ML15350A289

M151215: Scheduling Note and Slides - Hearing on Construction Permit for Shine Medical Isotope Production Facility: Section 189A of the Atomic Energy Act Proceeding

ML15350A289
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Site:	SHINE Medical Technologies
Issue date:	12/16/2015
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SCHEDULING NOTETitle: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICALISOTOPE PRODUCTION FACILITY:

SECTION 189A OF THEATOMIC ENERGY ACT PROCEEDING (Public Meeting)Scheduled:

Purpose:Duration:

Location:

December 15, 20159:00 amTo receive testimony and exhibits regarding the application ofSHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. Thetestimony will focus on unique features of the facility or novel issuesthat arose as part of the review process and other significant technical or policy issues associated with aspects of the staff'sreview that are important for the Commission to make its finaldecision.

The Commission will determine whether the staff's reviewhas been adequate to support the findings in 10 C.F.R. §§ 50.35(a)and 51 .105(a).1 dayCommissioners' Conference Room, 1st Floor OWENNOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.

20 mins.Participants:

Presentation (Note: Presenters seated at the table are listed, other staff available to answerquestions will be seated in the well and reser'ved rows.)Overview (SHINE Medical Technologies.

Inc.)At the table:Greg Piefer, Chief Executive

Officer, SHINEJim Costedio,

Manager, Licensing, SHINEBill Hennessy,

Manager, Engineering, SHINEEric Van Abel, Supervisor, Engineering, SHINEToi: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, NRRJane Marshall, Deputy Director, Division of License Renewal, NRRMarissa 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 SHINEconstruction permit application, and summary of regulatory findings.

The staffwill 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 ofthe construction permit application while the staff is expected to discuss its reviewprocess and requlatory conclusions.

Each panel should include a discussion of anypermit 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, SHINEEric Van Abel, Supervisor, Engineering, SHINECatherine Kolb, Supervisor, Engineering, SHINEStaff 10 mins.*At the table:Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRRSteven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRRMary 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 SafetyEvaluation 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, thispanel 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 permitconditions 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, SHINEEric Van Abel, Supervisor, Engineering, SHINECatherine Koib, Supervisor, Engineering, SHINEStaff 10 mains.*At the table:Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRRJoseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems CodeDevelopment Branch, Office of Nuclear Regulatory ResearchKevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSSI~~iSections of the application and the following chapters from the SafetyEvaluation Report:Chapter 13, "Accident Analyses,"

including discussion of novel application of10 CFR Part 50 and 70 accident analysis methodologies for radiological andchemical 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, thispanel 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) 2 is*24 mins.**Environmental

-Panel (2:10 pm)Applicant At the table:Katrina Pitas, Vice President, Business Development, SHINEBill Hennessy,

Manager, Engineering, SHINECatherine Kolb, Supervisor, Engineering, SHINETim Krause, Environmental Specialist, Sargent and Lundy10 mins.*Staff 25 mins.*At the table:Jane Marshall, Deputy Director, Division of License Renewal, NRRDavid Wrona, Chief, Environmental Review and Guidance Update Branch, NRRMichelle Moser, Project Manager and Biologist, NRRTopic: 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 EISo The scoping processo Consultations with other Federal, State, and local agencies andTribes/DOE as a cooperating agencyo The staff's independent review and analysiso Issuance of the Draft EIS, public meetings on the Draft EIS, andsolicitation of stakeholder comments on the Draft EISo 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 siteso Alternative technology o No-action alternative

• Summarize conclusions and recommendation including a summary of thebenefits and costs of the proposed actionCommission 0 & A (round of questions; 6 minutes each)24 mins.**BREA K5 mins.4 Closing (3:15) 5 is54 mins.Closing Statement by Applicant 15 rmins.*Greg Piefer, Chief Executive OfficerClosing Statement by Staff 15 rains.*William Dean, Director, NRRCommission 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 fitamong the panels.**Chapter 12, "Conduct of Operations,"

of the staff's SER includes evaluations ofSHINE's quality assurance program description and preliminary emergency plan.5 HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICALISOTOPE PRODUCTION FACILITY:

SECTION 189A OF THEATOMIC ENERGY ACT PROCEEDING (Public Meeting)December 15, 2015Slides/Handouts Overview-SHINE Medical Technologies, Inc.-NRC StaffSafety -Panel 1-SHINE Medical Technologies, Inc.-NRC StaffSafety -Panel 2-SHINE Medical Technologies, Inc.-NRC StaffEnvironmental

-Panel-SHINE Medical Technologies, Inc.-NRC Staff N RC-010United Nuclear Regulatory C~, mmtnslonProtecting People andt¢ the Environnwnt Construction PermitApplication ReviewSHINE 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

• Molybdenum-99 (99M0) Mc 0.90decays to

-Effective diagnosis o-Minimal exposureV

• 50,000 procedures daily Tc009* No domestically-produced supply ooo.oEstablishing a Domestic Supply* National policy objectives supportdomestic production capabilities

• Cost-sharing agreements encourage commercial partners* SHINE proposes to produce 99M0through uranium fission Preparing for SHINE Review* Interoffice working groupcontributed diverse expertise

• Public meetings engagedstakeholders

• Review coordinated with Federal,State, and local governments Allowing Construction

• SHINE application only seeksconstruction authorization

• Design details may be left foroperating license application

• Review assessed preliminary design and analysis Conducting the Safety Reviewcn~~itWTailoring Review Methodology

• Review accommodated uniquetechnology

• Staff used existing guidance* Staff determined whetherreasonable assurance that finaldesign will conform to designbases Additional Information

• Review supported by additional information

• In some cases, permit conditions necessary

• Regulatory commitments trackitems for resolution in final safetyanalysis report (FSAR)Environmental Regulations

• National Environmental Policy Act-Informs Federal decisionmaking-Public disclosure

• NRC's environmental regulations

-Title 10 of the Code of FederalRegulations (10 CFR) Part 51 Environmental Review Process* Opportunity for PublicInvolvement Proposed Janesville Site..... Agricultural fields....

• Previously disturbed

..... No surface water* featuresI No threatened orendangeredspce

• o historical orcultural resources Regulatory Basis* Commission authorized by AtomicEnergy Act, Section 103* Review primarily based on 10 CFRParts 20, 50, and 51* Review also considered 10 CFRPart 70 performance requirements Construction Permit Issuance* Preliminary design described

• Further technical or designinformation may be left for FSAR* Ongoing research anddevelopment has been identified

• Facility can be constructed andoperated without undue risk Permit Considerations

• Construction will not endangerpublic health and safety* SHINE technically and financially qualified

• Environmental requirements satisfied Introducing Review PanelsSafety Panel 1Safety Panel 2Environmental PanelLicensing Considerations Accident Analysis* Final Environmental Impact Statement Process* Analysis of Alternatives

• Summary ofConclusions andRecommendations Safe...Evaluation.Repor Chapters 1 and 4Safety Evaluation Re portChapter 13Final Environmental ImpactStatement Acronyms* FCSE -Division of Fuel CycleSafety, Safeguards, andEnvironmental Review* DLR -Division of LicenseRenewal* DPR -Division of Policy andRulemaking Acronyms* NMSS- Office of Nuclear MaterialSafety and Safeguards

• NRR -Office of Nuclear ReactorRegulation Exhibit SHN-026Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application OverviewDecember 15, 2015SHINE Medical Technologies, Inc. Mission* SHINE is dedicated to being the world leader in safe,clean, affordable production of medical tracers andcancer treatment elementsa Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients requiredby nearly 100,000 patients globally each day, whilemaintaining a minimal environmental impacta Will fill gap in supply chain caused by exiting foreignreactors, 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, decaysinto technetium-99m, which is used in morethan 40 million dosesannually* Stress tests and bonescans most common ofdozens of usesMedicalProchyedursUig"T7M72rn M~&7 A44~ 7717r ~ A7p17 7*? 1717 A7,7~, ~1717<nn{*fll t1717 krr. 7*7* *4747 777W ?77x7777 7ft.1777, Nr~ 777477*774 771~ '777 7,777* 1777 4,JSupply Situation with No New Capacity*Canada will stop operating the NRU reactor inMarch 2018* Following Canadian exit, there will be no NorthAmerican producerHighl relvantNEA Demand Growth (+35% ORC) vs,ig hl relvantcurrent processing

capacity, 2015-202because Mo-99 °decays ~1% per hour z0=Domestic supply ois necessary to j oensure US patient '°health717077 77477 470777 447-J* 471-077 4*4* 471077 4*177 417077 4777.477 77-077 7*477 770772014 2011 2014 2017 2011 2019 2020-.-NEAD.77772g177*

'40% WC,CU7071 ~71*$772 C8277777U4 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 ortargets in medical isotope supply chain* SHINE believes each of these points are essential tofulfill our missionTechnological Approach Reflects Core Values* Small systems:

Hundreds of times less power than isotopeproduction reactors being usedSLow source term--helps ensure safety of public and workforce

,Decay heat per system < 1 kW within 5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />soMinimizes waste nuclide generation compared to reactors* Low enriched uranium (LEU) reusable target* Reduces waste and costProduct 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 locatedon a previously undeveloped 91 acre parcel in thesouthern boundaries of theCity of Janesville inRock County, Wisconsin 7SHINE Facility Layout* The SHINE facility consists of an irradiation facility (IF)and a radioisotope production facility (RPF)ldiationacilityidioisotope roduction Facility8 SHINE Irradiation Facility='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal powerlevel and safety considerations to existing non-power reactors licensed under 10 CFR Part 50=However, due to subcriticality, the IUs did not meet the existingdefinition of utilization facility in 10 CFR 50.2' To align the licensing process with potential

hazards, the NRCissued a direct final rule modifying 10 CFR 50.2 definition ofutilization facility to include SHINE lUs* An IU consists of a subcritical

assembly, a neutrondriver, and supporting systemsSHINE Radioisotope Production Facility,The RPF is the portion of the SHINE facility used forpreparing target solution; extracting, purifying, andpackaging Mo-99; and the recycling and cleaning oftarget solution* Based on batch size (i.e., greater than 100 grams), theRPF meets the definition of a production facility asdefined in 10 CFR 50.2,1° SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to anexemption 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, 2013SRemaining PSAR ChaptersSA discussion of the preliminary plans for coping with emergencies, inaccordance 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 andReviewing 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 Fuelcycle Facility"

, Additional guidance (e.g., Regulatory Guides, ANSIStandards) used12 SHINE Facility Layout* Production, processing, and packaging operations located within one controlled, confined area13SHINE Process OverviewSSupercell Recycle LoopProductRecycle tankTSV andIrradiation Unit CellA~HoldPeriodic Cleanup Loopassociated cleanup* processes 4....-w Target Solution14 paato SHINE Irradiation Facility* An IU consists of a subcritical

assembly, a neutrondriver, 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 andpassively-cooled

• Redundant, fail-open dump valves* TSV is an annular vessel to be constructed ofZircaloy-4

• Natural convection within TSVSHINE's Fusion- FIssion CouplingVN'41411NeutronOriverNeutronMultiplier TargetSolutionVesselN'4> NRadioisotopes in solution15Subcritical AssemblySubcritical AssemblySupportStructure (SASS)TSV Dump Tank -,.TSV and NeutronS Multiplier (Internal to SASS)TSV Dump and Overflow Lines~(2 each)16 Neutron Driver and Tritium Purification System* One Neutron Driver perIU cell* Electrostatic accelerator witha gas target* D-T fusion reaction generates 14 MeV neutrons that drivethe fission process* Tritium purification system* Isotopically separates gases,and supplies clean tritium toneutron drivers* Tritium lines and processing equipment in gloveboxes andq double-walled pipe 1TSV Off-Gas and Primary Cooling Systems*TSV off-gas system (TOGS)* Contains the fission product1 TOGSgases i*of-aRemoves iodine from the* Recombines hydrogen andoxygen to maintain hydrogengas below the lowerflammability limit (LFL)* Subcritical assemblysubmersed in light water pool °-,* Provides shielding and heat s-,..,8AS8) removal ......18 Subcritical Assembly Irradiation Process* Uranium concentration of solution and any othernecessary parameters are measured* Operators use a 1/M startup methodology to monitorthe 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 protectthe primary system boundary (PSB) and ensure theTSV remains subcritical

• High flux trips* Primary cooling system temperature tripsSubcritical Assembly Irradiation Process' When irradiating the TSV:* Further solution addition is prevented

• Tritium is supplied to the target, and neutron driver output isgradually increased

• Reactivity decreases significantly in the assembly due to thestrong negative feedback* Normal irradiation mode operations are approximately 5.5 days-'Following

shutdown, light water pool provides decayheat 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 priorto sampling for release* Released through the Process IVessel Vent System (PWS)*Monitored and filtered discharge to ensure regulatory limits aremet*Recycling and cleaning targetsolution* Uranium extraction (U REX)process separates uranium for ......................

reuse Pu~Packagoe Engineered Safety Features (ESFs)* SHINE protects public health and safety during postulated accidents via aconfinement 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 pipingsystems* Ventilation systems* Instrument and control systems:Engineered Safety FeaturesActuation System (ESFAS)Radiological Integrated controlSystem (RIcS)Zo,,e 2Zen. 3Ventilation Zones in Production Facility22 Summary, Preliminary design described in the PSAR shows theSHINE facility can be constructed such that it meets theapplicable regulatory requirements

• Robust engineered and administrative controls havebeen identified to ensure protection of the public, theenvironment, and our workers, The plant is being designed with safety as the primarycriterion 23 NRC-01l' U.S.NRCUnited Stats Nuileair Regulatory Comnisslio Protecting People and the Emwironment Construction PermitApplication ReviewSHINE Medical Technologies Safety Panel IDecember 1 5o 201 5Panelists

• Alexander Adams, Jr.-Chief, Research and TestReactors 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

• Licensing process similar to thatof research and test reactors* Developed technology-specific guidance for application reviewAdvisory Committee on ReactorSafeguards (ACRS) Review* Staff presented at subcommittee and full committee meetings* ACRS recommended issuance ofconstruction permit* Staff adequately addressed questions regarding aircraftimpact and facility layup Irradiation Unit Licensing

• Irradiation units represent firstsubcritical utilization facilities

• Staff considered licensing under10 CFR Part 70* Given similarities to non-power

reactors, ultimately reviewedunder 10 CFR Part 50Irradiation Unit Design Features* Thermal power level similar tonon-power reactors* Safety considerations include:-Fission heat removal-Decay heat generation

-Fission gas release-Accident scenarios Production Facility Licensing

• Production facility will processirradiated materials containing special nuclear material* Similar to processes at existingfuel cycle facilities

• Staff used NUREG-1537 andInterim Staff GuidanceProposed Permit Conditions

• Criticality accident alarm system* Criticality events "not credible"

• Criticality safety analyses* Reactivity contributions fromfissile isotopes* Radiation shielding andoccupancy times Acronyms*NMSS- Office of Nuclear MaterialSafety and Safeguards

• NRR -Office of Nuclear ReactorRegulation Exhibit SIIN-027qSHINE'TMedical Technologies Commission Mandatory HearingSHINE Construction Permit Application Safety -Panel 1FacilityDecember 15, 2015SHINE Process OverviewRecycle LoopqIB12i~A Recycle tankProductTSV andIrradiation Unit Cell HlePeriodic Cleanup Loop* associated cleanup* processes

.4. *Target Solution~Preparation Design of Structures,

Systems, andCornponents a Certain structures,

systems, and components (SSCs)are designated safety-related because they are reliedupon to perform safety functions during normaloperation or design basis eventsa 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 ResearchReactors")

Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remainfunctional during normal conditions and during and following design basisevents to assure:1. The integrity of the primary system boundary;

2. The capability to shutdown the target solution vessel (TSV) and maintain thetarget solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which couldresult 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 marginof subcriticality;

5. That acute chemical exposures to an individual from licensed material orhazardous chemicals produced from licensed material could not lead toirreversible or other serious, long-lasting health effects to a worker or causemild transient health effects to any individual located outside the ownercontrolled area; or6. 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 designbasis earthquake (DBE) if they perform a safety-related function orif necessary to ensure they do not degrade the function andperformance of a safety-related SSC* SHINE Quality Levels (QLs):SQL-I: Safety-related SSCs are designated as QL-1 in the QualityAssurance Program Description (QAPD), and the full measure ofthe QAPD is applied to these SSCs-QL-2: Selected SSCs that support or protect the safety function ofsafety-related equipment are designated QL-2, and qualityelements are applied commensurate with the importance to safety*QL-3: Nonsafety SSCs that do not support or protect the safetyfunction of safety-related SSCs are designated QL-3Design of Structures,

Systems, andComponents

• Single failure criterion is applied to safety systems-Sufficient redundancy and independence that a single failure ofan active component does not result in loss of capability toperform its safety function-A single failure, in conjunction with initiating event, does notresult in the loss of the system's ability to perform its safetyfunction* SHINE system designs based on defense-in-depth practices, with preference for engineered and passivecontrols over administrative controls6 NRC-012-R SU.S.NRCUnited States Nuclear Regulatory Comni~ssion Protecting PrcopLt and the Enzmnment Construction PermitApplication ReviewSHINE Medical Technologies Safety Panel 2Decermber 1 5 201 5Panelists

• Steven Lynch-Project Manager, NRR* Joseph Staudenmeier

-Senior Reactor Systems Engineer, RES* Kevin Morrissey

-Project Manager, NMSS Review Methodology

• Two methodologies applied toSHINE accident analyses-Maximum hypothetical accident-Integrated safety analysis* Radiological and chemicalhazards evaluated against 10 CFRParts 20 and 70, respectively Irradiation Facility AccidentAnalysis* Irradiation facility characteristics:

-Operates at low power,pressure, and temperature

-Large heat sink for passivedecay heat removal-Radiological sources Event Identification

• Delineation of possible accidentcategories

• Identification of limiting accidentfor the category* Strategy to mitigate accident andlimit 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 couldbe the operational boundary Limiting Accident* Release of irradiated targetsolution from one TSV* Consequences bounded by RPFmaximum hypothetical accident* Meets 10 CFR Part 20 limits-5 rem for workers-100 mrem for publicProduction Facility AccidentAnalysis* Radiological and chemicalaccident analysis performed

• Defines facility hazards andcontrols that supportestablishment of design basis Production Facility AccidentAnalysis* Multiple event types:-Radiological accidents

-Chemical accidents

-Criticality accidents

-Fires-External events Exhibit SHN-028Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application Safety -Panel 2Accident AnalysisDecember 15, 2015Accident 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 AccidentTarget solution vessel (TSV) andsubcritical assembly supportstructure (SASS) integrity lost,target solution spills intoirradiation unit (IU) cell,Maximum inventories assumedin TSVSPool presence ignoredSHigh radiation

detected, initiates alarms and confinement

°High efficiency particulate air (HEPA) filters and charcoaladsorbers creditedSDose consequences

-Worker TEDE: 3.1 rem ..-Public (site boundary)

TEDE: TSV Q ........0 0017 remRPF Maximum Hypothetical Accident(Facility MHA)°The five noble gasstorage tanks rupturesimultaneously

° With the maximum inventory

• Contents are instantly releasedSHigh radiation levels initiatealarm and cell isolation

, Redundant isolation dampers close' 10% of the activity bypassesthe isolation dampers' 10% of the activity leaks* through penetrations TSV Oft G.~P~.rgeNORSNobk G.~Stosg. Ts,,k~Conden~ot~

Knock Oft Pro~es, Ves~eIThnk v~,,t Syften,R~dIo.ctWn LIqnId Wnte RPF Maximum Hypothetical Accident(Facility MHA)=Dose consequences

• Worker TEDE: rem*Public (site boundary)

TEDE: 0.082 remoThe MHA consequences are conservative

,Simultaneous, instantaneous rupture* Entirety of noble gas is transferred and releasedSThe five tanks are filled to capacity°Additional ventilation isolation dampers wouldclose, but are not credited-Actual doses would be lowerDoses to the Public FromAnalyzed Accidents Radiological consequences toworkers and the public are withinthe limits of 10 CFR 20.1101,20.1201, and 20.1301IEuU _______5 NRC-01 3<U.S.NRCUnited Stjres Nuclear Re~ul~tory Comtml$slon Protecting People and the Environment Construction PermitApplication ReviewSHINE Medical Technologies Panelists

• Jane Marshall-Deputy Director, Division ofLicense 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 FederalRegulations (10 CFR) Part 51-Environmental Standard ReviewPlan (NUREG-1 537)-Interim Staff GuidanceEnvironmental ImpactStatement (EIS)* 10 CFR 51.20* Project-specific decision-Potential significant impacts-First-of-a-kind facility with aunique application oftechnologies

-Public involvement maximized Scoping* 2 public meetings in Janesville, Wisconsin

• 5 oral comments* 6 written commentsDepartment of Energy (DOE)* National Environmental Policy Act-Lead agency: NuclearRegulatory Commission

-Cooperating agency: DOE* American Medical IsotopesProduction Act-Complementary environmental reviews Environmental Review AreasSocioeconomics andEnvironmental JusticeTerrestrial Resources Environmental ImpactsResource Area ImpactLand Use and Visual Resources SMALLAir Quality and Noise SMALLGeologic Environment SMALLEcological and Water Resources SMALLHistoric and Cultural Resources SMALLSocioeconomics SMALLHuman Health and Waste SMALLTransportation 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 theCommission

• Costs-Environmental and financial

• Benefits-Societal,

medical, andeconomicEnvironmental CostsProposed Janesville SiteChippewa Falls Alternative Stevens Point Alternative Alternative Technology No-action Alternative TrafficTraffic, NoiseTraffic1 Noise, VisualTrafficNone* SMALL impacts for all otherresource 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--

• 0Endangered SpeciesAct, Section 7National HistoricPreservation Act,Section 106No EffectNo Adverse Effect Draft Environmental ImpactStatement

• 2 public meetings in Janesville, Wisconsin

• 1 oral comment* 8 written commentsNRC Staff's Recommendation Staff recommends issuance of theconstruction permit.

Future NEPA Analyses* 10 CFR 51 .95(b) requires the staffto supplement the Final EIS-Matters that differ from theFinal EIS-New significant information Acronyms* NRR -Office of Nuclear ReactorRegulation Exhibit SHN-029Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application Environmental OverviewDecember 15, 2015Development of the Environmental Report* Began work October 2011* SHINE production facility will belocated in Janesville, RockCounty, Wisconsin

• Environmental Report follows theFinal Interim Staff GuidanceAugmenting NUREG-1 537ii 2 Structure and Content of the Environmental Report19.1 -Introduction 19.2 -Proposed Action19.3- Descrption of theAffected Environment 19.4- Impacts of theProposed Construction, Operations, andDecommissioning 19.5 -Alternatives 19.6 -Conclusions Purpose and need for the proposed action, Regulatory provisions, permits andrequired consultations 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 Land use and visual resources, Air quality and noise, Geooic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human healthLand 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 effectsNO-action alternative.

Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impactsUnavoidable adverse environmental

impacts, Relationship betweenshort-term uses and long-term productivity of the environment, Irreversible andirretrievable commitments of resources 36Scope of Field Investigations

=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 EcologyoMonthly Water Resources

+Water Quality=Water Levels UContext for Data Acquisition

,Site* 91.27 acre parcel located onthe south side of the City ofJanesville in Rock County, WI* Project Area*Circular area with a radiusapproximately 1 mile from thesite center point' Region' Circular area with a radius of5 miles from the site centerpoint' Larger context as appropriate (e.g., geology, air quality)' Region of Influence

, ,Rock County5Consultations

' 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

' Bureau of Indian Affairs' Native American Tribes (13):' Wisconsin Tribes:,Forest County Potawatomi Community, Wisconsin

°Ho-Chunk Nation of Wisconsin

• Non-Wisconsin Tribes:-' 11 Tribal Entities0~16 Alternative SitesConstruction SMALL impacts to allImpacts resource categories Construction 420 jobs; $635,000Benefits annual property taxpaymentsOperation SMALL impacts to allImpacts resource categories Operation 150 jobs: reliableBenefits source of diagnostic isotopes:

Mo-99,1-131. Xe-1 33;$680.000 annualproperty taxpaymentsMODERATE impactsto Visual Resources, Noise andTransportation 420 jobs; $635,000annual property taxpaymentsSMALL impacts to allresource categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99,1-131. Xe-i133:$680,000 annualproperty taxpaymentsMODERATE impactsto Land use, VisualResources, Noise,Ground Water, andTransportation 420 jobs: $635,000annual property taxpaymentsSMALL impacts to allresource categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99,1-131, Xe-i133;$680,000 annualproperty taxpaymentsSMALL impacts to allresource categories NoneSMALL impat to allresource categories None7Alternative Technologies Eu."lConstruction SMAL impat to allImpat resource categories Construction 420 jobs, $635,000Benefits annual property taxpaymentsOperation SMLL impact to allImpat reorce caeoriesOperation 150 jobs; reliableBenefits source of diagnostic isotopes:

Mo-99,1-131. Xe-i133;$680,000 annualproperty taxpaymentsSMALL impacts to allresource cateories 420 jobs; $635,000annual property taxpaymentsSMALL impacts to allresource categorie 150 jobs; reliablesource of Mo-99;$660,000 annualproperty taxpaymentsSMALL impacts to all SMALL impatsto allresource categories resource categorie 420 jobs; $635,000 Noneannual property taxpaymentsSMALL impacts to all SMALL impacts to allresource categorie resourc categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99, 1-131, Xe-133;$660,000 annualproperty taxpaymentsNone118 NRC Environmental Site AuditJuly 30- August 1, 2013* SHINE presentations on the production process and alternative site selection process-Janesville site visit°Walk down of proposed siteSDriving tourSRock River visitSSampling sites 1 and 2 along theunnamed tributary to the Rock River* Tour of the Janesville Wastewater Treatment Facility,Alternative site visits:-Stevens Point,Chippewa FallsISResponded to NRC Site Audit Information NeedsSHINE and The Community

• SHINE believes the relationships between thecompany, Janesville, and Wisconsin are important

• SHINE favors a policy of transparency with ourcommunity

, SHINE's actions support these principles a Participation in four public meetings per year (two SHINEhosted, two for city council)* SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plansa Regular updates provided to State of Wisconsin

• These activities have fostered a relationship of trust andenthusiasm for the project10 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) ofthe National Environmental Policy Act (NEPA) havebeen satisfied

°SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINEfacility supports issuance of the construction permit11 SCHEDULING NOTETitle: HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICALISOTOPE PRODUCTION FACILITY:

SECTION 189A OF THEATOMIC ENERGY ACT PROCEEDING (Public Meeting)Scheduled:

Purpose:Duration:

Location:

December 15, 20159:00 amTo receive testimony and exhibits regarding the application ofSHINE Medical Technologies, Inc. for a medical radioisotope irradiation and processing facility construction permit. Thetestimony will focus on unique features of the facility or novel issuesthat arose as part of the review process and other significant technical or policy issues associated with aspects of the staff'sreview that are important for the Commission to make its finaldecision.

The Commission will determine whether the staff's reviewhas been adequate to support the findings in 10 C.F.R. §§ 50.35(a)and 51 .105(a).1 dayCommissioners' Conference Room, 1st Floor OWENNOTE: Chairman to provide opening remarks, admit exhibits, and swear in witnesses.

20 mins.Participants:

Presentation (Note: Presenters seated at the table are listed, other staff available to answerquestions will be seated in the well and reser'ved rows.)Overview (SHINE Medical Technologies.

Inc.)At the table:Greg Piefer, Chief Executive

Officer, SHINEJim Costedio,

Manager, Licensing, SHINEBill Hennessy,

Manager, Engineering, SHINEEric Van Abel, Supervisor, Engineering, SHINEToi: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, NRRJane Marshall, Deputy Director, Division of License Renewal, NRRMarissa 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 SHINEconstruction permit application, and summary of regulatory findings.

The staffwill 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 ofthe construction permit application while the staff is expected to discuss its reviewprocess and requlatory conclusions.

Each panel should include a discussion of anypermit 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, SHINEEric Van Abel, Supervisor, Engineering, SHINECatherine Kolb, Supervisor, Engineering, SHINEStaff 10 mins.*At the table:Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRRSteven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRRMary 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 SafetyEvaluation 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, thispanel 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 permitconditions 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, SHINEEric Van Abel, Supervisor, Engineering, SHINECatherine Koib, Supervisor, Engineering, SHINEStaff 10 mains.*At the table:Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRRJoseph Staudenmeier, Senior Reactor Systems Engineer, Reactor Systems CodeDevelopment Branch, Office of Nuclear Regulatory ResearchKevin Morrissey, Project Manager, Fuel Manufacturing Branch, NMSSI~~iSections of the application and the following chapters from the SafetyEvaluation Report:Chapter 13, "Accident Analyses,"

including discussion of novel application of10 CFR Part 50 and 70 accident analysis methodologies for radiological andchemical 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, thispanel 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) 2 is*24 mins.**Environmental

-Panel (2:10 pm)Applicant At the table:Katrina Pitas, Vice President, Business Development, SHINEBill Hennessy,

Manager, Engineering, SHINECatherine Kolb, Supervisor, Engineering, SHINETim Krause, Environmental Specialist, Sargent and Lundy10 mins.*Staff 25 mins.*At the table:Jane Marshall, Deputy Director, Division of License Renewal, NRRDavid Wrona, Chief, Environmental Review and Guidance Update Branch, NRRMichelle Moser, Project Manager and Biologist, NRRTopic: 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 EISo The scoping processo Consultations with other Federal, State, and local agencies andTribes/DOE as a cooperating agencyo The staff's independent review and analysiso Issuance of the Draft EIS, public meetings on the Draft EIS, andsolicitation of stakeholder comments on the Draft EISo 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 siteso Alternative technology o No-action alternative

• Summarize conclusions and recommendation including a summary of thebenefits and costs of the proposed actionCommission 0 & A (round of questions; 6 minutes each)24 mins.**BREA K5 mins.4 Closing (3:15) 5 is54 mins.Closing Statement by Applicant 15 rmins.*Greg Piefer, Chief Executive OfficerClosing Statement by Staff 15 rains.*William Dean, Director, NRRCommission 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 fitamong the panels.**Chapter 12, "Conduct of Operations,"

of the staff's SER includes evaluations ofSHINE's quality assurance program description and preliminary emergency plan.5 HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICALISOTOPE PRODUCTION FACILITY:

SECTION 189A OF THEATOMIC ENERGY ACT PROCEEDING (Public Meeting)December 15, 2015Slides/Handouts Overview-SHINE Medical Technologies, Inc.-NRC StaffSafety -Panel 1-SHINE Medical Technologies, Inc.-NRC StaffSafety -Panel 2-SHINE Medical Technologies, Inc.-NRC StaffEnvironmental

-Panel-SHINE Medical Technologies, Inc.-NRC Staff N RC-010United Nuclear Regulatory C~, mmtnslonProtecting People andt¢ the Environnwnt Construction PermitApplication ReviewSHINE 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

• Molybdenum-99 (99M0) Mc 0.90decays to

-Effective diagnosis o-Minimal exposureV

• 50,000 procedures daily Tc009* No domestically-produced supply ooo.oEstablishing a Domestic Supply* National policy objectives supportdomestic production capabilities

• Cost-sharing agreements encourage commercial partners* SHINE proposes to produce 99M0through uranium fission Preparing for SHINE Review* Interoffice working groupcontributed diverse expertise

• Public meetings engagedstakeholders

• Review coordinated with Federal,State, and local governments Allowing Construction

• SHINE application only seeksconstruction authorization

• Design details may be left foroperating license application

• Review assessed preliminary design and analysis Conducting the Safety Reviewcn~~itWTailoring Review Methodology

• Review accommodated uniquetechnology

• Staff used existing guidance* Staff determined whetherreasonable assurance that finaldesign will conform to designbases Additional Information

• Review supported by additional information

• In some cases, permit conditions necessary

• Regulatory commitments trackitems for resolution in final safetyanalysis report (FSAR)Environmental Regulations

• National Environmental Policy Act-Informs Federal decisionmaking-Public disclosure

• NRC's environmental regulations

-Title 10 of the Code of FederalRegulations (10 CFR) Part 51 Environmental Review Process* Opportunity for PublicInvolvement Proposed Janesville Site..... Agricultural fields....

• Previously disturbed

..... No surface water* featuresI No threatened orendangeredspce

• o historical orcultural resources Regulatory Basis* Commission authorized by AtomicEnergy Act, Section 103* Review primarily based on 10 CFRParts 20, 50, and 51* Review also considered 10 CFRPart 70 performance requirements Construction Permit Issuance* Preliminary design described

• Further technical or designinformation may be left for FSAR* Ongoing research anddevelopment has been identified

• Facility can be constructed andoperated without undue risk Permit Considerations

• Construction will not endangerpublic health and safety* SHINE technically and financially qualified

• Environmental requirements satisfied Introducing Review PanelsSafety Panel 1Safety Panel 2Environmental PanelLicensing Considerations Accident Analysis* Final Environmental Impact Statement Process* Analysis of Alternatives

• Summary ofConclusions andRecommendations Safe...Evaluation.Repor Chapters 1 and 4Safety Evaluation Re portChapter 13Final Environmental ImpactStatement Acronyms* FCSE -Division of Fuel CycleSafety, Safeguards, andEnvironmental Review* DLR -Division of LicenseRenewal* DPR -Division of Policy andRulemaking Acronyms* NMSS- Office of Nuclear MaterialSafety and Safeguards

• NRR -Office of Nuclear ReactorRegulation Exhibit SHN-026Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application OverviewDecember 15, 2015SHINE Medical Technologies, Inc. Mission* SHINE is dedicated to being the world leader in safe,clean, affordable production of medical tracers andcancer treatment elementsa Highest priority is safely delivering a highly reliable, high-quality supply of the medical ingredients requiredby nearly 100,000 patients globally each day, whilemaintaining a minimal environmental impacta Will fill gap in supply chain caused by exiting foreignreactors, 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, decaysinto technetium-99m, which is used in morethan 40 million dosesannually* Stress tests and bonescans most common ofdozens of usesMedicalProchyedursUig"T7M72rn M~&7 A44~ 7717r ~ A7p17 7*? 1717 A7,7~, ~1717<nn{*fll t1717 krr. 7*7* *4747 777W ?77x7777 7ft.1777, Nr~ 777477*774 771~ '777 7,777* 1777 4,JSupply Situation with No New Capacity*Canada will stop operating the NRU reactor inMarch 2018* Following Canadian exit, there will be no NorthAmerican producerHighl relvantNEA Demand Growth (+35% ORC) vs,ig hl relvantcurrent processing

capacity, 2015-202because Mo-99 °decays ~1% per hour z0=Domestic supply ois necessary to j oensure US patient '°health717077 77477 470777 447-J* 471-077 4*4* 471077 4*177 417077 4777.477 77-077 7*477 770772014 2011 2014 2017 2011 2019 2020-.-NEAD.77772g177*

'40% WC,CU7071 ~71*$772 C8277777U4 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 ortargets in medical isotope supply chain* SHINE believes each of these points are essential tofulfill our missionTechnological Approach Reflects Core Values* Small systems:

Hundreds of times less power than isotopeproduction reactors being usedSLow source term--helps ensure safety of public and workforce

,Decay heat per system < 1 kW within 5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />soMinimizes waste nuclide generation compared to reactors* Low enriched uranium (LEU) reusable target* Reduces waste and costProduct 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 locatedon a previously undeveloped 91 acre parcel in thesouthern boundaries of theCity of Janesville inRock County, Wisconsin 7SHINE Facility Layout* The SHINE facility consists of an irradiation facility (IF)and a radioisotope production facility (RPF)ldiationacilityidioisotope roduction Facility8 SHINE Irradiation Facility='The SHINEF IF consists of eight subcritical irradiation units (IUs), which are comparable in thermal powerlevel and safety considerations to existing non-power reactors licensed under 10 CFR Part 50=However, due to subcriticality, the IUs did not meet the existingdefinition of utilization facility in 10 CFR 50.2' To align the licensing process with potential

hazards, the NRCissued a direct final rule modifying 10 CFR 50.2 definition ofutilization facility to include SHINE lUs* An IU consists of a subcritical

assembly, a neutrondriver, and supporting systemsSHINE Radioisotope Production Facility,The RPF is the portion of the SHINE facility used forpreparing target solution; extracting, purifying, andpackaging Mo-99; and the recycling and cleaning oftarget solution* Based on batch size (i.e., greater than 100 grams), theRPF meets the definition of a production facility asdefined in 10 CFR 50.2,1° SHINE Construction Permit Application SSHINE submitted the CP Application in two parts, pursuant to anexemption 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, 2013SRemaining PSAR ChaptersSA discussion of the preliminary plans for coping with emergencies, inaccordance 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 andReviewing 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 Fuelcycle Facility"

, Additional guidance (e.g., Regulatory Guides, ANSIStandards) used12 SHINE Facility Layout* Production, processing, and packaging operations located within one controlled, confined area13SHINE Process OverviewSSupercell Recycle LoopProductRecycle tankTSV andIrradiation Unit CellA~HoldPeriodic Cleanup Loopassociated cleanup* processes 4....-w Target Solution14 paato SHINE Irradiation Facility* An IU consists of a subcritical

assembly, a neutrondriver, 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 andpassively-cooled

• Redundant, fail-open dump valves* TSV is an annular vessel to be constructed ofZircaloy-4

• Natural convection within TSVSHINE's Fusion- FIssion CouplingVN'41411NeutronOriverNeutronMultiplier TargetSolutionVesselN'4> NRadioisotopes in solution15Subcritical AssemblySubcritical AssemblySupportStructure (SASS)TSV Dump Tank -,.TSV and NeutronS Multiplier (Internal to SASS)TSV Dump and Overflow Lines~(2 each)16 Neutron Driver and Tritium Purification System* One Neutron Driver perIU cell* Electrostatic accelerator witha gas target* D-T fusion reaction generates 14 MeV neutrons that drivethe fission process* Tritium purification system* Isotopically separates gases,and supplies clean tritium toneutron drivers* Tritium lines and processing equipment in gloveboxes andq double-walled pipe 1TSV Off-Gas and Primary Cooling Systems*TSV off-gas system (TOGS)* Contains the fission product1 TOGSgases i*of-aRemoves iodine from the* Recombines hydrogen andoxygen to maintain hydrogengas below the lowerflammability limit (LFL)* Subcritical assemblysubmersed in light water pool °-,* Provides shielding and heat s-,..,8AS8) removal ......18 Subcritical Assembly Irradiation Process* Uranium concentration of solution and any othernecessary parameters are measured* Operators use a 1/M startup methodology to monitorthe 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 protectthe primary system boundary (PSB) and ensure theTSV remains subcritical

• High flux trips* Primary cooling system temperature tripsSubcritical Assembly Irradiation Process' When irradiating the TSV:* Further solution addition is prevented

• Tritium is supplied to the target, and neutron driver output isgradually increased

• Reactivity decreases significantly in the assembly due to thestrong negative feedback* Normal irradiation mode operations are approximately 5.5 days-'Following

shutdown, light water pool provides decayheat 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 priorto sampling for release* Released through the Process IVessel Vent System (PWS)*Monitored and filtered discharge to ensure regulatory limits aremet*Recycling and cleaning targetsolution* Uranium extraction (U REX)process separates uranium for ......................

reuse Pu~Packagoe Engineered Safety Features (ESFs)* SHINE protects public health and safety during postulated accidents via aconfinement 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 pipingsystems* Ventilation systems* Instrument and control systems:Engineered Safety FeaturesActuation System (ESFAS)Radiological Integrated controlSystem (RIcS)Zo,,e 2Zen. 3Ventilation Zones in Production Facility22 Summary, Preliminary design described in the PSAR shows theSHINE facility can be constructed such that it meets theapplicable regulatory requirements

• Robust engineered and administrative controls havebeen identified to ensure protection of the public, theenvironment, and our workers, The plant is being designed with safety as the primarycriterion 23 NRC-01l' U.S.NRCUnited Stats Nuileair Regulatory Comnisslio Protecting People and the Emwironment Construction PermitApplication ReviewSHINE Medical Technologies Safety Panel IDecember 1 5o 201 5Panelists

• Alexander Adams, Jr.-Chief, Research and TestReactors 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

• Licensing process similar to thatof research and test reactors* Developed technology-specific guidance for application reviewAdvisory Committee on ReactorSafeguards (ACRS) Review* Staff presented at subcommittee and full committee meetings* ACRS recommended issuance ofconstruction permit* Staff adequately addressed questions regarding aircraftimpact and facility layup Irradiation Unit Licensing

• Irradiation units represent firstsubcritical utilization facilities

• Staff considered licensing under10 CFR Part 70* Given similarities to non-power

reactors, ultimately reviewedunder 10 CFR Part 50Irradiation Unit Design Features* Thermal power level similar tonon-power reactors* Safety considerations include:-Fission heat removal-Decay heat generation

-Fission gas release-Accident scenarios Production Facility Licensing

• Production facility will processirradiated materials containing special nuclear material* Similar to processes at existingfuel cycle facilities

• Staff used NUREG-1537 andInterim Staff GuidanceProposed Permit Conditions

• Criticality accident alarm system* Criticality events "not credible"

• Criticality safety analyses* Reactivity contributions fromfissile isotopes* Radiation shielding andoccupancy times Acronyms*NMSS- Office of Nuclear MaterialSafety and Safeguards

• NRR -Office of Nuclear ReactorRegulation Exhibit SIIN-027qSHINE'TMedical Technologies Commission Mandatory HearingSHINE Construction Permit Application Safety -Panel 1FacilityDecember 15, 2015SHINE Process OverviewRecycle LoopqIB12i~A Recycle tankProductTSV andIrradiation Unit Cell HlePeriodic Cleanup Loop* associated cleanup* processes

.4. *Target Solution~Preparation Design of Structures,

Systems, andCornponents a Certain structures,

systems, and components (SSCs)are designated safety-related because they are reliedupon to perform safety functions during normaloperation or design basis eventsa 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 ResearchReactors")

Safety-Related SSC Definition a Safety-related SSCs are those SSCs that are relied upon to remainfunctional during normal conditions and during and following design basisevents to assure:1. The integrity of the primary system boundary;

2. The capability to shutdown the target solution vessel (TSV) and maintain thetarget solution in a safe shutdown (SSD) condition;

3. The capability to prevent or mitigate the consequences of accidents which couldresult 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 marginof subcriticality;

5. That acute chemical exposures to an individual from licensed material orhazardous chemicals produced from licensed material could not lead toirreversible or other serious, long-lasting health effects to a worker or causemild transient health effects to any individual located outside the ownercontrolled area; or6. 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 designbasis earthquake (DBE) if they perform a safety-related function orif necessary to ensure they do not degrade the function andperformance of a safety-related SSC* SHINE Quality Levels (QLs):SQL-I: Safety-related SSCs are designated as QL-1 in the QualityAssurance Program Description (QAPD), and the full measure ofthe QAPD is applied to these SSCs-QL-2: Selected SSCs that support or protect the safety function ofsafety-related equipment are designated QL-2, and qualityelements are applied commensurate with the importance to safety*QL-3: Nonsafety SSCs that do not support or protect the safetyfunction of safety-related SSCs are designated QL-3Design of Structures,

Systems, andComponents

• Single failure criterion is applied to safety systems-Sufficient redundancy and independence that a single failure ofan active component does not result in loss of capability toperform its safety function-A single failure, in conjunction with initiating event, does notresult in the loss of the system's ability to perform its safetyfunction* SHINE system designs based on defense-in-depth practices, with preference for engineered and passivecontrols over administrative controls6 NRC-012-R SU.S.NRCUnited States Nuclear Regulatory Comni~ssion Protecting PrcopLt and the Enzmnment Construction PermitApplication ReviewSHINE Medical Technologies Safety Panel 2Decermber 1 5 201 5Panelists

• Steven Lynch-Project Manager, NRR* Joseph Staudenmeier

-Senior Reactor Systems Engineer, RES* Kevin Morrissey

-Project Manager, NMSS Review Methodology

• Two methodologies applied toSHINE accident analyses-Maximum hypothetical accident-Integrated safety analysis* Radiological and chemicalhazards evaluated against 10 CFRParts 20 and 70, respectively Irradiation Facility AccidentAnalysis* Irradiation facility characteristics:

-Operates at low power,pressure, and temperature

-Large heat sink for passivedecay heat removal-Radiological sources Event Identification

• Delineation of possible accidentcategories

• Identification of limiting accidentfor the category* Strategy to mitigate accident andlimit 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 couldbe the operational boundary Limiting Accident* Release of irradiated targetsolution from one TSV* Consequences bounded by RPFmaximum hypothetical accident* Meets 10 CFR Part 20 limits-5 rem for workers-100 mrem for publicProduction Facility AccidentAnalysis* Radiological and chemicalaccident analysis performed

• Defines facility hazards andcontrols that supportestablishment of design basis Production Facility AccidentAnalysis* Multiple event types:-Radiological accidents

-Chemical accidents

-Criticality accidents

-Fires-External events Exhibit SHN-028Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application Safety -Panel 2Accident AnalysisDecember 15, 2015Accident 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 AccidentTarget solution vessel (TSV) andsubcritical assembly supportstructure (SASS) integrity lost,target solution spills intoirradiation unit (IU) cell,Maximum inventories assumedin TSVSPool presence ignoredSHigh radiation

detected, initiates alarms and confinement

°High efficiency particulate air (HEPA) filters and charcoaladsorbers creditedSDose consequences

-Worker TEDE: 3.1 rem ..-Public (site boundary)

TEDE: TSV Q ........0 0017 remRPF Maximum Hypothetical Accident(Facility MHA)°The five noble gasstorage tanks rupturesimultaneously

° With the maximum inventory

• Contents are instantly releasedSHigh radiation levels initiatealarm and cell isolation

, Redundant isolation dampers close' 10% of the activity bypassesthe isolation dampers' 10% of the activity leaks* through penetrations TSV Oft G.~P~.rgeNORSNobk G.~Stosg. Ts,,k~Conden~ot~

Knock Oft Pro~es, Ves~eIThnk v~,,t Syften,R~dIo.ctWn LIqnId Wnte RPF Maximum Hypothetical Accident(Facility MHA)=Dose consequences

• Worker TEDE: rem*Public (site boundary)

TEDE: 0.082 remoThe MHA consequences are conservative

,Simultaneous, instantaneous rupture* Entirety of noble gas is transferred and releasedSThe five tanks are filled to capacity°Additional ventilation isolation dampers wouldclose, but are not credited-Actual doses would be lowerDoses to the Public FromAnalyzed Accidents Radiological consequences toworkers and the public are withinthe limits of 10 CFR 20.1101,20.1201, and 20.1301IEuU _______5 NRC-01 3<U.S.NRCUnited Stjres Nuclear Re~ul~tory Comtml$slon Protecting People and the Environment Construction PermitApplication ReviewSHINE Medical Technologies Panelists

• Jane Marshall-Deputy Director, Division ofLicense 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 FederalRegulations (10 CFR) Part 51-Environmental Standard ReviewPlan (NUREG-1 537)-Interim Staff GuidanceEnvironmental ImpactStatement (EIS)* 10 CFR 51.20* Project-specific decision-Potential significant impacts-First-of-a-kind facility with aunique application oftechnologies

-Public involvement maximized Scoping* 2 public meetings in Janesville, Wisconsin

• 5 oral comments* 6 written commentsDepartment of Energy (DOE)* National Environmental Policy Act-Lead agency: NuclearRegulatory Commission

-Cooperating agency: DOE* American Medical IsotopesProduction Act-Complementary environmental reviews Environmental Review AreasSocioeconomics andEnvironmental JusticeTerrestrial Resources Environmental ImpactsResource Area ImpactLand Use and Visual Resources SMALLAir Quality and Noise SMALLGeologic Environment SMALLEcological and Water Resources SMALLHistoric and Cultural Resources SMALLSocioeconomics SMALLHuman Health and Waste SMALLTransportation 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 theCommission

• Costs-Environmental and financial

• Benefits-Societal,

medical, andeconomicEnvironmental CostsProposed Janesville SiteChippewa Falls Alternative Stevens Point Alternative Alternative Technology No-action Alternative TrafficTraffic, NoiseTraffic1 Noise, VisualTrafficNone* SMALL impacts for all otherresource 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--

• 0Endangered SpeciesAct, Section 7National HistoricPreservation Act,Section 106No EffectNo Adverse Effect Draft Environmental ImpactStatement

• 2 public meetings in Janesville, Wisconsin

• 1 oral comment* 8 written commentsNRC Staff's Recommendation Staff recommends issuance of theconstruction permit.

Future NEPA Analyses* 10 CFR 51 .95(b) requires the staffto supplement the Final EIS-Matters that differ from theFinal EIS-New significant information Acronyms* NRR -Office of Nuclear ReactorRegulation Exhibit SHN-029Medical Technologies Commission Mandatory HearingSHINE Construction Permit Application Environmental OverviewDecember 15, 2015Development of the Environmental Report* Began work October 2011* SHINE production facility will belocated in Janesville, RockCounty, Wisconsin

• Environmental Report follows theFinal Interim Staff GuidanceAugmenting NUREG-1 537ii 2 Structure and Content of the Environmental Report19.1 -Introduction 19.2 -Proposed Action19.3- Descrption of theAffected Environment 19.4- Impacts of theProposed Construction, Operations, andDecommissioning 19.5 -Alternatives 19.6 -Conclusions Purpose and need for the proposed action, Regulatory provisions, permits andrequired consultations 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 Land use and visual resources, Air quality and noise, Geooic environment, Water resources, Ecological resources, Historic and cultural resources, Socioeconomics,s Human healthLand 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 effectsNO-action alternative.

Reasonable altemnatives, Cost-beneflt of the alternatives, Comparison of potential environmental impactsUnavoidable adverse environmental

impacts, Relationship betweenshort-term uses and long-term productivity of the environment, Irreversible andirretrievable commitments of resources 36Scope of Field Investigations

=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 EcologyoMonthly Water Resources

+Water Quality=Water Levels UContext for Data Acquisition

,Site* 91.27 acre parcel located onthe south side of the City ofJanesville in Rock County, WI* Project Area*Circular area with a radiusapproximately 1 mile from thesite center point' Region' Circular area with a radius of5 miles from the site centerpoint' Larger context as appropriate (e.g., geology, air quality)' Region of Influence

, ,Rock County5Consultations

' 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

' Bureau of Indian Affairs' Native American Tribes (13):' Wisconsin Tribes:,Forest County Potawatomi Community, Wisconsin

°Ho-Chunk Nation of Wisconsin

• Non-Wisconsin Tribes:-' 11 Tribal Entities0~16 Alternative SitesConstruction SMALL impacts to allImpacts resource categories Construction 420 jobs; $635,000Benefits annual property taxpaymentsOperation SMALL impacts to allImpacts resource categories Operation 150 jobs: reliableBenefits source of diagnostic isotopes:

Mo-99,1-131. Xe-1 33;$680.000 annualproperty taxpaymentsMODERATE impactsto Visual Resources, Noise andTransportation 420 jobs; $635,000annual property taxpaymentsSMALL impacts to allresource categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99,1-131. Xe-i133:$680,000 annualproperty taxpaymentsMODERATE impactsto Land use, VisualResources, Noise,Ground Water, andTransportation 420 jobs: $635,000annual property taxpaymentsSMALL impacts to allresource categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99,1-131, Xe-i133;$680,000 annualproperty taxpaymentsSMALL impacts to allresource categories NoneSMALL impat to allresource categories None7Alternative Technologies Eu."lConstruction SMAL impat to allImpat resource categories Construction 420 jobs, $635,000Benefits annual property taxpaymentsOperation SMLL impact to allImpat reorce caeoriesOperation 150 jobs; reliableBenefits source of diagnostic isotopes:

Mo-99,1-131. Xe-i133;$680,000 annualproperty taxpaymentsSMALL impacts to allresource cateories 420 jobs; $635,000annual property taxpaymentsSMALL impacts to allresource categorie 150 jobs; reliablesource of Mo-99;$660,000 annualproperty taxpaymentsSMALL impacts to all SMALL impatsto allresource categories resource categorie 420 jobs; $635,000 Noneannual property taxpaymentsSMALL impacts to all SMALL impacts to allresource categorie resourc categories 150 jobs; reliablesource of diagnostic isotopes:

Mo-99, 1-131, Xe-133;$660,000 annualproperty taxpaymentsNone118 NRC Environmental Site AuditJuly 30- August 1, 2013* SHINE presentations on the production process and alternative site selection process-Janesville site visit°Walk down of proposed siteSDriving tourSRock River visitSSampling sites 1 and 2 along theunnamed tributary to the Rock River* Tour of the Janesville Wastewater Treatment Facility,Alternative site visits:-Stevens Point,Chippewa FallsISResponded to NRC Site Audit Information NeedsSHINE and The Community

• SHINE believes the relationships between thecompany, Janesville, and Wisconsin are important

• SHINE favors a policy of transparency with ourcommunity

, SHINE's actions support these principles a Participation in four public meetings per year (two SHINEhosted, two for city council)* SHINE management involvement in community activities a Regular discussions with city leadership to coordinate plansa Regular updates provided to State of Wisconsin

• These activities have fostered a relationship of trust andenthusiasm for the project10 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) ofthe National Environmental Policy Act (NEPA) havebeen satisfied

°SHINE's weighing and balancing of the environmental, technical, and other costs and benefits of the SHINEfacility supports issuance of the construction permit11