ML20236N081

Responds to 980702 Application Requesting Registration of Bsi Photon Gauges.Listed Info Requested to Be Provided

ML20236N081
Person / Time
Issue date:	07/14/1998
From:	Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Galen Smith AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9807150001
Download: ML20236N081 (10)

Text

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j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001

• • • • • ,o July 14, 1998

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G.M. Smith, Jr., President g1 BSI instruments i

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101 Corporation Drive Aliquippa, PA 15001

Dear Mr. Smith:

This letter is in response to your application dated July 2,1998, requesting registration of BSI's Photon Gauges. Typically, the U.S. Nuclear Regulatory Commission (NRC) performs an initial acceptance review of an application upon receipt. In this case, NRC has performed a complete' technical evaluation your application. A copy of your application has been forwarded to NRC's Office of the Chief Financial Officer (OCFO) to address fee issues.

OCFO will contact you directly regarding fees.

As part of the review of your application, we noto that BSI referenced performance based criteria to describe the design of the devices. This led to deficient information being provided for many aspects of the application. Therefore, in order to continue our evaluation of your app" cation, we request that BSI provide the following information:

1.

For the Model NW-501 series, BSI identified a very wide range of specifications, including wide ranges in dimensions and installation criteria. Therefore, to ensure a timely response to your application for the other models (Models NW-201, -301, and 401 series), we suggest that the evaluation of the Model NW-501 series be treated separately. We will address evaluation of the Model NW-501 series in a separate letter. Therefore, the remainder of this letter addresses only the Models NW-201,

-301, and 401 series devices.

2.

Your application requests that the drawings provided with your application be withheld from public disclosure. In order for NRC to consider this request, you must submit an application, in accordance with 10 CFR 2.790, requesting NRC to withhold the information. The application must be accompanied by an affidavit as specified in 10 CFR 2.790(b)(4). An example affidavit is enclosed for your reference. Please note the similarity of the wording in the example affidavit to the wording in 10 CFR 2.790.

Section 2.790(b)(1) of 10 CFR Part 2 requires that each supporting application be accompanied by an rffidavit that contains a full statement of the reasons on the basis of which it is claimed that the information should be withheld from public disclosure.

The section further states that the Commission will consider whether the information is of a type customarily held in confidence by the applicant. Please note that, in general, only that information which can not be obtained through observation or measurement of components or documentation obtainable by a member of the public can be withheld as proprietary material.

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In addition,10 CFR 2.790(b)(1)(ii) requires that a non-proprietary version be-i submitted. In preparing the non-proprietary version place brackets around the material considered to be proprietary, and white out or black out the proprietary portions, leaving the non-proprietary portions intact.

. With regard to the diagrams and blueprints, information typically considered to be proprietary includes information such as dimensional tolerances and specific manufacturing notes or details listed on the drawing. Any additionalinformation on the drawings would be releasable. In order to address this, please identify the specific information on each drawing that BSI wishes to be held as proprietary.

A proprietary version (with the brackets), non-proprietary version (with the marked out information), and the new affidavit must be. submitted prior to the staff making its final proprietary determination. In accordance with 10 CFR 2.790(c), the information -

- sought to be withheld will be placed in the Commission's Public Document Room unless you provide the Commission with the requested information; or a request that the letter be withdrawn, within 30 (thirty) days of the date of this letter -

3.

Much of the information provided in your application indicates that BSI will evaluate the environmental conditions of the installation of the devices and determine the exact design of the devices based on BSI's evaluation. Specifically, this applies to exact dimensions and materials of construction of the devices, the design and materials of the sources, the use of tamper resistant hardware, and the construction of the labeling

' of the devices.. For each of these specifications, please provide details of how BSI will evaluate and conclude that the construction of the devices, including the items specified above, will maintain their integrity when subjected to the normal conditions of use and likely accident conditions.- BSI's evaluation should include criteria for correlating environmental conditions to device specifications.

4.

The drawing provided in your application does not provide sufficient information on the design of the source that will be incorporated into the device. Please provide complete specifications, including complete dimensions and materials of construction, of the source design that will be used in the device.

. 5.

Please provide specific information, including detailed drawings, on how the sources and source holders will be mounted into each device.

6.

Please provide the specifications for the epoxy that will be used to mount the sources.

Specifications should address how the epoxy will withstand being subjected to radiation, water, and chemicals that may be present during use of the devices.

7.

The drawings of each source housing provided in your application do not provide suffici$nt details'as discussed during our meeting on June 23,1998. Specifically, the draw;ngs do not include all the necessary dimensions, specifications on fasteners or welds, nor specifications for tamper resistant fasteners. Please re-submit drawings that include all necessary information.-

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3 8.

Your application indicates that the mounting mechanism for the source holders will be provided by BSI or a vendor of the users choice. Please provide specific information on the designs of mounting mechanisms. If BSI plans to evaluate mounting mechanisms based on each specific application, BSI needs to provide information on how it will evaluate the mounting mechanism to ensure it will withstand the normal conditions of use and likely accident conditions.

9.

Please indicate how the trefoil symbol will be included on the labeling of the devices.

10.

The proposed wording on the labeling of the devices indicates that loss, theft, or transfer of the devices be reported to BSI, NRC or the Agreement State. Please note that reporting of this information to BSI does not relieve the general licensee from reporting required information to the NRC or the Agreement State. Please indicate how the labeling will be modified to reflect this.

11.

The proposed wording on the labeling of the devices indicates that dismantling, maintenance, repair, and testing shall be performed by BSI. Please note that these activities may be performed by other specific licensees. Please indicate how the hbeling will be modified to reflect this.

12.

Please provide the limitations (i.e., extremes) on the normal conditions of use for the devices. This should include limitations on vibration, temperature, humidity, and other conditions that may effect device integrity. The registration will restrict use of the devices to the conditions specified by BSI.

13.

Please demonstrate that the devices will maintain their integrity when subjected to the normal conditions of use and likely accident conditions as specified by BSI. This demonstration should address impact, vibration, temperature, and humidity and may be supported by testing of prototype devices, engineering analysis, or analysis of operational history.

14.

Your application indicates that users will install the devices. Please indicate how generally-licensed users will be able to verify that the doses on contact with accessible surfaces will not exceed 0.5 mrem /hr (5 pSv/hr). In addition, please provide the doses users would likely receive during installation of the devices.

15.

Your evaluation of likely doses to users of the devices is based on the maximum radiation levels after mounting not exceeding 0.5 mrem /hr (5 pSv/hr) on any accessible surface of the application. Please demonstrate how this will be verified by BSI, including a commitment to verify this for each device as part of the quality assurance program, since the users will be installing the devices.

i 16.

Please indicate the model number and total activity for the device referenced in your I

safety analysis (page 11 of your application) as having a dose rate of 100 mrem /hr (1 mSv/hr) in the radiation beam at the surface of the device. Specifically indicate whether this is a design specification, for all models, for maximum exposure rate in the radiation or whether this is the maximum exposure rate for only one particular model.

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4 17.

Please supplement your safety analysis by providing information on an accident scenario where an individual would be exposed to the radiation beam.

18.

Your accident scenario for the safety analysis indicates that the source will maintain their integrity during a fire. Please either demonstrate how the sources will survive a fire or explosion or provide details of an accident scenario that includes resulting doses from sources that do not maintain their integrity. In the accident scenario where a source will not maintain its integrity, please address the consequences of inhalation and ingestion of radioactive material.

19.

Please commit to providing users (i.e., general licensees) with a listing of the Agreement State contacts so they can contact the Agreement States to verify compliance with Agreement State regulations. A copy of this listing can be found on NRC's homepage.

20.

Please note that there are typographic errors in the radiological safety instructions provided with your application. Specifically, references to 10 CFR 31.5(c)(8) & (9) are listed as 10 CFR 31.5@(8) & (9), and reference to 10 CFR 31.5(c)(10) is listed as 10 CFR 31.58(c)(10). Please commit to have this information corrected in the documentation that is sent to general licensees.

21.

Please commit to modify your instructions to users to note that the device is not required to be leak tested rather than indicating that the device is exempt from leak testing.

Please provide the requested information within thirty (30) days. If we do not receive the requested information 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. Once our evaluation is complete, we will forward a copy of the registration certificate to NRC's region I to support amendment of BSI's general distribution license. If you would like to discuss any of the issues identified in this letter or have any questions, please contact me at (301) 415-7231 or Mr. John Lubinski at (301) 415-7868.

NRC is open to having a telephone conference call or meeting with BSI to discuss in detail any of the items identified in this letter.

Sincerely, Steven L. Baggett, Deputy Branch Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

Example Affidavit cc: SKimberley, OCFO l

GPangbum, NRC Region I i

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i j:}.y Before me, the undersigned authority, personally ippeared Peter J. Morris, who, being by me duly sworn according to law, deposes and says that he is authorized to execute this Affidavit on

..... &.. 3 of Westinghouse Electric Corporation (" Westinghouse") and that the averments of fact set forth in u <yp.-

' Affidavit are true and correct to the best of his kriowledge, information, and belief:

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~&, Peter J. Morris, Manager s'.*y Strategic Safety and Regulatory issues Wd..~9 b5 Sworn to and subscribed

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Energy I have personal knowledge of the criteria and procedures utilized by Systems Business Unit in designating information es a trade secret, (3) confidential commercial or financial information. g, j

'},h Pursuant to the provisions of paragraph (b)(4) of Section 2.790 of the i i i determining (4) regulations, the fo!!owing is furnished for consideration by the Comm ss o l

hould be withheld.

whether the information sought to be withheld from public disc osure s "Ile information sought to be withheld from public disclosure is own (i) held in confidence by Westinghouse.

4 The information is of a type customarily held in confidence by We l basis for determining (ii) customarily disclosed to the public. Westin'ghouse has a rationa Y5 confidence by it and, in that connection, c..

the types of information customarily held tg,%

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i es of information utilizes a system to determine when and whether to hold certa n typ m n *.emtv in confidence. The application of that system a'nd the substance of th

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'kE C).pOb Under that system,'information is held in confidence if it falls i ii r potential several types, the release of which might result in the loss of an ex st n competitive advantage, as follows:

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(a) ne information reveals the distinguishing aspects of a process (or component, h.: w. a ~ere prevention of its use by any of x:

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competitive economic advantage over other companies.

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It consists of supporting data, including test data, relative to a process (or component, structure, tool, ethod, etc.), the application of which data securcs a competitive economic advantage, e.g., by optimization or improved

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Its use by a competitor wo'uld reduce his expenditure of resources or improve f

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assurance of quality, or licensing a similar product.

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It reveals cost or price information, production capacitics, budget levels, or commercial strategies of Westinghouse, its customers or suppliers.

(c)

It reveals aspects of past, present, or future Westinghouse or customer funded development plans and programs of potential commercial value to Westinghouse.

(f)

It contains patentable ideas, for which patent pmtection may be desirabic.

There are sound policy reasons behind the Westinghouse system which include the following:

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(a) ne use of such information by WestinE ouse gives Westinghouse a h

l competitive advantage over its competitors. It is, therefore, withhdd from n e;v <

disclosure to protect the Westinghouse competitive position.

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It is information which is marketable in many ways, ne extent to which such mwe m.cso. o information is available to competitors diminishes the Westinghouse ability to sell products and services involving the use of the information.

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Use by our competitor would put Westinghouse at a competitive disadvantage by reducing his expend"iture of resources at our expense.

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Each component of proprietary information peninent to a particular

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advantage. If competitors acquire components of proprietary information, any one component may be the key.,.,to the entire puzzle, thereby depriving Westinghouse of a cornhtitive advantage.

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Unrestricted disclosure,wouldjeopardize the position of prominence of i

Westinghouse in the world market, and thereby give a market advantage to the competition of those countries, e

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The Westinghouse capacity to invest corporate assets in researcti and i

J development depends upon the success in obtaining and maintaining a competitive advantage.

(iii)

The information is being transmitted to the Commission in confidence and, under the provisions of 10CFR Section 2.790, it is to be received in confidence by the Commission.

(iv)

The information sought to be protected is not available in public sourecs or available information has not been previously employed in the same original manner or method to the best of our knowledge and belief.

(v)

Enclosed is letter ET-NRC-92-3779, December 1992, being transmitted by Westinghouse Electric Corporation Q30 letter and Application for Withholding w

Proprieta:y 1.nformation from Public Disclosure, N. J. Liparuto (20, to Dr. Thomas Murley, Director, Office of NRR.' The pro' rietary information e ibmitt.d for use by p

Westinghouse Electric Corporatio'pt.

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plant and the associated design certification application and is expected to be applicable in other licensee subrilitta!S in response to certain NRC requirements for I

justification of licensing advanced nuclear power plant designs.

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.,,. :-f *;&:U<yx...t This information is part of that which will enable Westinghouse to:

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Demonstrate the design and safety of the AP600 Passive Safety Systems.

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Estab*ish applicable verification testing methods.

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Design 4.dvanced Nuclear Power Plants that meet NRC requirements.

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Estab>'sh technical and licensing approaches for the AP600 that will ultimately result in a certified designh /

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Assist customers in obtaining NRC approval for future plana.

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Funher this information has s.ubstantial commercial value as follows:

(a)

. Westinghouse plans to sell the use of similar information to its customers for purposes of meeting NRC requirements for advanced plant licenses.

(b)

Westinghouse can sell support and defense of the technology to its customers in the licensing process.

Public disclosure of this proprietary information is likely to cause substantial harm to the competitive position of Westinghouse because it would enhance the ability of competitors to provide similar advanced nuclear power designs and licensing defense services for commercial power reactors without commensurate expenses. Also, public disclosure of the informatiort would enable others to use the information to meet NRC requirements for liccasing documentation without purchasing the right to use the

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- The development of the technology described in part by the information is the result of applying the results of many years of experience in an intensive Westinghouse effort and the expenditure of a considerable sum of money.

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sechnical prograrns would have to be perfortned and a significant rnanpower effort,

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analytical methods and receivin's NRC, approval for those methods.

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