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{{#Wiki_filter:Northwest Medical IsotopesConstruction Permit Application Review*Mandatory Hearing (Overview Panel) | {{#Wiki_filter:Northwest Medical IsotopesConstruction Permit Application Review*Mandatory Hearing (Overview Panel) | ||
*January 23, 2018 Panelists | *January 23, 2018 Panelists*Michele Evans | ||
*Michele Evans | |||
-Deputy Director for Reactor Safety Programs and Mission Support, NRR | -Deputy Director for Reactor Safety Programs and Mission Support, NRR | ||
*MaryJane Ross | *MaryJane Ross | ||
| Line 27: | Line 26: | ||
-Deputy Director, NMSS/FCSE 2 | -Deputy Director, NMSS/FCSE 2 | ||
99Mo Overview | 99Mo Overview | ||
*99Mo decays to | *99Mo decays to 99m Tc-Effective diagnosis | ||
-Minimal exposure | -Minimal exposure | ||
*50,000 procedures daily | *50,000 procedures daily | ||
*No domestically | *No domestically | ||
-produced | -produced supply 3 Establishing a Domestic Supply of 99 Mo*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 | *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 | *Northwest Medical Isotopes would produce 99Mo by processing irradiated low enriched uranium targets 4 | ||
| Line 44: | Line 43: | ||
-Design details may be left for operating license application | -Design details may be left for operating license application | ||
-Target fabrication activities to be considered under a 10 CFR Part 70 application 6 | -Target fabrication activities to be considered under a 10 CFR Part 70 application 6 | ||
Conducting the Safety Review | Conducting the Safety Review 7 Environmental Review ACRS Review Mandatory Hearing Application Submitted to NRC Commission Decision on PermitSafetyReview Tailoring Review Methodology | ||
*Review accommodated unique aspects of the NWMI application | *Review accommodated unique aspects of the NWMI application | ||
*Staff adapted existing guidance for research reactors, production facilities, and fuel cycle facilities | *Staff adapted existing guidance for research reactors, production facilities, and fuel cycle facilities | ||
| Line 51: | Line 50: | ||
*In response to staff requests, NWMI provided additional information | *In response to staff requests, NWMI provided additional information | ||
*In some cases, permit conditions were necessary to support findings | *In some cases, permit conditions were necessary to support findings | ||
*Regulatory commitments track items for resolution in Final Safety Analysis | *Regulatory commitments track items for resolution in Final Safety Analysis Report 9 Environmental Requirements | ||
*National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure | *National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure | ||
*NRC environmentalregulations in 10 CFR Part 51 | *NRC environmentalregulations in 10 CFR Part 51 | ||
-NRC regulations implementing the National Environmental Policy Act | -NRC regulations implementing the National Environmental Policy Act 1 0 Environmental ReviewProcess E n vi ronme n t alSiteAuditDraft E n vi ronme n tal Impact StatementScoping*Comme n t Period**Opportunity for Public InvolvementFinal E n vi ronme n tal Impact Statement E n vi ronme n t alReportRequestforAdditional I n form ation 1 1 Proposed Discovery Ridge Site 1 2*Agriculturalland*Previouslydisturbed*No surface water features*No threatened or endangeredspecies*No historical or culturalresources Statutory and Regulatory Basis for Construction Permit Issuance | ||
*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 | *Commission authorized to issue permits by Atomic Energy Act, Section 103 | ||
*Applicable requirements in 10 CFR Parts 20, 50, and 51 | *Applicable requirements in 10 CFR Parts 20, 50, and 51 | ||
*Performance requirements in 10 CFR Part 70 also considered | *Performance requirements in 10 CFR Part 70 also considered 1 3 Construction Permit Findings | ||
*Preliminary facility design described | *Preliminary facility design described | ||
*Further technical or design information may be left for FSAR | *Further technical or design information may be left for FSAR | ||
*Ongoing research and development identified | *Ongoing research and development identified | ||
*Facility can be constructed and operated without undue risk | *Facility can be constructed and operated without undue risk 1 4 Construction Permit Considerations | ||
*Construction will not endanger public health and safety | *Construction will not endanger public health and safety | ||
*NWMI is technically and financially qualified | *NWMI is technically and financially qualified*Environmental requirements have been satisfied 1 5 Introducing the Review Panels 1 6 Panel Number Discussion Topics Evaluation AreasSafety Panel 1Licensing ConsiderationsSafetyEvaluation ReportChapters1, 4, and 12Safety Panel 2Accident Analysis MethodologySafety Evaluation ReportChapter 13Environmental Panel | ||
*Environmental requirements have been satisfied | |||
*Final EnvironmentalImpact Statement Process*Scope and Connected Actions | *Final EnvironmentalImpact Statement Process*Scope and Connected Actions | ||
*Analysis of AlternativesFinal Environmental Impact Statement Acronyms*NRR -Office of Nuclear Reactor Regulation | *Analysis of AlternativesFinal Environmental Impact Statement Acronyms*NRR -Office of Nuclear Reactor Regulation | ||
| Line 71: | Line 68: | ||
*DMLR-Division of Materials and License Renewal | *DMLR-Division of Materials and License Renewal | ||
*NMSS-Office of Nuclear Material Safety and Safeguards | *NMSS-Office of Nuclear Material Safety and Safeguards | ||
*FCSE-Division of Fuel Cycle Safety, Safeguards, and Environmental | *FCSE-Division of Fuel Cycle Safety, Safeguards, and Environmental Review 1 7 Acronyms*99 Mo-molybdenum | ||
-99* | -99*99m Tc-technetium | ||
-99m*NRC-U.S. Nuclear Regulatory Commission | -99m*NRC-U.S. Nuclear Regulatory Commission | ||
*NWMI-Northwest Medical Isotopes | *NWMI-Northwest Medical Isotopes | ||
*CFR-Code of Federal Regulations | *CFR-Code of Federal Regulations | ||
*ACRS-Advisory Committee on Reactor Safeguards | *ACRS-Advisory Committee on Reactor Safeguards | ||
*FSAR-final safety analysis report | *FSAR-final safety analysis report 1 8}} | ||
Revision as of 04:54, 6 July 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 99m Tc-Effective diagnosis
-Minimal exposure
- 50,000 procedures daily
- No domestically
-produced supply 3 Establishing a Domestic Supply of 99 Mo*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 7 Environmental Review ACRS Review Mandatory Hearing Application Submitted to NRC Commission 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 Report 9 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 1 0 Environmental ReviewProcess E n vi ronme n t alSiteAuditDraft E n vi ronme n tal Impact StatementScoping*Comme n t Period**Opportunity for Public InvolvementFinal E n vi ronme n tal Impact Statement E n vi ronme n t alReportRequestforAdditional I n form ation 1 1 Proposed Discovery Ridge Site 1 2*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 1 3 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 1 4 Construction Permit Considerations
- Construction will not endanger public health and safety
- NWMI is technically and financially qualified*Environmental requirements have been satisfied 1 5 Introducing the Review Panels 1 6 Panel Number Discussion Topics Evaluation AreasSafety Panel 1Licensing ConsiderationsSafetyEvaluation ReportChapters1, 4, and 12Safety Panel 2Accident Analysis MethodologySafety Evaluation ReportChapter 13Environmental 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 Review 1 7 Acronyms*99 Mo-molybdenum
-99*99m Tc-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 1 8