ML18025B121

Official Exhibit - NRC-010-MA-CM01 - Staff Presentation Slides - Overview (Jan. 16, 2018)

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Commission Mandatory Hearing Docket #: 05000609 Exhibit #: NRC-010-MA-CM01 Identified: 1/23/2018 Admitted: 1/23/2018 Withdrawn: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

• 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 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

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