ML22322A223

Shine Medical Technologies - Fire Protection Audit Summary Report

ML22322A223
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/02/2022
From:	Michael Balazik NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Technologies
Balazik M
References
EPID L-2019-NEW-0004
Download: ML22322A223 (1)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 2, 2022 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC -

SUMMARY

OF REGULATORY AUDIT OF FIRE PROTECTION PROGRAM 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 (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ML19337A275), March 27, 2020 (ML20105A295), August 28, 2020 ( ML20255A027),

November 13, 2020 (ML20325A026), December 10, 2020 (ML20357A084), and December 15, 2020 (ML21011A264), 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 Part 50, Domestic Licensing of Production and Utilization Facilities.

To enhance its review of fire protection topics described in SHINEs operating license application, the NRC staff conducted a virtual regulatory audit on April 8, 2021, consistent with NRC Office of Nuclear Reactor Regulation (NRR) Office Instruction LIC-111, Regulatory Audits, dated October 31, 2019 (ML19226A274). The NRC staff performed its audit in accordance with an electronic mail to SHINE on June 29, 2020 (ML20202A607) and the regulatory audit plan provided to SHINE by letter dated April 8, 2021 (ML21096A248). A summary of the regulatory audit is enclosed.

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 operating license application and may provide information supporting the NRC staffs safety evaluation.

G. Piefer If you have any questions, please contact me at (301) 415-2856, or by electronic mail at Michael.Balazik@nrc.gov.

Sincerely, Hardesty, Duane signing on behalf of Balazik, Michael on 12/02/22 Michael F. Balazik, 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:

Regulatory Audit Summary cc: See next page

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

Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 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 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

ML22322A223 NRR-106 OFFICE NRR/DANU/PM NRR/DRA/APLB NRR/DANU/BC NRR/DANU/PM NAME MBalazik JRobinson (HCruz for) (DHardesty for)

JBorromeo MBalazik DATE 11/18/2022 12/1/2022 12/2/2022 12/2/2022 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT

SUMMARY

REGARDING FIRE PROTECTION PROGRAM DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608

1.0 BACKGROUND

The U.S. Nuclear Regulatory Commission (NRC) staff is continuing its review of the SHINE Medical Technologies, LLC (SHINE) operating license application, submitted July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ML19337A275),

March 27, 2020 (ML20105A295), August 28, 2020 (ML20255A027), November 13, 2020 (ML20325A026), December 10, 2020 ( ML20357A084), and December 15, 2020 (ML21011A264). This regulatory audit is intended to assist the NRC staff in its review of fire protection topics described in the SHINE final safety analysis report (FSAR), submitted as part of SHINEs operating license application.

The NRC staff performed its audit in accordance with an electronic mail to SHINE on June 29, 2020 (ML20202A607) and the regulatory audit plan provided to the SHINE by letter dated April 8, 2021 (ML21096A248). The purpose of this regulatory was to review additional information necessary in determining that a reasonable assurance of adequate protection of public health and safety exist, that applicable regulatory requirements are met, and to identify information that requires docketing to support a regulatory finding regarding fire protection.

The audit entrance meeting was held on April 8, 2021, via teleconference and video conference.

The audit included the NRC staffs review of docketed and non-docketed information via the SHINE electronic reading room and teleconferences with SHINE.

2.0 REGULATORY BASIS AND GUIDANCE DOCUMENTS This audit supported the NRC staffs review of the SHINEs fire protection topics in accordance with the applicable regulatory requirements of Title 10 of the Code of Federal Regulations (10 CFR) and applicable guidance, as well as the guidance contained in NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ML042430055), and NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (ML042430048).

Enclosure

The NRC staff is also using the Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ML12156A069), and Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ML12156A075). As applicable, additional guidance cited in SHINEs FSAR or referenced in NUREG-1537, Parts 1 and 2, or the ISG Augmenting NUREG-1537, Parts 1 and 2, has been utilized in the review of the SHINE operating license application.

3.0 AUDIT LOCATION AND DATES The audit was conducted via teleconference and video conference.

Dates: April 8, 2021 Location: SHINE electronic reading room 4.0 NRC AUDIT TEAM MEMBERS Steven Lynch, Senior Project Manager Jay Robinson, Senior Fire Protection Engineer Charles Moulton, Fire Protection Engineer Naeem Iqbal, Fire Protection Engineer 5.0 APPLICANT PARTICIPANTS Jeff Bartelme, SHINE Medical Technologies, LLC et al.

6.0 DESCRIPTION

OF AUDIT ACTIVITIES AND

SUMMARY

OF OBSERVATIONS The following information, as listed in the audit plan dated April 8, 2021, was reviewed, and discussed with the SHINE:

SHINE updated fire protection program.

SHINE updated fire hazard analysis.

SHINE safe shutdown analysis.

SHINE radiological fire hazard analysis.

SHINE regulatory commitment listed in Appendix A of NUREG-2189, Safety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medical Radioisotope Production Facility.

SHINE fire protection facility design control process, design change control process, and the fire protection design criteria.

7.0 EXIT BRIEFING The NRC staff conducted an audit exit meeting via a teleconference and video conference on April 8, 2021. The NRC staff summarized its observations and described information needs that would likely be issued in a request for additional information as a result of the audit.

8.0 OPEN ITEMS AND PROPOSED CLOSURE PATHS Not applicable.

9.0 DEVIATIONS FROM THE AUDIT PLAN Not applicable.