ML20114E315

Shine Medical Technologies, LLC - Operating License Application Technical Review Schedule

ML20114E315
Person / Time
Site:	SHINE Medical Technologies
Issue date:	04/30/2020
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Lynch S, NRR/DANU/UNPL, 304-415-1524
References
EPID L-2019-NEW-0004
Download: ML20114E315 (6)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 30, 2020 Gregory Piefer, Ph.D.

Chief Executive Officer SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - OPERATING LICENSE APPLICATION TECHNICAL REVIEW SCHEDULE (EPID NO.

L-2019-NEW-0004)

Dear Dr. Piefer:

By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), and March 27, 2020 (ADAMS Accession No. ML20105A295), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions. The purpose of this letter is to communicate a revised review schedule of twenty-four months for the SHINE operating license application.

In accordance with 10 CFR Part 2, Agency Rules of Practice and Procedure, 10 CFR Part 50, and 10 CFR Part 51, the NRC staff performed an acceptance review of the SHINE operating license application and, by letter dated October 8, 2019 (ADAMS Accession No. ML19276D409), concluded that the application was acceptable for docketing under Docket Number 50-608. Following the acceptance and docketing of the application, the NRC staff engaged SHINE in public meetings and audits to support the safety and environmental reviews; resolve information gaps in the application; and establish a detailed application review schedule.

In support of the NRC staffs safety review, public meetings were held on December 4 - 5, 2019 (ADAMS Accession No. ML19337B537), and March 4 - 5, 2020 (ADAMS Accession No. ML20056E142), and a regulatory audit was conducted in March 2020 (ADAMS Accession No. ML20057F949), on topics related to instrumentation and control systems; physical security; criticality safety; accident analysis; design changes associated with the SHINE tritium purification system; thermal hydraulic design; and approach to human factors engineering. In support of the NRC staffs environmental review, an environmental site audit was conducted in February 2020 (ADAMS Accession No. ML19353C687) to identify information that differs or reflects significant new information from what was evaluated in NUREG-2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production

G. Piefer Facility, dated October 2015 (ADAMS Accession No. ML15288A046), and verify information in SHINEs supplemental environmental report.

Taking into consideration the information exchanged during these public meetings and the regulatory audits, as well as the receipt of supplemental information provided by SHINE, the NRC staff is revising its initial thirty-six month review schedule, which was established consistent with the generic milestone schedule for non-power production or utilization facility operating licensing application reviews as part of the NRCs implementation of Section 102(c) of the Nuclear Energy Innovation and Modernization Act. The NRC staff is now establishing a detailed review schedule of twenty-four months from the time of docketing the application, which will support making a final determination whether an operating license should be issued to SHINE by October 2021. The NRC staff anticipates that the total level of effort needed to complete the milestones detailed in the technical review schedule will be up to 22,000 staff hours. The NRC staff has also budgeted for up to $100,000.00 in contract support as a contingency for preparation of the supplemental environmental impact statement (EIS).

Through the second quarter of fiscal year 2020, the NRC staff has expended 6,194.75 staff hours of the estimated 22,000 staff hours on the review of the SHINE operating license application.

This letter forwards the enclosed SHINE Operating License Application Technical Review Schedule, comprised of the safety and environmental review milestones supporting the NRC staffs preparation of a final safety evaluation report and supplemental EIS supporting the final determination whether an operating license should be issued to SHINE. The NRC staff will follow the enclosed schedule to complete the reviews required by 10 CFR Part 50 and 10 CFR Part 51. This review schedule does not account for potential delays associated with the completion of construction of the facility.

In the coming months, the NRC staff expects to conduct additional regulatory audits and public meetings with SHINE to further the NRC staffs understanding of the information provided in SHINEs operating license application, as supplemented, and promote the efficiency of the NRC staffs review. The NRC staff also expects to issue requests for additional information as part of its review to resolve information insufficiencies in the application and to support the NRC staffs findings of reasonable assurance that the activities described in the operating license application can be conducted without endangering the health and safety of the public, and that such activities would be conducted in compliance with the Commissions regulations.

There are circumstances that may result in adjustments to the review schedule and resource estimate. Such circumstances include applicant delays in providing requested information to the NRC staff and the receipt of new information affecting the scope of the review. The NRC staff will promptly communicate any schedule or resource changes that would extend the expected review completion date beyond October 2021 or exceed the level of effort significantly beyond 22,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />.

G. Piefer If you have any questions, please contact me, the safety project manager, at (301) 415-1524, or by electronic mail at Steven.Lynch@nrc.gov or Jennifer Davis, the environmental project manager, at (301) 415-3835, or by electronic mail at Jennifer.Davis@nrc.gov.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001

Enclosure:

As stated cc: w/enclosure: See next page

SHINE Medical Technologies, LLC Docket No. 50-608 cc:

Jeff Bartelme Mark Freitag Licensing Manager City Manager SHINE Medical Technologies, LLC P.O. Box 5005 101 E. Milwaukee Street, Suite 600 Janesville, WI 53547-5005 Janesville, WI 53545 Bill McCoy Nathan Schleifer 1326 Putnam Avenue General Counsel Janesville, WI 53546 SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Alfred Lembrich Janesville, WI 53545 541 Miller Avenue Janesville, WI 53548 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA-23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Shelley Warwick Environmental Analysis Specialist-South Team Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 Test, Research and Training Reactor Newsletter Attention: Ms. Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115

ML20114E315 *concurred via e-mail NRR-106 OFFICE NRR/DANU/PM* NRR/DANU/LA* NMSS/REFS/BC* NRR/DANU/BC* NRR/DANU/PM*

NAME SLynch NParker RElliott GCasto SLynch DATE 4/30/2020 4/27/2020 4/30/2020 4/30/2020 4/30/2020 SHINE Medical Technologies, LLC Operating License Application Technical Review Schedule Scheduled Actual Technical Completion Completion Milestone Review Area Status Date Date Receipt of Operating License Safety and Application Environmental August 2019 August 2019 Complete Acceptance and Docketing of Safety and Operating License Application Environmental October 2019 October 2019 Complete Environmental Scoping December December Meeting Environmental 2019 2019 Complete Issuance of Notice of Opportunity to Request Safety and Environmental January 2020 January 2020 Complete Hearing Closing of Opportunity to Safety and Request Hearing Environmental March 2020 March 2020 Complete NUREG Publication of Draft Supplemental Environmental September Environmental 2020 TBD Pending Impact Statement Advisory Committee on Reactor Safeguards (ACRS) September Safety TBD Pending Subcommittee Meeting 2020 ACRS Subcommittee Meeting Safety February 2021 TBD Pending NUREG Publication of Final Supplemental Environmental Impact Environmental April 2021 TBD Pending Statement ACRS Subcommittee Meeting Safety June 2021 TBD Pending Draft Safety Evaluation Report Complete Safety July 2021 TBD Pending ACRS Full Committee September Meeting Safety 2021 TBD Pending Final Safety Evaluation September Report Safety 2021 TBD Pending Final Determination on Issuance of Operating Safety and Environmental October 2021 TBD Pending License Application Enclosure