ML20134P992

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Requests Info Re Ion Mobility Spectrometer Detector to Complete Review
ML20134P992
Person / Time
Issue date: 10/10/1996
From: Beverly Smith
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Mceachern A
CANADA
Shared Package
ML20134D368 List:
References
SSD, NUDOCS 9702260196
Download: ML20134P992 (2)
v • d • e


Text

. - . _ _ . _ . _. - - _ ___ _ _ _ . _ . _

$g5 afog-k UNITED STATES j

'f NUCLEAR REGULATORY COMMISSION WASHINGTON, D.c. 20565 0001

.....o october 10, 1996 2

Mr. Al McEachem, Director CPAD Technologies Inc.

66 Slater Street '

Ottawa, Ontario Canada l K1P SH1 i

Dear Mr. McEachern:

i l

This concems information about an lon Mobility Spectrometer (IMS) Detector which was submitted with your letter received July 10,19%, facsimiles dated September 4 and 23,1996, and letter dated September 23,1996. We are in the process of reviewing the information and have identified areas where additional information or clarification is needed. In order to i complete our review, please provide the following:

1.

The wording for the label to be attached to the analytical unit that was submitted in your facsimile dated September 4,1996, contains an incorrect statement. The label should be changed to say the device is exempt from regulations. However, a label that contains wording similar to that on the point of sale package would be sufficient also.

t Please provide the wording for the label to be attached to the analytical unit.

2. The label attached to the device itself and the point of sale package must identify the holder of the registration certificate - Galson Corporation. This can be accomplished by adding Calson Corporation or their license number to the label. Please provide the word *.g for the labels.

i 3. The model numbering scheme includes devices that use photo ionization in place of the Ni-63 source. For the devices that utilize photo ionization, it is recommended that this model numbering be modified to avoid any potential for mislabeling.

4. Your quality assurance program should meet the criteria discussed in Regulatory Guide 6.9, " Establishing Quality Assurance Programs for the Manufacture and Distribution of

' Sealed Sources and Devices Containing Byproduct Material." Please verify that your program meets these criteria, including Appendix C. This guide is included in this letter as an enclosure. Also included with this guide is an acceptable altemative to the quality control program specifications located on page C-4.

5. Dose assessments must be provided that demonstrate that the device meets the safety criteria in 10 CFR 32.27 (i.e., certain dose limits under normal use and disposal conditions). Therefore, please review these requirements and submit sufficient information to prove that the safety criteria can be met. NUREG/CR-1156,

" Environmental Assessment of lonization Chamber Smoke Detectors Containing Am-241,"is included with this letter as an enclosure to aid in the development of this additional information.

9702260196 961230 PDR RC *

@SD PDR

I 1

6.

Because the registratior, certificate will be in the name of Galson Corporation, a letter is needed from Galson Corporation stating that they will abide by all requirements of the l

Nuclear Regulatory Commission and commitments made by CPAD Technologies in the application for registration of the IMS Detector and any letters submitted to the NRC in {

i response to deficiencies identified during the review of the device.

1 7.

Please verify that the IMS Detector is used as a component in another device for the purpose of detecting explosives only.

We look forward to receiving the requested information as soon as possible, if you have any 4 questions, please contact me at (301) 415-5723 or Mr. John Lubinski at (301) 415-7868.

Sincerely, i

' Brian W. Smith, Health Physicist Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety

{

Office of Nuclear Material Safety and Safeguards l

Enclosures:

As stated cc: Mr. Michael Howe, Galson Corporation Distribution: i SSSS r/f SSD-96-66 NE01

, DOCUMENT NAME: P:\SSSS\CPAD\CPADDF3.LTR l Ta seeelve a copy of tido document,indcote in the box: *C* = Copy without ettschtnant/ enclosure "E" = Copy wrth ettschment/ enclosure 'N' = No copy

OFFICE SSSS d4 16 SSSS_ 53.J' Al l !

NAME Brian Smith John Lubinski DATE 10/p/96 10/se196 OFFICIAL RECORD COPY l

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0 pa ntouq h g- .

k UNITED STATES 5

  • S NUCLEAR REGULATORY COMMISSION E

o

$ WASHINGTON, o.C. 20555-0001 j ,

% g October 10, 1996 I

Mr. Al McEachem, Director CPAD Technologies Inc.

66 Slater Street Ottawa, Ontano Canada K1P SH1

Dear Mr. McEachern:

This concems information about an lon Mobility Spectrometer (IMS) Detector which was submitted with your letter received July 10,1996, facsimiles dated September 4 and 23,1996, and letter dated September 23,1996. We are in the process of reviewing the information and have identified areas where additionalinformation or clarification is needed. In order to complete our review, please provide the following:

1.

The wording for the label to be attached to the analytical unit that was submitted in your facsimile dated September 4,1996, contains an incorrect statement. The label should be changed to say the device is exempt from regulations. However, a label that contains wording similar to that on the point of sale package would be sufficient also.

Please provide the wording for the label to be attached to the analytical unit.

J

2. The label attached to the device itself and the point of sale package must identify the l

holder of the registratior, certificate - Galson Corporation. This can be accomplished by l'

adding Galson Corporation or their license number to the label. Please provide the wording for the labels.

3. The model numbering scheme includes devices that use photo ionization in place of the j Ni-63 source. For the devices that utilize photo ionization, it is recommended that this '

model numbering be modified to avoid any potential for mislabeling.

4. Your quality assurance program should meet the criteria discussed in Regulatory Guide 6.9, " Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material." Please verify that your program meets these criteria, including Appendix C. This guide is included in this letter as an enclosure. Also included with this guide is an acceptable attemative to the quality j control program specifications located on page C-4.

j

5. Dose assessments must be provided that demonstrate that the device meets the safety  ;

criteria in 10 CFR 32.27 (i.e., certain dose limits under normal use and disposal conditions). Therefore, please review these requirements and submit sufficient information to prove that the safety criteria can be met. NUREG/CR-1156,  !

" Environmental Assessment of lonization Chamber Smoke Datectors Containing Am-241," is included with this letter as an enclosure to aid in the development of this additionalinformation.

'I

e D ,

l

6. Because the registration certificate will be in the name of Galson Corporation, a letter is ,

needed from Galson Corporation stating that they will abide by all requirements of the I Nuclear Regulatory Commission and commitments made by CPAD Technologies in the l application for registration of the IMS Dtetector and any letters submitted to the NRC in - -I response to deficiencies identified during the review of the device.

7. Please verify that the IMS Detector is used as a component in another device for the l purpose of detecting explosives only.

l We look fonvard to receiving the requested information as soon as possible. If you have any questions, please contact me at (301) 415-5723 or Mr. Joha Lubinski at (301) 415-7868. l Sincerely, 1

Brian W. Smith, Health Physicist j Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosures:

As stated cc: Mr. Michael Howe, Galson Corporation Distribution:

SSSS r/f SSD-96-66 NE01 l I

DOCUMENT NAME: P:\SSSS\CPAD\CPADDF3.LTR Ta seceive a copy of this document. Indcate in the boa: "C" = Copy without attachment / enclosure *E" = Copy wrth attachtnant/er, closure *N* = No copy OFFICE SSSS (C4 4- SSSS M Al l l NAME Brian Smith John Lubinski l 10/p/96 DATE 10/to/96 i OFFICIAL RECORD COPY l

1

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