ML20247P228
| ML20247P228 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1998 |
| From: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stein R AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805270364 | |
| Download: ML20247P228 (6) | |
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UNITED STATES g-l*
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't WASHINGTON, D.C. 20555-0001
- %.....,4 May 20, 1998 Russell N. Stein, Vice President Gray Star, Inc.
Mt. Arlington Corporate Center 200 Valley Road, Suite 103 Mt. Arlington, NJ 07856
Dear Mr. Stein:
This letter is in regard to your application dated September 1996, requesting registration of the Model GrayStar irradiator and my letter dated January 27,1997, which asked for additional information in order to continue our evalua':on of your rec,uest. In your responso dated February 10,1997, you have indicated that you would provide further,information regarding the development and encapsulation tests of the special form source which you intended te use as well as regarding the quality assurance (QA) program and prototype testing for the irradiator.
To date, the requested information has not been received.
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Since, at the present time, a large amount of significant technical data are missing, we are terminating the review process of the application. This is without prejudice to the resubmission of a complete application fully addressing our questions. For your information I have delineated, in the Enclosure to this letter, the technical issues that need further clarification from you.
Please resubmit your application when complete, in the meantime, we would be happy to meet with you again if you wish to discuss the application process with us. Your design is a dual purpose device: (a) it is an irradiator which needs to meet the requirements of 10 CFR Part 36, and (b) it is also a transportation package which needs to meet the requirements of 10 CFR Part 71. Therefore, you should send NRC your resubmission in two separete applications: one for approval as an irradiator, and another for approval as a transportation package.
Please send the application for irradiator approval to me. The application for approval as a i
transportation package, as we had indicated to you in our meeting with you on May 7,1997, l
should be sent to Mr. Ross Chappell, Chief, Package Certification Section, Spent Fuel Project Office, Office of Nuclear Material Safety, NRC, Washington, DC 20555. You may reach Mr.
Chappell at (301) 415-8510.
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Mr. Russell N. Stein 2
Please also note that the design, development, testing, and fabrication of transportation packages must be performed in accordance with a OA program that has been approved, prior to commencement of any of the activities, by the NRC under the provision of 10 CFR Part 71.
Please send the QA program for approval to Ms. Patricia L. Eng, Chief, Transportation and Storage inspection Section, Spent Fuel Project Office, Office of Nuclear Material Safety, NRC, Washington, DC 20555. Ms. Eng can be reached at (301) 415-8577.
If you have any questions, please contact me at (301) 415-7231 or Mr. Steven Baggett at (301)415-7273.
Since
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m A, L rry W. Camper, hie terials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
as stated cc w/ encl: SKimberley, LFDCB i
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_.______________.____u
1 Mr. Russell N. Stein Please also note that the design, development, testing, and fabrication of transportation packages must be performed in accordance with a QA program that has been approved, prior to commencement of any of the activities, by the NRC under the provision of 10 CFR Part 71.
Please send the QA program for approval to Ms. Patricia L. Eng, Chief, Transportation and Storage Inspection Section, Spent Fuel Project Office, Office of Nuclear Material Safety, NRC, Washington, DC 20555. Ms. Eng can be reached at (301) 415-8577.
If you have any questions, please contact me at (301) 415-7231 or Mr. Steven Baggett at (301)415-7273.
Sincerely, (orig. signed by LCamper)
Larry W. Camper, Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards 1
Enclosure:
as stated I
cc w/ encl SKimberley, LFDCB Distribution:
IMNS r/f SSD-96-93 NE01 NMSS r/f RChappell/SFPO PEng/SFPO NRC Central File DCool/lMNS FCombs/IMNS CPaperiello/NMSS WKane/NMSS RBlough/RI PDR YES x
NO i
9 DOCUMENT NAME: PSGRAYSTAR.DF2 To receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy
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NAME JJank,ovich/jjff-SBaggett LQaylpeff v DATE 05/ p/98 yV 05/ [y/98 05/1.4198 4
OFFICIAL RECORD COPY I
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' Technical issues to be Addressed in Application for Registration of the Model GrayStar Irradiator The technical issues are listed below in the same order as they had been presented in NRC's
-letter dated January 27,1997. The listing below delineates the data that are still missing and need to be provided in order for the NRC to be able to conduct a review of the Model
' GrayStar irradiator design.
1.1 Selection of Cesium-137 Chloride as Source Material j
- Please provide the references as well as a discussion of the references that address the
. operating experience with this compound in applications comparable to the GrayStar design.
= - Provide material specifications for the source material: chemical composition, purity, acceptable impurities, dryness, etc.
-- When specifyisig cesium chloride as well as impumies, address the potential of chemical interaction with the inner wall of the capsule. Please note that integrity of the capsule wall must be demonstrated for the life of the capsule, i.e. long term effects of differing materials interacting with each other under varying environmental conditions must be addressed either by analysis, testing or references to previous experience.
2.' Use of Probabilistic Risk Assessment (PRA)
- Please note that PRA, as used by NRC, identifies initiating events and event sequences which might be contributors to risk; provides a realistic quantitative measure of the likelihood of these contributors; provides a realistic evaluation of the potential consequences associated with hypothetical accident sequences; and provides a reasonable risk-based framework for making decisions regarding design, operation, and siting. When such an approach is followed, the results of a PRA analysis identify all of the probabilisticly significant risk contributors, identify the
- most likely (dominant) accident sequences, and evaluate the consequences of hypothetical accident sequences. The GrayStar irradiator consists of a number of differing systems, such as
-- mechanical interlocks, hydraulic activators, electrical and electronic components, extemal and auxiliary power supplies, human operators. Consequently, a systematic analysis of the interaction of these systems, that of the feasible accident processes, and accident consequences would indicate the safety performance of the GrayStar device on the basis of objective terms.
- Specifically, you had referred to Drawing No.100400 in your letter dated February 10,1997, as one that shows that mechanical failures would not have safety consequences. The drawing does not provide sufficient detailed information to come to a conclusion that a PRA type
. analysis, as described above, would provide. Similarly, the Safety Analysis and the Regulatory Analysis sections of your application to which you had Iso referred in your February 10,1997, 3
letter regarding NRC's question of PRA provide only deterministic data on the basic' design in terms of isolated systems. To determine the safety function of the GrayStar system as a whole, we need to see the interaction of the various systems under realistic accident scenarios.
Enclosure
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Enclosure 2
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- 3. Chemical Compatibility of Differina Materials j
- in your letter dated February 10,1997, you had used the term " designed to accommodate electrochemical corrosion" when referring to the contact surfaces of a number of different -
components. Please describe the specific measures you have taken or the analyses you have conducted to assure chemical compatibility for the service life of the components under the environmental conditions that the materials encounter in the GrayStar system.
- 4. Sensitization of Stainless Steel
- You had indicated that further information would be provided later regarding this issue. Please address sensitization in future applications.
- 5. Thermal Cyclina and Phase Transformation of the Source Material
- In your response, you had indicated me heat-u ? cycle only. A PRA analysis will indicate j
whether other thermal cycles are likely to occur. In addition to operational use of the source, please also include any scenario that may result in thermal cycling during accidents in operation
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and during normal transportation as well as in transportation accidents.
- Please provide a drawing that shows the source capsule with the fill material inside. Your letter indicated that the sources are 3" high.' Drawing No. 500400 shows the source pencil with approximate dimensions of 3.15" high, but 46.47" long and 1.36" wide, indicating a relatively large volume of space with significant variations in linear dimensions. Therefore, the fill volume of the source material with respect to the inner volume of the source pencil must be analyzed or-tested for phase changes due to temperature changes.
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- 6. Ranoe of Environmental Conditions
- In your letter dated February 10,1997, you indicated that the range of environmental parameters had not yet been finalized. Please provide the values for these parameters in your application.
- Please also describe the conditions when the cleaning or flushing operations, which you l
referred to in your letter, will be needed. Please specify the criteria for initiating a cleaning or
, flushing process, the equipment, the cleaning agent and the pr'ocedure to be used.
- 7. Leak hosts
. - You indicated in your letter that the leak test procedures and the conduct of activities had not yet been developed. Since the GrayStar irradiator is a unique design, the conduct of leak tests i
is an important subject. Please describe in your application the radiation protection measures l
that may be needed for performing the leak tests as well as the likely exposure rate of the l
persons performing this function.
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. Enclosure 3
- 8. Sealed Source Qualification
' You indicated in your letter that test data on the performance capabilities of the source had not yet been available. Please provide the data when the); become available.
- Please note that sealed sources are usually tested to industry-accepted standards, such as American National Standard N542, " Sealed Radioactive Sources, Classification." The Standard specifies test methods and quantitative physical criteria for classification of sealed sources in
' terms of temperature, extemal pressure, impact, vibration, and puncture. We understand that the Standard may not be fully suitably for testing and classifying a source of such unique design as you intend to use. However, you must demonstrate the performance characteristics of the i
GrayStar source in terms similar to those for normal sources for NRC to proceed with the review j
of your application.-
. - In case you do not use an industry standard to qualify the GrayStar source, please provide
' NRC a complete test protocol describing such information as the description of the tests and the test equipment to be used; the rationale for selecting the tests; quantitative pass / fail criteria for
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l each of the tests as well as the rationale fc choosing the particular values for esch of the criteria; and the actual test data demonstrating how the source passed the tests.
- g. Role of Pluas to Seal the Source
- You indicated in your letter that plug performance data had not yet been available! Please provide the data in your application.
- Please note that a filled source, not an empty source, must pass the tests described above in -
Item 8.' Consequently, the capsule with plugs in place must maintain integrity as a containment vesselin the tests.
- Please also demonstrate that the plug material, and any sealant that may.be used in connection with the plug to perform its function, is chemically compatible with the capsule i
housing material and the fill material for the working life of the device.
- 10. Prototvoe Testina
- You indicated in your letter that the testing plan and test results had not yet been available.
Please describe in your application the test methods and the test results when available.
- - Please note that prototype testing includes tests performed.during pre-install,ation, installation and operational use of the device. The objective of testing is to demonstrate that the device
' performs in normal use and in likely accident conditions within the boundaries'specified for the design and approved in the registration. Therefore, testing must include all systems such as mechanical, electrical, hydraulic, and other systems which have a role in safety.
- Please also note that in industry practice for medical and irradiation devices certain routine tests are conducted as part of the normal periodic maintenance in order to assure that the '
equipment continues to operate within the specified boundaries. Therefore, please include a i
description of maintenance tests of systems which have a safety role in your application.-
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