ML18025B121: Difference between revisions
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{{#Wiki_filter:NorthwestMedical 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/FCSE2 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 targets4 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 hours 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 application6 Conducting the Safety Review7EnvironmentalReviewACRS 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 bases8 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 EnvironmentalRequirements*National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure*NRC environmentalregulations in 10 CFR Part 51-NRC regulations implementing the National Environmental Policy Act10 Environmental ReviewProcessEnvironmentalSiteAuditDraft Environmental Impact StatementScoping*Comment Period**Opportunity for Public InvolvementFinal Environmental Impact StatementEnvironmentalReportRequestforAdditionalInformation11 Proposed Discovery RidgeSite12*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 considered13 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 risk14 Construction Permit Considerations*Construction will not endanger public health and safety*NWMI is technically and financially qualified*Environmental requirements have been satisfied15 Introducing the Review Panels16PanelNumberDiscussion TopicsEvaluationAreasSafety 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 report18 | {{#Wiki_filter:NorthwestMedical 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/FCSE2 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 targets4 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 hours 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 application6 Conducting the Safety Review7EnvironmentalReviewACRS 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 bases8 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 EnvironmentalRequirements*National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure*NRC environmentalregulations in 10 CFR Part 51-NRC regulations implementing the National Environmental Policy Act10 Environmental ReviewProcessEnvironmentalSiteAuditDraft Environmental Impact StatementScoping*Comment Period**Opportunity for Public InvolvementFinal Environmental Impact StatementEnvironmentalReportRequestforAdditionalInformation11 Proposed Discovery RidgeSite12*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 considered13 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 risk14 Construction Permit Considerations*Construction will not endanger public health and safety*NWMI is technically and financially qualified*Environmental requirements have been satisfied15 Introducing the Review Panels16PanelNumberDiscussion TopicsEvaluationAreasSafety 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 report18}} | ||
}} | |||
Revision as of 02:14, 18 May 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
NorthwestMedical 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/FCSE2 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 targets4 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 application6 Conducting the Safety Review7EnvironmentalReviewACRS 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 bases8 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 EnvironmentalRequirements*National Environmental PolicyAct-Informs Federal decision making-Publicdisclosure*NRC environmentalregulations in 10 CFR Part 51-NRC regulations implementing the National Environmental Policy Act10 Environmental ReviewProcessEnvironmentalSiteAuditDraft Environmental Impact StatementScoping*Comment Period**Opportunity for Public InvolvementFinal Environmental Impact StatementEnvironmentalReportRequestforAdditionalInformation11 Proposed Discovery RidgeSite12*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 considered13 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 risk14 Construction Permit Considerations*Construction will not endanger public health and safety*NWMI is technically and financially qualified*Environmental requirements have been satisfied15 Introducing the Review Panels16PanelNumberDiscussion TopicsEvaluationAreasSafety 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 report18