ML20148M280

Request for Additional Information Related to Shine Medical Technologies, LLC Operating License Application (Enclosure)

ML20148M280
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/26/2020
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Bartelme J SHINE Medical Technologies
Lynch S
Shared Package
ML20148M278	List: ML20148M279 ML20148M280
References
CPMIF-001
Download: ML20148M280 (26)

Text

OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING OPERATING LICENSE APPLICATION FOR SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), and March 27, 2020 (ADAMS Accession No. ML20105A295), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.

During the NRC staffs review of the SHINE operating license application, questions have arisen for which additional information is needed. This request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. Specific chapters and technical areas of the SHINE operating license application covered by this RAI include the following:

• Chapter 1, The Facility

• Chapter 4a2, Irradiation Facility Description

• Chapter 7, Instrumentation and Control Systems

• Chapter 8, Electrical Power Systems

• Emergency Plan

• Quality Assurance Program Description

• Material Control and Accounting Plan Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE operating license application, which describes the SHINE irradiation facility, including the irradiation units, and radioisotope production facility , using the applicable 10 CFR regulations, as well as the guidance contained in NUREG-1537 Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ADAMS Accession No. ML042430055), and 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 (ADAMS Accession No. ML042430048). The NRC staff is also using the Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Enclosure

Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069), and Final Interim Staff Guidance [ISG]

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 (ADAMS Accession No. ML12156A075). As applicable, additional guidance cited in SHINEs FSAR or referenced in NUREG-1537, Parts 1 and 2, or the ISG Augmenting NUREG-1537, Parts 1 and 2, has been utilized in the review of the SHINE operating license application.

For the purposes of this review, the term reactor, as it appears in NUREG-1537, the ISG Augmenting NUREG-1537, and other relevant guidance can be interpreted to refer to SHINEs irradiation unit, irradiation facility, or radioisotope production facility, as appropriate within the context of the application and corresponding with the technology described by SHINE in its application. Similarly, for the purposes of this review, the term reactor fuel, as it appears in the relevant guidance listed above, may be interpreted to refer to SHINEs target solution.

Responses to the following request for additional information (RAI) are needed to continue the review of the SHINE operating license application.

Chapter 1 - The Facility RAI 1-1 NUREG-1537, Part 1, Appendix A, describes the applicability of 10 CFR 50.9, Completeness and accuracy of information. As required by 10 CFR 50.9, information provided by an applicant must be complete and accurate.

Throughout the SHINE operating license application, SHINE uses various terms to refer to the complete SHINE Medical Isotope Production Facility. Some of the terms used throughout the application include:

• Main production facility

• Radioisotope production facility

• Irradiation facility

• SHINE facility

• Medical isotope production facility It is unclear to the NRC staff how SHINE differentiates between these terms. For example, it is unclear whether the terms main production facility, SHINE facility, and medical isotope production facility are equivalent terms that may be used interchangeably or if the main production facility and radioisotope production facility are intended to be equivalent terms.

As authorized by Construction Permit No. CPMIF-001 (ADAMS Accession No. ML16041A473), the NRC staff understands that the proposed facility would comprise an irradiation facility and radioisotope production facility. The irradiation facility would consist of eight subcritical operating assemblies (or irradiation units), which would each be licensed as a utilization facility, as defined in 10 CFR 50.2, Definitions, and supporting structures, systems, and components (SSCs) for the irradiation of low enriched uranium. The radioisotope production facility would consist of hot cell structures, licensed collectively as a production facility, as defined in 10 CFR 50.2, and associated SSCs for the processing of irradiated material and extraction and purification of Mo-99. The irradiation facility and radioisotope production facility are collectively referred to as the SHINE Medical Isotope Production Facility in Construction Permit No.

CPMIF-001.

Clarification on SHINEs use of terminology is necessary for the NRC staff to clearly understand when SHINE is referencing portions of its facility to be licensed as either a utilization facility or production facility, as defined in the NRCs regulations and authorized by Construction Permit No. CPMIF-001. This information is necessary to ensure that SHINE has included complete and accurate information describing its facility and proposed operational activities.

Provide clear definitions of all terms used to refer to the SHINE Medical Isotope Production Facility, the irradiation facility, and radioisotope production facility, updating the FSAR as necessary.

Chapter 4 - Irradiation Unit and Radioisotope Production Facility Description RAI 4a-1 Section 50.9 of 10 CFR Part 50 requires information provided by an applicant be complete and accurate.

SHINE FSAR Section 4a2.2.1.2, Chemical Properties, provides the optimum uranium concentration predicted by the SHINE neutronics model in units of grams of uranium per liter; however, it is not clear to the NRC staff whether these units of concentration refer to grams of uranium per liter of target solution or per liter of solvent.

Clarify whether the uranium concentration provided in the FSAR is given in grams of uranium per liter of target solution or per liter of solvent.

The following regulatory requirement is applicable to RAIs 4a-2 through 4a-17:

Section 50.34(b)(2) of 10 CFR Part 50 requires, in part, that an FSAR include a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.

RAI 4a-2 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1, Reactor Fuel, states that information provided in the FSAR should include various phenomena that results in changes to the initial fuel composition, such as radiolytic gas formation.

SHINE FSAR Section 4a2.2.1.5, Off-Gas Formation, states that radiolysis rates for uranyl sulfate undergoing fission were determined using published experimental data. SHINE stated that the formation rate is 71 standard cubic feet per hour (scfh) (33 standard liters per minute[slpm]) consisting of 67 percent hydrogen and 33 percent oxygen. Additionally, SHINE states that the target solution vessel (TSV) off-gas system (TOGS) is designed to accommodate a hydrogen generation rate of at least 53 scfh (25 slpm). SHINE FSAR Section 4a2.8.2, System Process and Safety Functions, states that a safety function of the TOGS is to maintain hydrogen concentrations below values which could result in a hydrogen explosion overpressure capable of rupturing the primary system boundary (PSB), preventing release of radioactive material that could result in undue risk to health and safety of workers and the public. However, SHINE does not specify the basis for the formation rates related to fission power, uranium concentration, and power of hydrogen (pH). Further, SHINE has not provided the reference conditions (e.g., temperature and pressure) that support the basis of its standard volumetric flow rates This information is necessary for the NRC staff to understand whether the operation of TOGS can maintain a safe concentration level of hydrogen and oxygen during Mode 2 operation of the SHINE irradiation units.

(1) Provide the target solution fission power, uranium concentration, and pH that were used to determine the hydrogen and oxygen formation rates provided in Section 4a2.2.1.5. of the SHINE FSAR.

(2) Provide the reference conditions, such as temperature and pressure, used to calculate standard volumetric flow rates.

(3) Clarify the published experimental data SHINE used to determine the radiolysis rates for uranyl sulfate undergoing fission.

(4) Provide an explanation on the maximum hydrogen generation rate in the TSV, considering conservatism and uncertainty.

(5) Provide an explanation on the maximum hydrogen generation rate that the TOGS is designed to process, considering conservatism and uncertainty.

RAI 4a-3 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.7, Gas Management System, states that radiolytic gas recombiner must be capable of preventing a hydrogen deflagration or dentation anywhere within the gas confinement boundary.

SHINE FSAR Section 4a2.2.6, Neutron Multiplier, states that the neutron multiplier is an annulus of aluminum-clad uranium metal that serves to moderate and multiply the fast neutrons coming from the reactions initiated by the neutron driver. The NRC staff needs more information to understand the potential of hydrogen generation to ensure hydrogen concentrations are maintained below acceptable limits to prevent ignition and deflagration conditions within the as confinement boundary.

Clarify whether SHINE considered the potential of hydrogen generation within the gas confinement boundary. If hydrogen is generated, explain where this hydrogen may accumulate and what system or systems mitigate the hydrogen generated by a potential event.

RAI 4a-4 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1, Reactor Fuel, states that information provided should include various phenomena that results in potential fuel precipitation.

SHINE FSAR Section 4a2.6.3.5, Limiting Core Configuration, states that uranyl peroxide is known to precipitate out of uranyl sulfate solution under certain conditions of irradiation due to the presence of hydrogen peroxide formed from radiolysis effects. The formation of uranium precipitates is dependent on the rates of hydrogen peroxide production, the peroxide solubility, and the rate of decomposition. The key factors influencing these parameters include the solution chemistry (including pH and catalysts), temperature, and power density.

The NRC staff needs more information to understand how these parameters associated with solubility are monitored and maintained to prevent uranium precipitation from the target solution.

Explain how solubility, temperature, pH, power density, and any other target solution parameters are measured, monitored, and maintained within acceptable limits at zero power with cold conditions to prevent precipitation of uranium from the target solution.

RAI 4a-5 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.3, Reactor Vessel, states that all penetrations and attachments to the vessel below the fuel solution level should be designed to avoid loss of fuel solution.

SHINE FSAR Section 4a2.4.1.4, Location of Penetrations, describes TSV penetrations. However, it is not clear to the NRC staff which penetrations are only into the TSV or through the TSV. It is also not clear whether penetrations are voided or filled with target solution to ensure that the design avoids loss of fuel solution.

For each TSV penetration described in FSAR Section 4a2.4.1.4, clarify whether the penetration is into the TSV (i.e., open to TSV) or only transitions through the TSV (i.e., closed to TSV). Additionally, provide dimensions of each penetration, and clarify whether each penetration is voided or filled with target solution during Mode 2 operation of the irradiation units.

RAI 4a-6 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1, Reactor Fuel, states that the various phenomena that result in changes to the initial fuel composition and properties should be considered. Application submittals should include information on radiolytic gas formation, transport, and changes in void fraction, along with the reactivity implications of these items.

SHINE FSAR Section 4a2.2.1.6, TSV Operating Conditions, states that the bulk void fraction within the target solution is expected to be less than five percent.

Further, Table 4a2.6-10, Limiting Core Configuration Calculated Parameters, of the SHINE FSAR states the average void fraction. SHINE FSAR Section 4a2.6.1.2, TSV Operating Characteristics, states the estimated nominal average void fraction during Mode 2 operation of the irradiation units. However, it is unclear to the NRC staff how the void fraction within the target solution was determined.

Explain how the average void fraction in SHINE FSAR Table 4a2.6-10 was determined, including the basis for expecting the bulk void fraction within the target solution to be less than five percent.

RAI 4a-7 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.4, Biological Shield, states that the shield design should address damage from induced radioactivity in reactor components.

SHINE FSAR Section 4a2.3.3, Operation Overview, states that each deuterium-tritium fusion reaction produces a single high energy neutron of approximately 14.1 million electron volt [MeV] and a single high energy alpha particle of approximately 3.5 MeV. The neutrons produced radiate outward, with most entering the subcritical assembly system. However, it is unclear to the NRC staff what the potential is for radiation damage to safety-related SSCs caused by these high-energy neutrons.

(1) Discuss the potential for neutron streaming paths during Mode 2 operation of the irradiation units, including penetrations into the light water pool, that may allow high-energy neutrons to bypass the shielding provided by the light water.

(2) Explain any methods or materials used to prevent high-energy neutron radiation damage to safety-related SSCs within the irradiation unit cell, TOGS shielded cell, primary cooling room, and radioisotope production facility (RPF) valve pit.

RAI 4a-8 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.3, Reactor Vessels, states that the outer and inner surfaces of the vessel are designed and treated to avoid corrosion in locations that are inaccessible for the life of the vessel.

SHINE FSAR Section 4a2.4.1.3, Design Description of Materials and Supporting Structures, states that the TSV is constructed of 347 stainless steel, which has been shown to have high corrosion resistance in SHINE target solution environments and offer acceptable nuclear performance. However, it is unclear to the NRC staff what potential mechanisms contribute to the corrosion and embrittlement of the TSV over its lifetime. For example, tellurium, which is a fission product in nuclear reactor fuels, can embrittle the surface of grain boundaries of nickel-based structural materials. This information is necessary to ensure integrity of the TSV.

Explain the corrosive impact of trace fission products, such as tellurium, on the TSV and associated welds to ensure the integrity of the TSV and TSV dump tank. Additionally, explain any mitigation actions or monitoring SHINE plans to conduct related to corrosion of the TSV and TSV dump tank.

RAI 4a-9 The ISG Section 4a2.3, Part 2, Reactor Vessel, states that a plan should be in place to assess irradiation of and chemical damage to vessel materials.

Remedies for damage or a replacement plan should be discussed.

While SHINE FSAR Section 4a2.4.1.5, Chemical Interactions and Neutron Damage, provides SHINEs plan to assess irradiation of and chemical damage to the TSV, SHINE doesnt provide a discussion of any remedies for damage or a replacement plan for the TSV, TSV dump tank, and TOGS in the event of an adverse finding of damage.

Discuss remedies for damage to the PSB, a replacement plan, or an alternate approach to addressing an adverse finding of damage upon inspection of these components.

RAI 4a-10 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.2, Reactor Core Physics Parameters, states that calculation methods should be justified and traceable to their development and validation.

SHINE FSAR Section 4a2.6.2.1, Analysis Method and Code Validation, states that transient analyses are performed using the SHINE Transient Reactivity Integration Accelerator Driven Multiphysics (TRIAD) computer code, which is an extension of the Los Alamos National Laboratory (LANL)-developed dynamic system simulation tool. The TRIAD code calculates the integrated system response of the subcritical assembly system (SCAS), TOGS, neutron driver, and primary closed loop cooling system (PCLS). From the LANL code, SHINE added capability to the code, adjusted it to match SHINE subcritical assembly system parameters, and performed in-house verification and validation of the completed code. However, SHINE has not sufficiently described in the FSAR how it modified the LANL code and performed its validation and verification of the TRIAD computer code to justify its calculation methods.

Describe how SHINE modified the TRIAD code and why it is an acceptable model for analyzing SCAS, TOGS, neutron driver, and PCLS.

RAI 4a-11 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.3, Operating Limits, states that an applicant should justify the minimum negative reactivity that will ensure the safe shutdown of the reactor. This discussion should address the methods and the accuracy with which this negative reactivity can be determined to ensure its availability.

SHINE FSAR Section 4a2.6.3.4, Negative Reactivity, states that the TSV must drain within 183 seconds with a minimum TSV target solution volume, which is the limiting core configuration. However, it is unclear to the NRC staff why the SHINE FSAR does not address the maximum drain time of the TSV with a maximum TSV target solution volume.

Provide the maximum drain times for the TSV with the maximum solution volume or explain why maximum drain times are not needed for the maximum solution volume in the TSV to support transient or accident sequence analyses involving the shutdown of the TSV.

RAI 4a-12 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5, Nuclear Design, states, in part, that the FSAR should include information on the anticipated core evolution, accounting for changes in the fuel solution chemical stability caused by radiolysis.

SHINE FSAR Section 4a2.6.1.1, Gas Management System Effects, states that the radiolysis of water in the in the system and constant evaporation of target solution causes an anticipated increase in the reactivity during operation due to the holdup of water within the TOGS condensers and piping. However, it is unclear to the NRC staff whether there are other system paths for potential water loss due evaporation of the target solution. This information is necessary to ensure that there are not changes in the fuel solution that could affect the chemical stability or result in inadvertent criticality.

Clarify whether water vapor can condense in the TSV overflow lines or TSV dump tank and collect in the TSV dump tank and discuss whether this potential path for water loss was considered in the volume margin to criticality due to the increase in uranium concentration, providing updates to the FSAR as necessary.

RAI 4a-13 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.2.1, Reactor Fuel, states that the fuel operating parameters should consider characteristics that could limit fuel barrier integrity, such as physical stresses from mechanical or hydraulic forces (internal pressures).

SHINE FSAR Section 4a2.6.3.3, Credible Inadvertent Insertion of Reactivity, states that relief valves on the TSV maintain the TSV headspace pressure within the range of -4.5 to 15 psig (-31.0 to 103 kPa) should the TOGS pressure regulation fail. The NRC staff needs more information to understand the design bases of the vacuum and pressure relief valves to maintain TSV headspace pressure.

Provide the following information:

(1) The design basis for relief valve setpoint and flow capacity.

(2) The design basis for vacuum relief valve setpoint and flow capacity.

(3) The relief valve flow capacity at the setpoint pressure.

(4) The vacuum relief valve flow capacity at the setpoint pressure.

(5) An explanation on how much reactivity would need to be inserted to reach the high-pressure relief valve setpoint.

RAI 4a-14 The ISG Augmenting NUREG-1537, Part 2, Section 4a2.5.1, Normal Operating Conditions, states that information should include calculated core reactivities for the possible and planned configurations. The reactivity impacts of radiolytic gas and void formation, and condensate return to the core should be provided.

SHINE FSAR Section 4a2.8.2, System Process and Safety Functions, states that the TOGS condenses water vapor generated by the target solution in the TSV and returns the condensate to the TSV to limit water holdup in TOGS to less than three liters. Further, SHINE FSAR Section 4a2.2.2, Reactivity Control Mechanisms, states that water holdup by TOGS affects reactivity but is not a controlled variable. The NRC staff needs more information to understand the TOGS water holdup basis to ensure the margin to criticality is adequately maintained for possible and planned core configurations.

(1) Provide the basis, using bounding evaporation and condensation rates, for determining that the maximum water holdup for the TOGS is three liters.

(2) Provide an explanation of the water holdup points and volume within TOGS components, considering the orientation and size of tanks, blowers, and piping in the system, which could contribute to a reactivity insertion.

Chapter 7 - Instrumentation and Control Systems The following regulatory requirements are applicable to RAIs 7-1 through 7-8:

Section 50.34(b)(2) of 10 CFR Part 50 requires, in part, that an FSAR include a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.

Section 50.34(b)(2)(ii) of 10 CFR Part 50 states, in part, that for facilities other than nuclear reactors, such items as the instrumentation and control systems (I&C) shall be discussed insofar as they are pertinent.

The technical bases for RAIs 7-1 through 7-8 are drawn from the guidance contained in Chapter 7, Instrumentation and Control Systems, of NUREG-1537, Parts 1 and 2. RAIs 7-1 through 7-8 request that SHINE provide sufficient information for the NRC staff to make the applicable safety findings described in Chapter 7 of NUREG-1537, Part 2. As described in Section 7.2.1, Design Criteria, of NUREG-1537, Part 1, an applicant should discuss the criteria for developing the design bases for the I&C systems of the facility. The basis for evaluating the reliability and performance of the I&C systems should be included in the application. Consistent with Section 7.2, Design of Instrumentation and Control Systems, of NUREG-1537, Part 2, the NRC staff review the following for each of the I&C systems and subsystems described in the application:

• Design criteria

• Design bases

• System descriptions

• System performance analysis

• Conclusion With respect to design criteria, consistent with Section 3.1, Design Criteria, of NUREG-1537, Part 1, design criteria should include applicable standards, guides, and codes; NRC regulatory guides; and national, State, and local building, plumbing and electrical codes, as applicable.

Sufficient information is to be included in the application for the NRC staff to determine how applicable design criteria have been established and satisfied by the design of the facility using appropriate guidance, including appropriate codes and standards. Further, an application should describe the relationship between the design criteria and design bases to explain how systems are designed.

The information requested below is necessary for the NRC staff to determine that the requirements of paragraphs (b)(2) and (b)(2)(ii) of 10 CFR 50.34 have been satisfied and that sufficient detail has been provided as described in Chapter 7 of NUREG-1537, Parts 1 and 2.

RAI 7-1 Section 3.1 of the SHINE FSAR identifies the design criteria for the instrumentation and control (I&C) systems in the SHINE facility. Consistent with the guidance in NUREG-1537, described above, the NRC staff expects that Chapter 7 of the SHINE FSAR include the descriptions of how each I&C system meets the applicable design criteria. However, Chapter 7 of SHINEs FSAR does not describe how the I&C system designs implement SHINEs design criteria.

Further, Chapter 7, Instrumentation and Control Systems, of the SHINE FSAR includes the design bases for each I&C system. However, Chapter 7 of SHINEs FSAR does not describe the relationship between the design bases to the applicable design criteria in Chapter 3 of the SHINE FSAR.

(1) Describe how each I&C system meets each applicable design criterion listed in Section 3.1 of the SHINE FSAR.

(2) Describe the relationship between the design bases to each of the applicable design criterion listed in Section 3.1 of the SHINE FSAR.

RAI 7-2 Chapter 7 of the SHINE FSAR identifies additional system-specific design criteria for each I&C system (e.g., see: SHINE FSAR Section 7.4.2, Design Criteria).

In addition, Chapter 7 of the SHINE FSAR describes the design bases (e.g., see:

SHINE FSAR Section 7.4.3, Design Basis) and design attributes (e.g., see:

SHINE FSAR Section 7.4.4, Design Attributes) for each I&C system. The descriptions provided in the design attributes sections of Chapter 7 of the SHINE FSAR do not describe the design of the SHINE I&C systems in sufficient detail to permit understanding of the system designs and their relationship to the safety analyses.

For each I&C system, describe how the design implements (or meets) each of the system-specific design criteria identified in the subsections of Chapter 7 of the SHINE FSAR.

RAI 7-3 Chapter 7 of the SHINE FSAR includes a list of codes and standards that SHINE applied to the design of each I&C system (e.g., For the target solution vessel reactivity protection system (TRPS) design, this list is provided in Section 7.4.4.15, Quality, of the SHINE FSAR. Another list is provided in Section 7.9, References, of the SHINE FSAR.). However, it is not clear to the NRC staff how SHINE has used the codes and standards identified in the FSAR in the design of its I&C systems.

Describe how each of the codes or standards listed in the FSAR are used to design each of the I&C systems. This discussion should address how SHINE intends to comply or take exception from the relevant codes or standards.

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.

RAI 7-5 The SHINE FSAR states that the process integrated control system (PICS) will monitor, control, and operate the SHINE I&C systems in the SHINE irradiation facility (IF) and the radioisotope production facility (RPF). However, the SHINE FSAR does not clearly identify all I&C systems controlled by PICS (i.e., Figure 7.3-1, Process Integrated Control System Interfaces, of the FSAR refers to IF Process Systems, RPF Process Systems, and Other I&C Systems). Further, the FSAR identifies systems in the IF that will interface with the PICS, but does not identify systems in the RPF that will interface with the PICS.

(1) Identify all I&C systems that the PICS will monitor, control, and operate in the SHINE facility.

(2) Describe how the PICS will operate the SHINE facility and, in case of its failure, the safety controls included to mitigate or prevent an accident.

(3) Provide the system architecture that shows all systems that interface or interact with the PICS, not only those installed in the IF.

RAI 7-6 The SHINE FSAR uses the terms channel and division. However, the SHINE FSAR does not clearly define or distinguish what constitutes a channel or a division. For example, Section 7.2.5.3, Access Control, of the SHINE FSAR states, in part:

Each division of TRPS and ESFAS systems has a nonsafety-related MWS for the purpose of online monitoring and offline maintenance and calibration. The HIPS platform MWS supports online monitoring through one-way isolated communication ports.

The MWS is used to update setpoints and tunable parameters in the HIPS chassis when the safety function is out of service.

Physical and logical controls are put in place to prevent modifications to a safety channel when it is being relied upon to perform a safety function. A temporary cable and OOS switch are required to be activated before any changes can be made to an SFM. When the safety function is removed from service, either in bypass or trip, an indication is provided by the HIPS platform that can be used to drive an alarm in the facility control room to inform the operator. Adjustments to parameters are performed in accordance with facility technical specifications, including any that establish the minimum number of redundant safety channels that must remain operable for the applicable operating mode and conditions. [emphasis added]

This paragraph seems to use the terms channel and division interchangeably.

Define what constitutes a channel and what constitutes a division.

RAI 7-7 Section 50.36, Technical Specifications, of 10 CFR requires that each applicant for an operating license include proposed technical specifications (TSs). The proposed technical specifications (TSs) in the application should identify the safety systems necessary to protect the facility when a postulated accident occurs. The proposed TS should include: Limiting Conditions for Operation (LCOs), Limiting Safety System Settings (LSSSs), and surveillance requirements (SR). LCOs are the lowest functional capability or performance levels (e.g.,

LSSSs) of equipment required for safe operation of the facility. The SR should identify the tests performed on a predetermined periodicity to verify that required safety system is operating as assumed in the accident analyses and within the licensing basis or the facility is operating outside an LCOs. The TS should be based on the analysis provided in Chapter 13, Accident Analysis, of the FSAR.

The relationship between LCOs, LSSSs, and SRs are not clear and appears to be inconsistent in some cases for the respective descriptions in Chapters 7 and 13.

(1) Clarify inconsistencies among the instrument range, analytical limits, safety limits (SLs), and associated LSSSs in Chapters 7 and 13 of the application, as well as the TSs. The FSAR should include sufficient information to conclude that SLs are protected, and that LSSS and LCO settings were established through the analyses in Chapter 13.

(2) For the safety functions, verify and update the descriptions in the FSAR to be consistent with the description in the bases for TS for LSSSs.

RAI 7-8 Section 50.36(c)(2) of 10 CFR states that the TSs will include LCOs. Section CFR 50.36(c)(2)(i) of 10 CFR defines LCOs as the lowest functional capability or performance levels of equipment required for safe operation of the facility.

Section 50.36(a)(1) of 10 CFR states, in part, that [a] summary statement of the bases or reasons for such specifications, other than those covering administrative controls, shall also be included in the application, but shall not become part of the technical specifications.

Criterion 15 in Chapter 3 of the SHINE FSAR requires adequate reliability or redundancy to protect against the loss of a protection function when a component is removed from service. The design of the TRPS states that it meets the single failure criteria by having three independent channels of instrumentation (any two of which can initiate a protective action). In other words, any single failure in the TRPS would not prevent a protective action from being implemented. However, the TS LCOs only require two channels of instrumentation to be operable (see SHINE TS LCO 3.2.4); this means that SHINE would allow the TRPS to be operated indefinitely with one channel inoperable (an immediate shutdown is specified if only one is operable). The basis for SHINE TS LCO 3.2.4 states, in part:

The NFDS provides indication of neutron flux and TSV power during IU operations, as described in FSAR Section 7.8. The NFDS signals provide input to TRPS functions, as described in FSAR Subsection 7.4.5. Three Channels of NFDS are provided for each of the variables in Table 3.2.4, one Channel for each of Divisions A, B, and C. Only two Channels are required to be Operable to provide redundancy to protect against a single failure.

When all three Channels are Operable, actuation of the safety function occurs on 2-out-of-3 voting logic. When any single Channel is inoperable, the inoperable Channel is required to be placed in trip, effectively changing the voting logic to 1-out-of-2, preserving the single failure protection.

Any single Channel may be placed in bypass during performance of a required SR, effectively changing the voting logic to 2-out-of-2 (with two other Channels Operable) or 1-out-of-1 (with one other Channel Operable).

Additionally, the following note for SHINE TS LCO 3.2.4 is provided following Table 3.2.3, TRPS Interlocks, of the SHINE FSAR:

Any single required instrumentation Channel may be inoperable while the variable is in the condition of applicability for the purpose of performing a Channel Check or Channel Calibration.

However, the required actions in the TS do not include the requirement that

[w]hen any single Channel is inoperable, the inoperable Channel is required to be placed in trip, effectively changing the voting logic to 1-out-of-2, preserving the single failure protection. Furthermore, SHINE TS LCO 3.2.4 and the associated basis provide no restrictions on the length of time that operation in this condition is allowed, and no explanation is provided as to why unrestricted operation in a condition where the single failure criteria is not met provides adequate safety.

Based on this information in the SHINE FSAR and TS, it appears that when a single channel is in bypass, the system cannot meet the single failure criterion.

Further, because this LCO and associated basis provide no restrictions on the length of time that operation in this condition is allowed, the system can operate this way, in a condition where the single failure criteria is not met, for unlimited duration. Therefore, the NRC staff cannot determine how this unrestricted operation provides adequate safety to shut down the IF in the event of a single failure within the system.

Therefore, it seems the TS LCO is inconsistent with the description in the associated TS basis.

(1) Verify and update Chapter 7 of the SHINE FSAR and the proposed TS to clarify when a single channel is operable.

(2) Describe how placing a channel in bypass (i.e., reducing the number of operable channels) would affect the voting logic and preserve the single failure criteria.

Chapter 12 - Conduct of Operations SHINE FSAR Section 12.7, Emergency Plan, and Enclosures 9 (non-public) and 10 (public),

Emergency Plan, of the SHINE Operating License Application The following regulatory requirements are applicable to RAIs EP-1 through EP-7:

Section 50.36(b)(5)(v) of 10 CFR requests that an applicant for an operating license include plans for coping with emergency, including the items specified in 10 CFR Appendix E, Emergency Planning and Preparedness for Production and Utilization Facilities.

Following the guidance in Regulatory Guide 2.6, Revision 2, Emergency Planning for Research and Test Reactors and Other Non-Power Production and Utilization Facilities, the NRC staff has reviewed the SHINE emergency plan and developed the following RAIs using the American National Standards Institute (ANSI)/American Nuclear Society (ANS) standard ANSI/ANS-15.16-2015, Emergency Planning for Research Reactors. Regulatory Guide 2.6 endorses the use of this standard for non-power 10 CFR Part 50 facilities other than research and test reactors.

RAI EP-1 Section 3.3(2) of ANSI/ANS-15.16-2015 addresses authority and responsibilities for support agencies with a role in emergency preparedness and response.

Section 3.4, Emergency Support Organizations, of the SHINE Emergency Plan states in part, In the event the decision is made by the Emergency Director to request support from offsite organizations, the following offsite support agencies and organizations would provide assistance as described belowSHINE does not anticipate the need for State or Federal assistance. [emphasis added]

It is not clear to the NRC staff how SHINE determined that State or Federal assistance would not be needed.

Clarify whether the State of Wisconsin has been contacted to determine if it has the authority and responsibility for having radiological emergency responsibilities for emergency preparedness planning and emergency response assistance for the SHINE facility.

RAI EP-2 Section 3.7.1, Activation of emergency organization, of ANSI/ANS-15.16-2015 addresses notifications of off-site support organizations.

It is not clear to the NRC staff whether SHINE has coordinated off-site notifications of emergencies with the State of Wisconsin.

Clarify whether the State of Wisconsin been contacted to determine if it requests to be notified in the event of an emergency at the SHINE facility.

RAI EP-3 Section 3.10.1(2), of ANSI/ANS-15.16-2015 addresses provisions for coordinating periodic drills with off-site emergency personnel.

Clarify whether the State of Wisconsin and applicable local offsite response organizations has been contacted to determine if it requests to be offered the opportunity to participate in drills and exercises at the SHINE facility.

RAI EP-4 Section 3.5, Emergency Action Levels, of ANSI/ANS-15.16 discusses the considerations for establishing emergency action levels to initiate protective actions for onsite personnel and the public.

Section 5, Emergency Action Levels, of the SHINE emergency plan states, in part, that Emergency Action Levels (EALs) for the three standardized classifications of emergencies 1) Notification of Unusual Event, 2) Alert, and 3)

Site Area Emergency for the SHINE facility are found in Appendix 4, Emergency Action Levels. However, it is unclear to the NRC staff why the Emergency Classification of Notification of Unusual Event for Severe Natural Phenomena or External Event has duplicate EALs to that of the Emergency Classification of an Alert for the same event.

Explain why the Emergency Classification of Notification of Unusual Event for Severe Natural Phenomena or External Event has duplicate EALs to that of the Emergency Classification of an Alert for the same event. Specifically, address why items identified as (2) and (3) relating to seismic and flooding for the Notice of Unusual Event are the same criteria as (2) and (4) for an Alert.

RAI EP-5 Section 3.7.4, Protective Actions, of ANSI/ANS-15.16 discusses considerations for monitoring radiation dose rates and contamination levels onsite and offsite during an emergency.

Section 8.7.3, Onsite and Offsite Surveying, of the SHINE emergency plan states that [m]onitoring outside the facility and at the site boundary shall be implemented within four hours of declaring a Site Area Emergency involving a potential or actual release. Section 3.3.4, Radiation Safety Coordinator, of the SHINE emergency plan states that the radiation safety coordinator has the responsibility of making onsite and offsite dose assessments and projections.

However, this position is identified as called-in upon activation of the ERO

[Emergency Response Organization]. It further states that members of the radiation protection department and facility technical staff with radiation protection experience can fill this position. Additionally, Section 3.3.9, Assessment Teams, identifies this as one of the responsibilities of an Assessment Team. It is not clear to the NRC staff how SHINE determined that the proposed four-hour window for implementation of monitoring outside the facility and at the site boundary meets the criterion to take action promptly. It is also unclear what capabilities exist to monitor dose rates and contamination levels at the site boundary.

Clarify how the proposed four-hour window for implementation of monitoring outside the facility and at the site boundary meets the criteria to be able to take action promptly. Describe what capabilities exist on-shift to be able to monitor outside the facility and at the site boundary.

RAI EP-6 Section 3.8.3, First Aid and Medical Facilities, of ANSI/ANS-15.16 discusses the need for describing capabilities and measures for decontamination of persons exposed to radiation.

In Section 9.5, Decontamination Facilities, Supplies, and Controls, of the SHINE emergency plan SHINE states that [p]ersonnel are considered contaminated if they are found by direct frisk or use of portal monitor to have contamination above background. However, it is unclear if this statement is consistent with SHINEs operating procedures.

Clarify whether the description of contaminated persons in the SHINE emergency plan is consistent with its facility operating procedures.

RAI EP-7 Section 3.10.1, Training and Drills, of ANSI/ANS-15.16 discusses provisions for conducting emergency drills.

Section 11.4.4, Exercises, of the SHINE emergency plan states that onsite and offsite emergency plans shall be exercised every two years. It further states that a criticality accident response exercise should be conducted at least every three years. It is unclear to the NRC staff whether these differences in timing of exercises could create schedule conflicts.

Clarify whether the conduct of the emergency plan and criticality accident response exercises on different intervals would cause a conflict in exercise scheduling.

SHINE FSAR Section, 12.9 Quality Assurance, and Enclosure 7, Quality Assurance Program Description, of the SHINE Operating License Application, Supplement No. 2 The following regulatory requirements are applicable to RAIs QA-1 through QA-3:

Paragraph 50.34(b)(6)(ii) of 10 CFR requires that managerial and administrative controls to be used to assure safe operation of the facility to be licensed.

Section 50.9 of 10 CFR Part 50 requires information provided by an applicant be complete and accurate.

The NRC staff has reviewed SHINEs quality assurance program description (QAPD) using ANSI/ANS-15.8, Quality Assurance Program Requirements for Research Reactors, as applied by SHINE to the design, fabrication, construction, and operation of the SHINE facility.

RAI QA-1 In Enclosure 7 of the SHINE operating license application, SHINE submitted Revision 15 of the QAPD. The NRC staff previously approved Revision 7 of the QAPD. It is not clear to the NRC how the QAPD is controlled as the current revision does not provide a complete record of the changes that includes the following:

• Revision date

• Revision number

• Description of revision, including whether revisions resulted in a reduction in effectiveness

• Record of revision management approval Therefore, the SHINE QAPD may have potential reductions in commitments to the last NRC approved QAPD. The complete record of changes is necessary to ensure that SHINE is adequately implementing managerial and administrative controls at the facility and that information provided to the NRC staff is complete and accurate.

Provide a complete record of changes to the SHINE QAPD that includes the following:

• Revision date

• Revision number

• Description of revision, including whether revisions resulted in a reduction in effectiveness

• Record of revision management approval RAI QA-2 SHINE uses a custom definition of safety-related SSCs that is applied to the Quality Level (QL) SSCs and uses a graded approach to quality for other SSCs.

The graded approach to quality for this QAPD can be found in Enclosure 2, Graded Approach to Quality, of the SHINE QAPD, which states that QL-1 shall implement the full measures of the QAPD and shall apply to safety-related SSCs and safety-related activities.

In Section 1.3, Definitions, of the SHINE QAPD, the definition of safety-related SSCs uses the definition of safety-related items as defined in ANSI/ANS 15.8-1995. This definition replaces SHINEs previous definition of safety-related SSCs that the NRC staff accepted in Revision 7 of the SHINE QAPD. It is not clear to the NRC staff whether the revised definition of safety-related SSCs represents a reduction in effectiveness of the implementation SHINE QAPD as applied to Quality Level 1 SSCs.

Provide information explaining whether the revised definition of safety-related SSCs in the SHINEN QAPD represents a reduction in effectiveness of the implementation SHINE QAPD as applied to Quality Level 1 SSCs.

RAI QA-3 Enclosure 3, Procedures That Implement the QAPD, of the SHINE QAPD includes a column that is titled Baker Implementing Procedures, listing procedures that correspond to sections of the QAPD and SHINE implementing procedures. However, the roles and responsibilities and relationship of Baker to SHINE is not described in the QAPD.

Clarify whether Baker is an Appendix B to 10 CFR Part 50 supplier of services or is a contractor working under SHINEs QAPD. Additionally, clarify what service Baker is providing during the operational phase of the SHINE Medical Isotope Production Facility.

SHINE FSAR Section 12.13, Material Control and Accounting, and Enclosure 8, Material Control and Accounting Plan, of the SHINE Operating License Application, Supplement No. 2 RAI MCA-1 Paragraphs 74.43(b)(1)(ii) and (iii) of 10 CFR require, in part, a management structure be established, documented, and maintained that is independent of production and manufacturing responsibilities and assures separation of key responsibilities. Section 74.43(b)(2) of 10 CFR requires the overall planning, coordination, and administration of the material control and accounting (MC&A) function be invested in a single individual at an organizational level sufficient to assure independence of action and objectiveness of decisions.

Section 3.2.5 of the SHINE MC&A plan states that the Chemistry Manager is responsible for the analytical laboratories and lists the MC&A-related functions for which the Chemistry Manager is also responsible. Section 3.2.5 further states that the Chemistry Manager acts as the MC&A Manager and lists the MC&A program responsibilities for the Chemistry Manager acting as the MC&A Manager. However, it is not clear to the NRC staff how the separation of key responsibilities, independence of action, and objectiveness of decision-making is maintained between these two positions.

Provide information that clarifies the positions of the Chemistry Manager and the MC&A Manager to assure separation of key responsibilities, independence of action, and objectiveness of decisions.

RAI MCA-2 Paragraph 74.43(b)(1)(iii) of 10 CFR requires, in part, a management structure be established, documented, and maintained that assures separation of key responsibilities.

Sections 3.3.1, 3.3.2, and 3.3.3 of the SHINE MC&A plan describe the responsibilities for MC&A activities related to accounting, measurement, and control, respectively. In each of the three areas, the responsibilities are assigned to a Chemistry Department staff member. Chapter 5, Measurement Control System, of the SHINE MC&A plan describes the various activities performed for measurement control, including activities by the laboratories, laboratory staff, laboratory analyst, or Chemistry staff. Two examples are in Section 5.2, Calibrations, which states that laboratory instruments are calibrated by a laboratory analyst, and that scales are calibrated by qualified Chemistry staff.

There is not a clear separation of responsibilities between personnel with specific MC&A responsibilities and personnel performing measurements, performing calibrations, or handling special nuclear material (SNM).

Provide information that describes the position of a Chemistry Department staff member in areas other than MC&A that will ensure separation of key responsibilities.

RAI MCA-3 Paragraph 74.45(c)(1) of 10 CFR requires assigning responsibility for planning, coordinating, and administering a measurement control program to an individual who has no direct responsibility for performing measurements or for SNM processing or handling.

Section 3.3.2 of the SHINE MC&A plan states that a Chemistry Department staff member serves as the MC&A measurement control program coordinator.

However, it is not clear to the NRC staff whether the program coordinator has responsibility for performing measurements or for SNM processing and handling.

Provide information that clarifies the positions of Chemistry Department staff members and the responsibilities of the measurement control program coordinator to ensure that the coordinator has no direct responsibility for performing measurements or for SNM processing or handling.

RAI MCA-4 Paragraph 74.43(b)(4) of 10 CFR requires, in part, that personnel who work in key MC&A positions where mistakes could degrade the effectiveness of the MC&A system are trained to maintain a high level of safeguards awareness.

Section 3.4, Training and Qualification Requirements, of the SHINE MC&A plan discusses the MC&A training program. The plan describes general training for all employees, and additional training for individuals that perform specific MC&A activities. The plan does not state whether these individuals that perform specific MC&A activities are the key MC&A positions and does not indicate that they will be trained to maintain a high level of safeguards awareness.

Provide information to identify the key MC&A positions and describe how personnel in those key MC&A positions are trained to maintain a high level of safeguards awareness.

RAI MCA-5 Paragraph 74.45(b)(1) of 10 CFR requires a program for the measurement of all SNM received, produced, transferred between internal control areas, on inventory, or shipped, discarded, or otherwise removed from inventory, except for the material types listed in 10 CFR 74.45(b)(1)(i)-(iv).

Sections 4.1, Measurement Points, and 4.2.1 of the SHINE MC&A plan state that a nominal uranium-235 (U-235) value may be used for calculating U and U-235 content of other SNM in the physical inventory. Table 4-1, MC&A Measurement Points, of the SHINE MC&A plan also indicates that nominal values for some material types may be used. However, it is unclear to the NRC staff how SHINE is justifying the alternative use of nominal values instead of measured values for U and U-235 on the material types listed in Table 4-1 of the SHINE MC&A plan.

Provide information to justify the alternative use of nominal values instead of measured values for U and U-235 on the material types listed in Table 4-1 of the SHINE MC&A plan. Also clarify whether the nominal values are used for determining U-235 only, or for determining both U and U-235.

RAI MCA-6 Paragraph 74.45(b)(1) of 10 CFR requires a program for the measurement of all SNM received, produced, transferred between internal control areas, on inventory, or shipped, discarded, or otherwise removed from inventory, except for the material types listed in 10 CFR 74.45(b)(1)(i)-(iv).

Section 4.1 of the SHINE MC&A plan states that plutonium (Pu) quantities in the neutron multipliers and in the target solution are calculated. Section 4.1 also states that because of the low concentration of Pu in solution, and because of the significant dilution required to lower dose rate of samples, the Pu concentration in a sample of solution is unmeasurable. However, it is unclear to the NRC staff how SHINE calculated Pu quantities in the target solution and neutron multipliers.

Provide a more detailed explanation of how the Pu quantities in the target solution and neutron multipliers are calculated.

RAI MCA-7 Paragraph 74.45(b)(1) of 10 CFR requires a program for the measurement of all SNM received, produced, transferred between internal control areas, on inventory, or shipped, discarded, or otherwise removed from inventory, except for the material types listed in 10 CFR 74.45(b)(1)(i)-(iv).

The introduction to Chapter 4, Measurements, of the SHINE MC&A plan states that SHINE has measurement systems in place for quantifying the mass of U and U-235 of all SNM received, shipped, discarded, or listed in the physical inventory.

Section 4.1 states that U and U-235 content is measured for all items received or shipped. Section 4.2.1 of the SHINE MC&A plan states that element is measured for all SNM received, shipped, or inventoried, and that isotopic content is measured for all SNM received or shipped. In addition, Section 3.2.5 of the SHINE MC&A plan states that the Chemistry Manager is responsible for ensuring that all SNM items received, shipped, and inventoried are measured. None of the sections cited discuss measurement of SNM transferred between internal control areas. However, it is unclear to the NRC staff how SHINE is measuring SNM transferred between internal control areas.

Provide information on measurement of SNM transferred between internal control areas, or justify why SNM transferred between internal control areas is not measured as required by 10 CFR 74.45(b)(1).

RAI MCA-8 Paragraph 74.45(c)(3) of 10 CFR requires, in part, that potential sources of sampling error are identified and that samples are representative by performing process sampling tests using well characterized materials. It also requires that the tests are conducted, in part, whenever a new sampling procedure is used, a sampling procedure or technique is modified, or sample containers or storage are modified.

Section 4.2, Measurement Systems, of the SHINE MC&A plan states, in part, that detailed descriptions of sampling systems are provided in written procedures, and that sampling systems are evaluated using engineering studies to prove that samples are representative. Section 4.2.3, Volume Measurement Systems, also states that engineering studies are conducted to assure tank solutions are homogeneous and that samples are representative. The plan does not identify the potential sources of sampling error and does not indicate when sampling tests are to be conducted.

Provide a description of potential sources of sampling error and provide information on when sampling tests are conducted.

RAI MCA-9 Paragraph 74.45(c)(6) of 10 CFR requires, in part, the use of standards for the calibration and control of all measurement systems used for SNM accountability.

It further requires that calibrations shall be repeated whenever any significant change occurs in a measurement system or when program data indicate a need for recalibration.

Section 5.2, Calibrations, of the SHINE MC&A plan describes calibrations, and states that laboratory instruments are calibrated on a regular basis, and scales are calibrated annually. However, Section 5.2 does not indicate when calibrations are repeated.

Provide information on when measurement system calibrations are repeated.

RAI MCA-10 Paragraph 74.45(c)(7) of 10 CFR requires, in part, control measurements to provide current data for the determination of random error behavior. Paragraph 74.45(c)(7)(iii) of 10 CFR further states that the program shall include, as appropriate, replicate volume measurements of bulk process batches.

Section 5.4, Replicate Measurements, of the SHINE MC&A plan describes the use of replicate measurements in the measurement control program.

Section 6.1.2 of the SHINE MC&A plan discusses the estimation of random uncertainty (random error). However, neither Section 5.4 nor Section 6.1.2 include information on replicate volume measurements of bulk process batches.

It is noted that the table at the end of Section 6.1.2 does include some information on random variance determination for volume.

Provide information on the use of replicate measurements for volume determinations or, if not appropriate, justify why replicate measurements are not appropriate.

RAI MCA-11 Paragraph 74.45(c)(7) of 10 CFR requires, in part, control measurements to provide current data for the determination of random error behavior. Paragraph 74.45(c)(7)(v) of 10 CFR further states that the program shall include, as appropriate, replicate non-destructive assay (NDA) measurements of individual process containers (items), or alternatively, the use of data generated from the replicate measurements of NDA control standards as derived from the control standard program.

Section 5.4 of the SHINE MC&A plan describes the use of replicate measurements in the measurement control program. Section 5.4 states that for NDA systems, replicate measurements are not required because the quantity of SNM in waste measured by NDA is very small when compared with the total quantity of SNM in the inventory. Section 6.1.2 of the SHINE MC&A plan discusses the estimation of random uncertainty (random error). However, it does not include information on replicate NDA measurements.

Provide more detail on the use of replicate NDA measurements or, if not appropriate, justify why replicate measurements are not appropriate.

RAI MCA-12 Paragraph 74.45(c)(11) of 10 CFR requires, as part of the measurement control program, prompt investigation and appropriate corrective action whenever a control datum exceeds an 0.05 control limit.

Section 5.5, Control Limits, of the SHINE MC&A plan describes the use of control limits established to monitor measurement systems used for MC&A.

Section 5.5.1 describes the measurement control data analysis including potential problem indicators, and Section 5.5.2 describes response actions for the indicators listed. However, Sections 5.5.1 and 5.5.2 do not discuss the investigation or corrective actions taken when a control datum exceeds the 0.05 limit.

Provide a description of the investigation and corrective actions taken when a control datum exceeds the 0.05 limit.

RAI MCA-13 Paragraph 74.43(c)(4) of 10 CFR requires that procedures are maintained and followed for confirming the validity of prior measurements associated with unencapsulated and unsealed items on ending inventory.

Chapter 7, Physical Inventory Program, of the SHINE MC&A plan provides a description of the physical inventory program. Chapter 8, Item Control Program, describes item identity controls, storage controls and item monitoring activities. Chapter 11, Tamper-Safing, describes the characteristics and use of tamper-indicating devices (TIDs) and the description of tamper-safing records.

However, it is unclear whether there will be unencapsulated or unsealed items on ending inventory, nor whether there are procedures for confirming the prior measurement of those items.

Provide more detailed information on the use of TIDs, and on procedures for confirming the validity of prior measurements associated with unencapsulated and unsealed items on ending inventory, if applicable.

RAI MCA-14 Paragraph 74.43(c)(5)(v) of 10 CFR requires, in part, that inventory procedures are maintained and followed to assure that, upon completion of the physical inventory, all book and inventory records, for total plant and individual internal control areas, are reconciled with and adjusted to the results of the physical inventory.

Section 7.1, General Description, of the SHINE MC&A plan provides a general description of the physical inventory program. Section 7.1 states, in part, that differences between the accounting records and the ending physical inventory are investigated and reconciled. Section 7.2, Organization, Procedures, and Schedules, states, in part, that inventory activities include time to resolve differences between the book and physical inventories. Section 7.5, Conducting Physical Inventories, describes conducting the physical inventory, including activities undertaken after the inventory listing. These three sections discuss inventory reconciliation for the entire facility, but it is not clear whether book and inventory records are reconciled to the results of the inventory for individual internal control areas.

Provide information on how book and inventory records are reconciled with and adjusted to the results of the physical inventory for individual internal control areas.

RAI MCA-15 Paragraph 74.43(c)(5)(iv) of 10 CFR requires that cutoff procedures for records and reports are established so that only transfers for the inventory and material balance interval are included in the records for the material balance period in question.

Chapter 7 of the SHINE MC&A plan provides a description of the physical inventory program. Specifically, Section 7.3, Typical Inventory Composition, describes cutoff procedures for transfers and processing, and Section 7.5 describes conducting the physical inventory, including information on cutoff times for movement and processing and cleanout activities. Neither section discusses cutoff procedures for records and reports.

Provide information on how cutoff procedures for records and reports are established so that only transfers for the inventory and material balance interval are included in the records for the material balance period in question.

RAI MCA-16 Paragraph 74.43(c)(8)(iii) of 10 CFR requires, in part, that any occurrence of standard error of the inventory difference (SEID) exceeding 0.125 percent of active inventory be investigated and reported to the NRC.

Section 7.5 of the SHINE MC&A plan describes conducting the physical inventory, and Section 7.6, Inventory Difference Limits and Response Actions, describes inventory difference limits and response actions. Section 6.2.2 of the SHINE MC&A plan describes calculation of the SEID. These sections do not describe the steps taken to investigate and report when the SEID exceeds 0.125 percent of the active inventory.

Provide a description of the actions taken to investigate and report when the SEID exceeds 0.125 percent of the active inventory.

RAI MCA-17 Paragraph 74.43(b)(6) of 10 CFR specifies items that are exempted from the item control program requirements of 10 CFR 74.43(b)(5).

Section 8.2, General Description, of the SHINE MC&A plan provides a general description of the SHINE item control program. Included in the description is a list of exceptions (exemptions) to the item control program. The list of items is based on exemptions not consistent with those in 10 CFR 74.43(b)(6), but rather reflects those proposed in a Part 74 rulemaking that was subsequently terminated.

Provide a list of items that will be excepted from the item control program that is consistent with the requirements of 10 CFR 74.43(b)(6).

RAI MCA-18 Paragraph 74.43(b)(7) of 10 CFR requires conducting and documenting shipper-receiver comparisons for all SNM receipts.

Chapter 9, Receiving and Shipping Program, of the SHINE MC&A plan describes how SHINE will conduct and document shipper-receiver comparisons.

Section 9.1, Receiving Procedures, describes the SNM receiving procedures for the facility, and includes statements that the shippers gross weight may or may not include the TID, and that the information should be obtained from the shipper. It also states that the SHINE gross weight includes the SHINE TID, which makes verification of gross weight easier and more accurate if re-weighing is necessary. However, it is not clear to the NRC staff how the use of shipper or SHINE TIDs impacts conducting and documenting shipper-receiver comparisons.

Provide more detailed information on how the use of shipper or SHINE TIDs impacts conducting and documenting shipper-receiver comparisons.

RAI MCA-19 Paragraph 74.43(b)(8) requires, in part, performance of an independent assessment of the total MC&A system, assessing the performance of the system, reviewing its effectiveness, and documenting managements action on prior assessment recommendations. In addition, an MC&A plan must demonstrate how the system capabilities contained in 10 CFR 74.41(c) are achieved and maintained, and how such capabilities are used to achieve the performance objectives listed in 10 CFR 74.41(a).

Chapter 10, Assessment and Review of the MC&A Program, of the SHINE MC&A plan describes the assessment and review of SHINEs MC&A program.

Throughout the chapter, the applicant describes actions that should be taken instead of the actions that are taken.

Provide information to show that an independent assessment of the total MC&A system will be performed as required by the system capability in 10 CFR 74.43(b)(8).

RAI MCA-20 Paragraph 74.43(b)(8) of 10 CFR requires, in part, that independent assessments include a review and evaluation of any contractor who performs SNM accountability measurements for the applicant.

Chapter 10 of the SHINE MC&A plan describes the assessment and review of SHINEs MC&A program. The description does not include a review of any contractor who performs SNM accountability measurements for SHINE.

Provide information to show that the independent assessment includes a review and evaluation of any contractor who performs SNM accountability measurements for SHINE.

RAI MCA-21 Paragraph 74.43(d)(1) of 10 CFR requires a recordkeeping program that maintains records of the receipt, shipment, disposal, and current inventory associated with all possessed SNM.

Chapter 15 of the SHINE MC&A plan describes the recordkeeping program.

Chapter 15 contains a list of records, forms, reports, and procedures that are considered to be records, and a list of supplemental records which are necessary for MC&A. Neither list includes records of disposal of SNM.

Provide information on how records of disposal of SNM are included in the SHINE MC&A recordkeeping program.