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Home       > Electronic Reading       Room >       Document       Collections >       Generic       Communications >       Generic       Letters >       1999       > GL99001

UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE       OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

May 3, 1999
NRC GENERIC LETTER 99-01:RECENT NUCLEAR MATERIAL SAFETY AND SAFEGUARDS DECISION             ON BUNDLING EXEMPT QUANTITIES- Addressees:          
- Purpose: 
- Discussion: 
Addressees: 
All materials licensees.
Purpose:
The U.S. Nuclear Regulatory Commission is issuing this generic letter       to notify addressees about a recent Office of Nuclear Material Safety and       Safeguards decision concerning 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 sources; and       (c) the possession and use of bundled exempt sources, in unregistered       devices, by persons exempt from 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 possesses, uses, transfers, owns, or acquires       byproduct material in 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 manufacture, 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 commercial       distribution.

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 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.

Based upon a thorough reexamination, including discussions with       Agreement States to ascertain their perspectives, NRC 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, 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. The labeling       requirements in 10 CFR 32.19, which address shipments 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 ". .       . 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 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 byproduct material.

At this time, devices already in use, having multiple exempt quantities       of byproduct material, may continue to be used. NRC does not plan to take       any action regarding these devices or 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 warning labels bearing the standard       radiation warning symbol and standard magenta (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.

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.
/s/'d by             
Donald A. Cool, DirectorDivision of Industrial and                Medical Nuclear SafetyOffice 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 Letters
      (NUDOCS Accession Number 9904290155)       
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