ML010510171

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Request for Withholding Information from Public Disclosure, MDS Nordion Inc. C-198 Irradiator Source
ML010510171
Person / Time
Issue date: 06/05/2001
From: Samson Lee
NRC/NMSS/IMNS/MSIB
To: Charette M
MDS Nordion
References
SSD 00-50
Download: ML010510171 (3)


Text

Marc-André Charette Regulatory Affairs Senior Associate MDS Nordion 447 March Road Kanata, Ontario Canada, K2K 1X8

SUBJECT:

REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE, MDS NORDION INC. C-198 IRRADIATOR SOURCE

Dear Mr. Charette:

By MDS Nordion Inc.s (Nordions) application dated December 14, 2000, Nordion submitted an application for registration of the Model No. C-198 irradiator source assembly. Nordion provided additional information in letter dated January 30, 2001, and stated in affidavit dated January 30, 2001, that the letter contained the proprietary information related to the design of C-198. Nordion stated that the letter referenced above should be considered exempt from mandatory public disclosure for the following reasons:

1.

The disclosure of the information contained in the letter would compromise Nordions ability to compete in the market place.

2.

The information has been held in confidence by Nordion and any disclosure thereof for developmental purposes has been accompanied by a confidentiality agreement protecting the trade secrets contained herein.

3.

The information is not available in public sources.

We have reviewed Nordions January 30, 2001, letter in accordance with the requirements of 10 CFR 2.790 and, on the basis of your statements, have determined that the submitted information sought to be withheld contains proprietary information.

Therefore, Nordions letter, dated January 30, 2001, will be withheld from public disclosure pursuant to 10 CFR 2.790(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.

If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.

Sincerely,

/RA/

Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated Distribution:

MSIB r/f IMNS r/f SSD-00-50 ML010510171 File Name: K:\\Document Processing Center_Ascent\\ADAMSP8-2039\\downloads\\001 -

100\\038\\ML010510171.wpd To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy OFFICE MSIB E MSIB OGC NAME SLee JJankovich MSiemien DATE 02/20/01 02/ /01 02/ /01 OFFICIAL RECORD COPY

February 27, 2001 Marc-André Charette Regulatory Affairs Senior Associate MDS Nordion 447 March Road Kanata, Ontario Canada, K2K 1X8

SUBJECT:

REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE, MDS NORDION INC. C-198 IRRADIATOR SOURCE

Dear Mr. Charette:

By MDS Nordion Inc.s (Nordions) application dated December 14, 2000, Nordion submitted an application for registration of the Model No. C-198 irradiator source assembly. Nordion provided additional information in letter dated January 30, 2001, and stated in affidavit dated January 30, 2001, that the letter contained the proprietary information related to the design of C-198. Nordion stated that the letter referenced above should be considered exempt from mandatory public disclosure for the following reasons:

1.

The disclosure of the information contained in the letter would compromise Nordions ability to compete in the market place.

2.

The information has been held in confidence by Nordion and any disclosure thereof for developmental purposes has been accompanied by a confidentiality agreement protecting the trade secrets contained herein.

3.

The information is not available in public sources.

We have reviewed Nordions January 30, 2001, letter in accordance with the requirements of 10 CFR 2.790 and, on the basis of your statements, have determined that the submitted information sought to be withheld contains proprietary information.

Therefore, Nordions letter, dated January 30, 2001, will be withheld from public disclosure pursuant to 10 CFR 2.790(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.

If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.

Sincerely,

/RA/

Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards