ML20236P853
| ML20236P853 | |
| Person / Time | |
|---|---|
| Issue date: | 07/15/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Unetich R AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20236P855 | List: |
| References | |
| SSD, NUDOCS 9807170173 | |
| Download: ML20236P853 (3) | |
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, h.' 4 UNITED STATES g J.L g NUCLEAR REGULATORY COMMISSION O
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's WASHINGTON, D.C. 20555-0001
% jut ~ l B 1998 Ben Franklin Technology Center /WP ATTN: Robert Unetich, Board Member 2000 Technology Drive, Suite 250 Pittsburg, Pennsylvania 15219-3109
Dear Mr. Unetich:
As discussed during a June 19,1998, telephone conversation between Mr. G. M. (Bud) Smith, President, Berinold Systems Inc. (BSI) and Mr. John LubinsH, U.S. Nuclear Regulatory Commission (NRC), the NRC Office of the General Counsel nas determined that the NRC position that was transmitted in a June 3,1994, letter to Ronan Engineering Company was in error. Specifically, that decision 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 l
provided in 10 CFR 30.18, as set out in the regulation itelf, is applicable on!y as long as no j individual or discreet quantity of the byproduct rnaterials 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, BSl's instructions and the jig that it provides to its customers is in direct conflict with the NRC's !
requirements for labeling of exempt sources which instruct persons not to combine exempt quantities. The labeling requirements in section 32.19, which address shipments to persons ;
exempt, instruct 32.18 licensees to label the "immediate container" with information identifying j the radioisotope and the quantity of radioactivity, and in adCition to that information, "shall also bear the words ... ' Exempt Quantities Should Not Be Combined.'" Thereforc, 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 specific 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 was advised in a letter dated June 26,1998 (Enclosure), that they must discontinue their program of advising their customers to combine exempt quantity sources.
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 licensee's, BSI must have its general distribution license amended also.
In an application dated Januar/10,1998, BSI requested a specific license pursuant to I}
10 CFR 32.18 to distribute exempt quantities of specified byproduct material to persons exempt from licensing under 10 CFR 30.18. However, after a meeting with NRC on June 22,1998, BSI changed its application to request both an amendment of their license to manufacture and distribute the above device as a generally licensed device and to request a NRC device registry review for the above device.
9807170173 980715*
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R. Unetich > '
l To distribute a generally licensed gauging device pursuant to 10 CFR 31.5, the requirements in
, 10 CFR 32.51 must be met. Based on our initial review of BSl's application they must submit sufficient information relating to the design, manufacture, prototype testing, quality control, i labels, proposed uses, installation, servicing. leak testing, operating and safety instructions, and
. potential hazards of the device.
l . At this time, BSI devices already in use having muItiple exempt quantities of byproduct material i may continue to be used. NRC does not plan to take any action with respect to these dedas
. : or users unless a radiological safety hazard is identified. As discussed on June 23,1998, NRC L will allow BSI to continue to distribute devices having multiple exempt quantities of byproduct h material for a period of 60 days following the June 26,1998, letter.
L NRC plans to perform a risk assessment to determine if there are any public safety concerns 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 thwe devices to persons exempt from licensing.- It is antici9ated that the risk assessment and rulemaking process will take 2 to 3 years.
Sincerely,
! MM%
SlovenLBagpt Steven L. Baggett, Deputy Chief Materials Safety Branch -
L Division of Industrial and Medical Nuclear Safety
. Office of Nuclear Materials Safety and Safeguards cc:
Berthold Systems, Inc.-
ATTNi G.M. (Bud) Smith President 101 Corporate Drive U ' Aliquippa, Pennsylvania .15001 DISTRIBUTION NRC Fue Room IMNS r/f PDR NEol 2-SS
' SSD 98-76 TCombs w/ incoming DOCUMENT MAME: H:\EXEMPTi32.18\lNFoLTRs\BENFRANK.WPD 'See previous concurrence C = COVER E = COVER & ENCLOSURE N = NO COPY OFC MSB.NMSS* C' MSB.NMSS* C NAME ~ASKirkwood:ssk' SLBaggett oATE "07/14/98 07/14/98
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l R. Unetich l I To distribute a generally licensed gauging device pursuant to 10 CFR 31.5, the requirements in l 10 CFR 32.51 must be met. Based on our initial review of BSI's application they must submit sufficient information relating to the design, manufacture, prototype testing, quality control, l labels, proposed usas, installation, servicing, leak testing, operating and safety instructions, and t
potential hazards of the device.
l At this time, BSI devices already in use having multiple exempt quantities of byproduct rnaterial may continue to be used. NRC does not plan to take any action with respect to these devices l or users unless a radiological safety hazard is identified. As discussed on June 23,1998, NRC
- will allow BSI to continue to distribute devices having multiple exempt quantities of byproduct material for a period of 60 days following the June 26,1998, letter.
NRC plans to perform a risk assessment to determine if there are any public safety concerns i with these devices and whether any further action is warranted. If the risk assessment
- l. 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 l assessment and rulemaking process will take 2 to 3 years.
i l
i Sincerely, Steven L. Baggett, Deputy Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety l and Safeguards l cc:
Berthold Systems, Inc.
ATTN: G.M. (Bud) Smith President 101 Corporate Drive Aliquippa, Pennsylvania 15001
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DISTRIBUTION NRC File Room IMNs r/f PDR TEM"#7 DOCUMENT NAME: H:\ExEMPTl32.18\lNFoLTRs\BENFRANK.WPD C = COVER E = COVER & ENCLOSURE N = NO COPY OFC- MSB NMSS C MSB NMSS lb NAME' ASKirkww! ask d SLBagg tt DATE 07/ { eg 07/ 7 /98 OFFICIAL RECORD COPY