ML20154S399
| ML20154S399 | |
| Person / Time | |
|---|---|
| Issue date: | 10/26/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Reves S ARMY, DEPT. OF |
| References | |
| SSD, NUDOCS 9810270390 | |
| Download: ML20154S399 (2) | |
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UNITED STATES g
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. WASHINGTON, D.C. 2056H001 October 26, 1998.
Col. S. Reves U.S. Army Soldier and Biological Chemical Command, Project Manager for NBC Defense Systems
' Aberdeen Proving Ground, MD 21010-5423 1
Dear Col. Reves:
This refers to the Department of Army's application for registration and licensing of the model DTM, drift tube manifold, for use in the M22/GID-3 Automatic Chemical Agent Detector / Alarm.
The following information or clarification is needed to continue with our review of the application.
We would suggest that you review this letter and arrange a meeting with us to discuss the information needed to support your application prior to responding to this letter.
1.
The proposal to have the device dropped shipped from its distributor located in England to USA persons that would be exempt from the requirements for a license will need to be revised. We have had several discussions with our Office of General Counsel and have determined that for NRC to issue a license, the applicant must be an organization with an address in the United States at which it will receive, possess, and perform quality control checks on the products authorized for distribution and maintain records relating to NRC-related activities, and from which it will distribute the device.- Please identify the location that the products will be distributed from in the United States and what quality control checks will be performed on the device once it is received by the NRC licensed facility. Please note that in addition to NRC authorization to sell the product to person exempt from the requirements for a license, the United States facility must also have authorization to possess the material under a specific license. Please provide a copy of the facility's license.
2.
Based on the October 5,1998, letter the U.S. Army Soldier and Biological Chemical Command will be held responsible for the statements and representations, including the quality control program contained in the application and subsequent letters supporting the application.
3.
Army's memorandum dated September 30,1998 referenced a drawing, number 18/0614-2014 issue 2, that could not be found attached to the letter. Please provide a copy of the drawing.
4.
The realistic dose values given in the letter exceed the safety criteria in 10 CFR 32.27.
l' Army's memorandum dated June 3,1998, updated information regarding the demonstration that the device meets the safety criteria of 10 CFR 32.27. The June L
memorandum related the safety demonstration to doses received to a member of the public as define )in 10 CFR Part 20, or 100 mrem. However, the regulations require a demonstration that it is unlikely that the external radiation dose in any one year or the 9810270390 981026 PDR RC a
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S. Reves dose commitment resulting from the intake of radioactive materialin any one year will not exceed the dose to the appropriate organ as specified in 10 CFR 32.27, which references the table in 10 CFR 32.28. It should be noted that when 10 CFR Part 20 was changed, the basis for making a licensMg decision contained in 10 CFR Part 32 was not, therefore 10 CFR Part 20 limits are not applicable to consumer products. Please resubmit the demonstration that the device meets all of the safety criteria as defined in 10 CFR 32.27.
Please provide the requested information within thirty (30) days of the date of this letter. If we do not receive complete information, which fully addresses all issues, within thirty (30) days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application. If you have any questions, please contact me at (301) 415-7273, or Michele Burgess at (301) 415-5868.
l SIMSignedBy:
StevenLBaggett Steven L. Baggett, Deputy Branch Chief Materials Safety Branch i
i Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
cc:
Jeff Havener, Army Dan Nowak, Army t
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"C" = Copy without attachtnant/ enclosure "E" = Copy with attachment' enclosure "N' = No copy OFFICE MSB gg C
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NAME SBagget6mb DATE 10/ 7 9 /98 OFFICIAL RECORD COPY