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{{#Wiki_filter:NRC-010 Northwest Medical Isotopes Construction Permit Application Review | |||
* Mandatory Hearing (Overview Panel) | |||
* January 23, 2018 United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: NORTHWEST MEDICAL ISOTOPES, LLC (Medical Radioisotope Production Facility) | |||
Commission Mandatory Hearing Docket #: 05000609 Exhibit #: NRC-010-MA-CM01 Identified: 1/23/2018 Admitted: 1/23/2018 Withdrawn: | |||
Rejected: Stricken: | |||
Other: | |||
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 supply 3 | |||
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 Safety Review ACRS Review Application Commission Submitted to NRC Mandatory Decision Hearing on Permit Environmental Review 7 | |||
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 Policy Act | |||
- Informs Federal decision making | |||
- Public disclosure | |||
* NRC environmental regulations in 10 CFR Part 51 | |||
- NRC regulations implementing the National Environmental Policy Act 1 | |||
0 | |||
Environmental Review Process Environmental Report Draft Final Environmental Comment Environmental Environmental Site Audit Period | |||
* Impact Impact Statement Statement Scoping * | |||
* Opportunity for Public Request for Involvement Additional Information 1 | |||
1 | |||
Proposed Discovery Ridge Site | |||
* Agricultural land | |||
* Previously disturbed | |||
* No surface water features | |||
* No threatened or endangered species | |||
* No historical or cultural resources 1 | |||
2 | |||
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 Panel Number Discussion Topics Evaluation Areas Safety Panel 1 Licensing Safety Evaluation Considerations Report Chapters 1, 4, and 12 Safety Panel 2 Accident Analysis Safety Evaluation Methodology Report Chapter 13 Environmental Panel | |||
* Final Environmental Final Environmental Impact Statement Impact Statement Process | |||
* Scope and Connected Actions | |||
* Analysis of Alternatives 1 | |||
6 | |||
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 | |||
* 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 1 8}} |
Latest revision as of 02:32, 22 October 2019
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
NRC-010 Northwest Medical Isotopes Construction Permit Application Review
- Mandatory Hearing (Overview Panel)
- January 23, 2018 United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: NORTHWEST MEDICAL ISOTOPES, LLC (Medical Radioisotope Production Facility)
Commission Mandatory Hearing Docket #: 05000609 Exhibit #: NRC-010-MA-CM01 Identified: 1/23/2018 Admitted: 1/23/2018 Withdrawn:
Rejected: Stricken:
Other:
Panelists
- Deputy Director for Reactor Safety Programs and Mission Support, NRR
- MaryJane Ross-Lee
- Deputy Director, NRR/DLP
- Deputy Director, NRR/DMLR
- Deputy Director, NMSS/FCSE 2
99Mo Overview
- 99Mo decays to 99mTc
- Effective diagnosis
- Minimal exposure
- 50,000 procedures daily
- No domestically-produced supply 3
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 Safety Review ACRS Review Application Commission Submitted to NRC Mandatory Decision Hearing on Permit Environmental Review 7
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 Policy Act
- Informs Federal decision making
- Public disclosure
- NRC environmental regulations in 10 CFR Part 51
- NRC regulations implementing the National Environmental Policy Act 1
0
Environmental Review Process Environmental Report Draft Final Environmental Comment Environmental Environmental Site Audit Period
- Impact Impact Statement Statement Scoping *
- Opportunity for Public Request for Involvement Additional Information 1
1
Proposed Discovery Ridge Site
- Agricultural land
- Previously disturbed
- No surface water features
- No threatened or endangered species
- No historical or cultural resources 1
2
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 Panel Number Discussion Topics Evaluation Areas Safety Panel 1 Licensing Safety Evaluation Considerations Report Chapters 1, 4, and 12 Safety Panel 2 Accident Analysis Safety Evaluation Methodology Report Chapter 13 Environmental Panel
- Final Environmental Final Environmental Impact Statement Impact Statement Process
- Scope and Connected Actions
- Analysis of Alternatives 1
6
- 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
- 99Mo - molybdenum-99
- 99mTc - technetium-99m
- NRC - U.S. Nuclear Regulatory Commission
- NWMI - Northwest Medical Isotopes
- CFR - Code of Federal Regulations
- FSAR - final safety analysis report 1 8