ML22125A040

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

ML22125A040
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/16/2022
From:	Holly Cruz NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Cruz H
References
EPID L-2019-NEW-0004
Download: ML22125A040 (4)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 16, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - POTENTIAL IMPACTS TO OPERATING LICENSE APPLICATION TECHNICAL REVIEW SCHEDULE (EPID NO. L-2019-NEW-0004)

Dear Dr. Piefer:

The purpose of this letter is for the U.S. Nuclear Regulatory Commission (NRC) to communicate potential impacts to the review schedule for the SHINE Medical Technologies, LLC (SHINE) operating license application for its proposed SHINE Medical Isotope Production Facility (SHINE facility) (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML19211C044). The NRC previously communicated that it 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 (NEIMA) (ML22047A179). Due to uncertainty surrounding the timing of responses to information needs related to the SHINE Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, dated January 27, 2022 (ML22027A354), the timing of the completion of the software engineering validation related to the digital instrumentation and control review, and the submittal of the SHINE cyber security plan, the NRC is considering the potential need to delay the schedule.

Additional information needs may also be identified as the review progresses, due to recent and possible future design changes.

The NRC is currently following the schedule outlined in its SHINE Operating License Application Technical Review Schedule letter dated February 17, 2022 (ML22047A179), and the NRC staff will promptly communicate any schedule changes that would extend the expected review completion date beyond October 2022. Should such schedule changes impact the NEIMA milestone, the NRC will follow the established NEIMA reporting requirements, as required. At this point, the NRC does not anticipate any potential schedule delay will impact the staffs ability to complete the operating license application review in time to support the planned construction schedule for the SHINE facility to be substantially complete by May 2023.

G. Piefer 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 05/16/22 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 cc: 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. Box5005 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

ML22125A040 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 4/21/2022 5/10/2022 5/16/2022 5/16/2022