[Federal Register: October 1, 2007 (Volume 72, Number 189)]
[Rules and Regulations]
[Page 55863-55937]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc07-17]
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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
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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
[[Page 55865]]
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
[[Page 55868]]
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 (http://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 licensing
requirements are included. These exemptions allow for certain products
and materials containing byproduct material to be used without any
regulatory requirements imposed on the user. The two exemptions in 10
CFR 30.19, Self-luminous products containing tritium, krypton-85, or
promethium-147, and 10 CFR 30.20, Gas and aerosol detectors containing
byproduct material, are class exemptions which cover a broad class of
products. Under these provisions, new products can be approved for use
through the licensing process if the applicant demonstrates that the
specific product is within the class and meets certain radiation dose
criteria. This contrasts with other exemptions for which the level of
safety is controlled through such limits as specification of
radionuclides and quantities. Section 30.14, Exempt concentrations, and
Section 30.18, Exempt quantities, of NRC's regulations, are broad
materials exemptions, which allow the use of a large number of
radionuclides. The specific radionuclide limits on these concentrations
and quantities are contained in tables in 10 CFR 30.70 and 10 CFR
30.71, respectively. The remaining exemptions from licensing are
product specific, for which many assumptions can be and have been made
concerning how the product is distributed, used, and disposed of. This
final rule adds some products and materials containing NARM to some of
the previously existing exemptions. The table of exempt concentrations
in 10 CFR 30.70 already included all of the radionuclides and
associated limits contained in the equivalent section of the SSRs.
Thus, the NRC is not revising the exempt concentration table in this
final rule.
Exempt Quantities
Part C of the SSRs includes a list of exempt quantities which are
identical to those in 10 CFR 30.71 but includes an additional 13
radionuclides, which are accelerator produced. This final rule adds
these 13 radionuclides and their respective quantities, as already
included in the SSRs, to the list of exempt quantities in 10 CFR 30.71.
The technical bases of these values are similar to those used for the
existing values in 10 CFR 30.71.
The NRC considered whether there were additional radionuclides in
use under comparable State exemptions that should be accommodated under
10 CFR 30.71. It was noted that a few of the States' regulations for
exempt quantities include additional radionuclide-specific values, each
appearing in only one or two States' regulations. These radionuclides
are specifically exempted in only one or two States; thus, they do not
represent nationally recognized exemptions. It was also not clear as to
what approach was used to calculate their exemption values. Therefore,
the NRC is adding only the 13 radionuclides and values from the SSRs
for which there are adequate technical bases, and no further additions
to 10 CFR 30.71 are included in this final rule. It is noted, however,
that for other byproduct material, excluding alpha emitters, which is
the last item on the list in 10
[[Page 55873]]
CFR 30.71, Schedule B allows for 3.7 kBq (0.1 [mu]Ci) to be used as an
exempt quantity. This will apply to accelerator-produced radionuclides
as well. Minor changes are also being made to 10 CFR 30.18 to
accommodate any materials that may have been received before September
25, 1971, under a general license of a State similar to that then
provided in 10 CFR 31.4.
Timepieces Containing Radium-226
The exemption in 10 CFR 30.15(a)(1) is being revised to include
intact timepieces that were manufactured before the effective date of
this final rule and containing no more than 37 kBq (1 [mu]Ci) of
radium-226. This provision is consistent with the SSRs, except that the
rule is limited to ``intact'' timepieces. In the final rule, the repair
of timepieces was moved from the exemption to the general license to be
more consistent with the SSRs and to broaden the general license
provision. As discussed earlier, the possession of nonintact
timepieces, hands, and dials, and the repair of timepieces would be
covered by a new general license. This general license provision should
cover most current practices involving radium-226 and minimize impacts
upon individual collectors and small businesses. A general license is
automatically granted by NRC regulations to any person meeting the
general license criteria. No action is required from these persons to
obtain a general license, and no license or annual fees are applicable
to persons operating under this general license.
Self-Luminous Products
Although the SSR section similar to 10 CFR 30.19 includes an
exemption for previously acquired self-luminous articles containing
less than 3.7 kBq (0.1 [mu]Ci) of radium-226, 10 CFR 30.19 is not being
amended to include this exemption. The basis for not including this
exemption is that, as currently written, 10 CFR 30.19 only applies to
products manufactured and distributed under a specific license issued
under 10 CFR 32.22. The SSR exemption does not require that these
products be previously manufactured and distributed under a specific
license, nor do the SSRs provide for such a license with regard to
radium-226. Instead, the possession, use, and transfer of these items
will be subject to the general license for certain items and self-
luminous products containing radium-226 established in 10 CFR Part 31.
Smoke Detectors
Smoke detectors are included in the class exemption in 10 CFR 30.20
for gas and aerosol detectors. This exemption is being revised to
include previously manufactured detectors containing radium-226. The
provision for smoke detectors is different from the SSRs in that the
SSRs contain a specific limit of 3.7 kBq (0.1 [mu]Ci) for radium-226
that manufacturers may incorporate into the currently manufactured
detectors. However, the SS&D registry includes certificates for smoke
detectors categorized as exempt containing up to 74 kBq (2 [mu]Ci) of
radium-226. While some of these certificates are categorized as
``Active,'' meaning that continued distribution is permitted, a survey
of the States with these certificates confirmed that the distribution
of radium-226 in smoke detectors was, in fact, a past practice. The
provision added to 10 CFR 30.20 for detectors containing radium-226 is
limited to detectors previously manufactured and distributed under a
specific license issued by a State under comparable provisions to 10
CFR 32.26. Thus, similar standards were used in approving distribution
of these detectors for use under an exemption from licensing. This
exemption does not cover smoke detectors manufactured earlier with
larger quantities of radium-226 and authorized for use under a general
or specific license, or smoke detectors that may not have been
distributed under a specific license.
Distribution to Exempt Persons
The NRC retains the authority for authorizing distribution of
products and materials where the end user is exempt from licensing and
regulatory requirements by regulation in 10 CFR 150.15(a)(6), which
states, in part, that persons in Agreement States are not exempt from
the Commission's licensing and regulatory requirements with respect to
the transfer of possession or control of any equipment, device,
commodity, or other products containing byproduct material to persons
who are exempt from licensing and regulatory requirements of the
Commission. The NRC does not transfer this authority when a State
enters into an Agreement with the NRC. Therefore, persons who initially
transfer products containing byproduct material to persons who are
exempt from licensing must have a license from the NRC authorizing
these activities. These distributors also need a specific license from
either an Agreement State or from the NRC authorizing the possession
and use of the byproduct material. As a result of the expansion of the
definition of Byproduct material, the distribution of NARM to exempt
persons, including distribution by licensees in Agreement States, will
also be authorized only by the NRC. Currently, the States have only a
few licensees authorized to distribute to persons exempt from licensing
requirements. These are for exempt quantities of accelerator-produced
radioactive material. In finalizing this rule, the NRC has determined
that most, if not all, of these distribution licensees already have an
NRC license under 10 CFR 32.18 authorizing the distribution of exempt
quantities of pre-EPAct byproduct material. For these distribution
licensees, only a simple amendment of those NRC licenses will be
required as a result of this aspect of this final rule.
Existing General Licenses
General License for Devices in 10 CFR 31.5
Section 31.5 is the primary general license provision in 10 CFR
Part 31. It covers a broad range of devices ``designed and manufactured
for the purpose of detecting, measuring, gauging, or controlling
thickness, density, level, interface location, radiation, leakage, or
qualitative or quantitative chemical composition, or for producing
light or an ionized atmosphere.'' These devices must be distributed
under specific licenses issued under 10 CFR 32.51 or equivalent
regulations of an Agreement State. There are numerous SS&D certificates
for devices containing NARM that have been approved by the States for
use under a general license. These are almost all for devices
containing cobalt-57, sodium-22, or radium-226. In many cases, models
have been approved which are authorized to contain one of these
radionuclides or one or more other radionuclides that were byproduct
material before the EPAct. They have been evaluated under equivalent,
in most cases, or at least comparable, standards by the States. The
rule will accommodate generally licensed devices meeting the
restrictions of the general license that were previously approved by
the States under comparable provisions to 10 CFR 32.51. Active
certificates would stand with amendments, if needed, being made to the
distributors' licenses to cover the new categories of byproduct
material. Any new certificates would be issued by the NRC or the
Agreement States under the AEA encompassing the new definition of
Byproduct material.
The criteria for registration of generally licensed devices under
10 CFR 31.5(c)(13)(i) are revised to include a criterion for
registration by general licensees of devices containing 3.7
megabecquerels (MBq) (0.1 millicurie (mCi)) or more of radium-226. This
[[Page 55874]]
registration process is separate and quite different from the SS&D
registry. It requires physical inventories and certification of device
information by general licensees, allows the NRC and Agreement States
with equivalent regulations to more fully track generally licensed
devices meeting these criteria, and serves to remind general licensees
of their responsibilities under the general license. SS&D certificates
for generally licensed devices that will now come under 10 CFR 31.5
include devices with more than 3.7 MBq (0.1 mCi) of radium-226. These
devices will be subject to the registration requirement in 10 CFR
31.5(c)(13). Other certificates, which include devices with radium-226,
allow only much smaller quantities. These devices will not be required
to be registered. This criterion for registration of radium-226 was
chosen because of the low concentration levels which typically are
required for decontamination and decommissioning involving radium-226,
as well as the relative dispersibility of radium-226. A principal
purpose of the registration process concerns reducing losses of devices
that could significantly contaminate a smelter, if inadvertently
melted. The NRC does not believe there are accelerator-produced
materials used in significant quantities in these types of generally
licensed devices to warrant registration.
Distributors of NARM have typically also been distributors of pre-
EPAct byproduct material. Many of them have not excluded information
about transfers of devices containing NARM from reports of transfers
made to the NRC on generally licensed devices transferred into the NRC
jurisdiction. Therefore, the NRC already has information on some of
these devices in its general license tracking system. The NRC will work
with the States to examine methods to include State information. It is
expected that the registration process will identify additional devices
containing registrable quantities of radium-226, as users in many cases
will already be registering other devices with the NRC containing other
radionuclides and will need to add devices containing radium-226 during
the registration process. The requirements in 10 CFR 32.51, 32.51a, and
32.32 applicable to the manufacture or initial transfer of these
devices did not need revision to accommodate NARM.
Calibration and Reference Sources in 10 CFR 31.8
Section 31.8 provides a general license for the use of up to 185
kBq (5 [mu]Ci) of americium-241 in calibration and reference sources.
This final rule adds radium-226 to 10 CFR 31.8, consistent with the
SSRs. This general license is only applicable to specific licensees
that have calibration and reference sources as defined in 10 CFR 31.8,
and simply eliminates certain administrative requirements to address
these sources under the specific license. The sources are covered by
requirements applicable under the specific license, as well as
additional requirements in 10 CFR 31.8. The requirements in 10 CFR
32.57, 32.58, 32.59, and 32.102 applicable to licenses to manufacture
or initially transfer these sources are also amended to include radium-
226.
General License for In Vitro Test Kits in 10 CFR 31.11
In keeping with the equivalent section of the SSRs, cobalt-57, in
units not exceeding 370 kBq (10 microCi) each, is added to the general
license in 10 CFR 31.11 for use in certain in vitro clinical or
laboratory testing. Also, the requirements in 10 CFR 32.71, which
provide the licensing criteria for the manufacturer and distributor of
the products used under this general license, are revised to apply to
the cobalt-57 products included in the general license.
New General License for Certain Items and Self-Luminous Products
Containing Radium-226
The Commission specifically requested information on the types and
quantities of products containing radium-226 and any information that
could assist the NRC in more fully evaluating the potential impact to
public health and safety and the environment due to activities
involving radium-226 sources. As discussed earlier, the general license
provisions for radium-226 timepieces were changed to remove, from the
proposed rule, a limitation on the number of timepieces that could be
possessed. In response to public comment, the general license provision
within this section for luminous gauges and other luminous products
containing radium-226 was also changed with respect to the categories
of products covered and the numbers of products allowed to be kept at
any one location. This is discussed in this document under the section,
``Summary and Analysis of Public Comments on the Proposed Rule.''
Because 10 CFR 31.2 delineates the applicability of specific provisions
in 10 CFR part 30 to the general licenses of 10 CFR part 31, an
exemption from the reporting and recordkeeping requirements of 10 CFR
30.50 and 30.51 is added to further reduce the regulatory burden on
stakeholders. Furthermore, because many of the circumstances that would
require reporting under 10 CFR 30.50 are unlikely to occur, the NRC
believes that it is unnecessary to apply these requirements to this
general license and that the reporting requirements in 10 CFR 31.12 are
adequate.
The new section added to 10 CFR part 31 provides a general license
to any person for other products and discrete sources containing
radium-226 that are not exempted, and are apparently in the public
domain, but were not otherwise covered under a license and are not
specifically addressed in the SSRs. The general license includes: (1)
Antiquities originally intended for use by the general public and
distributed in the late 19th and early 20th centuries, such as radium
emanator jars, revigators, radium water jars, radon generators,
refrigerator cards, radium bath salts, and healing pads; (2) Nonintact
luminous timepieces and timepiece hands and dials not contained in
timepieces; (3) Luminous gauges and other items containing radium-226
installed in air, marine, or land vehicles (These include airplanes,
helicopters, jeeps, trucks, tanks, ships, landing vessels, artillery
pieces, and any other former military use vehicle no longer in control
of the military.); (4) All other luminous products, provided that no
more than 100 are used or stored at the same location at any one time;
and (5) Small radium sources containing no more than 37 kBq (1 microCi)
of radium-226 as discrete survey instrument calibration sources,
sources contained in radiation measuring instruments, sources used in
educational demonstrations (such as cloud chambers, and
spinthariscopes), electron tubes, lightning rods, ionization sources,
and static eliminators. As discussed earlier, this general license
allows any person to acquire, receive, possess, use, or transfer
radium-226 contained in the previously mentioned products. Persons who
receive, possess, use, or transfer the radium-226 items under the
general license are exempt from the provisions of 10 CFR parts 19, 20,
21, and 10 CFR 30.50 and 30.51 to the extent that the receipt,
possession, use, or transfer is within the terms of the general
license.
The general license prohibits the manufacture, assembly,
disassembly, repair, or import of products containing radium-226 except
for the repair of timepieces; prohibits export under the general
license; and requires that the product only be disposed of by transfer
to a specific licensee authorized to receive it or to a disposal
facility
[[Page 55875]]
authorized to dispose of the material in accordance with any Federal or
State solid or hazardous waste law. The general license also prohibits
abandonment of the product. The general license requires notifying the
NRC if there is any indication of a possible failure of, or damage to,
the product that could result in a loss of the byproduct material and
requires persons possessing these devices under the general license to
respond to written requests for information from the NRC.
It should be noted that 10 CFR 31.2 delineates the terms and
conditions of 10 CFR part 30 which apply to general licensees. These
provisions generally will not require general licensees to initiate any
actions.
It is the NRC's intent, through the general license provision, that
the Agreement States, to a large extent, will be able to maintain the
existing ``status quo'' in regulating these categories of discrete
sources of radium-226. The Agreement States may continue with their
programs, including requiring a specific Agreement State license or
decommissioning plan when larger numbers of products may be involved or
significant contamination of property has resulted.
Specifically Licensed Sealed Sources and Devices
Registration of Safety Information and Licensing of Sealed Sources and
Devices
The NRC is revising 10 CFR 30.32(g) to allow for the specific
licensing of sealed sources and devices containing NARM that were
previously regulated by the States. Sources and devices registered by
the States may be licensed under 10 CFR 30.32(g)(1), and the user is
only required to provide the manufacturer and model number as
registered in the SS&D registry.
A new paragraph (3) is also being added to 10 CFR 30.32(g) to allow
for the licensing of sealed sources and devices containing NARM for
which all of the information otherwise required is not available. This
second provision has been added in this final rule as a result of
public comment. Previously, if a source or device were not registered
in the SS&D registry, the applicant who wanted to use the source or
device would be required to submit all of the safety information
identified in 10 CFR 32.210(c), because this information had not been
submitted previously by the manufacturer or distributor as part of
registering the source or device. For older ``legacy'' devices for
which the manufacturer is no longer in existence, it may be impossible
to provide all of the categories of information identified in 10 CFR
32.210, as required by 10 CFR 30.32(g)(2). The provision being added as
10 CFR 30.32(g)(3) delineates additional information that will be
required to license a source or device for which all of the information
previously required is not available. The information must include a
description of the source or device, a description of radiation safety
features, intended use and associated operating experience, and results
of a recent leak test. The NRC licensing staff will review the
submitted information to make a licensing decision regarding possession
and use of the source and device. This new provision is only applicable
to sources and devices containing NARM manufactured before the
effective date of this final rule.
The information to be provided must demonstrate that there is
reasonable assurance that the radiation safety properties of the source
or device are adequate to protect health and minimize danger to life
and property. The amount of detail needed to make this finding will
depend on such things as the nature of the source or device and the
amount of information identified in 10 CFR 32.210(c) that is available.
However, generally, the source or device description might include the
radionuclide(s), source activity, chemical and physical form,
manufacturer's name, distributor's name, model number, construction
details such as source or device dimensions, source encapsulation, any
labeling, and a radiation profile. A description of device radiation
safety features might include shielding, on-off mechanisms or
indicators, methods for locking beam shutters, any safety warning
labels, type of installation including method of attachment to its
mounting if installed in a fixed location and means of relocation if
portable, and any automatic safety features. The description of the
intended use of the source or device could include how the source or
device is used, the types of users, the locations of use, the occasions
when persons will be near the device and the frequency of these
occasions, and the likely environments to which the source or device
will be subjected during normal use and likely accident conditions. A
description of associated operating experience using the source or
device should describe how the device has been used, particularly if
the device will be used in this manner in the future, should include
routine maintenance procedures and how frequently performed, should
note any operating problems and their resolution, and should identify
any parts that were repaired or replaced. A description of a recent
leak test should identify when the swipe was taken and evaluated and
describe how the leak test swipe was taken, the results, and who
conducted the evaluation.
Applicants are not authorized to remove sources from a device to
obtain source details, unless qualified and specifically authorized to
perform these activities under a license. For ``uncontained'' sources,
applicants will need to use caution and minimize exposure time when
attempting to gather details or information directly from the source.
Regulating the Accelerator-Produced Radioactive Material Used in
Medical Activities
When reviewing the public comments, it was clear that the
discussion in the proposed rule of the NRC's existing regulatory
framework for medical products, the distinction between radionuclide
production licensing and radioactive drug production licensing, and the
commercial and noncommercial distribution provisions, as well as the
introduction of the term ``consortium,'' were confusing to commenters.
In addition to responding to individual comments on these subjects in
the ``Summary and Analysis of Public Comments on the Proposed Rule''
section of this document, the following discussion is provided to give
a clearer overview of the NRC's regulatory framework than was provided
in the proposed rule discussion, particularly with respect to the
delineation between production of radionuclides and radioactive drugs.
Section 651(e) of the EPAct requires the NRC to consider the impact
of its regulations on the availability of radioactive drugs to
physicians and patients. After consideration, the NRC concluded that
its well established regulatory framework for the production,
distribution, and use of in vitro test kits, radioactive drugs (which
include biologics), and SS&Ds for medical use activities involving
byproduct material is also appropriate in large part to similar
products containing accelerator-produced radioactive materials. Using
the existing regulations could, with minor changes, minimize the impact
on the availability of radioactive drugs containing accelerator-
produced radionuclides. Therefore, this regulatory framework is applied
to the producers, distributors, and medical users of in vitro test
kits, radionuclides, radioactive drugs, and SS&Ds containing NARM that
are
[[Page 55876]]
included in the EPAct's expanded definition of Byproduct material.
Radionuclide Production
The preexisting regulatory framework is directly applicable to the
commercial production and distribution of NARM radionuclides. Longer-
lived accelerator-produced radionuclides used in medicine may include:
thallium-201, cobalt-57, and palladium-103. The shorter half-life PET
radionuclides may include: fluorine-18, oxygen-15, and carbon-11. The
production of radionuclides by accelerators (including PET
radionuclides from cyclotrons), as well as the subsequent possession
and use of these radionuclides, will be licensed under existing
requirements in 10 CFR part 30. The producer of the accelerator-
produced radionuclides (including PET radionuclides) can transfer these
radionuclides to manufacturers and other specific licensees under the
provisions of 10 CFR 30.41. This includes both commercial and
noncommercial distribution of accelerator-produced radionuclides
(including PET radionuclides) to specifically licensed universities and
research laboratories for basic research but not for use on human
beings, which is specifically excluded in the definition of Research
and development in 10 CFR 30.4.
These radionuclide production facilities include commercial nuclear
pharmacies with PET centers, i.e., facilities with cyclotrons used to
produce PET radionuclides. The NRC will review applications and the
associated radiation safety programs of these radionuclide production
facilities in accordance with the criteria in 10 CFR 30.33 and other
existing requirements such as 10 CFR parts 19 and 20. In meeting the
general training and experience requirement in 10 CFR 30.33(a)(3),
these applicants will need to have individuals with training and
experience in the production of PET radionuclides, i.e., the processes
from insertion of targets in the accelerator or cyclotron to
radiochemical isolation, purification, and testing. Individuals, such
as radiochemists, physicists, engineers, and others identified by the
applicant with appropriate training and experience, will be recognized
as authorized users (AUs) under the manufacturer's, producer's, or
pharmacy's 10 CFR part 30 license for the production of accelerator-
produced radionuclides (including PET radionuclides) using cyclotrons
or other types of accelerators. To ensure the continued availability of
accelerator-produced radionuclides used to manufacture or prepare
radioactive drugs, it is expected that individuals, who can demonstrate
that they performed the radionuclide production activities using an
accelerator at a radionuclide production facility under the NRC's
waiver (70 FR 51581; August 31, 2005), will be recognized as AUs as
long as their duties and responsibilities do not significantly change.
The applicant will be required to document that these individuals were
responsible for the production of radionuclides using a cyclotron or
accelerator when the waiver was in effect.
The NRC is distinguishing between the ``production of
radionuclides'' and ``preparation of radioactive drugs.'' Production of
radionuclides, which would include production of PET radionuclides
using a cyclotron (or other accelerator), is regulated under 10 CFR
part 30. Preparation of radioactive drugs for medical use from
radionuclides, including PET radionuclides, is regulated under 10 CFR
32.72 and 10 CFR part 35. Preparation of radioactive drugs for medical
use may occur at locations other than the production facility. In the
proposed rule, 10 CFR 32.72 included a provision to authorize
commercial nuclear pharmacies that were not registered with FDA or
registered with a State as a PET drug production facility to produce
PET radionuclides if their radiation safety programs meet the criteria
in 10 CFR 30.33. However, the purpose of 10 CFR 32.72 is to address the
criteria and requirements for the production and commercial
distribution of radioactive drugs for medical use, and not the
production of radionuclides. Therefore, the final rule does not include
this provision. Based on a review of the requirements in 10 CFR part
30, no revisions to the regulations are needed to license PET
radionuclide production under 10 CFR part 30.
10 CFR Part 32 Specific Production and Distribution Requirements.
Byproduct material may be transferred under 10 CFR 30.41 from one
specific licensee to another person authorized to receive the material.
However, not all transfers can be made under this provision, and
certain transfers (or distributions) require that the manufacturer,
preparer, or distributor meet specific provisions of 10 CFR part 32.
Specifically, a commercial radioactive drug manufacturer or a
commercial nuclear pharmacy must obtain a distribution license issued
under 10 CFR 32.71 to distribute certain in vitro test kits to
generally licensed medical and veterinary clinical laboratories, and a
medical distribution (MD) license issued under 10 CFR 32.72 to
commercially distribute radioactive drugs to 10 CFR part 35 (and
equivalent Agreement State) medical use licensees. The proposed rule
included revisions to the qualifications for a licensee to obtain a 10
CFR 32.72 MD license to more accurately describe the FDA registration
criteria and to include licensees registered with a State as a PET drug
production facility. These provisions are unchanged in the final rule.
No changes are necessary for MD licenses issued to medical SS&D
manufacturers under 10 CFR 32.74. The MD licenses issued under 10 CFR
32.72 and 10 CFR 32.74 authorize distribution for medical use (10 CFR
part 35 and equivalent State) licensees. Under the NRC's licensing
practice, most of the 10 CFR part 32 distribution licenses do not
authorize the possession and use of byproduct material; rather,
separate 10 CFR part 30 licenses are issued for this purpose.
PET radioactive drugs are made with radionuclides that are usually
very short lived. In addition to the commercial drug manufacturers and
commercial nuclear pharmacies, individual hospitals, educational
institutions, and Federal facilities may have cyclotrons used to
produce PET radionuclides and may also prepare PET drugs from these PET
radionuclides. Although most PET radionuclides are very short lived,
certain PET radionuclides with longer half-lives may be transported
from the production facility to the user's site. The longer-lived PET
radionuclides may also be combined with nonradioactive chemicals and
biologics to produce new PET radioactive drugs. Hence, there are
production and commercial distributions of some PET radioactive drugs
(e.g., fluorine-18 deoxyglucose) to medical users (10 CFR part 35
licensees).
Consortiums and Noncommercial Distribution
The extremely short-lived radionuclides used for medical use have
to be made into drugs and administered immediately after production,
essentially necessitating that the cyclotron be located in the medical
facility or in very close proximity. Some educational institutions,
medical use facilities, or Federal facilities may form ``consortiums''
with adjacent or nearby hospitals to jointly own or share in the
operation and maintenance costs of the PET radionuclide production
facility. ``Consortium'' in this context means an association of
medical use licensees, and a PET radionuclide production facility, in
the same geographical area, that jointly own or share in the operation
and maintenance cost of the
[[Page 55877]]
PET radionuclide production facility that produces PET radionuclides,
for use in producing radioactive drugs within the consortium, for
noncommercial distributions among its associated members for medical
use. The PET radionuclide production facility within the consortium
must be located at an educational institution or a Federal facility or
a medical facility. These facilities may produce PET radionuclides and
radioactive drugs for members of their consortium and make these PET
radionuclides and drugs available to these associated facilities
through noncommercial distributions. Before this rulemaking, the NRC's
regulations did not allow for the noncommercial distribution of
radioactive drugs to medical use licensees. The NRC's regulations in 10
CFR 32.72 for the manufacture, preparation, or transfer of radioactive
drugs cover only commercial distribution. Medical uses of drugs under
10 CFR 35.100, 35.200, and 35.300 were previously limited to drugs
obtained from a 10 CFR 32.72 licensee, or Agreement State equivalent,
or prepared by the medical use licensee under specific provisions in 10
CFR part 35. Because the NRC did not allow noncommercial distribution
of radioactive drugs, failure to address noncommercial distribution of
PET radioactive drugs in the this final rule would impact the
availability of these drugs to physicians and patients.
Therefore, the NRC developed a new regulatory process based upon
existing practices to minimize impact on the noncommercial distribution
of PET radioactive drugs to medical use licensees within such a
consortium. In accordance with this process, a part 35 medical use
facility that uses its own cyclotron to produce PET radionuclides for
use under its own medical use license, would not need to be licensed
for medical distribution under 10 CFR 32.72, but it would have to be
specifically authorized under 10 CFR part 30 for the production of PET
radionuclides.
The definition of Consortium incorporates the unique features
associated with the noncommercial distribution of PET radioactive
drugs. For example, the consortium members must be in the same
geographical area because of the short half-lives of PET radionuclides,
e.g., 1.8 hours for fluorine-18, 20 minutes for carbon-11, and 2
minutes for oxygen-15. The location of the PET radionuclide production
facility is limited to an educational institution or a Federal facility
or a medical facility because these are the noncommercial facilities
that would have cyclotrons that could produce PET radionuclides.
The NRC will review PET radionuclide production applications and
their radiation safety programs in accordance with the criteria in 10
CFR 30.32 and 30.33 and other applicable requirements. In the proposed
rule, only the noncommercial transfer of PET radioactive drugs between
10 CFR part 35 medical use licensees was considered. However, the NRC
recognized that the entity within the consortium with the PET
production operation may not be a medical licensee, but a university or
Federal facility. In addition, the radionuclide production facility
requires a specific license under 10 CFR part 30. For this reason, the
labeling provisions in 10 CFR 35.69, which would only have applied to
medical licensees, were relocated from 10 CFR part 35 to 10 CFR part
30.
The new definition of Consortium and the provisions for
noncommercial distribution are added to 10 CFR 30.4, 30.32, and 30.34
to allow for authorization of the production of PET radioactive drugs
for noncommercial transfer to medical use licensees within a
consortium. Thus, under these new provisions, a medical use facility,
educational institution, or Federal facility with a licensed PET
radionuclide production facility within its consortium does not need a
medical distribution license under 10 CFR 32.72 if it intends to
transfer PET radioactive drugs to members of its consortium. If it
intends to commercially distribute PET radioactive drugs or distribute
to medical licensees outside of its consortium, then a medical
distribution license under 10 CFR 32.72 would be required. In any
event, a specific authorization would be required to produce the PET
drugs for noncommercial transfer to medical use licensees within its
consortium. The requirements for authorization to produce PET drugs for
noncommercial transfer to consortium members and the definition of
Consortium are being added to 10 CFR 30.4. Specific requirements
applicable to this licensed activity are added to 10 CFR 30.34(j).
These requirements parallel the requirements for the commercial
distribution of PET radioactive drugs, e.g., the licensee is qualified
to produce radioactive drugs, the labeling contains consistent
information, transport containers are adequately shielded, and
radioactivity is accurately determined. Noncommercial distribution of
PET radioactive drugs within a consortium may occur among members that
are located in the same geographical area even if in different
jurisdictions (e.g., Federal facility or other NRC licensees and
Agreement State licensees). Thus, these new provisions are being
assigned a Compatibility Category B.
Minor revisions were proposed to 10 CFR part 35 to permit medical
use facilities to receive PET radioactive drugs by noncommercial
transfer and to permit the medical use licensee to use activity values
or activity concentration values for these PET radioactive drugs based
on the measurements made by a PET radioactive drug producer within its
consortium. The final rule also includes these provisions (in 10 CFR
35.65(b)(2) and (c)(3), 35.100(a), 35.200(a), and 35.300(a)), but the
provisions are revised to clarify that the PET radioactive drugs have
been produced by, and the measurements made by, the licensee authorized
under 10 CFR 30.32(j) to produce PET radioactive drugs for
noncommercial transfer to members of its consortium.
Authorized Nuclear Pharmacists (ANPs) and Authorized Users (AUs).
No regulatory changes were needed for ANPs to use all byproduct
material (i.e., reactor-produced radionuclides, PET radionuclides, and
other accelerator-produced radionuclides) to prepare PET radioactive
drugs and other radioactive drugs under the practice of pharmacy.
Medical use licensees that receive PET radionuclides that are added to
``cold kits'' may continue to prepare them under the same authorization
in 10 CFR 35.100(b), 35.200(b), and 35.300(b) as other unsealed
byproduct materials for medical use. However, a minor revision was made
to each of these sections to clarify that the ANP and the qualified AU
were not authorized under these sections to produce radionuclides.
Further, to ensure the availability of radioactive drugs made from
accelerator-produced radionuclides, nuclear pharmacists responsible for
the preparation of only PET or other NARM radioactive drugs under the
NRC's waiver (70 FR 51581; August 31, 2005) will be ``grandfathered''
and will not be required to meet the new training and experience
requirements as long as their duties and responsibilities under the new
license do not significantly change. The ``grandfathering'' provisions
are included in the revised provisions of 10 CFR 35.57 and 10 CFR
32.72(b)(4). The licensee is required by 10 CFR 32.72(b)(5) or 10 CFR
35.14(a) to document that these individuals were responsible for the
preparation of only PET or other NARM radioactive drugs when the waiver
was in effect.
[[Page 55878]]
To ensure a smooth transition and availability of radioactive drugs
and sealed sources made from accelerator-produced radionuclides for
medical use, those individuals, i.e., physicians, podiatrists,
dentists, and radiation safety officers (RSOs), who used only NARM
byproduct materials for medical uses under the NRC's waiver (70 FR
51581; August 31, 2005) will also be ``grandfathered'' in 10 CFR 35.57
as long as their duties and responsibilities do not change
significantly. These new grandfathering provisions are limited to those
who used only NARM during the waiver, because any prior use of ``old''
byproduct material would have been subject to the existing requirements
for being an AU or ANP or RSO.
These grandfathering provisions were in the proposed rule. However,
the final rule does not include revisions to the definition of an
Authorized user or Authorized nuclear pharmacist in 10 CFR 35.2. The
NRC concluded that the definitions did not need to be revised because
the grandfathering provisions for the RSOs, medical physicists, nuclear
pharmacists, physicians, dentists, and podiatrists, who used only
accelerator-produced radioactive material, were included in 10 CFR
35.57. Language has been added to 10 CFR 35.57 to clarify that these
individuals qualify as AUs and ANPs for purposes of the regulations in
part 35. In addition, these individuals could continue to work as AUs,
Authorized medical physicists (AMPs), or ANPs under the notification
provisions of 10 CFR 35.13 and 10 CFR 35.14.
The radiation safety knowledge needed to safely use NARM for
medical uses or for use in the practice of pharmacy is similar to that
for other byproduct material. Therefore, individuals who only used NARM
radioactive drugs or sealed sources in the practice of medicine or
pharmacy will be authorized for use of all similar byproduct material
for the same uses. The reverse is also true that individuals already
authorized to use byproduct material in 10 CFR part 35 for medical use
or for use in the practice of pharmacy are authorized to use NARM.
Further, no changes were made to the training and experience criteria
in 10 CFR part 35 for any authorized individual.
Actions Taken To Ensure Availability of Accelerator-Produced
Radioactive Drugs
In summary, to minimize the regulatory impact on the availability
of accelerator-produced radioactive drugs, the NRC is taking the
following actions: (1) Applying its established regulatory framework to
the commercial distribution of these drugs; (2) expanding the
regulations to permit production of PET drugs by medical use licensees,
educational institution licensees, and Federal licensees for
noncommercial distribution to members of their consortium; (3)
permitting medical use licensees to use activity or activity
concentration values measured by the PET radioactive drug producer in
their consortium when determining dosages; (4) ``grandfathering''
current medical and pharmacy users of accelerator-produced radioactive
drugs; and (5) retaining the existing training and experience criteria
in 10 CFR part 35 for authorized individuals.
In addition, as discussed under ``Implementation Strategy'' in this
document, the NRC is revising Parts 30, 32, and 35 to authorize persons
that used accelerator-produced radioactive material under the NRC's
waiver (70 FR 51581; August 31, 2005) to continue to use these
materials after the waiver is terminated, provided that these persons
apply for a license or request for a license amendment within the
allotted time frames. This regulatory provision allows all persons,
including those who manufacture, produce, transfer, receive, acquire,
own, possess, or use these materials, to continue with their activities
including medical activities until the NRC makes its final licensing
decision. This provision also ensures the availability of accelerator-
produced radionuclides, radioactive drugs, and sealed sources and
devices used for medical uses.
Amendments and Notifications for PET Radionuclide Production and
Delivery Lines
The NRC reviewed its regulations in 10 CFR Part 35 to determine if
there were radiation safety provisions in its existing regulations that
needed revision to incorporate unique radiation safety issues
associated with the use of accelerator-produced radionuclides for
medical use. The medical use of extremely short-lived radionuclides,
e.g., oxygen-15, requires that a PET radioactive drug containing this
radionuclide be administered in the imaging and localization medical
use area (10 CFR 35.200) immediately after the radionuclide is produced
by the cyclotron and processed as a radioactive drug. This necessitates
that the medical use area be co-located with the cyclotron or have a
PET radioactive drug delivery line from the PET radionuclide
production/PET radioactive drug processing area. This introduces the
potential for a high radiation area in a medical use area that would
otherwise be a low radiation area. This is a unique situation and was
not envisioned when the NRC developed the requirements that permitted
licensees to make changes in the areas where byproduct material is used
only in accordance with 10 CFR 35.100 or 10 CFR 35.200 without
submitting a license amendment. As a result, changes have been made to
the requirements in revised 10 CFR 35.13, ``License amendments,'' 10
CFR 35.14, ``Notifications,'' and 10 CFR 35.15, ``Exemptions regarding
Type A specific licenses of broad scope.'' The final rule provides that
an amendment is required for a limited specific medical use licensee in
the unique situation described previously if the changes involved
movement of the cyclotron or a PET radioactive drug delivery line from
the PET radionuclide production/PET radioactive drug processing area.
Changes to the typical 10 CFR 35.100 and 10 CFR 35.200 medical use
areas are not affected. Section 35.15 is revised to clarify that a
licensee possessing a Type A specific license of broad scope would not
need to meet the notification requirements in 10 CFR 35.14(b)(5) for
any changes to the area of use identified in its application where
byproduct material is used in accordance with 10 CFR 35.100 or 10 CFR
35.200. This provision was revised from the proposed rule.
Strontium/Rubidium Generators
Contamination limits for strontium-82/rubidium-82 generators and
related requirements consistent with similar provisions of the SSRs are
added to 10 CFR part 35. The contamination limits are no more than 0.02
kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02
[mu]Ci of strontium-82 per mCi of rubidium-82 chloride), or no more
than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection
(0.2 [mu]Ci of strontium-85 per mCi of rubidium-82). These limits and
requirements to measure the contamination for compliance with these
limits are added to 10 CFR 35.204, with corresponding recordkeeping
requirements added to 10 CFR 35.2204. A corresponding provision for
these tests and associated recordkeeping is also added to 10 CFR 30.34
for nonmedical use licensees, such as commercial nuclear pharmacies,
using these generators.
[[Page 55879]]
Appendix B to Part 20--Annual Limits on Intake (ALIs) and Derived Air
Concentrations (DACs) of Radionuclides for Occupational Exposure;
Effluent Concentrations; Concentrations for Release to Sewerage
The comparable provisions in Part D of the SSRs do not include any
new accelerator-produced radionuclides other than the ones already in
10 CFR part 20, Appendix B. The NRC considered whether some other
radionuclide-specific values should be added to 10 CFR part 20,
Appendix B. Because nitrogen-13 and oxygen-15 are two of the
accelerator-produced radionuclides that are produced for medical uses,
the NRC performed a preliminary calculation of values based on dose
factors published in National Council on Radiation Protection and
Measurements (NCRP) Report No. 123 on Screening Models for Releases of
Radionuclides to Atmosphere, Surface Water, and Ground. Certain dose
conversion factors were not readily available. Results from these
preliminary calculations yielded a derived air concentration (DAC)
based on the submersion scenario for both nitrogen-13 and oxygen-15 of
about 1.48 x 10-2 becquerels per milliliter (Bq/ml) (4 x
10-6 [mu]Ci/ml) for occupational exposure and a
corresponding effluent concentration of 7.4 x 10-4 Bq/ml (2
x 10-8 [mu]Ci/ml) for exposure of members of the public.
These calculated values are larger than the default values for DAC and
effluent concentration by a factor of 40 and 20, respectively, in 10
CFR part 20, Appendix B. Because the approach used in calculating
values for nitrogen-13 and oxygen-15 is different from that used for
other radionuclides included in 10 CFR part 20, Appendix B, the NRC did
not include adding specific values for these radionuclides in the
proposed rule. Because certain medical communities had expressed the
desire of having specific DACs for these two radionuclides, the
Commission specifically requested public comment on the default values,
and whether it should include larger specific values for oxygen-15 and
nitrogen-13 in the final rule. As a result of comments, these values
have been added to 10 CFR part 20, Appendix B, in the final rule. This
is discussed further in this document under ``Summary and Analysis of
Public Comments on the Proposed Rule.''
Emergency Planning
The regulations in 10 CFR 30.32(i)(1) require applications for
specific licenses for byproduct material in unsealed form, on foils or
plated sources, or sealed in glass in excess of the quantities in 10
CFR 30.72, ``Schedule C--Quantities of radioactive materials requiring
consideration of the need for an emergency plan for responding to a
release,'' to contain either an evaluation showing that the maximum
dose to a person offsite, due to a release of radioactive materials,
would not exceed 0.01 sievert (Sv) (1 rem) effective dose equivalent or
0.05 Sv (5 rems) to the thyroid, or an emergency plan for responding to
a release of radioactive material. Schedule C also contains a release
fraction for each radionuclide against which aspects of the evaluation
submitted in place of an emergency plan must be compared in accordance
with 10 CFR 30.32(i)(2).
Although Part P, ``Contingency Planning for Response to Radioactive
Material Emergencies,'' of the SSRs addresses an emergency plan, a
value for radium-226 is not specifically listed. The NRC staff
therefore considered NUREG-1140, ``A Regulatory Analysis on Emergency
Preparedness for Fuel Cycle and Other Radioactive Material Licensees,''
dated August 1991. NUREG-1140 was used as the technical basis in a past
rulemaking effort related to quantities of radioactive materials
requiring an emergency plan. NUREG-1140 provided the basis for 10 CFR
30.72 Schedule C values. Schedule C also contains a default value for
alpha emitters of 74 gigabecquerels (GBq) (2 curies (Ci)) (with release
fraction 0.001), which would apply to discrete sources of radium-226
absent a specific value being added to the table. However, the quantity
value for radium-226 in NUREG-1140 is 3.7 terabecquerels (TBq) (100 Ci)
along with a release fraction value of 0.001. This final rule adds
radium-226 with the quantity 3.7 TBq (100 Ci) and release value 0.001
to 10 CFR 30.72 Schedule C, which is consistent with the technical
basis for the original emergency planning requirements. It is expected
that few, if any, licensees, or applicants for a license, would have
3.7 TBq (100 Ci) of discrete sources of radium-226. Because the ``rule
of ratios'' applies (See Footnote 1 to 10 CFR 30.72), licenses
authorizing other byproduct material, in quantities approaching values
that would require emergency planning, which are being amended to add
significant quantities of discrete sources of radium-226, could
potentially result in authorizing total quantities of byproduct
material that would meet the criteria for emergency plan requirements.
It is not expected that accelerator-produced radioactive materials are
used in significant enough quantities to affect the applicability of
emergency plan requirements.
Low-Level Radioactive Waste and Decommissioning
Low-Level Radioactive Waste
Section 651(e)(3) of the EPAct mandates that the newly added
byproduct material is not considered to be low-level radioactive waste
for the purposes of the Low-Level Radioactive Waste Policy Amendments
Act (42 U.S.C. 2021b) (LLRWPAA). The intent of this provision is that
the newly added byproduct material is not to be impacted by the compact
process of the LLRWPAA. This provision does not have an impact on the
NRC's policy and requires only a minor change to the regulations to
ensure that the term ``low-level radioactive waste,'' when used in the
NRC's requirements, does not include the newly added byproduct
material.
Although the newly added byproduct material is not considered low-
level radioactive waste, it does pose a similar hazard, and it does
need to be disposed of appropriately. Section 651(e)(3) of the EPAct
requires that the newly added byproduct material must be disposed of in
a facility that: (1) Is adequate to protect public health and safety;
and (2) is licensed by the Commission or by an Agreement State. Even
though it is not low-level radioactive waste, this provision clarifies
that the newly added byproduct material is to be disposed of in a
facility licensed by the NRC under 10 CFR part 61 or the Agreement
State requirements, which are compatible to 10 CFR part 61. This
provision also allows for the disposal of the newly added byproduct
material in a facility licensed by the NRC under other parts of the
NRC's regulations, such as facilities licensed under 10 CFR part 40,
Appendix A.
To ensure that disposal facilities licensed under 10 CFR part 61
continue to be adequate to protect public health and safety, the NRC
must consider the specific health and safety issues associated with
disposal of discrete sources of radium. Rather than making any changes
to 10 CFR part 61 at this time, the NRC will evaluate any specific
disposals of discrete sources of radium at an NRC-licensed disposal
facility under 10 CFR 61.58, ``Alternative requirements for waste
classification and characteristics.'' The NRC has not identified any
other radionuclides being added to the definition of Byproduct material
that require any specific evaluations to ensure the proper disposal of
waste in accordance with 10 CFR part 61.
[[Page 55880]]
Notwithstanding the previously mentioned provisions for the NRC or
Agreement State licensing of the disposal facility for the newly added
byproduct material, Section 651(e)(3) of the EPAct does not affect the
authority of any entity to dispose of the newly added byproduct
material at a disposal facility in accordance with any Federal or State
solid or hazardous waste law, including the Solid Waste Disposal Act.
This means that Federal and State solid or hazardous waste laws can
continue to be used as an authority to permit disposal of this newly
added byproduct material. Disposal solutions already in place to allow
disposal of the newly added byproduct material are unaffected by the
EPAct. To implement this provision of the EPAct, the NRC is changing
its regulations in 10 CFR Part 20 to redefine Waste to allow disposal
of the newly added byproduct material in the NRC-regulated disposal
facilities or in a disposal facility permitted under Federal or State
solid or hazardous waste laws.
Appendix G of 10 CFR Part 20, the uniform manifesting requirements
for low-level radioactive waste, includes numerous requirements
containing the words ``low-level radioactive waste'' and ``waste.''
This is potentially confusing because the newly added byproduct
material is not low-level radioactive waste in accordance with the
provisions of the EPAct. However, no changes have been made to Appendix
G to 10 CFR Part 20. The text changes made to the 10 CFR Part 20
regulations to clarify that the newly added byproduct materials are not
``low-level radioactive waste'' make it clear that the Appendix G to 10
CFR Part 20 requirements must be met if any of the newly added
byproduct material waste is to be disposed of at a facility licensed
under 10 CFR Part 61 or an equivalent Agreement State rule.
Decommissioning Issues
The inclusion of accelerator-produced radioactive material that is
used for a commercial, medical, or research activity, in the definition
of Byproduct material, requires the NRC to ensure that decommissioning
funding is adequate at accelerator facilities to adequately
decontaminate and decommission their facilities for license
termination. Radioactive materials produced in accelerator facilities,
that are produced, extracted or converted after extraction for use for
commercial, medical, or research purposes and that are no longer
residing in the accelerator, are not a concern for decommissioning.
However, materials intentionally or incidentally made radioactive as a
result of the production of the radioactive materials for use for
commercial, medical, or research purposes must be managed safely. Any
radioactive material residing in the accelerator or within the facility
that houses the accelerator must be adequately considered for safe
operation, and managed appropriately at the time of decommissioning of
the accelerator-produced radionuclide production facility, including
the accelerator, and the NRC must ensure that adequate financial
assurances are put in place to address the costs of decommissioning
when the radionuclide production operation ceases, and the accelerator
is shutdown, and the license is terminated. As with all decontamination
and decommissioning situations, short-lived radionuclides are expected
to decay to safe levels before license termination. Therefore, only
radionuclides with a half-life of more than 120 days, that are present
in sufficient quantities specified in 10 CFR 30.35, need to be
addressed for the purposes of establishing adequate financial
assurances for decommissioning.
Similarly, the addition of discrete sources of radium-226 in the
definition of Byproduct material requires the NRC to ensure that
decommissioning funding is adequate for holders of specific licenses
for possession of discrete sources of radium-226. Radium-226 is already
included in Appendix B of 10 CFR Part 30 to determine the required
level of financial assurance for holders of specific licenses in
accordance with the requirements of 10 CFR 30.35. Therefore, applicants
for specific licenses to possess discrete sources of radium-226 will
need to assure that adequate financial assurances are provided for the
types of sources and the total amount of radium-226 contained in the
sources they will possess. Holders of general licenses for possession
of discrete sources of radium-226 do not need financial assurance for
decommissioning. However, in accordance with the approach for general
and specific licensing of discrete sources of radium-226 being
undertaken by the NRC in this final rule, a general licensee may become
subject to specific licensing if the accumulated number of discrete
sources of radium-226 exceeds the allowable quantities of a general
license. If a general licensee becomes subject to specific licensing,
the licensee would be required to acquire the financial assurances
required under 10 CFR 30.35.
The NRC believes that the financial assurance requirements included
in 10 CFR 30.35 are adequate to ensure that any person who will receive
a specific license authorizing possession and use of byproduct material
will be required to have adequate financial assurance in place for
decommissioning the facility. Therefore, the NRC is not changing the
regulations governing financial assurance for decommissioning.
The NRC is cognizant of the potential existence of facilities and
sites which may be, or have the potential to become, contaminated with
significant amounts of radium-226 from past practices or operations.
Additionally, the potential exists for significant quantities of
discrete sources of radium-226 to have been previously disposed of by
both licensees and nonlicensees at their facilities. The existing
requirements for licensing and decommissioning in 10 CFR Part 30 are
sufficient to address these situations for any facilities that will
apply for a specific license or amendment to authorize possession of
discrete sources of radium-226 for their current operations. The
applications to the NRC, in these cases, would include a facility-
specific decommissioning plan that addresses the current contamination
and any previous onsite disposals.
There are no similar assurances for any facility that is currently
contaminated from discrete sources of radium-226 but is not licensed.
With the inclusion of discrete sources of radium-226 in the definition
of Byproduct material, the NRC acquires the regulatory authority to
address these situations where a specific license has not been issued
(or where a potential licensee cannot be identified). At this time,
there is not enough known about the breadth or depth of these potential
radium-226 contamination situations to determine if any additional
requirements may be needed to address them. Therefore, the NRC will
address these situations on a case-by-case basis as they are identified
following the effective date of this final rule.
D. License Application and Annual Fees
The NRC is required to recover approximately 90 percent of its
budget authority each year under the Omnibus Budget Reconciliation Act
of 1990 (OBRA-90), as amended. Therefore, the NRC charges licensing,
inspection, and annual fees to its applicants and licensees. Each type
of fee includes agency and program overhead. The NRC revises these fees
each year in light of its current fiscal year budget and other factors,
including changes in the regulatory efforts associated with the
different classes of licensees.
[[Page 55881]]
Persons applying for a license with the NRC, or requesting a