ML22160A424

AFFIDAVIT-Request for Validation Recommendation from the U.S. DOT, Package No. F-522, Certificate No. CDN2094B(U)-96, Revision 4 (Docket No. 71-3091)

ML22160A424
Person / Time
Site:	07103091
Issue date:	06/08/2022
From:	Coombs M BWXT Medical, Ltd
To:	Division of Fuel Management
Shared Package
ML22160A277	List: ML22160A421 ML22160A422 ML22160A424
References
A33010, L-2022-DOT-0004
Download: ML22160A424 (1)

Text

BWXT Medical Ltd.

Medical 447 March Rd., Ottawa, ON, K2K 1X8 www.bwxt.com AFFIDAVIT I, Martyn Coombs, in my capacity as President, have been duly authorized to apply for withholding from public disclosure of proprietary information by and on half of BWXT Medical Ltd. (BWXT Medical), do depose and say:

1. I, Martyn Coombs, am the President of BWXT Medical.

2. The information provided in BWXT Medical's submission to the US Department of Transportation (DOT) for the F522 transport package endorsement, specifically procedures IS/TR 2650 F522 (8),

"Engineering Assessment of the Ability of the F-522 Family of Type B Packages to Meet IAEA SSR-6, 2012 Edition", IS/QA 2663 2000(3), "Radioactive Material Transport Package Quality Plan" and IS/DS 2651 F522 (7), "Design, Manufacturing and Operating Specification for the F-522 Family of Transport Packages" are the property of BWXT Medical. These documents contain privileged and confidential information related to the design process, technical information and procedures of BWXT Medical.

3. BWXT Medical has expended extensive funds and manpower in developing the aforementioned document and any release or disclosure of information to third parties would enable third parties to use this information to fabricate, use and register a similar products while reducing their development risk and cost. This would compromise BWXT Medical's ability to compete in the marketplace. As these documents represent our transport package design and regulatory submission, and they provide a detailed description of the package, testing and regulatory justifications implemented by BWXT Medical, the redacted text of IS/QA 2663 2000(3) and IS/OS 2651 F522 (7) and the entire text of IS/DS 2650 F522 (8) should be withheld from public disclosure.

4. The information has been held in confidence by BWXT Medical and any disclosure by BWXT Medical thereof for business purposes, developmental purposes or otherwise has been protected by and accompanied by a confidentiality agreement protecting the trade secrets and proprietary information contained therein .

5. The information is being transmitted to the US DOT in confidence.

6. This information is not available in public sources.

7. The information contained in this affidavit is, to the best of my knowledge, true and correct.

Sworn before me this ~ day of :fµ, _,,,JJE , 2022 in the City of Ottawa, Ontario, Canada.

Michel H. Goulet Martyn Coombs Notary Public in and for the President Province of Ontario, Canada BWXT Medical Ltd.

Michel H. Goulet notaryonwheels.ca (613) 447-4399 11-300 Earl Grey Dr. #401 Kanata, ON K2T 1G1