ML18025B121

Official Exhibit - NRC-010-MA-CM01 - Staff Presentation Slides - Overview (Jan. 16, 2018)

ML18025B121
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	01/16/2018
From:	NRC/OGC
To:	NRC/OCM
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54173
Download: ML18025B121 (18)

Text

Northwest Medical IsotopesConstruction Permit Application Review*Mandatory Hearing (Overview Panel)

• January 23, 2018 Panelists

• Michele Evans

-Deputy Director for Reactor Safety Programs and Mission Support, NRR

• MaryJane Ross

-Lee-Deputy Director, NRR/DLP

• Joseph Donoghue

-Deputy Director, NRR/DMLR

• Brian Smith

-Deputy Director, NMSS/FCSE 2

99Mo Overview

• 99Mo decays to 99mTc-Effective diagnosis

-Minimal exposure

• 50,000 procedures daily

• No domestically

-produced supply3 Establishing a Domestic Supply of 99Mo*NRC supports U.S. policy objectives to establish domestic 99Mo production

• First construction permit for domestic 99Mo production issued to SHINE Medical Technologies in 2016

• Northwest Medical Isotopes would produce 99Mo by processing irradiated low enriched uranium targets 4

Conducting the NWMI Review

• Review of NWMI application supported by procedural efficiencies and previous licensing experience

-Two-part application submission

-Document templates

-Permit condition supporting quality assurance implementation

• Staff and contractors spent ~12,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> reviewing NWMI application 5

Authorizing Construction

• NWMI seeks authorization to construct 10 CFR Part 50 production facility*Staff review based on preliminary design and analysis of facility

-Design details may be left for operating license application

-Target fabrication activities to be considered under a 10 CFR Part 70 application 6

Conducting the Safety Review 7Environmental ReviewACRS ReviewMandatory HearingApplication Submitted to NRCCommission Decision on PermitSafetyReview Tailoring Review Methodology

• Review accommodated unique aspects of the NWMI application

• Staff adapted existing guidance for research reactors, production facilities, and fuel cycle facilities

• Review focused on whether there was reasonable assurance that the final design would conform to design bases 8

Additional Information

• In response to staff requests, NWMI provided additional information

• In some cases, permit conditions were necessary to support findings

• Regulatory commitments track items for resolution in Final Safety Analysis Report9 Environmental Requirements

• National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure

• NRC environmentalregulations in 10 CFR Part 51

-NRC regulations implementing the National Environmental Policy Act 10 Environmental ReviewProcessEnvironmentalSiteAuditDraft Environmental Impact StatementScoping*Comment Period**Opportunity for Public InvolvementFinal Environmental Impact Statement EnvironmentalReportRequestforAdditional Information11 Proposed Discovery Ridge Site12*Agriculturalland*Previouslydisturbed

• No surface water features*No threatened or endangeredspecies*No historical or culturalresources Statutory and Regulatory Basis for Construction Permit Issuance

• Commission authorized to issue permits by Atomic Energy Act, Section 103

• Applicable requirements in 10 CFR Parts 20, 50, and 51

• Performance requirements in 10 CFR Part 70 also considered 13 Construction Permit Findings

• Preliminary facility design described

• Further technical or design information may be left for FSAR

• Ongoing research and development identified

• Facility can be constructed and operated without undue risk 14 Construction Permit Considerations

• Construction will not endanger public health and safety

• NWMI is technically and financially qualified

• Environmental requirements have been satisfied 15 Introducing the Review Panels 16PanelNumberDiscussion Topics Evaluation AreasSafety Panel 1Licensing ConsiderationsSafetyEvaluation ReportChapters1, 4, and 12Safety Panel 2Accident Analysis MethodologySafety Evaluation ReportChapter13Environmental Panel

• Final EnvironmentalImpact Statement Process*Scope and Connected Actions

• Analysis of AlternativesFinal Environmental Impact Statement Acronyms*NRR -Office of Nuclear Reactor Regulation

• DLP -Division of Licensing Projects

• DMLR-Division of Materials and License Renewal

• NMSS-Office of Nuclear Material Safety and Safeguards

• FCSE-Division of Fuel Cycle Safety, Safeguards, and Environmental Review17 Acronyms*99Mo-molybdenum

-99*99mTc-technetium

-99m*NRC-U.S. Nuclear Regulatory Commission

• NWMI-Northwest Medical Isotopes

• CFR-Code of Federal Regulations

• ACRS-Advisory Committee on Reactor Safeguards

• FSAR-final safety analysis report 18