ML20236V026
| ML20236V026 | |
| Person / Time | |
|---|---|
| Issue date: | 07/27/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hyer R TN TECHNOLOGIES, INC. (FORMERLY TEXAS NUCLEAR CORP.) |
| Shared Package | |
| ML20236V029 | List: |
| References | |
| SSD, NUDOCS 9807310250 | |
| Download: ML20236V026 (4) | |
Text
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
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..... July 27, 1998 TN Technologies ATTN: Ralph S. Hyer, Radiation Safety Officer and Manager of Regulatory Affairs 2555 North Interstate Highway 35 Post Office Box 800 Round Rock, Texas 78680-0800
Dear Mr. Hyer:
Your letter dated March 31,1998, expressed your concern that exempt quantities of radioactive material were being distributed in industrial gauging devices with exempt quantities above the !
regulatory limits. In confirmation of your concern, a reexamination of 10 CFR 30.18, " Exempt Quantities," has determined that combining of exempt sources is inconsistent with the regulations pursuant to 10 CFR 30.18,32.18,32.19 and 32.20.
The U.S. Nuclear Regulatory Commission (NRC), Office of the General Counsel has determined that the NRC position that was transmitted in a June 3,1994, letter to another gauge distributor was in error. Because the exem.otion 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, gauge manufacturer's instructions to customers to install sources in gauges 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 the \
radioisotope and the quantity of radioactivity, and in addition to that information, "shall also \
l bear the words . ' Exempt Quantities Should Not 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 tc 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 discourage, grouping exempt quantities of byproduct material.
Authorized licensees may distribute these devices to specific or general licensees. However, in order to do so, they must have their device designs evaluated and registered with the NRC or an Agreement State. In addition, to distribute a generally licensed gauging device pursuant to 10 CFR 31.5, the requirements in 10 CFR 32.51 must be met. An applicant must 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. .
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R. Hyer At this time, NRC does not plan to take any action regarding devices already in use having multiple exempt quantities of byprotect material unless a radiological safety hazard is identified. In addition, as of the date of this letter, NRC will allow BSI and Ronan, companies that have been distributing these types of devices, to continue to distribute devices designed to incorporate multiple exempt quantities of byproduct material until August 25 and 29,1998, respectively.
NRC plans to perform a risk assessment to determine if: 1) the bundling of exempt quantities I in gauging devices, and the distribution of these devices to persons exempt from licensing, is I acceptable without the imposition of regulatory controls, 2) if there are any other public safety )
concerns with these devices, and 3) 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.
Sincerely,
/,, j
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Steven L. Baggett, Deputy Chief l Materials Safety Branch ,
Division of Industrial and l Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards cc: JLubenau, NRC, OCM/GJD 2
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July 27, 1998 TN Technologies ATTN: Ralph S. Hyer, ;
Radiation Safety Officer and i Manager of Regulatory Affairs 2555 North Interstate Highway 35 Post Office Box 800 Round Rock, Texas 78680-0800
Dear Mr. Hyer:
Your letter dated March 31,1998, expressed your concern that exempt quantities of radioactive !
material were being distributed in industrial gauging devices with exempt quantities above the regulatory limits, in confirmation of your concern, a reexamination of 10 CFR 30.18, " Exempt Quantities," has determined that combining of exempt sources is inconsistent with the regulations pursuant to 10 CFR 30.18,32.18,32.19 and 32.20.
The U.S. Nuclear Regulatory Commission (NRC), Office of the General Counsel has determined that the NRC position that was transmitted in a June 3,1994, letter to another i gauge distributor was in error 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, gauge manufacturer's instructions to customers to install sources in gauges 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 the ,
radioisotope and the quantity of radioactivity, and in addition to that information, "shall also bear the words .. ' Exempt Quantities Should Not 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 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 discourage, grouping exempt quantities of byproduct material.
Authorized licensees may distribute these devices to specific or general licensees. However, in order to do so, they must have their device designs evaluated and registered with the NRC or an Agreement State. In addition, to distribute a generally licensed gauging device pursuant i i to 10 CFR 31.5, the requirements in 10 CFR 32.51 must be met. An applicant must 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.
j
9 R. Hyer At this time, NRC does not plan to take any action regarding devices already in use having multiple exempt quantities of byproduct material unless a radiological safety hazard is identified. In addition, as of the date of this letter, NRC will allow BSI and Ronan, companies that have been distributing these typen of devices, to continue to distribute devices designed to incorporate multiple exempt quantities of byproduct material until August 25 and 29,1998,
- respectively.
NRC plans to perform a risk assessment to determine if; 1) the bundling of exempt quantities in gauging devices, and the distribution of these devices to persons exempt from licensing, is acceptable without the imposition of regulatory controls, 2) if there are any other public safety concerns with these devices, and 3) 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 Jevices to persons exempt from licensing. It is anticipated that the risk assessment and rulemaking process will take 2 to.3 years.
Sincerely, (orig,signedby)
Steven L. Baggett, Deputy Chief Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards cc: JLubenau, NRC, OCM/GJD DISTRIBUTION NRc File Room IMNS r/f PDR 9 NEO-2-sSD-6 SSD 98-76 TCombs w/ incoming DOCUMENT NAME: H:\ EXEMPT \32.18\lNFoLTRs\RHYER.WP3 C = COVER / E = COVER & ENCLOSURE N = NO COPY OFC MsB NMsS [ C MSB.NM '
C NAME ASKirkwood:ask SLBaggett DATE 07 /98 07/ 19 8 OFFICIAL RECORD COPY l
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