United States Nuclear Regulatory Commission - Protecting People and the Environment

Distribution of Gems Irradiated in Research Reactors (Generic Letter No. 88-04)

                                UNITED STATES
                           WASHINGTON, D.C. 20555

                              February 23, 1988



          LETTER 88-04; SEE ALSO GENERIC LETTER 86-11, DATED JUNE 25, 1986) 

On June 25, 1986, we notified you that research reactor licensees might be 
irradiating and distributing products containing induced radioactivity to 
unlicensed persons in violation of NRC regulations. We noted that 10 CFR 
Section 30.14 prohibits introduction of byproduct material into a product 
for distribution to an unlicensed person, unless the distributor has a 
specific license issued pursuant to 10 CFR Section 32.11 which permits such 
distribution. We also noted that due to a long-standing policy against 
radioactive toys, novelties, and adornments, the staff has not granted 
licenses for distribution of irradiated gems or similar materials. 

Throughout 1986 and 1987, we have received numerous inquiries from licensees
and others, requesting that NRC take a definitive position with respect to 
neutron-irradiated gems such as topaz. These persons reported that large 
quantities of irradiated topaz are on the United States retail market from 
both foreign and domestic sources. They requested that, in the interest of 
fairness and consistency, as well as protection of the public health, NRC 
expeditiously resolve the issue. 

Applications will now be considered for interim licenses authorizing the 
distribution of neutron-irradiated gems, particularly topaz, to unlicensed 
persons pursuant to 10 CFR Section 32.11. The NRC will also develop a policy
which recognizes the existence of radiation doses and risks which are too 
low to justify regulation to protect public health and safety. Based on this
policy, specific regulations will be developed for classes of radioactive 
materials such as irradiated gems. The interim licenses, if granted, will 
not be subject to the prohibition against distribution of products intended 
for application to a human being. However, license applications must meet 
the other requirements of 10 CFR Sections 32.11, 30.14, and 30.70. The 
radioactivity concentration limit for any single radionuclide is given in 
Schedule A of 10 CFR Section 30.70. The limit applicable for multiple 
radionuclides may be calculated using the method specified in Note 2 of 10 
CFR Section 30.70. 

The interim licenses will authorize distribution of cut, finished gems only,
because the potential for occupational radiation exposures associated with 
cutting and grinding gems is much higher than for normal consumer use. 

License applications must describe the proposed methods for identification 
and measurements of the radionuclides in the gems, and the quality control 
procedures for assuring that all gems released to the public are below the 
limits specified in 10 CFR Section 30.70. 


Multiple Addresses                  -2-

The NRC staff is aware that neutron-irradiated topaz has been imported into 
the United States which contains radioactivity above the limits specified in
10 CFR Sections 30.14 and 30.70. Accordingly, consistent with the 
requirements of 10 CFR Section 32.11, the staff plans to control 
distribution of irradiated gems at the source and, thus, envisions two 
principal groups of applicants for distribution licenses, i.e., domestic 
reactors and initial importers. Both groups will be subject to similar 
regulatory requirements. 

Those reactor licensees who are currently distributing, or intend to 
distribute irradiated gemstones to unlicensed persons must obtain a license 
which specifically authorizes this activity.  Applications for distribution 
licenses should be submitted with proper fee (see 10 CFR Part 170) to: 

               U.S. Nuclear Regulatory Commission 
               Division of Industrial and Medical Nuclear Safety 
               Washington, DC 20555 

Persons (such as secondary distributors and individual consumers) who 
receive gems from an NRC-licensed distributor do not need a license. Only 
the initial distributor in the United States must be licensed pursuant to 10 
CFR Section 32.11. 

This letter is for information only and does not require a response. Those 
persons who are currently irradiating and/or distributing irradiated 
gemstones should immediately contact the NRC Division of Industrial and 
Medical Nuclear Safety to discuss current and planned activities so that a 
determination can be made on the course of action that should be taken. 
Questions concerning NRC distribution licenses may be directed to Michael 
Lamastra (301-492-0639). Questions concerning non-power reactor licenses may
be directed to Lester Rubenstein (301-492-1118). Questions concerning 
license fees may be directed to Glenda Jackson (301-492-8740). 

                                   Frank J. Miraglia, Associate Director
                                     for Projects
                                   Office of Nuclear Reactor Regulation

                                   Richard E. Cunningham, Director
                                   Division of Industrial and
                                     Medical Nuclear Safety
                                   Office of Nuclear Material
                                     Safety and Safeguards
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