ML20210N374
| ML20210N374 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1999 |
| From: | Jim Hickey NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mcginley M MINE SAFETY APPLIANCES CO. |
| References | |
| SSD, NUDOCS 9908110087 | |
| Download: ML20210N374 (7) | |
Text
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e July 29, 1999 l
l MaryT McGinley Radiation Safety Officer Mine Safety Appliance Company
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instrument Division j
P.O. Box 427 Pittsburgh, PA 15230
Dear Ms. McGinlay:
We have reviewed your application dated February 24,1999, related to MSA Field lon Spectroscopy (FIS) Device Registration. We find your information submitted to date lacking significant amounts of the required information for us to reach a decision. With incoraplete documents and inadequate information we are not able to complete our evaluation of your device. Therefore, we have discontinued our review of your application.
t Our discontinuance of the review 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 in a timely manner. Ericlosure 1, is j
a summary of our major areas of concern that you need to address.
Pursuant to your request we have reviewed your application sad material in accordance with the requiremert of 10 CFR 2.790. We are unable to grant your blanket request of withholding all drawinge as stated in your application. We have determined only certain portions of the requested information to be withheld contains trade secrets, and proprietary commercial information. Our findings are detailed in Enclosure 2.
Please provide NRC with p oprietary and non proprietary packages pursuant to 10CFR 22.790 (b)(1)(ii). An affidavit attested by Notary Public must be submitted prior to the staff making its firial determination. The revised affidavit and documents must be submitted to the NRC within 30 days from the date of this letter, if not in accordanco with 10 CFR 2.790(c) the information sought to be withheld will be placed in Commission Public Document Room.
If you have any questions, ple se call me on (301)415-7231 or Ujagar S. Bhachu of my staff at (301)415-7894.
/
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION g
WASHINoToN. D.C. 3o656 0001 fl July 29, 1999 gg Mary T. McGinley Radiation Seiety Officer Mine Safety Appliance Company instrument Division P.O. Box 427 Pittsburgh, PA 15230
Dear Ms. McGinley:
We have reviewed your application dated February 24,1999, related to MSA Field lon Spectroscopy (FIS) Device Registration. We find your information submitted to date lacking signrfica the required information for us to reach a decision. With incomplete documents and inadequate information we are not able to complete our evaluation of your device. Therefore, we have discontinued our review of your application.
Our discontinuance of the review 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 suff information to allow NRC to evaluate your device in a timely manner. Enclosure 1, is a summary our major areas of concem that you need to address.
Pursuant to your request we have reviewed your apphcation and material in accordance with requirements of 10 CFR 2.790. We are unable to grant youI information to be withheld contains trade secrets, and proprietary comroercialinformation. Our findings are detailed in Enclosure 2.
Please provide NRC with proprietary and non proprietary packages pursuant to 10CFR 2 (b)(1)(ii). An affidavit attested by Notary Public must be submitted prior to the staff determination. The revised affidavit and documents must be submitted to the NRC within 3 l
from the date of this letter,if not in accordance with 10 CFR 2.790(c) the information soug withheld will be placed in Commission Jublic Document Room.
If you have any questions, please call me on (301)415-7231 or Ujagar S. Bhachu of m (301)415-7894 Sincerely, f
v+r' f
i John W. N. Hick, Branch Chief Materials Safety and Inspection Branch l
Division of Industrial and
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Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated l
cc. w/oncl: Skimberly, LFOCB
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- 1. Programmatic issues 1.1 Use Please clarify whether you are requesting this product to be reviewed under provisions of General or Exempt distribution. In the application, Under Summary information, page 4 you are proposing the use of these devices by persons exempt from licensing. In the same paragraph you have indicated the principal rules and regulations and contents of the application that would lead one to conclude that the application is being made for distribution to persons to be generally licensed. In support of your application in Attachment 7 you have included a copy of a registration certificate related to a similar device.
Please note this certificate was issued for the product to be used by persons generally licensed. (CO-376-D-103-G.) Throughout the application there are many references to requirements related to Generally Licensed devices that are not required for exempt products. Please revise and modify the application and ensure consistency and constancy.
1.2 Prototype Testing Please provide prototype testing data. You must provide information that verifies that the product design will maintain its integrity when subjected to conditions of l
normal use and likely accident conditions. ( See Section 10.5 NUREG 1556 Vol.
3.) Also demonstrate as to how the scope and the envelop of the tests have captured the structure and operational features of both the ACAMS SF/AF and OEM-FIS Sensory Assemblies.
1.3 Draft 03-ACAMS-SF/AF Manual This draft of the manualis incomplete. Please provide a complete final manual.
1.4 NI 63 Source Please clarify the max.it'um source activity. A maximum source activity of 6 mci.
On Drawing 6267-SK-392 is inconsistent with the values shown in "the affidavit" attached to the application (page 5 Of 23). Source activity value shown on the referenced page is 5.2 mci. (typical) and j
10 mci. (maximum.)
- 2. Specific lasues 2.1 (Please see Enclosure 2)
' 2.2 Please be advised that source models similar to NEP 004P (Ni-63) as shown in the registration certificate NR-476-S-131-S have been reported by the Army to exceed leak test requirements.
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2.3 Part 32.51 (b) requires a device leak testing frequency of six-months and makes provisions for device leak tests at intervals longer than six-months. MSA P,asline a Subsidiary of Mine Safety Appliances Co., Instruments Division has previously registered a similar model of this type of ion-spectrometer cromatograph with Colorado Department of Public Health and the Environment. The first page of
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the registration certificate number CO-376-D-103-G, dated May 29,1997, states
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a leak testing frequency of six-months.
In view of the above reported leaking of similar sources you should justify a leak test frequency of 36 months or why the product should be an exempt product with no requirements for leak terting.
2.4 Please clarify the purpose and the intended user of this attachment..
2.5 Emergency response directions given in this section should provide directions related to disposal requirements if a device is contaminated with a chemical agent.
2.7 Attachments Your ISO 9001 certificate expires in August 1999. Please confirm your commitment to maintain your ISO 9001 certification.
2.9 Baseline Manual page numbers at the bottom of the page and top right hand corner are not the same. Please have these apparent discrepancies eradicated.
Also, Figure 19 has no page number.
2.10 Atiachment 10 Multi capillary column (MCC) is not shown on Figure 2-2.
item 2. ( page 3.16) is incomplete Please provide the missing Appendix "A."
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Enclocure 2 REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE MINE SAFETY APPLIANCE COMPANY. 03-ACAMS-SF/AF AND OEM-FIS SENSOR ASSEMBLY By Mine Safety Appliance Company's (MSA) application dated February 24,1999, MSA l
submitted an application for registration of Automatic Continuous Air Monitoring System l
(ACAMS). In a notarized affidavit signed by Mr. George R. McGee, indicated that the application contained proprietary drawings and information.
MSA stated that all MSA drawings referenced in the application should be considered exempt l
from mandatory public disclosure for these drawings contain trade secrets. More specifically l
MSA claimed that drawings contain designs, dimensions and tolerance that if released to the l
public will seriously and adversely impact their competitive advantage in the Field of lon Spectrometry since MSA has spent Millions of dollars developing the FIS Technology and trade secrets contained in these drawings.
Section 2.790(b)1 of 10 CFR Part 2 requires that each request for withholding of information l
from the public must be accompanied by an affidavit that contains a full statement of the reasons on the basis of which it is claimed that the information should be withheld from the public. The section further states that the Commission will consider whether the information is of the type customarily held in confidence by the applicant.
In general, only that information which cannot be obtained through observations or i
measurements of components or documentation obtainable by the general public can be withheld as proprietary material. With regard to engineering drawings, information generally l
considered being proprietary includes information such as dimensional tolerances, technical l
specifications of materials, manufacturing notes or specific assembly directions. Any remaining l
information on the drawings would be released, in view of this you may elect to identify specific information on each drawing that you wish to withhold as proprietary, and provide nonproprietary versions in accordance with 10 CFR 2.790 (b) (1) (ii). To assist you we have identified the drawings that are considered proprietary.
l Part A,03-ACAMS-SF/AF ASSEMBLY l
Page 2.
Bracket FIS SENSOR MM 10008366 Information shown Attachment 1, Part A, Page 2 can be easily acquire,l by a member of the public. This drawing does not contain material's specifications or tolerances. Therefore, it cannot qualify as a proprietary item.
Page 5.
Base Sub Assembly MM 10006892 The. majority of information on this drawing can be released to the public.
You may wish to include a revised version of this drawing in the non-proprietary package. The revised drawing need not include machining tolerances for two parts.
Page 6 TubeInner MM 10002740 This drawing will be withheld from the public as a proprietary item.
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Page 7 Base, PEEK MM 10002748 The contents of this drawing qualify it as a proprietary item.
Page 8.
Base Sub Assembly Phase 1 MM 10006893 The contents of this drawing qualify it as a proprietary item.
Page 9.
Guard Ring MM 10003399 The contents of this drawing qualify it as a proprietary item.
Your application does not list Attachment 9 Part A, Page 10. This drawing vriii ce released to public.
l Part B Page 3.
OEM Sensor Sub Assembly Mark ll MM 10004229 The contents of this drawing qualify it as a proprietary item.
l Page 4.
Sensor Base Suo Assembly MM 10004230 The majority of information on this drawing can be released to the public. You may wish to include a revised version of this drawing in the non-proprietary package. The revised drawing need not include machining tolerances for two parts.
Page 5.
Base Insert MM 10004225 The contents of this drawing qualify it as a proprietary item.
Page 6.
Tube outer Electrode
' =:M 10002744 The contents of this drawing qualify it as a proprietary item.
Page 7 Sleeve for Peek Base MM 10002746 The contents of this drawing qualify it as a proprietary item.
l Page 8.
Tube Inner MM 10002740 The contents of this drawing qualify it as a proprietary item.
Page 9.
Guard Ring MM 10009916 l
The contents of this drawing qualify it as a proprietary item.
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., Part E, Source Mounting Section 1 ACAMS-SF/AF Page 1. Manifold Inlet The contents of this drawing qualify it as a proprietary item.
Section 2 - OEM-FIS SENSOR ASSEMBLY Page 1.
Tube Manifold and Heated inlet MM 10009902 The contents of this drawing qaalify it as a proprietary item.
Please note all other drawings submitted with the application will be rr leased to the Commissions Public Document Room as indicated in the c.over letter.
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, being duly affirmed, do depose and say as follows:
I am submitting this document to confirm NRC staff findings and in furtherance of the Company's application to withhold from public only the drawings listed in Enclosure 2.
If the basis for withholding these drawings or information from public inspection should change i
in the future that the information could then be made available for public inspection, I undertake to notify NRC promptly.
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