ML20126G523

Shine Medical Technologies, LLC - Regulatory Audit Plan Related to Electrical Power Systems

ML20126G523
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/07/2020
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Lynch S, NRR/DANU/UNPL, 301-415-1524
Shared Package
ML20126G522	List: ML20126G523 ML20126G524
References
EPID NO. L-2019-NEW-0004
Download: ML20126G523 (7)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 7, 2020 Gregory Piefer, Ph.D.

Chief Executive Officer SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC REGULATORY AUDIT RE:

ELECTRICAL POWER SYSTEMS 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 (ADAMS Accession No. ML19337A275), and March 27, 2020 (ADAMS Accession No. ML20105A295), 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 support its review of the electrical power systems described in SHINEs operating license application, the NRC staff will conduct a virtual regulatory audit from May 11 to May 15, 2020, to gain a better understanding of the application. The audit may include review of documentation and discussions with SHINE personnel and management. The enclosed audit plan provides additional details of the objective and scope of the audit. To facilitate an efficient audit, please provide ready access to requested documentation in the SHINE electronic reading room.

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.

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

Sincerely,

/RA/

Steven T. Lynch, 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 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 E. 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 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

ML20057F949 Package *concurred via e-mail OFFICE NRR/DANU/UNPL/PM* NRR/DANU/UNPL/LA* NRR/DEX/EEOB* NRR/DANU/UNPL/BC* NRR/DANU/UNPL/PM*

NAME SLynch NParker BTitus GCasto SLynch DATE 5/6/2020 5/6/2020 5/7/2020 5/7/2020 5/7/2020 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT PLAN REGARDING ELECTRICAL POWER SYSTEMS DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY 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), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), and March 27, 2020 (ADAMS Accession No. ML20105A295). This regulatory audit is intended to assist the NRC staff in its review of the electrical power systems described in the SHINE final safety analysis report (FSAR), submitted as part of SHINEs operating license application.

Regulatory Bases for the Audit The purpose of this audit is to support the NRC staffs review of the licensees proposed electrical power systems described in the Chapter 8, Electrical Power Systems, of the SHINE FSAR in accordance with the applicable regulatory requirements of Title 10 of the Code of Federal Regulations 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, (ADAMS Accession Nos.: ML042430055 and ML042430048, respectively).

Regulatory Scope for the Audit The NRC staff will review the SHINE FSAR, technical specification (TS) requirements, and supporting reference documentation related to the SHINE electrical power systems. This audit will provide information necessary to continue the NRC staffs evaluation of the SHINE operating license application. In addition, the regulatory audit may identify additional information that will be required to be docketed to support the basis of the licensing decision and will allow NRC staff to more efficiently gain insights on the operating license application. To support this audit, the NRC staff will review documentation uploaded to SHINEs electronic reading room and participate in teleconference and video conference discussions with the applicant.

Enclosure

Information Needed for the Audit SHINE should be prepared to support the NRC staff by having a copy of SHINEs FSAR and TSs readily available. Additionally, the licensee should be prepared to provide supporting documents and reports, calculations, and computer code verification to support the analysis documented in the FSAR, bases for TSs, or rationale for any required plans and procedures, as necessary.

Audit Team The NRC staff performing this audit will be:

• Steven Lynch (Project Manager)

• Jorge Cintron-Rivera (Electrical Engineer)

• Sheila Ray (Electrical Engineer)

Audit Team Logistics The virtual audit will initiate on May 11, 2020, and continue through May 15, 2020, as needed, until NRC staff has an adequate understanding of the issues to be addressed to facilitate the continued review of the operating license application. Audit activities may be conducted as teleconference and video conference supported activities, as appropriate and efficient to the gathering of information by the NRC staff. The audit period may be reduced or extended, dependent on the NRC staff and licensee progress in addressing audit topics and questions.

Additional audit activities may be planned in advance, as necessary, to support the understanding of information necessary to facilitate the continued review of the operating license application.

Deliverables At the completion of the regulatory audit the NRC staff will prepare a regulatory audit summary, which will be issued within 90 days after the audit. The regulatory audit summary will include the documents reviewed, the audit activities, and any requests for additional information (RAI) that were discussed or that will be issued based on the audit, as applicable.

Audit Topics and Questions The questions for discussion during the audit are primarily based on the regulatory audit topics provided as an attachment to this letter (ADAMS Accession No. ML20126G524). At the conclusion of the audit, necessary RAIs will be drafted to ensure the licensee has a clear understanding of the RAI scope.

Proposed Audit Schedule Monday, May 11, 2020 9:30 AM Entrance meeting, introductions, project status, overview of reference material 10:30 AM Audit 12:00 PM Break for lunch 1:00 PM Resume audit 4:00 PM Daily summary 5:00 PM End for the day Tuesday, May 12, 2020 8:00 AM Resume audit 12:00 PM Break for lunch 1:00 PM Resume audit 4:00 PM Daily summary 5:00 PM End for the day Wednesday, May 13, 2020 8:00 AM Resume audit 12:00 PM Break for lunch 1:00 PM Resume audit 4:00 PM Daily summary 5:00 PM End for the day Thursday, May 14, 2020 8:00 AM Resume audit 12:00 PM Break for lunch 1:00 PM Discussion of audit questions 4:30 PM Daily Summary 5:00 PM End for the day Friday, May 15, 2020 8:00 AM Resume audit 12:00 PM Break for lunch 1:00 PM Discussion of audit questions 4:30 PM Exit meeting 5:00 PM Conclude audit