ML19343A823
| ML19343A823 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/12/2019 |
| From: | SHINE Medical Technologies |
| To: | Office of Nuclear Material Safety and Safeguards |
| Jennifer Davis | |
| References | |
| Download: ML19343A823 (22) | |
Text
SHINE Medical Technologies, LLC (SHINE)
Operating License Application Review Process and Environmental Scoping Meeting 1
December 12, 2019
2 Purpose of Todays Meeting
- Provide an overview of the operating license application review process
- Safety review
- Environmental review
- Receive public input on the scope of the environmental review
3 Background
- Molybdenum-99 (99Mo) decays to technetium-99m (99mTc) and is used for medical procedures
- Until recently, no domestically-produced 99Mo supply since late 1980s
- Aging international reactors, dependence on foreign suppliers, and extended repairs jeopardize and disrupt international supply
4 Role of the NRC
- Conduct reviews of applications for facilities proposing to manufacture, irradiate, and process low enriched uranium (LEU) and molybdenum targets
- Reviews support establishment of a domestically-available and reliable supply of 99Mo
5 NRC Regulatory Oversight
- Governing Statutes
- Atomic Energy Act of 1954, as amended
- Energy Reorganization Act of 1974
- NRCs Mission Statement
- Protect public health and safety
- Promote common defense and security
- Protect the environment
6 SHINE Technology
- SHINE proposes to fission an LEU target solution in 8 irradiation units licensed as utilization facilities
- 99Mo recovered from irradiation solution in hot cells licensed as a production facility SHINE 99Mo Production Process Source: SHINE Webpage
7 Site Location Approximately 4 miles south of Janesville, WI Approximately 91 acres Bordered by U.S.
Highway 51 and the Southern Wisconsin Regional Airport
8 Construction Permit Application Review
- Application submitted in 2013
- Conducted safety and environmental reviews
- Safety Evaluation Report
- Environmental Impact Statement
- NRC issued Construction Permit No.
CPMIF-001 to SHINE on February 29, 2016
- Construction activities began September 2019
9 Operating License Application
- Operating license application submitted in July 2019
- Final Safety Analysis Report (FSAR)
- Environmental Report Supplement
- A notice of acceptance of the application for docketing was published in the Federal Register on October 15, 2019 (84 FR 55187)
10 10 Safety and Environmental Review Process
- Initial NRC staff review of the application
- Request(s) for additional information (RAI)
- Potential for contested hearing
- Decision to grant or deny operating license
11 11 Operating License Application Review Process Operation License Application submitted to NRC Safety Review Environmental Review NRC Operating License Decision Review by ACRS Hearing*
- If a Request for Hearing is Granted
12 12 Safety Review Methodology
- Review tailored to design and safety significance of technology
- NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors
- Interim Staff Guidance Augmenting NUREG-1537
- Other guidance and engineering judgement used, as appropriate
13 13 Environmental Review
- National Environmental Policy Act (NEPA)
- Informs Federal decision making
- Public disclosure of environmental impacts and other considerations
- NRCs environmental regulations are located at 10 CFR Part 51
14 14 Scope of Environmental Review
- Staff will prepare a supplement to the SHINE Final EIS (NUREG-2183)
- The supplement will only cover matters that differ from or reflect significant new information
15 15 Environmental Review Issue NOI Scoping Process (public comments)
Prepare Supplement Issue Draft Supplement (public comments)
Address Public Comments Prepare Final Supplement Issue Final Supplement Issue Record of Decision NOI= notice of intent Green boxes= opportunity for public participation
16 16 Supplement to the Final EIS The supplement will:
- Update the prior environmental review
- Describe matters that differ or reflect significant new information since publication of the EIS
17 17 Focus of Review Changes to:
- Facility design (e.g., changes to building footprint)
- Facility operation (e.g., change in the number of workers)
- Natural or physical environment
- Regulatory environment (new permits)
18 18 Role of Public Comments on the Staffs Review Public Comments on Environmental Review EIS Supplement Operating License Decision Advisory Committee on Reactor Safeguards Independent Review Safety Evaluation Report Scoping process Draft Supplement publication
19 19 How to Submit Comments
- Todays meeting
- By mail (please reference SHINE operating license application review)
Office of Administration ATTN: Program Management, Announcements and Editing Staff Mail Stop: TWFN-7-A60M U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
20 20 How to Submit Comments (cont.)
- Online at https://www.regulations.gov/.
Enter ID: NRC-2019-0173
- Please note that comments will not be edited to remove identifying information.
- Comments must be submitted by January 13, 2020.
21 21 Document Locations
- Hedberg Public Library 316 S Main St Janesville, WI 53545
- NRC Agencywide Documents Access and Management System (ADAMS):
https://www.nrc.gov/reading-rm/adams.html Enter Accession No. ML19211C139
22 Steven Lynch, Project Manager Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Email: Steven.Lynch@nrc.gov Phone: 301-415-1524 Jennifer Davis, Senior Project Manager Division of Rulemaking, Environmental, & Financial Support Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Email: Jennifer.Davis@nrc.gov Phone: 301-415-3835 Contact Information