ML22220A261

Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications

ML22220A261
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/12/2022
From:	Holly Cruz NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Technologies
Cruz H
Shared Package
ML22227A200	List: ML22220A261
References
CPMIF-001, EPID L-2019-NEW-0004
Download: ML22220A261 (7)

Text

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

SUBJECT:

SHINE TECHNOLOGIES, LLC REGULATORY REPORT ON THE AUDIT OF CHAPTER 14, TECHNICAL SPECIFICATIONS, DESCRIBED IN OPERATING LICENSE APPLICATION (EPID NO. L-2019-NEW-0004)

Dear Dr. Piefer:

By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), SHINE Technologies, LLC (SHINE) submitted its application for an operating license.

Enclosed is a report on the regulatory audit conducted by staff of the U.S. Nuclear Regulatory Commission (NRC) in connection with its review of the application, in addition to Chapter 14, Technical Specifications, of the SHINE final safety analysis report and responses to requests for additional information. This regulatory audit was held to close technical gaps identified during the review of the technical specifications.

The audit report does not make any licensing conclusions or findings, but it is part of the administrative record of the NRC staffs review of the application and may provide information supporting the NRC staffs safety evaluation.

The audit followed the plans provided to SHINE by letters dated May 12, 2022, May 20, 2022, and June 10, 2022 (via BOX), unless otherwise noted in the enclosed report. The enclosed report with attachments constitutes the final report on the audit.

September 12, 2022

G. Piefer 2

If you have any questions, please contact me at (301) 415-1053, or by email 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: See next page Signed by Cruz, Holly on 09/12/22

SHINE 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 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

ML22227A200 Package NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 8/19/2022 8/24/2022 9/9/2022 9/12/2022

Enclosure OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT REPORT REGARDING TECHNICAL SPECIFICATIONS OPERATING LICENSE APPLICATION SHINE TECHNOLOGIES, LLC DOCKET NO. 50-608 Location:

Virtual (audit activities were also conducted via the electronic reading room)

Dates:

June 3, 2022, from 10:00am to 11:00am June 10, 2022, from 10:00am to 12:00pm June 17, 2022, from 3:00pm to 4:00pm July 5, 2022, from 3:00pm to 5:00pm July 15, 2022, from 10:00am to 11:00am August 5, 2022, from 1:00pm to 2:00pm Audit Team Members:

Michael Balazik, U.S. Nuclear Regulatory Commission Duane Hardesty, U.S. Nuclear Regulatory Commission - Audit Team Leader Dinesh Taneja, U.S. Nuclear Regulatory Commission Norbert Carte, U.S. Nuclear Regulatory Commission Michael Waters, U.S. Nuclear Regulatory Commission Licensee Representatives:

Jeff Bartelme, SHINE Technologies, LLC et al.

Background

By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), SHINE Technologies, LLC (SHINE) submitted its application for an operating license.

This report summarizes the regulatory audit conducted by staff of the U.S. Nuclear Regulatory Commission (NRC) on June 3, June 10, June 17, July 5, July 15, and August 5, 2022. This audit was conducted in connection with the NRC staffs review of the application. The audit report does not make any licensing conclusions or findings, but it is part of the administrative record of the NRC staffs review of the application and may provide information supporting the NRC staffs safety evaluation. The audit followed the plans provided to SHINE by letters dated May 12, 2022, May 20, 2022, and June 10, 2022 (via BOX), unless otherwise noted in this report.

2 Regulatory Bases for the Audit The purpose of the audit was to close technical gaps identified during the review of Chapter 14, Technical Specifications. The licensees proposed technical specifications is being reviewed in accordance with the applicable regulatory requirements of Title 10 of the Code of Federal Regulations Part 50, Domestic Licensing of Production and Utilization Facilities, and applicable guidance provided in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Part 1, Format and Content, and Part 2, Standard Review Plan and Acceptance Criteria (ML042430055 and ML042430048, respectively).

Audit Activities The following activities were performed during the audit:

1.

Entrance Meeting At the entrance meeting on June 3, 2022, the NRC staff explained the scope and desired outcomes for the audit. The NRC staff stated that after completion of the audit, an audit report will be prepared and sent to SHINE.

2.

Review of Audit Topics and Questions This audit was held to: (1) gain a better understanding of information underlying the application in the area of technical specifications, (2) identify specific information that will require docketing to support the basis of the licensing or regulatory decision; and (3) identify a closure path for the audit topics provided in the audit plan. Closure paths for the audit topics are provided as attachments to this audit report.

The audit addressed updates to the SHINE final safety analysis report and associated responses to requests for additional information on technical specifications. Additionally, the NRC staff conducted document reviews using the electronic reading room as part of the audit.

3.

Exit Briefing An exit briefing was held on August 5, 2022. During this exit briefing, the audit team restated the purpose of the meeting, and summarized the status of the technical specifications review. It was noted that during the audit, SHINE had stated that it would provide supplemental information on the docket to address additional information needs identified by the NRC staff.

The NRC staff stated that based on SHINE providing this supplemental information to address information needs identified by the NRC staff, the NRC staff considers the audit plan items closed. However, the NRC staff noted that it is still continuing its review of the SHINE operating license application, including the supplemental information, and that additional audits may be necessary. No disagreements with the audit summary were noted by the licensee during the exit briefing.

3 4.

Audit Resolution Comments based on the audit discussion have been captured in attachments 1-3 (ML22227A199, ML22227A126, ML22227A127, respectively). SHINE plans to provide updated technical specifications to address the comments.