ML20069B161
| ML20069B161 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies, 99902034 |
| Issue date: | 02/24/2020 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20069B152 | List: |
| References | |
| 2020-SMT-0020 | |
| Download: ML20069B161 (5) | |
Text
THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR § 2.390 February 24, 2020 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 2020-SMT-0020
References:
(1) U.S. Nuclear Regulatory Commission, "SHINE Medical Technologies, LLC Public Meeting on Operating License Application," Public Meeting Announcement, February 21, 2020 (ML20052G475)
Meeting Slides for the March 4 and 5. 2020 Public Meeting between SHINE Medical Technologies, LLC and the NRC A meeting is scheduled between SHINE Medical Technologies, LLC (SHINE) and the NRC staff (Reference 1) to discuss technical topics related to the SHINE operating license application.
The enclosed meeting slides and supplemental information contain information which SHINE requests to be withheld from public disclosure, including proprietary information in accordance with 1 O CFR 2.390(a)(4), export controlled information (ECI) in accordance with 1 O CFR 2.390(a)(3), and security-related information (SRI) in accordance 1 O CFR 2.390{d). SRI was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31, Revision 1. The meeting slides and supplemental information are provided via optical storage media (OSM). provides the non-public version of the SHINE meeting slides for the discussion regarding design changes to the tritium purification system (TPS). Enclosure 1 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. Due to the proprietary nature of the discussion, SHINE requests the NRG close a portion of the meeting session regarding design changes to the TPS to the public and withhold Enclosure 1 from public disclosure under 1 O CFR 2.390. provides the public version of the SHINE meeting slides for the discussion regarding design changes to the TPS. provides the non-public version of the SHINE meeting slides for the discussion regarding the SHINE safety analysis methodology. Enclosure 3 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. Due to the proprietary nature of the discussion, SHINE requests the NRC close a portion the meeting session regarding the SHINE safety analysis methodology to the public and withhold Enclosure 3 from public disclosure under 1 O CFR 2.390.
Enclosures 1 and 3 contain security related information.
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosures 1, 3, and 5, 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 provides the public version of the SHINE meeting slides for the discussion regarding the SHINE safety analysis methodology. provides the non-public version of the draft SHINE safety analysis approach as supplemental information to support the discussion of the SHINE safety analysis. SHINE will incorporate the safety analysis approach into the SHINE Safety Analysis Report following the discussion with the NRC Staff. SHINE is not seeking NRC review and approval of the enclosed SHINE safety analysis approach. The SHINE licensing basis accident analysis, including methodology, is described in Chapter 13 of the Final Safety Analysis Report (FSAR). contains proprietary information, a subset of which has been determined to be ECI.
SHINE requests the NRC withhold Enclosure 5 from public disclosure under 1 O CFR 2.390. provides the public version of the draft SHINE safety analysis approach. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosures 1, 3, and 5 and the proprietary nature of the discussion surrounding the content of the meeting slides for the subject meeting sessions, pursuant to 1 O CFR 2.390. SHINE requests that the NRC withhold Enclosures 1, 3, and 5 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 1, 3, and 5, this letter is uncontrolled.
If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
Very truly yours, c!J~
Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosures cc:
Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 1, 3, and 5)
ENCLOSURE 7 SHINE MEDICAL TECHNOLOGIES, LLC MEETING SLIDES FOR THE MARCH 4 AND 5, 2020 PUBLIC MEETING BETWEEN SHINE MEDICAL TECHNOLOGIES, LLC AND THE NRC AFFIDAVIT OF JAMES COSTEDIO 2 pages follow
AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN
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COUNTY OF ROCK
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I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, LLC (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 (NRG) and apply for the withholding of information from public disclosure. The purpose of this affidavit is to provide the information required by 10 CFR 2.390(b) in support of SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted in the meeting slides provided by letter 2020-SMT-0020 with enclosures and the related meeting discussion. SHINE requests that the confidential information contained in Enclosures 1, 3, and 5, 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 NRG 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 1, 3, and 5, 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 1, 3, and 5, and the related meeting discussion, is not available to the public to the best of my knowledge and belief.
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- c. The information contained in Enclosures 1, 3, and 5, 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 1, 3, and 5, 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 1, 3, and 5, 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 1, 3, and 5, 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 1, 3, and 5, and the related meeting discussion, is transmitted to the NRG in confidence and under the provisions of 1 O GFR 2.390; it is to be received in confidence by the NRG. The information is properly marked.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on February 24, 2020.
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Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC 2