ML20206A080

Forwards Draft Ltr to Berthold Re Submittal of Sufficient Info on Design,Manufacture,Prototype Testing, Quality Control,Labels,Proposed Uses,Installation & Potential Hazards of Listed Device

ML20206A080
Person / Time
Issue date:	10/23/1998
From:	Kirkwood A NRC
To:	Steven Baggett NRC
Shared Package
ML20137M141	List: ML20206A029 ML20206A042 ML20206A066 ML20206A080 ML20206A088
References
SSD, NUDOCS 9904280049
Download: ML20206A080 (5)

Text

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[ Steven Ba0gett . Berthold Letter dated 6/26/98 attached Page il 4

~ From: Anthony Kirkwood

-To: SLB  !

Date: Fri, Oct 23,199811:29 AM

Subject:

Berthold Letter dated 6/26/98 attached l 4

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18tev:n Baocett . 881.WP5 Page il

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g~ 1 Berthold Systems, Inc.

ATTN: G.M. (Bud) Smith

. President 101 Corporate Drive Aliquippa, Pennsylvania 15001 2 -

Dear Mr. Smith:

]:

Please be advised that Berthold Systems, Inc. (BSI) must discontinue its program of advising its customers to combine exempt quantity sources. As discussed during the June 19,1998

telephone conversation between you and Mr. Lubinski, Nuclear Regulatory Commission (NRC), the NRC Office of General Counsel (OGC) has determined that the NRC position that was transmitted in a June 3,1994, . letter to Ronan Engineering Company, was in error.

Specifically, NRC now finds that combining of exempt sources is inconsistent with the regulations pursuant to 10 CFR 30.18,32.18,32.19 and 32.20. Because the exemption provided in 10 CFR 30.18, as set out in the regulation itself, is applicable only as long as no individual or discreet quantity of the byproduct materials exceeds the quantity limits specified in 10 CFR 30.71, Schedule B, and as long as the quantities set out in that schedule are originally.

received and remain separate and distinct from other quantities of exempt byproduct materials, Ronan's instructions and the jig that it provides to its customers is in direct conflict with the l

NRC's requirements for labeling of exempt sources which in Aruct persons not to combine l exempt quantities. The labeling requirements in stction 32.19, which address shipments to j persons exempt, instruct 32.18 licensees to label the "immediate container" witn information identifying the radioisotope and the quantity of radioa*:tivity, and in addition to that information, "

shall also bear the words ... ' Exempt Quantities Should set Be Combined." Therefore, while the exemption in section 30.18 provides for persons without a license to possess and use a

wide variety of byproduct materials, and to possess and use specif'c byproduct materials without restriction as to the total quantity which may be possessed and used at any one time, the regulations do not authorize, but rather prohibit, grouping exempt quantities of byproduct material.

BSI may distribute these devices to specific or general licensees. However, in order to do so, BSI must have the device design evaluated and registered with the NRC and if distributed to general licensees BSI must have its general distribution license amended.

In'an application dated January 10,1998, you requested a specif~c license pursuant to

.10 CFR 32.18 to distribute exempt quantities of specified byproduct material to persons exempt from licensing under 10 CFR 30.18. However, we understand you want to change your application to request both a license to manufacture and distribute a generally licewed device and a NRC device registry review.

To distribute a generally licensed gauging device pursuant to 10 CFR 31.5, the requirements in 4

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[Stev:n Baggett- SSI.WP5 Page 2]

4 10 CFR 32.51 must be met. Based on our initial review of your application you inust submit sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device.

l l

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. l Stev:n Baggett - BSI.WPJ 5 Page 3l j.-

G. M. (Bud) Smith However, as discussed during the June 22,1998, meeting between you and Mr. Steven Baggett, because of the low risk associated with a device containing 500 microcuries of cesium-137, flexibility in the device review will ba considered. I have enclosed a copy of the I

~ handout from this meeting detailing the usual requirements for a NRC generally licensed j device review. In short, however, the following information should be provided:

1. For all modele please supply a set of drawings that adequately describe the construction ci the devices.

2. Provide the maximum number and activity of the sources to be used in the device.

3. Please explain how you will prevent access to the sources by the general licensee.

4. Please describe how the labels will meet the requirements in Section 32.51(a)(3),

10 CFR 32.

5. Please confirm that dose levels on contact will not exceed 0.5 millirem per hour.

6. Dose assessments must be provided that demonstrate that the device meets Section 32.51,10 CFR Part 32 safety criteria, i.e., it is unlikely that a person will receive in 1 year a dose in excess of 10 percent of the annual limits in 10 CFR 20.1201(a) or the intamal organ dose limit of Column IV of the table in 10 CFR 32.24. Please provide adequate dose scenarios based on the radiation levels around the device.

7. Results of prototype testing or engineering analysis to demonstrate device maintain its integrity during likely conditions of use.

8. Provide a description of your Quality Assurance program including a commitment to verify radiat!on levels and test for removable contamination.

9. Describe servicing that you will provide and that general licensee's may perform. In doing so, please provide safety instructions that will be provided to the general licensee's.

At this tire e, devices already in use having multiple exempt quantities of byproduct material may continue to be used. NRC does not plan to take any action with respect to these devices

~

or users unless a radiological safety hazard is identified. In addition, as discussed during our meeting of June 22 and during your meeting with NRC in your congressional representative's office on June 23,1998, NRC will allow E 31 to continue to distribute devices having multiple exempt quantities of byproduct material for a period of 60 days from the date of this letter.

NRC plans to perform a risk assessment to determine if there are any public safety concems with these devices and whether any further action is warranted. If the risk assessment demonstrates a low risk to the public, NRC would initiate rulemaking to authorize the

, distribution of these devices to persons exempt from licensing. it is anticipated that the risk assessment and rulemaking process will take 2 to 3 years, i 1

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l Coven Baggett - BSt.WP5 Page 51 -

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' G. M. (Bud) Smith- 3'-

. We look forward to receiving the required information as soon as possible. If you have any questions, please contact me at (301) 415-6140 or Mr. John Lubinski at (301) 415-7868.

Sincerely,

. Anthony S. Kirkwood Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards Control No. 021947

Enclosures:

As stated cc: Mary Keller, Berthold Systems, Inc.

George Kury, Berthold Systems, Inc.

Tom Combs, NRC/OCA John McGrath, RI ,

Vickie Jeffs, State of Kentucky DISTRIBUTION NRC FHo Room . IMNS r# SSD r# PDR YEs DOCUMENT NAME: H:EXEMPTW2.189EFLTRSSSI.WPs C = COVER E = COVER & ENCLOSURE N = NO COPY oFC MS8:NMSS I MS8:NMSS l MSBNMSS l OGC l NAME ASKirkwood ask SL8ennett LWCamper SATreby OATE 06/ 2 06/ 2 06/ m- 06/ 2 OFC iMNS NMSS l l l l l NAME FCCombs 1 OATE 06/ m i OFFICIAL RECORD COPY ao