ML20236H126
| ML20236H126 | |
| Person / Time | |
|---|---|
| Issue date: | 07/02/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Vondera V ARMY, DEPT. OF |
| References | |
| SSD, NUDOCS 9807070094 | |
| Download: ML20236H126 (5) | |
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$3H% k UNITED STATES I
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NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 20555-0001
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July 2, 1998
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Vernon E. Vondera Chief, Safety Office Department of the Army U.S. Army Tank, Automotive, I
and Armaments Command Rock Island, IL 61299-7630
Dear Mr. Vondera:
This letter is in response to the information submitted in your application dated December 8, 1997, and sutsequent letters thereto, requesting registration of the Model ACADA cell module for use by persons exempt from licensing in accordance with 10 CFR 30.20. Review of your initial application indicated that the request could not be approved for registration as an exempt use product due to the Army's desire to be able to disassemble the device for repair purposes.
In order to address this primary issue, as well as other deficient areas in the application, Mr.
Anthony Kirkwood and Ms. Michele Burgess of the NRC participated in a deficiency teleconference call with you and a number of other Army staff involved in this registration request. During the call, NRC staff discussed an alternate approach of registering the internal cell module as the exempt use product, in lieu of registering the entire device. This approach would allow for repair and disassembly of the electronics, while preserving the integrity of the component registered as the exemp*. use product. It was indicated that the Army intended to pursue this alternate approach. The call was continued in order to discuss what would be necessary for you to submit with regard to this new approach, to inform that you would need to define exactly what would constitute the exempt use product, and to ensure that it was clearly understood that the component defined as the exempt use product would be required to meet all -
regulations and requirements for an exempt use product. Specific areas discussed included quality assurance / control, labeling, and radiatien levels.
We have reviewed the additional information submitted in response to the call, and have identified the following issues that remain to be addressed:
1.
The information you have submitted in support of your request includes sections that are marked as proprietary. Please be aware that you may request that certain portions of your submittal to NRC be withheld from public disclosure as proprietary information. To do this, you must execute an affidavit as specified in 10 CFR 2.790. You must list all portions that you wish to be held proprietary, along with your reasoning as to why that is \\0 appropriate. For each document or page, please submit two copies. One copy should be an unmarked copy containing allinformation. The second copy should have removed from it, all information that you wish to be held proprietary. This second copy will be l
placed in the NRC's public document room. While it is allowable, please refrain from submitting proprietary information in support of a registration unless necessary. Keep in mind that all registration certificates in the Sealed Source and Device Registry, and all NRC licenses are considered to be in the public domain, and are therefore may be viewed by any member of the public who requests to see them.
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9007070094 900702 PDR RC e
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f V. Vondera 2.
Please note that there will be a restriction on the registration certificate and exempt distribution license that the device is authorized for use only in aerosol detectors designed to protect life or property from fires and airborne hazard.
. 3.
The maximum activity for the currently approved custom device is 30 mci (2 sources @
15 millicuries each). In addition, the Army's letter, dated May 18,1998, indicates that the maximum activity for the exempt product would be identical. However, the proposed labeling says 0.02 Ci. Please clarify this discrepancy and verify the correct maximum activity requested for the exempt-use product.
4.
Please submit sufficient prototype testing, historical use documentation, or engineering analysis to demonstrate that the exempt product will withstand drop and impact forces that the product may encounter during normal use and likely accident conditions.
5.
Your application referenced a number of requirements imposed on the user, including:
a.
M22 QCP, Issue 4,18 May 1998,3.3 requires wipe test before and after maintenance or testing, and i
b.
3.4.3 requires wipe testing annually and at transfer.
Please note that requirements (i.e., use, maintenance, and leak testing) can not be imposed on users exempt from licensing in accordance with 10 CFR 30.20. Please verify that you will modify the instructions that you will provide to the user to ensure they do not contain statements which state, or imply, that there are requirements on the user.
6.
The proposed labeling for the point of sale (POS) package includes the words " Licensed to US Army under Section 32.27 of Title 10 Code of Federal Regulations." This wording incorrectly implies that the user is licensed. The requirements of 10 CFR 32,29 requires that the label list the pcrson licensed under 32.26 to transfer the device Please verify that you will remove the incorrect wording, and insert wording in accordance with 10 CFR 32.29. The distributor may be identified by name or by NRC exempt license number (i.e.,
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" Distributed under (insert E license #)").
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7.
In accordance with 10 CFR 32.29(b)(3)(iii), please add "USNRC" before the words
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" safety criteria in 10 CFR 32.27" on the proposed label for the POS package.
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8.
.Please indicate the point in the disassembly process described in the document " Video tape Narrative for Degree of Access to Source Material (NiG3) Supporting Exemption License Application for M22 ACADA/GID-3, Issue 5" dated May 14,1998, that illustrates the product that you are requesting to be registered.
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9.
Please note that the design of an exempt use product must preclude user access 1o the source. Multiple layers are not adequate to constitute tamper-resistant design. Please submit information indicating how the design will be made tamper-resistant. Commonly used methods include, but are not limited to, welds, rivets, and solder filled screw heads.
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In addition, please provide the maximum extemal radiation levels with 30 mci, not
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I 20 mci and indicate the activity in the device used to measure the maximum external I
radiation levels listed in Section 6 of the Army's letter dated December 18,1997. Please note that the maximum external radiation levels must be provided for the external surface of the product that it to be considered the exempt use product.
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11.
Please address the following discrepancies between the video and the written narrative for the video a.
the video does not show performance of step 18 of the narrative b.
the narrative indicates that a special tool is required to perform step 20, however, in the video, no special tool appears to be used. The step appears to be l
performed with only needle nose pliers and wire cutters (used as grips).
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12.
The quality assurance / quality control (QA/QC) procedures submitted do not satisfy the requirements in Appendix C to Regulatory Guide (RG) 6.9.- Please review your QA/QC L
procedures and address allissues of non-conformance. Note that your procedures may be more restrictive, however, your procedures should meet the RG 6.9 standards at a 1
minimum unless you provide an alternative. Particular items identified during our review include:
a.
Regarding the issues of a U.S. point of distribution, r 9ase either make a commitment that the sampling will be done at the U.o. point of distribution, or propose an alternate approach that provides the sarce degree of assurance.
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Items that have been commonly found in alternate approaches include audits of the manufacturer and paperwork checks at the U.S. point of distribution prior to release, Please note that copies of all paperwork must be maintair'ed at the licensee's facility.
b.
Your QA/QC procedures do not provide sufficient detail regarding the information that will be verified during incoming, assembly, and final inspections and audits, to demonstrate that the product distributed has been checked to ensure that it is manufactured and assembled in accordance with the drawings and specifications submitted in your application, that all safety features are intact, that there is no removable contamination, and that the radiation levels are within the maximum levels specified in your application. Please submit additionalinformation that addresses these' concerns.
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V. Vondera c.
- The leak test threshold specified in the RG 6.9 is 0.005 microcurie. In addition, the RG 6.9'. specifies that, although up to 75 units may be tested with a single wipe test, the threshold remains at 0.005 microcurie. Contrary to this, your i procedures specify the threshold as 250 nanocuries for a sample lot of five.
Please submit corrected procedures that are in accordance with the minimum
- requirements specified in the RG 6.9.-
d.
QA/QC procedures state that the sample size will be reduced to 20 % after the first 3 months if no failures detected. For lot sizes less than 200, or lot sizes from
- 201 to 214, this is not in accordance with the minimum sampling rates listed in c
the RG 6.9. Please submit corrected procedures which are in accordance with the minimum sampling rates in the RG 6.9.
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e.
' Regarding disposition of failed lots, please note that, per the RG, the acceptance number for failure of lots is zero. For Iots that fail inspection, they must be either -
(1).100% rejected, or (2) 100% retested for the inspection criteria that the sampie unit failed.11t is not clear that your procedures are in accordance with this (reference M22 QCP, Appendix A, item 2). Please submit additionalinformation demonstrating that disposition of failed lots will meet this as a minimum.
f.
The QA/QC procedures addresses procedures for qualifying potential foil subcontractors. Please note that the exempt product may incorporate only those
. sources identified in your application and approved for use in your product by the NRC. Please identify all sources that you wish to incorporate into your design.
You may reference a previously registered source, or you may register your own source design. Please note that if you wish to register your own source design, you must submit sufficient information to allow the NRC to perform a safety evaluation of that new source.' Please refer to NRC's NUREG-1556, Vol. 3 (draft) as guidance regarding the information that you need v. ubmit.
g.
The QA/QC procedures submitted indicates that "the production concession
. permits the use of material, parts, or batch of parts which are currently non-conforming within the stated requirements". Please be advised that you must manufacture and distribute the product in accordance.with the statements and
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representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate. Please verify f
' that you understand this restriction.
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U V. Vondera 13.
Please indicate how you plan to deal with those units that have already been : distributed for use under specific license (i.e., continue use under specific license, retrofit).
14.
. Please provide the most updated complete device and assembly drawings for all parts contained in the device that is defined as the exempt use product.
' Please provide the requested information within thirty (30) days of the date of this letter. If we do not receive complete information, that 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.
Sincerely,
/s Steven L. Baggett, Deputy Branch Chief Materials Safety Branch Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety.
and Safeguards y
Distribution:
IMNS r/f SSD-97-78 NE02-SSD-1 I
DOCUMENT NAME: H:\\ACADA.DE3
- T1 receive a copy of this document. Indicate in the bos: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE MSB lC MSB
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l NAME' MBurgess/mb SBaggett DATE 06/26 /98 7/ 7
/98 OFFICIAL RECORD COPY l
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