ML21089A228

Shine Medical Technologies, LLC - Physical Security Plan Audit Summary

ML21089A228
Person / Time
Site:	SHINE Medical Technologies
Issue date:	04/21/2021
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Lynch S
References
EPID L-2019-NEW-0004
Download: ML21089A228 (8)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 21, 2021 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 AUDIT RELATED TO THE PHYSICAL SECURITY PLAN (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 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),

November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. 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 the review of SHINEs physical security plan associated with its operating license application the NRC staff conducted a regulatory audit from August 31, 2020, to September 3, 2020. A summary of the regulatory audit is enclosed.

G. Piefer If SHINE has any questions please contact me at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.

Sincerely, Signed by Lynch, Steven on 04/20/21 Steven T. Lynch, 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

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

ML21089A228 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/BC (A) NRR/DANU/PM NAME SLynch NParker TTate DHardesty SLynch DATE 3/30/2021 3/31/2021 4/14/2021 4/16/2021 4/21/2021 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT

SUMMARY

REGARDING PHYSICAL SECURITY PLAN DESCRIBED IN OPERATING LICENSE APPLICATION SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 Location: SHINE Medical Technologies, LLC, Janesville, Wisconsin Dates: August 31, 2020 - September 3, 2020 Audit Team Members: Steven Lynch (Senior Project Manager)

Elizabeth Reed (Security Specialist, Research and Test Reactors)

Tim Harris (Senior Program Manager, Materials Security)

Charles Teal (Program Manager, Materials Security)

Licensee Representatives: Jeff Bartelme, Director of Licensing Jim Costedio, Vice President of Regulatory Affairs and Quality Catherine Kolb, Operations Manager Bill Hennessy, Contractor Roger Thomas, Electrical Engineer Marty Price, Electrical Engineer

1.0 BACKGROUND

By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),

November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. ML21011A264), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Enclosure

Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities. This regulatory audit was intended to assist the NRC staff in its review of the physical security plan (PSP) described in the SHINE final safety analysis report (FSAR),

submitted as part of SHINEs operating license application.

This audit supported the NRC staffs review of the licensees PSP using the applicable 10 CFR requirements, 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 (ADAMS Accession No. 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 (ADAMS Accession No. ML042430048). 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 (ADAMS Accession No. 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 (ADAMS Accession No. 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.

The NRC staff also conducted this regulatory audit in response to direction provided in the Commissions Staff Requirements Memorandum (SRM)-18-00631, Response to (SRM)-

COMSECY-17-0008 on Physical Protection for Non-Power Production and Utilization Facilities Intending to Produce Molybdenum-99, dated September 26, 2019.

The audit was conducted in accordance with the audit plan and associated topics (ADAMS Accession No. ML20240A253).

2.0 AUDIT ACTIVITIES AND OBSERVATIONS Entrance Briefing The NRC staff discussed the goals and objectives of the audit at the entrance briefing, which focused on gaining a better understanding of the proposed SHINE PSP. In addition, it was discussed that the regulatory audit may identify additional information that would be required to be docketed to support the basis of the licensing decision and allow the NRC staff to more efficiently gain insights on the operating license application. Further, the NRC staff indicated 1 SRM-18-0063 and associated documents, including SECY-18-0063, Response to (SRM)-COMSECY-17-0008 on Physical Protection for Non-Power Production and Utilization Facilities Intending to Produce Molybdenum-99, dated June 4, 2018; SRM-COMSECY-17-0008, Staff Requirements-COMSECY-17-0008-Physical Protection for Non-Power Production and Utilization Facilities Intending to Produce Molybdenum-99, dated August 1, 2017; and COMSECY-17-0008, Physical Protection for Non-Power Production and Utilization Facilities Intending to Produce Molybdenum-99, dated February 22, 2017, are withheld from public disclosure to protect security-related information.

that the information gained from the audit review would assist the NRC staff to better focus any requests for additional information (RAIs) needed to support the review.

Site Tour The licensee provided the NRC staff with a comprehensive site tour. The NRC staff observed the areas for the use and storage of special nuclear material and radioactive material.

Review of Audit Information The topics and questions that were discussed during the regulatory audit were primarily based on the non-public regulatory audit topics provided to SHINE on August 13, 2020.

The following information, as listed in the audit plan dated August 28, 2020, was reviewed and discussed with the licensee:

Discussion on SHINE compliance with 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.

The licensee indicated that it would provide information demonstrating compliance with the reference regulation in a supplement to its PSP.

Discussion on SHINE compliance with 10 CFR Part 73, Physical Protection of Plants and Materials.

The licensee indicated that it would provide information demonstrating compliance with the reference regulation in a supplement to its PSP.

SHINE draft PSP, technical specification requirements, and supporting reference documentation related to the SHINE PSP.

NRC staff reviewed the documents listed above as applicable to the PSP. The licensee indicated that it would provide updated information reflecting agreements made onsite in a supplement to its PSP.

Exit Briefing On September 3, 2020, the audit team held an exit briefing with the licensee. No issues or concerns were identified by the licensee during the on-site audit exit briefing. The NRC staff indicated the on-site audit was concluded but the audit would continue until the NRC staff determined that it had sufficient information to complete its review of the PSP.

3.0 RESULTS OF REGULATORY AUDIT The NRC audit team discussed the need for RAIs to capture the information on the docket consistent with the applicable regulatory requirements in 10 CFR Parts 37, 50, and 73.

The NRC staff discussed the need to obtain the information in the following areas in support of its review of the PSP in a RAI to be issued following the regulatory audit:

A request to update the PSP to include more details on detection, assessment, and response procedures; A request to clarify which site-specific supplemental security measures will be incorporated into the SHINE operating license; and A request to update the PSP to include more details on the access authorization program.