Requirements for Expanded Definition of Byproduct Material, 55864-55937 [07-4735]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 72, Number 189 (Monday, October 1, 2007)]
[Rules and Regulations]
[Pages 55864-55937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4735]



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Part II





Nuclear Regulatory Commission





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10 CFR Parts 20, 30, et al.



Requirements for Expanded Definition of Byproduct Material; Final Rule

Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Rules 
and Regulations

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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20, 30, 31, 32, 33, 35, 50, 61, 62, 72, 110, 150, 170, 
and 171

RIN 3150-AH84


Requirements for Expanded Definition of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations to include jurisdiction over discrete sources of radium-
226, accelerator-produced radioactive materials, and discrete sources 
of naturally occurring radioactive material, as required by the Energy 
Policy Act of 2005 (EPAct), which was signed into law on August 8, 
2005. The EPAct expanded the Atomic Energy Act of 1954 definition of 
Byproduct material to include any discrete source of radium-226, any 
material made radioactive by use of a particle accelerator, and any 
discrete source of naturally occurring radioactive material, other than 
source material, that the Commission, in consultation with other 
Federal officials named in the EPAct, determines would pose a similar 
threat to the public health and safety or the common defense and 
security as a discrete source of radium-226, that are extracted or 
converted after extraction for use for a commercial, medical, or 
research activity. In so doing, these materials were placed under the 
NRC's regulatory authority. The EPAct also mandated that the 
Commission, after consultation with the States and other stakeholders, 
issue final regulations establishing requirements that the Commission 
determines necessary under the EPAct. This rulemaking effort has been 
undertaken in response to that mandate and includes significant 
contributions from many States that have regulated the naturally 
occurring and accelerator-produced radioactive material, the 
Organization of Agreement States, Inc., the Conference of Radiation 
Control Program Directors, Inc. (CRCPD), and other stakeholders. In 
addition, this final rule was informed and guided by the CRCPD's 
applicable Suggested State Regulations for the Control of Radiation. 
Licensees, individuals, and other entities who are engaged in 
activities involving the newly defined byproduct material in both 
Agreement States and non-Agreement States and United States Territories 
will be affected by this rulemaking.

DATES: Effective Date: This final rule is effective on November 30, 
2007.

FOR FURTHER INFORMATION CONTACT: Lydia Chang, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6319, e-mail lwc1@nrc.gov; or Catherine R. Mattsen, Office of Federal 
and State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6264, e-mail crm@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background
II. Discussion
    A. The New, Expanded Definition of Byproduct Material
    B. The NRC's Regulatory Approach
    C. Changes to Existing NRC Regulations to Accommodate the New 
Byproduct Material
    D. License Application and Annual Fees
    E. Implementation Strategy
III. Summary and Analysis of Public Comments on the Proposed Rule
IV. Section-by-Section Analysis of Final Revisions
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Voluntary Consensus Standards
VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability
IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
XIII. Congressional Review Act

I. Background

The Energy Policy Act of 2005

    On August 8, 2005, the President signed into law the EPAct. Among 
other provisions, Section 651(e) of the EPAct expanded the definition 
of Byproduct material as defined in Section 11e. of the Atomic Energy 
Act of 1954 (AEA), placing additional byproduct material under the 
NRC's jurisdiction, and required the Commission to provide a regulatory 
framework for licensing and regulating this additional byproduct 
material.
    Specifically, Section 651(e) of the EPAct expanded the definition 
of Byproduct material by: (1) Adding any discrete source of radium-226 
that is produced, extracted, or converted after extraction, before, on, 
or after the date of enactment of the EPAct for use for a commercial, 
medical, or research activity; or any material that has been made 
radioactive by use of a particle accelerator and is produced, 
extracted, or converted after extraction, before, on, or after the date 
of enactment of the EPAct for use for a commercial, medical, or 
research activity (Section 11e.(3) of the AEA); and (2) adding any 
discrete source of naturally occurring radioactive material, other than 
source material, that the Commission, in consultation with the 
Administrator of the Environmental Protection Agency (EPA), the 
Secretary of the Department of Energy (DOE), the Secretary of the 
Department of Homeland Security (DHS), and the head of any other 
appropriate Federal agency, determines would pose a threat similar to 
the threat posed by a discrete source of radium-226 to the public 
health and safety or the common defense and security; and is extracted 
or converted after extraction before, on, or after the date of 
enactment of the EPAct for use in a commercial, medical, or research 
activity (Section 11e.(4) of the AEA).
    Although Section 651(e) of the EPAct became effective on August 8, 
2005, the NRC did not have regulations in place that would specifically 
apply to this newly covered byproduct material (hereafter referred to 
as NARM). The EPAct also allowed the NRC to issue waivers to States and 
other entities while developing final regulations for NARM. A waiver 
was issued on August 31, 2005 (70 FR 51581).

Previous Regulatory Structures for NARM

    The AEA authorizes the States to assume regulatory control of 
certain radioactive materials provided the State has an adequate 
program to protect the public health and safety and is compatible with 
the NRC's program for regulation of these materials and enters into an 
agreement with the NRC. As authorized by Section 274b of the AEA, 34 
States have assumed responsibility for regulating certain activities 
related to radioactive material by entering into agreements with the 
NRC. The activities regulated by these ``Agreement States'' include the 
use of byproduct material, source material, and special nuclear 
material. Each Agreement State issues licenses to persons who use these 
materials in that State except for DOE, other Government agencies, and 
Federally recognized Indian Tribes. The NRC issues licenses to persons 
using these materials in non-Agreement States.
    Before enactment of the EPAct, the NRC did not have authority over 
NARM or regulations for this type of material. Although the NRC has not 
regulated NARM in the past, all 34 Agreement States and certain non-
Agreement States have regulatory programs for NARM. The NRC's 
regulations did require licensees to account for dose contributed from 
NARM, as well as dose

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contributed from other byproduct, source, or special nuclear material, 
because the definition of Occupational dose encompasses both licensed 
material and nonlicensed material such as NARM sources at a licensed 
facility. In addition, the NRC requires in its radiological criteria 
for license termination that licensees consider other nondiscrete 
sources, including radium, during decommissioning activities at sites 
contaminated with source material, such as rare-earth processing 
facilities.
    Currently, there are 16 non-Agreement States plus United States 
(U.S.) Territories. Although most non-Agreement States and U.S. 
Territories have some type of programs for NARM, the regulatory 
structures vary greatly. Certain non-Agreement States have established 
a licensing structure for regulating their NARM users. As such, the 
regulatory structure could parallel the NRC regulations issued in Title 
10 of the Code of Federal Regulations (10 CFR) applicable to the 
current materials program, or it could parallel the Suggested State 
Regulations for the Control of Radiation (SSRs) developed by the CRCPD. 
Other non-Agreement States or U.S. Territories have elected to use 
registration as their regulatory structure for managing the NARM users. 
Some States register facilities; others register both facilities and 
devices. Some States use registration information to conduct 
inspections; others use registration to identify facility locations for 
security purposes. In general, there is limited regulatory oversight 
where registration is used in non-Agreement States. It was, in part, 
due to this lack of national consistency, that the EPAct placed these 
materials under the NRC's jurisdiction.
    Agreement States have regulated NARM use for many decades in a 
fairly uniform and consistent manner. The Agreement States have 
accomplished this by using the same standards to regulate NARM as those 
used to regulate other byproduct, source, and special nuclear material 
under the NRC's authority. In many respects, regulations applicable to 
NARM adopted by the Agreement States are compatible with the NRC's 
regulations for the current materials program, or parallel the CRCPD's 
SSRs.
    Although Agreement States do have some provisions specifically for 
NARM, in general, the regulatory structure used by Agreement States 
does not distinguish between NARM and other radioactive material. NARM 
users in the Agreement States are expected to implement all aspects of 
standards for their radiation protection programs with respect to NARM, 
including those aspects relating to receipt, possession, use, storage, 
transfer, transportation, and disposal of NARM. This regulatory 
structure also subjects NARM users in the Agreement States to the same 
licensing, inspection, and enforcement policies as those using other 
byproduct, source, or special nuclear materials. In addition, this 
regulatory structure allows for both specific and general licensing of 
various NARM products, the distribution of certain NARM items to 
persons exempt from regulation and, in most cases, includes provisions 
to review and approve proposals for sealed sources and devices 
containing NARM.
    The Agreement States have regulated a vast array of NARM produced 
for medical, industrial, research and development, commercial, and 
consumer purposes. In many Agreement States, this regulatory structure 
also captures some types of nondiscrete sources found in the oil and 
gas industry or mining industry; moreover, it captures inadvertently 
produced activation products from the use of proton beams for medical 
radiation therapy. However, the regulation of these nondiscrete sources 
and activation products varies from Agreement State to Agreement State.

Other Federal Agencies' Regulatory Authority Over NARM

    Although the States had the primary responsibility for regulating 
the use of NARM before the passage of the EPAct, certain Federal 
regulations continue to apply under some circumstances, such as 
environmental protection, workplace safety, drug safety, 
transportation, and disposal. With the passage of the EPAct, the NRC 
will have primary responsibility for radiation safety and in regulating 
the use of these materials in cooperation with the States, with the 
exception of those activities that are self-regulated by the DOE.
    Other Federal agencies have regulations or have established 
programs for self-regulating certain activities involving NARM. The 
Department of Transportation (DOT) regulates interstate transport of 
NARM. In cooperation with DOT, the NRC approves Type B packages through 
regulations in 10 CFR Part 71. The EPA has established controls for 
certain NARM through several authorities, including the Clean Air Act, 
the Safe Drinking Water Act, the Toxic Substances Control Act, the 
Resource Conservation and Recovery Act, and the Comprehensive 
Environmental Response, Compensation, and Liability Act. The 
Occupational Safety and Health Administration (OSHA) of the Department 
of Labor has the oversight for occupational health and safety for 
radiation protection. It has regulations governing radiation protection 
in the workplace, including provisions addressing the exposure of 
minors to radioactive material in the workplace, but defers to the NRC 
on AEA materials. The Department of Commerce (DOC) has controlled the 
export of radioactive material. Before the enactment of the EPAct, the 
DOC regulated the export of all radium-226. With the enactment of the 
EPAct, the NRC will regulate the export of discrete sources of radium-
226; DOC retains jurisdiction to regulate the export of nondiscrete 
sources of radium-226. The Consumer Product Safety Commission 
regulations have addressed hazardous substances other than byproduct, 
source, and special nuclear materials currently regulated by the NRC. 
The Food and Drug Administration (FDA) regulates all drugs (including 
drugs containing radioactive materials) by requiring good manufacturing 
practices to assure the purity, potency, and consistency of finished 
drugs with their labeling in establishing the safety and effectiveness 
of these drugs.
    Section 651(e)(3) of the EPAct provides that byproduct material, as 
defined by Section 11e.(3) or 11e.(4) of the AEA, may only be 
transferred to and disposed of in a disposal facility that is adequate 
to protect public health and safety, and is licensed by either the NRC 
or a State that has entered into an agreement with the Commission under 
Section 274b of the AEA or at a disposal facility in accordance with 
any Federal or State solid or hazardous waste law, including the Solid 
Waste Disposal Act, also known as the Resource Conservation and 
Recovery Act (RCRA).

Development of the Suggested State Regulations (SSRs)

    Since enactment of the AEA in 1954, scientists continue to develop 
new technologies in producing radionuclides, such as the use of 
particle accelerators. At the beginning of the 20th century, naturally 
occurring radioactive material, including radium-226, was routinely 
used in consumer products and in cancer treatment. Because there was no 
Federal mandate to regulate these materials, most States have since 
established regulatory structures for both accelerator-produced 
radioactive material and naturally occurring radioactive material, 
including radium-226.
    In 1968, CRCPD was chartered as a nonprofit organization to provide 
a forum for enhancing communication among States and Federal agencies

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regarding radiation regulations and to promote a uniform radiation 
protection environment for all radioactive material. Throughout the 
years, CRCPD developed policies and guidance for its member States. In 
addition, CRCPD is responsible for the development of model 
regulations, known as the SSRs. Under the SSRs' regulatory framework, 
NARM has been a regulated radioactive material comparable to byproduct 
material. Nearly all of the Agreement States have based their 
regulations on this model for NARM.
    For NARM regulation only, CRCPD also established ``Licensing 
States'' similar to the Agreement State Program under Section 274 of 
the AEA. Licensing States recognized by CRCPD under criteria found in 
Publication 94-8, ``CRCPD Recognition of Licensing States for the 
Regulation and Control of NARM,'' are those States that have 
demonstrated an adequate and consistent regulatory control program for 
NARM. Licensing State designation assures comparable regulatory 
structures with respect to NARM, and other States may grant reciprocal 
recognition of their licenses or acceptance of their licensees' 
manufactured products.

Issuance of Waiver on August 31, 2005

    Section 651(e) of the EPAct became effective immediately upon 
signature by the President on August 8, 2005. Before enactment of the 
EPAct, the NRC did not have authority over NARM or regulations in place 
that would specifically apply to this material. Nonetheless, persons 
engaged in activities involving NARM could be, and States seeking to 
continue regulation of NARM would be, in technical violation of the 
AEA.
    Section 651(e)(5) of the EPAct authorized the Commission to issue a 
waiver of the requirements of Section 651(e) to any entity with respect 
to NARM for specified periods of time if the Commission determined that 
the waiver was in accordance with the protection of the public health 
and safety and the promotion of the common defense and security. The 
Commission determined that there was no basis to conclude that these 
materials would not continue to be used in a manner that is protective 
of public health and safety while the waiver is in effect. The 
Commission also determined that it would be in the best interest of the 
public to allow continued use of NARM, especially for medical purposes, 
and to allow the States to continue to regulate NARM until the 
Commission could codify new regulations for these materials.
    The Commission believed that granting the waiver would allow the 
States to continue with their regulatory programs, allow persons 
engaged in activities involving NARM to continue their operations in a 
safe manner, and allow continued access to medical 
radiopharmaceuticals. In addition, it would enable the Commission to 
work with the States in developing appropriate regulations for NARM and 
in formulating a sound Transition Plan for implementation of these 
regulations. It would also provide an opportunity for non-Agreement 
States that currently do not have Agreement State regulatory programs 
under Section 274b. of the AEA to consider entering into an agreement 
with the NRC. The Commission determined that issuance of the waiver 
would be in accordance with the protection of public health and safety 
and the promotion of the common defense and security.
    The Commission granted a waiver (70 FR 51581; August 31, 2005) from 
the requirements of Section 651(e) of the EPAct to: (1) All persons 
engaged in export from or import into the U.S. of byproduct material 
through August 7, 2006, unless terminated sooner if the Commission 
determined that an earlier termination was warranted; and except with 
regard to the requirements of the DOC relating to export of byproduct 
material; (2) all persons acquiring, delivering, receiving, possessing, 
owning, using, or transferring byproduct material through August 7, 
2009, unless terminated sooner if the Commission determined that an 
earlier termination was warranted; and (3) all States that had entered 
into an agreement with the Commission under Section 274b. of the AEA, 
and States that had not entered into such an Agreement, through August 
7, 2009, unless terminated sooner if the Commission determined an 
earlier termination was warranted, or for an Agreement State if the 
Commission made certain determinations required by Section 
651(e)(5)(B)(ii) of the EPAct.

Stakeholder Involvement in the Rulemaking Process

    The NRC took several initiatives in an effort to enhance 
stakeholder involvement and to improve efficiency during the rulemaking 
process. With assistance from the Organization of Agreement States 
(OAS) and CRCPD, the NRC was able to obtain participation of several 
State representatives in various working groups in the development of 
the proposed rule. Principals from OAS and CRCPD, representing 
interests for both Agreement States and non-Agreement States, also 
participated in the steering committee forming a partnership with the 
NRC in making rulemaking decisions. In an effort to keep stakeholders 
informed, the NRC held a public roundtable meeting in early November. 
In addition, the NRC has met with other Federal agencies to ensure 
coordination regarding this rulemaking.
    The NRC held a public meeting on November 9, 2005, to discuss 
rulemaking activities to incorporate NARM into its regulatory 
framework. The public meeting was in a ``roundtable'' format to allow 
stakeholders an opportunity to discuss concerns and to enhance 
interaction among all interested parties on the subject of the NRC 
regulating NARM. Representatives from other Federal agencies, States, 
and a broad spectrum of interest groups were invited to participate in 
the ``roundtable'' discussion. A transcript of this meeting is 
available via the NRC's and other related documents are available from 
(see FOR FURTHER INFORMATION CONTACT section of this document.)
    Following the public meeting, the NRC received five written 
comments from interested parties related to the discussion at the 
meeting and the rulemaking activities. These comment letters were 
reviewed and considered by the NRC staff in the development of the 
proposed rule.
    In addition to the public meeting, the NRC interacted and met with 
FDA staff to exchange information regarding the NRC's NARM rulemaking 
efforts and the FDA's regulations for accelerator-produced drugs. The 
primary objective of the FDA's regulations is to ensure medical safety, 
purity, potency, and effectiveness of the drugs, and that of the NRC's 
regulations is to ensure radiation safety. During the meeting, areas of 
potential dual regulation were discussed. Because the NRC and the FDA 
have different missions, the associated regulations are more 
complementary than duplicative. FDA has published a proposed rule (70 
FR 55038; September 20, 2005), ``Current Good Manufacturing Practice 
for Positron Emission Tomography Drugs,'' and expects to finalize the 
rule soon. The FDA's final rule will establish criteria for the 
production and process/quality controls for the Positron Emission 
Tomography (PET) drugs in PET centers registered with the FDA.
    The NRC hosted a meeting of Federal agency representatives on 
November 22, 2005, to discuss the development of a definition of 
Discrete source to be added to the NRC's regulations. Agencies 
represented at this meeting were DOT, DOE, including the National 
Nuclear Security Administration, Department of

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Defense, DOC, EPA, and the U.S. Customs and Border Protection. A draft 
definition was formulated. This definition formed the basis for the 
definition in the proposed rule, with only minor changes and text 
rearrangement for clarity.
    The NRC published the proposed rule to establish the regulatory 
framework for the newly defined byproduct material on July 28, 2006 (71 
FR 42952). Thirty-nine comment letters were received. The commenters 
included a number of States, Federal agencies, professional 
organizations, universities, medical communities, industries, and 
individuals.

II. Discussion

A. The New, Expanded Definition of Byproduct Material

    Section 651(e) of the EPAct expanded the definition of Byproduct 
material to include: (1) Any discrete source of radium-226 that is 
produced, extracted, or converted after extraction, before, on, or 
after the date of enactment of the EPAct for use for a commercial, 
medical, or research activity; (2) any material that has been made 
radioactive by use of a particle accelerator and is produced, 
extracted, or converted after extraction, before, on, or after the date 
of enactment of the EPAct for use for a commercial, medical, or 
research activity; and (3) any discrete source of naturally occurring 
radioactive material, other than source material, that the Commission, 
in consultation with the Administrator of the EPA, the Secretary of 
DOE, the Secretary of DHS, and the head of any other appropriate 
Federal agency, determines would pose a threat similar to the threat 
posed by a discrete source of radium-226 to the public health and 
safety or the common defense and security, and that is extracted or 
converted after extraction, before, on, or after the date of enactment 
of the EPAct for use in a commercial, medical, or research activity. 
The NRC is revising the definition of Byproduct material in 10 CFR 
Parts 20, 30, 50, 72, 150, 170, and 171 to be consistent with the 
EPAct. The same revision to the definition of Byproduct material was 
made in a separate rulemaking for 10 CFR Part 110 (April 20, 2006; 71 
FR 20336). A different definition for the term Byproduct material is 
used in 10 CFR Part 40, because 10 CFR Part 40 regulations are limited 
to source material and the tailings or wastes associated with the 
extraction or concentration of source material. Therefore, 10 CFR Part 
40 regulations are not impacted by the EPAct, and the definition of 
Byproduct material in that Part remains unchanged by this rule.
    Since the publication of the proposed rule, and after considering 
the comments on the new definition of byproduct material, the 
Commission has taken a closer look at the scope of the Commission's 
jurisdiction over the newly added byproduct material. The EPAct covers 
discrete sources of radium-226 and accelerator-produced radioactive 
material that is ``produced, extracted, or converted after extraction, 
before, on, or after August 8, 2005, for use for commercial, medical, 
or research activity'' (emphasis added). Notwithstanding that a 
discrete source of radium-226 may have originated from a commercial 
supplier, the Commission has determined that discrete sources of 
radium-226 still in control of the military do not constitute 
``commercial use'' under the EPAct, and are therefore, outside the 
Commission's jurisdiction. Defining ``commercial use'' to include all 
material supplied to the military from a commercial supplier would 
result in virtually all military use of this material to be 
``commercial use.'' This would vitiate any distinction that the EPAct 
intended to make for military use, as opposed to commercial use, by 
excluding military use from its coverage.
    However, this exclusion from the coverage of the EPAct only applies 
to a certain type of military use, i.e., NARM used for ``military 
operations.'' The term ``military operations'' covers what is 
traditionally understood as the military's primary mission for national 
defense, including warfare, combat, and battlefield missions, and, of 
course, training for battlefield missions. NARM used, or available for 
use, for these purposes would be excluded from the coverage of the 
EPAct and from the coverage of this rule. If the material is intended 
for use in military operations, it is excluded from the coverage of 
this rule notwithstanding the fact that it was originally produced by a 
commercial supplier. In addition, ``military operational'' material 
includes material still under the control of the military, i.e., in 
storage, or material that may be subject to decontamination and 
disposal.
    Other use of NARM by the military would be covered by this rule. 
Under the Commission's interpretation of the EPAct, NARM, whether 
discrete sources or accelerator material, that is produced, extracted, 
or converted for use or has been used, in medical or research 
activities, or in a manner similar to a commercial activity, e.g., 
military museums, is covered by the EPAct and this rule. Furthermore, 
NARM that was used for military operations but is no longer under the 
control of the military, has been sold, or is in the possession of 
private individuals, is also within the coverage of this rule.
    The NRC intends to interact with the Department of Defense to 
obtain a common understanding of the uses of radium-226 and 
accelerator-produced radioactive material by the military to resolve 
any potential issues regarding the application of the Commission's 
interpretation of the EPAct in regard to any specific case of military 
use.
Radium-226
    Radium is a chemically reactive, silvery white, radioactive, 
metallic element with an atomic number of 88 and symbol of Ra. Radium-
226, the most abundant and most stable isotope of radium, is formed by 
the radioactive disintegration of thorium-230 in the decay series 
starting with uranium-238. Radium-226 can be found in all uranium ores. 
The half-life of radium-226 is 1599 years. Radium-226 emits alpha 
particles and gamma radiation and decays to radon gas.
    Although radium was discovered in the ore pitchblende by the 
chemists Marie and Pierre Curie in 1898, no one understood the dangers 
of radium until later in the twentieth century. Based on radium's 
properties, especially its ability to stimulate luminescence, 
industries started manufacturing hundreds of consumer products 
containing radium. Radium was added to products such as hair tonic, 
toothpaste, ointments, and elixirs. Radium paint was used in the mid-
1900s to paint the hands and numbers of some clocks, watches, 
doorknobs, and other objects to make them glow in the dark. Glow-in-
the-dark watch and clock faces were particularly popular. Most of these 
uses were eventually discontinued for health and safety reasons, but 
its wide use in luminescent paints continued through World War II 
because radium's luminescent glow made aircraft and vehicle dials, 
gauges, and other instruments visible at night. Many of these early 
products still remain in the possession of museums and individual 
collectors. Large inventories of radium-226 luminescent military and 
aircraft devices remain and periodically turn up in repair shops, and 
have resulted in contamination incidents.
    In more recent times, radium sources were used in industrial 
radiography and industrial smoke detectors. Currently, radium sources 
are still being used in some industrial products, such as industrial 
gauges, that measure certain

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physical properties such as moisture and density.
Accelerator-Produced Radioactive Material

Particle Accelerators

    A particle accelerator is a device that imparts kinetic energy to 
subatomic particles by increasing their speed through electromagnetic 
interactions. Particle accelerators are used to produce radioactive 
material by directing a beam of high speed particles at a target 
composed of a specifically selected element, which is usually not 
radioactive. Nuclei in the target are struck by the high speed 
particles and undergo a nuclear transformation. A nuclide that is 
struck is transformed into a different nuclide. By careful selection of 
the target element, the particles accelerated, and the operating 
parameters of the accelerator (e.g., beam energy), a resultant proton-
heavy nuclide can be produced. Usually the nuclide produced is 
radioactive and is created for the use of its radiological properties. 
The process of transforming nuclei from a stable element into a 
radionuclide is called activation. In some cases, the target is 
selected so that the accelerator produces a neutron beam that is, in 
turn, used to activate nuclides that are then used for their 
radioactive properties. Some particle accelerators are not used to 
produce radioactive material, but instead the high energy beam produced 
by the particle accelerator is used directly, for example, to treat 
cancer patients.
    The two basic designs of particle accelerators are linear and 
circular, also known as cyclotron. In either case, charged particles 
are injected into the accelerator to form a beam. The beam is 
accelerated and focused onto the target. In the circular designs, the 
beam must be directed to travel in a circular shaped path. For all 
accelerators, the process of accelerating, focusing, and directing the 
beam is accomplished by a combination of electrically charged 
structures and magnetic fields in the accelerator. During operation, 
these internal structures will be struck by particles from the beam and 
activated incidentally.
    Particle accelerators are often classified by the maximum energy of 
the accelerated particles, expressed in megaelectron-volts (MeV). An 
electron-volt is the amount of energy imparted to an electron by an 
accelerating potential of one volt. The small cyclotrons that produce 
radionuclides used in PET nuclear medicine usually operate at energies 
of up to about 30 MeV. By comparison, the accelerators used in basic 
physics research facilities reach energies in excess of 1000 MeV.
    For the purposes of this rulemaking, the NRC divided particle 
accelerators into three groupings: (1) Those that are always operated 
to intentionally produce radioactive materials in quantities useful for 
their radioactive properties for a commercial, medical, or research 
activity; (2) those that are operated to produce only particle beams 
and not radioactive materials; and (3) accelerators that are used to 
produce both radioactive materials and particle beams for other uses. 
Examples of accelerators that are operated to produce only particle 
beams and not radioactive materials include linear accelerators used 
for medical treatment of cancer and other health-related conditions. 
Other examples include the experimental particle physics research 
colliders used to probe the fundamental properties of nature (as long 
as that is their only use) and electron microscopes, i.e., particle 
accelerators that probe the structure of materials at a very small 
dimension (high magnification). Ion implanters are particle 
accelerators used to modify the electrical properties of materials in 
semiconductor fabrication. In these activities, no radioactive material 
is intentionally created; all activation is incidental to the intended 
use of the accelerator.
    The NRC will regulate the radioactive material both intentionally 
and incidentally produced by all accelerators that are intentionally 
operated to produce a radioactive material for its radioactive 
properties. The NRC will not regulate the incidental radioactive 
material produced by accelerators that are operated to produce only 
particle beams and not radioactive materials for use for a commercial, 
medical, or research activity. For those accelerators that are used to 
produce both radioactive material and particle beams, the NRC will 
regulate the intentionally produced radioactive material and all of the 
incidentally produced radioactive material, including incidental 
radioactive material produced when the accelerator is operated to 
produce radioactive material, as well as incidental radioactive 
material produced when it is operated to produce only a particle beam. 
The incidental radioactive materials produced in these accelerators are 
indistinguishable, so both will be considered byproduct material. The 
NRC believes very few, if any, accelerators are operated in this way.
    The EPAct does not give the NRC authority to regulate the 
possession or use of particle accelerators. The NRC has not adopted any 
rule regarding the operation of a particle accelerator or the 
qualification of any person maintaining or operating a particle 
accelerator. However, nothing in the EPAct directs the NRC to change 
the policy that radiation safety standards must consider unregulated as 
well as regulated sources of radiation. The NRC will continue to 
require any person subject to the dose limits in 10 CFR Part 20 to 
continue to include the radiation dose from the operation of a particle 
accelerator in meeting the dose limitations. The NRC is aware that the 
operation of a particle accelerator may activate materials in the 
structure of the building and facilities housing the accelerator. The 
NRC intends to assure the safe decommissioning of particle accelerator 
buildings and facilities, including the removal and disposal of 
activated building materials, to assure that the dose limits to members 
of the public are not exceeded. The decommissioning of these facilities 
will be required to meet the radiation dose limits in 10 CFR Part 20 
Subpart E--Radiological Criteria for License Termination.
    The majority of accelerator-produced radioactive material is now 
created for use in medicine. The NRC is aware of only two operations in 
the U.S. and a few importers, mostly from Europe and Canada, that are 
commercial producers of accelerator-produced radioactive material for 
use in industrial activities. The regulatory approach for manufacturing 
accelerator-produced radioactive material for industrial purposes is 
similar to the regulatory approach for manufacturing accelerator-
produced radioactive material for medical purposes.

Accelerator-Produced Radioactive Material Used in Medical Activities

    Medical use of radioactive material began over 50 years ago. The 
medical use of sealed and unsealed radioactive materials continues to 
be an important component of medical specialties for both diagnosis and 
therapy purposes. The use of small quantities of unsealed radioactive 
materials (radiopharmaceuticals) in nuclear medicine is an integral 
part of patient care and is extremely valuable in the early diagnosis 
and treatment of medical conditions. Radiation oncology uses larger 
amounts of radioactivity in sealed sources to deliver therapeutic or 
palliative radiation doses.
    Almost all reactor-produced byproduct radionuclides for radioactive 
drugs are imported into the U.S., as well as most reactor-produced 
radionuclides used in sealed sources, although some used in radioactive 
drugs and sealed

[[Page 55869]]

sources are also produced in an NRC-regulated nonpower reactor. 
Commercial manufacturers primarily use the imported radionuclides to 
produce specific sealed sources, radioactive drugs, and biologics. 
Commercial nuclear pharmacies may use radiochemicals to prepare 
radioactive drugs, as well as commercially produced radioactive drugs 
and drug sources, such as molybdenum-99/technetium-99m generators, to 
prepare unit dosages of other radioactive drugs.
    The U.S. has a limited number of commercial radionuclide production 
facilities that use accelerators to produce radionuclides, such as 
thallium-201, iodine-123, indium-111, and gallium-67 used in 
radioactive drugs. A larger number of radionuclide production 
facilities (often referred to as PET centers) use cyclotrons to produce 
the PET radionuclides fluorine-18, carbon-11, nitrogen-13, and oxygen-
15 for use in PET radioactive drugs. PET radionuclides decay by 
positron emission and, because of their relatively short half-life 
(minutes to hours), are produced at locations in close proximity to the 
patients (e.g., in hospitals or academic institutions) or at nearby 
locations.
    Palladium-103, the most common accelerator-produced medical use 
radionuclide contained in a sealed source, was originally produced at 
reactor facilities. Other radionuclides used in medical radiation 
therapy can also be produced with either reactors or accelerators. With 
the new definition of Byproduct material, sealed sources that can be 
produced from either pathway will be uniformly regulated. At this time, 
there are no teletherapy or remote afterloader or gamma stereotactic 
radiosurgery units with accelerator-produced sources.
    Because production accelerators for medical radionuclides (e.g., 
PET production facilities) and industrial radionuclides are used to 
intentionally produce radioactive material for use of its radioactive 
properties for a commercial, medical, or research activity, the NRC 
will regulate both the radionuclides produced in these accelerators as 
well as the incidentally activated radioactive material.
Other Naturally Occurring Radioactive Material With Similar Risk as 
Radium-226
    The EPAct amended the definition of Byproduct material to include 
any discrete source of naturally occurring radioactive material, other 
than source material, that the Commission, in consultation with the 
Administrator of the EPA, the Secretary of Energy, the Secretary of 
Homeland Security, and the head of any other appropriate Federal 
agency, determines would pose a threat similar to the threat posed by a 
discrete source of radium-226 to the public health and safety or the 
common defense and security, and is extracted or converted after 
extraction, before, on, or after the date of enactment of the EPAct for 
use in a commercial, medical, or research activity.
    The inclusion of discrete sources of naturally occurring 
radioactive material into the definition of Byproduct material is 
contingent on the Commission's determination, in consultation with 
other Federal agencies, that these discrete sources would pose a threat 
similar to the threat posed by a discrete source of radium-226. The NRC 
has not currently identified any discrete sources of naturally 
occurring radioactive material under this provision, and the rule does 
not contain criteria for making such a determination. For comparison, 
the International Atomic Energy Agency (IAEA) has identified a list of 
sources that are considered to pose a high risk to human health and 
safety if not managed safely and securely. The IAEA Code of Conduct on 
the Safety and Security of Radioactive Sources (Code of Conduct) 
identified certain quantities of 26 radionuclides that pose a 
significant risk to individuals, society, and the environment. The 
activity of these radionuclides at the IAEA Code of Conduct Category 1 
or 2 level could be fatal or cause permanent injury to a person who 
handled them or was otherwise in contact with them for a short time, if 
not safely managed or securely protected. Of these 26 sources, only two 
naturally occurring radionuclides are listed: Radium-226 and polonium-
210. Because this rule addresses discrete sources of radium-226, the 
only other naturally occurring radioactive material similar in hazard 
to radium-226 when using the IAEA criteria is polonium-210. However, 
naturally occurring polonium is scarce. One ton of uranium ore contains 
only about 100 micrograms (0.0001 grams) of polonium. Due to its 
scarcity in nature, polonium-210 used for commercial purposes is 
usually produced by bombarding bismuth-209 with neutrons in a nuclear 
reactor and had been regulated by the NRC before the EPAct. 
Additionally, polonium-210 is unlikely to be commercially used in 
individual radioactive sources with activity levels that would place 
them within the IAEA Code of Conduct Category 1 or 2. Hence, the NRC 
has determined that no other discrete sources of naturally occurring 
radioactive material pose a threat similar to the radium-226-level or 
IAEA Code of Conduct Category 1 or 2 sources.
    Through interaction with other Federal agencies and States during 
development of the rule, the NRC concluded that, at this time, only 
polonium-210 has the potential to pose a threat similar to the threat 
posed by a discrete source of radium-226 to the public health and 
safety or the common defense and security. The NRC had already been 
regulating the use and possession of polonium-210 because it is 
produced in nuclear reactors and is rarely extracted as naturally 
occurring radioactive material. Therefore, although this rule adds this 
category of byproduct material to the definitions in the regulations, 
at this time, the NRC's regulations will not apply to any discrete 
sources of naturally occurring radioactive material, other than radium-
226. The EPAct has provided a mechanism for the Commission to include 
additional discrete sources of naturally occurring radioactive material 
in the future following consultation with other Federal agencies, if 
the need arises to consider other naturally occurring radioactive 
material as byproduct material. No further revision to the regulations 
will be necessary to begin regulating a material identified through 
this mechanism. However, the NRC will provide an opportunity for public 
input before applying its regulations to other naturally occurring 
radionuclides that the NRC determines in consultation with other 
federal agencies, pose a threat similar to the threat posed by discrete 
source of radium-226.

B. The NRC's Regulatory Approach

Consideration of Suggested State Regulations for the Control of 
Radiation (SSRs)
    All 34 Agreement States have regulations for NARM. Twelve non-
Agreement States and certain U.S. Territories have some type of 
regulatory structure for NARM, while four non-Agreement States have no 
program for regulating NARM. The EPAct mandated that the NRC use model 
State standards to the maximum extent practicable in issuing 
regulations for the expanded definition of Byproduct material. The NRC 
considered the SSRs published by CRCPD (https://www.crcpd.org/free_
docs.asp) as the model State standard in developing this rule. Most 
Agreement States have regulated discrete sources of radium and 
accelerator-produced radioactive

[[Page 55870]]

material in a manner similar to and under the same requirements as 
reactor-produced radioactive material. Few provisions in the SSRs exist 
solely to address these materials. Where specific provisions do exist 
in the SSRs for these materials, they have been evaluated for possible 
inclusion in the NRC's regulations.
    For radionuclide-specific values listed in 10 CFR part 20, 
Appendices B and C, the NRC found that there are no other radionuclides 
identified in the SSRs that are not already included in 10 CFR part 20. 
As discussed further in this document under Section C., ``Changes to 
Existing NRC Regulations to Accommodate the New Byproduct Material,'' 
most of the specific provisions related to NARM radionuclides in the 
SSRs have been adopted in this rule. These include exempt quantities in 
10 CFR 30.18 and 10 CFR 30.71, an exemption for timepieces in 10 CFR 
30.15, a general license for calibration and reference sources in 10 
CFR 31.8, a general license for use of radioactive material for certain 
in vitro clinical or laboratory testing in 10 CFR 31.11, contamination 
limits for strontium-82/rubidium-82 generators, and requirements to 
measure the contamination limits in 10 CFR 35.204 with corresponding 
recordkeeping requirements in 10 CFR 35.2204.
    While SSRs do exist that address other types of naturally occurring 
radioactive material that are not covered by the EPAct or these new 
regulations, discrete sources of radium and accelerator-produced 
radioactive material are covered under the same provisions of the SSRs 
that apply to reactor-produced radioactive material. There is general 
agreement among the States, reflected in the SSRs, that the new 
categories of byproduct material should be regulated under the same 
requirements as reactor-produced radioactive material. This rule takes 
the same regulatory approach. Most of the requirements that will apply 
to users of the newly regulated material are preexisting NRC 
requirements.
Other Related Rulemakings
    The NRC amended its regulations in 10 CFR Part 110 revising the 
definition of Byproduct material to include discrete sources of radium-
226, accelerator-produced radioactive material, and discrete sources of 
naturally occurring radioactive material (71 FR 20336; April 20, 2006). 
In addition, an earlier amendment (70 FR 37985; July 1, 2005) added 
discrete sources of radium to 10 CFR Part 110, Appendix P. Together, 
the two amendments satisfy the requirements of Section 651(d) of the 
EPAct pertaining to the export or import of Category 1 or Category 2 
radiation sources as defined by the IAEA Code of Conduct. By this final 
rule, the NRC is again amending is regulations in 10 CFR Part 110 to 
include a definition of Discrete source.
    Section 651(d) of the EPAct also requires the NRC to issue 
regulations establishing a mandatory tracking system for radiation 
sources, including radium-226, in the U.S. The NRC issued a final rule 
for national source tracking of sealed sources (71 FR 65686; November 
8, 2006) that included radium-226 sources.
Definition of Discrete Source
    The EPAct extended the definition of Byproduct material in the AEA 
to include any discrete source of radium-226 and certain other 
naturally occurring radioactive material that is produced, extracted, 
or converted after extraction, before, on, or after the date of the 
enactment of the EPAct, for use for a commercial, medical, or research 
activity. The term Discrete source is not defined in the EPAct, and the 
EPAct specifically mandates that the final regulations, in establishing 
requirements necessary to carry out the amendment, shall include a 
definition of the term Discrete source. The definition of Discrete 
source is used for purposes of the new definition of Byproduct material 
in the case of radium-226 and other naturally occurring radioactive 
material other than source material. The term Discrete source is not 
used in conjunction with accelerator-produced radioactive material in 
the EPAct language.
    Thus, the EPAct gave the NRC authority over discrete sources of 
radium-226 but not over diffuse sources of radium-226. The EPAct did 
not extend the NRC's authority over radium-226 as it occurs in nature, 
or over other processes where radium-226 may be unintentionally 
concentrated. The focus was on those materials that presented a threat 
to public health and safety or to the common defense and security 
similar to the threat posed by discrete radium-226 sources. Scale from 
pipes used in the fossil fuel industry, fly ash from coal powerplants, 
phosphate fertilizers, or residuals from treatment of water to meet 
drinking water standards are not considered discrete sources. However, 
uranium and thorium within these materials may become licensable source 
material depending upon their concentration.
    The definition of Discrete source in the proposed rule was ``a 
radioactive source with physical boundaries, which is separate and 
distinct from the radioactivity present in nature, and in which the 
radionuclide concentration has been increased by human processes with 
the intent that the concentrated radioactive material will be used for 
its radiological properties.'' As a result of public comments on the 
proposed rule, the NRC changed the wording of the definition of 
Discrete source from that in the proposed rule. Discrete source is 
defined in this final rule as ``a radionuclide that has been processed 
so that its concentration within a material has been purposely 
increased for use for commercial, medical, or research activities.'' 
The changes are for clarification purposes only and do not change the 
original intent of the proposed definition of Discrete source or the 
scope of the NRC's regulation of radium-226 or other naturally 
occurring radioactive materials identified in the future. The intent of 
the revised definition continues to be consistent with the proposed 
rule in that the NRC's authority is not intended to extend to all 
naturally occurring radioactive material, specifically not to naturally 
occurring radioactive material that is found in nature in its original 
form and location, or that which is moved or concentrated inadvertently 
by some man-made process. A discrete source will have the same 
radiological characteristics (e.g., type of radiation, half-life) as 
the radionuclide found in nature but will have been purposefully 
concentrated for use for its specific properties after it has been 
removed from its original location in nature. This definition excludes 
the NRC's jurisdiction over inadvertent movement or concentration of 
naturally occurring radioactive material such as scale from pipes used 
in the fossil fuel industry, fly ash from coal power plants, or 
phosphate fertilizers. It also excludes NRC jurisdiction over residuals 
from treatment of water. While radium, in particular, may be 
intentionally concentrated in this case, it is not for the purpose of 
using the radium, but to improve water quality. Only if, and when, this 
radium were further processed for use would it be considered a discrete 
source, and thus byproduct material. Neither the changes to the AEA as 
a result of the EPAct, nor anything in this rulemaking changes the 
NRC's authority, in any manner, over source material.
    The words ``a radionuclide that has been processed so that its 
concentration within a material has been purposely increased'' are 
intended to further clarify that the extraction or processing relates 
to the intent to use the radionuclide itself, and not a material

[[Page 55871]]

that happens to contain the radionuclide, such as fertilizer. The 
addition of the phrase ``for use for commercial, medical, or research 
activities'' repeats a constraint that also appears in the definition 
of Byproduct material. The NRC has repeated this constraint in order to 
ensure that when the term ``discrete source'' is used separately from 
the term ``byproduct material,'' it will not be interpreted more 
broadly, but it will be clear that only material which is intended for 
use for commercial, medical, or research activities is being 
referenced.
    It should also be noted that in accordance with this definition of 
Discrete source, once a discrete source meets the definition of 
Byproduct material, any contamination resulting from the use of such 
discrete sources of this byproduct material will also be considered 
byproduct material. This issue is discussed further in this document 
under ``Summary and Analysis of Public Comments on the Proposed Rule.''

C. Changes to Existing NRC Regulations To Accommodate the New Byproduct 
Material

    The Commission has authority to issue both general and specific 
licenses for the use of byproduct material and to exempt byproduct 
material from regulatory control under Section 81 of the AEA. A general 
license, as provided by regulation, grants authority to a person for 
certain activities involving byproduct material and is effective 
without the filing of an application with the Commission or the 
issuance of a licensing document to a particular person. Requirements 
for general licensees appear in the regulations and are designed to be 
commensurate with the specific circumstances covered by each general 
license.
    In considering the expansion of the definition of Byproduct 
material to include discrete sources of radium-226 and accelerator-
produced radioactive material, the NRC has evaluated products and 
materials previously approved by the States for use under an exemption 
from licensing and under a general license. Generally, the NRC's intent 
in this rule is to accommodate existing products and materials that 
were previously regulated by the States under similar provisions, if 
the potential doses are similar to those expected from other currently 
regulated products and materials. Many of these products have not been 
made for some time, so some of the provisions in this rule are limited 
to items manufactured in the past, which may still be in use or in 
storage.
    The bases of these exemptions and general licenses are primarily 
the SSRs and also information in NRC's sealed source and device (SS&D) 
registry. The SS&D registry is the NRC's national database of technical 
information on sealed sources and devices. Manufacturers or 
distributors may submit a request to the NRC for an evaluation of a 
product's radiation safety information and for registration of the 
product. After satisfactory completion of the evaluation, the NRC 
issues a certificate of registration to the person making the request, 
and this certificate is added to the SS&D registry. Many Agreement 
States have similar registration procedures, and registration 
certificates for the sources and devices they review are added to the 
national SS&D registry. The NRC also has included SS&D certificates for 
NARM, which have been issued by the States. While this is not a 
complete database with respect to NARM, it includes detailed 
information about many products containing NARM previously evaluated by 
the States. In addition to SSRs and the information in the SS&D 
registry, the specific provisions of the various States also were 
considered in developing this rule.
Regulating Items Containing Radium-226
    Currently, items or products containing radium-226 are unique in 
that there are no new items in consumer commerce using radium-226 
byproduct material. Although certain industrial devices such as 
moisture density gauges containing radium-226 are still in use, most 
radium-226 articles have not been produced for at least 20 years. 
Beginning in the early 1900s, radium-226 was used to make self-
luminescent paint and incorporated in watch and clock dials and hands 
and later used to illuminate airplane instrumentation dials and gauges 
as well as markers and signs. Beginning in the 1950s, other 
radionuclides began to replace radium-226 as a self-luminescent 
material due to the recognition of the radiological hazard associated 
with radium-226. Currently, the radionuclides of choice for self-
luminescent applications are promethium-147 and tritium due to the much 
reduced radiological hazard vis-a-vis radium-226.
    Based on the National Council on Radiation Protection and 
Measurements in Report 95, ``Radiation Exposure of the U.S. Population 
from Consumer Products and Miscellaneous Sources,'' radium-226 has not 
been used in radioluminescent watches since 1968 and clocks since 1978. 
In fact, radium-226 timepieces are currently kept largely as 
collectors' items and only infrequently used by consumers as 
timepieces. When originally manufactured, the quantity of radium-226 
employed in watch and clock dials and hands varied by timepiece size, 
manufacturer, model, and from item to item. While the quantity of 
radium-226 varied in the timepieces, there is a general agreement for 
typical average and upper bound quantities. Based upon the spectrum of 
timepiece sizes, wristwatches have the smallest quantity, with pocket 
watches and clocks having quantities several times higher than 
wristwatches. The radioactivity associated with wristwatches is 
generally on the order of several kilobecquerel (kBq) (tenths of a 
microcurie ([mu]Ci)) with an average of 5.6 kBq (0.15 ([mu]Ci)). Pocket 
watches may have radioactivity of about 13 kBq (0.35 [mu]Ci), and 
clocks are typically 18 kBq (0.5 [mu]Ci). However, collections of 
pocket watches and clocks are rare when compared to wristwatches.
    Before the discontinuation of the manufacturing of timepieces 
containing radium-226 in the 1970s, radium-226-illuminated timepieces 
were widely distributed throughout the country as a common consumer 
product. To date, a large number of radium-226 timepieces are still 
owned by individuals as valued heirlooms or collectors' items or are on 
display in museums. Because museums and collectors normally collect a 
wide range of timepieces, a portion of their collection may contain 
radium-226 timepieces. Some businesses and a few collectors are also 
engaged in repairing and refurbishing timepieces either as a hobby or 
professionally, and these activities may occasionally involve 
timepieces containing radium-226. Because these timepieces were 
manufactured before the NRC assumed regulatory authority over radium-
226, and because these timepieces are already in public possession, the 
NRC intends to minimize regulatory impact to individuals, museums, or 
other entities in possession of these timepieces. In finalizing the 
rule, the NRC made its determination based on no significant risk to 
public health and safety and the environment.
    In the proposed rule, the NRC proposed to exempt intact timepieces 
containing no more than 37 kBq (1 [mu]Ci) of radium-226 per timepiece 
and repair of no more than 10 timepieces in any one year. In addition, 
the NRC proposed to generally license no more than 50 timepiece hands 
and dials used or stored at the same location at any one time. Due to 
lack of sufficient health and safety information to make a final 
regulatory decision, the NRC conducted

[[Page 55872]]

a scoping study for estimating potential radiological doses to 
individuals associated with use, storage, and repair of radium-226 
timepieces. The scoping approach taken by the NRC used widely accepted 
methods and employed conservative assumptions for various scenarios 
involving use, storage, and repair of radium-226 timepieces. Because 
the scoping study was designed to be conservative and meaningful and 
yet easy to perform, it is to be expected that the actual doses would 
be significantly lower than those predicted by the scoping study.
    To evaluate the potential doses associated with the proposed 
exemption of radium-226 timepieces, 37 kBq (1 [mu]Ci) of radium-226 per 
timepiece was used in the scoping study instead of the typical average 
activities for timepieces, which provided for additional conservatism. 
Radon-222 is a decay product in the radium-226 decay series and may be 
emitted from the timepiece into the surrounding atmosphere and thus 
result in exposure to an individual in proximity to the timepiece. It 
is believed that the radon-222 emanating from the paint is almost 
totally trapped within the watch. Because of the age of radium-226 
timepieces, and because there is no established method for quantifying 
the trapping behavior, the scoping study conducted by the NRC assumed 
that the entire inventory of decay products instantly escaped and 
became uniformly distributed into the surrounding building volume. This 
assumption is obviously very conservative. As a result, the estimated 
inhalation doses associated with radon-222 are extremely conservative. 
The scoping study found that the estimated doses to a collector for 
repair, storage, and use of a radium-226 timepiece range from a 
fraction of 0.01 millisievert/yr (mSv/yr) [1 millirem/yr (mrem/yr)] to 
a few mSv/yr (mrem/yr) to over 1 mSv/yr (100 mrem/yr).
    At one time, there were repair facilities refurbishing radium 
timepieces on a regular basis by replacing radium-226 paint with 
tritium paint. Scraping off the radium-226 paint may have resulted in 
significant contamination. The NRC is not aware of any current 
operations in which individuals are still routinely handling radium 
watches in such a way as to create a contamination problem. Based upon 
the estimated doses for repairs, the NRC believes that a specific limit 
on the annual number of repairs is not necessary. As long as these 
repairs are taking place under a general license, actions could always 
be taken if the Commission receives information that suggests that the 
public health and safety are not being adequately protected.
    The NRC's intent is to minimize regulatory impact on those private 
collectors and museums as much as possible, and to be as consistent as 
possible with the regulatory approach taken by the Agreement States, 
many of whom have been regulating radium-226 for several decades. 
Accordingly, in light of the public comments received, the Agreement 
States' rulemaking involvement and the results of the scoping study in 
finalizing the rule, the NRC revised the proposed revisions related to 
radium-226 timepieces. Primarily, the change made in this final rule is 
to broaden the general license provision for the radium-226 timepieces. 
Specifically, the NRC has concluded that a finite number of annual 
repairs as well as a limitation on the number of nonintact timepieces 
and timepiece hands and dials is unnecessary and not warranted based 
upon the NRC's understanding of radium-226 timepieces either in 
collections or in use. As a result of the scoping study and in response 
to public comments, the NRC has concluded that it is appropriate to 
recategorize the repair of timepieces from an activity allowed under an 
exemption from licensing to one covered by a general license. This 
categorization is also more consistent with the Agreement States' 
existing exemption provision.
    Although not mandated by regulations, the NRC advises that 
individual collectors or persons engaged in repair of these devices 
should use good practices such as wearing gloves when handling radium-
226 timepieces, hands, and dials, and washing hands to minimize 
potential exposure to the radioactive material. In addition, individual 
collectors should ensure that storage areas are well ventilated to 
minimize potential exposure due to accumulation of radon-222 gas and 
should avoid unnecessary exposure to these types of timepieces.
Exemptions From Licensing
    In 10 CFR Part 30, a number of exemptions from licens