ML20210G247
| ML20210G247 | |
| Person / Time | |
|---|---|
| Issue date: | 07/26/1999 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hallisey R CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS |
| References | |
| GL-99-01, NUDOCS 9908030042 | |
| Download: ML20210G247 (9) | |
Text
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UNITED STATES g
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NUCLEAR REGULATORY COMMISSION 4
WASHINGTON, D.C. 20666-0001 July 26, 1999 Mr. Robert Hallisey, Chairperson Conference of Radiation Control Program Directors, Inc.
4 Office of Executive Director 205 Capital Avenue Frankfor1, Kentucky 40601
Dear Mr. Hallisey:
In a letter dated February 2,1998, Mr. Steven Baggett informed Dr. Jill Lipoti, then Chairperson of the Conference of Radiation Control Program Directori, !nc. (CRCPD), that the U.S. Nuclear 4
Regulatory Commission (NRC) would be completing a reexaminat;on of 10 CFR 30.18, " Exempt Quantities," and would notify the CRCPD of its conclusions. This letter provides the status of i
NRC's reexamination of 10 CFR 30.18.
As you may know, on June 3,1994, NRC determined that, under certain limited circumstances, bundling of exempt sources did not present a health and safety hazard. However, early in 1998, NRC received a request for permission to distribute an increased number of bundled sources for use in similar devices. As a result, NRC became concerned that the individual numbers of exempt sources bundled in such devices would reach some point where a general or specific license would normally be required. In the case where the bundled exempt sources remained exempt, NRC would have no mechanism to ensure their safe possession, use, and disposal.
NRC learned that two vendors had distributed gauging devices capable of containing multiple exempt quantities of byproduct material to persons exempt from licensing. In June of last year, shortly after our contacts with both vendors advising them no+ to continue distributing their devices to exempt persons, trmy agreed to only distribute these devices to general licensees. At
'l that time, NRC decided not to take ar.y action regarding devices already in use unless a radiological safety hazard was identified. Both of these vendors, one located in Pennsylvania and the other in Kentucky, have obtained licenses to distribute their devices as generally licensed gauges.
However, NRC decided to remind all of its materials licensees of our exempt distribution licensing requirements and to indirectly inform persons exempt from all licensing requiremer,ts
.h of our recommendations about devices utilizing multiple exempt sources. Generic y
Letter 99-01 (GL 99-01), *Recent Nuclear Material Safety and Safeguards Decision on Bundling Exempt Quantities,'" dated May 3,1999 (Enclosed), has now been issued indicating that NRC does not authorize the distribution of bundled exempt sources or any devices designed to use bundled exempt sources to persons exempt from licensing. In addition, in separate communications to the two known manufacturers of these devices, NRC asked them to send l
copies of the Generic Letter to their exempt customers who had received their devices.
g6Whh5 9908030042 990726 ea
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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 May 3,1999 NRC GENERIC LETTET 99-01: RECENT NUCLEAR MATERIAL SAFETY AND SAFEGUARDS DECISION ON BUNDLING EXEMPT QUANTITIES Addressees: All materials licensees.
i
Purpose:
1 The U.S. Nuclear Regulatory Commission (NRC) is issuing this generic letter to notify addressees about a recent Office of Nuclear Material Safety and Safeguards decision conceming bundling exempt quantities. NRC does not authorize: (a) the bundling of exempt
]
quantities of byproduct material; (b) any program advising persons to combine exempt quantity j
sources; and (c) the possession and use of bundled exempt sources, in unregistered devices, j
by persons exempt froai licensing. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate. However, no specific action nor written response is required.
Discussion:
The NRC regulations that exempt any person from the requirements for a license for byproduct material are found in 10 CFR 30.18. A person is exempt from licensing requirements to the extent that such a person pnssesses, uses, transfers, owns, or acquires byproduct materialin individual quantities, each of which does not exceed the applicable quantity in 10 CFR 30.71, Schedule B (i.e., an " exempt quantity"). A person wishing to commercially distribute or initially transfer products containing byproduct material, such as exempt quantity check sources, to persons exempt from licensing, must obtain an exempt distribution license from NRC.
To obtain an exempt distribution license from NRC, product information must be submitted as outlined in 10 CFR Part 32 and, specifically, for exempt quantities, as outlined in 10 CFR 32.18, 32.19, and 32.20. In addition, pursuant to 10 CFR 32.18(c), NRC will not approve a license to manuf acture, process, produce, package, repackage, or transfer quantities of byproduct material to persons exempt, pursuant to 10 CFR 30.18, if the exempt quantities are incorporated into any manufactured or assembled commodity, product, or device intended for commercia! distribution.
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O GL 99-01 May 3,1999 Page 2 of 3 Several years ago staff became aware of the bundling of a limited number of exempt quantity sources in gauging devices. On June 3,1994, NRC determined that, under certain limited circumstances, bundling of exempt sources did not present a health and safety hazard.
However, recently NRC has received requests for permission to distribute an increased number of bundled sources in similar devices. As a result, NRC became concemed that the individual numbers of exempt sources bundled in such devices would reach some point where a general or specific license would normally be required. In the case where the bundled exempt sources remained exempt, NRC would have no mechanism to ensure their safe possession, use, and disposal.
Based upon a thorough reexamination, including discussions with Agreement States to ascertain their perspectives, NRU now has determined that combining any exempt sources is inconsistent with the regulations, pursuant to 10 CFR 30.18,32.18,32.19, and 32.20.
Instructing persons exempt from licensing to combine exempt quantities, and providing devices for them to do so, is in direct conflict with NRC's requirements for labeling of exempt sources.
Section 32.19 specifically instructs persons not to combine exempt quantities, since the exemption provided in 10 CFR 30.18 is applicable only as long as no individual nor discreet quantity of the byproduct materials exceeds the quantity limits specified in 10 CFR 30.71, i
Schedule B, and as l'ng as the quantities set out in that schedule are originally received and remain separate and distinct from other quantities of exc.pt byproduct materials. The labeling requirements in 10 CFR 32.19, which address rhipments to exempt persons, instruct 10 CFR 32.18 licensees to label the "immediate container" with information identifying the radioisotope and the quantity of radioactivity, and in addition to that information, the container l
".. shall also bear the words... ' Exempt Quantities Should Not Be Combined.'" Therefore, although the exemption in 10 CFR 30.18 provides for persons without a license to possess and I
use a wide variety of byproduct materials, and to possess and use specific byproduct materials without restriction as to the total quantity that may be possessed and used at any one time, the regulations do not authorize, but rather discourage, grouping exempt quantities of i
byproduct material.
At this time, devices already in use, having multiple exempt quantities of byproduct material, l
may continue to be used. NRC does not plan to take any action regarding these devices or l
users unless a radiological safety hazard is identified. However, persons possessing such devices should maintain control and account for these devices and the exempt sources contained within them. To this end, it is good practice to clearly label the devices with radioactive materials waming labels bearing the standard radiation waming symbol and standard msgenta (or purple) and yellow colors. Additionally, it is preferable to not dispose of devices containing multiple exempt sources through ordinary commercial waste disposal or metal recycling channels because of the presence of bundled radioactive material. If devices containing sources are no longer needed, the supplier should be consulted for advice regarding proper disposal options.
I
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l GL 99-01 May 3,1999 Page 3 of 3 NRC plans to further evaluate the risks associated with' these devices. After this evaluation, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of
- these devices and assure the protection of the public health and safety and with consideration
. of property protection. It is anticipated that the evaluation and rulemaking process, if undertaken, will take 2 to 3 years.
if you have any questions about this matter, please call the technical contact listed below or the appropriate regional office.
Donald A. Cool, Director Division of Industrial and j
Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Contact:
Anthony S. Kirkwood, NMSS
.(301) 415-6140.
E-mail: ask@nrc. gov
Attachment:
List of Recently issued NRC Generic Letter's.
)
Attachment GL 99-01 May 3,1999 w
Page 1 of 1 LIST OF RECENTLY ISSUED GENERIC LETTERS GENERIC DATE OF LETTER SUBJECT ISSUANCE ISSUED TO 98-01, Supp.1 Year 2000 Readiness of Computer 1/11/99 All holders of operating li Systems at Nuclear Power Plants licenses for nuclear power Plants, except those who have permanently ceased operations and have certified i
that fuel has been permanently removed from the reactor vessel.
98-05 Bol ling Water Reactor Licensees 11/10/98 All holders of operating Use of the BWRVIP-05 Report licenses (or construction To Request Relief From Augmented parmits) for BWRs, except Examination Requirements on Reactor those who have permanently Pressure Vessel Circumferential Shell ceased operations and have Welds certified that fuel has been permanently removed from the reactor vessel.
98-04 Potential for Degradation of the 07/14/98 All holders of operating Emergency Core Cooling System licenses for nuclear power And the Containment Spray System reactors, except those who After a Loss-of-Coolant Accident have permanently ceased Because of Construction and operations and have certified Protective Coating Deficiencies that fuel has been and Foreign Materialin Containment p6Tnanently removed from the reactor vessel.
98-03 NMSS Licensees' and Certificate 06/22/98 Alllicensees or certificate Holders' Year 2000 Readiness holders for uranium Programs hexafluoride production plants, uranium enrichment plants, and uranium fue!
fabrication plants, except those that have permanently ceased operations OP = Operating License CP = Construction Permit NPR = Nuclear Power Reactors i
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R, Hallisey e NRC plans to determine if: 1) the bundling of exempt quantities in gauging devices, and the distribution of these devices to persons exempt irom licensing, is acceptable without the imposition of regulatory controls, 2)if there are any other public safety concems with these devices, and 3) whether any further action is warranted. If the 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 assessment and rulemaking process, if indicated, wi'l take 2 to 3 years.
Sincerely, l
i
/
Donald A Cool, Director
/
Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety '
and Safeguards
/
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Enclosure:
As stated cc:
Stanley R. Marshall, OAS Rita Aldrich, NY Donald Flater, IA C. Hardin, CRCPD J. Lipoti, NJ R. Hallisey, MA Distribution NRC Central Fi!s IMNs r/f NMss r/f Fsturz TCombs/OCA PLohaus/OSP PDR-Yes DOCUMENT NAME: HAEXEMPT\\32.18MNFOLTRs\\CRCPD9.WPD
- see previous concurrence
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To rea"Ivo a copy of this doeurnent, indicate in the box: "C" = Copy without attachrruent' enclosure
- E" = Copy with at achnwn enclosure
- N" - No copy OFFICE MSB l -lMSB l
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IMNS l
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NAME ASKirkwood ask/ce
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- SATreby FCCombs DATE 7/24198 7/27 /98 40 #Jbf'l 8/ 5 /98 f/ 7/99 5/ /09 OFFICE IMNSI
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OFFICIAL RECORD COPY h
p R, Hallisey 2-NRC plans to further evaluate the risks associated with these devices. After this evaluation, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of these devices and assure the protection of the public health and safety and with consideration of property protection it is anticipated that the evaluation and rulemaking process, if u1dertaken, will take 2 to 3 years.
Sincere y, 4
Donald A Cool, Director Division of Industrial and Medical Nuclear Gafety j
Office of Nuclear Material Safety and Safeguards 1
Enclosure:
As stated cc:
Stanley R. Marshall, OAS Rita Aldrich, NY Donald Flater, IA C. Hardin, CRCPD J. Lipoti, NJ R. Hallisey,MA Distribution:
NRC Central File IMNsr#
NMss r#
Fsturz TCombs/OCA PLohaus/OsP PDR-Yes DOCUMENT NAME: H:\\ EXEMPT \\32.18\\lNFOLTRs\\CRCPD10.WPD
- see previous concurrence T3 receive a copy of this docun' et. Indicate in the box:
"C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE Ms0 l
l MSS l
MsB
[Cl OGC IMNs l
l NAME ASKirkwood:ask/ce
- sLBeggett &
Camper '
SATreby FCCombs DATE 7/24 /98 7/27 /98 8/ 5 /98 7/ /99 7/ /99 OFFICE IMNS l
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l ll NAME DACool DATE 7/
/90 ll OFFICIAL RECORD COPY l
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J. Lipoti, Ph.D.
2 I
Gauging devices containing multiple exempt quantities of byproduct material may still be distributed to specific or general licensees provided that the device design is evaluated and registered with the NRC or an authorized Agreement State and provided the vendor is authorized to distribute the device by a specific license. For example, if the device is distributed to a general licensee, the distributor must have a valid manufacturing and distribution license obtained from 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.
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 devices to persons exempt from licensing. It is anticipated that the risk assessment and rulemaking process will take 2 to 3 years.
j Sincerely, i
Frederick C. Comos, Acting Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards cc: Roland Fletcher, OAS Rita Aldrich, NY Donald Flater, IA G.M. Smith, BSI B. Cahill, Renan V. Jeffs, KY C. Hardin, CRCPD Distribution: Closes IMNs-6099 NRC Central File IMNS r/f NMs3 r/f TCombs/OCA RBangart/OsP PoR oOCUMENT NAME: AllPOTI.AsK
- see previous concurrence
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Ta receive a copy of this document, indicate in the box: "C" = Copy without attachment /erMsure
- g* = Copy with attachment / enclosure "N" = No copy OPflCE MSB l
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OGC NAME ASKirkwood ask/ce
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DATE 7/24 /98 7/27 198 g798' 8/ /93 8/ S8 OFFICE l
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e J. Lipoti, Ph.D.
2 At this time, NRC does not plan to take any act. ion regarding devices already in use beving multiple exempt quantities of byproduct material unless a radiological safety hazardfs d
identified. In addition, as of the date of this letter, NRC will abw BSI and Ronang ompanies that have been distributing these types of devices, to continue to distribute devjces designed to incorporate multiple exempt quantities of byproduct material until August 25 arid 29,1998, respectively.
i NRC plans to perform a risk assessment to determine if: 1) the bundlin of exempt quantities in gauging devices, and the distribution of these devices to rarsons eyempt from licensing, is acceptable without the imposition of regulatory controls, 2) If there,pfe 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 inIi the distribution of these devices to persons exempt from licensing. ate rulemaking to It is anticipated that the risk assessment and rulemaking process will take 2 to 3 years Sincerely, l
FrederickC. Combs, Acting Director Division'of industrial and Mejffcal Nuclear Safety Office of Nuclear Material Safety and Safeguards cc: Roland Fletcher, OAS Rita Aldrich, NY Donald Flater, IA G.M. Smith, BSI B. Cahill, Ronan j
V. Jeffs, KY C. Hardin, CRCPD Distribution: Clos'e IMNS-6099 NRC Central File /
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DOCUMENT NAME: H:)EXE M PTT32.18\\l N FOLTRS\\C RC PD.AS 1 i
Te receive e copy of this document / indicate in the box: 'C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
- N" = No copy OFFICE MSB
/
lc MSB l (, MSB lC RAG iMNS NAME' ASKiridvood:ask/ce SBaggett LCamper JPiccone FCCombs DATE 7/A4 /98 A
7/ 77 /9 8 7/
/98 7/ /98 7/ /98 OFFICE ISP OGC NAME / RBangart STreby DATE/
7/ /98 7/ /98 ll OFFICIAL RECORD COPY i
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=
1 Robert Hallisey Chairperson Conference of Radiation Control j
Program Directors, Inc.
1 Office of Executive Director 205 Capital Avenue
)
Frankfort, Kentucky 40601 J
l
Dear Mr. Hallisey:
In a letter dated February 2,1998, Mr. Steven Baggett informed Dr. Jill Lipoti, then Chairperson
)
of the Conference of Radiation Control Program Directors, Inc. (CRCPD), that the U.S. Nuc! ear Regulatory CommisLion (NRC) would be completing a reexamination of 10 CFR 30.18, " Exempt j
Ouantities," and would notify the CRCPD of its conclusions. This letter provides the status of NRC's reexamination of 10 CFR 30.18.
As you may know, on June 3,1994, NRC determined that, under certain limited circumstances, bundling of exempt sources did not present a health and safety hazard. However, early in 1998, NRC received a request for permission to distribute an increased number of bundled sources for use in similar devices. As a result, NRC became concerned that the individual numbers of exempt sources bundled in such devices would reach some point where a general
]
or specific license would normally be required. In the case where the bundled exempt sources remained exempt, NRC would have no mechanism to ensure their safe possession, use, and disposal.
f NRC learned that two vendors had distributed gauging devices capable of containing multiple exempt quantities of byproduct material to persons exempt from licensing. In June of last year, shortly after our contacts with both vendors advising them not to continue distributing their devices to exempt persons, they agreed to only distribute these devices to general licensees.
At that time, NRC decided not to take any action regarding devices already in use unless a radiological safety hazard was identified. Both of these vendors, one located in Pennsylvania
)
. and the other in Kentucky, have obtained licenses to distribute their devices as generally 1
licensed gauges.
However, NRC decided to remind all of its materials licensees of our exempt distribution liceasing requireme;as and to indirectly inform persons exempt from all licensing requirements j
of our recommendaticrs about devices utilizing multiple exempt sources. Generic Letter 99-01 (GL 99-01), "Recent Nuclear Material Safety and Safeguards Decision on Bundling Exempt Quantities," dated May 3,1999 (Enclosed), has now been issued indicating that NRC does not authorize the distribution of bundled exempt sources or any devices designed to use bundled exempt cources to pemons exempt from licensing. In addition, in separate j
communications to the two known manufacturers of these devices, NRC asked them to send copies of the Generic Letter to their exempt customers who had received their devices.
R, Hallisey,.
)
NRC plans to further evaluate the risks associated with these devices following the completion of a current risk analysis on all exempt products. After our evaluations, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of these devices and assure the protection of the public health and safety and with consideration of property protection it is anticipated that the evaluations and rulemaking process will take 2 to 3 years.
Sincerely,
[ orig signed by]
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
Enclosure:
As stated cc: Stanley R. Marshall, OAS Rita Aldrich, NY Donald Flater, IA Charles Hardin, CRCPD Jill Lipoti, NJ 1
oistribution:
NRC Central File IMNS r/f NMSS r/f FSturz TCombs/OCA PLohaus/OSP PDR-Yes DOCUMENT NAME: G:\\KIRKWOOD\\CRCPD11.WPD
- See previous concurrence 7h88fb Ta receive e copo of this document, ind6cate in the box: "C" = Copy without attachment / enclosure "E" = Copy w,th attachmeetienclosurn
N" = No copy OFFICE MSB l
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l MSB lC OGC NAME ASKirkwood.asA/ce *
- "___^*
Camper
- SATreby
- DATE 7/24 /98
-7Aa7-44 8/ 5 198 7/08 /99 OFFICE IMNS l
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NAME DAC'oT,//p/f DATE 7/ 2'r 199 OFFICIAL RECORD COPY
R, Hallisey NRC plans to further evaluate the risks associated with these devices following the completion of a current risk analysis on all exempt products. After our evaluations, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of these devices and assure the protection of the public health and safety and with consideration of property protection. It is anticipated that the evaluations and rulemaking process will take 2 to 3 years.
Sincerely,
[ orig. signed by]
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety j
Office of Nuclear Material Safety and Safeguards
]
Enclosure:
As stated cc: Stanley R. Marshall, OAS Rita Aldrich, NY Donald Flater, IA Charles Hardin, CRCPD Jill Lipoti, NJ Distribution-NRC Central Filo IMNs r/f NMSS r/f Fsturz TCombs/OCA PLohaus/OSP PDR-Yes DOCUMENT NAME: G:\\KIRKWOOD\\CRCPD11.WPD
- see previous concurrence 7[.28/'/I Ta receive e copo of thie document, Indicate in the box "C" = Copy without attachment /enclostre "E" = Copy with attr.chment/enclostne "N" = No copy OFFICE MSB l
MSS l
MsB lC OGC NAME ASKirkwood ask/ce
- Camper
- SATreby *
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DATE 7/24 /98
-#aF-4s 8/ 5 /98 7/08 199 OFFICE IMNs l
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l NAME DACoiC//)f [
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DATE 7/ 24 /99
~
OFFICIAL RECORD COPY L.._
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j R. Hallisey NRC plans to further evaluate the risks associated with these devices following the completion of a current risk analysis on all exempt products. After our evaluations, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of these devices and assure the protection of the public health and safety and with consideration of property protection. It is anticipated that the evaluations and rulemaking process will take 2 to 3 years.
Sincerely, s
&kfhk,f4[
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc: Stanley R. Marshall, OAS Rita Aldrich, NY Donald Flater, IA Charles Hardin, CRCPD Jill Lipoti, NJ t
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