Information Notice 2009-12, Exempt Distribution Licensing Requirements for Irradiated Gemstones
| ML091190196 | |
| Person / Time | |
|---|---|
| Issue date: | 07/27/2009 |
| From: | Robert Lewis NRC/FSME/DMSSA |
| To: | |
| Dimmick, L FSME/MSSA/LB (301) 415-7833 | |
| References | |
| IN-09-012 | |
| Download: ML091190196 (10) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555
July 27, 2009
NRC INFORMATION NOTICE 2009-12:
EXEMPT DISTRIBUTION LICENSING
REQUIREMENTS FOR IRRADIATED
GEMSTONES
ADDRESSEES
All holders of NRC exempt distribution licenses authorized to distribute irradiated gemstones.
Organizations associated with importing, distributing or selling irradiated gemstones or jewelry
containing irradiated gemstones. All Radiation Control Program Directors and State Liaison
Officers.
PURPOSE
The U.S. Nuclear Regulatory Commission is issuing this information notice (IN) to: 1)
emphasize the NRC requirements governing the import into and initial distribution within the
U.S. of irradiated gemstones containing byproduct material, and 2) emphasize that after the
initial distribution of irradiated gemstones under an exempt distribution license, subsequent
distributions (including export) are not subject to any other licensing or regulatory restriction.
It is expected that licensees, importers, and distributors will review this information and assure
that they comply with applicable requirements. No specific action or written response is
required.
DESCRIPTION OF CIRCUMSTANCES
Irradiated gemstones fall within the jurisdiction of the Nuclear Regulatory Commission (NRC or
Commission) pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Policy
Act of 2005. The process of enhancing the gemstones color through bombardment with either
neutrons or electrons can induce radioactivity in the gemstones, making the gemstones slightly
radioactive. The initial distribution of these gemstones within the U.S. is required to be by NRC
licensed distributors pursuant to 10 CFR Parts 30 and 32. The initial distributors are required to
conduct radiological surveys of each batch of gemstones to ensure that any residual
radioactivity is below regulatory limits prior to being made available to the general public.
In a July 28, 1987, Commission Paper (SECY-87-186), NRC staff requested Commission
direction on how to apply certain regulations in 10 CFR Parts 30 and 32 pertaining to the
distribution of irradiated gemstones. In particular, the NRC staff had questions about how to
apply 10 CFR 32.11, which establishes criteria for granting a specific NRC license to initially
transfer certain products containing byproduct material; and 10 CFR 30.14, which grants an
exemption from this license requirement to persons transferring products containing byproduct
material not exceeding the concentrations listed in 10 CFR 30.70. The NRC staff also had
questions regarding 10 CFR 32.11(c), which requires that an applicant who intends to introduce
exempt quantities of byproduct material into products (or transfer such products) provide
reasonable assurance that the product is not likely to be incorporated in any other product
designed for application to a human being.
In a November 24, 1987, memorandum to staff (follow-up to SECY-87-186), the Commission
directed the staff to issue interim exempt distribution licenses to distributors of irradiated
gemstones, and to grant exemption to the requirements of 10 CFR 32.11(c), while developing a
policy statement based on the level of risk. The conditions of the exempt distribution license
required that the licensee meet other requirements of 10 CFR 32.11, 30.14, and 30.70.
On September 25, 1990, the NRC issued Information Notice No. 90-62, Requirements for
Import and Distribution of Neutron-Irradiated Gems, to remind U.S. distributors of gemstones, including importers, of long-standing NRC requirements in 10 CFR Part 30 governing U.S.
distribution, and 10 CFR Part 110 governing the import (and distribution) of neutron-irradiated
gems, and to provide information on the NRCs planned actions on unauthorized activities.
The NRC issued a number of exempt distribution licenses for irradiated gemstones in the late
1980s and early 1990s, but, by 2001, all had expired.
BACKGROUND
In August of 2005, the Energy Policy Act of 2005 expanded the definition of byproduct material
to include material made radioactive in particle accelerators and produced, converted, or
extracted for commercial, medical, or research activities. The NRC published its final rule on
regulations implementing this expanded jurisdiction on October 1, 2007, with an effective date of
November 30, 2007 (72 FRN 55864). Rulemaking for the expanded definition of byproduct
material brought irradiated gemstones to the fore again because gemstones irradiated in
particle accelerators are now under NRC jurisdiction.
In 2007, the NRC learned that there were gemstones on the market that were imported and
distributed by a number of companies without an NRC distribution license. Accordingly, the
NRC conducted selected surveys of the inventory in the market and held a public meeting with
industry representatives and other stakeholders to gather more information. In the July 26,
2007, public meeting, NRC staff met with jewelers industry representatives and other
stakeholders to discuss the regulatory requirements for distribution of irradiated gemstones. In
that meeting, industry representatives stated that they were concerned about significant
interruption in providing certain gemstones to the market. At the same time, they expressed
their commitment and willingness to cooperate with the NRC to ensure public health and safety
and to prevent further unauthorized distribution. Subsequently, in November 2007, the NRC
issued licenses to three organizations, and several other applications were pending before the
NRC. In February 2008, the NRC issued a Fact Sheet, Irradiated Gemstones, stating that it
had no reason to believe that irradiated gemstones currently on the United States market are
unsafe. However, the NRC is taking actions to ensure that from this point forward all irradiated
gemstones will be distributed in compliance with NRC regulations.
DISCUSSION
NRC regulations provide exemptions from the requirements for an NRC license to persons who
receive, possess, use, transfer, own or acquire byproduct material in exempt distribution
products. These exemptions are set forth in 10 CFR Part 30, Rules of General Applicability to
Domestic Licensing of Byproduct Material. See, e.g., 10 CFR 30.14, Exempt concentrations,
10 CFR 30.18, Exempt quantities. Exempt distribution products can include silicon chips, electron tubes, resins, check sources, carbon-14 urea capsules, gun-sights and smoke
detectors. Such products are distributed by persons who have a specific NRC license
authorizing such distribution to persons who would not require an NRC license.
Exemptions from licensing requirements are based primarily on the NRCs determination that
the exempted classes of products or types of uses will not constitute an unreasonable risk to the
common defense or security or to public health and safety. These exemptions do not apply to
persons who manufacture, process, produce, incorporate byproduct material into, initially
transfer for sale, or distribute products containing byproduct material.
Generally, distribution of byproduct materialincluding irradiated gemstonesto persons
exempt from NRC regulations can only be made by persons who have a specific NRC license
authorizing such distribution. After the initial distribution of the irradiated gemstones by an
NRC-licensed distributor, the gemstones are no longer regulated. Therefore, subsequent
distributors, jewelers, other retailers and consumers do not need to be licensed by the NRC.
Each NRC-licensed initial distributor of irradiated gemstones is required to ensure that its
gemstones are tested and distributed in accordance with the specifications provided in its
license application. Generally speaking, the licenses provide a safeguard against the possibility
that gemstones reach the market too soon after irradiation. The initial distribution licensee must
perform sophisticated surveys to verify that its gemstones meet NRC requirements. These
specific licenses are issued by the Commission and are referred to as exempt distribution or
E licenses. Persons authorized to initially transfer or distribute these products must also have
a license authorizing the possession or use of radioactive material. If the distributor is in an
Agreement State (one of thirty-six states that have entered into an agreement with the NRC to
regulate certain classes of radioactive materials), the distributor must obtain its possession
license from the Agreement State. Otherwise, NRC will issue the possession license.
The primary regulations applying to the distribution of irradiated gemstones are:
10 CFR 30.14 exempts from the requirements for a license persons to receive, possess, use, transfer, own, or acquire products or materials containing byproduct material provided that the
byproduct material concentrations are not in excess of those specified in 10 CFR 30.70. 10
CFR 30.70 contains a table of exempt concentration levels.
10 CFR 32.11 describes the conditions and requirements necessary to obtain license approval
for the introduction of byproduct material in exempt concentrations into products for transfer to
individual not requiring a license. 10 CFR 32.11(c) requires that the license applicant provide
reasonable assurance that the exempted product is not likely to be incorporated into any other
product designed for application to a human being If the NRC finds that these criteria are met, the NRC will issue an exempt distribution license. 10 CFR 32.12 establishes records and material transfer report requirements associated with the
exempt distribution license licensed under section 32.11, and requires that material transfer
reports, covering transfers made during the calendar year, be submitted to the NRC annually by
January 31 of the following year.
10 CFR 110.27, General license for imports, provides a general license to persons to import
byproduct material if the importer is specifically licensed to possess the material.
Irradiated gemstones meeting the criteria in 10 CFR 30.14 may be distributed/transferred under
an exempt distribution license as specified in 10 CFR 32.11, to others that are not required to
have a license (e.g., wholesalers, retailers, and members of the public).
CONCLUSION
Initial distributors of irradiated gemstones must comply with the NRCs regulatory and licensing
requirements. The NRC maintains the authority to take enforcement action against
unauthorized distribution of irradiated gemstones that contain radiation induced byproduct
material. The NRC is also providing verification of licenses to the U.S. Customs Service.
Importers can distribute irradiated gemstones under the following conditions:
1. The importer possesses a valid NRC or state license to possess the gemstones
containing byproduct material and is authorized to distribute them under an NRC exempt
distribution license; or
2. Gemstones containing byproduct material were previously distributed to U.S and
foreign customers under the terms of a valid NRC exempt distribution license, and
therefore, can subsequently be distributed (including re-import into the U.S.) without
further regulatory control.
Therefore, importers and distributors of irradiated gemstones should consider taking steps to
ensure that the irradiated gemstones have been distributed initially under an NRC exempt
distribution license. Secondary and subsequent distributors and retailers do not need exempt
distribution licenses. To help recipients of this IN comply with NRC import and exempt
distribution regulations, NRC staff strongly recommends consideration of the following with
respect to import documentation for irradiated gemstones:
1. All imported gemstones should be accompanied by clear documentation as to
whether they are irradiated or not.
2. In the United States, only an NRC or State licensee can receive, and only an NRC
distribution licensee can initially distribute irradiated gemstones. Documentation
provided by the supplier should state the U.S. distributor licensee name and NRC license
number.
3. Irradiated gems from U.S. facilities, which may have been exported, may be imported
by non-licensees if they were previously distributed in or from the U.S. under the terms of
an NRC distribution license. Documentation for such re-imports should state the name
of the NRC distribution licensee and NRC distribution license number. A facility
operating license number is not sufficient. 4. Imported gemstones will be subject to checks by the U.S. Customs Service or NRC.
Undocumented gems may be subject to import delays and returned to the foreign
suppliers, pending receipt of proper documentation.
The NRC is aware that irradiated gemstones containing induced radioactivity were distributed
within the U.S. without the required exempt distribution license between 2002 and 2007. NRC
staff conducted radiological surveys of a sample of these gemstone inventories, which revealed
that current inventories of such gemstones in the U.S. presented no health risk. In addition, NRC recognizes that significant time has transpired since these gemstones were irradiated, allowing decay of the induced radioactivity. Therefore, NRC has determined that all gemstones
currently in the U.S., and irradiated prior to November 2007, can be distributed without an
exempt distribution license.
The NRC advises recipients of this IN that willfully acquiring gemstones for distribution in
violation of NRC regulations may result in enforcement action.
CONTACT
This IN requires neither specific action nor written response. If you have any questions about
the information in this notice, please contact the technical contact listed below or the appropriate
regional office.
Robert Lewis, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contacts: Lisa Dimmick
(301) 415-0694
E-mail: Lisa.Dimmick@nrc.gov
Enclosures:
1. List of Recently Issued FSME Generic Communications
2. Frequently Asked Questions Associated with Irradiated Gemstones 4. Imported gemstones will be subject to checks by the U.S. Customs Service or NRC.
Undocumented gems may be subject to import delays and returned to the foreign
suppliers, pending receipt of proper documentation.
The NRC is aware that irradiated gemstones containing induced radioactivity were distributed
within the U.S. without the required exempt distribution license between 2002 and 2007. NRC
staff conducted radiological surveys of a sample of these gemstone inventories, which revealed
that current inventories of such gemstones in the U.S. presented no health risk. In addition, NRC recognizes that significant time has transpired since these gemstones were irradiated, allowing decay of the induced radioactivity. Therefore, NRC has determined that all gemstones
currently in the U.S., and irradiated prior to November 2007, can be distributed without an
exempt distribution license.
The NRC advises recipients of this IN that willfully acquiring gemstones for distribution in
violation of NRC regulations may result in enforcement action.
CONTACT
This IN requires neither specific action nor written response. If you have any questions about
the information in this notice, please contact the technical contact listed below or the appropriate
regional office.
Robert Lewis, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contacts: Lisa Dimmick
(301) 415-0694
E-mail: Lisa.Dimmick@nrc.gov
Enclosures:
1. List of Recently Issued FSME Generic Communications
2. Frequently Asked Questions Associated with Irradiated Gemstones
ML091190196 OFC
MSSA:SMPB
MSSA:LB
MSSA:MSEA
NAME
JDeCicco: sxg6 JFoster
AMcIntosh
JOwens
DATE
05/05/09
05/11/09
04/29/09
05/19 /09 OFC
FSME:MSSA
NAME
BJones
SMagruder, Jr
RLewis
DATE
06/02/09
06/15/09
06/22/09
OFFICIAL RECORD COPY
IN 2009-12 Enclosure 1 List of Recently Issued Office of Federal and State Material
and Environmental Management Programs Generic Communications
Date
GC No.
Subject
Addressees
01/12/09 IN-2008-22 Molybdenum-99 Breakthrough in
Molybdenum-99/Technetium-99m
Generators
All U.S. Nuclear Regulatory Commission
medical, radiopharmacy, molybdenum-99/
technetium-99m generator manufacturers, and
master material licensees authorized to
manufacture or use generators. All Agreement
State radiation control program directors and
State liaison officers.
01/22/09 IN-2009-01 National Response Framework
All holders of operating licenses or certificates
for nuclear power plants, research and test
reactors, independent spent fuel storage
installations, fuel cycle facilities, and
radioactive materials. All holders of operating
licenses for uranium recovery facilities and all
holders of licenses or certificates for the
following types of facilities undergoing
decommissioning: nuclear power plants, research and test reactors, fuel cycle facilities, and uranium recovery facilities.
02/03/09 IN-2009-05 Contamination Events Resulting from
Damage to Sealed Radioactive Sources
During Gauge Dismantlement and
Nonroutine Maintenance Operations
All U.S. Nuclear Regulatory Commission
materials licensees; all Agreement State
Radiation Control Program Directors and State
Liaison Officers.
03/30/09 IN-2009-07 Withholding of Proprietary
Information from Public Disclosure
All current holders of and potential applicants
for licenses, certificates of compliance, permits, or standard design certifications, as
well as any other persons submitting a request
that information be withheld from public
disclosure under the provisions of Title 10 of
the Code of Federal Regulations (10 CFR)
Section 2.390, Public inspections, exemptions, requests for withholding.
04/29/09 RIS-2009-05 Uranium Recovery Policy Regarding: (1)
The Process for Scheduling Licensing
Reviews of Applications for New
Uranium Recovery Facilities and (2) The
Restoration of Groundwater at Licensed
Uranium In-Situ Recovery Facilities
All holders of operating licenses for uranium
recovery facilities and all companies who have
submitted applications to construct new
uranium recovery facilities of all types
(conventional mills, heap leach operations, and
in-situ recovery facilities) or letters of intent to
submit such applications.
05/07/09 RIS-2009-07 Status Update for the Implementation
of NRC Regulatory Authority for Certain
Naturally Occurring and Accelerator- Produced Radioactive Material
All U.S. Nuclear Regulatory Commission
material and fuel cycle licensees. All Radiation
Control Program Directors and State Liaison
Officers.
Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State
Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at
the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html
IN 2009-12 Enclosure 2 Frequently Asked Questions on Irradiated Gemstones
For consumers:
1. Why and how are gemstones irradiated?
2. Does irradiation make the gemstones radioactive?
3. Is it dangerous to wear blue topaz?
4. Should I stop wearing blue topaz?
5. A jeweler told me it is now illegal to sell blue topaz because it causes cancer - is this
true?
6. How can I tell if my jewelry has been irradiated?
7. Will I receive a radiation "dose" from wearing blue topaz or other irradiated gemstones?
For Jewelers and Distributors:
8. Why is NRC scaring industry and disrupting the sale of irradiated gemstones?
9. Do I need an NRC license to sell blue topaz or other irradiated gemstones?
10. Why is an "exempt distribution" license required for the initial distribution of irradiated
gemstones?
11. Am I selling "contraband"?
12. Should I stop selling these popular gemstones?
13. I read that there was a ban on selling irradiated gemstones. Is this true?
14. Why do some irradiated gemstones fall under NRCs authority, while others do not?
1. Why and how are gemstones irradiated?
Gemstones are irradiated in order to enhance and deepen their color. They can be irradiated in
a nuclear reactor (neutron bombardment), an accelerator (electron bombardment), or by
exposure to gamma rays in a cobalt-60 irradiator. The most commonly treated stone is topaz, which becomes blue as a result of the exposure to radiation.
2. Does irradiation make the gemstones radioactive?
Possibly. Generally, the longer the gemstones are exposed to radiation - and the more intense
the radiation - the deeper the resulting color; also, this increases the chance that trace elements
in the stone will be "activated" and become radioactive. It is important to note that activation is
most likely to occur in gemstones that are treated in a nuclear reactor, though treatment in an
accelerator can also make gemstones radioactive. Treatment in a cobalt-60 irradiator does not
render gemstones radioactive.
3. Is it dangerous to wear blue topaz?
No. The NRC has no indication that wearing irradiated gemstones can be harmful. There have
been no reported cases of anyone being harmed by wearing irradiated gemstones.
IN 2009-12 Enclosure 2 4. Should I stop wearing blue topaz?
From a safety standpoint, there is no reason to stop wearing blue topaz or any other irradiated
gemstones.
5. A jeweler told me it is now illegal to sell blue topaz because it causes cancer - is
this true?
No. There is no reason to believe blue topaz or any other irradiated gemstone poses any health
risk. The NRC has not advised, requested, or ordered any retailers or distributors to stop selling
irradiated gemstones.
6. How can I tell if my jewelry has been irradiated?
A skilled gemologist might be able to tell by examining the gemstone. However, it can be very
difficult to determine whether a stone has been treated in a reactor, accelerator or irradiator.
Residual radioactivity can be detected with some hand-held survey meter; however, determining
whether the radiation is below NRCs regulatory limits requires a trained radiation professional
to use sophisticated survey equipment.
7. Will I receive a radiation "dose" from wearing blue topaz or other irradiated
gemstones?
Possibly, but it would be an extremely small dose. A study done by the NRC estimated that a
person wearing a blue topaz stone at the highest level of radioactivity allowed for distribution
under NRC regulations would receive an annual dose of 0.03 millirem (NUREG 1717, page 2-
21). By contrast, a chest X-ray is about 10 millirem, and average annual natural background is
about 360 millirem in the United States.
8. Why is NRC scaring industry and disrupting the sale of irradiated gemstones?
Early in 2007, the NRC contacted several large retailers of blue topaz seeking information about
how the gemstones reached the U.S. market. The agency sought this information in order to
restore the regulatory framework for the proper distribution of these gemstones under the
Atomic Energy Act and NRC regulations. The NRC did not request any specific actions of
industry. Industry groups and retailers have cooperated with the NRC in its efforts. The NRC
continues to survey batches of gemstones for radiation. Surveys conducted to date have not
given the agency any indication that current inventories are a health risk.
9. Do I need an NRC license to sell blue topaz or other irradiated gemstones?
Probably not. NRC regulations cover material made radioactive in a nuclear reactor and particle
accelerators. The initial transfer of these materials must be made according to an NRC
distribution license. If the radioactivity levels are below certain limits in NRCs regulations, the
materials become "exempt" from further regulation, and further distribution, including to the end
consumer, does not need to be licensed. This means individual jewelers do not need to be
licensed provided the gemstones they sell were initially distributed by an NRC licensee.
IN 2009-12 Enclosure 2 By the end of 2007, the NRC issued three distribution licenses for blue topaz, and other license
applications are under review.
10. Why is an "exempt distribution" license required for the initial distribution of
irradiated gemstones?
The license provides a safeguard against the possibility that gemstones might reach the market
too soon after irradiation, with radioactivity above NRC limits. The distribution licensee is
required to perform sophisticated surveys to verify that the gemstones meet NRC requirements
for exempt distribution.
11. Am I selling "contraband"?
No. Current inventories in retail outlets and distribution channels have not been distributed by
an NRC licensee, but these should not be considered contraband. For gemstones irradiated
prior to 2007, the NRC has decided that no additional actions are necessary to ensure health
and safety of the public. For all gemstones irradiated after November 2007, the NRC will
enforce the requirements of the exempt distribution licenses of the initial distribution.
12. Should I stop selling these popular gemstones?
That is a business decision only you can make. The NRC has sought information from industry
about how irradiated gemstones reach the U.S. market, but the agency has not requested any
action, including a halt in sales.
13. I read that there was a ban on selling irradiated gemstones. Is this true?
Not a ban by the NRC. When the NRC approached industry groups early in 2007 seeking
information about the distribution of irradiated gemstones, several retailers pulled their
gemstones from the market in response. This was a voluntary action on their part. The NRC did
not request or impose any such action.
14. Why do some irradiated gemstones fall under NRCs authority, while others do
not?
This is simply because of the way the law has been written. The Atomic Energy Act gave NRC
regulatory authority over radioactive material produced in reactors. In the Energy Policy Act of
2005, Congress extended this authority to include accelerator-produced radioactive material
that is used for a commercial, medical, or research activity. NRC regulations implementing this
expanded authority took effect November 30, 2007. Information on these regulations and the
agencys transition plan for implementing them is available on the NRC web site, http://www.nrc.gov/ .
Some gemstones treated at low energy in an accelerator may not actually become radioactive, so they would not qualify as radioactive material under NRC authority. Also, gemstones
irradiated in a cobalt-60 irradiator do not become radioactive.