ML20147A761
| ML20147A761 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/1997 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| References | |
| SSD, NUDOCS 9701280296 | |
| Download: ML20147A761 (3) | |
Text
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y-UNITED STATES 4
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WASHINGTON, D.C. 20555 4001
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January 24, 1997 MEMORANDUM TO:
John Kinneman, Chief Nuclear Material Safety Branch 1
Division of Radiation Safety and Safeguards n
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FROM:
Steven Baggett, Chief
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. v Sealed Source Safety Section
~7 Medical, Academic, and Commerci t'
2 Use Safety Branch Division of Industrial and Medical Nuclear Safety
SUBJECT:
RESPONSE TO TECHNICAL ASSISTANCE REQUEST CONCERNING VICTOR J. BORTOLOT, Ph.D.
This memorandum is in response to your technical assistance request dated April 26,1994, conceming the devices being used and proposed for use by the licensee, Victor J. Bortolot, Ph.D., License No. 06-17253-01, Control No. 116381. Since the receipt of this request, the Sealed Source Safety Section has corresponded with Dr. Bortolot conceming review and registration of his devices. Two letters were sent to Dr. Bortolot: the first, March 1,1995, requested additional information on the devices currently in use; and the second, November 16, 1995, requested information within 30 days, otherwise the application would be considered abandoned. Dr. Bortolot responded with a letter dated December 11,1995, stating that he would like to resubmit the license application renewal in its original form without the additional sources and devices, that is, as submitted in his previous license renewals.
The technical assistance request contained three requests for assistance in properly categorizing and authorizing the activities of Dr. Bortolot's licente. These requests and responses are as follows:
1.
Please confirm the categorization of the two devices currently in use by Dr. Bortolot.
The devices are categorized as " measurement instruments," however, Dr. Bortolot believes they should be categorized as "irradiators."
Response
The two devices utilized by Dr. Boriolot more closely meet the classification of "Irradiators Self Shielded Less Than 10,000 Curies," Program Code 03510. These devices are designed to irradiate materials. Once irradiated, the materials are heated and analyzed using a thermoluminescence measurement system. The radiation utilized does not measure anything.
The " measurement"is made subsequent to the irradiation. The radiation is used to alter / modify the material, similar to the purpose of the gencric irradiator. However, the isotopes utilized and the low activities are not charrieristic of the generic irradiator.
CONTACT:
Brian Smith N0m
( i> 415-5723 01 0
9701280296 970124 PDR RC SSD PDR
John Kinneman 2
thermoluminescence measurement system. The radiation utilized does not measure anything.
The " measurement"is made subsequent to the irradiation. The radiation is used to alter / modify the material, similar to the purpose of the generic irradiator. However, the isotopes utinzed and the low activities are not characteristic of the generic irradiator.
1 Measuring systems" are designed to measure resulting radiation levels once the radiation has passed through or backscattered from the material of interest. This measurement then relates J
to a certain quantity, level, or amount. Also included in measuring systems are gas chromatographes and x-ray fluorescence devices. The two devices used by Dr. Bortolot do not utilize radiation in the same manner as devices classified as " measuring systems."
It is our conclusion that these devices do not fit exactly into either category. After reviewing the information submitted with the 1992 renewal, the two devices used by Dr. Bortolot appear to be adequately desi@ed and the procedures listed for the safe use of these appears sufficient. In addition, Dr. Bortolot states that his annual exposure has not been greater than 250 mR during the term of his current license. Due to the three year inspection period for"irradiators,"
categorization as "irradiators" would be imprudent and would be a pcor use of agency resources. Therefore, due to the low risk involved with the use of these two devices and the more appropriate inspection frequency of once every seven years, the two devices should be categorized as " Measuring Systems Analytical Instruments," Program Code 03122.
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1 2.
Please determine if any irradiators, or devices used with the irradiators, require a review.
Specifically, the applic.ation dated March 20,1992, contains descriptions of additional 1
devices that may be distributed in the future.
Response
i No, these new irradiators do not need to be reviewed. Dr. Bortolot, in his letter dated December 11,1995, to Region I with cc to Steven Baggett, stated that he wishes "to re-submit his license j
application renewal in its original form without the additions, that is, as submitted in 1081 and 1986." In the 1981 and 1986 applications, only two devices are requested to be used in his analytical laboratory. Therefore, since these new devices will neither be used by Dr. Bortolot or distributed to other licensees, a device review is not necessary. However, at such time in the future that Dr. Bortolot determines that he will require the use of these devices or any others, or wishes to distribute these to other licensees, a device review will be required for those models.
3.
Please confirm if a device review and registration is necessary for possession and use of the sources in deues in Dr. Bortolot's analytical laboratory as he has been licensed in the past.
Response
No, review and registration of these devices is not necessary. These two devices have been in Dr. Bortolot's possession and licensed for use since 1981. At the time of obtaining his materials possession and use license, he supplied sufficient safety information on the two devices for the license reviewer to approve their use in Dr. Bortolot's analyticallaboratory. The requirements for a licensee to apply for a review and registration of a device Lecame effective in August 1987.
In the preamble to the amendment to 10 CFR Parts 30 and 32 incorporating these
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John Kinneman 3
requirements, it states that the amendment is merely a codification of current administrative practice and requires no additional action for sources and devices presently used because necessary safety information was evaluated before issuance of the specific license to the user.
4 However, if a user modifies a device currently licensed for use or wishes to manufacture and distribute commercially a new device, a safety review of the device and registration is necessary.
Dr. Bortolot may still distribute the devices commercially without sources since this is outside NRC authority. The purchasers of the devices would be required to apply for a custom review and registratiori for their devices. We highly discourage this practice. One of his devices, a model 801 sample irradiator, has been reviewed and registered for custom use in the past.
However, Dr. Bortolot may continue to distribute his devices with sources commercially to 4
holders of research and development and broad scope licenses. Policy and Guidance Directive 84-22 permits those holders of research and development and broad scope licenses with the license condition to use byproduct material in "any form" to use sealed sources in devices 3
without the device being reviewed and registered.
cc:
Ms. Elizabeth Ullrich, Region l DISTRIBUTION: SE4H45MG9iEGE fuI 6SD 7V' 2r 1555 "//
DOCUMENT NAME: P:\\SSSS\\BORTOLOT\\BORTOLOT. TAR To,eceive a copy of this document, Indicate in the boa: "C" = Copy without attachment / enclosure
'E' = Copy with attachtnent/ enclosure "N" = No copy OFFICE SSSS l6 IMAB us l
OC/LFARB C
l NAME BSmith 6K SBaggett GJacksonG/
DATE 12l#'/96 12/%/96
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