ML22335A572

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Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information
ML22335A572
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/01/2022
From: Jim Costedio
SHINE Health. Illuminated
To:
Office of Nuclear Reactor Regulation, Document Control Desk
References
2022-SMT-0124
Download: ML22335A572 (1)


Text

3400 Innovation Ct

  • Janesville, WI 53546
  • 877.512.6554
  • info@shinemed.com
  • www.SHINEtechnologies.com December 1, 2022 2022-SMT-0124 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)

(2) NRC electronic mail to SHINE Technologies, LLC, SHINE Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems (EPID No. L-2019-NEW-0004), dated December 1, 2022 SHINE Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, Wisconsin (Reference 1). The NRC staff determined that confirmatory information was required to enable the staffs continued review of the SHINE operating license application (Reference 2).

provides the SHINE responses to the NRC staffs request for confirmatory information.

If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on December 1, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc:

Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health

Page 1 of 2 ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE RESPONSE TO REQUEST FOR CONFIRMATORY INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff determined that confirmatory information was required (Reference 1) to enable the continued review of the SHINE Technologies, LLC (SHINE) operating license application (Reference 2). The following information is provided by SHINE in response to the NRC staffs request.

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.

SHINE Response SHINE confirms that the information related to manual controls in the facility control room contained in Subsection 7.1.5 of the FSAR is accurate.

Page 2 of 2 References

1. NRC electronic mail to SHINE Technologies, LLC, SHINE Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems (EPID No. L-2019-NEW-0004), dated December 1, 2022
2. SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)