ML22047A179
| 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
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 February 17, 2022 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, 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 Signed by Cruz, Holly on 02/17/22
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Licensing Manager SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Nathan Schleifer General Counsel SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 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 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548
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
Enclosure SHINE Medical Technologies, LLC Operating License Application Technical Review Schedule Milestone Technical Review Area Previous Scheduled Completion Date Updated Scheduled Completion Date Actual Completion Date Status Receipt of Operating License Application Safety and Environmental August 2019 August 2019 Complete Acceptance and Docketing of Operating License Application Safety and Environmental October 2019 October 2019 Complete Environmental Scoping Meeting Environmental December 2019 December 2019 Complete Issuance of Notice of Opportunity to Request Hearing Safety and Environmental January 2020 January 2020 Complete Closing of Opportunity to Request Hearing Safety and Environmental March 2020 March 2020 Complete Advisory Committee on Reactor Safeguards (ACRS)
Subcommittee Information Meeting Safety September 2020 November 2020 Complete SHINE Submission of Source and Byproduct Materials License Amendment Request Safety and Environmental April 2021 April 2021 Complete Issuance of Source and Byproduct Materials License Amendment Request Safety and Environmental TBD November 2021 December 2021 Complete SHINE Submission of Environmental Report Supplement Environmental TBD November 2021 November 2021 Complete SHINE Submission of Operating License Application Supplement for Staggered Approach Safety and Environmental July 2021 January 2022 January 2022 Complete ACRS Project Overview Meeting Safety N/A February 2022 February 2022 Complete Milestone Technical Review Area Previous Scheduled Completion Date Updated Scheduled Completion Date Actual Completion Date Status NUREG Publication of Draft Supplemental Environmental Impact Statement Environmental August 2021 April 2022 TBD Pending ACRS Subcommittee Meetings Safety TBD March -
September 2022 TBD Pending Draft Safety Evaluation Report Complete Safety September 2021 September 2022 TBD Pending ACRS Full Committee Meeting Safety TBD September 2022 TBD Pending Final Safety Evaluation Report Safety October 2021 October 2022 TBD Pending NUREG Publication of Final Supplemental Environmental Impact Statement Environmental December 2021 October 2022 TBD Pending