ML20135D589

Requests More Info or Clarification Re IMS Cell Submitted w/960603 Ltr

ML20135D589
Person / Time
Issue date:	01/22/1997
From:	Beverly Smith NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Sujata Goetz AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9703050353
Download: ML20135D589 (4)

Text

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g-rg'% UNITED STATES l

j s* Ij NUCLEAR REGULATORY COMMISSION j

l' WASHINGTON, D.C. 20006 4 001 i January 22, 1997

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Scott Goetz l i ETG, Inc.

1400 Taylor Avenue  ;

! P.O. Box 9840 j Baltimore, MD 21284-9840

Dear Mr. Goetz:

l This concoms information about an lon Mobility Spectrometry (IMS) Cell which was submitted i with yourletter dated June 3,1996. We are in the process of reviewing the information and have identified areas where additionalinformation or clarification is needed, in order to l complete our review, please provide the following:

1.

It is unclear from your application whether you wish to register the IMS Cell or the 3

models of devices in which it is used. Therefore, please provide a clarification as to j

which is requested to be registered. However, if the IMS Cell is not identicalin each

device, then each variation of the IMS Cell would be required to be evaluated if you wish '

the IMS Cell to be registered. The following questions are based on the assumption that j the models of devices will be registered.

i 2.

10 CFR 32.26 requires sufficient information conceming the design, construction, and

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i manufacture of the device to be submitted to demonstrate the safety criteria of 10 CFR 32.27 will be met. Please provide a complete set of engineering drawings and other i

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_ appropriate information surficient to provide this demonstration. The drawings should provide all materials of construction, dimensions, methods of fabrication, and means for i

i mounting the source and source holder in the device. A detailed description of all special design features that protect the source from abuse, control the hazard from direct or scattered radiation, and discourage unauthorized access to the source should i be included. If the IMS Cellis modified for use in any of the different devices, these

{ modifications should be included.

} 3.

A model Chemical Agent Monitor (CAM) is currently registered as a specifically licensed j

1 device to the Department of the Army for use as a custom device. Is your model CAM related to this model, and if so, how? The CAM registered to the Army uses a tritium light source for a back light to a dial. Will the CAM distributed by ETG also contain such a source?

4.

The GP-lMS and FP-lMS lon mobility spectrometers are currently registered as generally licensed devices. These devices are permitted to use a Ni-63 source with an activity of 15 mCl. Please confirm that the activity requested to be used in the exempt versions of these devices is 10 mci?

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7 S. Goetz 5. The designs of the models CAM, GP-lMS, and FP-lMS that are currently listed on a registration certificate do not include the Amersham models NBC and NBCD sources as approved sources for use in the devices. In addition, the designs of these sources are i substantially different than the NER-004R source which is a ring source; the NBC is a rectangular foil source and the NBCD has the Ni-63 directly electroplated to the source j l housing. Please indicate how all source models will be installed into all conficurations of

the IMS Coll.

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' 6. The Department of the Army's designs of the models CAM and Improved Chemical Agent Monitor (ICAM) require that certain components of the IMS Cell (including the Ni-l t

63 source) to be replaced periodically. Do you expect the IMS Cell for any of your models to need to be replaced during its useful life? If so, indicate who is intended to be j- permitted to replace the IMS Cell and provide a dose assessment for this action, l including all assumptions made. How will replacement IMS Cells be obtained?

i 7. 10 CFR 32.29(b) requires the label attached to the licensed product and the point of sale

, package to identify the person licensed under 10 CFR 32.26 to manufacture / distribute

) the product (i.e., the holder of the registration certificate and distribution license - ETG, l Inc.). This can be accomplished by adding ETG, Inc., the license number, or some other unique identification to the label. The license number is the number of the exempt

! distribution license (e.g., N - ### - M - E). The point of sale label must also contain j the name of the radionuclide and quantity of activity. This information was not provided i in labels provided in your application. Please provide the wording or samples of these  !

labels that demonstrate compliance with the requirements of 10 CFR 32.29(b).

l l 8. The labels on the IMS Cell and detector need to be permanently affixed to the device l l

and made of a material that will retain its integrity during use. Please indicate the l I

! materials of construction of the labels and the method and location of attachment. If i

l applicable, please provide information on the label adhesive, such as solubility, effective

! temperature range, etc.

, 9. Please provide the extremes of environmental and operating conditions (e.g.,

4 temperature, humidity, corrosive atmosphere, vibration, etc.) the device may experience

!- during normal use. If the device will be exposed to corrosive atmospheres, please ,

i provide an assessment of the detriment that will be caused to the source (e.g., leakage l of material, increased solubility, etc.) and its containment.

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10. With respect to prototype testing, the analysis performed for the CAM and FP-lMS and GP-lMS is acceptable. However, information that verifies the IMS Cell will withstand

representative testing while in the ICAM, ICAM-D, and ICAM-APD should be provided. l

! An engineering analysis or comparison to a similar device is permitted in place of actual  !

. testing. In addition, Section 5.2 of your application states that the instruments ,

"successfully completed DoD military standard vibration, rough handling and )

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environmental tests." Please provide a description of these tests and the results. In l l

addition, please provide a description of the expected detriment to the device under the j severest of expected conditions of use, handling, and storage (such as temperature extremes, drops, etc.).

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11. 10 CFR 32.29(a) requires an applicant to provide information on an adequate quality control program to ensure that each production lot meets the design standarde approved l by the U.S. Nuclear Regulatory Commission. These design standards and criteria are l discussed in Regulatory Guide 6.9, " Establishing Quality Assurance Programs for the  !

. Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct i

Material." We are unable to determine if your program meets these criteria. Please j i demonstrate how your program meets these criteria, particularly Appendix C of this i document. This guide is included in this letter as enclosure 1. Also included is an

, acceptable attemative (enclosure 2) to the quality control program specifications for i distribution of exempt devices which are located on page C-4 of Regulatory Guide 6.9.

! 'l l 12. Please provide the design specifications of the epoxy used to hold the nickel source in 1 place. This should include the following as they relate to its intended conditions of use:

l the solubility of the epoxy, the expected detriment due to the beta dose to the epoxy for the maximum activity of the source, and the effective temperature range of the epoxy.

13f A useful life of the device of 15 years was stated in your application. What is the basis for this determination?

14. Section 6 of your application states the extemal dose rate at the surface of the cell.

Please provide the maximum dose rates at 5 and 25 centimeters from any extemal surface of the device. In addition, if the usar of the device is expected to perform maintenance on the IMS Cell, please proviue the maximum dose rates at 5 and 25 centimeters from any extemal surface of the IMS Cell.

In your Maryland registration certificate for the GP-lMS and FP-lMS, it is stated that the IMS Cell may be used by other original equipment manufacturers as a component of their products. This cannot be the case with this IMS Cell when intended for use under 10 CFR 30.20. The requirement in 10 CFR 30.20 requires the design of the detector to protect life or property from fires or airbome hazards. Therefore, all models of devices which willincorporate the IMS Cell must be listed in the registration certificate. If you wish to distribute another device with the IMS Cell included as a component, the device must be intended to meet this requirement and the registration certificate must be amended to include this model prior to distribution.

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S. Goetz -[ .,

We look forward to receiving the requested information as soon as possible. If you have any ,

questions, please contact me at (301) 415-5723 or Mr. Douglas Broaddus at (301) 415-5847. l i

Sincerely, 16I Brian W. Smith, Health Physicist

. Sealed Source Safety Section ,

Medical, Academic, and Commercial Use Safety Branch i Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards e

Enclosures:

As stated 1 cc: Mr. Greg Smith, RSO, Inc.

1 Distribution:

SSSS r/f SSD-96-55 vAE01 DOCUMENT NAME: C:\96 FILES \SSSS\ETG\NR###101.DEF Ta seceive a copy of this document,Indcate in the box: 'C' Copy without attachment > enclosure *E* = Copy with attachment / enclosure *N* = No copy OFFICE SSSS , lC SSSS,. lC l l l NAME BSmith kb DBrokd'dUs DATE 0181/97 01/5/97 OFFICIAL RECORD COPY ,

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