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Northwest Medical Isotopes, LLC - Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional Information - Letter Dated January 19, 2016
	ML16053A204
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	02/12/2016
From:	Haass C; Northwest Medical Isotopes
To:	Martinez N; Document Control Desk, Division of License Renewal
Shared Package
ML16053A221	List: ML16053A204; ML16053A205; ML16053A206; ML16053A207; ML16053A208; ML16053A209; ML16053A210; ML16053A211; ML16053A212;
References
	NWMI-LTR-2016-002 NWMI-2016-RAI-001, Rev. 0
	Download: ML16053A204 (5)
	v • d • e

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NWMI NORTHWEST MEDICAL IOOE February 12, 2016 NWMI-LTR-20 16-002 Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-000 1 Ms. Nancy Martinez Environmental Project Manager Environmental Review and Guidance Branch Division of License Renewal Office of Nuclear Reactor Regulation RE: Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information - Letter Dated January 19, 2016 (ADAMS Accession No. ML15364A376)

References:

1. Northwest Medical Isotopes, LLC Letter to U.S. Nuclear Regulatory Commission, dated November 20, 2015, Docket No. 50-609 (ADAMS Accession No. ML15328A010)

2. U.S. Nuclear Regulatory Commission letter to Northwest Medical Isotopes, LLC, dated November 2, 2015, Docket No. 50-609 (ADAMS Accession No. ML15288A102)

3. Northwest Medical Isotopes, LLC Letter to U.S. Nuclear Regulatory Commission, dated February 5, 2015 (ADAMS Accession No. ML14349A501) and Associated Part One Submittal, Environmental Report ADAMS Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131)

Dear Ms. Martinez:

Northwest Medical Isotopes, LLC (NWMJ) is providing the attached response to the U.S. Nuclear Regulatory Commission request for additional information for the environmental review (Round 2) dated January 19, 2016.

The required affidavit to withhold information from public disclosure is provided in Attachment 1.

NWMIN considers the information in Attachment 2 to be proprietary and requests that the attachment be withheld from public disclosure, pursuant to 10 CFR 2.390, "Public Inspections, Exemptions, Requests for Withholding."

The attachments to this letter include the following:

Attachment 1 - The required affidavit to withhold information from public disclosure per 10 CFR 2.390

Attachment 2 - Non-public (proprietary and business sensitive) version of the letter; the information is provided on in hard copy

Attachment 3 - Public (non-proprietary) version of the letter; the information is provided in hard copy A4 0/

Ms. Nancy Martinez Page 2 NWMI requests that Attachment 2 be withheld from public disclosure pursuant to 10 CFR 2.390 and be uncontrolled or can be made available to the public.

In addition, NWMI is submitting this response to the NRC in accordance with 10 CFR 50.30(b), "Oath or Affirmation," and 10 CFR 50.4, "Written Communications."

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

Executed on February 12, 2016.

ff you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes .com.

Sincerely, Carolyn C. Haass Chief Operating Officer

Enclosures:

Attachments 1, 2, and 3 cc: Mr. Michael Balazik Mr. Alexander Adams Research and Test Reactors Branch A Research and Test Reactors Branch A Office of Nuclear Reactor Regulation Office of Nuclear Reactor Regulation Northwest Medical Isotopes, LLC I815 NW 9th Aye, Suite 256 [ Corvallis, OR 97330

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,.. NORTHWEST MEDICALSOTOPES ATTACHMENT 1 AFFIDAVIT TO WITHHOLD PROPRIETARY INFORMATION FROM PUBLIC DISCLOSURE (Pursuant to 10 CFR 2.390)

10 CFR 2.390 AFFIDAVIT OF Carolyn C. Haass I, Carolyn C. Haass, hereby affirm and state as follows:

1. I am the Chief Operating Officer of Northwest Medical Isotopes, LLC (NWN'I), and I have been authorized to execute this affidavit on behalf of NWMI.

2. The information contained in the enclosed letter dated February 12, 2016, is proprietary commercial information related to NWMI becoming a domestic supplier of molybdenum-99 (99Mo). The proprietary information (Response to the U.S. Nuclear Regulatory Agency Request for Additional Information, Round 2 - Environmental Review of the Northwest Medical Isotopes, LLC, Construction Permit Application, Non-Pubic Version) includes sensitive business information created by or for NWMI. This information should be held in confidence by the U.S.

Nuclear Regulatory Commission (NRC) and withheld from public disclosure.

3. In making this application for withholding of proprietary information of which it is the owner, NWMI believes that the information qualifies for withholding under the exemption from disclosure set forth in the Freedom of Information Act (FOIA), 5 U.S .C. Section 552(b)(4), the Trade Secrets Act, 18 U.S.C. Section 1905, and NRC regulations in 10 CER 2.390(a)(4) for trade secrets and commercial information because:

a. This information is owned by NWMIV. Specifically, information related to the target dimensions, material composition, and mass or information that would reasonably allow knowledgeable people to deduce this information and experimental results should be with held from public disclosure. This information is considered proprietary and would significantly affect any competitive advantage that this target configuration creates.

b. This information is of a type that is customarily held in confidence by NWMI, and there is a rational basis for doing so because the information includes sensitive business information.

c. The information is being transmitted to the NRC voluntarily and in confidence.

d. This information is not available in public sources and could not be gathered readily from other publicly available information.

e. Public disclosure of this information would create substantial harm to the competitive position of NWMVI by disclosing certain business decisions NWMI has made or is considering, and the analysis that went behind those decisions. Development and evaluation of this commercial information was achieved at, and disclosure could lead to additional, significant cost to NWMVI.

f. Public disclosure of the information sought to be withheld is likely to cause substantial harm to NWMI' S competitive position and foreclose or reduce the availability of profit-making opportunities. The value of the information goes beyond the disclosure of actual information pertaining to NWMI's potential business, and includes substantial time and work towards developing the project by NWMI and its associates. The research, development, engineering, and analytical costs comprise a substantial investment of time and money by NWMI. The precise value of the information is difficult to quantify, but clearly is substantial.

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NORTHWESTMEDICAL ISOTOPES

g. NWMI's competitive advantage will be lost if its competitors are able to use the results of NWMVI' s activities to aid their own commercial activities. The value of this information to NWMI would be lost if the information was disclosed to the public. Making such information available to other entities without their having been required to undertake a similar expenditure of resources would unfairly provide competitors with a significant advantage, and deprive NWMI of the opportunity to exercise its competitive advantage to seek an adequate return on a large investment.

Carolyn C. Haass, Vice President Subscribed and sworn before me, a Notary Public, in and for the State of Colorado, this 12th day of February, 2016.

Witness my hand and Notarial Seal.

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KATHLEEN M. ROBINSON V 0,.._(*Af'--'-

NOTARY PUBLIC STATE OF COLORADO Notary Public NOTARY ID # 20034032360 MY COMMISSION EXPIRES SEPTEMBER 25, 2019 My commission expires: '1 - *-6 o*2-) //

Date Al1-2

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NWMI NORTHWEST MEDICAL IOOE February 12, 2016 NWMI-LTR-20 16-002 Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-000 1 Ms. Nancy Martinez Environmental Project Manager Environmental Review and Guidance Branch Division of License Renewal Office of Nuclear Reactor Regulation RE: Northwest Medical Isotopes, LLC Responses to the U.S. Nuclear Regulatory Commission Environmental Request for Additional information - Letter Dated January 19, 2016 (ADAMS Accession No. ML15364A376)