ML18173A137
| ML18173A137 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 06/20/2018 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML18173A104 | List: |
| References | |
| 2018-SMT-0050 | |
| Download: ML18173A137 (9) | |
Text
THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR § 2.390 June 20, 2018 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 2018-SMT-0050
References:
(1) U.S. Nuclear Regulatory Commission, "Pre-Application Meeting on Technical Topics Associated with SHINE Medical Technologies, Inc.
Operating License Application," Meeting Notice, June 18, 2018 (ML18169A317)
Meeting Slides for the June 28, 2018 Public Meeting between SHINE Medical Technologies, Inc. and the NRG A meeting is scheduled between SHINE Medical Technologies, Inc. (SHINE) and the NRG 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, and instrumentation and control. provides the SHINE meeting slides for the discussion regarding SHINE's regulatory approach to the development of the material control and accounting (MC&A) plan. provides the SHINE meeting slides for the non-public discussion regarding design changes related to the process vessel vent system. SHINE requests that the NRG withhold, in its entirety, from public disclosure under 1 O CFR 2.390. provides the SHINE meeting slides for the discussion regarding SHIN E's design and implementation of instrumentation and control protection systems. In addition to proprietary information, Enclosure 3 contains security-related information which was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31. SHINE requests that the NRG withhold Enclosure 3, in its entirety, from public disclosure under 1 O CFR § 2.390. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 2 and 3, pursuant to 10 CFR § 2.390. SHINE requests that the NRG withhold Enclosures 2 and 3, in their entirety, from public disclosure under 1 O CFR § 2.390. Upon removal of Enclosures 2 and 3, this letter is uncontrolled. contains both proprietary and security-related information.
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosures 2 and 3, this letter is uncontrolled.
101 E. Milwaukee Street, Suite 600 I Janesville, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com
Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR § 2.390 If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.
Very truly yours,
~
mes Costedio ce 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 3) contains both proprietary and security-related information.
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosures 2 and 3, this letter is uncontrolled.
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
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 SHINE'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 4 SHINE MEDICAL TECHNOLOGIES, INC.
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
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) ss.
COUNTY OF ROCK
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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. SHINE requests that the confidential information contained in Enclosures 2 and 3 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 3 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 3 is not available to the public to the best of my knowledge and belief.
- c. The information contained in Enclosures 2 and 3 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 3 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 3 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 3 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 3 is transmitted to the NRC in confidence and under the provisions of 1 O 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 June 20, 2018.
~ ffj;:2 Vic; President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
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