ML20198H419
| ML20198H419 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mcgregor R NORDION INTERNATIONAL, INC. |
| Shared Package | |
| ML20138M295 | List: |
| References | |
| SSD, NUDOCS 9812290338 | |
| Download: ML20198H419 (2) | |
Text
-
pwoo h
UNITED STATES m*
f j
NUCLEAR RESULATORY COMMISSION e
t WASHINGTON, D.C. 20665-0001 l
April 15, 1998 1
Mr. Ronald McGregor, Manager i
Regulatory Affairs MDS Nordion, Inc.
447 March Road Kanata, Ontario Canada K2K 1X8
SUBJECT:
REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE, DESIGN CHANGE? TO MDS NORDION INC. C-188 SEALED SOURCE AND GAMMACELL-40 DEVICE
Dear Mr. McGregor:
By MDS Nordion Inc.'s (Nordion's) applications dated February 16,1998 and February 27, 1998, and Mr. Grant Malkoske's affidavits dated February 16,1998, and February 26,1998, Nordion submitted design changes to the Model C-188 sealed source and to the Model Gammacell-40 irradiation device. The origina! designs have been approved by NRC under Registration Certificate No. NR-0220-S-103-S and NPe220-D-101 S respectively, For the Model C-188 source, Nordion has requested that the following parts in the application be withheld from public disclosure pursuant to 10 CFR 2.790:
- Appendix A, Drawing Nos. IN/TR 1380 C306 Rev 1 and IN/SS1381 C188 Rev 1 ;
- Appendix C, Sealed source classification tests;
- Appendix D, Special form material tests.
l l
For the Model Gammacell-40 device, Nordion has requested that the following parts in the application be withheld from public disclosure pursuant to 10 CFR 2.790:
l
- Appendix B, Drawing Nos. A08983 issue N, A08953 issue T, C104002-071 lssue A, l
A08984 Issue AD.
Nordion stated that the information specified above should be considered exempt from mandatory public disclosure for the following reasons:
1.
The disclosure of the information contained in the drawings and test reports would cause irreparable harm to Nordion, in particular the drawings contains information, developed l
by Nordion with Nordion's resources regarding materials, heat treatments and the i
validation tests show the upper limits of the technical capabilities of the devices.
2.
The information is not available in public sources.
We have reviewed Nordion's applications and the material 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 commercial information.
9812290338 991221 l
9311 910S %
~._
I R. McGregor 2
l j
Therefore, the version of the submitted information marked as proprietary will be withheld from public disclosure pursuant to 10 CFR 2.790(b)(5) and Section 103(b) of the Atomic Energy Act l
of 1954, as amended.
l 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 futura such that the information could then be mads 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 i
adverse to the above, you will t's notified in advance of any public disclosure.
Sincerel,
j Ste[e
. Baggett, Deputy Branch Chief Materials Safety Branch Division of Industdal and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
SSSS r/f SSD-98 35 SSD-96-31 MEGN N6/G SSD File # NR-220-S-103-S
%dTiTe fRR-220-D-117gy DOCUMENT NAME: P:\\PROPR.NOR To receive a copy of this document, Indlcate in the bos:
- C* = Copy without attachment / enclosure
- 6" = C9py w,th attachmant/ enclosure
- N' = No copy OFFICE IMAB
).p) lC. OGC l(L IMAB (g
A/
NAME JJankovipq MPSiemier*
SBaggetf
~
DATE 3/,2998 V 3/25/98
$//d /98 OFFICIAL RECORD COPY
- S':e previous concurrence
.