ML20202H094
| ML20202H094 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/1999 |
| From: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mcginley M MINE SAFETY APPLIANCES CO. |
| References | |
| SSD, NUDOCS 9902080008 | |
| Download: ML20202H094 (3) | |
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February 4, 1999
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Mine and Safety Appliance Company Attn: Mary T. McGinley Radiation Safety Officer P.O. Box 427 Pittsburgh, PA 15230
Dear Ms. McGinley:
We have completed a preliminary review of your application dated January 7,1999, requesting registration of the Automatic Air Monitoring System and various similar models as a type of l
chromatograph, which uses ion spectrometer technology. In reviewing the application, we find it is lacking significant amount of the required information. In an Enclosure to this letter, we have
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- summarized the major areas of concern not addressed in your application.
4 With incomplete documents and unavailability of adequate information, NRC Staff is unable to complete a safety evaluation of your device. Therefore,we have discontinued the review of your application. This is without prejudice to re-submission of your application. If you decide to re-submit your application for registration, please ensure that you have included sufficient information to allow NRC to evaluate your device and similar instruments.
If you have any questions, please call me on (301)415-7231 or Ujagar S. Bhachu of my staff on (301)415-7894.
Sincerely, i
s/
Larry W. Camper, Chief Materials Safety Branch
{y Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc. w/ encl: Skimberty, LFDCB DISTRIBUTION:
N RC Central File IMNS r/f SSD 99-02 NMSS r/f
.NEO1p DOCUMENT NAME:
0%camswpd To receive a copy of this document, indicate in the box:
"C"e Copy w/o att/ encl. "E" = Copy w/att/pf91"N" = No copy OFC MSB Q, hk NAME UBhachh/I hnhper DATE 2/ h/99 2/
/99
- OFFICIAL RECORD COPY 9902080008 990204 j
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ENCLOSURE 1.
A Reauest for Withholdina of Confidential Information 1.1 Pursuant to your request we reviewed your application and material in accordance with the requirements of 10 CFR 2.790. We are unable to grant your blanket request for withholding of information as stated in your application. We have determined that only certain portions of the requested information to be withheld contains trade secrets, and proprietary commercial information. In general, only that information which cannot be obtained through observations or measurements of components or documentation obtainable by a member of the public can be withheld as proprietary material.
With regards to engineering drawings, information generally considered being proprietary includes information such as dimensional tolerances, technical specifications of materials, manufacturing notes or specific assembly directions. Any remaining information on the drawings would be released. Please identify specific information on each drawing that you wish to withhold as proprietary per 10 CFR 2.790 (b) (1) (ii) and provide nonproprietary versions in accordance with 10CFR 2.790(b)(1)(ii).
Operational and service manuals are normally provided to the purchasers of the equipment. We are unable to grant at this time that the information contained in these manuals is proprietary. Based on this finding you may wish to address the contents of these manuals. Please provide NRC with proprietary and nonproprietary packages or marked documents.
An affidavit attested by Notary Public must be submitted prior to the staff making its final determination. The revised affidavit and documents must be submitted to the NRC in 30 days from the date of this letter,if not in accordance with 10 CFR 2.790 (c), the information sought to be withheld will be placed in the NRC Public Document Room.
1.2 10 CFR 2.790 requires that an assessment be made of substantial harm to the competitive position of the owner taking in to account the value of the information to the owner. Please provide the estimated effort or money expended by the owner in developing the information, and the ease and difficulty with which the information could be properly acquired or duplicated.
1.3 Please confirm in the affidavit that the information provided in the application is owned by MSA.
2.
Desian & Drawinas Drawings attached to your application do not provide complete annotated engineering design and/or construction drawings of critical safety components, specification sheets, materials list, and/or detailed written description. Drawings of safety critical parts and components should be fully dimensioned with tolerances, including identification of the safety critical parts, indicate the materials of construction or refer to material specification sheet or a list, indicate fabrication and assembly methods, and include a drawing number 2
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and revision date or number. Some drawings included in the application do not carry MSA name, issue date, revision number and confidentiality annotation. Page numbering system is missing from the attachments therefore it is impossible to be certain whether NRC has received all the contents of associated with an attachment.
1 3.
Operational Procedures.
It appears that these procedures have not been reviewed and approved internally by MSA, as the bottom of the page to Attachment 6, of your application, reads... " MARY-l WOULD LIST STEVE DAY, LAVIE (SP) AND YOURSELF. DO YOU GUYS HAVE PAGERS."
4.
Igaling.
Please pr vide all test results and/or reports.
5.
Draft instrumental Instruction Manual This draft has quite a few blank pages. Please provide complete documents since you are requesting withholding of this document.
6.0 Prototvoe Testina No fixed schedule is provided for the field testing of the devices.
7.0 QA/OC Manual Please prcvide a copy of a Standard ISO QA Program Certificate or a OA/QC Plan.
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