ML22152A108

Shine Medical Technologies LLC - Regulatory Audit Plan for Tech Specs

ML22152A108
Person / Time
Site:	SHINE Medical Technologies
Issue date:	06/06/2022
From:	Joshua Borromeo NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Technologies
Balazik M
References
EPID L-2019-NEW-0004
Download: ML22152A108 (6)

Text

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

SUBJECT:

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

Dear Dr. Piefer:

The U.S. Nuclear Regulatory Commission (NRC) staff has prepared an audit plan related to the review of Chapter 14, Technical Specifications, of the SHINE Medical Technologies, LLC operating license application. The enclosed audit plan provides the regulatory basis for the audit, describes the scope of the audit, and identifies the audit team.

The audit will be conducted virtually with the potential for an onsite meeting and is intended to close gaps identified during the technical review. As such, the audit will start on June 3, 2022.

Additional audit sessions will be scheduled to support the continued review of the operating license application.

Following completion of the audit, the NRC staff will provide an audit summary. The summary will include a description of any information identified during the audit that will need to be docketed to supplement the application and allow the NRC staff to continue its review.

June 2, 2022

G. Piefer If you have any questions, please contact me at (301) 415-1217, or by electronic mail at Joshua.Borromeo@nrc.gov.

Sincerely, Joshua M. Borromeo, Chief 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 Helvenston, Edward signing on behalf of Borromeo, Joshua on 06/02/22

SHINE Medical Technologies, LLC Docket 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

ML22152A108 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NAME MBalazik NParker JBorromeo DATE 6/2/2022 6/2/2022 6/2/2022

Enclosure OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT PLAN, REGARDING CHAPTER 14, TECHNICAL SPECIFICATIONS OPERATING LICENSE APPLICATION SHINE MEDICAL TECHNOLOGIES, LLC DOCKET NO. 50-608

Background

The U.S. Nuclear Regulatory Commission (NRC) staff is continuing its review of the SHINE Medical Technologies, LLC (SHINE) operating license application, submitted by letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), including Chapter 14, Technical Specifications, of the SHINE final safety analysis report (FSAR). For this audit, the NRC staff reviewed SHINEs proposed technical specifications (TSs) dated on January 26, 2022 (ML22034A633), as supplemented on March 9, 2022, and March 18, 2022 (ML22068A217 and ML22077A086, respectively). This regulatory audit is intended to close technical gaps identified during the review of Chapter 14, as well as promote clarity of the TSs.

Regulatory Audit Bases The licensees proposed TSs 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). Additionally, the NRC staff is using the applicable guidance in American National Standards Institute/American Nuclear Society-15.1-2007, The Development of Technical Specifications for Research Reactors, for this review.

Regulatory Scope The scope of this audit addresses SHINEs proposed TSs for the SHINE facility.

Desired Outcomes for the Audit The desired outcomes of the audit are to: (1) gain a better understanding of information underlying the application in the area of TSs; (2) identify specific information that will require docketing to support the basis of the licensing or regulatory decision; and (3) close items or identify a closure path.

Information and Material necessary for the Regulatory Audit The NRC staff anticipates SHINE identifying additional documents that may address audit items.

Audit Team The NRC staff participating in this audit will be:

Duane Hardesty (NRR/DANU) - Audit Team Leader

Norbert Carte (NRR/DEX)

Michael Waters (NRR/DEX)

Michael Balazik (NRR/DANU)

Molly-Kate Gavello (NRR/DANU)

Joshua Wilson (NRR/DSS)

Joshua Borromeo (NRR/DANU)

Audit Team Logistics The virtual audit will start on June 3, 2022. This audit session will address the comments and questions on SHINEs proposed TSs. Should an additional audit session be needed, it will be scheduled accordingly. Additional audit sessions will be planned in advance to support the understanding of information necessary to facilitate the continued review of the operating license application. The NRC staff may request portions of the audit be conducted at the site with SHINE staff.

Deliverables At the completion of the regulatory audit, the NRC staff will prepare a regulatory audit report, which will be issued within 60 days after the audit.