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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
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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
- Deputy Director, NRR/DLP
- Deputy Director, NRR/DMLR
- Deputy Director, NMSS/FCSE 2
99Mo Overview
- Effective diagnosis
- Minimal exposure
- 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 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
- 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
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
- NMSS - Office of Nuclear Material Safety and Safeguards
- FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review 1 7
Acronyms
- NRC - U.S. Nuclear Regulatory Commission
- NWMI - Northwest Medical Isotopes
- CFR - Code of Federal Regulations
- FSAR - final safety analysis report 1 8