ML22047A179

Shine Review Schedule Update Letter-Phased Approach

ML22047A179
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/17/2022
From:	Holly Cruz NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Cruz H
References
Construction Permit No. CPMIF-001, EPID L-2022-NEW-0004
Download: ML22047A179 (6)

Text

February 17, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - UPDATE TO OPERATING LICENSE APPLICATION TECHNICAL REVIEW SCHEDULE IN RESPONSE TO PHASED STARTUP OPERATIONS APPLICATION SUPPLEMENT (EPID NO. L-2022-NEW-0004)

Dear Dr. Piefer:

The purpose of this letter is to provide an update on schedule and resource needs in response to the SHINE Medical Technologies, LLC (SHINE) Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML22027A354). In anticipation of this supplement, the U.S. Nuclear Regulatory Commission (NRC) sent SHINE a letter on August 3, 2021, acknowledging that a new review schedule would be developed once the NRC staff received and assessed the supplement (ADAMS Accession No. ML21209A997). As such, based on the review of the phased startup operations application supplement, the NRC staff determined that it could accommodate the additional scope and plans to complete the operating license application review by October 2022, in accordance 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. To itemize the resources required to support the review of the phased startup operations application supplement, the NRC staff created a new enterprise project identifier (EPID No. L-2022-NEW-0004). The NRC staff anticipates that the total level of effort needed to support this review will be up to 1,000 staff hours (approximately 5 percent of the original estimate of 22,000 staff hours for the review of the SHINE operating license application).

Enclosed with this letter is the current SHINE Operating License Application Technical Review Schedule. The NRC staff will follow the enclosed schedule to complete the reviews required by 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. 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 and promote the efficiency of the NRC staffs review. The NRC staff may need to issue requests for additional information as part of its review to resolve information insufficiencies in the

supplement and to support the NRC staffs findings of reasonable assurance. Untimely resolution of information insufficiencies, particularly in the phased startup operations application supplement and remainder of the instrumentation and control systems review, may result in extending the review schedule. 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 changes that would extend the expected review completion date beyond October 2022.

If you have any questions, please contact me at (301) 415-1053, or by electronic mail at Holly.Cruz@nrc.gov.

Sincerely, Signed by Cruz, Holly on 02/17/22 Holly D. Cruz, Senior 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 Technologies, LLC P.O. Box 5005 3400 Innovation Court Janesville, WI 53547-5005 Janesville, WI 53546 Bill McCoy Nathan Schleifer 1326 Putnam Avenue General Counsel Janesville, WI 53546 SHINE Technologies, LLC 3400 Innovation Court Alfred Lembrich Janesville, WI 53546 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 Ave 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: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115

ML22047A179 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 2/14/2022 2/17/2022 2/17/2022 2/17/2022 SHINE Medical Technologies, LLC Operating License Application Technical Review Schedule Previous Updated Actual Technical Scheduled Scheduled Milestone Completion Status Review Area Completion Completion Date Date Date Receipt of Operating Safety and August 2019 - August 2019 Complete License Application Environmental Acceptance and Docketing Safety and of Operating License October 2019 - October 2019 Complete Environmental Application Environmental Scoping December December Environmental - Complete Meeting 2019 2019 Issuance of Notice of Safety and Opportunity to Request January 2020 - January 2020 Complete Environmental Hearing Closing of Opportunity to Safety and March 2020 - March 2020 Complete Request Hearing Environmental Advisory Committee on Reactor Safeguards (ACRS) September November Safety - Complete Subcommittee Information 2020 2020 Meeting SHINE Submission of Source and Byproduct Safety and April 2021 - April 2021 Complete Materials License Environmental Amendment Request Issuance of Source and Safety and November December Byproduct Materials License TBD Complete Environmental 2021 2021 Amendment Request SHINE Submission of November November Environmental Report Environmental TBD Complete 2021 2021 Supplement SHINE Submission of Operating License Safety and July 2021 January 2022 January 2022 Complete Application Supplement for Environmental Staggered Approach ACRS Project Overview Safety N/A February 2022 February 2022 Complete Meeting Enclosure

Previous Updated Actual Technical Scheduled Scheduled Milestone Completion Status Review Area Completion Completion Date Date Date NUREG Publication of Draft Supplemental Environmental Environmental August 2021 April 2022 TBD Pending Impact Statement March -

ACRS Subcommittee Safety TBD September TBD Pending Meetings 2022 Draft Safety Evaluation September September Safety TBD Pending Report Complete 2021 2022 ACRS Full Committee September Safety TBD TBD Pending Meeting 2022 Final Safety Evaluation Safety October 2021 October 2022 TBD Pending Report NUREG Publication of Final December Supplemental Environmental Environmental October 2022 TBD Pending 2021 Impact Statement