ML18187A216
| ML18187A216 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 07/02/2018 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| 2018-SMT-0054 | |
| Download: ML18187A216 (59) | |
Text
THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 1 O CFR § 2.390 July 2, 2018 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 2018-SMT-0054
References:
(1) U.S. Nuclear Regulatory Commission, "Pre-Application Meeting on Technical Topics Associated vyith SHINE Medical Technologies, Inc.
Operating License Application," Meeting Notice, June 18, 2018 (ML18169A317)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated June 20, 2018, Meeting Slides for the June 28, 2018 Public Meeting between SHINE Medical Technologies, Inc. and the NRC Resubmittal of Meeting Slides for the June 28, 2018 Public Meeting between SHINE Medical Technologies, Inc. and the NRC A meeting was held between SHINE Medical Technologies, Inc. (SHINE) and the NRC staff (Reference 1) to discuss topics related to SHIN E's operating license application, including material control and accounting of special nuclear material, design changes to the process vessel vent system (PVVS), and instrumentation and control. SHINE has determined that the proprietary markings of the meeting slides, previously provided via Reference (2),
require revision. provides the SHINE meeting slides for the discussion regarding SHIN E's regulatory approach to the development of the material control and accounting (MC&A) plan. provides the non-public (proprietary) version of the SHINE meeting slides for the discussion regarding design changes related to the PVVS. Due to the proprietary nature of the discussion, SHINE requests the NRC close the meeting session regarding design changes related to the PVVS to the public and withhold Enclosure 2, in its entirety, from public disclosure under 1 O CFR 2.390. provides the public (non-proprietary) version of the SHINE meeting slides for the discussion regarding design changes related to the PVVS. contains both proprietary and security-related information.
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosures 2 and 4, this letter is uncontrolled.
101 E. Milwaukee Street, Suite 600 I Janesville, WI 53545 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed.com
/
Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 1 O CFR § 2.390 provides the non-public (proprietary) version of the SHINE meeting slides for the discussion regarding SHINE's safety-related instrumentation and control. In addition to proprietary information, Enclosure 4 contains security-related information which was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31. Due to the proprietary nature of the discussion, SHINE requests the NRC close the meeting session regarding SHINE's safety-related instrumentation and control to the public and withhold, in its entirety, from public disclosure under 1 O CFR 2.390. provides the public (non-proprietary) version of the SHINE meeting slides for the discussion regarding SHINE's safety-related instrumentation and control. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 2 and 4 and the proprietary nature of the discussion surrounding the content of the meeting slides for the subject meeting sessions, pursuant to 10 CFR § 2.390. SHINE requests that the NRC withhold Enclosures 2 and 4 from public disclosure, in their entirety, and close the related meeting sessions to the public, under 1 O CFR § 2.390. Upon removal of Enclosures 2 and 4, this letter is uncontrolled.
If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.
Very truly yours, mes Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosures cc:
Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 2 and 4) contains both proprietary and security-related information.
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosures 2 and 4, this letter is uncontrolled.
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
RESUBMITTAL OF MEETING SLIDES FOR THE JUNE 28, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC REGULATORY APPROACH TO THE DEVELOPMENT OF THE SHINE MATERIAL CONTROL AND ACCOUNTING (MC&A) PLAN 3 pages follow
Regulatory Approach to the Development of the SHINE Material Control and Accounting (MC&A) Plan Jeff Bartelme, Licensing Manager Health. llluminatedT:
SHINE MC&A Plan - Regulatory Requirements
- To support operation of the SHINE medical isotope production facility, SHINE is in the preliminary stages of developing the Material Control and Accounting (MC&A)
Plan which meets the requirements of 10 CFR Part 74, "Material Control and Accounting of Special Nuclear Material" As SHINE will seek authorization to possess special nuclear material of moderate strategic significance (low enriched uranium enriched to 19.75 weight percent U-235), the SHINE MC&A Plan will meet the requirements of Subpart D of 10 CFR Part 74
- In accordance with the requirements of 10 CFR § 74.41, SHINE will submit the MC&A Plan for Commission review and approval as part of the SHINE Operating License Application SHINE Medical Technologies I 2
SHINE MC&A Plan - Regulatory Guidance
- The NRC Staff has not issued regulatory guidance for the development of MC&A plans for facilities possessing special nuclear material of moderate strategic significance
- In lieu of existing regulatory guidance, SHINE intends on developing the MC&A Plan following the guidance of the September 2013 Draft for Comment version of NUREG-2159, "Acceptable Standard Format and Content for the Material Control and Accounting Plan Required for Special Nuclear Material of Moderate Strategic Significance"
- SHINE is seeking NRC Staff feedback on the planned approach described above, including any additional considerations in SHIN E's planned implementation of NUREG-2159 (draft for comment) guidance in the development of the SHINE MC&A Plan SHINE Medical Technologies I 3
ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.
RESUBMITTAL OF MEETING SLIDES FOR THE JUNE 28, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC PROCESS VESSEL VENT SYSTEM DESIGN PUBLIC VERSION 15 pages follow
Process Vessel Vent System Design Adam Gonnering, Process Systems Manager Health. llluminatedT:
Topics
- PSAR Design
- Design Update
- Codes and Standards
- Design Improvements
- Safety Analysis
- Fire Detection and Suppression Health. llluminatedT~
SHINE Medical Technologies I 2
PSAR Design - Two Systems Noble Gas Removal System Identified as maximum hypothetical accident (MHA) for the SHINE facility Store target solution vessel off-gas system (TOGS) off-gas for noble gas radioactive decay Release decayed off-gas to process vessel vent system (PVVS)
Monitor off-gas releases to ensure radioactivity levels are below regulatory limits for discharge to the environment Process Vessel Vent System Sweep the RPF process tanks to reduce hydrogen concentration Prevent detonations or deflagrations in process vessels from potential hydrogen accumulation Treat off-gas to remove excess acids Transfer treated off-gas to ventilation zone 1 Maintain process vessels at a negative pressure Design intent to capture noble gases from process vessel vents SHINE Medical Technologies I 3
Maximum Hypothetical Accident (PSAR)
- Noble gas removal system accident bounds SHINE facility Five noble gas tanks rupture simultaneously releasing contents instantly to noble gas storage cell Pressurization of cell drives release Tanks at maximum inventory of noble gas source term at initiation of event Redundant bubble-tight dampers isolate intake and exhaust ventilation of the cell on high radiation indication Control room operators notified of excess radiation levels in noble gas storage cell Radiation alarms available locally and in control room to notify personnel of radiation leakage.
Workers evacuate area.
High radiation levels in process facility isolate ventilation zone 2
- Total effective dose equivalents are within regulatory limits 10 CFR 20.1201 and 10 CFR 20.1301 Worker - 3.59 rem Site boundary - 0.0820 rem Nearest resident - 0.0115 rem
- SHINE expected pressures and volumes of this system would have needed to increase from the PSAR SHINE Medical Technologies I 4
Noble Gas Removal System (PSAR)
- 1. ~
lK lf~*II.O,, l lllu:e>h
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P,-DC'III
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SHINE Medical Technologies I 5
Process Vessel Vent System (PSAR)
SHINE Medical Technologies I 6
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Proposed Process Vessel Vent System Design Proprietary Information SHINE Medical Technologies I 7
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Proposed Process Vessel Vent System Design Proprietary Information SHINE Medical Technologies I 8
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Proposed Process Vessel Vent System Flow Diagram Proprietary Information SHINE Medical Technologies I 9
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
PVVS Design Codes and Standards Proprietary Information SHINE Medical Technologies po
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
PVVS Design Improvements Proprietary Information SHINE Medical Technologies 111
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Preliminary PVVS Hazards Proprietary Information SHINE Medical Technologies 112
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Preliminary PVVS Hazards Proprietary Information SHINE Medical Technologies 113
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Carbon Fire Detection & Suppression Methods Proprietary Information SHINE Medical Technologies 114
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Conclusion
[
Proprietary Information
- PSAR design Five compressed gas storage tanks for TOGS gases PVVS processed decayed noble gas and reduced hydrogen concentration in process tanks Maximum hypothetical accident for SHINE facility Proprietary Information J
SHINE Medical Technologies 115
ENCLOSURE 5 SHINE MEDICAL TECHNOLOGIES, INC.
RESUBMITTAL OF MEETING SLIDES FOR THE JUNE 28, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC SAFETY-RELATED INSTRUMENTATION AND CONTROL (l&C) OVERVIEW PUBLIC VERSION 33 pages follow
Safety-Related Instrumentation and Control (l&C) Overview Eric Van Abel, SHINE Medical Technologies, Inc.
Gregg Clarkson, Rock Creek Innovations, LLC Health. llluminatedT:
SHINE Medical Technologies - Instrumentation and Control
- SHINE Medical Isotope Production Facility Overview SH IN E Production Process Overview
- SHINE Irradiation Process Discussions SH IN E Facility Control Room Rock Creek Highly Integrated Protection System (HIPS)
HIPS Design Approach and HIPS Module Overview
- TRPS/ESFAS Architecture
- TRPS and ESFAS Design, Development, and Implementation
- Application Specific Action Items (ASAI) Evaluation Equipment Qualification for SHINE Protection system Rock Creek Innovations Programmable Logic Lifecycle Process Health. llluminatedT~
SHINE Medical Technologies I 2
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Security-Related Information - Withheld Under 1 O CFR § 2.390 Facility Layout - General Arrangement Proprietary Information Security-Related Information SHINE Medical Technologies I 3
Process Overview - Irradiation Facility
- 1. Periodic solution
.. ~---~ PRODUCT preparation
- 2. Solution chemistry check
- 3. Staging to fill TSV
- 4. Irradiation
- 5. Extraction and purification
- 6. Periodic solution cleanup and disposal m
TARGET SOLUTION PREPARATION
[11 SUBCRmCAL ASSEMBLY rn HOLD ----- *
- TANK
~
SU PERCELL PERIODIC DISPOSAL
@]
PERIODIC CLEANUP LOOP SHINE Medical Technologies I 4
Irradiation Process
- Small Systems: Hundreds of Times Less Power than Isotope Production Reactors
- Low source term-helps ensure safety of public and workforce
- Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />
- Minimizes waste nuclide generation compared to reactors
- Driven by Low-energy Electrostatic Accelerator
- System must be driven to operate, no criticality
- Hundreds of times less waste than reactors
- Electrostatic technology simple, demonstrated and cost effective
- Multiple Units Provide Operational Scalability and Flexibility
- Batch Control Philosophy - -5.5 Day Irradiation Cycle per Irradiation Unit with Each Irradiation Unit Capable of Startup Independently, On Demand
"\\
SHINE Medical Technologies I 5
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Subcritical Assembly Proprietary Information SHINE Medical Technologies I 6
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Preliminary Irradiation Process Function, Variables, and Actuation Components Proprietary Information
- Safety Interlocks
- Automatically Initiates Shutdow via Opening Redundant Dump Valves and Redundant Neutron Driver Supply Breakers Proprietary Information SHINE Medical Technologies I 7
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Security-Related Information - Withheld Under 10 CFR § 2.390 Facility Control Room (FCR)
Proprietary Information Security-Related Information Proprietary Information Proprietary Information Security-Related Information Proprietary Information Security-Related Information SHINE Medical Technologies I 8
SHINE Medical Technologies - Rock Creek Innovations Partnership
- Partnership for the design and implementation of the SHINE Safety l&C Systems RCI has architected multiple Field Programmable Gate Array (FPGA) based safety l&C platforms with expertise focused on the design, licensing, and deployment in multiple protection system applications
- Integrated team approach for the specification, design, and build of the Shine TSV Reactivity Protection System (TRPS) and Engineered Safety Feature Actuation System (ESFAS) Safety l&C Systems.
- Highly Integrated Protection System (HIPS)
Hybrid Analog/Digital System with FPGA logic on all modules implementing multiple deterministic finite state machines (no executable software)
HIPS Topical Report (TR) has been approved by the Nuclear
~§itil~S Health. Illuminated:
p ROCKCREEK INNOVATIONS, LLC Regulatory Commission (NRC) and Advisory Committee on Reactor highly integrated protection system Safeguards (ACRS)
SHINE Medical Technologies I 9
HIPS Platform Design Approach
- The highly integrated protection system (HIPS) is designed to provide a robust platform for safety-related and important-to-safety applications
- Key design concepts incorporate the following fundamental design principles:
independence redundancy diversity and defense-in-depth (D3) predictability and repeatability
- Hybrid analog and digital system with field programmable gate array (FPGA) programmable logic on all modules implementing multiple deterministic finite state-machines
- There is no executable software within the HIPS platform runtime environment. The use of programmable logic allows the platform to implement robust end to end self-test features. The programmable logic also provides for mitigation of future equipment obsolescence.
SHINE Medical Technologies po
HIPS Modules Overview The HIPS platform consists of the HIPS chassis and a system of modules that are interchangeable between chassis Module Name Abbreviation Description/Use Signal conditioning and actuation determination of safety Safety Function function(s). Provides scaled value of input process to Module SFM nonsafety controls and safety display for monitoring purposes (FPGA and analog).
Communications CM Controls, collects, and transmits information between HIPS Module modules or to external components (FPGA and analog).
Equipment Provides final equipment actuation output and includes EIM priority logic circuitry for automatic and manual actuation Interface Module inputs (FPGA and analog).
Hardwired Converts hardwired contact inputs into logic levels for direct Module HWM connection on dedicated backplane traces to a particular module as per the detail application design (analog only).
The HIPS platform is an FPGA-based platform - there is no executable software within the runtime environment SHINE Medical Technologies 111
Independence
- All modules operate independently and asynchronously
- SFM independence features
- galvanic isolation between different inputs (ISMs) on an SFM
- functional independence of each SFM (unique FPGA images)
- functional logic for the safety data paths, monitoring, and calibration/testing are independent from each other
- optocoupler isolation between FPGA and input signals
- CM independence features
- only one-way isolated communications allowed for interdivisional communications or communications outside of the platform
- EIM independence features
- actuation priority logic (APL) is composed of discrete components independent of the FPGA logic manual actuation and non-safety inputs connect directly to the APL (isolation via HWM and not input to FPGA)
- all inputs and outputs are individually isolated from EIM discrete logic circuitry SHINE Medical Technologies 112
Independence (continued)
FPGA logic on any module cannot be modified while installed in a chassis All interdivisional data communication is
-- through one-way isolated fiber optic ports on the CMs Bidirectional interdivisional data
~ ~ ~-+/-._... co.mmunication is not allowed i~: 1 communications logic for each M1B
} Separate and dedicated
~g~ ~
data bus within a chassis No capability for remote access to the system SHINE Medical Technologies 113
Redundancy
- Specific system architecture must be evaluated separately to confirm it meets the single failure criterion
- HIPS platform internal redundancy
- redundant power supplies to feed HIPS modules
- triple redundant safety data paths allow for communication error detection and limits a fault to a single bus without compromising safety actuations
- loss or removal of a CM generates an alarm but does not result in trip or actuation of the end device
- redundant safety data communications and EIM configuration allows for on line maintenance (hot swapping of modules)
- internal redundancy results in simplified self-testing circuitry SHINE Medical Technologies 114
Diversity Equipment diversity
- the FPGA portion of an SFM, CM, and EIM is the only portion of the HIPS platform vulnerable to software logic-based common cause failures (CCFs)
- the HIPS platform requires at least two different FPGA architectures (one time programmable [OTP] or flash-based and static random-access memory [SRAM-based])
Design diversity intentional differences are required in the software tools used for FPGA development SRAM Cell Gate Silicon Oxide (metal)
Positivety doped drain l Positively doped source Standard MOSFET Transistor.
,:n metal
-.-~
tal
~
- \\ -
.:. t **. l L J l 1.L.,
Pt-Pat Negatively Doped Sihcon PMOS transistor is shown. NMOS transistor would have positively doped silicon with negatively doped supply and drain Flash Cell Silicon 01cide Control11ate (polysilicon)
Can have positively doped silicon with nesatively doped r.upply and dram Floating Gate Transistor SHINE Medical Technologies 115
Predictability and Repeatability
- A single clock base is used for logic performed on each module's FPGA as well as being used to derive the safety data bus (SOB) bit frequency and sampling bits on the communication buses
- Safety functions are processed by three redundant sets of dedicated logic to provide error detection and fault tolerance
- lntradivisional communications within a chassis are implemented with a master-slave communication protocol using simple differential RS-485 virtual point-to-point or multi-drop bus communication
- Master and slave modules communicate asynchronously
- All SOB communication transactions have identical duration SHINE Medical Technologies p6
Simplicity
- There is no executable software within the HIPS platform runtime environment
- Each module functions autonomously on its own single clock domain
- Inherent SFM independence results in simpler trip determination logic
- Use of triple module redundancy within a division provides simpler self-testing schemes and maintenance, and also improves availability
- FPGA functions implemented with finite states machines to achieve deterministic behavior
- Deterministic behavior allows use of a simple communication protocol using predefined message structure with fixed time intervals
- Asynchronous communication avoids complex synchronization techniques SHINE Medical Technologies 117
Calibration, Testing, and Diagnostics
- In-chassis calibration of set points/tunable parameters can be performed for the SFM when the SFM is taken out of service; all other modules are either unable to be changed or only capable of changes when removed from the chassis
- All components, except the discrete APL of the EIM, have self-testing capabilities to ensure the information transmitted to the next step in the safety data path are correct
- Each module ensures that it is functioning correctly and the error checking on the communication buses ensure correct transfer of data 1gn:ndo~~tn1ng *************llnp~teTt~t~~~~gule *************************************************************************
SFM a e Y unc ion
'Built-in Self-Test
.-------o~_l;-,-~~-~~c-:,...~o-n--. I Co;~;~~!~::,~:"'
(~ !~~)...................................
Communication
'Built-in Self-Test Module Functional Logic (BIST)
- 1*commun1cat1on *bus*******************************************************************.**********
.--------"----~**...... error.detect1n.9............ lBuilt-;~l~~~-Test........... "'*......................
1---.........=~-=---......-l I
Periodic EIM Output surveillance testing High Drive Out ut SHINE Medical Technologies J18
HIPS Platform Summary
- The HIPS platform is based on the fundamental l&C design principles of independence redundancy diversity and defense-in-depth predictability and repeatability
- The HIPS platform was developed to provide a simple and reliable solution for safety related l&C applications which support meeting the guidelines and the requirements of the N RC's regulatory guides and IEEE standards applicable to safety-related and important-to-safety applications
- The HIPS platform is based upon FPGA technology which has been previously approved by the NRC for safety-related applications
- The licensing topical report (LTR) demonstrates how the HIPS platform key design concepts meet the fundamental l&C design principles
- The LTR also describes testing and diagnostic concepts and how the key design concepts are implemented to achieve overall simplicity SHINE Medical Technologies 119
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Overall SHINE l&C Architecture Proprietary Information SHINE Medical Technologies 120
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
TRPS High-Level Architecture Proprietary Information SHINE Medical Technologies 121
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
TRPS Module-Level Architecture Proprietary Information SHINE Medical Technologies 122
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
TRPS Process State Diagram Proprietary Information SHINE Medical Technologies 123
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
ESFAS High-Level Architecture Proprietary Information SHINE Medical Technologies 124
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
ESFAS Module-Level Architecture Proprietary Information SHINE Medical Technologies 125
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
TRPS and ESFAS Design Development Diagram Proprietary Information SHINE Medical Technologies 126
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Correlation of Codes and Standards Proprietary Information SHINE Medical Technologies 127
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Application Specific Action Items (ASAI) Evaluation Proprietary Information SHINE Medical Technologies 128
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Application Specific Action Items (ASAI) Evaluation Proprietary Information SHINE Medical Technologies 129
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Equipment Qualification for SHINE Protection System Proprietary Information SHINE Medical Technologies 130
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
RCI Programmable Logic Lifecycle Process Proprietary Information SHINE Medical Technologies 131
Proprietary Information - Withheld from Public Disclosure Under 10 CFR § 2.390(a)(4)
Proprietary Information INE Medical Technologies 132
Conclusions
- SHINE is planning to use the HIPS Platform for safety-related l&C systems in the SHINE facility Hybrid analog and digital system using field programmable gate arrays (FPGAs)
- The technology has been selected as the best solution from a range of technologies, including purely analog, hybrid, and purely digital
- Incorporates fundamental design principles for safety:
Independence Redundancy Diversity and defense-in-depth Predictability and repeatability
- Trip logic is clearly implemented and fully testable
- Simple - No executable software SHINE Medical Technologies 133
ENCLOSURE 6 SHINE MEDICAL TECHNOLOGIES, INC.
RESUBMITTAL OF MEETING SLIDES FOR THE JUNE 28, 2018 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, INC. AND THE NRC AFFIDAVIT OF JAMES COSTEDIO 2 pages follow
AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN
)
) ss.
COUNTY OF ROCK
)
I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, Inc. (SHINE), do hereby affirm and state:
- 1.
I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure. The purpose of this affidavit is to provide the information required by 1 O CFR 2.390(b) in support of SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the public meeting slides provide by letter 2018-SMT-0050 with enclosures and the related meeting discussion. SHINE requests that the confidential information contained in Enclosures 2 and 4, and the related meeting discussion, be withheld from public disclosure in their entirety.
- 2.
I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.
- 3.
Pursuant to the provisions of paragraph (a)(4) of 1 O CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld.
- a. The information sought to be withheld from public disclosure contained in Enclosures 2 and 4, and the related meeting discussion, is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. This information is and has been held in confidence by SHINE.
- b. The information sought to be protected in Enclosures 2 and 4, and the related meeting discussion, is not available to the public to the best of my knowledge and belief.
- c. The information contained in Enclosures 2 and 4, and the related meeting discussion, is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls. SHINE limits access to these elements to those with a "need to know," and subject to maintaining confidentiality.
- d. The proprietary information sought to be withheld from public disclosure in Enclosures 2 and 4, and the related meeting discussion, includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope production facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in Enclosures 2 and 4 and the related meeting discussion, would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.
- e. Public disclosure of the information in Enclosures 2 and 4, and the related meeting discussion, would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations, assumptions, processes, and current position. Its use by a competitor could substantially improve their competitive position in the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.
- f.
The information contained in Enclosures 2 and 4, and the related meeting discussion, is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on July 2, 2018.
s ostedio ice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
2