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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: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 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 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}} |
|
---|
Category:Legal-Exhibit
MONTHYEARML18058B0452018-02-0606 February 2018 Official Exhibit - NWMI-012-MA-CM01 - Northwest Medical Isotopes, LLC Responses to Commission'S Public Post-Hearing Questions ML18058B0462018-02-0606 February 2018 Official Exhibit - NRC-014-MA-CM01 - NRC Staff Responses to Commission Post-Hearing Questions (Feb. 6, 2018) ML18025B0992018-01-23023 January 2018 Official Exhibit - NWMI-004-R-MA-CM01 - Northwest Medical Isotopes, LLC Presentation Slides: Overview Presentation ML18025B1182018-01-16016 January 2018 Official Exhibit - NRC-004-MA-CM01 - NRC Staff Revised Responses to Commission Pre-Hearing Questions (Jan. 16, 2018) ML18025B0972018-01-16016 January 2018 Official Exhibit - NWMI-001-R-MA-CM01 - Northwest Medical Isotopes, LLC Responses to Commission'S Public Pre-Hearing Questions ML18025B0982018-01-16016 January 2018 Official Exhibit - NWMI-003-R-MA-CM01 - Statement of Qualifications in Support of Northwest Medical Isotopes, LLC Medical Radioisotope Production Facility Construction Permit Application ML18025B1002018-01-16016 January 2018 Official Exhibit - NWMI-005-R-MA-CM01 - Northwest Medical Isotopes, LLC Presentation Slides: Safety 1 Presentation ML18025B1042018-01-16016 January 2018 Official Exhibit - NWMI-006-R-MA-CM01 - Northwest Medical Isotopes, LLC Presentation Slides: Safety 2 Presentation ML18025B1062018-01-16016 January 2018 Official Exhibit - NWMI-007-R-MA-CM01 - Northwest Medical Isotopes, LLC Presentation Slides: Environmental Presentation ML18025B1082018-01-16016 January 2018 Official Exhibit - NWMI-011-R-MA-CM01 - Applicant'S Pre-Filed Testimony of Carolyn C. Haass for the Mandatory Hearing on Uncontested Issues for the Northwest Medical Isotopes, LLC Medical Radioisotope Production Facility ML18025B1132018-01-16016 January 2018 Official Exhibit - NRC-002-MA-CM01 - Draft Construction Permit for Northwest Medical Isotopes, LLC (Nov. 17, 2017) (Revised Jan. 16, 2018) ML18025B1172018-01-16016 January 2018 Official Exhibit - NRC-003-MA-CM01 - Draft Summary Record of Decision, Construction Permit Application for the Northwest Medical Isotopes, LLC Radioisotope Production Facility (Nov. 17, 2017) (Revised Jan. 16, 2018) ML18025B1212018-01-16016 January 2018 Official Exhibit - NRC-010-MA-CM01 - Staff Presentation Slides - Overview (Jan. 16, 2018) ML18025B1262018-01-16016 January 2018 Official Exhibit - NRC-012-MA-CM01 - Staff Presentation Slides - Safety Panel 2 (Jan. 16, 2018) ML18025B1292018-01-16016 January 2018 Official Exhibit - NRC-013-MA-CM01 - Staff Presentation Slides - Environmental Panel (Jan. 16, 2018) ML18025B1232018-01-16016 January 2018 Official Exhibit - NRC-011-MA-CM01 - Staff Presentation Slides - Safety Panel 1 (Jan. 16, 2018) ML18025B0902017-12-18018 December 2017 Official Exhibit - NWMI-010-MA-CM01 - Exemption Request Pursuant to 10 CFR 70.17, from Requirement of 10 CFR 70.21(f), Filing, for Northwest Medical Isotopes, LLC Radioisotope Production Facility, Dated December 18, 2017 ML18025B0872017-12-14014 December 2017 Official Exhibit - NWMI-008-MA-CM01 - Federal, State of Missouri, City of Columbia, and Boone County Letters of Support for the Construction and Operation of the Northwest Medical Isotopes, LLC Radioisotope Production Facility ML18025B1382017-11-30030 November 2017 Official Exhibit - NRC-008-MA-CM01 - Safety Evaluation Report Related to the Northwest Medical Isotopes, LLC Construction Permit Application for a Production Facility (Nov. 2017) (as Revised Jan. 2018) ML18025B1112017-11-16016 November 2017 Official Exhibit - NRC-001-MA-CM01 - SECY-17-0116, Staff Statement in Support of the Uncontested Hearing for Issuance of a Construction Permit for the Northwest Medical Isotopes, LLC Production Facility (Nov. 16, 2017) ML18025B1582017-09-30030 September 2017 Official Exhibit - NRC-006C-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. 3, Chapter 3 (Sep. 2017) ML18025B1682017-09-30030 September 2017 Official Exhibit - NRC-006G-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. 3, Chapters 13 Through 18 (Sep. 2017) ML18025B1652017-09-30030 September 2017 Official Exhibit - NRC-006F-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. 3, Chapters 11 Through 12 (Sep. 2017) ML18025B1622017-09-30030 September 2017 Official Exhibit - NRC-006E-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. 3, Chapters 5 Through 10 (Sep. 2017) ML18025B1602017-09-30030 September 2017 Official Exhibit - NRC-006D-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. 3, Chapter 4 (Sep. 2017) ML18025B1552017-09-30030 September 2017 Official Exhibit - NRC-006B-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - Preliminary Safety Analysis Report (Psar), NWMI-2013-021, Rev. 3, Chapters 1 Through 2 (Sep. 2017) ML18025B0892017-09-15015 September 2017 Official Exhibit - NWMI-009-MA-CM01 - Clean Water Act Section 401 Water Quality Certification of Northwest Medical Isotopes, LLC Facility in Boone County, NUREG-2209/CEK007189 ML18025B1402017-05-31031 May 2017 Official Exhibit - NRC-009-MA-CM01 - NUREG-2209, Final Environmental Impact Statement for the Construction Permit for Northwest Medical Isotopes Radioisotope Production Facility (May 2017) ML18025B1722015-06-30030 June 2015 Official Exhibit - NRC-006I-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. Oa, Chapter 19, 19-131 Through End (Jun. 2015) ML18025B1702015-06-30030 June 2015 Official Exhibit - NRC-006H-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - PSAR, NWMI-2013-021, Rev. Oa, Chapter 19, Beginning Through 19-130 (Jun. 2015) ML18025B1542015-02-15015 February 2015 Official Exhibit - NRC-006A-MA-CM01 - Northwest Medical Isotopes, LLC, Construction Permit Application - Cover Letter and General and Financial Information (Feb. 5, 2015) 2018-02-06
[Table view] |
Text
Northwest Medical IsotopesConstruction Permit Application Review*Mandatory Hearing (Overview Panel)
- January 23, 2018 Panelists
-Deputy Director for Reactor Safety Programs and Mission Support, NRR
-Lee-Deputy Director, NRR/DLP
-Deputy Director, NRR/DMLR
-Deputy Director, NMSS/FCSE 2
99Mo Overview
-Minimal exposure
-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 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
- 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
- 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