ML22348A067

Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems

ML22348A067
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/01/2022
From:	Michael Balazik NRC/NRR/DANU/UNPL
To:	Bartelme J, Piefer G SHINE Technologies
References
EPID L-2019-NEW-0004, CPMIF-001
Download: ML22348A067 (1)

Text

From:

Michael Balazik To:

Jeffrey Bartelme Cc:

Holly Cruz; Josh Borromeo

Subject:

RCI for FSAR Chapter 7, Instrumentation and Control Date:

Thursday, December 1, 2022 10:07:00 AM Dr. Gregory Piefer, Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546

SUBJECT:

SHINE TECHNOLOGIES, LLC - REQUEST FOR CONFIRMATORY INFORMATION RELATED TO INSTRUMENTATION AND CONTROL SYSTEMS (EPID NO. L-2019-NEW-0004)

Dear Dr. Piefer:

By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE 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 (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.

During the NRC staffs review of SHINEs operating license application, questions have arisen for which confirmatory information is needed. The enclosed request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report, submitted in connection with the operating license application, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RCI is Chapter 7, Instrumentation and Control Systems.

It is requested that SHINE provide responses to the enclosed RCI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RCI, the NRC staff is available to meet with SHINE to clarify the scope of information and level of detail expected to be included in the RCI response. SHINE may coordinate the scheduling and agendas for any such meetings with the responsible project manager assigned to this project.

In accordance with 10 CFR 50.30(b), Oath or affirmation, SHINE must execute its response in a signed original document under oath or affirmation. The response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in the response that is considered

sensitive or proprietary, that SHINE seeks to have withheld from the public, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to safeguards should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements. Following receipt of the confirmatory information, the NRC staff will continue its evaluation of the subject chapters and technical areas of the SHINE operating license application.

As the NRC staff continues its review of SHINEs operating license application, additional RCIs for other chapters and technical areas may be developed. The NRC staff will transmit any further questions to SHINE under separate correspondence.

If SHINE has any questions, or needs additional time to respond to this request, please contact me at 301-415-2856, or by electronic mail at Michael.Balazik@nrc.gov.

OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR CONFIRMATORY INFORMATION REGARDING OPERATING LICENSE APPLICATION FOR SHINE TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608

By letter dated July 17, 2019 (Agencywide Documents Access and Management System Accession No. ML19211C044), as supplemented, SHINE 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 (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.

During the NRC staffs review of the SHINE operating license application, and the review of documents during the audit, questions have arisen for which confirmatory information is needed. This request for confirmatory information (RCI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. Specific chapters and technical areas of the SHINE operating license application covered by this RCI include the following:

Chapter 7, Instrumentation and Control Systems Applicable Regulatory Requirements and Guidance Documents Section 50.34, Contents of applications; technical information, paragraph (b) of 10 CFR states, in part, that [t]he final safety analysis report shall include information that describes the facility, presents the design bases and the limits on its operation, and presents a safety analysis of the structures, systems, and components and of the facility as a whole. Section 50.34, subparagraph (b)(4) of 10 CFR states, in part, that final analysis and evaluation of the design and performance of structures, systems, and components with the objective stated in paragraph (a)(4) of this section and taking into account any pertinent information developed since the submittal of the preliminary safety analysis report.

RCI 7-17 For SHINE FSAR Section 7.1.5, Control Console and Displays, confirm that manual controls in the facility control room (FCR) consist of a single system level manual actuation switch for each automatic target solution vessel reactivity protection system (TRPS) and engineered safety features actuation system (ESFAS) safety function. These manual actuation switches are connected to the hardwired module (HWM) in the TRPS and ESFAS chassis. The HWM converts the manual actuation signals to logic level voltages that are placed on the backplane for use by the modules that require them. The manual actuation components are input into the actuation and priority logic (APL) associated with each EIM via the HWM. The APL accepts inputs from the following sources:

1a Digital trip signal from the scheduling, bypass, and voting modules (SBVM) 1b Non-digital manual system level trip signal from the FCR 2a Non-digital manual enable nonsafety signal from the FCR 2b Non-digital position indication signal from an HWM

2c Non-digital control signals from the process integrated control system (PICS)

The non-digital signals are diverse from the digital portion of the TRPS and ESFAS. Discrete logic is used by the APL for actuating a single device based on the highest priority. Regardless of the state of the digital trip signal from the SBVM, manual initiation can always be performed at the system level. If the enable nonsafety control permissive is active and there are no automatic or manual actuation signals present, the PICS is capable of operating trip and actuation components. The result from the APL is used to actuate equipment connected to the equipment interface module (EIM). Actuation component status is transmitted to the EIM and is sent to the monitoring and indication bus (MIB), along with the status of the safety data bus (SDB) signals.

Best Regards, Michael Balazik Project Manager/Inspector Non-Power Production and Utilization Facility Licensing Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Michael.Balazik@nrc.govl Tel: (301) 415-2856