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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION ADVISORY COMMITTEE ON REACTOR SAFEGUARDS WASHINGTON, DC 20555 - 0001 December 15, 2022 The Honorable Christopher T. Hanson Chair U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION ADVISORY COMMITTEE ON REACTOR SAFEGUARDS WASHINGTON, DC 20555 - 0001 The Honorable Christopher T. Hanson Chair U.S. Nuclear Regulatory Commission Washington, DC 20555-0001


==SUBJECT:==
==SUBJECT:==
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==Dear Chair Hanson:==
==Dear Chair Hanson:==
During the 701st meeting of the Advisory Committee on Reactor Safeguards (ACRS),
During the 701st meeting of the Advisory Committee on Reactor Safeguards (ACRS),
November 29 - December 2, 2022, we completed our review of the SHINE Technologies, LLC (SHINE or the applicant), operating license (OL) application for its Medical Isotope Production Facility and the staffs associated Safety Evaluation Report (SER) with no open items.
November 29 - December 2, 2022, we completed our review of the SHINE Technologies, LLC (SHINE or the applicant), operating license (OL) application for its Medical Isotope Production Facility and the staffs associated Safety Evaluation Report (SER) with no open items.
During our review, we had the benefit of interactions with representatives of the Nuclear Regulatory Commission staff and the applicant. This included a visit to the SHINE construction site in Janesville, Wisconsin, in August 2022. We also benefited from the documents referenced. Appendix I lists the chronology of Full Committee and Subcommittee meetings on this topic. Appendix II contains the list of our memoranda on SER chapter reviews. This letter report fulfills the ACRS review requirement in Title 10 of the Code of Federal Regulations (10 CFR) Section 50.58, Hearings and report of the Advisory Committee on Reactor Safeguards.
During our review, we had the benefit of interactions with representatives of the Nuclear Regulatory Commission staff and the applicant. This included a visit to the SHINE construction site in Janesville, Wisconsin, in August 2022. We also benefited from the documents referenced. Appendix I lists the chronology of Full Committee and Subcommittee meetings on this topic. Appendix II contains the list of our memoranda on SER chapter reviews. This letter report fulfills the ACRS review requirement in Title 10 of the Code of Federal Regulations (10 CFR) Section 50.58, Hearings and report of the Advisory Committee on Reactor Safeguards.
CONCLUSION AND RECOMMENDATION
CONCLUSION AND RECOMMENDATION 1.
: 1. The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility.
The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility.
: 2. The OL for the SHINE Medical Isotope Production Facility should be issued.
2.
The OL for the SHINE Medical Isotope Production Facility should be issued.
BACKGROUND When operational, the SHINE Medical Isotope Production Facility will provide a domestic, reliable supply of molybdenum-99 (Mo-99) for medical applications. Not utilizing highly enriched uranium for medical isotope production supports U.S. national security interests and nuclear non-proliferation policy objectives.
BACKGROUND When operational, the SHINE Medical Isotope Production Facility will provide a domestic, reliable supply of molybdenum-99 (Mo-99) for medical applications. Not utilizing highly enriched uranium for medical isotope production supports U.S. national security interests and nuclear non-proliferation policy objectives.
December 15, 2022


C.T. Hanson                                       Facility Description SHINE submitted an OL application for the SHINE Medical Isotope Production Facility to produce Mo-99 in accordance with the requirements contained in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, on July 17, 2019. The facility would be licensed as a non-power utilization and production facility (NPUF), as defined in 10 CFR 50.2, Definitions. Issuance of the OL would authorize SHINE to operate this facility for 30 years.
C.T. Hanson Facility Description SHINE submitted an OL application for the SHINE Medical Isotope Production Facility to produce Mo-99 in accordance with the requirements contained in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, on July 17, 2019. The facility would be licensed as a non-power utilization and production facility (NPUF), as defined in 10 CFR 50.2, Definitions. Issuance of the OL would authorize SHINE to operate this facility for 30 years.
The facility includes an irradiation facility and a radioisotope production facility. The irradiation facility consists of eight subcritical operating assemblies (or irradiation units). The radioisotope production facility consists of hot cell structures for the processing of the irradiated solution.
The facility includes an irradiation facility and a radioisotope production facility. The irradiation facility consists of eight subcritical operating assemblies (or irradiation units). The radioisotope production facility consists of hot cell structures for the processing of the irradiated solution.
The Mo-99 production process begins in an irradiation unit where accelerator-driven deuterons bombard tritium gas to create a fusion reaction, producing neutrons. This neutron flux is enhanced by a neutron multiplier and induces fission in the low-enriched uranyl sulfate target solution, creating Mo-99 as a byproduct. The Mo-99 is extracted and purified in the radioisotope production facility.
The Mo-99 production process begins in an irradiation unit where accelerator-driven deuterons bombard tritium gas to create a fusion reaction, producing neutrons. This neutron flux is enhanced by a neutron multiplier and induces fission in the low-enriched uranyl sulfate target solution, creating Mo-99 as a byproduct. The Mo-99 is extracted and purified in the radioisotope production facility.
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Operating License Review Approach We conducted our review of the Final Safety Analysis Report (FSAR) and draft SER with no open items on a chapter-by-chapter basis. Individual members were assigned chapters or topics for detailed technical review. The entire SHINE Subcommittee participated in chapter briefings with the staff and applicant. The cognizant member summarized findings in a memorandum reflecting subsequent Full Committee deliberation. This approach provided a comprehensive, in-depth review of the SHINE submittal. The overall process significantly reduced the number of presentations required of the staff and applicant for our review.
Operating License Review Approach We conducted our review of the Final Safety Analysis Report (FSAR) and draft SER with no open items on a chapter-by-chapter basis. Individual members were assigned chapters or topics for detailed technical review. The entire SHINE Subcommittee participated in chapter briefings with the staff and applicant. The cognizant member summarized findings in a memorandum reflecting subsequent Full Committee deliberation. This approach provided a comprehensive, in-depth review of the SHINE submittal. The overall process significantly reduced the number of presentations required of the staff and applicant for our review.
Our review identified a number of items not thoroughly addressed in the initial FSAR and SER.
Our review identified a number of items not thoroughly addressed in the initial FSAR and SER.
Concerns relative to the OL were resolved during subsequent meetings. Beyond that, the Appendix II memoranda expand upon several other noteworthy points, including:
Concerns relative to the OL were resolved during subsequent meetings. Beyond that, the Appendix II memoranda expand upon several other noteworthy points, including:  
The importance of human factors and actions in the conduct of operations of an irradiation and radioisotope production facility Coordination with local community resources to respond to low-frequency hazards (e.g., fire, chemical, and aircraft impact)
 
The importance of human factors and actions in the conduct of operations of an irradiation and radioisotope production facility
 
Coordination with local community resources to respond to low-frequency hazards (e.g., fire, chemical, and aircraft impact)


C.T. Hanson                                               Broadening of cyber security assessments to all critical digital assets required for mission critical system operation DISCUSSION The staff review followed NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Parts 1 and 2, supplemented by guidance in the associated Interim Staff Guidance document. In our review of this first-of-a-kind facility, we identified the following three noteworthy attributes that characterize the innovativeness of the design and the completeness of this application.
C.T. Hanson Broadening of cyber security assessments to all critical digital assets required for mission critical system operation DISCUSSION The staff review followed NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Parts 1 and 2, supplemented by guidance in the associated Interim Staff Guidance document. In our review of this first-of-a-kind facility, we identified the following three noteworthy attributes that characterize the innovativeness of the design and the completeness of this application.
SHINE Safety Characteristics The SHINE facility incorporates several important safety features. The low power density irradiation units are designed to automatically shut down the irradiation process and place the target solution into a safe stable passively cooled condition without immediate operator actions. Criticality during the dissolving and filling processes is largely precluded by the engineering design. Additionally, critically safe vessels or double contingency controls are used for fissile solutions in the production facility.
SHINE Safety Characteristics The SHINE facility incorporates several important safety features. The low power density irradiation units are designed to automatically shut down the irradiation process and place the target solution into a safe stable passively cooled condition without immediate operator actions. Criticality during the dissolving and filling processes is largely precluded by the engineering design. Additionally, critically safe vessels or double contingency controls are used for fissile solutions in the production facility.
SHINE Safety Analysis Approach Using common hazard evaluation methods, such as Hazard and Operability Analysis and Failure Modes and Effects Analysis, the SHINE Safety Analysis (SSA) methodology provides a systematic approach to identify, evaluate, and group credible accident sequences. Both internal and external events were considered. Results were ranked using a risk matrix. Design Basis Accidents (DBAs) were identified as those events with maximum consequences for each accident sequence grouping. The DBAs were used to identify those structures, systems, and components (SSCs) and procedural controls required to prevent unacceptable consequences.
SHINE Safety Analysis Approach Using common hazard evaluation methods, such as Hazard and Operability Analysis and Failure Modes and Effects Analysis, the SHINE Safety Analysis (SSA) methodology provides a systematic approach to identify, evaluate, and group credible accident sequences. Both internal and external events were considered. Results were ranked using a risk matrix. Design Basis Accidents (DBAs) were identified as those events with maximum consequences for each accident sequence grouping. The DBAs were used to identify those structures, systems, and components (SSCs) and procedural controls required to prevent unacceptable consequences.
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Our review also explored the adequacy of assumed sensor response times to mitigate accident sequences because they affect the margins for proposed setpoints. In response to our questions and an audit completed by the staff, the applicant revised the FSAR to explicitly list
Our review also explored the adequacy of assumed sensor response times to mitigate accident sequences because they affect the margins for proposed setpoints. In response to our questions and an audit completed by the staff, the applicant revised the FSAR to explicitly list


C.T. Hanson                                       these response times. Subsequently, the staff completed independent evaluations of the associated margins. The additional input from SHINE and the staff addressed our concerns.
C.T. Hanson these response times. Subsequently, the staff completed independent evaluations of the associated margins. The additional input from SHINE and the staff addressed our concerns.
Technical Specifications Justifications SHINEs proposed Technical Specifications (TSs) address relevant safety limits, limiting safety system settings, limiting control settings, limiting conditions for operation (LCOs), and surveillance requirements (SRs). The staff assessed these TSs as well as design features that affect SSC function, availability, or reliability, and administrative controls to ensure their required availability.
Technical Specifications Justifications SHINEs proposed Technical Specifications (TSs) address relevant safety limits, limiting safety system settings, limiting control settings, limiting conditions for operation (LCOs), and surveillance requirements (SRs). The staff assessed these TSs as well as design features that affect SSC function, availability, or reliability, and administrative controls to ensure their required availability.
The processes associated with SHINE isotope production include several interrelated irradiation and chemical processes that must be controlled by TSs. A key example of this is the prevention of uranyl peroxide precipitation. Uranyl peroxide can form and precipitate from the target solution if the concentration exceeds the temperature dependent solubility limit. The equilibrium uranyl peroxide concentration and precipitation limit are functions of temperature (power),
The processes associated with SHINE isotope production include several interrelated irradiation and chemical processes that must be controlled by TSs. A key example of this is the prevention of uranyl peroxide precipitation. Uranyl peroxide can form and precipitate from the target solution if the concentration exceeds the temperature dependent solubility limit. The equilibrium uranyl peroxide concentration and precipitation limit are functions of temperature (power),
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==SUMMARY==
==SUMMARY==
The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility. The OL for the SHINE Medical Isotope Production Facility should be issued.
The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility. The OL for the SHINE Medical Isotope Production Facility should be issued.
Sincerely, Signed by Rempe, Joy on 12/15/22 Joy L. Rempe Chairman ACRS APPENDICES:
Sincerely, Joy L. Rempe Chairman ACRS APPENDICES:
Appendix I: Chronology of the ACRS Review of the SHINE, LLC, Operating License Application Appendix II: Lead Member Memoranda on SER Chapters with no Open Items, SHINE Medical Technologies, LLC, Operating License Application
Appendix I: Chronology of the ACRS Review of the SHINE, LLC, Operating License Application Appendix II: Lead Member Memoranda on SER Chapters with no Open Items, SHINE Medical Technologies, LLC, Operating License Application Signed by Rempe, Joy on 12/15/22


C.T. Hanson                                   REFERENCES
C.T. Hanson REFERENCES 1.
: 1. SHINE Medical Technologies, LLC, Application for an Operating License, July 17, 2019 (ML19211C143).
SHINE Medical Technologies, LLC, Application for an Operating License, July 17, 2019 (ML19211C143).
: 2. SHINE Medical Technologies, LLC, General and Financial Information, Enclosure 2, July 17, 2019 (ML19211C089).
2.
: 3. SHINE Medical Technologies, LLC, Overview of Phased Approach to Initial Facility Operations, February 26, 2021 (ML21057A340).
SHINE Medical Technologies, LLC, General and Financial Information, Enclosure 2, July 17, 2019 (ML19211C089).
: 4. SHINE Medical Technologies, LLC, Final Safety Analysis Report, Application for an Operating License, Supplement No. 30, August 31, 2022 (ML22249A148).
3.
: 5. SHINE Technologies, LLC, Application for an Operating License Supplement No. 15, Submittal of the Phased Startup Operations Application Supplement, January 27, 2022 (ML22027A353).
SHINE Medical Technologies, LLC, Overview of Phased Approach to Initial Facility Operations, February 26, 2021 (ML21057A340).
: 6. SHINE Technologies, LLC, Application for an Operating License Supplement No. 31, Revision to the Phased Startup Operations Application Supplement, September 28, 2022 (ML22271A962).
4.
: 7. United States Nuclear Regulatory Commission, Safety Evaluation Report for SHINE Technologies, LLC, Operating License Application, November 29, 2022 (ML22314A132).
SHINE Medical Technologies, LLC, Final Safety Analysis Report, Application for an Operating License, Supplement No. 30, August 31, 2022 (ML22249A148).
: 8. Advisory Committee on Reactor Safeguards, Report on the Safety Aspects of the Construction Permit Application for SHINE Medical Technologies, Inc. Medical Isotope Production Facility, October 15, 2015 (ML15286A426).
5.
: 9. NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 28, 1996 (ML042430055).
SHINE Technologies, LLC, Application for an Operating License Supplement No. 15, Submittal of the Phased Startup Operations Application Supplement, January 27, 2022 (ML22027A353).
: 10. 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 29, 1996 (ML042430048).
6.
: 11. 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 (ML12156A069).
SHINE Technologies, LLC, Application for an Operating License Supplement No. 31, Revision to the Phased Startup Operations Application Supplement, September 28, 2022 (ML22271A962).
: 12. 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 (ML12156A075).
7.
 
United States Nuclear Regulatory Commission, Safety Evaluation Report for SHINE Technologies, LLC, Operating License Application, November 29, 2022 (ML22314A132).
APPENDIX I Chronology of the ACRS Review of the SHINE Medical Technologies, LLC, Operating License Application The following table lists ACRS interactions on the SHINE Operating Licensing Application Review Subcommittee (SC)/Full             Date                   Subject                             Transcript ML#
8.
Committee (FC)
Advisory Committee on Reactor Safeguards, Report on the Safety Aspects of the Construction Permit Application for SHINE Medical Technologies, Inc. Medical Isotope Production Facility, October 15, 2015 (ML15286A426).
Meetings Non-power production or           October 22, 2020      NPUF Subcommittee Review            ML20339A634 utilization facility (NPUF)                               Approach Subcommittee (SC)
9.
NPUF SC                           November 4, 2020       Overview of SHINE Medical           ML20345A277 Isotope Production Facility NPUF SC                           January 12, 2021       NPUF Subcommittee Review             ML21055A548 Approach NPUF SC                           February 16, 2022     Overview of SHINE Medical           ML22060A150 Isotope Production Facility and Phased Approach NPUF SC                           March 17, 2022         Chapters 1, 2, 4, 5, & 6             ML22095A053 694th ACRS FULL                   April 6-8, 2022       Review of memorandums for COMMITTEE (FC)                                            Chapters 2, 4, 5, & 6               N/A1 SHINE SC (previously the           May 6, 2022           Chapters 3, 8, 9 & 11               ML22158A263 NPUF SC)
NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 28, 1996 (ML042430055).
SHINE SC                           May 17-18, 2022       Chapter 6, Section 6b.3,             ML22172A022 Chapter 12, Section 12.7,           ML22172A025 Chapter 12, Section 12.13 &
10.
Chapter 13 696th ACRS FC                     June 1, 2022           Review of memorandums for Chapters 1, 2, 4, 5, & 6             N/A SHINE SC                           June 21, 2022         Review of technical issues           ML22193A110 identified in memorandums for Chapters 4, 8, 9, 11, 12.7, 12.13, & 13 SHINE SC                           July 19-20, 2022       Chapter 3, Section 3.1               ML22243A210 (Design Criteria), Chapter 7         ML22243A217 (Instrumentation and Control Systems), Chapter 9, Section 9a.3 (Fire Protection), Chapter 12, Section 7.9 (Human Factors Engineering), Chapter 12, Section 12.10 (Operator Training/Requalification) &
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 29, 1996 (ML042430048).
Chapter 12, Section 12.11 (Startup Plan) 1 Transcription does not exist. Committee deliberations are reflected in the associated review memorandum. See Appendix II of this letter report.
11.
698th ACRS FC September 7, 2022 Review of memorandums for       ML22278A065 Chapter 3, Section 3.1 (Design Criteria), Chapter 9, Section 9a.3 (Fire Protection),
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 (ML12156A069).
12.
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 (ML12156A075).
APPENDIX I Chronology of the ACRS Review of the SHINE Medical Technologies, LLC, Operating License Application The following table lists ACRS interactions on the SHINE Operating Licensing Application Review Subcommittee (SC)/Full Committee (FC)
Meetings Date Subject Transcript ML#
Non-power production or utilization facility (NPUF)
Subcommittee (SC)
October 22, 2020 NPUF Subcommittee Review Approach ML20339A634 NPUF SC November 4, 2020 Overview of SHINE Medical Isotope Production Facility ML20345A277 NPUF SC January 12, 2021 NPUF Subcommittee Review Approach ML21055A548 NPUF SC February 16, 2022 Overview of SHINE Medical Isotope Production Facility and Phased Approach ML22060A150 NPUF SC March 17, 2022 Chapters 1, 2, 4, 5, & 6 ML22095A053 694th ACRS FULL COMMITTEE (FC)
April 6-8, 2022 Review of memorandums for Chapters 2, 4, 5, & 6 N/A1 SHINE SC (previously the NPUF SC)
May 6, 2022 Chapters 3, 8, 9 & 11 ML22158A263 SHINE SC May 17-18, 2022 Chapter 6, Section 6b.3, Chapter 12, Section 12.7, Chapter 12, Section 12.13 &
Chapter 13 ML22172A022 ML22172A025 696th ACRS FC June 1, 2022 Review of memorandums for Chapters 1, 2, 4, 5, & 6 N/A SHINE SC June 21, 2022 Review of technical issues identified in memorandums for Chapters 4, 8, 9, 11, 12.7, 12.13, & 13 ML22193A110 SHINE SC July 19-20, 2022 Chapter 3, Section 3.1 (Design Criteria), Chapter 7 (Instrumentation and Control Systems), Chapter 9, Section 9a.3 (Fire Protection), Chapter 12, Section 7.9 (Human Factors Engineering), Chapter 12, Section 12.10 (Operator Training/Requalification) &
Chapter 12, Section 12.11 (Startup Plan)
ML22243A210 ML22243A217 1 Transcription does not exist. Committee deliberations are reflected in the associated review memorandum. See Appendix II of this letter report.
698th ACRS FC September 7, 2022 Review of memorandums for Chapter 3, Section 3.1 (Design Criteria), Chapter 9, Section 9a.3 (Fire Protection),
Chapter 12, Section 7.9 (Human Factors Engineering),
Chapter 12, Section 7.9 (Human Factors Engineering),
Chapter 12, Section 12.10 (Operator Training/Requalification) &
Chapter 12, Section 12.10 (Operator Training/Requalification) &
Chapter 12, Section 12.11 (Startup Plan) 698th ACRS FC September 9, 2022 Chapter 14, Technical           ML22278A068 Specifications, Cybersecurity,
Chapter 12, Section 12.11 (Startup Plan)
                                & Programmable Lifecycle Overview.
ML22278A065 698th ACRS FC September 9, 2022 Chapter 14, Technical Specifications, Cybersecurity,  
SHINE SC     October 21, 2022 Chapter 7, Section 7.4.3       ML22334A138 (Process Integrated Systems)
& Programmable Lifecycle Overview.
                                & Phased Startup Operations SHINE SC     November 15,     Review of memorandums for       N/A 2022              Chapters 7, 14, Cybersecurity,
ML22278A068 SHINE SC October 21, 2022 Chapter 7, Section 7.4.3 (Process Integrated Systems)  
                                & Programmable Lifecycle Overview and discussion of Draft Final Letter Report.
& Phased Startup Operations ML22334A138 SHINE SC November 15, 2022 Review of memorandums for Chapters 7, 14, Cybersecurity,  
701st ACRS FC November 29 -     Report on the Safety Aspects   ML22348A105 December 2, 2022  of the SHINE Medical Technologies, LLC, Operating License Application Review APPENDIX II Lead Member Memoranda on SER Chapters with no Open Items SHINE Medical Technologies, LLC, Operating License Application Subject                                         Date               ADAMS Accession Number Input for ACRS Review of SHINE Operating       April 29, 2022    ML22111A049 License - Safety Evaluation for Chapter 2, Site Characteristics Input for ACRS Review of SHINE Operating       September 26, 2022 ML22258A308 License - Safety Evaluation for Chapter 3, Design of Structures, Systems, &
& Programmable Lifecycle Overview and discussion of Draft Final Letter Report.
Components Input for ACRS Review of SHINE Operating       April 27, 2022    ML22111A143 License - Safety Evaluation for Chapter 4, Facility Description Input for ACRS Review of SHINE Operating       April 27, 2022    ML22111A169 License - Safety Evaluation for Chapter 5, Cooling Systems Input for ACRS Review of SHINE Operating       May 4, 2022        ML22111A177 License - Safety Evaluation for Chapter 6, Engineered Safety Features Input for ACRS Review of SHINE Operating       July 8, 2022      ML22175A188 License - Safety Evaluation for Chapter 6, Engineered Safety Features, Section 6B.3, Criticality Safety Input for ACRS Review of SHINE Operating       November 16, 2022  ML22319A217 License - Safety Evaluation for Chapter 7, Instrumentation and Control Systems Input for ACRS Review of SHINE Operating       September 26, 2022 ML22258A305 License - Safety Evaluation for Chapter 7, Instruments & Control Systems, Section 7.4.9, Human Factors Engineering Input for ACRS Review of SHINE Operating       July 12, 2022      ML22175A192 License - Safety Evaluation for Chapter 8, Electrical Power Systems Input for ACRS Review of SHINE Operating       July 11, 2022      ML22164A915 License - Safety Evaluation for Chapter 9, Auxiliary Systems Input for ACRS Review of SHINE Operating       September 23, 2022 ML22258A307 License - Safety Evaluation for Chapter 9, Auxiliary Systems, Section 9A.2.3, Fire Protection Systems & Programs Input for ACRS Review of SHINE Operating       July 12, 2022      ML22164A913 License - Safety Evaluation for Chapter 11, Radiation Protection Program and Waste Management Input for ACRS Review of SHINE Operating       September 27, 2022 ML22258A310 License - Safety Evaluation for Chapter 12, Conduct of Operations (Operator Training and Requalification, and Startup Plan)
N/A 701st ACRS FC November 29 -
Input for ACRS Review of SHINE Operating       November 17, 2022  ML22321A191 License Application - Safety Evaluation Report for Chapter 12, Conduct of Operations, Section 12.4.14, Cybersecurity Input for ACRS Review of SHINE Operating       July 11, 2022      ML22164A914 License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.7, Emergency Plan Input for ACRS Review of SHINE Operating       July 8, 2022      ML22164A917 License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.13, Material Control and Accountability Input for ACRS Review of SHINE Operating       July 8, 2022      ML22175A182 License - Safety Evaluation for Chapter 13, Accident Analysis Input for ACRS Review of SHINE Operating       November 16, 2022  ML22321A210 License Application - Software Life Cycle Input for ACRS Review of SHINE Operating       November 17, 2022  ML22321A139 License Application - Safety Evaluation Report for Chapter 14, Technical Specifications C.T. Hanson                                                                     December 15, 2022
December 2, 2022 Report on the Safety Aspects of the SHINE Medical Technologies, LLC, Operating License Application Review ML22348A105 APPENDIX II Lead Member Memoranda on SER Chapters with no Open Items SHINE Medical Technologies, LLC, Operating License Application Subject Date ADAMS Accession Number Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 2, Site Characteristics April 29, 2022 ML22111A049 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 3, Design of Structures, Systems, &
Components September 26, 2022 ML22258A308 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 4, Facility Description April 27, 2022 ML22111A143 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 5, Cooling Systems April 27, 2022 ML22111A169 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 6, Engineered Safety Features May 4, 2022 ML22111A177 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 6, Engineered Safety Features, Section 6B.3, Criticality Safety July 8, 2022 ML22175A188 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 7, Instrumentation and Control Systems November 16, 2022 ML22319A217 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 7, Instruments & Control Systems, Section 7.4.9, Human Factors Engineering September 26, 2022 ML22258A305 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 8, Electrical Power Systems July 12, 2022 ML22175A192 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 9, Auxiliary Systems July 11, 2022 ML22164A915 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 9, Auxiliary Systems, Section 9A.2.3, Fire Protection Systems & Programs September 23, 2022 ML22258A307 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 11, Radiation Protection Program and Waste Management July 12, 2022 ML22164A913 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations (Operator Training and Requalification, and Startup Plan)
September 27, 2022 ML22258A310 Input for ACRS Review of SHINE Operating License Application - Safety Evaluation Report for Chapter 12, Conduct of Operations, Section 12.4.14, Cybersecurity November 17, 2022 ML22321A191 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.7, Emergency Plan July 11, 2022 ML22164A914 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.13, Material Control and Accountability July 8, 2022 ML22164A917 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 13, Accident Analysis July 8, 2022 ML22175A182 Input for ACRS Review of SHINE Operating License Application - Software Life Cycle November 16, 2022 ML22321A210 Input for ACRS Review of SHINE Operating License Application - Safety Evaluation Report for Chapter 14, Technical Specifications November 17, 2022 ML22321A139
 
C.T. Hanson  


==SUBJECT:==
==SUBJECT:==
REPORT ON THE SAFETY ASPECTS OF THE SHINE MEDICAL TECHNOLOGIES, LLC, OPERATING LICENSE APPLICATION REVIEW Accession No: ML22342A144         Publicly Available (Y/N): Y   Sensitive (Y/N): N If Sensitive, which category?
REPORT ON THE SAFETY ASPECTS OF THE SHINE MEDICAL TECHNOLOGIES, LLC, OPERATING LICENSE APPLICATION REVIEW Accession No: ML22342A144 Publicly Available (Y/N): Y Sensitive (Y/N): N If Sensitive, which category?
Viewing Rights:     NRC Users or     ACRS only or       See restricted distribution OFFICE     ACRS*       SUNSI Review* ACRS*           ACRS*             ACRS*
Viewing Rights:
NAME       CBrown       CBrown         LBurkhart       SMoore           JRempe DATE       12/8/22     12/8/22       12/8/22         12/12/22         12/15/22 OFFICIAL RECORD COPY}}
NRC Users or ACRS only or See restricted distribution OFFICE ACRS*
SUNSI Review*
ACRS*
ACRS*
ACRS*
NAME CBrown CBrown LBurkhart SMoore JRempe DATE 12/8/22 12/8/22 12/8/22 12/12/22 12/15/22 OFFICIAL RECORD COPY December 15, 2022}}

Latest revision as of 11:55, 27 November 2024

Report on the Safety Aspects of the Shine Medical Technologies, LLC, Operating License Application Review - Full Committee - December 2022
ML22342A144
Person / Time
Issue date: 12/15/2022
From: Rempe J
Advisory Committee on Reactor Safeguards
To: Christopher Hanson
NRC/Chairman
Brown C
References
Download: ML22342A144 (1)
v • d • e


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION ADVISORY COMMITTEE ON REACTOR SAFEGUARDS WASHINGTON, DC 20555 - 0001 The Honorable Christopher T. Hanson Chair U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

SUBJECT:

REPORT ON THE SAFETY ASPECTS OF THE SHINE MEDICAL TECHNOLOGIES, LLC, OPERATING LICENSE APPLICATION REVIEW

Dear Chair Hanson:

During the 701st meeting of the Advisory Committee on Reactor Safeguards (ACRS),

November 29 - December 2, 2022, we completed our review of the SHINE Technologies, LLC (SHINE or the applicant), operating license (OL) application for its Medical Isotope Production Facility and the staffs associated Safety Evaluation Report (SER) with no open items.

During our review, we had the benefit of interactions with representatives of the Nuclear Regulatory Commission staff and the applicant. This included a visit to the SHINE construction site in Janesville, Wisconsin, in August 2022. We also benefited from the documents referenced. Appendix I lists the chronology of Full Committee and Subcommittee meetings on this topic. Appendix II contains the list of our memoranda on SER chapter reviews. This letter report fulfills the ACRS review requirement in Title 10 of the Code of Federal Regulations (10 CFR) Section 50.58, Hearings and report of the Advisory Committee on Reactor Safeguards.

CONCLUSION AND RECOMMENDATION 1.

The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility.

2.

The OL for the SHINE Medical Isotope Production Facility should be issued.

BACKGROUND When operational, the SHINE Medical Isotope Production Facility will provide a domestic, reliable supply of molybdenum-99 (Mo-99) for medical applications. Not utilizing highly enriched uranium for medical isotope production supports U.S. national security interests and nuclear non-proliferation policy objectives.

December 15, 2022

C.T. Hanson Facility Description SHINE submitted an OL application for the SHINE Medical Isotope Production Facility to produce Mo-99 in accordance with the requirements contained in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, on July 17, 2019. The facility would be licensed as a non-power utilization and production facility (NPUF), as defined in 10 CFR 50.2, Definitions. Issuance of the OL would authorize SHINE to operate this facility for 30 years.

The facility includes an irradiation facility and a radioisotope production facility. The irradiation facility consists of eight subcritical operating assemblies (or irradiation units). The radioisotope production facility consists of hot cell structures for the processing of the irradiated solution.

The Mo-99 production process begins in an irradiation unit where accelerator-driven deuterons bombard tritium gas to create a fusion reaction, producing neutrons. This neutron flux is enhanced by a neutron multiplier and induces fission in the low-enriched uranyl sulfate target solution, creating Mo-99 as a byproduct. The Mo-99 is extracted and purified in the radioisotope production facility.

Construction Permit Application During the 628th meeting of the ACRS, October 7 - 10, 2015, we reviewed the construction permit (CP) application for the SHINE Medical Isotope Production Facility. After completing our review, we recommended the CP for this facility be approved. The SHINE CP was issued on February 29, 2016, and construction commenced in September 2019.

During the OL review, the applicant proposed a phased approach that allows operation of some irradiation units while the remaining units were being installed. The staff determined that this approach did not pose an impact to safety. We concur.

Operating License Review Approach We conducted our review of the Final Safety Analysis Report (FSAR) and draft SER with no open items on a chapter-by-chapter basis. Individual members were assigned chapters or topics for detailed technical review. The entire SHINE Subcommittee participated in chapter briefings with the staff and applicant. The cognizant member summarized findings in a memorandum reflecting subsequent Full Committee deliberation. This approach provided a comprehensive, in-depth review of the SHINE submittal. The overall process significantly reduced the number of presentations required of the staff and applicant for our review.

Our review identified a number of items not thoroughly addressed in the initial FSAR and SER.

Concerns relative to the OL were resolved during subsequent meetings. Beyond that, the Appendix II memoranda expand upon several other noteworthy points, including:

The importance of human factors and actions in the conduct of operations of an irradiation and radioisotope production facility

Coordination with local community resources to respond to low-frequency hazards (e.g., fire, chemical, and aircraft impact)

C.T. Hanson Broadening of cyber security assessments to all critical digital assets required for mission critical system operation DISCUSSION The staff review followed NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Parts 1 and 2, supplemented by guidance in the associated Interim Staff Guidance document. In our review of this first-of-a-kind facility, we identified the following three noteworthy attributes that characterize the innovativeness of the design and the completeness of this application.

SHINE Safety Characteristics The SHINE facility incorporates several important safety features. The low power density irradiation units are designed to automatically shut down the irradiation process and place the target solution into a safe stable passively cooled condition without immediate operator actions. Criticality during the dissolving and filling processes is largely precluded by the engineering design. Additionally, critically safe vessels or double contingency controls are used for fissile solutions in the production facility.

SHINE Safety Analysis Approach Using common hazard evaluation methods, such as Hazard and Operability Analysis and Failure Modes and Effects Analysis, the SHINE Safety Analysis (SSA) methodology provides a systematic approach to identify, evaluate, and group credible accident sequences. Both internal and external events were considered. Results were ranked using a risk matrix. Design Basis Accidents (DBAs) were identified as those events with maximum consequences for each accident sequence grouping. The DBAs were used to identify those structures, systems, and components (SSCs) and procedural controls required to prevent unacceptable consequences.

As a result, these SSCs are categorized as safety-related.

SHINE hazard analysis documents were not provided on the docket but were made available to us. These documents are thorough, well structured, and reflect an in-depth, systematic approach for the selection of DBAs used in accident analyses. The applicant did not rely on pre-conceived notions or tabulated lists to identify DBAs, satisfying our generic concern about licensing basis event identification.

SHINE used the concept of maximum hypothetical accident (MHA) to demonstrate compliance with acceptable limits for both radiological and chemical consequences. SHINEs evaluation indicates that the MHA is a large break in the top of the Target Solution Vessel Off-gas System which allows all radioactive gases to escape into the confinement. Consequences of exposure to facility staff and the public were evaluated to be within regulatory acceptance criteria. The DBA analysis identified that the limiting accident not involving the irradiation facility is a tritium purification system failure; this accident results in consequences similar to those of the MHA (and within the acceptance criteria).

Our review also explored the adequacy of assumed sensor response times to mitigate accident sequences because they affect the margins for proposed setpoints. In response to our questions and an audit completed by the staff, the applicant revised the FSAR to explicitly list

C.T. Hanson these response times. Subsequently, the staff completed independent evaluations of the associated margins. The additional input from SHINE and the staff addressed our concerns.

Technical Specifications Justifications SHINEs proposed Technical Specifications (TSs) address relevant safety limits, limiting safety system settings, limiting control settings, limiting conditions for operation (LCOs), and surveillance requirements (SRs). The staff assessed these TSs as well as design features that affect SSC function, availability, or reliability, and administrative controls to ensure their required availability.

The processes associated with SHINE isotope production include several interrelated irradiation and chemical processes that must be controlled by TSs. A key example of this is the prevention of uranyl peroxide precipitation. Uranyl peroxide can form and precipitate from the target solution if the concentration exceeds the temperature dependent solubility limit. The equilibrium uranyl peroxide concentration and precipitation limit are functions of temperature (power),

uranium concentration, pH, and catalyst concentration.

The applicant provided extensive details related to the basis for the TSs for each of the LCOs and the SRs related to uranyl peroxide precipitation. We find the bases for these LCOs and SRs to be extremely detailed and easy to follow.

SUMMARY

The staff SER provides a comprehensive review of important safety aspects of the design and operation of the SHINE facility. The OL for the SHINE Medical Isotope Production Facility should be issued.

Sincerely, Joy L. Rempe Chairman ACRS APPENDICES:

Appendix I: Chronology of the ACRS Review of the SHINE, LLC, Operating License Application Appendix II: Lead Member Memoranda on SER Chapters with no Open Items, SHINE Medical Technologies, LLC, Operating License Application Signed by Rempe, Joy on 12/15/22

C.T. Hanson REFERENCES 1.

SHINE Medical Technologies, LLC, Application for an Operating License, July 17, 2019 (ML19211C143).

2.

SHINE Medical Technologies, LLC, General and Financial Information, Enclosure 2, July 17, 2019 (ML19211C089).

3.

SHINE Medical Technologies, LLC, Overview of Phased Approach to Initial Facility Operations, February 26, 2021 (ML21057A340).

4.

SHINE Medical Technologies, LLC, Final Safety Analysis Report, Application for an Operating License, Supplement No. 30, August 31, 2022 (ML22249A148).

5.

SHINE Technologies, LLC, Application for an Operating License Supplement No. 15, Submittal of the Phased Startup Operations Application Supplement, January 27, 2022 (ML22027A353).

6.

SHINE Technologies, LLC, Application for an Operating License Supplement No. 31, Revision to the Phased Startup Operations Application Supplement, September 28, 2022 (ML22271A962).

7.

United States Nuclear Regulatory Commission, Safety Evaluation Report for SHINE Technologies, LLC, Operating License Application, November 29, 2022 (ML22314A132).

8.

Advisory Committee on Reactor Safeguards, Report on the Safety Aspects of the Construction Permit Application for SHINE Medical Technologies, Inc. Medical Isotope Production Facility, October 15, 2015 (ML15286A426).

9.

NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 28, 1996 (ML042430055).

10.

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 29, 1996 (ML042430048).

11.

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 (ML12156A069).

12.

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 (ML12156A075).

APPENDIX I Chronology of the ACRS Review of the SHINE Medical Technologies, LLC, Operating License Application The following table lists ACRS interactions on the SHINE Operating Licensing Application Review Subcommittee (SC)/Full Committee (FC)

Meetings Date Subject Transcript ML#

Non-power production or utilization facility (NPUF)

Subcommittee (SC)

October 22, 2020 NPUF Subcommittee Review Approach ML20339A634 NPUF SC November 4, 2020 Overview of SHINE Medical Isotope Production Facility ML20345A277 NPUF SC January 12, 2021 NPUF Subcommittee Review Approach ML21055A548 NPUF SC February 16, 2022 Overview of SHINE Medical Isotope Production Facility and Phased Approach ML22060A150 NPUF SC March 17, 2022 Chapters 1, 2, 4, 5, & 6 ML22095A053 694th ACRS FULL COMMITTEE (FC)

April 6-8, 2022 Review of memorandums for Chapters 2, 4, 5, & 6 N/A1 SHINE SC (previously the NPUF SC)

May 6, 2022 Chapters 3, 8, 9 & 11 ML22158A263 SHINE SC May 17-18, 2022 Chapter 6, Section 6b.3, Chapter 12, Section 12.7, Chapter 12, Section 12.13 &

Chapter 13 ML22172A022 ML22172A025 696th ACRS FC June 1, 2022 Review of memorandums for Chapters 1, 2, 4, 5, & 6 N/A SHINE SC June 21, 2022 Review of technical issues identified in memorandums for Chapters 4, 8, 9, 11, 12.7, 12.13, & 13 ML22193A110 SHINE SC July 19-20, 2022 Chapter 3, Section 3.1 (Design Criteria), Chapter 7 (Instrumentation and Control Systems), Chapter 9, Section 9a.3 (Fire Protection), Chapter 12, Section 7.9 (Human Factors Engineering), Chapter 12, Section 12.10 (Operator Training/Requalification) &

Chapter 12, Section 12.11 (Startup Plan)

ML22243A210 ML22243A217 1 Transcription does not exist. Committee deliberations are reflected in the associated review memorandum. See Appendix II of this letter report.

698th ACRS FC September 7, 2022 Review of memorandums for Chapter 3, Section 3.1 (Design Criteria), Chapter 9, Section 9a.3 (Fire Protection),

Chapter 12, Section 7.9 (Human Factors Engineering),

Chapter 12, Section 12.10 (Operator Training/Requalification) &

Chapter 12, Section 12.11 (Startup Plan)

ML22278A065 698th ACRS FC September 9, 2022 Chapter 14, Technical Specifications, Cybersecurity,

& Programmable Lifecycle Overview.

ML22278A068 SHINE SC October 21, 2022 Chapter 7, Section 7.4.3 (Process Integrated Systems)

& Phased Startup Operations ML22334A138 SHINE SC November 15, 2022 Review of memorandums for Chapters 7, 14, Cybersecurity,

& Programmable Lifecycle Overview and discussion of Draft Final Letter Report.

N/A 701st ACRS FC November 29 -

December 2, 2022 Report on the Safety Aspects of the SHINE Medical Technologies, LLC, Operating License Application Review ML22348A105 APPENDIX II Lead Member Memoranda on SER Chapters with no Open Items SHINE Medical Technologies, LLC, Operating License Application Subject Date ADAMS Accession Number Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 2, Site Characteristics April 29, 2022 ML22111A049 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 3, Design of Structures, Systems, &

Components September 26, 2022 ML22258A308 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 4, Facility Description April 27, 2022 ML22111A143 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 5, Cooling Systems April 27, 2022 ML22111A169 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 6, Engineered Safety Features May 4, 2022 ML22111A177 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 6, Engineered Safety Features, Section 6B.3, Criticality Safety July 8, 2022 ML22175A188 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 7, Instrumentation and Control Systems November 16, 2022 ML22319A217 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 7, Instruments & Control Systems, Section 7.4.9, Human Factors Engineering September 26, 2022 ML22258A305 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 8, Electrical Power Systems July 12, 2022 ML22175A192 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 9, Auxiliary Systems July 11, 2022 ML22164A915 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 9, Auxiliary Systems, Section 9A.2.3, Fire Protection Systems & Programs September 23, 2022 ML22258A307 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 11, Radiation Protection Program and Waste Management July 12, 2022 ML22164A913 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations (Operator Training and Requalification, and Startup Plan)

September 27, 2022 ML22258A310 Input for ACRS Review of SHINE Operating License Application - Safety Evaluation Report for Chapter 12, Conduct of Operations, Section 12.4.14, Cybersecurity November 17, 2022 ML22321A191 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.7, Emergency Plan July 11, 2022 ML22164A914 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 12, Conduct of Operations, Section 12.13, Material Control and Accountability July 8, 2022 ML22164A917 Input for ACRS Review of SHINE Operating License - Safety Evaluation for Chapter 13, Accident Analysis July 8, 2022 ML22175A182 Input for ACRS Review of SHINE Operating License Application - Software Life Cycle November 16, 2022 ML22321A210 Input for ACRS Review of SHINE Operating License Application - Safety Evaluation Report for Chapter 14, Technical Specifications November 17, 2022 ML22321A139

C.T. Hanson

SUBJECT:

REPORT ON THE SAFETY ASPECTS OF THE SHINE MEDICAL TECHNOLOGIES, LLC, OPERATING LICENSE APPLICATION REVIEW Accession No: ML22342A144 Publicly Available (Y/N): Y Sensitive (Y/N): N If Sensitive, which category?

Viewing Rights:

NRC Users or ACRS only or See restricted distribution OFFICE ACRS*

SUNSI Review*

ACRS*

ACRS*

ACRS*

NAME CBrown CBrown LBurkhart SMoore JRempe DATE 12/8/22 12/8/22 12/8/22 12/12/22 12/15/22 OFFICIAL RECORD COPY December 15, 2022

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