valves in table 3.4.3-a to be closure tested quarterly and that each TPS glovebox be leaked-tested every two years. Section 4.4.1, Containment, of ANSI/ANS 15.1-2007 states that a functional test should be performed quarterly, and a leak test performed annually to biennially. The NRC staff finds that this frequency is in accordance with guidance in ANSI/ANS 15.1-2007. Therefore, the staff finds the surveillance requirement acceptable.

The proposed TS 3.4, LCO 3.4.4, states the following:

Each supercell Confinement damper listed in Table 3.4.4-a shall be LCO 3.4.4 Operable. A damper is considered Operable if:

1. The damper is capable of closing on demand from ESFAS Note - A single damper in a flow path may be inoperable for up to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> during the performance of required surveillances.

Applicability Supercell process operations in-progress in the associated hot cell Action According to Table 3.4.4 SR 3.4.4 1. Dampers listed in Table 3.4.4-a shall be closure tested quarterly.

2. Dampers listed in Table 3.4.4-a shall be leak-tested every two years.

The table 3.4.4, Supercell Confinement Damper Actions, states:

Action Completion Time 6-20

1. If one or more flow path(s) with one isolation damper is inoperable, Close at least one damper in the affected flow path 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> OR Suspend hot cell operations involving the introduction of 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> liquids into the associated hot cell AND Drain target solution and radioactive liquids in process lines from the associated hot cell. 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />

2. If one or more flow path(s) with two isolation dampers are inoperable, Close at least one damper in the affected flow path 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> OR Suspend hot cell operations involving the introduction of liquids into the associated hot cell 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> AND Drain target solution and radioactive liquids in process lines from the associated hot cell. 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> LCO 3.4.4 specifies that each supercell confinement damper in Table 3.4.4-a, Supercell Confinement Dampers, shall be operable by closing on demand from ESFAS when supercell operations are in-progress in the hot cell and provides actions to be taken if they are inoperable.

The NRC staff finds that this condition would ensure that ESFAS automatically isolates the supercell areas to prevent the inadvertent release of radioactive material. The staff also finds that if the dampers listed in Table 3.4.4-a are inoperable, either the flow path is isolated by closing a damper or hot cell operations are suspended which involves no further introduction of liquids into the hot cell and the draining of all solutions that are in the process lines. The staff finds that the completion time allows for investigation and the performance of minor repairs and is based on the continued availability of the redundant isolation damper with the low likelihood of a release occurring during a 6-hour duration. Therefore, the staff finds the limiting condition for operation acceptable.

SR 3.4.4 requires that each supercell confinement damper in table 3.4.4-a to be closure tested quarterly and be leaked-tested every two years. Section 4.4.1, Containment, of ANSI/ANS 15.1-2007 states that a functional test should be performed quarterly, and a leak test performed annually to biennially. The NRC staff finds that this frequency is in accordance with guidance in ANSI/ANS 15.1-2007. Therefore, the staff finds the surveillance requirement acceptable.

6b.5 Review Findings The NRC staff reviewed the descriptions and discussions of SHINEs RPF ESFs, as described in SHINE FSAR Section 6b2, as supplemented, against the applicable regulatory requirements and using appropriate regulatory guidance and acceptance criteria. Based on its review of the information in the FSAR and independent confirmatory review, the staff determined that:

(1) SHINE described the design of the RPF and identified the major features or components incorporated therein for the protection of the health and safety of the public.

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(2) The processes to be performed, the operating procedures, the facility and equipment, the use of the facility, and other TSs, provide reasonable assurance that the applicant will comply with the regulations in 10 CFR Part 50 and 10 CFR Part 20 and that the health and safety of the public will be protected.

(3) The issuance of an operating license for the facility would not be inimical to the common defense and security or to the health and safety of the public.

Based on the above determinations, the NRC staff finds that the descriptions and discussions of SHINEs RPF ESFs are sufficient and meet the applicable regulatory requirements and guidance and acceptance criteria for the issuance of an operating license.

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