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University of Missouri-Columbia Research Reactor - Mo-99 Presentation and Affidavit for June 2, 2016 Public Meeting
	ML16146A188
Person / Time
Site:	University of Missouri-Columbia
Issue date:	05/23/2016
From:	Rhonda Butler; Univ of Missouri - Columbia
To:	; Document Control Desk, Office of Nuclear Reactor Regulation
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Ml16146A226	List: ML16146A188;
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UNIVERSITY of MISSOURI RESEARCH REACTOR CENTER May 23, 2016 U.S. Nuclear Regulatory Commission Attention: Document Control Desk Mail Station Pl-37 Washington, DC 20555-0001

Reference:

Docket 50-186 University of Missouri-Columbia Research Reactor Mo-99 Presentation and Affidavit for June 2, 2016 public meeting Enclosed you will find the University of Missouri-Columbia Research Reactor's presentations and affidavit for the public meeting to be held on June 2, 2016.

If you have any questions, please contact Ralph A. Butler, Director, at 573-882-5296 or ButlerRa@missouri.edu Sincerely, i:2U~

Ralph A. Butler, P.E.

Director RAB/des Enclosures 1513 Research Park Drive Columbia, MO 65211 Phone: 573-882-4211 Fax: 573-882-6360 Web: www.murr.missouri.edu Fighting Cancer with Tomorrow's Technology

+ GSNERAL A'l'OMICS

.IJND IJ.PPIUA71t;;O t:OMPANIES GENERAL ATOMICS AFFIDAVIT OF RICHARD G. MILLER I, Richard G. Miller, Deputy Director for Nuclear Technology & Materials, Energy Group, General Atomics, do hereby affirm and state:

(1) I have been delegated the function of reviewing information described in paragraph 3 which General Atomics requests be withheld from public disclosure or publication and I am authorized to execute this affidavit on behalf of General Atomics.

(2) The affidavit is submitted under the provisions of 10CFR Part 2.390 in order to withhold the enclosed/attached confidential commercial and proprietary information (as set forth in paragraph 3 following) of General Atomics from public disclosure or publication.

(3) General Atomics has partnered with The Missouri University Research Reactor (MURR) and Nordion to develop the Reactor-Based Mo-99 Supply System (RB-MSS) Project using its Selective Gas Extraction of Mo-99 process. The information sought to be withheld is related to the development and licensing of General Atomics' technology for deployment at MURR.

The information is contained in a presentation titled "Reactor Based Mo-99 Supply System Project: Revised Licensing Approach" presented to the U.S. Nuclear Regulatory Commission by MURR, dated June 2, 2016.

Essentially each and every page of this document contains proprietary material developed by General Atomics, and for General Atomics by its partners MURR and Nordion that is "business sensitive" and/or "trade secret".

(4) In making this application for withholding of proprietary information of which it is the owner, General Atomics relies upon the exemption from disclosure set forth is the Freedom of Information Act ("FOIA"), 5 USC Sec. 552(b)(4) and the Trade Secrets Act, 18 USC Sec. 1905, and NRC regulations 10CFR Part 9.17(a)(4) and 2.390(a)(4) for "trade secrets and commercial or financial information obtained from a person and privileged or confidential." The material for which exemption from disclosure is hereby sought is all "confidential commercial information," and/or also qualify under the narrower definition of "trade secret," within the meanings assigned to those terms for purposes of FOIA Exemption 4 in, respectively, Critical Mass Energy Project v. Nuclear Regulatory Commission, 975F2d871 (DC Cir. 1992), and Public Citizen Health Research Group v. FDA. 704F2d1280 (DC Cir. 1983).

(5) Some examples of categories of information which fit into the definition of proprietary information are:

3550 GENERAL ATOMICS COURT, SAN DIEGO, CA 92121-1122 PO BOX 85608, SAN DIEGO, CA 92186-5608 (858) 455-3000

a. Information that discloses a process, method, or apparatus, including supporting data and analyses, where prevention of its use by General Atomics' competitors without license from General Atomics constitutes a competitive economic advantage over other companies;

b. Information which, if used by a competitor, would reduce his or her expenditure of resources or improve his or her competitive position in the design, manufacture, shipment, installation, assurance or quality, or licensing of a similar product.

c. Information which discloses patentable subject matter for which it may be desirable to obtain patent protection.

(6) The information sought to be withheld is being submitted to the NRC in confidence. The information is of a sort customarily held in confidence, is of a sort customarily held in confidence by General Atomics, and is in fact so held. The information sought to be withheld has, to the best of my knowledge and belief, consistently been held in confidence by General Atomics. No public disclosure has been made, and it is not available in public sources. All disclosures to third parties, including any required transmittals to the NRC, have been made, or must be made, pursuant to regulatory provisions or proprietary agreements which provide for maintenance of the information in confidence.

(7) Initial approval of proprietary treatment of a document is made by the manager of the originating business unit, the person most likely to be acquainted with the value and sensitivity of the information in relation to industry knowledge. Access to such documents within General Atomics is limited on a "need to know" basis.

Disclosures outside General Atomics are limited to regulatory bodies, customers, and potential customers, and their agents, suppliers, and licensees, and others with a legitimate need for the information, and then only in accordance with appropriate regulatory provisions or proprietary non-disclosure agreements for protecting the information from further disclosure.

(8) The information classified as proprietary was developed and compiled by General Atomics at a significant cost to General Atomics. This information is classified as proprietary because it contains detailed data and analytical results not available elsewhere. This information would provide other parties, including competitors, with information from General Atomics technical database and the results of evaluations performed by General Atomics. Release of this information would improve a competitor's position without the competitor having to expend similar resources for the development of the database. A significant effort has been expended by General Atomics to develop this information.

(9) Public disclosure of the information sought to be withheld is likely to cause substantial harm to General Atomics' competitive position. The information is part of General Atomics' selective gas extraction technology base, and its commercial value extends beyond the original development cost.

The research, development, engineering, and analytical costs associated with General Atomics' unique selective gas extraction system and process comprise a substantial investment of time and resources by General Atomics.

GENERAL ATOMICS Richard G. Miller, Deputy Director Nuclear Materials and Technologies Division Energy Group

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