ML15351A291
| ML15351A291 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/08/2015 |
| From: | NRC/OGC |
| To: | NRC/OCM |
| SECY RAS | |
| References | |
| Mandatory Hearing 2, RAS 28630, 50-608-CP | |
| Download: ML15351A291 (18) | |
Text
United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.
(Medical Radioisotope Production Facility)
Commission Mandatory Hearing Docket #: 05000608 NRC-010 Exhibit #: NRC-010-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:
Rejected: Stricken:
Other:
Construction Permit Application Review SHINE Medical Technologies Overview December 15, 2015
Panelists
- William Dean - Director, NRR
- Mirela Gavrilas - Deputy Director, NRR/DPR
- Jane Marshall - Deputy Director, NRR/DLR
- Marissa Bailey - Director, NMSS/FCSE 2
Introduction to Molybdenum-99
- Molybdenum-99 (99Mo) decays to technetium-99m
- Effective diagnosis
- Minimal exposure
- 50,000 procedures daily
- No domestically-produced supply 3
Establishing a Domestic Supply
- National policy objectives support domestic production capabilities
- Cost-sharing agreements encourage commercial partners
- SHINE proposes to produce 99Mo through uranium fission 4
Preparing for SHINE Review
- Interoffice working group contributed diverse expertise
- Public meetings engaged stakeholders
- Review coordinated with Federal, State, and local governments 5
Allowing Construction
- SHINE application only seeks construction authorization
- Design details may be left for operating license application
- Review assessed preliminary design and analysis 6
Conducting the Safety Review 7
Tailoring Review Methodology
- Review accommodated unique technology
- Staff used existing guidance
- Staff determined whether reasonable assurance that final design will conform to design bases 8
Additional Information
- Review supported by additional information
- In some cases, permit conditions necessary
- Regulatory commitments track items for resolution in final safety analysis report (FSAR) 9
Environmental Regulations
- National Environmental Policy Act
- Informs Federal decision making
- Public disclosure
- NRCs environmental regulations
- Title 10 of the Code of Federal Regulations (10 CFR) Part 51 10
Environmental Review Process Environmental Report Draft Final Environmental Environmental Comment Environmental Site Audit Impact Period
- Impact Statement Statement Scoping *
- Opportunity for Public Request for Involvement Additional Information 11
Proposed Janesville Site
- Agricultural fields
- Previously disturbed
- No surface water features
- No threatened or endangered species
- No historical or cultural resources 12
Regulatory Basis
- Commission authorized by Atomic Energy Act, Section 103
- Review primarily based on 10 CFR Parts 20, 50, and 51
- Review also considered 10 CFR Part 70 performance requirements 13
Construction Permit Issuance
- Preliminary design described
- Further technical or design information may be left for FSAR
- Ongoing research and development has been identified
- Facility can be constructed and operated without undue risk 14
Permit Considerations
- Construction will not endanger public health and safety
- SHINE technically and financially qualified
- Environmental requirements satisfied 15
Introducing Review Panels Panel Number Discussion Topics Evaluation Areas Safety Panel 1 Licensing Considerations Safety Evaluation Report Chapters 1 and 4 Safety Panel 2 Accident Analysis Safety Evaluation Report Chapter 13 Environmental Panel
- Final Environmental Final Environmental Impact Impact Statement Statement Process
- Analysis of Alternatives
- Summary of Conclusions and Recommendations 16
- FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review
- DLR - Division of License Renewal
- DPR - Division of Policy and Rulemaking 17
- NMSS - Office of Nuclear Material Safety and Safeguards
- NRR - Office of Nuclear Reactor Regulation 18
United States Nuclear Regulatory Commission Official Hearing Exhibit In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.
(Medical Radioisotope Production Facility)
Commission Mandatory Hearing Docket #: 05000608 NRC-010 Exhibit #: NRC-010-MA-CM01 Identified: 12/15/2015 Admitted: 12/15/2015 Withdrawn:
Rejected: Stricken:
Other:
Construction Permit Application Review SHINE Medical Technologies Overview December 15, 2015
Panelists
- William Dean - Director, NRR
- Mirela Gavrilas - Deputy Director, NRR/DPR
- Jane Marshall - Deputy Director, NRR/DLR
- Marissa Bailey - Director, NMSS/FCSE 2
Introduction to Molybdenum-99
- Molybdenum-99 (99Mo) decays to technetium-99m
- Effective diagnosis
- Minimal exposure
- 50,000 procedures daily
- No domestically-produced supply 3
Establishing a Domestic Supply
- National policy objectives support domestic production capabilities
- Cost-sharing agreements encourage commercial partners
- SHINE proposes to produce 99Mo through uranium fission 4
Preparing for SHINE Review
- Interoffice working group contributed diverse expertise
- Public meetings engaged stakeholders
- Review coordinated with Federal, State, and local governments 5
Allowing Construction
- SHINE application only seeks construction authorization
- Design details may be left for operating license application
- Review assessed preliminary design and analysis 6
Conducting the Safety Review 7
Tailoring Review Methodology
- Review accommodated unique technology
- Staff used existing guidance
- Staff determined whether reasonable assurance that final design will conform to design bases 8
Additional Information
- Review supported by additional information
- In some cases, permit conditions necessary
- Regulatory commitments track items for resolution in final safety analysis report (FSAR) 9
Environmental Regulations
- National Environmental Policy Act
- Informs Federal decision making
- Public disclosure
- NRCs environmental regulations
- Title 10 of the Code of Federal Regulations (10 CFR) Part 51 10
Environmental Review Process Environmental Report Draft Final Environmental Environmental Comment Environmental Site Audit Impact Period
- Impact Statement Statement Scoping *
- Opportunity for Public Request for Involvement Additional Information 11
Proposed Janesville Site
- Agricultural fields
- Previously disturbed
- No surface water features
- No threatened or endangered species
- No historical or cultural resources 12
Regulatory Basis
- Commission authorized by Atomic Energy Act, Section 103
- Review primarily based on 10 CFR Parts 20, 50, and 51
- Review also considered 10 CFR Part 70 performance requirements 13
Construction Permit Issuance
- Preliminary design described
- Further technical or design information may be left for FSAR
- Ongoing research and development has been identified
- Facility can be constructed and operated without undue risk 14
Permit Considerations
- Construction will not endanger public health and safety
- SHINE technically and financially qualified
- Environmental requirements satisfied 15
Introducing Review Panels Panel Number Discussion Topics Evaluation Areas Safety Panel 1 Licensing Considerations Safety Evaluation Report Chapters 1 and 4 Safety Panel 2 Accident Analysis Safety Evaluation Report Chapter 13 Environmental Panel
- Final Environmental Final Environmental Impact Impact Statement Statement Process
- Analysis of Alternatives
- Summary of Conclusions and Recommendations 16
- FCSE - Division of Fuel Cycle Safety, Safeguards, and Environmental Review
- DLR - Division of License Renewal
- DPR - Division of Policy and Rulemaking 17
- NMSS - Office of Nuclear Material Safety and Safeguards
- NRR - Office of Nuclear Reactor Regulation 18