ML15258A348

Shine Medical Technologies, Inc. Application for Construction Permit Preliminary Safety Analysis Report Revisions

ML15258A348
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/27/2015
From:	Bynum R SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML15258A587	List: ML15258A348 ML15258A532 ML15258A533 ML15258A596 ML15258A597 ML15258A598
References
SMT-2015-039
Download: ML15258A348 (9)

Text

SHINE' Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 August27,2015 SMT-2015-039 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, Inc. letter to NRG, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)

(2) SHINE Medical Technologies, Inc. letter to NRG, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)

(3) SHINE Medical Technologies, Inc. letter to NRG, dated October 15, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14296A189)

SHINE Medical Technologies, Inc. Application for Construction Permit Preliminary Safety Analysis Report Revisions Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). SHINE has reviewed the Preliminary Safety Analysis Report (PSAR) and determined that revisions are necessary to the description of the aircraft hazard analysis and the chemical hazards analysis provided in Chapter 2, and the description of the SHINE organization provided in Chapter 12. provides an update to the SHINE evaluation of the aircraft hazard and the SHINE evaluation of chemical hazards provided in Section 2.2 of the PSAR. Enclosure 1 is provided via optical storage media (OSM) as OSM#1. provides Revision 1 of the SHINE Response to RAI 12.1-1 and RAI 12.2-1, previously provided via Reference (3). Enclosure 2 is provided via OSM as OSM#2 provides a non-public (proprietary) revision to the SHINE PSAR, incorporating the changes described in Enclosures 1 and 2. Enclosure 3 is provided via OSM as OSM#3.

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 from public disclosure under 10 CFR 2.390.

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 3, this letter is uncontrolled.

2555 Industrial Drive I Monona, WI 53713 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com

Document Control Desk Page2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 provides a public (non-proprietary) revision to the SHINE PSAR, incorporating the changes described in Enclosures 1 and 2. Enclosure 4 is provided via OSM as OSM#4. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 3 contains information proprietary to SHINE.

Upon removal of Enclosure 3, this letter is uncontrolled.

If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.

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

Executed on August 27, 2015.

Very truly yours, R. Vann Bynum, Ph.D.

Chief Operating Officer SHINE Medical Technologies, Inc.

Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 3)

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 3, this letter is uncontrolled.

ENCLOSURE1 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT REVISIONS UPDATE TO THE EVALUATION OF AIRCRAFT HAZARD AND THE EVALUATION OF CHEMICAL HAZARDS PROVIDED IN THE PRELIMINARY SAFETY ANALYSIS REPORT

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ENCLOSURE2 SHINE MEDICAL TECHNOLOGIES, INC.

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ENCLOSURE 3 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT REVISIONS PRELIMINARY SAFETY ANALYSIS REPORT NON-PUBLIC VERSION (OSM#3)

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Upon removal of Enclosure 3, this letter is uncontrolled.

ENCLOSURE 4 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT REVISIONS PRELIMINARY SAFETY ANALYSIS REPORT PUBLIC VERSION (OSM#4)

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ENCLOSURES SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT REVISIONS AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow

AFFIDAVIT OF RICHARD VANN BYNUM STATE OF WISCONSIN )

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COUNTY OF DANE )

I, Richard Vann Bynum, Chief Operating Officer 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 (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 SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the SHINE preliminary safety analysis report revisions transmitted by letter SMT-2015-039 with enclosures. SHINE requests that the confidential information contained in Enclosure 3 be withheld from public disclosure in its 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 10 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 Enclosure 3 of SMT-2015-039 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 Enclosure 3 is not available to the public to the best of my knowledge and belief.

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c. The information contained in Enclosure 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 Enclosure 3 includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope 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 Enclosure 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 Enclosure 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 Enclosure 3 of SMT-2015-039 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 August 27, 2015.

l.~It:. Ph.D.

COO- SHINE Medical Technologies, Inc.

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