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{{#Wiki_filter:SCHEDULING NOTE Title: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY:
{{#Wiki_filter:SCHEDULING NOTE Title:               HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)Scheduled:
Scheduled:           December 15, 2015 9:00 am Purpose:            To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a) and 51 .105(a).
Purpose: Duration: Location: December 15, 2015 9:00 am To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision.
Duration:            1 day Location:            Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.
The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a)and 51 .105(a).1 day Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.
20 mins.
20 mins.Participants:
Participants:                                                                   Presentation (Note: Presenters questions          seatedinatthe will be seated       thewell table are and  listed, other reser'ved      staff available to answer rows.)
Presentation (Note: Presenters seated at the table are listed, other staff available to answer questions will be seated in the well and reser'ved rows.)Overview (SHINE Medical Technologies.
Overview (SHINE Medical Technologies. Inc.)                                         30 mins.*
Inc.)At the table: Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each)30 mins.*24 mins.**1 30 mins.*At the table: William Dean, Director, Office of Nuclear Reactor Regulation (NRR)Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings.
At the table:
The staff will also discuss its review methodology and how it applied the Commission's regulations.
Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each)                             24 mins.**
Commission 0 & A (round of questions; 6 minutes each) 24 mins.**BREAK 5 mins.NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions.
1
Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.Safety- Panel 1 (11:15 am)Applicant 5 mins.*At the table: Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff 10 mins.*At the table: Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)Toi:Sections of the application and the following chapters from the Safety Evaluation Report: Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.2 Note that the panel will not have specific topics to discuss for the following chapters.
 
If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Cooling Systems" o Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each) 24 mains.**BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)Safety -Panel 2 (1:30 pm)Applicant 5 mins.*At the table: Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff 10 mains.*At the table: Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report: Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.
30 mins.*
Note that the panel will not have specific topics to discuss for the following chapters.
At the table:
If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11, "Radiation Protection Program and Waste Management," including proposed permit condition o Chapter 12, "Conduct of Operations"~***
William Dean, Director, Office of Nuclear Reactor Regulation (NRR)
o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualification" 3 Commission 0 & A (round of questions; 6 minutes each) 2 is*24 mins.**Environmental  
Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)
-Panel (2:10 pm)Applicant At the table: Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy 10 mins.*Staff 25 mins.*At the table: Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement* Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings. The staff will also discuss its review methodology and how it applied the Commission's regulations.
o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice* Discuss the analysis of alternatives including:
Commission 0 & A (round of questions; 6 minutes each)                               24 mins.**
BREAK                                                                                 5 mins.
NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.
Safety- Panel 1 (11:15 am)
Applicant                                                                             5 mins.*
At the table:
Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff                                                                               10 mins.*
At the table:
Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)
Toi:Sections of the application and the following chapters from the Safety Evaluation Report:
Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.
2
 
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o   Chapter 2, "Site Characteristics" o   Chapter 3, "Design of Structures, Systems, and Components" o   Chapter 5, "Cooling Systems" o   Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each)                             24 mains.**
BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)
Safety - Panel 2 (1:30 pm)
Applicant                                                                           5 mins.*
At the table:
Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff                                                                             10 mains.*
At the table:
Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report:
Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o   Chapter 8, "Electrical Power Systems" o   Chapter 9, "Auxiliary Systems" o   Chapter 11, "Radiation Protection Program and Waste Management,"
including proposed permit condition o   Chapter 12, "Conduct of Operations"~***
o   Chapter 14, "Technical Specifications" o   Chapter 15, "Financial Qualification" 3
 
Commission 0 & A (round of questions; 6 minutes each)                         224 mins.**
is*
Environmental   - Panel (2:10 pm)
Applicant                                                                       10 mins.*
At the table:
Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy Staff                                                                           25 mins.*
At the table:
Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement
* Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice
* Discuss the analysis of alternatives including:
o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative
o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative
* Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each)24 mins.**BREA K 5 mins.4 Closing (3:15) 5 is 54 mins.Closing Statement by Applicant 15 rmins.*Greg Piefer, Chief Executive Officer Closing Statement by Staff 15 rains.*William Dean, Director, NRR Commission Q & A and Closing Statements 24 rmins.***For presentation only and does not include time for Commission 0 & A's.**AII Commissioners will have an opportunity to ask questions after each panel.Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.**Chapter 12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.5 HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY:
* Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each)                           24 mins.**
SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)December 15, 2015 Slides/Handouts Overview-SHINE Medical Technologies, Inc.-NRC Staff Safety -Panel 1-SHINE Medical Technologies, Inc.-NRC Staff Safety -Panel 2-SHINE Medical Technologies, Inc.-NRC Staff Environmental  
BREA K                                                                           5 mins.
-Panel-SHINE Medical Technologies, Inc.-NRC Staff N RC-010 United Nuclear Regulatory C~, mmtnslon Protecting People andt¢ the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists* William Dean* Mirela Gavrilas* Jane Marshall* Marissa Bailey-Director, NRR-Deputy Director, NRR/DPR-Deputy Director, NRR/DLR-Director, NMSS/FCSE Introduction to Molybdenum-99
4
* Molybdenum-99 (9 9 M0) Mc 0.90 decays to -Effective diagnosis o-Minimal exposureV* 50,000 procedures daily Tc009* No domestically-produced supply ooo.o Establishing a Domestic Supply* National policy objectives support domestic production capabilities
 
* Cost-sharing agreements encourage commercial partners* SHINE proposes to produce 9 9 M0 through uranium fission Preparing for SHINE Review* Interoffice working group contributed diverse expertise* Public meetings engaged stakeholders
Closing (3:15)                                                                   554 mins.
is Closing Statement by Applicant                                                   15 rmins.*
Greg Piefer, Chief Executive Officer Closing Statement by Staff                                                       15 rains.*
William Dean, Director, NRR Commission Q & A and Closing Statements                                         24 rmins.**
*For presentation only and does not include time for Commission 0 & A's.
**AII Commissioners will have an opportunity to ask questions after each panel.
Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
  **Chapter12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.
5
 
HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
December 15, 2015 Slides/Handouts Overview
-SHINE Medical Technologies, Inc.
-NRC Staff Safety - Panel 1
-SHINE Medical Technologies, Inc.
-NRC Staff Safety - Panel 2
-SHINE Medical Technologies, Inc.
-NRC Staff Environmental   - Panel
-SHINE Medical Technologies, Inc.
-NRC Staff
 
N RC-010
          *U.S.NRC United Sriae* Nuclear Regulatory C~,mmtnslon ProtectingPeople andt¢   the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists
* William Dean                 -   Director, NRR
* Mirela Gavrilas              -   Deputy Director, NRR/DPR
* Jane Marshall                -   Deputy Director, NRR/DLR
* Marissa Bailey              -   Director, NMSS/FCSE
 
Introduction to Molybdenum-99
* Molybdenum-99 (99 M0)       Mc   0.90 decays to technetium-99m(*o,,
  - Effective diagnosis     o
  - Minimal exposureV
* 50,000 procedures daily     Tc009
* No domestically-produced supply                     ooo.o Establishing a Domestic Supply
* National policy objectives support domestic production capabilities
* Cost-sharing agreements encourage commercial partners
* SHINE proposes to produce 99 M0 through uranium fission
 
Preparing for SHINE Review
* Interoffice working group contributed diverse expertise
* Public meetings engaged stakeholders
* Review coordinated with Federal, State, and local governments Allowing Construction
* Review coordinated with Federal, State, and local governments Allowing Construction
* SHINE application only seeks construction authorization
* SHINE application only seeks construction authorization
* Design details may be left for operating license application
* Design details may be left for operating license application
* Review assessed preliminary design and analysis Conducting the Safety Review cn~~itW Tailoring Review Methodology
* Review assessed preliminary design and analysis
 
Conducting the Safety Review cn~~itW Tailoring Review Methodology
* Review accommodated unique technology
* Review accommodated unique technology
* Staff used existing guidance* Staff determined whether reasonable assurance that final design will conform to design bases Additional Information
* Staff used existing guidance
* Staff determined whether reasonable assurance that final design will conform to design bases
 
Additional Information
* Review supported by additional information
* Review supported by additional information
* In some cases, permit conditions necessary* Regulatory commitments track items for resolution in final safety analysis report (FSAR)Environmental Regulations
* In some cases, permit conditions necessary
* National Environmental Policy Act-Informs Federal decision making-Public disclosure
* Regulatory commitments track items for resolution in final safety analysis report (FSAR)
Environmental Regulations
* National Environmental Policy Act
  - Informs Federal decision making
  - Public disclosure
* NRC's environmental regulations
* NRC's environmental regulations
-Title 10 of the Code of Federal Regulations (10 CFR) Part 51 Environmental Review Process* Opportunity for Public Involvement Proposed Janesville Site..... Agricultural fields....
  - Title 10 of the Code of Federal Regulations (10 CFR) Part 51
* Previously disturbed..... No surface water* features I No threatened or endangeredspce
 
* o historical or cultural resources Regulatory Basis* Commission authorized by Atomic Energy Act, Section 103* Review primarily based on 10 CFR Parts 20, 50, and 51* Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance* Preliminary design described* Further technical or design information may be left for FSAR* Ongoing research and development has been identified
Environmental Review Process
* Facility can be constructed and operated without undue risk Permit Considerations
* Opportunity for Public Involvement Proposed Janesville Site
* Construction will not endanger public health and safety* SHINE technically and financially qualified* Environmental requirements satisfied Introducing Review Panels Safety Panel 1 Safety Panel 2 Environmental Panel Licensing Considerations Accident Analysis* Final Environmental Impact Statement Process* Analysis of Alternatives
    .....         Agricultural fields
* Summary of Conclusions and Recommendations Safe...Evaluation.Repor Chapters 1 and 4 Safety Evaluation Re port Chapter 13 Final Environmental Impact Statement Acronyms* FCSE -Division of Fuel Cycle Safety, Safeguards, and Environmental Review* DLR -Division of License Renewal* DPR -Division of Policy and Rulemaking Acronyms* NMSS- Office of Nuclear Material Safety and Safeguards
    ....
* NRR -Office of Nuclear Reactor Regulation Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission* SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come Medical Isotopes* Molybdenum-99 (Mo-99), the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annually* Stress tests and bone scans most common of dozens of uses MedicalProchyedursUig"T7 M72rn M~&7 A44~ 7717r ~ A7p17 7*? 1717 A7,7~, ~1717<nn{*fll t1717 krr. 7*7* *4747 77 7 W ?77x7777 7ft.1777, Nr~ 777477*774 771~ '777 7,777* 1777 4, J Supply Situation with No New Capacity*Canada will stop operating the NRU reactor in March 2018* Following Canadian exit, there will be no North American producer Highl relvantNEA Demand Growth (+35% ORC) vs, ig hl relvantcurrent processing capacity, 2015-202 because Mo-99 &deg;decays ~1% per hour z0=Domestic supply o is necessary to j o ensure US patient '&deg;health 717077 77477 470777 4 4 7-J* 471-077 4*4* 471077 4*177 417077 4777.477 77-077 7*477 77077 2014 2011 2014 2017 2011 2019 2020-.-NEAD.77772g177*  
* Previously disturbed
'40% WC, CU7071 ~71*$772 C8277777 U 4 SHINE Medical Technologies, Inc. Core Values=SHINE mission driven by our core values-Ensure health and safety of the public and our workforce* Minimize environmental impacts of medical isotope production
          ..... No surface water
* Ensure minimal or no disruption to patient supply chain* Ensure cost effectiveness and therefore patient access* Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain* SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values* Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce ,Decay heat per system < 1 kW within 5 hours oMinimizes waste nuclide generation compared to reactors* Low enriched uranium (LEU) reusable target* Reduces waste and cost Product compatible with current supply chain* Eliminates need for HEU* Driven by low-energy electrostatic accelerator
* I features No threatened or endangeredspce
* o historical or cultural resources
 
Regulatory Basis
* Commission authorized by Atomic Energy Act, Section 103
* Review primarily based on 10 CFR Parts 20, 50, and 51
* Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance
* Preliminary design described
* Further technical or design information may be left for FSAR
* Ongoing research and development has been identified
* Facility can be constructed and operated without undue risk
 
Permit Considerations
* Construction will not endanger public health and safety
* SHINE technically and financially qualified
* Environmental requirements satisfied Introducing Review Panels Safety Panel 1     Licensing Considerations   Safe...Evaluation.Repor Chapters 1 and 4 Safety Panel 2      Accident Analysis          Safety Evaluation Re port Chapter 13 Environmental Panel
* Final Environmental      Final Environmental Impact Impact Statement        Statement Process
* Analysis of Alternatives
* Summary of Conclusions and Recommendations
 
Acronyms
* FCSE -         Division of Fuel Cycle Safety, Safeguards, and Environmental Review
* DLR -         Division of License Renewal
* DPR   -Division       of Policy and Rulemaking Acronyms
* NMSS- Office of Nuclear Material Safety and Safeguards
* NRR   -       Office of Nuclear Reactor Regulation
 
Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission
* SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come
 
Medical Isotopes
* Molybdenum-99 (Mo-99),
the most widely-used medical isotope, decays into technetium-99m,                   MedicalProchyedursUig"T which is used in more                               7*.                      7 than 40 million doses annually
* Stress tests and bone scans most common of dozens of uses M72rn M~&7A44~ 7717r ~7        A7p17     7*? 1717A7,7~, ~1717
                                        <nn{*fll t1717krr. 7*7* *4747 77 W ?77x77777ft.1777, Nr~     777477*774 771~'777       7,777* 1777                                             4, J
Supply Situation with No New Capacity
  *Canada will stop operating the NRU reactor in March 2018
* Following Canadian exit, there will be no North American producer Highl relvantNEA                           Demand Growth (+35% ORC) vs, ig hl relvantcurrent                         processing capacity,       2015-202 z0 because Mo-99           &deg; decays ~1% per       *.
hour                 *..
  =Domestic supply
* o is necessary to       j o ensure US patient       '&deg; health                     71707777477 470777447-J* 471-077     4*4* 4710774*177 4170774777.477 77-077 7*477 77077 2014       2011           2014         2017       2011       2019         2020
                                -.- NEAD.77772g177* '40%WC, CU7071~71*$772 C8277777 U
4
 
SHINE Medical Technologies, Inc. Core Values
  =SHINE mission driven by our core values
    - Ensure health and safety of the public and our workforce
* Minimize environmental impacts of medical isotope production
* Ensure minimal or no disruption to patient supply chain
* Ensure cost effectiveness and therefore patient access
* Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain
* SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values
* Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce
      ,Decay heat per system < 1 kW within 5 hours oMinimizes waste nuclide generation compared to reactors
* Low enriched uranium (LEU) reusable target
* Reduces waste and cost Product compatible with current supply chain
* Eliminates need for HEU
* Driven by low-energy electrostatic accelerator
* System must be driven to operate, no criticality
* System must be driven to operate, no criticality
* Hundreds of times less waste than reactors* Electrostatic technology simple, demonstrated and cost effective SHINE Medical Technologies, Inc., The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7 SHINE Facility Layout* The SHINE facility consists of an irradiation facility (IF)and a radioisotope production facility (RPF)ldiation acility idioisotope roduction Facility 8 SHINE Irradiation Facility='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50=However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs* An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility ,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution* Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2 ,1&deg; SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)SPart I of the Application submitted March 26, 2013*PSAR Chapter 2 (Site Characteristics)
* Hundreds of times less waste than reactors
=PSAR Chapter 19 (Environmental Review),General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013=The SHINE facility will be licensed under 10 CFR Part 50,"Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria* NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"* Interim Staff Guidance augmenting NUREG-1 537* Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility" , Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12 SHINE Facility Layout* Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop Product Recycle tank TSV and Irradiation Unit Cell A~Hold Periodic Cleanup Loop associated cleanup* processes 4....-w Target Solution 14 paato SHINE Irradiation Facility* An IU consists of a subcritical assembly, a neutron driver, and supporting systems* Major supporting systems include:* Light water pool system (LWPS)* Target solution vessel (TSV) off-gas system (TOGS).Primary closed loop cooling system (PCLS)* Tritium purification system (TPS)* Primary system at near-atmospheric pressure* Target solution is drained to dump tank via gravity* Dump tank is criticality-safe by geometry and passively-cooled
* Electrostatic technology simple, demonstrated and cost effective
* Redundant, fail-open dump valves* TSV is an annular vessel to be constructed of Zircaloy-4
 
* Natural convection within TSV SHINE's Fusion- FIssion Coupling V N'4 14 11 Neutron Oriver Neutron Multiplier Target Solution Vessel N'4> N Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support Structure (SASS)TSV Dump Tank -,.TSV and Neutron S Multiplier (Internal to SASS)TSV Dump and Overflow Lines~(2 each)16 Neutron Driver and Tritium Purification System* One Neutron Driver per IU cell* Electrostatic accelerator with a gas target* D-T fusion reaction generates 14 MeV neutrons that drive the fission process* Tritium purification system* Isotopically separates gases, and supplies clean tritium to neutron drivers* Tritium lines and processing equipment in gloveboxes and q double-walled pipe 1 TSV Off-Gas and Primary Cooling Systems*TSV off-gas system (TOGS)* Contains the fission product1 TOGS gases i*of-aRemoves iodine from the* Recombines hydrogen and oxygen to maintain hydrogen gas below the lower flammability limit (LFL)* Subcritical assembly submersed in light water pool &deg;-,* Provides shielding and heat s-,..,8AS8) removal ......18 Subcritical Assembly Irradiation Process* Uranium concentration of solution and any other necessary parameters are measured* Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV* TSV is filled in discrete increments
SHINE Medical Technologies, Inc.
* Final fill level is approximately 5% by volume below critical* Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
, The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7
* High flux trips* Primary cooling system temperature trips Subcritical Assembly Irradiation Process' When irradiating the TSV:* Further solution addition is prevented* Tritium is supplied to the target, and neutron driver output is gradually increased* Reactivity decreases significantly in the assembly due to the strong negative feedback* Normal irradiation mode operations are approximately 5.5 days-'Following shutdown, light water pool provides decay heat removal* On a loss of off-site power, pool passively removes heat* Temperature rise of 12&deg;F (7&deg;(c) after 90 days without cooling Radioisotope Production Facility*Extracting, purifying and packaging Mo-99 in supercells-Laboratory scale purification process*Noble Gas Removal System (NGRS) stores TSV off-gas*Held for 40 days of decay prior to sampling for release* Released through the Process I Vessel Vent System (PWS)*Monitored and filtered discharge to ensure regulatory limits are met*Recycling and cleaning target solution* Uranium extraction (U REX)process separates uranium for ......................
SHINE Facility Layout
reuse Pu~Packagoe Engineered Safety Features (ESFs)* SHINE protects public health and safety during postulated accidents via a confinement system ,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor-Low dispersion forces in processes byConfinement functions provided ,,,F, RPF;Biological shielding (IU cells, hot cells, trenches, tank vaults)Isolation valves on piping systems* Ventilation systems* Instrument and control systems: Engineered Safety Features Actuation System (ESFAS)Radiological Integrated control System (RIcS)Zo,,e 2 Zen. 3 Ventilation Zones in Production Facility 22 Summary , Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements
* The SHINE facility consists of an irradiation facility (IF) and a radioisotope production facility (RPF) ldiation acility idioisotope roduction Facility 8
* Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers , The plant is being designed with safety as the primary criterion 23 NRC-01l' U.S.NRC United Stats Nuileair Regulatory Comnisslio Protecting People and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 1 5o 201 5 Panelists* Alexander Adams, Jr.-Chief, Research and Test Reactors Licensing Branch, NRR* Steven Lynch-Project Manager, NRR* Mary Adams-Project Manager, NMSS Licensing Considerations
 
SHINE Irradiation Facility
='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50
    =However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2
  ' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs
*An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility
,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution
*Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2
                                        ,1&deg;
 
SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)
SPart I of the Application submitted March 26, 2013
        *PSAR Chapter 2 (Site Characteristics)
        =PSAR Chapter 19 (Environmental Review)
        ,General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013
=The SHINE facility will be licensed under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria
* NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"
* Interim Staff Guidance augmenting NUREG-1 537
* Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility"
, Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12
 
SHINE Facility Layout
* Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop                                   Product A  Recycle tank TSV and Irradiation Unit Cell ~Hold Periodic Cleanup Loop associated cleanup
* processes 4....
                                              -wTargetpaato 14 Solution
 
SHINE Irradiation Facility SHINE'sFusion-FIssion Coupling
* An IU consists of a subcritical assembly, a neutron driver, and supporting systems
* Major supporting systems include:
V
* Light water pool system (LWPS)
* Target solution vessel (TSV) off-gas system (TOGS)                                         Neutron Oriver
        . Primary closed loop cooling system (PCLS)
N
* Tritium purification system (TPS)                                       '4 Neutron Multiplier
* Primary system at near-atmospheric pressure                       14 11
* Target solution is drained to dump tank via gravity                                             Target Solution
* Dump tank is criticality-safe by geometry and                                               Vessel passively-cooled                                                                     N
* Redundant, fail-open dump valves
                                                                                            '4> N
* TSV is an annular vessel to be constructed of Zircaloy-4
* Natural convection within TSV Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support                                                                         TSV and Neutron Structure                                                                       S      Multiplier (SASS)                                                                         (Internal to SASS)
TSV Dump Tank -,.
TSV Dump and Overflow Lines
              ~(2                                     each) 16
 
Neutron Driver and Tritium Purification System
* One Neutron Driver per IU cell
* Electrostatic accelerator with a gas target
* D-T fusion reaction generates 14 MeV neutrons that drive the fission process
* Tritium purification system
* Isotopically separates gases, and supplies clean tritium to neutron drivers
* Tritium lines and processing q    equipment in gloveboxes and double-walled pipe             1 TSV Off-Gas and Primary Cooling Systems
*TSV off-gas system (TOGS)
* Contains the fission product1     TOGS gases                             i
  *of-aRemoves iodine from the
* Recombines hydrogen and oxygen to maintain hydrogen gas below the lower flammability limit (LFL)
* Subcritical assembly submersed in light water                 *"
pool                                       &deg;-,
* Provides shielding and heat         s-,..,8AS8) removal                                         ......
18
 
Subcritical Assembly Irradiation Process
*Uranium concentration of solution and any other necessary parameters are measured
*Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV
* TSV is filled in discrete increments
* Final fill level is approximately 5% by volume below critical
* Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
* High flux trips
* Primary cooling system temperature trips Subcritical Assembly Irradiation Process
' When irradiating the TSV:
* Further solution addition is prevented
* Tritium is supplied to the target, and neutron driver output is gradually increased
* Reactivity decreases significantly in the assembly due to the strong negative feedback
* Normal irradiation mode operations are approximately 5.5 days
-'Following shutdown, light water pool provides decay heat removal
* On a loss of off-site power, pool passively removes heat
* Temperature rise of 12&deg;F (7&deg;(c) after 90 days without cooling
 
Radioisotope Production Facility
*Extracting, purifying and packaging Mo-99 in supercells
    -Laboratory scale purification process
*Noble Gas Removal System (NGRS) stores TSV off-gas
    *Held for 40 days of decay prior to sampling for release
* Released through the Process           I Vessel Vent System (PWS)
    *Monitored and filtered discharge to ensure regulatory limits are met
*Recycling and cleaning target solution
* Uranium extraction (UREX) process separates uranium for                                       ......................
reuse                                                       Pu~Packagoe Engineered Safety Features (ESFs)
* SHINE protects public health and safety during postulated accidents via a confinement system
    ,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor
    -Low dispersion forces in processes byConfinement functions provided                 ,,,F,                             RPF; Biological shielding (IU cells, hot cells, trenches, tank vaults)
Isolation valves on piping systems
* Ventilation systems
* Instrument and control systems:                                                             Zo,,e2 Zen. 3 Engineered Safety Features Actuation System (ESFAS)
Radiological Integrated control System (RIcS)                       Ventilation Zones in Production Facility 22
 
Summary
, Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements
* Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers
, The plant is being designed with safety as the primary criterion 23
 
NRC-01l
            ' U.S.NRC United Stats Nuileair Regulatory Comnisslio ProtectingPeople and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 15o 201 5 Panelists
* Alexander Adams, Jr.
  - Chief, Research and Test Reactors Licensing Branch, NRR
* Steven Lynch
  - Project Manager, NRR
* Mary Adams
  - Project Manager, NMSS
 
Licensing Considerations
* SHINE seeks to construct commercial non-power utilization and production facilities
* SHINE seeks to construct commercial non-power utilization and production facilities
* Licensing process similar to that of research and test reactors* Developed technology-specific guidance for application review Advisory Committee on Reactor Safeguards (ACRS) Review* Staff presented at subcommittee and full committee meetings* ACRS recommended issuance of construction permit* Staff adequately addressed questions regarding aircraft impact and facility layup Irradiation Unit Licensing* Irradiation units represent first subcritical utilization facilities
* Licensing process similar to that of research and test reactors
* Staff considered licensing under 10 CFR Part 70* Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features* Thermal power level similar to non-power reactors* Safety considerations include:-Fission heat removal-Decay heat generation
* Developed technology-specific guidance for application review Advisory Committee on Reactor Safeguards (ACRS) Review
-Fission gas release-Accident scenarios Production Facility Licensing* Production facility will process irradiated materials containing special nuclear material* Similar to processes at existing fuel cycle facilities
* Staff presented at subcommittee and full committee meetings
* ACRS recommended issuance of construction permit
* Staff adequately addressed questions regarding aircraft impact and facility layup
 
Irradiation Unit Licensing
* Irradiation units represent first subcritical utilization facilities
* Staff considered licensing under 10 CFR Part 70
* Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features
* Thermal power level similar to non-power reactors
* Safety considerations include:
  - Fission heat removal
  - Decay heat generation
  - Fission gas release
  - Accident scenarios
 
Production Facility Licensing
* Production facility will process irradiated materials containing special nuclear material
* Similar to processes at existing fuel cycle facilities
* Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
* Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
* Criticality accident alarm system* Criticality events "not credible"* Criticality safety analyses* Reactivity contributions from fissile isotopes* Radiation shielding and occupancy times Acronyms*NMSS- Office of Nuclear Material Safety and Safeguards
* Criticality accident alarm system
* NRR -Office of Nuclear Reactor Regulation Exhibit SIIN-027 qSHINE'T Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety -Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq IB12i~A Recycle tank Product TSV and Irradiation Unit Cell Hl e Periodic Cleanup Loop* associated cleanup* processes.4. *Target Solution~Preparation Design of Structures, Systems, and Cornponents a Certain structures, systems, and components (SSCs)are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")
* Criticality events "not credible"
Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure: 1. The integrity of the primary system boundary;2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
* Criticality safety analyses
: 3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
* Reactivity contributions from fissile isotopes
: 5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or 6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur Seismic Design and Quality Levels* Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC* SHINE Quality Levels (QLs): SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs-QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety*QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
* Radiation shielding and occupancy times
* Single failure criterion is applied to safety systems-Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function-A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function* SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6 NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion Protecting PrcopLt and the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists* Steven Lynch-Project Manager, NRR* Joseph Staudenmeier
 
-Senior Reactor Systems Engineer, RES* Kevin Morrissey-Project Manager, NMSS Review Methodology
Acronyms
* Two methodologies applied to SHINE accident analyses-Maximum hypothetical accident-Integrated safety analysis* Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis* Irradiation facility characteristics:
*NMSS- Office of Nuclear Material Safety and Safeguards
-Operates at low power, pressure, and temperature
* NRR - Office of Nuclear Reactor Regulation
-Large heat sink for passive decay heat removal-Radiological sources Event Identification
 
Exhibit SIIN-027 qSHINE'T     Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq                                 Product IB12i~
A   Recycle tank TSV and Irradiation Unit Cell     Hl e
Periodic Cleanup Loop
* associated cleanup
* processes
                                                            .4.
* Target Solution
            ~Preparation
 
Design Cornponents    of Structures, Systems, and a Certain structures, systems, and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")
Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure:
: 1. The integrity of the primary system boundary;
: 2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
: 3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;
: 4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
: 5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or
: 6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur
 
Seismic Design and Quality Levels
* Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC
* SHINE Quality Levels (QLs):
SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs
    -QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety
    *QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
* Single failure criterion is applied to safety systems
    -Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function
    - A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function
* SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6
 
NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion ProtectingPrcopLtand the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists
* Steven Lynch
  - Project Manager, NRR
* Joseph Staudenmeier
  - Senior Reactor Systems Engineer, RES
* Kevin Morrissey
  - Project Manager, NMSS
 
Review Methodology
* Two methodologies applied to SHINE accident analyses
  - Maximum hypothetical accident
  - Integrated safety analysis
* Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis
* Irradiation facility characteristics:
  - Operates at low power, pressure, and temperature
  - Large heat sink for passive decay heat removal
  - Radiological sources
 
Event Identification
* Delineation of possible accident categories
* Delineation of possible accident categories
* Identification of limiting accident for the category* Strategy to mitigate accident and limit consequences
* Identification of limiting accident for the category
* Analysis of dose consequences Safety Concept* Detection of high radiation levels* Confinement of radiation source* Evacuate workers* Filter releases to environment
* Strategy to mitigate accident and limit consequences
* Emergency planning zone could be the operational boundary Limiting Accident* Release of irradiated target solution from one TSV* Consequences bounded by RPF maximum hypothetical accident* Meets 10 CFR Part 20 limits-5 rem for workers-100 mrem for public Production Facility Accident Analysis* Radiological and chemical accident analysis performed* Defines facility hazards and controls that support establishment of design basis Production Facility Accident Analysis* Multiple event types:-Radiological accidents-Chemical accidents-Criticality accidents-Fires-External events Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety -Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios*Bases for identification of accidents:.Hazard and Operability Study (HAZOPS)SPreliminary Hazard Analysis (PHA)*List of events from NUREG-1 537 and the Interim Staff Guidance (ISG)augmenting NUREG-1537 ,Experience of the hazards analysis team*Current preliminary design information SQualitative evaluations within categories ,Quantitative evaluations to determine consequences
* Analysis of dose consequences Safety Concept
*Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)&deg;Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")
* Detection of high radiation levels
IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell ,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement
* Confinement of radiation source
&deg;High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences-Worker TEDE: 3.1 rem ..-Public (site boundary)
* Evacuate workers
TEDE: TSV Q ........0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)&deg;The five noble gas storage tanks rupture simultaneously
* Filter releases to environment
&deg; With the maximum inventory*Contents are instantly released SHigh radiation levels initiate alarm and cell isolation , Redundant isolation dampers close' 10% of the activity bypasses the isolation dampers' 10% of the activity leaks* through penetrations TSV Oft G.~P~.rge NORS Nobk G.~Stosg. Ts,,k~Conden~ot~
* Emergency planning zone could be the operational boundary
Knock Oft Pro~es, Ves~eI Thnk v~,,t Syften, R~dIo.ctWn LIqnId Wnte RPF Maximum Hypothetical Accident (Facility MHA)=Dose consequences
 
*Worker TEDE: rem*Public (site boundary)
Limiting Accident
TEDE: 0.082 rem oThe MHA consequences are conservative ,Simultaneous, instantaneous rupture* Entirety of noble gas is transferred and released SThe five tanks are filled to capacity&deg;Additional ventilation isolation dampers would close, but are not credited-Actual doses would be lower Doses to the Public From Analyzed Accidents Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301 I EuU _______5 NRC-01 3<U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon Protecting People and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists* Jane Marshall-Deputy Director, Division of License Renewal, NRR* David Wrona-Branch Chief, NRR* Michelle Moser-Project Manager, NRR Environmental Review* National Environmental Policy Act* Environmental review process-Title 10 of Code of Federal Regulations (10 CFR) Part 51-Environmental Standard Review Plan (NUREG-1 537)-Interim Staff Guidance Environmental Impact Statement (EIS)* 10 CFR 51.20* Project-specific decision-Potential significant impacts-First-of-a-kind facility with a unique application of technologies
* Release of irradiated target solution from one TSV
-Public involvement maximized Scoping* 2 public meetings in Janesville, Wisconsin* 5 oral comments* 6 written comments Department of Energy (DOE)* National Environmental Policy Act-Lead agency: Nuclear Regulatory Commission
* Consequences bounded by RPF maximum hypothetical accident
-Cooperating agency: DOE* American Medical Isotopes Production Act-Complementary environmental reviews Environmental Review Areas Socioeconomics and Environmental Justice Terrestrial Resources Environmental Impacts Resource Area Impact Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Ecological and Water Resources SMALL Historic and Cultural Resources SMALL Socioeconomics SMALL Human Health and Waste SMALL Transportation SMALL to MODERATE Reasonable Alternatives
* Meets 10 CFR Part 20 limits
  - 5 rem for workers
  - 100 mrem for public Production Facility Accident Analysis
* Radiological and chemical accident analysis performed
* Defines facility hazards and controls that support establishment of design basis
 
Production Facility Accident Analysis
* Multiple event types:
  - Radiological accidents
  - Chemical accidents
  - Criticality accidents
  - Fires
  - External events
 
Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios
*Bases for identification of accidents:
    .Hazard and Operability Study (HAZOPS)
SPreliminary Hazard Analysis (PHA)
    *List of events from NUREG-1 537 and the Interim Staff Guidance (ISG) augmenting NUREG-1537
    ,Experience of the hazards analysis team
    *Current preliminary design information SQualitative evaluations within categories
    ,Quantitative evaluations to determine consequences
*Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)
    &deg;Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")
 
IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell
      ,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement
  &deg;High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences
      -Worker TEDE: 3.1 rem                   ..
      -Public (site boundary) TEDE:   TSV Q                         ........
0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)
  &deg;The five noble gas                               TSV Oft G.~
storage tanks rupture                             P~.rge simultaneously                                 NORS
      &deg;With the maximum inventory
      *Contents are instantly released                         Nobk G.~
Stosg. Ts,,k~
SHigh radiation levels initiate alarm and cell isolation
, Redundant isolation dampers close Conden~ot~
      ' 10% of the activity bypasses                       KnockOft          Pro~es,Ves~eI Thnk             v~,,t Syften, the isolation dampers
      ' 10% of the activity leaks R~dIo.ctWn
* through penetrations                                                  LIqnIdWnte
 
RPF Maximum Hypothetical Accident (Facility MHA)
Doses to the Public From Analyzed Accidents
=Dose consequences
    *Worker TEDE: *3.6 rem
    *Public (site boundary) TEDE: 0.082 rem oThe MHA consequences are conservative
    ,Simultaneous, instantaneous rupture
* Entirety of noble gas is transferred and released SThe five tanks are filled to capacity
    &deg;Additional ventilation isolation dampers would close, but are not credited
-Actual doses would be lower Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301                       EuU      _______
I 5
 
NRC-01 3
            <U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon ProtectingPeople and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists
* Jane Marshall
  - Deputy Director, Division of License Renewal, NRR
* David Wrona
  - Branch Chief, NRR
* Michelle Moser
  - Project Manager, NRR
 
Environmental Review
* National Environmental Policy Act
* Environmental review process
  - Title 10 of Code of Federal Regulations (10 CFR) Part 51
  - Environmental Standard Review Plan (NUREG-1 537)
  - Interim Staff Guidance Environmental Impact Statement (EIS)
* 10 CFR 51.20
* Project-specific decision
  - Potential significant impacts
  - First-of-a-kind facility with a unique application of technologies
  - Public involvement maximized
 
Scoping
* 2 public meetings in Janesville, Wisconsin
* 5 oral comments
* 6 written comments Department of Energy (DOE)
* National Environmental Policy Act
  - Lead agency: Nuclear Regulatory Commission
  - Cooperating agency: DOE
* American Medical Isotopes Production Act
  - Complementary environmental reviews
 
Environmental Review Areas Socioeconomics and               Terrestrial Environmental Justice               Resources Environmental Impacts Resource Area                       Impact Land Use and Visual Resources                 SMALL Air Quality and Noise                         SMALL Geologic Environment                           SMALL Ecological and Water Resources                 SMALL Historic and Cultural Resources               SMALL Socioeconomics                                 SMALL Human Health and Waste                         SMALL Transportation                           SMALL to MODERATE
 
Reasonable Alternatives
* No-action alternative
* No-action alternative
* Alternative sites-Chippewa Falls-Stevens Point* Alternative technologies Alternative Technologies
* Alternative sites
* Neutron capture* Aqueous homogenous reactor* Linear-accelerator-based
  - Chippewa Falls
-Analyzed in depth Costs and Benefits* Purpose-Inform recommendation to the Commission
  - Stevens Point
* Costs-Environmental and financial* Benefits-Societal, medical, and economic Environmental Costs Proposed Janesville Site Chippewa Falls Alternative Stevens Point Alternative Alternative Technology No-action Alternative Traffic Traffic, Noise Traffic 1 Noise, Visual Traffic None* SMALL impacts for all other resource areas Benefits* Support United States (U.S.)policy* Support U.S. public health needs* Economic benefits-Increased tax revenue-New employment opportunities Consultations
* Alternative technologies Alternative Technologies
* 0 0 6 .~ 3--
* Neutron capture
* 0 Endangered Species Act, Section 7 National Historic Preservation Act, Section 106 No Effect No Adverse Effect Draft Environmental Impact Statement* 2 public meetings in Janesville, Wisconsin* 1 oral comment* 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.
* Aqueous homogenous reactor
Future NEPA Analyses* 10 CFR 51 .95(b) requires the staff to supplement the Final EIS-Matters that differ from the Final EIS-New significant information Acronyms* NRR -Office of Nuclear Reactor Regulation Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report* Began work October 2011* SHINE production facility will be located in Janesville, Rock County, Wisconsin* Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii 2 Structure and Content of the Environmental Report 19.1 -Introduction 19.2 -Proposed Action 19.3- Descrption of the Affected Environment 19.4- Impacts of the Proposed Construction, Operations, and Decommissioning 19.5 -Alternatives 19.6 -Conclusions Purpose and need for the proposed action, Regulatory provisions, permits and required consultations Site location and layout, Radioisotope facility description, Water consumption and treatment.
* Linear-accelerator-based
Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials Land use and visual resources, Air quality and noise, Geooic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health Land use and visual resources, Air quality and noise, Geologic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics, Human health, Waste management, Transportation, Postulated accidents, Environmental justice, Cumulative effects NO-action alternative.
  - Analyzed in depth
Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3 6 Scope of Field Investigations
 
=Phase I Environmental Site Assessment
Costs and Benefits
&deg;General Reconnaissance
* Purpose
+Soil Borings/Geotechnical Investigation ,Well Installation
  -   Inform recommendation to the Commission
&deg;Phase I Archaeological Investigation
* Costs
&deg;Baseline Visual Assessment
  -   Environmental and financial
*Wetland Delineation
* Benefits
&deg;Quarterly Ecological Investigations
  -   Societal, medical, and economic Environmental Costs Proposed Janesville Site   Traffic Chippewa Falls Alternative Traffic, Noise Stevens Point Alternative Traffic1 Noise, Visual Alternative Technology     Traffic No-action Alternative     None
=Aquatic Ecology ,Terrestrial Ecology oMonthly Water Resources+Water Quality=Water Levels U Context for Data Acquisition ,Site* 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI* Project Area*Circular area with a radius approximately 1 mile from the site center point' Region' Circular area with a radius of 5 miles from the site center point' Larger context as appropriate (e.g., geology, air quality)' Region of Influence , ,Rock County 5 Consultations
* SMALL impacts for all other resource areas
' City of Janesville
 
' Rock County-Wisconsin Department of Natural Resources-Wisconsin State Historic Preservation Office (SHPO)-Wisconsin Department of Transportation-U.S. Fish and Wildlife Service o ,E,' Federal Aviation Administration
Benefits
' Bureau of Indian Affairs' Native American Tribes (13): ' Wisconsin Tribes: ,Forest County Potawatomi Community, Wisconsin&deg;Ho-Chunk Nation of Wisconsin* Non-Wisconsin Tribes:-' 11 Tribal Entities 0~1 6 Alternative Sites Construction SMALL impacts to all Impacts resource categories Construction 420 jobs; $635,000 Benefits annual property tax payments Operation SMALL impacts to all Impacts resource categories Operation 150 jobs: reliable Benefits source of diagnostic isotopes:
* Support United States (U.S.)
Mo-99, 1-131. Xe-1 33;$680.000 annual property tax payments MODERATE impacts to Visual Resources, Noise and Transportation 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 150 jobs; reliable source of diagnostic isotopes:
policy
Mo-99, 1-131. Xe-i133:$680,000 annual property tax payments MODERATE impacts to Land use, Visual Resources, Noise, Ground Water, and Transportation 420 jobs: $635,000 annual property tax payments SMALL impacts to all resource categories 150 jobs; reliable source of diagnostic isotopes:
* Support U.S. public health needs
Mo-99, 1-131, Xe-i133;$680,000 annual property tax payments SMALL impacts to all resource categories None SMALL impat to all resource categories None 7 Alternative Technologies Eu."l Construction SMAL impat to all Impat resource categories Construction 420 jobs, $635,000 Benefits annual property tax payments Operation SMLL impact to all Impat reorce caeories Operation 150 jobs; reliable Benefits source of diagnostic isotopes:
* Economic benefits
Mo-99, 1-131. Xe-i133;$680,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categorie 150 jobs; reliable source of Mo-99;$660,000 annual property tax payments SMALL impacts to all SMALL impatsto all resource categories resource categorie 420 jobs; $635,000 None annual property tax payments SMALL impacts to all SMALL impacts to all resource categorie resourc categories 150 jobs; reliable source of diagnostic isotopes:
  - Increased tax revenue
Mo-99, 1-131, Xe-133;$660,000 annual property tax payments None 11 8 NRC Environmental Site Audit July 30- August 1, 2013* SHINE presentations on the production process and alternative site selection process-Janesville site visit&deg;Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River* Tour of the Janesville Wastewater Treatment Facility ,Alternative site visits:-Stevens Point ,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community* SHINE believes the relationships between the company, Janesville, and Wisconsin are important* SHINE favors a policy of transparency with our community , SHINE's actions support these principles a Participation in four public meetings per year (two SHINE hosted, two for city council)* SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plans a Regular updates provided to State of Wisconsin* These activities have fostered a relationship of trust and enthusiasm for the project 10 Conclusions o The SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied&deg;SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11 SCHEDULING NOTE Title: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY:
  - New employment opportunities Consultations
SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)Scheduled:
* 0 0 6 .~ 3--
Purpose: Duration: Location: December 15, 2015 9:00 am To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision.
* 0 Endangered Species   No Effect Act, Section 7 National Historic Preservation Act,   No Adverse Effect Section 106
The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. &sect;&sect; 50.35(a)and 51 .105(a).1 day Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.
 
20 mins.Participants:
Draft Environmental Impact Statement
Presentation (Note: Presenters seated at the table are listed, other staff available to answer questions will be seated in the well and reser'ved rows.)Overview (SHINE Medical Technologies.
* 2 public meetings in Janesville, Wisconsin
Inc.)At the table: Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each)30 mins.*24 mins.**1 30 mins.*At the table: William Dean, Director, Office of Nuclear Reactor Regulation (NRR)Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings.
* 1 oral comment
The staff will also discuss its review methodology and how it applied the Commission's regulations.
* 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.
Commission 0 & A (round of questions; 6 minutes each) 24 mins.**BREAK 5 mins.NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions.
 
Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.Safety- Panel 1 (11:15 am)Applicant 5 mins.*At the table: Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff 10 mins.*At the table: Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)Toi:Sections of the application and the following chapters from the Safety Evaluation Report: Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.2 Note that the panel will not have specific topics to discuss for the following chapters.
Future NEPA Analyses
If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Cooling Systems" o Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each) 24 mains.**BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)Safety -Panel 2 (1:30 pm)Applicant 5 mins.*At the table: Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff 10 mains.*At the table: Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report: Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.
* 10 CFR 51 .95(b) requires the staff to supplement the Final EIS
Note that the panel will not have specific topics to discuss for the following chapters.
  - Matters that differ from the Final EIS
If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11, "Radiation Protection Program and Waste Management," including proposed permit condition o Chapter 12, "Conduct of Operations"~***
  - New significant information Acronyms
o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualification" 3 Commission 0 & A (round of questions; 6 minutes each) 2 is*24 mins.**Environmental
* NRR   -Office       of Nuclear Reactor Regulation
-Panel (2:10 pm)Applicant At the table: Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy 10 mins.*Staff 25 mins.*At the table: Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement* Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
 
o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice* Discuss the analysis of alternatives including:
Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report
* Began work October 2011
* SHINE production facility will be located in Janesville, Rock County, Wisconsin
* Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii                             2
 
Structure and Content of the Environmental Report 19.1 - Introduction       Purpose and need for the proposed action, Regulatory provisions, permits and required consultations 19.2 - Proposed Action      Site location and layout, Radioisotope facility description, Water consumption and treatment. Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials 19.3- Descrption of the    Land use and visual resources, Air quality and noise, Geooic environment, Affected Environment        Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health 19.4- Impacts of the        Land use and visual resources, Air quality and noise, Geologic environment, Proposed Construction,      Water resources, Ecological resources, Historic and cultural resources, Operations, and            Socioeconomics, Human health, Waste management, Transportation, Decommissioning            Postulated accidents, Environmental justice, Cumulative effects 19.5 - Alternatives        NO-action alternative. Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts 19.6 - Conclusions          Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3
Scope of Field Investigations 6
  =Phase I Environmental Site Assessment
  &deg;General Reconnaissance
  +Soil Borings/Geotechnical Investigation
  ,Well Installation
  &deg;Phase I Archaeological Investigation
  &deg;Baseline Visual Assessment
  *Wetland Delineation
  &deg;Quarterly Ecological Investigations
        =Aquatic Ecology
        ,Terrestrial Ecology oMonthly Water Resources
        +Water Quality
      =Water Levels
 
Context for Data Acquisition U
    ,Site
* 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI
* Project Area
          *Circular area with a radius approximately 1 mile from the site center point
  ' Region
        ' Circular area with a radius of 5 miles from the site center point
        ' Larger context as appropriate (e.g., geology, air quality)
  ' Region of Influence
      , ,Rock County 5
Consultations
  ' City of Janesville
  ' Rock County
    -Wisconsin Department of Natural Resources
    -Wisconsin State Historic Preservation Office (SHPO)
    -Wisconsin Department of Transportation
    -U.S. Fish and Wildlife Service
  ' Federal Aviation Administration
  ' Bureau of Indian Affairs
* o ,E, 0
  ' Native American Tribes (13):
        ' Wisconsin Tribes:
              ,Forest County Potawatomi Community, Wisconsin
              &deg;Ho-Chunk Nation of Wisconsin
* Non-Wisconsin Tribes:
  -         ' 11 Tribal Entities
~1                                           6
 
Alternative Sites Construction SMALL impacts to all  MODERATE impacts      MODERATE impacts      SMALL impacts to all Impacts     resource categories   to Visual Resources,  to Land use, Visual  resource categories Noise and              Resources, Noise, Transportation        Ground Water, and Transportation Construction 420 jobs; $635,000     420 jobs; $635,000    420 jobs: $635,000    None Benefits    annual property tax    annual property tax    annual property tax payments              payments              payments Operation   SMALL impacts to all  SMALL impacts to all  SMALL impacts to all  SMALL impat to all Impacts     resource categories    resource categories    resource categories  resource categories Operation   150 jobs: reliable     150 jobs; reliable    150 jobs; reliable    None Benefits     source of diagnostic  source of diagnostic  source of diagnostic isotopes: Mo-99,      isotopes: Mo-99,      isotopes: Mo-99, 1-131. Xe-1 33;       1-131. Xe-i133:        1-131, Xe-i133;
              $680.000 annual       $680,000 annual        $680,000 annual property tax           property tax          property tax payments              payments              payments 7
Alternative Technologies Construction Impat Construction Benefits Eu."l SMAL impat to all resource categories 420 jobs, $635,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 420 jobs; $635,000 annual property tax payments SMALL impatsto all resource categorie None Operation      SMLL impact to all    SMALL impacts to all SMALL impacts to all SMALL impacts to all Impat          reorce caeories        resource categorie    resource categorie  resourc categories Operation      150 jobs; reliable     150 jobs; reliable                        None 150 jobs; reliable Benefits      source of diagnostic   source of Mo-99;      source of diagnostic isotopes: Mo-99,      $660,000 annual      isotopes: Mo-99, 1-1-131. Xe-i133;        property tax          131, Xe-133;
                $680,000 annual       payments             $660,000 annual property tax                                property tax payments                                     payments 11                                                  8
 
NRC Environmental Site Audit July 30- August 1, 2013
* SHINE presentations on the production process and alternative site selection process
-Janesville site visit
      &deg;Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River
* Tour of the Janesville Wastewater Treatment Facility
,Alternative site visits:
      -Stevens Point
      ,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community
* SHINE believes the relationships between the company, Janesville, and Wisconsin are important
* SHINE favors a policy of transparency with our community
, SHINE's actions support these principles a Participation    in four public meetings per year (two SHINE hosted, two for city council)
* SHINE management involvement in community activities a  Regular discussions with city leadership to coordinate plans a  Regular updates provided to State of Wisconsin
* These activities have fostered a relationship of trust and enthusiasm for the project 10
 
Conclusions oThe SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate
=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied
&deg;SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11
 
SCHEDULING NOTE Title:              HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
Scheduled:          December 15, 2015 9:00 am Purpose:            To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. &sect;&sect; 50.35(a) and 51 .105(a).
Duration:            1 day Location:            Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.
20 mins.
Participants:                                                                    Presentation (Note: Presenters questions          seatedinatthe will be seated      thewell table are and   listed, other reser'ved      staff available to answer rows.)
Overview (SHINE Medical Technologies. Inc.)                                        30 mins.*
At the table:
Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each)                              24 mins.**
1
 
30 mins.*
At the table:
William Dean, Director, Office of Nuclear Reactor Regulation (NRR)
Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)
Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings. The staff will also discuss its review methodology and how it applied the Commission's regulations.
Commission 0 & A (round of questions; 6 minutes each)                              24 mins.**
BREAK                                                                                  5 mins.
NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.
Safety- Panel 1 (11:15 am)
Applicant                                                                            5 mins.*
At the table:
Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff                                                                                10 mins.*
At the table:
Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)
Toi:Sections of the application and the following chapters from the Safety Evaluation Report:
Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.
2
 
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o  Chapter 2, "Site Characteristics" o  Chapter 3, "Design of Structures, Systems, and Components" o  Chapter 5, "Cooling Systems" o  Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each)                            24 mains.**
BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)
Safety - Panel 2 (1:30 pm)
Applicant                                                                          5 mins.*
At the table:
Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff                                                                            10 mains.*
At the table:
Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report:
Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o   Chapter 8, "Electrical Power Systems" o   Chapter 9, "Auxiliary Systems" o   Chapter 11, "Radiation Protection Program and Waste Management,"
including proposed permit condition o   Chapter 12, "Conduct of Operations"~***
o  Chapter 14, "Technical Specifications" o  Chapter 15, "Financial Qualification" 3
 
Commission 0 & A (round of questions; 6 minutes each)                         224 mins.**
is*
Environmental  - Panel (2:10 pm)
Applicant                                                                       10 mins.*
At the table:
Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy Staff                                                                           25 mins.*
At the table:
Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement
* Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice
* Discuss the analysis of alternatives including:
o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative
o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative
* Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each)24 mins.**BREA K 5 mins.4 Closing (3:15) 5 is 54 mins.Closing Statement by Applicant 15 rmins.*Greg Piefer, Chief Executive Officer Closing Statement by Staff 15 rains.*William Dean, Director, NRR Commission Q & A and Closing Statements 24 rmins.***For presentation only and does not include time for Commission 0 & A's.**AII Commissioners will have an opportunity to ask questions after each panel.Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.**Chapter 12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.5 HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY:
* Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each)                           24 mins.**
SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)December 15, 2015 Slides/Handouts Overview-SHINE Medical Technologies, Inc.-NRC Staff Safety -Panel 1-SHINE Medical Technologies, Inc.-NRC Staff Safety -Panel 2-SHINE Medical Technologies, Inc.-NRC Staff Environmental  
BREA K                                                                           5 mins.
-Panel-SHINE Medical Technologies, Inc.-NRC Staff N RC-010 United Nuclear Regulatory C~, mmtnslon Protecting People andt&#xa2; the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists* William Dean* Mirela Gavrilas* Jane Marshall* Marissa Bailey-Director, NRR-Deputy Director, NRR/DPR-Deputy Director, NRR/DLR-Director, NMSS/FCSE Introduction to Molybdenum-99
4
* Molybdenum-99 (9 9 M0) Mc 0.90 decays to -Effective diagnosis o-Minimal exposureV* 50,000 procedures daily Tc009* No domestically-produced supply ooo.o Establishing a Domestic Supply* National policy objectives support domestic production capabilities
 
* Cost-sharing agreements encourage commercial partners* SHINE proposes to produce 9 9 M0 through uranium fission Preparing for SHINE Review* Interoffice working group contributed diverse expertise* Public meetings engaged stakeholders
Closing (3:15)                                                                   554 mins.
is Closing Statement by Applicant                                                   15 rmins.*
Greg Piefer, Chief Executive Officer Closing Statement by Staff                                                       15 rains.*
William Dean, Director, NRR Commission Q & A and Closing Statements                                         24 rmins.**
*For presentation only and does not include time for Commission 0 & A's.
**AII Commissioners will have an opportunity to ask questions after each panel.
Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
  **Chapter12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.
5
 
HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
December 15, 2015 Slides/Handouts Overview
-SHINE Medical Technologies, Inc.
-NRC Staff Safety - Panel 1
-SHINE Medical Technologies, Inc.
-NRC Staff Safety - Panel 2
-SHINE Medical Technologies, Inc.
-NRC Staff Environmental   - Panel
-SHINE Medical Technologies, Inc.
-NRC Staff
 
N RC-010
          *U.S.NRC United Sriae* Nuclear Regulatory C~,mmtnslon ProtectingPeople andt&#xa2;   the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists
* William Dean                 -   Director, NRR
* Mirela Gavrilas              -   Deputy Director, NRR/DPR
* Jane Marshall                -   Deputy Director, NRR/DLR
* Marissa Bailey              -   Director, NMSS/FCSE
 
Introduction to Molybdenum-99
* Molybdenum-99 (99 M0)       Mc   0.90 decays to technetium-99m(*o,,
  - Effective diagnosis     o
  - Minimal exposureV
* 50,000 procedures daily     Tc009
* No domestically-produced supply                     ooo.o Establishing a Domestic Supply
* National policy objectives support domestic production capabilities
* Cost-sharing agreements encourage commercial partners
* SHINE proposes to produce 99 M0 through uranium fission
 
Preparing for SHINE Review
* Interoffice working group contributed diverse expertise
* Public meetings engaged stakeholders
* Review coordinated with Federal, State, and local governments Allowing Construction
* Review coordinated with Federal, State, and local governments Allowing Construction
* SHINE application only seeks construction authorization
* SHINE application only seeks construction authorization
* Design details may be left for operating license application
* Design details may be left for operating license application
* Review assessed preliminary design and analysis Conducting the Safety Review cn~~itW Tailoring Review Methodology
* Review assessed preliminary design and analysis
 
Conducting the Safety Review cn~~itW Tailoring Review Methodology
* Review accommodated unique technology
* Review accommodated unique technology
* Staff used existing guidance* Staff determined whether reasonable assurance that final design will conform to design bases Additional Information
* Staff used existing guidance
* Staff determined whether reasonable assurance that final design will conform to design bases
 
Additional Information
* Review supported by additional information
* Review supported by additional information
* In some cases, permit conditions necessary* Regulatory commitments track items for resolution in final safety analysis report (FSAR)Environmental Regulations
* In some cases, permit conditions necessary
* National Environmental Policy Act-Informs Federal decision making-Public disclosure
* Regulatory commitments track items for resolution in final safety analysis report (FSAR)
Environmental Regulations
* National Environmental Policy Act
  - Informs Federal decision making
  - Public disclosure
* NRC's environmental regulations
* NRC's environmental regulations
-Title 10 of the Code of Federal Regulations (10 CFR) Part 51 Environmental Review Process* Opportunity for Public Involvement Proposed Janesville Site..... Agricultural fields....
  - Title 10 of the Code of Federal Regulations (10 CFR) Part 51
* Previously disturbed..... No surface water* features I No threatened or endangeredspce
 
* o historical or cultural resources Regulatory Basis* Commission authorized by Atomic Energy Act, Section 103* Review primarily based on 10 CFR Parts 20, 50, and 51* Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance* Preliminary design described* Further technical or design information may be left for FSAR* Ongoing research and development has been identified
Environmental Review Process
* Facility can be constructed and operated without undue risk Permit Considerations
* Opportunity for Public Involvement Proposed Janesville Site
* Construction will not endanger public health and safety* SHINE technically and financially qualified* Environmental requirements satisfied Introducing Review Panels Safety Panel 1 Safety Panel 2 Environmental Panel Licensing Considerations Accident Analysis* Final Environmental Impact Statement Process* Analysis of Alternatives
    .....         Agricultural fields
* Summary of Conclusions and Recommendations Safe...Evaluation.Repor Chapters 1 and 4 Safety Evaluation Re port Chapter 13 Final Environmental Impact Statement Acronyms* FCSE -Division of Fuel Cycle Safety, Safeguards, and Environmental Review* DLR -Division of License Renewal* DPR -Division of Policy and Rulemaking Acronyms* NMSS- Office of Nuclear Material Safety and Safeguards
    ....
* NRR -Office of Nuclear Reactor Regulation Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission* SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come Medical Isotopes* Molybdenum-99 (Mo-99), the most widely-used medical isotope, decays into technetium-99m, which is used in more than 40 million doses annually* Stress tests and bone scans most common of dozens of uses MedicalProchyedursUig"T7 M72rn M~&7 A44~ 7717r ~ A7p17 7*? 1717 A7,7~, ~1717<nn{*fll t1717 krr. 7*7* *4747 77 7 W ?77x7777 7ft.1777, Nr~ 777477*774 771~ '777 7,777* 1777 4, J Supply Situation with No New Capacity*Canada will stop operating the NRU reactor in March 2018* Following Canadian exit, there will be no North American producer Highl relvantNEA Demand Growth (+35% ORC) vs, ig hl relvantcurrent processing capacity, 2015-202 because Mo-99 &deg;decays ~1% per hour z0=Domestic supply o is necessary to j o ensure US patient '&deg;health 717077 77477 470777 4 4 7-J* 471-077 4*4* 471077 4*177 417077 4777.477 77-077 7*477 77077 2014 2011 2014 2017 2011 2019 2020-.-NEAD.77772g177*  
* Previously disturbed
'40% WC, CU7071 ~71*$772 C8277777 U 4 SHINE Medical Technologies, Inc. Core Values=SHINE mission driven by our core values-Ensure health and safety of the public and our workforce* Minimize environmental impacts of medical isotope production
          ..... No surface water
* Ensure minimal or no disruption to patient supply chain* Ensure cost effectiveness and therefore patient access* Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain* SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values* Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce ,Decay heat per system < 1 kW within 5 hours oMinimizes waste nuclide generation compared to reactors* Low enriched uranium (LEU) reusable target* Reduces waste and cost Product compatible with current supply chain* Eliminates need for HEU* Driven by low-energy electrostatic accelerator
* I features No threatened or endangeredspce
* o historical or cultural resources
 
Regulatory Basis
* Commission authorized by Atomic Energy Act, Section 103
* Review primarily based on 10 CFR Parts 20, 50, and 51
* Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance
* Preliminary design described
* Further technical or design information may be left for FSAR
* Ongoing research and development has been identified
* Facility can be constructed and operated without undue risk
 
Permit Considerations
* Construction will not endanger public health and safety
* SHINE technically and financially qualified
* Environmental requirements satisfied Introducing Review Panels Safety Panel 1     Licensing Considerations   Safe...Evaluation.Repor Chapters 1 and 4 Safety Panel 2      Accident Analysis          Safety Evaluation Re port Chapter 13 Environmental Panel
* Final Environmental      Final Environmental Impact Impact Statement        Statement Process
* Analysis of Alternatives
* Summary of Conclusions and Recommendations
 
Acronyms
* FCSE -         Division of Fuel Cycle Safety, Safeguards, and Environmental Review
* DLR -         Division of License Renewal
* DPR   -Division       of Policy and Rulemaking Acronyms
* NMSS- Office of Nuclear Material Safety and Safeguards
* NRR   -       Office of Nuclear Reactor Regulation
 
Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission
* SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come
 
Medical Isotopes
* Molybdenum-99 (Mo-99),
the most widely-used medical isotope, decays into technetium-99m,                   MedicalProchyedursUig"T which is used in more                               7*.                      7 than 40 million doses annually
* Stress tests and bone scans most common of dozens of uses M72rn M~&7A44~ 7717r ~7        A7p17     7*? 1717A7,7~, ~1717
                                        <nn{*fll t1717krr. 7*7* *4747 77 W ?77x77777ft.1777, Nr~     777477*774 771~'777       7,777* 1777                                             4, J
Supply Situation with No New Capacity
  *Canada will stop operating the NRU reactor in March 2018
* Following Canadian exit, there will be no North American producer Highl relvantNEA                           Demand Growth (+35% ORC) vs, ig hl relvantcurrent                         processing capacity,       2015-202 z0 because Mo-99           &deg; decays ~1% per       *.
hour                 *..
  =Domestic supply
* o is necessary to       j o ensure US patient       '&deg; health                     71707777477 470777447-J* 471-077     4*4* 4710774*177 4170774777.477 77-077 7*477 77077 2014       2011           2014         2017       2011       2019         2020
                                -.- NEAD.77772g177* '40%WC, CU7071~71*$772 C8277777 U
4
 
SHINE Medical Technologies, Inc. Core Values
  =SHINE mission driven by our core values
    - Ensure health and safety of the public and our workforce
* Minimize environmental impacts of medical isotope production
* Ensure minimal or no disruption to patient supply chain
* Ensure cost effectiveness and therefore patient access
* Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain
* SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values
* Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce
      ,Decay heat per system < 1 kW within 5 hours oMinimizes waste nuclide generation compared to reactors
* Low enriched uranium (LEU) reusable target
* Reduces waste and cost Product compatible with current supply chain
* Eliminates need for HEU
* Driven by low-energy electrostatic accelerator
* System must be driven to operate, no criticality
* System must be driven to operate, no criticality
* Hundreds of times less waste than reactors* Electrostatic technology simple, demonstrated and cost effective SHINE Medical Technologies, Inc., The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7 SHINE Facility Layout* The SHINE facility consists of an irradiation facility (IF)and a radioisotope production facility (RPF)ldiation acility idioisotope roduction Facility 8 SHINE Irradiation Facility='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50=However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs* An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility ,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution* Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2 ,1&deg; SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)SPart I of the Application submitted March 26, 2013*PSAR Chapter 2 (Site Characteristics)
* Hundreds of times less waste than reactors
=PSAR Chapter 19 (Environmental Review),General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013=The SHINE facility will be licensed under 10 CFR Part 50,"Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria* NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"* Interim Staff Guidance augmenting NUREG-1 537* Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility" , Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12 SHINE Facility Layout* Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop Product Recycle tank TSV and Irradiation Unit Cell A~Hold Periodic Cleanup Loop associated cleanup* processes 4....-w Target Solution 14 paato SHINE Irradiation Facility* An IU consists of a subcritical assembly, a neutron driver, and supporting systems* Major supporting systems include:* Light water pool system (LWPS)* Target solution vessel (TSV) off-gas system (TOGS).Primary closed loop cooling system (PCLS)* Tritium purification system (TPS)* Primary system at near-atmospheric pressure* Target solution is drained to dump tank via gravity* Dump tank is criticality-safe by geometry and passively-cooled
* Electrostatic technology simple, demonstrated and cost effective
* Redundant, fail-open dump valves* TSV is an annular vessel to be constructed of Zircaloy-4
 
* Natural convection within TSV SHINE's Fusion- FIssion Coupling V N'4 14 11 Neutron Oriver Neutron Multiplier Target Solution Vessel N'4> N Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support Structure (SASS)TSV Dump Tank -,.TSV and Neutron S Multiplier (Internal to SASS)TSV Dump and Overflow Lines~(2 each)16 Neutron Driver and Tritium Purification System* One Neutron Driver per IU cell* Electrostatic accelerator with a gas target* D-T fusion reaction generates 14 MeV neutrons that drive the fission process* Tritium purification system* Isotopically separates gases, and supplies clean tritium to neutron drivers* Tritium lines and processing equipment in gloveboxes and q double-walled pipe 1 TSV Off-Gas and Primary Cooling Systems*TSV off-gas system (TOGS)* Contains the fission product1 TOGS gases i*of-aRemoves iodine from the* Recombines hydrogen and oxygen to maintain hydrogen gas below the lower flammability limit (LFL)* Subcritical assembly submersed in light water pool &deg;-,* Provides shielding and heat s-,..,8AS8) removal ......18 Subcritical Assembly Irradiation Process* Uranium concentration of solution and any other necessary parameters are measured* Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV* TSV is filled in discrete increments
SHINE Medical Technologies, Inc.
* Final fill level is approximately 5% by volume below critical* Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
, The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7
* High flux trips* Primary cooling system temperature trips Subcritical Assembly Irradiation Process' When irradiating the TSV:* Further solution addition is prevented* Tritium is supplied to the target, and neutron driver output is gradually increased* Reactivity decreases significantly in the assembly due to the strong negative feedback* Normal irradiation mode operations are approximately 5.5 days-'Following shutdown, light water pool provides decay heat removal* On a loss of off-site power, pool passively removes heat* Temperature rise of 12&deg;F (7&deg;(c) after 90 days without cooling Radioisotope Production Facility*Extracting, purifying and packaging Mo-99 in supercells-Laboratory scale purification process*Noble Gas Removal System (NGRS) stores TSV off-gas*Held for 40 days of decay prior to sampling for release* Released through the Process I Vessel Vent System (PWS)*Monitored and filtered discharge to ensure regulatory limits are met*Recycling and cleaning target solution* Uranium extraction (U REX)process separates uranium for ......................
SHINE Facility Layout
reuse Pu~Packagoe Engineered Safety Features (ESFs)* SHINE protects public health and safety during postulated accidents via a confinement system ,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor-Low dispersion forces in processes byConfinement functions provided ,,,F, RPF;Biological shielding (IU cells, hot cells, trenches, tank vaults)Isolation valves on piping systems* Ventilation systems* Instrument and control systems: Engineered Safety Features Actuation System (ESFAS)Radiological Integrated control System (RIcS)Zo,,e 2 Zen. 3 Ventilation Zones in Production Facility 22 Summary , Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements
* The SHINE facility consists of an irradiation facility (IF) and a radioisotope production facility (RPF) ldiation acility idioisotope roduction Facility 8
* Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers , The plant is being designed with safety as the primary criterion 23 NRC-01l' U.S.NRC United Stats Nuileair Regulatory Comnisslio Protecting People and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 1 5o 201 5 Panelists* Alexander Adams, Jr.-Chief, Research and Test Reactors Licensing Branch, NRR* Steven Lynch-Project Manager, NRR* Mary Adams-Project Manager, NMSS Licensing Considerations
 
SHINE Irradiation Facility
='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50
    =However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2
  ' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs
*An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility
,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution
*Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2
                                        ,1&deg;
 
SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)
SPart I of the Application submitted March 26, 2013
        *PSAR Chapter 2 (Site Characteristics)
        =PSAR Chapter 19 (Environmental Review)
        ,General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013
=The SHINE facility will be licensed under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria
* NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"
* Interim Staff Guidance augmenting NUREG-1 537
* Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility"
, Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12
 
SHINE Facility Layout
* Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop                                   Product A  Recycle tank TSV and Irradiation Unit Cell ~Hold Periodic Cleanup Loop associated cleanup
* processes 4....
                                              -wTargetpaato 14 Solution
 
SHINE Irradiation Facility SHINE'sFusion-FIssion Coupling
* An IU consists of a subcritical assembly, a neutron driver, and supporting systems
* Major supporting systems include:
V
* Light water pool system (LWPS)
* Target solution vessel (TSV) off-gas system (TOGS)                                         Neutron Oriver
        . Primary closed loop cooling system (PCLS)
N
* Tritium purification system (TPS)                                       '4 Neutron Multiplier
* Primary system at near-atmospheric pressure                       14 11
* Target solution is drained to dump tank via gravity                                             Target Solution
* Dump tank is criticality-safe by geometry and                                               Vessel passively-cooled                                                                     N
* Redundant, fail-open dump valves
                                                                                            '4> N
* TSV is an annular vessel to be constructed of Zircaloy-4
* Natural convection within TSV Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support                                                                         TSV and Neutron Structure                                                                       S      Multiplier (SASS)                                                                         (Internal to SASS)
TSV Dump Tank -,.
TSV Dump and Overflow Lines
              ~(2                                     each) 16
 
Neutron Driver and Tritium Purification System
* One Neutron Driver per IU cell
* Electrostatic accelerator with a gas target
* D-T fusion reaction generates 14 MeV neutrons that drive the fission process
* Tritium purification system
* Isotopically separates gases, and supplies clean tritium to neutron drivers
* Tritium lines and processing q    equipment in gloveboxes and double-walled pipe             1 TSV Off-Gas and Primary Cooling Systems
*TSV off-gas system (TOGS)
* Contains the fission product1     TOGS gases                             i
  *of-aRemoves iodine from the
* Recombines hydrogen and oxygen to maintain hydrogen gas below the lower flammability limit (LFL)
* Subcritical assembly submersed in light water                 *"
pool                                       &deg;-,
* Provides shielding and heat         s-,..,8AS8) removal                                         ......
18
 
Subcritical Assembly Irradiation Process
*Uranium concentration of solution and any other necessary parameters are measured
*Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV
* TSV is filled in discrete increments
* Final fill level is approximately 5% by volume below critical
* Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
* High flux trips
* Primary cooling system temperature trips Subcritical Assembly Irradiation Process
' When irradiating the TSV:
* Further solution addition is prevented
* Tritium is supplied to the target, and neutron driver output is gradually increased
* Reactivity decreases significantly in the assembly due to the strong negative feedback
* Normal irradiation mode operations are approximately 5.5 days
-'Following shutdown, light water pool provides decay heat removal
* On a loss of off-site power, pool passively removes heat
* Temperature rise of 12&deg;F (7&deg;(c) after 90 days without cooling
 
Radioisotope Production Facility
*Extracting, purifying and packaging Mo-99 in supercells
    -Laboratory scale purification process
*Noble Gas Removal System (NGRS) stores TSV off-gas
    *Held for 40 days of decay prior to sampling for release
* Released through the Process           I Vessel Vent System (PWS)
    *Monitored and filtered discharge to ensure regulatory limits are met
*Recycling and cleaning target solution
* Uranium extraction (UREX) process separates uranium for                                       ......................
reuse                                                       Pu~Packagoe Engineered Safety Features (ESFs)
* SHINE protects public health and safety during postulated accidents via a confinement system
    ,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor
    -Low dispersion forces in processes byConfinement functions provided                 ,,,F,                             RPF; Biological shielding (IU cells, hot cells, trenches, tank vaults)
Isolation valves on piping systems
* Ventilation systems
* Instrument and control systems:                                                             Zo,,e2 Zen. 3 Engineered Safety Features Actuation System (ESFAS)
Radiological Integrated control System (RIcS)                       Ventilation Zones in Production Facility 22
 
Summary
, Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements
* Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers
, The plant is being designed with safety as the primary criterion 23
 
NRC-01l
            ' U.S.NRC United Stats Nuileair Regulatory Comnisslio ProtectingPeople and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 15o 201 5 Panelists
* Alexander Adams, Jr.
  - Chief, Research and Test Reactors Licensing Branch, NRR
* Steven Lynch
  - Project Manager, NRR
* Mary Adams
  - Project Manager, NMSS
 
Licensing Considerations
* SHINE seeks to construct commercial non-power utilization and production facilities
* SHINE seeks to construct commercial non-power utilization and production facilities
* Licensing process similar to that of research and test reactors* Developed technology-specific guidance for application review Advisory Committee on Reactor Safeguards (ACRS) Review* Staff presented at subcommittee and full committee meetings* ACRS recommended issuance of construction permit* Staff adequately addressed questions regarding aircraft impact and facility layup Irradiation Unit Licensing* Irradiation units represent first subcritical utilization facilities
* Licensing process similar to that of research and test reactors
* Staff considered licensing under 10 CFR Part 70* Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features* Thermal power level similar to non-power reactors* Safety considerations include:-Fission heat removal-Decay heat generation
* Developed technology-specific guidance for application review Advisory Committee on Reactor Safeguards (ACRS) Review
-Fission gas release-Accident scenarios Production Facility Licensing* Production facility will process irradiated materials containing special nuclear material* Similar to processes at existing fuel cycle facilities
* Staff presented at subcommittee and full committee meetings
* ACRS recommended issuance of construction permit
* Staff adequately addressed questions regarding aircraft impact and facility layup
 
Irradiation Unit Licensing
* Irradiation units represent first subcritical utilization facilities
* Staff considered licensing under 10 CFR Part 70
* Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features
* Thermal power level similar to non-power reactors
* Safety considerations include:
  - Fission heat removal
  - Decay heat generation
  - Fission gas release
  - Accident scenarios
 
Production Facility Licensing
* Production facility will process irradiated materials containing special nuclear material
* Similar to processes at existing fuel cycle facilities
* Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
* Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
* Criticality accident alarm system* Criticality events "not credible"* Criticality safety analyses* Reactivity contributions from fissile isotopes* Radiation shielding and occupancy times Acronyms*NMSS- Office of Nuclear Material Safety and Safeguards
* Criticality accident alarm system
* NRR -Office of Nuclear Reactor Regulation Exhibit SIIN-027 qSHINE'T Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety -Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq IB12i~A Recycle tank Product TSV and Irradiation Unit Cell Hl e Periodic Cleanup Loop* associated cleanup* processes.4. *Target Solution~Preparation Design of Structures, Systems, and Cornponents a Certain structures, systems, and components (SSCs)are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")
* Criticality events "not credible"
Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure: 1. The integrity of the primary system boundary;2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
* Criticality safety analyses
: 3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
* Reactivity contributions from fissile isotopes
: 5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or 6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur Seismic Design and Quality Levels* Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC* SHINE Quality Levels (QLs): SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs-QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety*QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
* Radiation shielding and occupancy times
* Single failure criterion is applied to safety systems-Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function-A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function* SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6 NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion Protecting PrcopLt and the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists* Steven Lynch-Project Manager, NRR* Joseph Staudenmeier
 
-Senior Reactor Systems Engineer, RES* Kevin Morrissey-Project Manager, NMSS Review Methodology
Acronyms
* Two methodologies applied to SHINE accident analyses-Maximum hypothetical accident-Integrated safety analysis* Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis* Irradiation facility characteristics:
*NMSS- Office of Nuclear Material Safety and Safeguards
-Operates at low power, pressure, and temperature
* NRR - Office of Nuclear Reactor Regulation
-Large heat sink for passive decay heat removal-Radiological sources Event Identification
 
Exhibit SIIN-027 qSHINE'T     Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq                                 Product IB12i~
A   Recycle tank TSV and Irradiation Unit Cell     Hl e
Periodic Cleanup Loop
* associated cleanup
* processes
                                                            .4.
* Target Solution
            ~Preparation
 
Design Cornponents    of Structures, Systems, and a Certain structures, systems, and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")
Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure:
: 1. The integrity of the primary system boundary;
: 2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
: 3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;
: 4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
: 5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or
: 6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur
 
Seismic Design and Quality Levels
* Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC
* SHINE Quality Levels (QLs):
SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs
    -QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety
    *QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
* Single failure criterion is applied to safety systems
    -Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function
    - A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function
* SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6
 
NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion ProtectingPrcopLtand the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists
* Steven Lynch
  - Project Manager, NRR
* Joseph Staudenmeier
  - Senior Reactor Systems Engineer, RES
* Kevin Morrissey
  - Project Manager, NMSS
 
Review Methodology
* Two methodologies applied to SHINE accident analyses
  - Maximum hypothetical accident
  - Integrated safety analysis
* Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis
* Irradiation facility characteristics:
  - Operates at low power, pressure, and temperature
  - Large heat sink for passive decay heat removal
  - Radiological sources
 
Event Identification
* Delineation of possible accident categories
* Delineation of possible accident categories
* Identification of limiting accident for the category* Strategy to mitigate accident and limit consequences
* Identification of limiting accident for the category
* Analysis of dose consequences Safety Concept* Detection of high radiation levels* Confinement of radiation source* Evacuate workers* Filter releases to environment
* Strategy to mitigate accident and limit consequences
* Emergency planning zone could be the operational boundary Limiting Accident* Release of irradiated target solution from one TSV* Consequences bounded by RPF maximum hypothetical accident* Meets 10 CFR Part 20 limits-5 rem for workers-100 mrem for public Production Facility Accident Analysis* Radiological and chemical accident analysis performed* Defines facility hazards and controls that support establishment of design basis Production Facility Accident Analysis* Multiple event types:-Radiological accidents-Chemical accidents-Criticality accidents-Fires-External events Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety -Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios*Bases for identification of accidents:.Hazard and Operability Study (HAZOPS)SPreliminary Hazard Analysis (PHA)*List of events from NUREG-1 537 and the Interim Staff Guidance (ISG)augmenting NUREG-1537 ,Experience of the hazards analysis team*Current preliminary design information SQualitative evaluations within categories ,Quantitative evaluations to determine consequences
* Analysis of dose consequences Safety Concept
*Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)&deg;Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")
* Detection of high radiation levels
IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell ,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement
* Confinement of radiation source
&deg;High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences-Worker TEDE: 3.1 rem ..-Public (site boundary)
* Evacuate workers
TEDE: TSV Q ........0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)&deg;The five noble gas storage tanks rupture simultaneously
* Filter releases to environment
&deg; With the maximum inventory*Contents are instantly released SHigh radiation levels initiate alarm and cell isolation , Redundant isolation dampers close' 10% of the activity bypasses the isolation dampers' 10% of the activity leaks* through penetrations TSV Oft G.~P~.rge NORS Nobk G.~Stosg. Ts,,k~Conden~ot~
* Emergency planning zone could be the operational boundary
Knock Oft Pro~es, Ves~eI Thnk v~,,t Syften, R~dIo.ctWn LIqnId Wnte RPF Maximum Hypothetical Accident (Facility MHA)=Dose consequences
 
*Worker TEDE: rem*Public (site boundary)
Limiting Accident
TEDE: 0.082 rem oThe MHA consequences are conservative ,Simultaneous, instantaneous rupture* Entirety of noble gas is transferred and released SThe five tanks are filled to capacity&deg;Additional ventilation isolation dampers would close, but are not credited-Actual doses would be lower Doses to the Public From Analyzed Accidents Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301 I EuU _______5 NRC-01 3<U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon Protecting People and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists* Jane Marshall-Deputy Director, Division of License Renewal, NRR* David Wrona-Branch Chief, NRR* Michelle Moser-Project Manager, NRR Environmental Review* National Environmental Policy Act* Environmental review process-Title 10 of Code of Federal Regulations (10 CFR) Part 51-Environmental Standard Review Plan (NUREG-1 537)-Interim Staff Guidance Environmental Impact Statement (EIS)* 10 CFR 51.20* Project-specific decision-Potential significant impacts-First-of-a-kind facility with a unique application of technologies
* Release of irradiated target solution from one TSV
-Public involvement maximized Scoping* 2 public meetings in Janesville, Wisconsin* 5 oral comments* 6 written comments Department of Energy (DOE)* National Environmental Policy Act-Lead agency: Nuclear Regulatory Commission
* Consequences bounded by RPF maximum hypothetical accident
-Cooperating agency: DOE* American Medical Isotopes Production Act-Complementary environmental reviews Environmental Review Areas Socioeconomics and Environmental Justice Terrestrial Resources Environmental Impacts Resource Area Impact Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Ecological and Water Resources SMALL Historic and Cultural Resources SMALL Socioeconomics SMALL Human Health and Waste SMALL Transportation SMALL to MODERATE Reasonable Alternatives
* Meets 10 CFR Part 20 limits
  - 5 rem for workers
  - 100 mrem for public Production Facility Accident Analysis
* Radiological and chemical accident analysis performed
* Defines facility hazards and controls that support establishment of design basis
 
Production Facility Accident Analysis
* Multiple event types:
  - Radiological accidents
  - Chemical accidents
  - Criticality accidents
  - Fires
  - External events
 
Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios
*Bases for identification of accidents:
    .Hazard and Operability Study (HAZOPS)
SPreliminary Hazard Analysis (PHA)
    *List of events from NUREG-1 537 and the Interim Staff Guidance (ISG) augmenting NUREG-1537
    ,Experience of the hazards analysis team
    *Current preliminary design information SQualitative evaluations within categories
    ,Quantitative evaluations to determine consequences
*Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)
    &deg;Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")
 
IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell
      ,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement
  &deg;High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences
      -Worker TEDE: 3.1 rem                   ..
      -Public (site boundary) TEDE:   TSV Q                         ........
0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)
  &deg;The five noble gas                               TSV Oft G.~
storage tanks rupture                             P~.rge simultaneously                                 NORS
      &deg;With the maximum inventory
      *Contents are instantly released                         Nobk G.~
Stosg. Ts,,k~
SHigh radiation levels initiate alarm and cell isolation
, Redundant isolation dampers close Conden~ot~
      ' 10% of the activity bypasses                       KnockOft          Pro~es,Ves~eI Thnk             v~,,t Syften, the isolation dampers
      ' 10% of the activity leaks R~dIo.ctWn
* through penetrations                                                  LIqnIdWnte
 
RPF Maximum Hypothetical Accident (Facility MHA)
Doses to the Public From Analyzed Accidents
=Dose consequences
    *Worker TEDE: *3.6 rem
    *Public (site boundary) TEDE: 0.082 rem oThe MHA consequences are conservative
    ,Simultaneous, instantaneous rupture
* Entirety of noble gas is transferred and released SThe five tanks are filled to capacity
    &deg;Additional ventilation isolation dampers would close, but are not credited
-Actual doses would be lower Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301                       EuU      _______
I 5
 
NRC-01 3
            <U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon ProtectingPeople and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists
* Jane Marshall
  - Deputy Director, Division of License Renewal, NRR
* David Wrona
  - Branch Chief, NRR
* Michelle Moser
  - Project Manager, NRR
 
Environmental Review
* National Environmental Policy Act
* Environmental review process
  - Title 10 of Code of Federal Regulations (10 CFR) Part 51
  - Environmental Standard Review Plan (NUREG-1 537)
  - Interim Staff Guidance Environmental Impact Statement (EIS)
* 10 CFR 51.20
* Project-specific decision
  - Potential significant impacts
  - First-of-a-kind facility with a unique application of technologies
  - Public involvement maximized
 
Scoping
* 2 public meetings in Janesville, Wisconsin
* 5 oral comments
* 6 written comments Department of Energy (DOE)
* National Environmental Policy Act
  - Lead agency: Nuclear Regulatory Commission
  - Cooperating agency: DOE
* American Medical Isotopes Production Act
  - Complementary environmental reviews
 
Environmental Review Areas Socioeconomics and               Terrestrial Environmental Justice               Resources Environmental Impacts Resource Area                       Impact Land Use and Visual Resources                 SMALL Air Quality and Noise                         SMALL Geologic Environment                           SMALL Ecological and Water Resources                 SMALL Historic and Cultural Resources               SMALL Socioeconomics                                 SMALL Human Health and Waste                         SMALL Transportation                           SMALL to MODERATE
 
Reasonable Alternatives
* No-action alternative
* No-action alternative
* Alternative sites-Chippewa Falls-Stevens Point* Alternative technologies Alternative Technologies
* Alternative sites
* Neutron capture* Aqueous homogenous reactor* Linear-accelerator-based
  - Chippewa Falls
-Analyzed in depth Costs and Benefits* Purpose-Inform recommendation to the Commission
  - Stevens Point
* Costs-Environmental and financial* Benefits-Societal, medical, and economic Environmental Costs Proposed Janesville Site Chippewa Falls Alternative Stevens Point Alternative Alternative Technology No-action Alternative Traffic Traffic, Noise Traffic 1 Noise, Visual Traffic None* SMALL impacts for all other resource areas Benefits* Support United States (U.S.)policy* Support U.S. public health needs* Economic benefits-Increased tax revenue-New employment opportunities Consultations
* Alternative technologies Alternative Technologies
* 0 0 6 .~ 3--
* Neutron capture
* 0 Endangered Species Act, Section 7 National Historic Preservation Act, Section 106 No Effect No Adverse Effect Draft Environmental Impact Statement* 2 public meetings in Janesville, Wisconsin* 1 oral comment* 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.
* Aqueous homogenous reactor
Future NEPA Analyses* 10 CFR 51 .95(b) requires the staff to supplement the Final EIS-Matters that differ from the Final EIS-New significant information Acronyms* NRR -Office of Nuclear Reactor Regulation Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report* Began work October 2011* SHINE production facility will be located in Janesville, Rock County, Wisconsin* Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii 2 Structure and Content of the Environmental Report 19.1 -Introduction 19.2 -Proposed Action 19.3- Descrption of the Affected Environment 19.4- Impacts of the Proposed Construction, Operations, and Decommissioning 19.5 -Alternatives 19.6 -Conclusions Purpose and need for the proposed action, Regulatory provisions, permits and required consultations Site location and layout, Radioisotope facility description, Water consumption and treatment.
* Linear-accelerator-based
Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials Land use and visual resources, Air quality and noise, Geooic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health Land use and visual resources, Air quality and noise, Geologic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics, Human health, Waste management, Transportation, Postulated accidents, Environmental justice, Cumulative effects NO-action alternative.
  - Analyzed in depth
Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3 6 Scope of Field Investigations
 
=Phase I Environmental Site Assessment
Costs and Benefits
&deg;General Reconnaissance
* Purpose
+Soil Borings/Geotechnical Investigation ,Well Installation
  -   Inform recommendation to the Commission
&deg;Phase I Archaeological Investigation
* Costs
&deg;Baseline Visual Assessment
  -   Environmental and financial
*Wetland Delineation
* Benefits
&deg;Quarterly Ecological Investigations
  -   Societal, medical, and economic Environmental Costs Proposed Janesville Site   Traffic Chippewa Falls Alternative Traffic, Noise Stevens Point Alternative Traffic1 Noise, Visual Alternative Technology     Traffic No-action Alternative     None
=Aquatic Ecology ,Terrestrial Ecology oMonthly Water Resources+Water Quality=Water Levels U Context for Data Acquisition ,Site* 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI* Project Area*Circular area with a radius approximately 1 mile from the site center point' Region' Circular area with a radius of 5 miles from the site center point' Larger context as appropriate (e.g., geology, air quality)' Region of Influence , ,Rock County 5 Consultations
* SMALL impacts for all other resource areas
' City of Janesville
 
' Rock County-Wisconsin Department of Natural Resources-Wisconsin State Historic Preservation Office (SHPO)-Wisconsin Department of Transportation-U.S. Fish and Wildlife Service o ,E,' Federal Aviation Administration
Benefits
' Bureau of Indian Affairs' Native American Tribes (13): ' Wisconsin Tribes: ,Forest County Potawatomi Community, Wisconsin&deg;Ho-Chunk Nation of Wisconsin* Non-Wisconsin Tribes:-' 11 Tribal Entities 0~1 6 Alternative Sites Construction SMALL impacts to all Impacts resource categories Construction 420 jobs; $635,000 Benefits annual property tax payments Operation SMALL impacts to all Impacts resource categories Operation 150 jobs: reliable Benefits source of diagnostic isotopes:
* Support United States (U.S.)
Mo-99, 1-131. Xe-1 33;$680.000 annual property tax payments MODERATE impacts to Visual Resources, Noise and Transportation 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 150 jobs; reliable source of diagnostic isotopes:
policy
Mo-99, 1-131. Xe-i133:$680,000 annual property tax payments MODERATE impacts to Land use, Visual Resources, Noise, Ground Water, and Transportation 420 jobs: $635,000 annual property tax payments SMALL impacts to all resource categories 150 jobs; reliable source of diagnostic isotopes:
* Support U.S. public health needs
Mo-99, 1-131, Xe-i133;$680,000 annual property tax payments SMALL impacts to all resource categories None SMALL impat to all resource categories None 7 Alternative Technologies Eu."l Construction SMAL impat to all Impat resource categories Construction 420 jobs, $635,000 Benefits annual property tax payments Operation SMLL impact to all Impat reorce caeories Operation 150 jobs; reliable Benefits source of diagnostic isotopes:
* Economic benefits
Mo-99, 1-131. Xe-i133;$680,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categorie 150 jobs; reliable source of Mo-99;$660,000 annual property tax payments SMALL impacts to all SMALL impatsto all resource categories resource categorie 420 jobs; $635,000 None annual property tax payments SMALL impacts to all SMALL impacts to all resource categorie resourc categories 150 jobs; reliable source of diagnostic isotopes:
  - Increased tax revenue
Mo-99, 1-131, Xe-133;$660,000 annual property tax payments None 11 8 NRC Environmental Site Audit July 30- August 1, 2013* SHINE presentations on the production process and alternative site selection process-Janesville site visit&deg;Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River* Tour of the Janesville Wastewater Treatment Facility ,Alternative site visits:-Stevens Point ,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community* SHINE believes the relationships between the company, Janesville, and Wisconsin are important* SHINE favors a policy of transparency with our community , SHINE's actions support these principles a Participation in four public meetings per year (two SHINE hosted, two for city council)* SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plans a Regular updates provided to State of Wisconsin* These activities have fostered a relationship of trust and enthusiasm for the project 10 Conclusions o The SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied&deg;SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11}}
  - New employment opportunities Consultations
* 0 0 6 .~ 3--
* 0 Endangered Species   No Effect Act, Section 7 National Historic Preservation Act,   No Adverse Effect Section 106
 
Draft Environmental Impact Statement
* 2 public meetings in Janesville, Wisconsin
* 1 oral comment
* 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.
 
Future NEPA Analyses
* 10 CFR 51 .95(b) requires the staff to supplement the Final EIS
  - Matters that differ from the Final EIS
  - New significant information Acronyms
* NRR   -Office       of Nuclear Reactor Regulation
 
Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report
* Began work October 2011
* SHINE production facility will be located in Janesville, Rock County, Wisconsin
* Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii                             2
 
Structure and Content of the Environmental Report 19.1 - Introduction       Purpose and need for the proposed action, Regulatory provisions, permits and required consultations 19.2 - Proposed Action      Site location and layout, Radioisotope facility description, Water consumption and treatment. Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials 19.3- Descrption of the    Land use and visual resources, Air quality and noise, Geooic environment, Affected Environment        Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health 19.4- Impacts of the        Land use and visual resources, Air quality and noise, Geologic environment, Proposed Construction,      Water resources, Ecological resources, Historic and cultural resources, Operations, and            Socioeconomics, Human health, Waste management, Transportation, Decommissioning            Postulated accidents, Environmental justice, Cumulative effects 19.5 - Alternatives        NO-action alternative. Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts 19.6 - Conclusions          Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3
Scope of Field Investigations 6
  =Phase I Environmental Site Assessment
  &deg;General Reconnaissance
  +Soil Borings/Geotechnical Investigation
  ,Well Installation
  &deg;Phase I Archaeological Investigation
  &deg;Baseline Visual Assessment
  *Wetland Delineation
  &deg;Quarterly Ecological Investigations
        =Aquatic Ecology
        ,Terrestrial Ecology oMonthly Water Resources
        +Water Quality
      =Water Levels
 
Context for Data Acquisition U
    ,Site
* 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI
* Project Area
          *Circular area with a radius approximately 1 mile from the site center point
  ' Region
        ' Circular area with a radius of 5 miles from the site center point
        ' Larger context as appropriate (e.g., geology, air quality)
  ' Region of Influence
      , ,Rock County 5
Consultations
  ' City of Janesville
  ' Rock County
    -Wisconsin Department of Natural Resources
    -Wisconsin State Historic Preservation Office (SHPO)
    -Wisconsin Department of Transportation
    -U.S. Fish and Wildlife Service
  ' Federal Aviation Administration
  ' Bureau of Indian Affairs
* o ,E, 0
  ' Native American Tribes (13):
        ' Wisconsin Tribes:
              ,Forest County Potawatomi Community, Wisconsin
              &deg;Ho-Chunk Nation of Wisconsin
* Non-Wisconsin Tribes:
  -         ' 11 Tribal Entities
~1                                           6
 
Alternative Sites Construction SMALL impacts to all   MODERATE impacts      MODERATE impacts      SMALL impacts to all Impacts     resource categories   to Visual Resources,   to Land use, Visual   resource categories Noise and              Resources, Noise, Transportation        Ground Water, and Transportation Construction 420 jobs; $635,000     420 jobs; $635,000     420 jobs: $635,000   None Benefits    annual property tax    annual property tax    annual property tax payments               payments              payments Operation    SMALL impacts to all  SMALL impacts to all  SMALL impacts to all SMALL impat to all Impacts      resource categories   resource categories    resource categories  resource categories Operation    150 jobs: reliable    150 jobs; reliable     150 jobs; reliable    None Benefits    source of diagnostic  source of diagnostic  source of diagnostic isotopes: Mo-99,      isotopes: Mo-99,      isotopes: Mo-99, 1-131. Xe-1 33;        1-131. Xe-i133:        1-131, Xe-i133;
              $680.000 annual        $680,000 annual       $680,000 annual property tax          property tax          property tax payments               payments              payments 7
Alternative Technologies Construction Impat Construction Benefits Eu."l SMAL impat to all resource categories 420 jobs, $635,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 420 jobs; $635,000 annual property tax payments SMALL impatsto all resource categorie None Operation      SMLL impact to all    SMALL impacts to all  SMALL impacts to all SMALL impacts to all Impat          reorce caeories        resource categorie    resource categorie   resourc categories Operation      150 jobs; reliable    150 jobs; reliable                         None 150 jobs; reliable Benefits      source of diagnostic   source of Mo-99;      source of diagnostic isotopes: Mo-99,      $660,000 annual      isotopes: Mo-99, 1-1-131. Xe-i133;        property tax          131, Xe-133;
                $680,000 annual        payments              $660,000 annual property tax                                property tax payments                                     payments 11                                                   8
 
NRC Environmental Site Audit July 30- August 1, 2013
* SHINE presentations on the production process and alternative site selection process
-Janesville site visit
      &deg;Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River
* Tour of the Janesville Wastewater Treatment Facility
,Alternative site visits:
      -Stevens Point
      ,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community
* SHINE believes the relationships between the company, Janesville, and Wisconsin are important
* SHINE favors a policy of transparency with our community
, SHINE's actions support these principles a Participation   in four public meetings per year (two SHINE hosted, two for city council)
* SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plans a Regular updates provided to State of Wisconsin
* These activities have fostered a relationship of trust and enthusiasm for the project 10
 
Conclusions oThe SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate
=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied
&deg;SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11}}

Revision as of 04:13, 31 October 2019

M151215: Scheduling Note and Slides - Hearing on Construction Permit for Shine Medical Isotope Production Facility: Section 189A of the Atomic Energy Act Proceeding
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SCHEDULING NOTE Title: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)

Scheduled: December 15, 2015 9:00 am Purpose: To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a) and 51 .105(a).

Duration: 1 day Location: Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.

20 mins.

Participants: Presentation (Note: Presenters questions seatedinatthe will be seated thewell table are and listed, other reser'ved staff available to answer rows.)

Overview (SHINE Medical Technologies. Inc.) 30 mins.*

At the table:

Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

1

30 mins.*

At the table:

William Dean, Director, Office of Nuclear Reactor Regulation (NRR)

Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)

Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings. The staff will also discuss its review methodology and how it applied the Commission's regulations.

Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

BREAK 5 mins.

NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.

Safety- Panel 1 (11:15 am)

Applicant 5 mins.*

At the table:

Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff 10 mins.*

At the table:

Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)

Toi:Sections of the application and the following chapters from the Safety Evaluation Report:

Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.

2

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Cooling Systems" o Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each) 24 mains.**

BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)

Safety - Panel 2 (1:30 pm)

Applicant 5 mins.*

At the table:

Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff 10 mains.*

At the table:

Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report:

Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11, "Radiation Protection Program and Waste Management,"

including proposed permit condition o Chapter 12, "Conduct of Operations"~***

o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualification" 3

Commission 0 & A (round of questions; 6 minutes each) 224 mins.**

is*

Environmental - Panel (2:10 pm)

Applicant 10 mins.*

At the table:

Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy Staff 25 mins.*

At the table:

Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement

  • Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:

o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice

  • Discuss the analysis of alternatives including:

o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative

  • Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

BREA K 5 mins.

4

Closing (3:15) 554 mins.

is Closing Statement by Applicant 15 rmins.*

Greg Piefer, Chief Executive Officer Closing Statement by Staff 15 rains.*

William Dean, Director, NRR Commission Q & A and Closing Statements 24 rmins.**

  • For presentation only and does not include time for Commission 0 & A's.
    • AII Commissioners will have an opportunity to ask questions after each panel.

Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.

    • Chapter12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.

5

HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)

December 15, 2015 Slides/Handouts Overview

-SHINE Medical Technologies, Inc.

-NRC Staff Safety - Panel 1

-SHINE Medical Technologies, Inc.

-NRC Staff Safety - Panel 2

-SHINE Medical Technologies, Inc.

-NRC Staff Environmental - Panel

-SHINE Medical Technologies, Inc.

-NRC Staff

N RC-010

  • U.S.NRC United Sriae* Nuclear Regulatory C~,mmtnslon ProtectingPeople andt¢ the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists
  • Jane Marshall - Deputy Director, NRR/DLR

Introduction to Molybdenum-99

  • Molybdenum-99 (99 M0) Mc 0.90 decays to technetium-99m(*o,,

- Effective diagnosis o

- Minimal exposureV

  • 50,000 procedures daily Tc009
  • No domestically-produced supply ooo.o Establishing a Domestic Supply
  • National policy objectives support domestic production capabilities
  • Cost-sharing agreements encourage commercial partners
  • SHINE proposes to produce 99 M0 through uranium fission

Preparing for SHINE Review

  • Interoffice working group contributed diverse expertise
  • Public meetings engaged stakeholders
  • Review coordinated with Federal, State, and local governments Allowing Construction
  • SHINE application only seeks construction authorization
  • Design details may be left for operating license application
  • Review assessed preliminary design and analysis

Conducting the Safety Review cn~~itW Tailoring Review Methodology

  • Review accommodated unique technology
  • Staff used existing guidance
  • Staff determined whether reasonable assurance that final design will conform to design bases

Additional Information

  • Review supported by additional information
  • In some cases, permit conditions necessary
  • Regulatory commitments track items for resolution in final safety analysis report (FSAR)

Environmental Regulations

  • National Environmental Policy Act

- Informs Federal decision making

- Public disclosure

  • NRC's environmental regulations

- Title 10 of the Code of Federal Regulations (10 CFR) Part 51

Environmental Review Process

  • Opportunity for Public Involvement Proposed Janesville Site

..... Agricultural fields

....

  • Previously disturbed

..... No surface water

  • I features No threatened or endangeredspce
  • o historical or cultural resources

Regulatory Basis

  • Commission authorized by Atomic Energy Act, Section 103
  • Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance
  • Preliminary design described
  • Further technical or design information may be left for FSAR
  • Ongoing research and development has been identified
  • Facility can be constructed and operated without undue risk

Permit Considerations

  • Construction will not endanger public health and safety
  • SHINE technically and financially qualified
  • Environmental requirements satisfied Introducing Review Panels Safety Panel 1 Licensing Considerations Safe...Evaluation.Repor Chapters 1 and 4 Safety Panel 2 Accident Analysis Safety Evaluation Re port Chapter 13 Environmental Panel
  • Final Environmental Final Environmental Impact Impact Statement Statement Process
  • Analysis of Alternatives
  • Summary of Conclusions and Recommendations

Acronyms

  • FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review
  • NMSS- Office of Nuclear Material Safety and Safeguards
  • NRR - Office of Nuclear Reactor Regulation

Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission

  • SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come

Medical Isotopes

the most widely-used medical isotope, decays into technetium-99m, MedicalProchyedursUig"T which is used in more 7*. 7 than 40 million doses annually

  • Stress tests and bone scans most common of dozens of uses M72rn M~&7A44~ 7717r ~7 A7p17 7*? 1717A7,7~, ~1717

<nn{*fll t1717krr. 7*7* *4747 77 W ?77x77777ft.1777, Nr~ 777477*774 771~'777 7,777* 1777 4, J

Supply Situation with No New Capacity

  • Canada will stop operating the NRU reactor in March 2018
  • Following Canadian exit, there will be no North American producer Highl relvantNEA Demand Growth (+35% ORC) vs, ig hl relvantcurrent processing capacity, 2015-202 z0 because Mo-99 ° decays ~1% per *.

hour *..

=Domestic supply

  • o is necessary to j o ensure US patient '° health 71707777477 470777447-J* 471-077 4*4* 4710774*177 4170774777.477 77-077 7*477 77077 2014 2011 2014 2017 2011 2019 2020

-.- NEAD.77772g177* '40%WC, CU7071~71*$772 C8277777 U

4

SHINE Medical Technologies, Inc. Core Values

=SHINE mission driven by our core values

- Ensure health and safety of the public and our workforce

  • Minimize environmental impacts of medical isotope production
  • Ensure minimal or no disruption to patient supply chain
  • Ensure cost effectiveness and therefore patient access
  • Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain
  • SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values
  • Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce

,Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> oMinimizes waste nuclide generation compared to reactors

  • Reduces waste and cost Product compatible with current supply chain
  • Eliminates need for HEU
  • Driven by low-energy electrostatic accelerator
  • System must be driven to operate, no criticality
  • Hundreds of times less waste than reactors
  • Electrostatic technology simple, demonstrated and cost effective

SHINE Medical Technologies, Inc.

, The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7

SHINE Facility Layout

  • The SHINE facility consists of an irradiation facility (IF) and a radioisotope production facility (RPF) ldiation acility idioisotope roduction Facility 8

SHINE Irradiation Facility

='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50

=However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2

' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs

  • An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility

,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution

  • Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2

,1°

SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)

SPart I of the Application submitted March 26, 2013

  • PSAR Chapter 2 (Site Characteristics)

=PSAR Chapter 19 (Environmental Review)

,General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013

=The SHINE facility will be licensed under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria

  • NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"
  • Interim Staff Guidance augmenting NUREG-1 537
  • Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility"

, Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12

SHINE Facility Layout

  • Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop Product A Recycle tank TSV and Irradiation Unit Cell ~Hold Periodic Cleanup Loop associated cleanup
  • processes 4....

-wTargetpaato 14 Solution

SHINE Irradiation Facility SHINE'sFusion-FIssion Coupling

  • An IU consists of a subcritical assembly, a neutron driver, and supporting systems
  • Major supporting systems include:

V

  • Light water pool system (LWPS)
  • Target solution vessel (TSV) off-gas system (TOGS) Neutron Oriver

. Primary closed loop cooling system (PCLS)

N

  • Tritium purification system (TPS) '4 Neutron Multiplier
  • Primary system at near-atmospheric pressure 14 11
  • Target solution is drained to dump tank via gravity Target Solution
  • Dump tank is criticality-safe by geometry and Vessel passively-cooled N
  • Redundant, fail-open dump valves

'4> N

  • TSV is an annular vessel to be constructed of Zircaloy-4
  • Natural convection within TSV Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support TSV and Neutron Structure S Multiplier (SASS) (Internal to SASS)

TSV Dump Tank -,.

TSV Dump and Overflow Lines

~(2 each) 16

Neutron Driver and Tritium Purification System

  • One Neutron Driver per IU cell
  • Electrostatic accelerator with a gas target
  • D-T fusion reaction generates 14 MeV neutrons that drive the fission process
  • Isotopically separates gases, and supplies clean tritium to neutron drivers
  • Tritium lines and processing q equipment in gloveboxes and double-walled pipe 1 TSV Off-Gas and Primary Cooling Systems
  • TSV off-gas system (TOGS)
  • Contains the fission product1 TOGS gases i
  • Subcritical assembly submersed in light water *"

pool °-,

  • Provides shielding and heat s-,..,8AS8) removal ......

18

Subcritical Assembly Irradiation Process

  • Uranium concentration of solution and any other necessary parameters are measured
  • Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV
  • TSV is filled in discrete increments
  • Final fill level is approximately 5% by volume below critical
  • Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
  • High flux trips
  • Primary cooling system temperature trips Subcritical Assembly Irradiation Process

' When irradiating the TSV:

  • Further solution addition is prevented
  • Tritium is supplied to the target, and neutron driver output is gradually increased
  • Reactivity decreases significantly in the assembly due to the strong negative feedback
  • Normal irradiation mode operations are approximately 5.5 days

-'Following shutdown, light water pool provides decay heat removal

  • On a loss of off-site power, pool passively removes heat
  • Temperature rise of 12°F (7°(c) after 90 days without cooling

Radioisotope Production Facility

  • Extracting, purifying and packaging Mo-99 in supercells

-Laboratory scale purification process

  • Noble Gas Removal System (NGRS) stores TSV off-gas
  • Held for 40 days of decay prior to sampling for release
  • Released through the Process I Vessel Vent System (PWS)
  • Monitored and filtered discharge to ensure regulatory limits are met
  • Recycling and cleaning target solution

reuse Pu~Packagoe Engineered Safety Features (ESFs)

  • SHINE protects public health and safety during postulated accidents via a confinement system

,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor

-Low dispersion forces in processes byConfinement functions provided ,,,F, RPF; Biological shielding (IU cells, hot cells, trenches, tank vaults)

Isolation valves on piping systems

  • Ventilation systems
  • Instrument and control systems: Zo,,e2 Zen. 3 Engineered Safety Features Actuation System (ESFAS)

Radiological Integrated control System (RIcS) Ventilation Zones in Production Facility 22

Summary

, Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements

  • Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers

, The plant is being designed with safety as the primary criterion 23

NRC-01l

' U.S.NRC United Stats Nuileair Regulatory Comnisslio ProtectingPeople and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 15o 201 5 Panelists

- Chief, Research and Test Reactors Licensing Branch, NRR

- Project Manager, NRR

  • Mary Adams

- Project Manager, NMSS

Licensing Considerations

  • SHINE seeks to construct commercial non-power utilization and production facilities
  • Licensing process similar to that of research and test reactors
  • Staff presented at subcommittee and full committee meetings
  • ACRS recommended issuance of construction permit
  • Staff adequately addressed questions regarding aircraft impact and facility layup

Irradiation Unit Licensing

  • Irradiation units represent first subcritical utilization facilities
  • Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features
  • Thermal power level similar to non-power reactors
  • Safety considerations include:

- Fission heat removal

- Decay heat generation

- Fission gas release

- Accident scenarios

Production Facility Licensing

  • Similar to processes at existing fuel cycle facilities
  • Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
  • Criticality accident alarm system
  • Criticality events "not credible"
  • Criticality safety analyses
  • Reactivity contributions from fissile isotopes
  • Radiation shielding and occupancy times

Acronyms

  • NMSS- Office of Nuclear Material Safety and Safeguards
  • NRR - Office of Nuclear Reactor Regulation

Exhibit SIIN-027 qSHINE'T Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq Product IB12i~

A Recycle tank TSV and Irradiation Unit Cell Hl e

Periodic Cleanup Loop

  • associated cleanup
  • processes

.4.

  • Target Solution

~Preparation

Design Cornponents of Structures, Systems, and a Certain structures, systems, and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")

Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure:

1. The integrity of the primary system boundary;
2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;
4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or
6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur

Seismic Design and Quality Levels

  • Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC
  • SHINE Quality Levels (QLs):

SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs

-QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety

  • QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
  • Single failure criterion is applied to safety systems

-Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function

- A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function

  • SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6

NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion ProtectingPrcopLtand the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists

- Project Manager, NRR

- Senior Reactor Systems Engineer, RES

  • Kevin Morrissey

- Project Manager, NMSS

Review Methodology

  • Two methodologies applied to SHINE accident analyses

- Maximum hypothetical accident

- Integrated safety analysis

  • Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis
  • Irradiation facility characteristics:

- Operates at low power, pressure, and temperature

- Large heat sink for passive decay heat removal

- Radiological sources

Event Identification

  • Delineation of possible accident categories
  • Identification of limiting accident for the category
  • Strategy to mitigate accident and limit consequences
  • Analysis of dose consequences Safety Concept
  • Detection of high radiation levels
  • Confinement of radiation source
  • Evacuate workers
  • Filter releases to environment
  • Emergency planning zone could be the operational boundary

Limiting Accident

  • Release of irradiated target solution from one TSV
  • Consequences bounded by RPF maximum hypothetical accident

- 5 rem for workers

- 100 mrem for public Production Facility Accident Analysis

  • Radiological and chemical accident analysis performed
  • Defines facility hazards and controls that support establishment of design basis

Production Facility Accident Analysis

  • Multiple event types:

- Radiological accidents

- Chemical accidents

- Criticality accidents

- Fires

- External events

Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios

  • Bases for identification of accidents:

.Hazard and Operability Study (HAZOPS)

SPreliminary Hazard Analysis (PHA)

  • List of events from NUREG-1 537 and the Interim Staff Guidance (ISG) augmenting NUREG-1537

,Experience of the hazards analysis team

  • Current preliminary design information SQualitative evaluations within categories

,Quantitative evaluations to determine consequences

  • Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)

°Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")

IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell

,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement

°High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences

-Worker TEDE: 3.1 rem ..

-Public (site boundary) TEDE: TSV Q ........

0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)

°The five noble gas TSV Oft G.~

storage tanks rupture P~.rge simultaneously NORS

°With the maximum inventory

  • Contents are instantly released Nobk G.~

Stosg. Ts,,k~

SHigh radiation levels initiate alarm and cell isolation

, Redundant isolation dampers close Conden~ot~

' 10% of the activity bypasses KnockOft Pro~es,Ves~eI Thnk v~,,t Syften, the isolation dampers

' 10% of the activity leaks R~dIo.ctWn

  • through penetrations LIqnIdWnte

RPF Maximum Hypothetical Accident (Facility MHA)

Doses to the Public From Analyzed Accidents

=Dose consequences

  • Worker TEDE: *3.6 rem
  • Public (site boundary) TEDE: 0.082 rem oThe MHA consequences are conservative

,Simultaneous, instantaneous rupture

  • Entirety of noble gas is transferred and released SThe five tanks are filled to capacity

°Additional ventilation isolation dampers would close, but are not credited

-Actual doses would be lower Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301 EuU _______

I 5

NRC-01 3

<U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon ProtectingPeople and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists

  • Jane Marshall

- Deputy Director, Division of License Renewal, NRR

- Branch Chief, NRR

- Project Manager, NRR

Environmental Review

  • National Environmental Policy Act
  • Environmental review process

- Title 10 of Code of Federal Regulations (10 CFR) Part 51

- Environmental Standard Review Plan (NUREG-1 537)

- Interim Staff Guidance Environmental Impact Statement (EIS)

  • Project-specific decision

- Potential significant impacts

- First-of-a-kind facility with a unique application of technologies

- Public involvement maximized

Scoping

  • 5 oral comments
  • 6 written comments Department of Energy (DOE)
  • National Environmental Policy Act

- Lead agency: Nuclear Regulatory Commission

- Cooperating agency: DOE

  • American Medical Isotopes Production Act

- Complementary environmental reviews

Environmental Review Areas Socioeconomics and Terrestrial Environmental Justice Resources Environmental Impacts Resource Area Impact Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Ecological and Water Resources SMALL Historic and Cultural Resources SMALL Socioeconomics SMALL Human Health and Waste SMALL Transportation SMALL to MODERATE

Reasonable Alternatives

  • No-action alternative
  • Alternative sites

- Chippewa Falls

- Stevens Point

  • Alternative technologies Alternative Technologies
  • Neutron capture
  • Aqueous homogenous reactor
  • Linear-accelerator-based

- Analyzed in depth

Costs and Benefits

  • Purpose

- Inform recommendation to the Commission

  • Costs

- Environmental and financial

  • Benefits

- Societal, medical, and economic Environmental Costs Proposed Janesville Site Traffic Chippewa Falls Alternative Traffic, Noise Stevens Point Alternative Traffic1 Noise, Visual Alternative Technology Traffic No-action Alternative None

  • SMALL impacts for all other resource areas

Benefits

  • Support United States (U.S.)

policy

  • Support U.S. public health needs
  • Economic benefits

- Increased tax revenue

- New employment opportunities Consultations

  • 0 0 6 .~ 3--
  • 0 Endangered Species No Effect Act, Section 7 National Historic Preservation Act, No Adverse Effect Section 106

Draft Environmental Impact Statement

  • 1 oral comment
  • 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.

Future NEPA Analyses

  • 10 CFR 51 .95(b) requires the staff to supplement the Final EIS

- Matters that differ from the Final EIS

- New significant information Acronyms

  • NRR -Office of Nuclear Reactor Regulation

Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report

  • Began work October 2011
  • SHINE production facility will be located in Janesville, Rock County, Wisconsin
  • Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii 2

Structure and Content of the Environmental Report 19.1 - Introduction Purpose and need for the proposed action, Regulatory provisions, permits and required consultations 19.2 - Proposed Action Site location and layout, Radioisotope facility description, Water consumption and treatment. Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials 19.3- Descrption of the Land use and visual resources, Air quality and noise, Geooic environment, Affected Environment Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health 19.4- Impacts of the Land use and visual resources, Air quality and noise, Geologic environment, Proposed Construction, Water resources, Ecological resources, Historic and cultural resources, Operations, and Socioeconomics, Human health, Waste management, Transportation, Decommissioning Postulated accidents, Environmental justice, Cumulative effects 19.5 - Alternatives NO-action alternative. Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts 19.6 - Conclusions Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3

Scope of Field Investigations 6

=Phase I Environmental Site Assessment

°General Reconnaissance

+Soil Borings/Geotechnical Investigation

,Well Installation

°Phase I Archaeological Investigation

°Baseline Visual Assessment

  • Wetland Delineation

°Quarterly Ecological Investigations

=Aquatic Ecology

,Terrestrial Ecology oMonthly Water Resources

+Water Quality

=Water Levels

Context for Data Acquisition U

,Site

  • 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI
  • Project Area
  • Circular area with a radius approximately 1 mile from the site center point

' Region

' Circular area with a radius of 5 miles from the site center point

' Larger context as appropriate (e.g., geology, air quality)

' Region of Influence

, ,Rock County 5

Consultations

' City of Janesville

' Rock County

-Wisconsin Department of Natural Resources

-Wisconsin State Historic Preservation Office (SHPO)

-Wisconsin Department of Transportation

-U.S. Fish and Wildlife Service

' Federal Aviation Administration

' Bureau of Indian Affairs

  • o ,E, 0

' Native American Tribes (13):

' Wisconsin Tribes:

,Forest County Potawatomi Community, Wisconsin

°Ho-Chunk Nation of Wisconsin

  • Non-Wisconsin Tribes:

- ' 11 Tribal Entities

~1 6

Alternative Sites Construction SMALL impacts to all MODERATE impacts MODERATE impacts SMALL impacts to all Impacts resource categories to Visual Resources, to Land use, Visual resource categories Noise and Resources, Noise, Transportation Ground Water, and Transportation Construction 420 jobs; $635,000 420 jobs; $635,000 420 jobs: $635,000 None Benefits annual property tax annual property tax annual property tax payments payments payments Operation SMALL impacts to all SMALL impacts to all SMALL impacts to all SMALL impat to all Impacts resource categories resource categories resource categories resource categories Operation 150 jobs: reliable 150 jobs; reliable 150 jobs; reliable None Benefits source of diagnostic source of diagnostic source of diagnostic isotopes: Mo-99, isotopes: Mo-99, isotopes: Mo-99, 1-131. Xe-1 33; 1-131. Xe-i133: 1-131, Xe-i133;

$680.000 annual $680,000 annual $680,000 annual property tax property tax property tax payments payments payments 7

Alternative Technologies Construction Impat Construction Benefits Eu."l SMAL impat to all resource categories 420 jobs, $635,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 420 jobs; $635,000 annual property tax payments SMALL impatsto all resource categorie None Operation SMLL impact to all SMALL impacts to all SMALL impacts to all SMALL impacts to all Impat reorce caeories resource categorie resource categorie resourc categories Operation 150 jobs; reliable 150 jobs; reliable None 150 jobs; reliable Benefits source of diagnostic source of Mo-99; source of diagnostic isotopes: Mo-99, $660,000 annual isotopes: Mo-99, 1-1-131. Xe-i133; property tax 131, Xe-133;

$680,000 annual payments $660,000 annual property tax property tax payments payments 11 8

NRC Environmental Site Audit July 30- August 1, 2013

  • SHINE presentations on the production process and alternative site selection process

-Janesville site visit

°Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River

  • Tour of the Janesville Wastewater Treatment Facility

,Alternative site visits:

-Stevens Point

,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community

  • SHINE believes the relationships between the company, Janesville, and Wisconsin are important
  • SHINE favors a policy of transparency with our community

, SHINE's actions support these principles a Participation in four public meetings per year (two SHINE hosted, two for city council)

  • SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plans a Regular updates provided to State of Wisconsin
  • These activities have fostered a relationship of trust and enthusiasm for the project 10

Conclusions oThe SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate

=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied

°SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11

SCHEDULING NOTE Title: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)

Scheduled: December 15, 2015 9:00 am Purpose: To receive testimony and exhibits regarding the application of SHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a) and 51 .105(a).

Duration: 1 day Location: Commissioners' Conference Room, 1st Floor OWEN NOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.

20 mins.

Participants: Presentation (Note: Presenters questions seatedinatthe will be seated thewell table are and listed, other reser'ved staff available to answer rows.)

Overview (SHINE Medical Technologies. Inc.) 30 mins.*

At the table:

Greg Piefer, Chief Executive Officer, SHINE Jim Costedio, Manager, Licensing, SHINE Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Toi:Overview Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

1

30 mins.*

At the table:

William Dean, Director, Office of Nuclear Reactor Regulation (NRR)

Mirela Gavrilas, Deputy Director, Division of Policy and Rulemaking, NRR Jane Marshall, Deputy Director, Division of License Renewal, NRR Marissa Bailey, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)

Toi:Overview of SHINE construction permit application and contents, summary of key safety and environmental information associated with the SHINE construction permit application, and summary of regulatory findings. The staff will also discuss its review methodology and how it applied the Commission's regulations.

Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

BREAK 5 mins.

NOTE: For the remaininq panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and requlatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.

Safety- Panel 1 (11:15 am)

Applicant 5 mins.*

At the table:

Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Staff 10 mins.*

At the table:

Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Mary Adams, Senior Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Materials Safety and Safeguards (NMSS)

Toi:Sections of the application and the following chapters from the Safety Evaluation Report:

Chapter 1, "The Facility," and Chapter 4, "Irradiation Unit and Radioisotope Production Facility Description," including discussion of the unique licensing considerations for SHINE's subcritical utilization facilities and production facility.

2

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Cooling Systems" o Chapter 6, "Engineered Safety Features," including proposed permit conditions o Chapter 7, "Instrumentation and Control Systems" Commission 0 & A (round of questions; 6 minutes each) 24 mains.**

BREAK (Lunch Break-A pprox. 12:00-1:30 pmo)

Safety - Panel 2 (1:30 pm)

Applicant 5 mins.*

At the table:

Bill Hennessy, Manager, Engineering, SHINE Eric Van Abel, Supervisor, Engineering, SHINE Catherine Koib, Supervisor, Engineering, SHINE Staff 10 mains.*

At the table:

Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Joseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory Research Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSS I~~iSections of the application and the following chapters from the Safety Evaluation Report:

Chapter 13, "Accident Analyses," including discussion of novel application of 10 CFR Part 50 and 70 accident analysis methodologies for radiological and chemical exposure accidents.

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11, "Radiation Protection Program and Waste Management,"

including proposed permit condition o Chapter 12, "Conduct of Operations"~***

o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualification" 3

Commission 0 & A (round of questions; 6 minutes each) 224 mins.**

is*

Environmental - Panel (2:10 pm)

Applicant 10 mins.*

At the table:

Katrina Pitas, Vice President, Business Development, SHINE Bill Hennessy, Manager, Engineering, SHINE Catherine Kolb, Supervisor, Engineering, SHINE Tim Krause, Environmental Specialist, Sargent and Lundy Staff 25 mins.*

At the table:

Jane Marshall, Deputy Director, Division of License Renewal, NRR David Wrona, Chief, Environmental Review and Guidance Update Branch, NRR Michelle Moser, Project Manager and Biologist, NRR Topic: Final Environmental Impact Statement

  • Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:

o The decision to prepare an EIS o The scoping process o Consultations with other Federal, State, and local agencies and Tribes/DOE as a cooperating agency o The staff's independent review and analysis o Issuance of the Draft EIS, public meetings on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts from the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice

  • Discuss the analysis of alternatives including:

o Range of reasonable alternatives o Alternative sites o Alternative technology o No-action alternative

  • Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission 0 & A (round of questions; 6 minutes each) 24 mins.**

BREA K 5 mins.

4

Closing (3:15) 554 mins.

is Closing Statement by Applicant 15 rmins.*

Greg Piefer, Chief Executive Officer Closing Statement by Staff 15 rains.*

William Dean, Director, NRR Commission Q & A and Closing Statements 24 rmins.**

  • For presentation only and does not include time for Commission 0 & A's.
    • AII Commissioners will have an opportunity to ask questions after each panel.

Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.

    • Chapter12, "Conduct of Operations," of the staff's SER includes evaluations of SHINE's quality assurance program description and preliminary emergency plan.

5

HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL ISOTOPE PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)

December 15, 2015 Slides/Handouts Overview

-SHINE Medical Technologies, Inc.

-NRC Staff Safety - Panel 1

-SHINE Medical Technologies, Inc.

-NRC Staff Safety - Panel 2

-SHINE Medical Technologies, Inc.

-NRC Staff Environmental - Panel

-SHINE Medical Technologies, Inc.

-NRC Staff

N RC-010

  • U.S.NRC United Sriae* Nuclear Regulatory C~,mmtnslon ProtectingPeople andt¢ the Environnwnt Construction Permit Application Review SHINE Medical Technologies Panelists
  • Jane Marshall - Deputy Director, NRR/DLR

Introduction to Molybdenum-99

  • Molybdenum-99 (99 M0) Mc 0.90 decays to technetium-99m(*o,,

- Effective diagnosis o

- Minimal exposureV

  • 50,000 procedures daily Tc009
  • No domestically-produced supply ooo.o Establishing a Domestic Supply
  • National policy objectives support domestic production capabilities
  • Cost-sharing agreements encourage commercial partners
  • SHINE proposes to produce 99 M0 through uranium fission

Preparing for SHINE Review

  • Interoffice working group contributed diverse expertise
  • Public meetings engaged stakeholders
  • Review coordinated with Federal, State, and local governments Allowing Construction
  • SHINE application only seeks construction authorization
  • Design details may be left for operating license application
  • Review assessed preliminary design and analysis

Conducting the Safety Review cn~~itW Tailoring Review Methodology

  • Review accommodated unique technology
  • Staff used existing guidance
  • Staff determined whether reasonable assurance that final design will conform to design bases

Additional Information

  • Review supported by additional information
  • In some cases, permit conditions necessary
  • Regulatory commitments track items for resolution in final safety analysis report (FSAR)

Environmental Regulations

  • National Environmental Policy Act

- Informs Federal decision making

- Public disclosure

  • NRC's environmental regulations

- Title 10 of the Code of Federal Regulations (10 CFR) Part 51

Environmental Review Process

  • Opportunity for Public Involvement Proposed Janesville Site

..... Agricultural fields

....

  • Previously disturbed

..... No surface water

  • I features No threatened or endangeredspce
  • o historical or cultural resources

Regulatory Basis

  • Commission authorized by Atomic Energy Act, Section 103
  • Review also considered 10 CFR Part 70 performance requirements Construction Permit Issuance
  • Preliminary design described
  • Further technical or design information may be left for FSAR
  • Ongoing research and development has been identified
  • Facility can be constructed and operated without undue risk

Permit Considerations

  • Construction will not endanger public health and safety
  • SHINE technically and financially qualified
  • Environmental requirements satisfied Introducing Review Panels Safety Panel 1 Licensing Considerations Safe...Evaluation.Repor Chapters 1 and 4 Safety Panel 2 Accident Analysis Safety Evaluation Re port Chapter 13 Environmental Panel
  • Final Environmental Final Environmental Impact Impact Statement Statement Process
  • Analysis of Alternatives
  • Summary of Conclusions and Recommendations

Acronyms

  • FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review
  • NMSS- Office of Nuclear Material Safety and Safeguards
  • NRR - Office of Nuclear Reactor Regulation

Exhibit SHN-026 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Overview December 15, 2015 SHINE Medical Technologies, Inc. Mission

  • SHINE is dedicated to being the world leader in safe, clean, affordable production of medical tracers and cancer treatment elements a Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients required by nearly 100,000 patients globally each day, while maintaining a minimal environmental impact a Will fill gap in supply chain caused by exiting foreign reactors, and ensure continuity of essential treatments for U.S. patients for decades to come

Medical Isotopes

the most widely-used medical isotope, decays into technetium-99m, MedicalProchyedursUig"T which is used in more 7*. 7 than 40 million doses annually

  • Stress tests and bone scans most common of dozens of uses M72rn M~&7A44~ 7717r ~7 A7p17 7*? 1717A7,7~, ~1717

<nn{*fll t1717krr. 7*7* *4747 77 W ?77x77777ft.1777, Nr~ 777477*774 771~'777 7,777* 1777 4, J

Supply Situation with No New Capacity

  • Canada will stop operating the NRU reactor in March 2018
  • Following Canadian exit, there will be no North American producer Highl relvantNEA Demand Growth (+35% ORC) vs, ig hl relvantcurrent processing capacity, 2015-202 z0 because Mo-99 ° decays ~1% per *.

hour *..

=Domestic supply

  • o is necessary to j o ensure US patient '° health 71707777477 470777447-J* 471-077 4*4* 4710774*177 4170774777.477 77-077 7*477 77077 2014 2011 2014 2017 2011 2019 2020

-.- NEAD.77772g177* '40%WC, CU7071~71*$772 C8277777 U

4

SHINE Medical Technologies, Inc. Core Values

=SHINE mission driven by our core values

- Ensure health and safety of the public and our workforce

  • Minimize environmental impacts of medical isotope production
  • Ensure minimal or no disruption to patient supply chain
  • Ensure cost effectiveness and therefore patient access
  • Eliminate need for highly enriched uranium (HEU) reactors or targets in medical isotope supply chain
  • SHINE believes each of these points are essential to fulfill our mission Technological Approach Reflects Core Values
  • Small systems: Hundreds of times less power than isotope production reactors being used SLow source term--helps ensure safety of public and workforce

,Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> oMinimizes waste nuclide generation compared to reactors

  • Reduces waste and cost Product compatible with current supply chain
  • Eliminates need for HEU
  • Driven by low-energy electrostatic accelerator
  • System must be driven to operate, no criticality
  • Hundreds of times less waste than reactors
  • Electrostatic technology simple, demonstrated and cost effective

SHINE Medical Technologies, Inc.

, The SHINE facility is located on a previously undeveloped 91 acre parcel in the southern boundaries of the City of Janesville in Rock County, Wisconsin 7

SHINE Facility Layout

  • The SHINE facility consists of an irradiation facility (IF) and a radioisotope production facility (RPF) ldiation acility idioisotope roduction Facility 8

SHINE Irradiation Facility

='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50

=However, due to subcriticality, the IUs did not meet the existing definition of utilization facility in 10 CFR 50.2

' To align the licensing process with potential hazards, the NRC issued a direct final rule modifying 10 CFR 50.2 definition of utilization facility to include SHINE lUs

  • An IU consists of a subcritical assembly, a neutron driver, and supporting systems SHINE Radioisotope Production Facility

,The RPF is the portion of the SHINE facility used for preparing target solution; extracting, purifying, and packaging Mo-99; and the recycling and cleaning of target solution

  • Based on batch size (i.e., greater than 100 grams), the RPF meets the definition of a production facility as defined in 10 CFR 50.2

,1°

SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to an exemption to 10 CFR 2.101 (a)(5)

SPart I of the Application submitted March 26, 2013

  • PSAR Chapter 2 (Site Characteristics)

=PSAR Chapter 19 (Environmental Review)

,General and Financial Information SPart 2 of the Application submitted May 31, 2013 SRemaining PSAR Chapters SA discussion of the preliminary plans for coping with emergencies, in accordance with 10 CFR 50.34(a)(10), provided September 25, 2013

=The SHINE facility will be licensed under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" Regulatory Guidance and Acceptance Criteria

  • NUREG-1 537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors"
  • Interim Staff Guidance augmenting NUREG-1 537
  • Incorporates relevant guidance from NUREG-1 520, "Standard Review Plan for the Review of a License Application for a Fuel cycle Facility"

, Additional guidance (e.g., Regulatory Guides, ANSI Standards) used 12

SHINE Facility Layout

  • Production, processing, and packaging operations located within one controlled, confined area 13 SHINE Process Overview SSupercell Recycle Loop Product A Recycle tank TSV and Irradiation Unit Cell ~Hold Periodic Cleanup Loop associated cleanup
  • processes 4....

-wTargetpaato 14 Solution

SHINE Irradiation Facility SHINE'sFusion-FIssion Coupling

  • An IU consists of a subcritical assembly, a neutron driver, and supporting systems
  • Major supporting systems include:

V

  • Light water pool system (LWPS)
  • Target solution vessel (TSV) off-gas system (TOGS) Neutron Oriver

. Primary closed loop cooling system (PCLS)

N

  • Tritium purification system (TPS) '4 Neutron Multiplier
  • Primary system at near-atmospheric pressure 14 11
  • Target solution is drained to dump tank via gravity Target Solution
  • Dump tank is criticality-safe by geometry and Vessel passively-cooled N
  • Redundant, fail-open dump valves

'4> N

  • TSV is an annular vessel to be constructed of Zircaloy-4
  • Natural convection within TSV Radioisotopes in solution 15 Subcritical Assembly Subcritical Assembly Support TSV and Neutron Structure S Multiplier (SASS) (Internal to SASS)

TSV Dump Tank -,.

TSV Dump and Overflow Lines

~(2 each) 16

Neutron Driver and Tritium Purification System

  • One Neutron Driver per IU cell
  • Electrostatic accelerator with a gas target
  • D-T fusion reaction generates 14 MeV neutrons that drive the fission process
  • Isotopically separates gases, and supplies clean tritium to neutron drivers
  • Tritium lines and processing q equipment in gloveboxes and double-walled pipe 1 TSV Off-Gas and Primary Cooling Systems
  • TSV off-gas system (TOGS)
  • Contains the fission product1 TOGS gases i
  • Subcritical assembly submersed in light water *"

pool °-,

  • Provides shielding and heat s-,..,8AS8) removal ......

18

Subcritical Assembly Irradiation Process

  • Uranium concentration of solution and any other necessary parameters are measured
  • Operators use a 1/M startup methodology to monitor the reactivity increase in the TSV
  • TSV is filled in discrete increments
  • Final fill level is approximately 5% by volume below critical
  • Automatic safety systems will be designed to protect the primary system boundary (PSB) and ensure the TSV remains subcritical
  • High flux trips
  • Primary cooling system temperature trips Subcritical Assembly Irradiation Process

' When irradiating the TSV:

  • Further solution addition is prevented
  • Tritium is supplied to the target, and neutron driver output is gradually increased
  • Reactivity decreases significantly in the assembly due to the strong negative feedback
  • Normal irradiation mode operations are approximately 5.5 days

-'Following shutdown, light water pool provides decay heat removal

  • On a loss of off-site power, pool passively removes heat
  • Temperature rise of 12°F (7°(c) after 90 days without cooling

Radioisotope Production Facility

  • Extracting, purifying and packaging Mo-99 in supercells

-Laboratory scale purification process

  • Noble Gas Removal System (NGRS) stores TSV off-gas
  • Held for 40 days of decay prior to sampling for release
  • Released through the Process I Vessel Vent System (PWS)
  • Monitored and filtered discharge to ensure regulatory limits are met
  • Recycling and cleaning target solution

reuse Pu~Packagoe Engineered Safety Features (ESFs)

  • SHINE protects public health and safety during postulated accidents via a confinement system

,Radionuclide inventory in any one confinement area is approximately 10,000 times less than a power reactor

-Low dispersion forces in processes byConfinement functions provided ,,,F, RPF; Biological shielding (IU cells, hot cells, trenches, tank vaults)

Isolation valves on piping systems

  • Ventilation systems
  • Instrument and control systems: Zo,,e2 Zen. 3 Engineered Safety Features Actuation System (ESFAS)

Radiological Integrated control System (RIcS) Ventilation Zones in Production Facility 22

Summary

, Preliminary design described in the PSAR shows the SHINE facility can be constructed such that it meets the applicable regulatory requirements

  • Robust engineered and administrative controls have been identified to ensure protection of the public, the environment, and our workers

, The plant is being designed with safety as the primary criterion 23

NRC-01l

' U.S.NRC United Stats Nuileair Regulatory Comnisslio ProtectingPeople and the Emwironment Construction Permit Application Review SHINE Medical Technologies Safety Panel I December 15o 201 5 Panelists

- Chief, Research and Test Reactors Licensing Branch, NRR

- Project Manager, NRR

  • Mary Adams

- Project Manager, NMSS

Licensing Considerations

  • SHINE seeks to construct commercial non-power utilization and production facilities
  • Licensing process similar to that of research and test reactors
  • Staff presented at subcommittee and full committee meetings
  • ACRS recommended issuance of construction permit
  • Staff adequately addressed questions regarding aircraft impact and facility layup

Irradiation Unit Licensing

  • Irradiation units represent first subcritical utilization facilities
  • Given similarities to non-power reactors, ultimately reviewed under 10 CFR Part 50 Irradiation Unit Design Features
  • Thermal power level similar to non-power reactors
  • Safety considerations include:

- Fission heat removal

- Decay heat generation

- Fission gas release

- Accident scenarios

Production Facility Licensing

  • Similar to processes at existing fuel cycle facilities
  • Staff used NUREG-1537 and Interim Staff Guidance Proposed Permit Conditions
  • Criticality accident alarm system
  • Criticality events "not credible"
  • Criticality safety analyses
  • Reactivity contributions from fissile isotopes
  • Radiation shielding and occupancy times

Acronyms

  • NMSS- Office of Nuclear Material Safety and Safeguards
  • NRR - Office of Nuclear Reactor Regulation

Exhibit SIIN-027 qSHINE'T Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 1 Facility December 15, 2015 SHINE Process Overview Recycle Loopq Product IB12i~

A Recycle tank TSV and Irradiation Unit Cell Hl e

Periodic Cleanup Loop

  • associated cleanup
  • processes

.4.

  • Target Solution

~Preparation

Design Cornponents of Structures, Systems, and a Certain structures, systems, and components (SSCs) are designated safety-related because they are relied upon to perform safety functions during normal operation or design basis events a SSCs must be able to perform their design basis functions during normal operation and under required accident conditions a SSCs that are determined to have safety significance are designed, fabricated, and tested commensurate with the criteria set forth in ANSI/ANS-1 5.8 ("Quality Assurance Program Requirements for Research Reactors")

Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remain functional during normal conditions and during and following design basis events to assure:

1. The integrity of the primary system boundary;
2. The capability to shutdown the target solution vessel (TSV) and maintain the target solution in a safe shutdown (SSD) condition;
3. The capability to prevent or mitigate the consequences of accidents which could result in potential exposures comparable to the applicable guideline exposures set forth in 10 CFR 20;
4. That all nuclear processes are subcritical, including use of an approved margin of subcriticality;
5. That acute chemical exposures to an individual from licensed material or hazardous chemicals produced from licensed material could not lead to irreversible or other serious, long-lasting health effects to a worker or cause mild transient health effects to any individual located outside the owner controlled area; or
6. That an intake of 30 mg or greater of uranium in soluble form by any individual located outside the owner controlled area does not occur

Seismic Design and Quality Levels

  • Plant SSCs are designed to withstand the effects of the design basis earthquake (DBE) if they perform a safety-related function or if necessary to ensure they do not degrade the function and performance of a safety-related SSC
  • SHINE Quality Levels (QLs):

SQL-I: Safety-related SSCs are designated as QL-1 in the Quality Assurance Program Description (QAPD), and the full measure of the QAPD is applied to these SSCs

-QL-2: Selected SSCs that support or protect the safety function of safety-related equipment are designated QL-2, and quality elements are applied commensurate with the importance to safety

  • QL-3: Nonsafety SSCs that do not support or protect the safety function of safety-related SSCs are designated QL-3 Design of Structures, Systems, and Components
  • Single failure criterion is applied to safety systems

-Sufficient redundancy and independence that a single failure of an active component does not result in loss of capability to perform its safety function

- A single failure, in conjunction with initiating event, does not result in the loss of the system's ability to perform its safety function

  • SHINE system designs based on defense-in-depth practices, with preference for engineered and passive controls over administrative controls 6

NRC-012-R SU.S.NRC United States Nuclear Regulatory Comni~ssion ProtectingPrcopLtand the Enzmnment Construction Permit Application Review SHINE Medical Technologies Safety Panel 2 Decermber 1 5 201 5 Panelists

- Project Manager, NRR

- Senior Reactor Systems Engineer, RES

  • Kevin Morrissey

- Project Manager, NMSS

Review Methodology

  • Two methodologies applied to SHINE accident analyses

- Maximum hypothetical accident

- Integrated safety analysis

  • Radiological and chemical hazards evaluated against 10 CFR Parts 20 and 70, respectively Irradiation Facility Accident Analysis
  • Irradiation facility characteristics:

- Operates at low power, pressure, and temperature

- Large heat sink for passive decay heat removal

- Radiological sources

Event Identification

  • Delineation of possible accident categories
  • Identification of limiting accident for the category
  • Strategy to mitigate accident and limit consequences
  • Analysis of dose consequences Safety Concept
  • Detection of high radiation levels
  • Confinement of radiation source
  • Evacuate workers
  • Filter releases to environment
  • Emergency planning zone could be the operational boundary

Limiting Accident

  • Release of irradiated target solution from one TSV
  • Consequences bounded by RPF maximum hypothetical accident

- 5 rem for workers

- 100 mrem for public Production Facility Accident Analysis

  • Radiological and chemical accident analysis performed
  • Defines facility hazards and controls that support establishment of design basis

Production Facility Accident Analysis

  • Multiple event types:

- Radiological accidents

- Chemical accidents

- Criticality accidents

- Fires

- External events

Exhibit SHN-028 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Safety - Panel 2 Accident Analysis December 15, 2015 Accident Initiating Events and Scenarios

  • Bases for identification of accidents:

.Hazard and Operability Study (HAZOPS)

SPreliminary Hazard Analysis (PHA)

  • List of events from NUREG-1 537 and the Interim Staff Guidance (ISG) augmenting NUREG-1537

,Experience of the hazards analysis team

  • Current preliminary design information SQualitative evaluations within categories

,Quantitative evaluations to determine consequences

  • Postulated an irradiation facility (IF) and radioisotope production facility (RPF) Maximum Hypothetical Accident (MHA)

°Establishes an outer limit consequence, bounds other accidents SMost limiting MHA was in the RPF ("Facility MHA")

IF Postulated Maximum Hypothetical Accident Target solution vessel (TSV) and subcritical assembly support structure (SASS) integrity lost, target solution spills into irradiation unit (IU) cell

,Maximum inventories assumed in TSV SPool presence ignored SHigh radiation detected, initiates alarms and confinement

°High efficiency particulate air (HEPA) filters and charcoal adsorbers credited SDose consequences

-Worker TEDE: 3.1 rem ..

-Public (site boundary) TEDE: TSV Q ........

0 0017 rem RPF Maximum Hypothetical Accident (Facility MHA)

°The five noble gas TSV Oft G.~

storage tanks rupture P~.rge simultaneously NORS

°With the maximum inventory

  • Contents are instantly released Nobk G.~

Stosg. Ts,,k~

SHigh radiation levels initiate alarm and cell isolation

, Redundant isolation dampers close Conden~ot~

' 10% of the activity bypasses KnockOft Pro~es,Ves~eI Thnk v~,,t Syften, the isolation dampers

' 10% of the activity leaks R~dIo.ctWn

  • through penetrations LIqnIdWnte

RPF Maximum Hypothetical Accident (Facility MHA)

Doses to the Public From Analyzed Accidents

=Dose consequences

  • Worker TEDE: *3.6 rem
  • Public (site boundary) TEDE: 0.082 rem oThe MHA consequences are conservative

,Simultaneous, instantaneous rupture

  • Entirety of noble gas is transferred and released SThe five tanks are filled to capacity

°Additional ventilation isolation dampers would close, but are not credited

-Actual doses would be lower Radiological consequences to workers and the public are within the limits of 10 CFR 20.1101, 20.1201, and 20.1301 EuU _______

I 5

NRC-01 3

<U.S.NRC United Stjres Nuclear Re~ul~tory Comtml$slon ProtectingPeople and the Environment Construction Permit Application Review SHINE Medical Technologies Panelists

  • Jane Marshall

- Deputy Director, Division of License Renewal, NRR

- Branch Chief, NRR

- Project Manager, NRR

Environmental Review

  • National Environmental Policy Act
  • Environmental review process

- Title 10 of Code of Federal Regulations (10 CFR) Part 51

- Environmental Standard Review Plan (NUREG-1 537)

- Interim Staff Guidance Environmental Impact Statement (EIS)

  • Project-specific decision

- Potential significant impacts

- First-of-a-kind facility with a unique application of technologies

- Public involvement maximized

Scoping

  • 5 oral comments
  • 6 written comments Department of Energy (DOE)
  • National Environmental Policy Act

- Lead agency: Nuclear Regulatory Commission

- Cooperating agency: DOE

  • American Medical Isotopes Production Act

- Complementary environmental reviews

Environmental Review Areas Socioeconomics and Terrestrial Environmental Justice Resources Environmental Impacts Resource Area Impact Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Ecological and Water Resources SMALL Historic and Cultural Resources SMALL Socioeconomics SMALL Human Health and Waste SMALL Transportation SMALL to MODERATE

Reasonable Alternatives

  • No-action alternative
  • Alternative sites

- Chippewa Falls

- Stevens Point

  • Alternative technologies Alternative Technologies
  • Neutron capture
  • Aqueous homogenous reactor
  • Linear-accelerator-based

- Analyzed in depth

Costs and Benefits

  • Purpose

- Inform recommendation to the Commission

  • Costs

- Environmental and financial

  • Benefits

- Societal, medical, and economic Environmental Costs Proposed Janesville Site Traffic Chippewa Falls Alternative Traffic, Noise Stevens Point Alternative Traffic1 Noise, Visual Alternative Technology Traffic No-action Alternative None

  • SMALL impacts for all other resource areas

Benefits

  • Support United States (U.S.)

policy

  • Support U.S. public health needs
  • Economic benefits

- Increased tax revenue

- New employment opportunities Consultations

  • 0 0 6 .~ 3--
  • 0 Endangered Species No Effect Act, Section 7 National Historic Preservation Act, No Adverse Effect Section 106

Draft Environmental Impact Statement

  • 1 oral comment
  • 8 written comments NRC Staff's Recommendation Staff recommends issuance of the construction permit.

Future NEPA Analyses

  • 10 CFR 51 .95(b) requires the staff to supplement the Final EIS

- Matters that differ from the Final EIS

- New significant information Acronyms

  • NRR -Office of Nuclear Reactor Regulation

Exhibit SHN-029 Medical Technologies Commission Mandatory Hearing SHINE Construction Permit Application Environmental Overview December 15, 2015 Development of the Environmental Report

  • Began work October 2011
  • SHINE production facility will be located in Janesville, Rock County, Wisconsin
  • Environmental Report follows the Final Interim Staff Guidance Augmenting NUREG-1 537 ii 2

Structure and Content of the Environmental Report 19.1 - Introduction Purpose and need for the proposed action, Regulatory provisions, permits and required consultations 19.2 - Proposed Action Site location and layout, Radioisotope facility description, Water consumption and treatment. Cooling and heating dissipation systems, Waste systems, Storage, treatment and transportation of radioactive and nonradioactive materials, including LEU, waste, radioisotopes and any other materials 19.3- Descrption of the Land use and visual resources, Air quality and noise, Geooic environment, Affected Environment Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human health 19.4- Impacts of the Land use and visual resources, Air quality and noise, Geologic environment, Proposed Construction, Water resources, Ecological resources, Historic and cultural resources, Operations, and Socioeconomics, Human health, Waste management, Transportation, Decommissioning Postulated accidents, Environmental justice, Cumulative effects 19.5 - Alternatives NO-action alternative. Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impacts 19.6 - Conclusions Unavoidable adverse environmental impacts, Relationship between short-term uses and long-term productivity of the environment, Irreversible and irretrievable commitments of resources 3

Scope of Field Investigations 6

=Phase I Environmental Site Assessment

°General Reconnaissance

+Soil Borings/Geotechnical Investigation

,Well Installation

°Phase I Archaeological Investigation

°Baseline Visual Assessment

  • Wetland Delineation

°Quarterly Ecological Investigations

=Aquatic Ecology

,Terrestrial Ecology oMonthly Water Resources

+Water Quality

=Water Levels

Context for Data Acquisition U

,Site

  • 91.27 acre parcel located on the south side of the City of Janesville in Rock County, WI
  • Project Area
  • Circular area with a radius approximately 1 mile from the site center point

' Region

' Circular area with a radius of 5 miles from the site center point

' Larger context as appropriate (e.g., geology, air quality)

' Region of Influence

, ,Rock County 5

Consultations

' City of Janesville

' Rock County

-Wisconsin Department of Natural Resources

-Wisconsin State Historic Preservation Office (SHPO)

-Wisconsin Department of Transportation

-U.S. Fish and Wildlife Service

' Federal Aviation Administration

' Bureau of Indian Affairs

  • o ,E, 0

' Native American Tribes (13):

' Wisconsin Tribes:

,Forest County Potawatomi Community, Wisconsin

°Ho-Chunk Nation of Wisconsin

  • Non-Wisconsin Tribes:

- ' 11 Tribal Entities

~1 6

Alternative Sites Construction SMALL impacts to all MODERATE impacts MODERATE impacts SMALL impacts to all Impacts resource categories to Visual Resources, to Land use, Visual resource categories Noise and Resources, Noise, Transportation Ground Water, and Transportation Construction 420 jobs; $635,000 420 jobs; $635,000 420 jobs: $635,000 None Benefits annual property tax annual property tax annual property tax payments payments payments Operation SMALL impacts to all SMALL impacts to all SMALL impacts to all SMALL impat to all Impacts resource categories resource categories resource categories resource categories Operation 150 jobs: reliable 150 jobs; reliable 150 jobs; reliable None Benefits source of diagnostic source of diagnostic source of diagnostic isotopes: Mo-99, isotopes: Mo-99, isotopes: Mo-99, 1-131. Xe-1 33; 1-131. Xe-i133: 1-131, Xe-i133;

$680.000 annual $680,000 annual $680,000 annual property tax property tax property tax payments payments payments 7

Alternative Technologies Construction Impat Construction Benefits Eu."l SMAL impat to all resource categories 420 jobs, $635,000 annual property tax payments SMALL impacts to all resource cateories 420 jobs; $635,000 annual property tax payments SMALL impacts to all resource categories 420 jobs; $635,000 annual property tax payments SMALL impatsto all resource categorie None Operation SMLL impact to all SMALL impacts to all SMALL impacts to all SMALL impacts to all Impat reorce caeories resource categorie resource categorie resourc categories Operation 150 jobs; reliable 150 jobs; reliable None 150 jobs; reliable Benefits source of diagnostic source of Mo-99; source of diagnostic isotopes: Mo-99, $660,000 annual isotopes: Mo-99, 1-1-131. Xe-i133; property tax 131, Xe-133;

$680,000 annual payments $660,000 annual property tax property tax payments payments 11 8

NRC Environmental Site Audit July 30- August 1, 2013

  • SHINE presentations on the production process and alternative site selection process

-Janesville site visit

°Walk down of proposed site SDriving tour SRock River visit SSampling sites 1 and 2 along the unnamed tributary to the Rock River

  • Tour of the Janesville Wastewater Treatment Facility

,Alternative site visits:

-Stevens Point

,Chippewa FallsI SResponded to NRC Site Audit Information Needs SHINE and The Community

  • SHINE believes the relationships between the company, Janesville, and Wisconsin are important
  • SHINE favors a policy of transparency with our community

, SHINE's actions support these principles a Participation in four public meetings per year (two SHINE hosted, two for city council)

  • SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plans a Regular updates provided to State of Wisconsin
  • These activities have fostered a relationship of trust and enthusiasm for the project 10

Conclusions oThe SHINE environmental review was conducted pursuant to 10 CFR Part 51 and is adequate

=The requirements of Sections 102(2) (A), (C), and (E) of the National Environmental Policy Act (NEPA) have been satisfied

°SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINE facility supports issuance of the construction permit 11

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