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



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Part II





Nuclear Regulatory Commission





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10 CFR Parts 20, 30, et al.



Requirements for Expanded Definition of Byproduct Material; Final Rule

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

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NUCLEAR REGULATORY COMMISSION

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

RIN 3150-AH84


Requirements for Expanded Definition of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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

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

FOR FURTHER INFORMATION CONTACT: Lydia Chang, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6319, e-mail [email protected]; 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 [email protected].

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 an 
amendment to their current licenses that may result in the addition of 
a new fee category, are required to pay a license application fee under 
10 CFR Part 170, unless exempt under the fee exemption provisions of 10 
CFR 170.11. The application fees for materials users are ``flat'' fees 
that are calculated by multiplying the average professional staff hours 
needed to process the application by the professional staff-hour rate 
in 10 CFR 170.20 ($258 in the FY 2007 final fee rule). An application 
fee must generally be paid for each applicable fee category.
    Additionally, all persons who hold licenses issued by the NRC are 
subject to annual fees under 10 CFR Part 171, unless exempt under the 
provisions of 10 CFR 171.11. The 10 CFR Part 171 fee categories, and 
the associated fees for materials users, are provided in 10 CFR 171.16, 
and must generally be paid for each applicable fee category. A licensee 
may request consideration as a small entity for the annual fees which 
may result in a reduced fee, as described in 10 CFR 171.16.
    The annual fees for the materials users fee class are calculated 
based on the NRC's budgeted resources allocated to regulating these 
types of licensees, less any receipts received from this fee class for 
10 CFR Part 170 activities. The net dollar value of budgeted resources 
for this fee class is allocated to all materials user fee categories 
(subclasses) based on the average application and inspection costs 
associated with each category. This approach provides a proxy for 
allocating the generic and other regulatory resources to the diverse 
categories of licensees based on how much it costs the NRC to regulate 
each fee category. The fee calculation also considers the inspection 
frequency (priority based), which is indicative of the safety risk and 
resulting regulatory costs associated with these categories of 
licenses.
    The license application fees schedule is in 10 CFR 170.31. The 
annual fees schedule is in 10 CFR 171.16. The fee amounts included in 
the proposed rule were based on the FY 2005 fees. The fee amounts noted 
in the final rule are based on the final FY 2007 fees. The final 2007 
fee rule was published June 6, 2007 (72 FR 31402).
    The NRC believes that the majority of the NRC's licensees affected 
by this final rulemaking will be using radioactive material in a manner 
similar to their existing authorizations, and their existing fee 
categories should not change as a result of this rule. However, some 
licensees may need to amend their licenses to add one or more new fee 
categories, if applicable, for new uses and radioactive material now 
considered byproduct material, i.e., accelerator-produced radioactive 
material or discrete sources of radium-226.
    The NRC is establishing three new fee categories for activities 
that were not previously covered by its regulations. The new fee 
categories apply to certain items previously manufactured and self-
luminous products containing radium-226 and to the production of 
accelerator-produced radioactive material. In determining the fees for 
these new categories, the NRC evaluated existing fee categories that 
the NRC believes require a similar level of regulatory effort as these 
newly regulated activities for actions such as licensing, inspection, 
and event response.
    Most individuals and other entities collecting items containing 
radium-226 are expected to be eligible to be exempt from license under 
10 CFR 30.15 or for a general license under the new 10 CFR 31.12, 
``General license for certain items and other self-luminous products 
containing radium-226.'' Therefore, they would be subject to the 
requirements of 10 CFR 30.15 or 10 CFR 31.12 (e.g. proper disposal of 
the radioactive material). However, if a person collects more than the 
number of items or limits specified in these sections, that person will 
be required to obtain a specific license and be subject to the 
regulations regarding license application and annual fees. The NRC is 
establishing a new fee category, 3.R., with a two-tiered fee level, for 
those persons requiring a specific license for items containing radium-
226. The distinction between the two fee levels is based on the number 
of items or limits specified in 10 CFR 31.12(a)(4) or (5) and the 
estimate of the level of regulatory effort between the two levels. 
Licensees who currently possess radium sources in amounts that exceed 
the general license provisions of 10 CFR 31.12 would be required to add 
the sources to their specific license. This would normally subject the 
licensee to the fees in this new fee category. However, if the radium-
226 sources are used for operational purposes that are covered under 
another fee category, the licensee will not be subject to the fees in 
this new fee category. This exception will not apply if the radium 
sources are possessed for storage only.
    The first new fee Category 3.R.1. is for persons possessing 
quantities greater than the number of items or limits in 10 CFR 
31.12(a)(4) or (5), but less than or equal to 10 times these 
quantities. Because the estimated level of regulatory effort is 
comparable to the level of effort for Category 8, Civil defense, the 
license application and annual fees for 3.R.1. will be $590 and $2,100, 
respectively. The second new fee Category 3.R.2. is for persons 
possessing quantities greater than 10 times the number of items or 
limits in 10 CFR 31.12(a)(4) or (5). The license application and annual 
fees for this new category, 3.R.2., will be $1,400 and $2,700, 
respectively, comparable to the fees for Category 3.P., ``All other 
specific byproduct material licenses, except those in Categories 4A 
through 9D.''
    Persons who wish to disassemble, repair, or assemble products 
containing radium-226 will be required to obtain a specific license and 
will be subject to the applicable license application and annual fees. 
The NRC is including this use in fee Category 3.B., ``Other licenses 
for possession and use of byproduct material issued under 10 CFR Part 
30 of this chapter for processing or manufacturing of items containing 
byproduct material for commercial distribution.'' The license 
application fee for this category will be $4,600, and the annual fee 
will be $8,400.
    The NRC is adding a new fee Category 3.S. for the production of 
accelerator-produced radioactive materials. The NRC is adding this new 
fee category because these production activities need to be 
distinguished from those activities that only involve the use of 
already-prepared radionuclides. The regulatory effort for the new fee 
Category 3.S. is estimated to be similar to that for fee Category 3.C. 
The license application and annual fees for this new category will be 
$8,000 for the application fee and $10,900 for the annual fee. The 
annual fee for category 3.S. in this final rule is slightly less than 
that for category 3.C. because the category 3.S. fee does not include a 
portion of the low-level waste (LLW) surcharge, while the category 3.C. 
fee does. This is because the licensees in fee category 3.C. directly 
benefit from the NRC's LLW activities, but the licensees in fee 
category 3.S. do not. Fee amounts included in this final rule are 
different from those included in the proposed rule because they are 
based on the FY 2007 Fee Schedules instead of the FY 2005 Fee 
Schedules.

E. Implementation Strategy

    Specific provisions are included in this rule, and several actions 
are planned in conjunction with, or following, the issuance of this 
final rule covering the newly added byproduct material, including:
    (1) Issuance and publication of a Transition Plan for the orderly

[[Page 55882]]

transition of regulatory authority for the newly added byproduct 
material;
    (2) Termination of the waiver issued by the NRC (70 FR 51581; 
August 31, 2005) for the States and users of the newly added byproduct 
material; and
    (3) Inclusion of specific provisions allowing users of the newly 
added byproduct material to continue with their activities for a period 
of time while coming into compliance with the newly issued regulations.
Transition Plan
    Section 651(e) of the EPAct requires the NRC, in issuing new 
regulations for the newly added byproduct material, to prepare and 
publish a Transition Plan for the orderly transition of regulatory 
authority over the newly added byproduct material for Agreement and 
non-Agreement States. The EPAct requires that the Transition Plan 
describe the conditions under which a State (including U.S. Territories 
and the District of Columbia) may exercise authority over the newly 
added byproduct material, and include a statement of the Commission, 
that any agreement between the Commission and a State under Section 
274b. of the AEA, covering byproduct material, and entered into before 
the date of publication of the Transition Plan, be considered to 
include the newly added byproduct material. The statement of the 
Commission is subject to a certification provided by the Governor of 
the State to the Commission on the date of publication of the 
Transition Plan that: (1) the State has a program for licensing the 
newly covered byproduct material that is adequate to protect the public 
health and safety, as determined by the Commission; and (2) the State 
intends to continue to implement the regulatory responsibility of the 
State with respect to the byproduct material. The NRC also will include 
in the Transition Plan the process it will use to terminate the waiver 
issued by the NRC on August 31, 2005, and for the transition of 
regulatory authority following expiration or earlier termination of the 
waiver.
Termination of Waiver
    The waiver issued by the NRC (70 FR 51581; August 31, 2005) is 
effective through August 7, 2009 (except terminated August 7, 2006, for 
the import and export of materials covered by the waiver), unless 
terminated earlier by the Commission. The waiver applies to Agreement 
and non-Agreement State regulatory programs and users of the newly 
added byproduct material, and allows persons owning, using, and 
otherwise engaging in activities involving the material to continue 
with their activities and the States to continue to regulate this 
material during the applicable waiver period. All persons in States 
(including U.S. Territories and the District of Columbia) that do not 
have an agreement with the Commission under Section 274b. of the AEA 
that covers the newly added byproduct material on or before August 7, 
2009, will automatically be subject to the NRC regulatory authority for 
the material on August 8, 2009. The waiver also may be terminated 
earlier than August 7, 2009, if the Commission determines that an 
earlier termination is warranted.
    For a new or existing Agreement State that intends to implement the 
regulatory program of the State with respect to the newly added 
byproduct material, Section 651(e) of the EPAct requires that the 
waiver be terminated for the State when the Commission determines that 
the State has entered into an agreement with the Commission, under 
Section 274b. of the AEA, that the State program covers the newly added 
byproduct material, and that the State program for licensing the newly 
added byproduct material is adequate to protect the public health and 
safety. The Commission determination and termination of the waiver will 
be noticed in the Federal Register (Notification of Waiver 
Termination). Users of the newly added byproduct material currently 
licensed, or registered, by an Agreement State that continues to 
implement its regulatory program, with respect to the newly added 
byproduct material, will continue to be subject to the Agreement State 
regulatory authority.
    With regard to the States that do not have an existing agreement 
with the Commission under Section 274b. of the AEA (non-Agreement 
States), the waiver period provides additional time for those States 
that desire to establish such an agreement for the newly added 
byproduct materials to develop a program. To establish this agreement 
with the Commission, the Governor of the current non-Agreement State 
will need to request an agreement with the Commission. The process of 
establishing these agreements can take 3 or more years to complete. 
Options will be considered, on a case-by-case basis, to limit the 
impact of the transition of authority on affected users of the new 
byproduct material in the State.
    Additional details on the process that the NRC will use to 
terminate the waiver for Agreement and non-Agreement States and users 
in these States will be provided in the Commission's Transition Plan, 
as required by Section 651(e) of the EPAct. The NRC plans to publish 
the Transition Plan following publication of this final rule and before 
the effective date of this final rule.
Notification of Waiver Termination
    The Commission is terminating the waiver for Government agencies 
and Federally recognized Indian Tribes on the effective date of this 
final rule because there is currently limited regulatory oversight for 
the newly added byproduct material at these facilities. Waiver 
termination is necessary to require Government agencies and Federally 
recognized Indian Tribes to comply with the new requirements and for 
the NRC to ensure protection of public health and safety for the newly 
added byproduct material.
    The Commission has also determined that an earlier termination is 
warranted and is therefore terminating the waiver for persons owning, 
using, and otherwise engaging in activities involving the newly added 
byproduct material in the following States on the effective date of 
this final rule: Delaware, Indiana, Wyoming, and Montana, as well as 
the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. The 
effective date of this final rule is 60 days after the date of 
publication in the Federal Register. Waiver termination is necessary to 
require persons owning, using, and otherwise engaging in activities 
involving the newly added byproduct material in these States, U.S. 
Territories, and the District of Columbia to comply with the new 
requirements and for the NRC to ensure protection of public health and 
safety for the newly added byproduct material.
Implementation Period
    Although Government agencies, Federally recognized Indian Tribes, 
and certain persons owning, using, and otherwise engaging in activities 
involving the newly added byproduct material in the States of Delaware, 
Indiana, Wyoming, and Montana, and the District of Columbia, Puerto 
Rico, and the U.S. Virgin Islands are already being regulated by the 
NRC for the AEA 11e.(1) and 11e.(2) byproduct material, the NRC is 
allowing a transitional period for them to submit a license amendment 
or a new license application for the newly added byproduct material. 
This final rule allows an additional 6-month period from the effective 
date of the final rule to apply for a license amendment; and an 
additional 12-month period from the effective date of the final rule to 
apply for a new license.

[[Page 55883]]

    In addition, the rule contains specific provisions that gives 
Governmental agencies, Federally recognized Indian Tribes, and persons 
owning, using, and otherwise engaging in activities involving the newly 
added byproduct material, in the States of Delaware, Indiana, Wyoming, 
and Montana, and the District of Columbia, Puerto Rico, and the U.S. 
Virgin Islands, the authority to continue to use the newly added 
byproduct material during the period following the waiver termination 
until the date of the NRC's final licensing determination, provided 
that either a license amendment or a license application is submitted 
within the specified time frame and while complying with all other 
aspects of the regulations (e.g., event reporting, personnel dosimetry) 
upon the effective date of this final rule.
    For persons owning, using, and otherwise engaging in activities 
involving the newly added byproduct material, compliance with the rule 
will be required depending on the date of waiver termination. For 
certain States and persons, the NRC plans to terminate the waiver 
earlier than the final date of the waiver, i.e., August 7, 2009. A 
decision for early termination will depend on a number of factors, 
including the status of an Agreement State Governor's certification of 
adequate program for the newly added byproduct material, status of a 
non-Agreement State's application to become an Agreement State, and 
activities or areas under exclusive NRC jurisdiction. Upon waiver 
termination, all persons that possess the new byproduct materials must 
be in compliance with NRC regulations. It is noted that being in 
compliance with the NRC regulations includes, for example, meeting the 
reporting and recordkeeping requirements for the new byproduct material 
once the waiver is terminated. In addition, such persons will either be 
required to: (1) apply for license amendments for the new byproduct 
material within 6 months from the date the waiver is terminated, if 
they hold an NRC specific byproduct materials license; or (2) submit a 
license application for the new byproduct material within 12 months 
from the date the waiver is terminated. It is noted that authorization 
statements for certain licenses are inclusive of byproduct materials 
and their uses so that an amendment may not be needed to specifically 
add NARM to the license.
    During the time between the termination of the waiver and the 
user's application for an NRC license or license amendment, users in 
Government agencies, Federally recognized Indian Tribes, and non-
Agreement States will be under the NRC's jurisdiction for enforcement 
purposes. The NRC will handle enforcement cases involving the use of 
the newly regulated materials on a case-by-case basis. However, should 
the number of cases involving these materials be larger than 
anticipated, the staff will prepare additional enforcement guidance to 
ensure consistency in handling such issues.

III. Summary and Analysis of Public Comments on the Proposed Rule

    The proposed rule on Requirements for Expanded Definition of 
Byproduct Material was published on July 28, 2006 (71 FR 42952). The 
comment period ended on September 11, 2006. The NRC received 39 comment 
letters on the proposed rule. Comment letters were submitted from the 
States, other Federal agencies, professional organizations, 
universities, medical communities, industries, and individuals. On 
August 22, 2006, the NRC held a public meeting in Las Vegas, Nevada, on 
the proposed rule during the comment period. Copies of the public 
comments and the public meeting transcripts are available for review in 
the NRC Public Document Room, 11555 Rockville Pike, Rockville, 
Maryland.
    In addition to requesting public comments on the proposed rule, the 
NRC specifically requested additional information or comments on 15 
specific items outlined in Section II.G. of the proposed rule. A 
synopsis of the items and type of comments received are as follows:
    Item 1--Technical Information to Support Exemption of Old Radium-
226 Sources. One commenter provided information on potential pressure 
build-up within radium sources that could lead to the release of radium 
into the environment. Another commenter provided a reference to an FDA 
document. There were comments on the availability of information on 
radium-226 items and on exemption of antiquities. The NRC appreciates 
the information. A discussion of the comments on exemption of 
antiquities and associated response is included later in this document 
under ``Comments Related to Radium-226.''
    Item 2--Extent of Use of Accelerators. No comments were received 
regarding the extent of accelerators that are used to intentionally 
produce radioactive material and also used to generate particle beams 
for basic science research. One commenter indicated that the 
commenter's organization does not operate any particle accelerators for 
the purpose of producing radioactive materials and producing particle 
beams for other uses. Another commenter informed the NRC that it will 
be building a new accelerator facility where radionuclides will be 
produced.
    Item 3--Information on Decommissioning of Accelerator Facilities. 
Several comments were received regarding information on decommissioning 
of accelerator facilities, including accelerator components and 
facility building materials that may become activated. A detailed 
discussion of the comments and response is included later in this 
document under ``Comments on Waste and Decommissioning.''
    Item 4--Inclusion of Specific ALI and DAC Values. In response to 
the NRC's question on whether to develop specific ALI and DAC values 
for oxygen-15 and nitrogen-13 for inclusion in 10 CFR Part 20, Appendix 
B, several commenters provided specific DAC values. A discussion of the 
values and the methodology used can be found later in this document 
under ``Comments on Other General Requirements.''
    Item 5--Exemption of Radium-226 Timepiece Repairs. In regard to the 
appropriateness of the proposed exemptions to allow repairs of 10 
radium-226 timepieces per year, one commenter suggested increasing the 
proposed limit of 10 per year to 18. The commenter did not provide 
specific data concerning how active the repair of radium-226 timepieces 
may be or the safety significance of the proposed exemption. However, 
there were several comments related to radium-226 exemptions. Detailed 
discussion of these comments and the associated responses is included 
later in this document under ``Comments Related to Radium-226.''
    Item 6--Health and Safety Information of Radium-226 Sources. The 
NRC requested information on the health and safety impact from 
activities involving radium-226 sources, in particular, information to 
support a technical basis for an exemption as an alternative to the 
proposed general licensing approach. Several commenters indicated that 
they believed that an exemption would be preferable to a general 
license for items containing radium-226, but no specific health and 
safety impact information was provided. Most commenters agreed that 
more information about risk is needed to make a final decision. 
Discussion of comments associated with this issue is included later in 
this document under ``Comments Related to Radium-226.''
    Item 7--Existing and Proposed Fee Categories. The NRC requested 
information on whether the majority of

[[Page 55884]]

licensees would remain in the existing fee categories and whether new 
NARM licensees would fall under the current fee categories or the new 
proposed fee categories. No specific information on this issue was 
received from the commenters. However, several commenters indicated 
that they believed that there is no need to establish a new fee 
category for the production of accelerator-produced radioactive 
material. All of the comments related to fees are discussed later in 
this document under ``Comments on Licensing Fees and Fee Categories''.
    Item 8--Licensing Boundaries for Radium-226 Private Collectors. No 
information was received on whether private collectors of items or 
products containing radium-226 would remain within the boundaries of 
the proposed general license or be required to obtain a specific 
license and be charged with the associated licensing fees. One 
commenter recommended that an ``exception'' be extended to certain 
organizations. A discussion of radium-226 exemptions is included in 
subsection ``Comments Related to Radium-226,'' and a discussion of fees 
is included later in this document under ``Comments on Licensing Fees 
and Fee Categories''.
    Item 9--Two-Tiered Fees for Radium-226. No information was received 
regarding the two-tiered license fees proposed for possession of 
different quantities of radium-226 items. Comments received on the 
proposed fee categories and amounts are discussed later in this 
document under ``Comments on Licensing Fees and Fee Categories''.
    Item 10--Effective Date and Implementation Periods. Several 
comments were received on the proposed effective date and 
implementation periods of the rule. A discussion is included later in 
this document under ``Comments on Waiver Termination and 
Transitioning.''
    Item 11--Compatibility Category Designations. All comments related 
to the compatibility category designations are discussed later in this 
document under ``Comments Related to Agreement States and Other 
Government Agencies''.
    Item 12--Environmental Assessment. Comments received on the draft 
Environmental Assessment were considered in the final Environmental 
Assessment and Finding of No Significant Impact.
    Item 13--Information Collections. No comments were received on the 
information collections aspects of the rule.
    Item 14--Regulatory Analysis. No comments were received on the 
draft Regulatory Analysis.
    Item 15--Impact to Small Business. No comments were received on the 
impacts of the rule on small businesses.
    General information and editorial suggestions received on the 
proposed rule are appreciated but do not need to be discussed in this 
final rulemaking. Comments associated with nuclear reactors and the 
high-level waste repository are outside the scope of this rulemaking; 
therefore, they will not be addressed in this section. All other 
comments have been grouped into broad categories, and a detailed 
discussion of the comments and the NRC's responses are as follows:

Comments Related to Agreement States and Other Government Agencies

Agreement State Compatibility Designations
    Comment: The comments received on ``compatibility'' are primarily 
centered around one main concern: Implementation of the requirements 
for the Compatibility Category of Health and Safety (H&S) for several 
definitions. The basic concern expressed by these commenters was that 
the States should not be required to amend their definitions in their 
State statutes and regulations. In particular, some commenters were 
concerned about the designation of H&S for the definition of Byproduct 
material. These commenters indicated that they would support an H&S 
designation if the Statements of Consideration to the final rule 
provided that the NRC's initial determination of the adequacy of 
definitions would rely on a Governor's certification that the State's 
program was ``adequate,'' and that if the Governor's certification was 
accepted, no changes to the State's definitions would be required. As 
an alternative, some commenters suggested that the Statements of 
Consideration recognize that the States could use alternative language 
in their definitions including the use of the more generic term of 
``radioactive material,'' rather than revise the definitions to conform 
with the new definitions. In the absence of implementing those 
suggestions, these commenters recommended that the Compatibility 
Category designation for definitions be changed from H&S to D.
    These commenters generally indicated that if those suggestions 
could not be implemented, they would recommend that the NRC designate 
the definitions it was changing as Compatibility D.
    NRC Response: The NRC does not agree with the commenters' assertion 
that the designation for the definition of Byproduct material should be 
changed from H&S. The NRC also does not agree that the Governor's 
certification of the adequacy of an Agreement State's program should 
relate to the need for the State to revise its regulations. However, 
the States may continue to use the existing definition including 
Radioactive material in State statutes and regulations, although there 
may be limited areas where a State may need to revise its regulations 
to include material now under the jurisdiction of the NRC (e.g., exempt 
distribution for certain materials).
    The NRC applied the criteria in Management Directive (MD) 5.9, 
``Adequacy and Compatibility of Agreement State Programs,'' in 
evaluating the compatibility category of the definitions, and 
determined that a category of H&S is appropriate for the definition of 
Byproduct material. MD 5.9 provides that an H&S designation is 
appropriate for elements that are not required for compatibility but 
have been identified as having a particular health and safety role in 
the regulation of agreement material within the State. In accordance 
with this designation, the State should adopt program elements, based 
on those of the NRC, that embody the essential objectives of the NRC 
program elements because of particular health and safety 
considerations. A category of H&S is appropriate for the definition of 
Byproduct material because the absence of the essential objectives of 
the program element from an Agreement State program could create a 
situation that could directly result in exposure to an individual in 
excess of basic radiation protection standards.
    MD 5.9 provides that the NRC program elements in Compatibility 
Category D are those that do not meet the criteria of Compatibility 
Categories A, B, or C, and thus, do not need to be adopted by the 
Agreement States for purposes of compatibility. The NRC has determined 
that a Compatibility D designation is not appropriate for the 
definition of Byproduct material because if the definition of Byproduct 
material or another term which encompasses all of the byproduct 
material regulated by the State were not somewhere within the State 
program (i.e., in statute or in regulations), it is possible that some 
byproduct material could escape regulatory oversight with a result of 
exposure to an individual in excess of the 10 CFR Part 20 limits. The 
State regulatory program must include Sections 11e.(3) and 11e.(4) 
byproduct

[[Page 55885]]

material in its regulatory program if the Agreement includes this 
material, thus, an H&S designation (an assessment of adequacy) is 
appropriate.
    In implementing the Commission's policy on Agreement States, a 
designation of H&S for the definition of Byproduct material will 
require NRC staff to continue to assure that the essential objectives 
(i.e. Sections 11e.(3) and (4) byproduct materials are addressed in the 
regulatory program) are met. The NRC staff notes that under a 
designation of D, this assurance would not be obtained because program 
elements designated D are not a required part of an Agreement State 
program (they could be dropped from or not included in the Agreement 
State program, and the program could still be found adequate and 
compatible).
    Comment: With regard to the definitions in 10 CFR 35.2 of 
Authorized nuclear pharmacist, Authorized user, and Positron Emission 
Tomography (PET), one commenter recommended that any Agreement State 
that has rule language essentially the same as the current CRCPD's SSRs 
should be considered to have compatible rules and should not have to 
revise those rules regardless of the level of compatibility assigned by 
the NRC. The commenter further recommended that the NRC might include 
this recognition in the Statements of Consideration.
    NRC Response: The NRC has determined that it is not necessary to 
change the current definitions for an Authorized user or Authorized 
nuclear pharmacist. This rule does not change the existing definitions 
or impact the existing compatibility designation for these definitions. 
The definition of Positron Emission Tomography is not in the SSRs, and 
it is identified in the final rule as having a designation of ``H&S,'' 
which assures that the State's regulatory programs adequately address 
the essential objectives of the NRC program elements when using the 
term Positron Emission Tomography.
    Comment: For each of the sections with a Compatibility B Category, 
it is not clear that the NRC accepts the language of the States that is 
essentially identical to the SSRs.
    NRC Response: For the definitions and sections assigned a 
Compatibility B designation, the NRC cannot automatically accept the 
States' language; the States' regulations must be reviewed. Agreement 
State regulations will be reviewed according to Office of Federal and 
State Materials and Environmental Management Programs (FSME) Procedure 
201 (SA-201) and should be submitted within 3 years of publication, in 
accordance with the NRC's 1997 Policy Statement on Adequacy and 
Compatibility of Agreement State Programs (62 FR 46517; September 3, 
1997). The NRC notes that portions of the SSRs may be outdated and do 
not reflect recent amendments (e.g., definitions of Authorized user and 
Authorized nuclear pharmacist) and so cannot be used.
    Comment: Referring to 10 CFR 32.72, a commenter recommends that the 
NRC specifically recognize that an Agreement State will not be required 
to amend its comparable regulation, as long as that comparable 
regulation provides for the same control of the manufacture and initial 
distribution of radium-226 sources under a general license as was 
provided in the proposed regulation.
    NRC Response: The NRC does not agree with the comment. Section 
32.72 in 10 CFR Part 30 authorizes specific licensees to manufacture, 
prepare, and distribute radioactive drugs to medical use licensees. 
This provision does not include generally licensed material. Further, 
the NRC is unaware of any radioactive drugs containing radium-226. 
Agreement States have 3 years to adopt regulatory requirements 
compatible with 10 CFR 32.72 revisions.
    For a specific license to allow the manufacture or initial transfer 
of calibration or reference sources containing radium-226, under 10 CFR 
32.57, for distribution to persons generally licensed, the NRC has 
included provisions in 10 CFR 31.8 to recognize specific licenses 
issued for these sources by a State with comparable regulations.
    Comment: A commenter stated that the NRC's deliberate use of 
Compatibility B and H&S categories sets the tone that its 
considerations are preeminent. Another commenter stated that the 
language of the EPAct indicates that the burden should be on the NRC to 
bring its regulations into conformance with the Agreement State 
regulations. The commenter also stated that whether or not the NRC is 
making an effort to obey the EPAct language to cooperate with the 
States or use model State standards will depend on whether the NRC 
accepts the Agreement States' regulations. The commenter believes that 
the Agreement State regulations do not need to be changed to be exactly 
like the NRC's.
    NRC Response: In accordance with AEA Section 274b, for an agreement 
between the NRC and a State, a State program must be adequate to 
protect public health and safety and be compatible with the NRC. The 
EPAct gives the NRC jurisdiction over NARM byproduct material, and does 
not mandate that the NRC bring its regulations into conformance with 
the Agreement State regulations, but only requires that the Commission, 
to the maximum extent practicable, cooperate with the States and use 
model State standards. The Commission has fulfilled this mandate by 
working closely throughout the development of this final rule with OAS, 
the CRCPD, and other stakeholders, and by considering the model State 
standards. As discussed previously, the NRC applied criteria laid out 
in MD 5.9, ``Adequacy and Compatibility of Agreement State Programs,'' 
which includes criteria for the NRC to designate compatibility and 
adequacy categories to the NRC's regulations and coordinating 
amendments for radioactive material included in the Agreement. In 
promulgating the final rule, these criteria were applied to the 
definitions and other requirements of the EPAct to determine the 
appropriate compatibility categories.
Interaction With Other Federal Agencies
    Comment: A commenter asked if any Memorandum of Understanding (MOU) 
between the NRC and the DOT on byproduct materials would be affected by 
the changes in the proposed rule.
    NRC Response: The roles and responsibility between DOT and the NRC 
in the regulation of the transportation of radioactive material are 
clearly described in an MOU signed on June 8, 1979, and published in 
the Federal Register (44 FR 38690; July 2, 1979). As delineated in the 
MOU, the DOT is generally responsible for regulating safety in 
transportation of all hazardous material, including radioactive 
material, and the NRC is responsible for regulating safety in receipt, 
possession, use, and transfer of byproduct, source, and special nuclear 
materials. The NRC is also responsible for approval of package designs 
for fissile materials and for other radioactive materials in quantities 
exceeding Type A limits. In reviewing the language of the existing MOU, 
the NRC has determined that no change is necessary as a result of this 
final rule. The MOU stated that the NRC is authorized to regulate, 
among other things, byproduct material under the AEA of 1954, as 
amended, and the Energy Reorganization Act of 1974, as amended. Because 
the EPAct amends the AEA, the expanded definition of Byproduct material 
will automatically be subject to the MOU. In addition, there are 
routine interactions between the NRC and the DOT, and the DOT is aware 
of the expanded definition of Byproduct material.

[[Page 55886]]

    Comment: A commenter asked if the proposed changes in the 
regulations would have any impact on accelerators or accelerator 
radionuclides that are taken to sea or out of the U.S., and if those 
changes would also impact the EPA's responsibilities, treaty 
requirements, or Status of Forces agreements. For example, the 
commenter noted that a research vessel, military hospital, or Centers 
for Disease Control vessel leaving the U.S. for foreign ports and 
returning to the U.S. may have an electron microscope or metabolic (Na, 
Cl, K) studies with accelerator-produced radionuclides on board. The 
commenter asked if activation from neutron radiography on board these 
ships would be an issue. The commenter also asked if the proposed 
changes would affect machines that the U.S. Customs uses to radiograph 
containers in foreign ports before they are placed on shipboard if the 
machine is greater than 1 MeV. The commenter also wanted to know how 
replaced parts of those machines will be handled, whether all parts 
would be controlled, and whether they could be disposed of in a foreign 
state.
    NRC Response: The commenter appears to be concerned, in part, about 
regulatory requirements pertaining to U.S. originated accelerator-
produced radioactive material taken outside of the U.S., i.e., export 
of accelerator-produced radioactive material. Part 110 of the NRC's 
regulations governs export and import of radioactive material within 
the NRC's regulatory jurisdiction. On April 20, 2006 (71 FR 20336), the 
NRC issued a final rule amending 10 CFR Part 110 to reflect the EPAct's 
augmentation of the NRC's regulatory jurisdiction to include 
accelerator-produced radioactive material. Specifically, the rule added 
``accelerator-produced radioactive material'' to the definition of 
Byproduct material in 10 CFR 110.2 and Appendix L to 10 CFR Part 110. 
Export and import of all byproduct material, including accelerator-
produced radioactive material, are governed by 10 CFR Part 110. There 
is no difference in regulatory treatment between byproduct material 
produced by an accelerator and byproduct material produced in a 
reactor.
    The commenter also asks whether this rule would affect U.S. 
Customs' use of ``radiograph machines.'' The NRC does not believe this 
final rule would have any impact on the Customs and Border Protection's 
use of radiograph machines because these machines use byproduct 
material that is already regulated by the NRC because the material is 
produced in a reactor. With the revised definition of Byproduct 
material, there will be no difference in regulatory treatment between 
byproduct material produced by an accelerator and byproduct material 
produced in a reactor. If the radiograph machine uses the accelerator-
produced radioactive material, it would now be subject to the same 
regulatory requirements as the machine-used byproduct material produced 
in a reactor. The NRC's or any other requirements on the use of 
byproduct material in radiograph machines would be no different from 
the pre-EPAct condition for both the domestic and export context.
    Neutron radiograph machines do not use byproduct material; they are 
actually accelerators. Only neutron beams are generated in these types 
of radiograph machines for imaging purposes. Because these types of 
radiograph machines (or accelerators) do not produce radioactive 
material for use for commercial, medical, or research activities, the 
NRC has no regulatory authority over these machines or the activation 
material produced incidental to imaging operation.
    Comment: A commenter recommended that the NRC pursue an MOU with 
OSHA in order for the NRC to assume regulatory jurisdiction over the 
occupational exposure to ionizing radiation in non-Agreement States. 
The commenter noted that before the expansion of the NRC's jurisdiction 
over NARM, OSHA had jurisdiction for occupational health and safety in 
non-Agreement States. The commenter noted that OSHA published a request 
for information to better understand what, if any, changes OSHA needed 
to consider in its regulation of the use of ionizing radiation in the 
workplace (See: Occupational Exposure to Ionizing Radiation--Request 
for Information; 70 FR 22828; May 3, 2005). The commenter recommended 
that the NRC work actively with OSHA to streamline the regulatory 
requirements and eliminate duplication of authority over the use of 
NARM in non-Agreement States.
    NRC Response: The NRC has been working, and continues to work, with 
OSHA and other Federal agencies through the Interagency Steering 
Committee on Radiation Standards (ISCORS) to coordinate issues and 
activities, including the development of Federal Guidance for 
Occupational Exposure to Radiation and regulations related to radiation 
protection and safety. The NRC recognizes that the existing MOU is now 
out of date with respect to references of enabling legislation and the 
respective jurisdictions of the two agencies as a result of the EPAct. 
However, the procedures specifying the interactions between OSHA and 
the NRC and the authority and responsibilities of each agency remain 
appropriate and valid to cover interactions in the newly enacted 
jurisdictional framework. Thus, the NRC does not believe that there is 
an imminent need to reexamine and update the MOU.
    Comment: Several commenters requested clarification on the NRC's 
jurisdiction and role regarding radium-226 contaminated sites or old 
landfills, especially for sites currently under remediation by either 
the EPA or an authorized State under the RCRA or the Comprehensive 
Environmental Response, Compensation, and Liability Act (CERCLA, also 
known as Superfund) programs. One commenter asked if the NRC and EPA 
have executed an MOU for Superfund sites. Another commenter asked if 
the NRC/EPA MOU on decommissioning (2002) will be impacted by this 
rule. Another commenter suggested that the NRC and EPA should have a 
dialogue to discuss a collaborative approach to address licensing of 
discrete sources covered by this rule that are already considered as 
part of the Superfund efforts. The commenter indicated that such 
dialogue would complement ongoing coordination between EPA and the NRC 
under the existing MOU, ``Consultation and Finality on Decommissioning 
and Decontamination of Contaminated Sites''.
    NRC Response: Under the EPAct, the NRC has the regulatory authority 
over any discrete source of radium-226 that is produced, extracted, or 
converted after extraction, before, on, or after the date of enactment 
of the act for use for a commercial, medical, or research activity. 
Hence, the NRC has the jurisdiction over old landfills or disposal 
sites contaminated with radium-226 due to past operations or disposal 
of discrete sources of radium-226.
    The NRC typically has regulatory authority over sites undergoing 
radiological decommissioning, even those sites that also contain EPA 
hazardous materials (CERCLA and RCRA). The NRC and EPA have entered 
into site-specific agreements via formal letters in which the license 
for a site undergoing decommissioning was put in abeyance and 
regulatory authority for decommissioning the site deferred to the EPA. 
There is no MOU for these agreements because they are rare and very 
site specific. The NRC anticipates that this site-specific process will 
continue.
    The current MOU ``Consultation and Finality on Decommissioning and

[[Page 55887]]

Decontamination of Contaminated Sites'' between the NRC and EPA defines 
the policy for deferral of regulatory authority between the two 
agencies for radiological decommissioning and decontamination of the 
NRC-licensed sites. The MOU specifically provides that under certain 
clearly defined criteria, EPA agrees to a basic policy of EPA deferral 
to the NRC decisionmaking in the decommissioning of the NRC-licensed 
sites without the need for consultation. If the criteria are not met, 
the MOU directs the NRC to consult with the EPA regarding the site. The 
MOU does not provide for the deferral of regulatory authority from the 
NRC to the EPA.
    The NRC has routine interactions with EPA through ISCORS and 
through informal communications among staff on a multitude of subject 
areas. Currently, there are seven subcommittees in ISCORS, including 
Cleanup, Federal Guidance, Mixed Waste, Naturally Occurring Radioactive 
Material, Recycle, Risk Harmonization, and Sewage Sludge Subcommittees. 
The NRC will continue to work closely with EPA though ISCORS and other 
informal mechanisms regarding decommissioning and decontamination of 
sites.
    Because the NRC had been deferring regulatory authority to the EPA 
on a site-by-site basis in the past, the NRC believes, at this time, 
that there may not be a need to revise the existing MOU. Once the NRC 
has gained sufficient experience in dealing with old disposal sites 
contaminated with the newly added byproduct material and if significant 
issues arise regarding shared regulatory authority, the NRC will 
cooperate with EPA in evaluating the need to amend the existing MOU and 
in determining an approach in resolving issues in managing these old 
disposal sites.
    Comment: A commenter noted that the discussions on current 
regulatory structures for NARM, and on other Federal agencies' 
regulatory authority over NARM, do not mention that some Federal 
licensees, such as licensees who hold a Master Materials License (MML), 
have established self-regulation requirements for NARM use. The 
commenter recommended that the NRC should describe the MML licensees' 
role in the regulation of NARM.
    NRC Response: MML licensees are the NRC licensees and are required 
to comply with the NRC regulations. The fact that some MML licensees 
have established self-regulating requirements for accelerator-produced 
radioactive material and may have issued permits to their permittees 
for these materials is noted.
    Comment: A commenter stated that requirements under several 
sections related to a master materials license address ``a permit 
issued by a Commission master material license broad scope permittee'' 
with the implication that a broad-scope permittee is required to issue 
such a permit. The commenter stated that, in most cases, the permittee 
might issue an authorization or other type of document for an AU. The 
commenter requested that the regulatory requirement be revised as ``a 
permit, or other authorization, issued by a Commission master material 
license broad-scope permittee''.
    NRC Response: The NRC does not agree that this language is 
ambiguous. The use of the phrase ``a permit issued by a Commission 
broad scope licensee'' has been used by the NRC in 10 CFR Part 35 since 
the 1994 ``Radiopharmacy Rule'' (59 FR 61781; December 2, 1994) to 
designate the document that the broad-scope Radiation Safety Committee 
issues to individuals to permit or authorize them to use specific 
radionuclides for licensed activities. The same term was used in the 
major revision to 10 CFR Part 35 (67 FR 20370, April 24, 2002) for the 
same type of documentation issued by the MML broad-scope permittee to 
individuals at its facility.

Comments on Defining the Byproduct Material

    Comment: A commenter, discussing the proposed Byproduct material 
definition in 10 CFR 20.1003 and 30.4, believes the wording ``produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005,'' was confusing and ambiguous, stating that the phrase, 
``before, on, or after August 8, 2005,'' appears to be meaningless and 
that it was not clear whether the phrase referred only to material 
``converted after extraction,'' or to material ``produced, extracted, 
or converted after extraction''.
    NRC Response: The phrase, ``before, on, or after August 8, 2005,'' 
has been incorporated into the definition of Byproduct material in the 
AEA as a result of the language of the EPAct. It is included in the 
definition in the final rule because it is important to be clear that 
materials that have been produced, extracted, or converted after 
extraction at any time, even before promulgation of the EPAct, are 
included. This phrase is intended to apply to all of these activities, 
i.e., the production, extraction, and conversion after extraction. Not 
having such an explicit phrase in the definition may raise questions 
regarding applicability of the regulations for materials resulting from 
past activities.

Definition of Discrete Source

    Comment: Commenters generally supported the stated result of the 
definition as to the limits of NRC's authority and specifically the 
proposed limitation of the definition to exclude radium-bearing wastes 
generated by many facilities, including drinking water treatment plants 
and oil and gas production facilities. One commenter specifically 
agreed with the definition stating that it captured the important 
aspects of the discussions at the public and interagency meetings, as 
well as the original intent of earlier versions of legislation 
incorporated into the EPAct. However, other commenters expressed 
concerns about the clarity of the definition. Several commenters stated 
that some of the provisions in the proposed definition of discrete 
source, such as the requirements that the source have physical 
boundaries and that the materials have been concentrated for their 
radiological properties, were ambiguous and could lead to uneven 
regulation. The commenters recommended that the NRC revise the proposed 
definition, and two commenters suggested alternate definitions.
    One commenter stated that the phrases ``with physical boundaries'' 
and ``which is separate and distinct from the radioactivity present in 
nature'' in the proposed definition of Discrete source could cause 
confusion. The commenter stated that the requirement for physical 
boundaries without further description or statement of the purpose of 
the physical boundaries is ambiguous and leaves room for uneven 
regulation. Commenters were also concerned with the words, ``which is 
separate and distinct from the radioactivity present in nature,'' 
particularly with the usage of ``radioactivity.'' One commenter stated 
that a workable definition is crucial to keep unintended materials from 
being captured.
    Other commenters expressed concern about the phrase, ``with the 
intent that the concentrated radioactive material will be used for its 
radiological properties,'' with one commenter recommending that it be 
deleted. This commenter noted that it has encountered situations where 
discrete sources of radium-226 were deposited over a large area of land 
in which there were discrete nuggets and that there was no way of 
determining whether the discrete nuggets were produced for their 
radiological properties or not.

[[Page 55888]]

    NRC Response: The proposed definition of Discrete source 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.'' It is clear from some of the comments 
that the proposed definition of Discrete source, particularly the 
phrase ``with physical boundaries,'' creates confusion that would, 
among other things, present problems with the regulation of material no 
longer in its original form, but which the NRC intends to regulate.
    The wording in the final rule has been revised to clarify the 
ambiguities that gave rise to these comments. The revised definition of 
Discrete source is ``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''.
    With the modification of the definition of Discrete source to 
eliminate the word ``separate'' and the phrase ``with physical 
boundaries,'' radium contamination resulting from the use of purposely 
concentrated radium-226 falls within the definition of Discrete source. 
These changes should make it clearer that the NRC's jurisdiction 
continues through decommissioning. The radiological criteria for 
unrestricted use in 10 CFR 20.1402 refer to residual radioactivity that 
is distinguishable from background. Some commenters appeared concerned 
that for purposes of decommissioning, it would not be possible to 
distinguish between the atoms of material that had been purposely 
concentrated for use for its radiological properties from atoms of 
material present in nature. This concern is not warranted because, in 
practice, this is not the methodology used to determine the need for 
decontamination.
    The revised definition also removes the requirement that the 
purpose for concentrating radium-226 (or other identified naturally 
occurring radioactive material) be specifically for use of its 
radiological properties. However, this change is not expected to have 
any practical effect on the regulation of radium-226, as all known uses 
of radium-226 have been for its radiological properties and not 
primarily its chemical or physical properties. The only effect of 
revising the definition would be if a future use is made of a highly 
radioactive naturally occurring material involving chemical or 
physical, but not radiological, properties. To constitute byproduct 
material as it is now defined in Section 11e.(4) of the revised AEA, 
this material would have to have been determined by the Commission to 
meet the standard of threat similar to that of radium-226.
    The comments on the definition of Discrete source relate mainly to 
questions concerning what naturally occurring radioactive material will 
be considered byproduct material, and thus be regulated by the NRC. In 
revising the definition of Discrete source, the Commission has also 
added the condition that to be a discrete source, the radionuclide has 
been processed so that its concentration within a material has been 
purposely increased ``for use for commercial, medical, or research 
activities.'' The addition of this limiting phrase may appear 
redundant, as the words ``for use for a commercial, medical, or 
research activity'' are already in the definition of Byproduct 
material, and a discrete source is a subcategory of byproduct material. 
However, the addition of these words to the definition of Discrete 
source ensures an understanding that the term ``discrete source,'' 
where used in the regulations other than in the definition section of 
the regulations, will be subject to this limitation.
    The Commission interprets the words in the definition of Byproduct 
material, ``produced, extracted, or converted after extraction for use 
for a commercial, medical, or research activity,'' to mean a purposeful 
activity whereby the radium-226, or other specific radionuclide, if 
identified in accordance with Section 11e.(4) of the revised AEA, is 
processed for the use of the radium-226 (or other specific 
radionuclide). This purposeful activity must relate to the radium-226 
(or other radionuclide) and not to the overall material that 
inadvertently contains radium-226, for example, fertilizer. However, 
this activity need not involve an actual isotopic separation process 
specifically separating radium-226 from radium-228. In addition, the 
``new'' byproduct material consists of the specific radionuclides only, 
and not the associated material. For example, in a radium salt, the 
atoms other than those of radium in the salt are not part of the 
byproduct material. The NRC notes that the original definition of 
Discrete source, as it had been proposed, was written to contain strict 
constraints to guard against any potential interpretation that the NRC 
was extending its jurisdiction in an unintended or unauthorized manner. 
However, the NRC has found that these constraints were, in a large 
part, unwarranted because, as already noted, a discrete source is a 
subset of the specifically delineated byproduct material that is being 
regulated and must, therefore, be constrained by the general definition 
of the new Byproduct material. In this connection, the NRC also removed 
the words ``distinct from the radioactivity present in nature'' as an 
unnecessary condition.
    Comment: Some commenters had questions concerning the regulatory 
authority over the manufacture of radiological sources and the 
associated waste management. One commenter noted that the EPAct does 
not assign responsibility to the NRC for regulating the manufacture of 
discrete sources, rather, the NRC's responsibility applies after a 
discrete source is produced. The commenter asked whether the Agreement 
States would be required to regulate the manufacturing and waste 
management aspects of source production, and also who is responsible 
for radiological safety if the manufacturing occurs in a non-Agreement 
State. Another commenter asserted that the manufacture of radium 
sources should be specifically licensed, even though the radium may not 
yet meet the definition of a Discrete source.
    NRC Response: The EPAct gave the NRC authority to regulate radium-
226 that is produced, extracted, or converted after extraction, before, 
on, or after the date of enactment for use for a commercial, medical, 
or research activity. Therefore, the NRC does have authority for 
regulating the manufacture of sources, and the NRC's responsibility 
applies before, on, or after a source is produced. This should be more 
evident with the revised wording of the definition of Discrete source. 
Radium-226 is byproduct material and under the NRC's jurisdiction if it 
is purposely concentrated and produced, extracted, or converted after 
extraction, for use for a commercial, medical, or research activity.
    Section 30.3, ``Activities requiring license,'' states ``Except as 
provided in paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) of this 
section and for persons exempt as provided in this part and part 150 of 
this chapter, no person shall manufacture, produce, transfer, receive, 
acquire, own, possess, or use byproduct material except as authorized 
in a specific or general license issued in accordance with the 
regulations in this chapter.'' Therefore, the NRC will regulate the 
manufacture of products involving the intentional use of discrete 
sources of radium-226, as well as resulting wastes. A specific license 
will be required for the manufacture of such radium sources.

[[Page 55889]]

    Comment: A commenter asked if the proposed definition of Discrete 
source would include sources that are electroplated, i.e., where the 
radioactivity is on the surface of the source and is not encapsulated 
and therefore is not separate from nature (such as radium needles).
    NRC Response: Electroplated sources are included as the wording of 
the definition in the final rule clarifies.
    Comment: A commenter recommended that the NRC add the definition of 
Discrete source to 10 CFR Part 35 in addition to 10 CFR Parts 20 and 
30.
    NRC Response: The NRC Part 35 licensees are required to comply with 
10 CFR Parts 20 and 30. The term Discrete source is being defined in 
those regulations. Therefore, it is not necessary to repeat the 
definition in Part 35.
Other Naturally Occurring Radioactive Material
    Comment: Two commenters asserted that they believe the NRC should 
consider other criteria in addition to the International Atomic Energy 
Agency Code of Conduct Categories 1 and 2 to determine if there are any 
other nuclides that would pose a threat to public health and safety and 
common defense and security similar to that posed by a discrete source 
of radium-226.
    One commenter did not believe that using IAEA Categories 1 and 2 to 
measure the risk of other nuclides against the risk posed by discrete 
sources of radium-226 meets the EPAct requirement to consider 
comparative risk to public health and safety as well as common defense 
and security. The commenter stated that within the U.S., IAEA 
Categories 1 and 2 have been associated with ``high-risk'' sources and 
activities of concern to common defense and security, not to health and 
safety. The commenter argued that instead, because IAEA regards 
uncontrolled Categories 1, 2, and 3 sources as potentially dangerous to 
human health, Category 3 is also a threat, and the NRC's analysis 
should at least include that Category in addition to Categories 1 and 
2.
    However, the commenter agreed with the NRC that polonium-210 does 
not need to be included in the definition of Byproduct material under 
the category of naturally occurring radioactive materials posing a 
similar risk as radium because the production of polonium-210 discrete 
sources for commercial, medical, or research use is by activation in a 
reactor, and therefore it is already regulated as byproduct material.
    Another commenter asked if, by using IAEA Categories 1 and 2 to 
measure other nuclides' comparative risk to radium-226, the NRC meant 
to only regulate materials that could be fatal or cause permanent 
injury if they are not safely managed or securely protected. The 
commenter asked whether discrete sources of radium-226 that do not meet 
the IAEA Category 1 or 2 definitions would not be regulated in the 
expanded definition of Byproduct material. The commenter asserted that 
regulations for radioactive materials should not be based solely on 
acute effects.
    NRC Response: The EPAct expanded the definition of Byproduct 
material to include any discrete source of naturally occurring 
radioactive material, other than source material, that the NRC, 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. The legislation, 
and the proposed rule, do not contain criteria for making such a 
comparison or determination. The NRC, in its meeting with other Federal 
agencies, considered the IAEA list of sources in its Code of Conduct 
that are considered to pose a high risk to human health and safety if 
not managed safety and securely as a point of initiation for 
comparison. The NRC did not intend the Code of Conduct listing to be 
the sole criterion to measure comparative risk to public health and 
safety. Currently, the NRC, in consultation with other Federal 
agencies, has not found any other naturally occurring radioactive 
material that is extracted or converted after extraction that is used 
for a commercial, medical, or research activity that poses a threat to 
public health and safety, or to common defense and security, similar to 
radium-226. Discrete sources of radium-226 much lower in activity than 
discussed in the IAEA Code of Conduct are addressed in the regulations 
that will protect public health and safety. For instance, there are no 
exempt concentration or quantity levels for radium-226 in 10 CFR Part 
30. There are Annual Limits on Intake and Derived Air Concentration 
limits in Appendix B to 10 CFR Part 20 for 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 for 
byproduct material. The NRC, along with other Federal agencies, will 
use all of these criteria to determine if there are any other naturally 
occurring radioactive material posing a threat to public health and 
safety similar to radium-226. In addition, the NRC did not intend to 
imply that it was limiting its regulatory authority over radium-226 at 
quantities which could be fatal or cause permanent damage, or basing 
its regulations for radioactive material solely on acute effects.

Comments Related to Radium-226

    Comment: A commenter, noting that radium-226 is a naturally 
occurring material present in most city water supplies, asked how the 
NRC proposes to differentiate regulated doses from background doses, 
and normal levels of radium-226 in building materials from regulated 
radium-226 contamination. The commenter also noted that because of 
radium's high excretion rate, bioassays may need to include weekly to 
monthly fecal analyses to suppress the missed dose to a value less than 
a few Roentgen Equivalent Man (Rem) per year. The commenter asserted 
that it is highly unlikely that licensees will be able to determine if 
a nonoccupational individual received less than 1 mSv (100 mrem).
    NRC Response: The NRC's regulations in 10 CFR 20.1502 specify the 
criteria that licensees must address to show compliance with monitoring 
requirements for occupational dose limits. The regulation requires 
licensees in monitoring occupational exposure to take into account 
radiation from both licensed and unlicensed radiation sources under the 
control of the licensee. Occupational exposure does not include doses 
from background radiation. It is true that radium is ubiquitous in 
nature. However, there are methods that can be used to determine and 
subtract background radiation from dose measurements of occupational 
dose, such as determining ambient exposure by surveys or monitoring in 
the absence of byproduct material, and using this information to 
subtract background component from readings that include a total of 
both background and occupational exposure.
    External exposure from radium-226 sources comes from its daughter 
product and gamma radiation, and occupational exposure is usually 
determined by a radiation dosimeter (badge). For internal exposure, a 
licensee can measure the concentration of radioactive material in the 
air in the work area, the quantity of radionuclide in the body, the 
quantity of radionuclide excreted by the body, or a

[[Page 55890]]

combination of all these measurements. Excretion measurement is not the 
only method to determine dose from internal exposure.
    Comment: A commenter asked if, for source activity reporting and 
internal/external dosimetry, owners would be required to report any 
information about the radionuclide products that come from radium 
(daughter products). The commenter asked whether the most current 
International Commission on Radiological Protection (ICRP)/National 
Council on Radiation Protection and Measurements (NCRP) internal/
external dosimetry standards will be used by the NRC, and if the newer 
consensus standards regarding actinide uptakes would be acceptable. The 
commenter also asked whether the American National Standards Institute 
(ANSI)/Health Physics Society (HPS) N43.4-2000 Classification of 
Radioactive Self-Luminous Light Sources Standard is a reference 
document that will be used by the NRC.
    NRC Response: If the daughter products came from byproduct material 
(i.e., the radium-226 parent was byproduct material), the internal and 
external exposure would be required to be considered. Daughters from 
radium-226, which are not byproduct material, would not fall under the 
NRC's jurisdiction. However, 10 CFR 20.1502 specifies that, for 
occupational exposure, licensees must take into account radiation from 
both licensed and unlicensed radiation sources under the control of the 
licensee.
    The current methodology used in 10 CFR Part 20 is from Federal 
Guidance Report Number 11, ``Limiting Values of Radionuclide Intake and 
Air Concentration and Dose Conversion Factors for Inhalation, 
Submersion, and Ingestion,'' for internal dose coefficients, and ICRP 
26, ``Recommendations of the International Commission on Radiological 
Protection, January 1977,'' for external exposure. Radium-226 values in 
Appendix B to 10 CFR Part 20 came from the Federal Guidance Report 
Number 11. The methodologies are not being changed at this time.
    The ANSI/HPS N43.4-2000 Standard, Classification of Radioactive 
Self-Luminous Light Sources, was not specifically referenced in the 
regulations or in the Statements of Consideration to the proposed rule. 
The N43.4-2000 Standard classifies certain radioactive self-luminous 
light sources but does not establish design or safety standards. It is 
more for the use of the supplier or user to establish design features 
by providing minimum prototype testing requirements for these types of 
sources, and promoting uniformity in the production of these types of 
light sources.
    Comment: A commenter stated that under the proposed rulemaking (10 
CFR 30.32(g)), any specific license applications authorizing prostate 
brachytherapy must identify source manufacturers and model numbers of 
Palladium-103 brachytherapy sources. The commenter suggested that this 
requirement could be avoided by amending 10 CFR 30.32(g) to remove the 
requirement for identifying manufacturers and model numbers for sources 
authorized for any medical uses (specifically those per 10 CFR 35.400).
    The commenter also believes that the proposed rule was unclear 
about how some legacy radium-226 sources that were not eligible for a 
general license could be specifically licensed per the 10 CFR 30.32(g) 
requirements.
    NRC Response: Revision of 10 CFR 30.32(g) to remove the requirement 
for identifying manufacturers and model numbers for sources authorized 
for any medical uses (specifically those per 10 CFR 35.400) is outside 
the scope of this rulemaking effort. However, the NRC is revising 10 
CFR 30.32(g) to address the issue of sealed sources to address the 
information required from licensees that have legacy sources containing 
the newly defined byproduct materials that are not in the SS&D 
registry.
    Comment: A commenter asserted that the radium-226 issues are likely 
to be much larger and broader than believed. The commenter also noted 
that there are few consultants available with radium experience and 
asked whether the NRC has considered that it may have to act as a 
resource to answer questions and resolve problems.
    NRC Response: The NRC recognizes that there may be broad issues 
regarding radium and that, although radium-226 was widely used in the 
past, there does not appear to be a significant volume of information 
concerning its health and safety implications and past uses. The NRC 
plans to develop a link on its public website under Nuclear Materials 
for ``Frequently Asked Questions'' to try to help answer some of the 
questions about radium as they arise.
Regulating Items Containing Radium-226
    Comment: In response to Question 1 in NRC's request for additional 
information on issues in the proposed rule, technical information to 
support an exemption for old radium-226 sources, several commenters 
discussed the availability of data on the possession and disposal of 
radium items. The commenters stated that they do not believe that a 
consolidated source of information on the items, their location, or 
owners exists that could provide enough safety information for the NRC 
to make an informed decision on the regulation of these items.
    One commenter recommended that the NRC conduct a systematic study 
to assess the potential individual and collective (population) 
radiation doses associated with the use, possession, transfer, and 
disposal of regulated radium items, especially antiquities, and 
suggested that the study could be similar to NUREG-1717, ``Systematic 
Radiological Assessment of Exemptions for Source and Byproduct 
Materials.'' The commenter further recommended that the NRC review 
NUREG/CP-0001, ``Radioactivity in Consumer Products,'' dated August 
1978, for more information on radium in watches, smoke detectors, 
lightning rods, and other consumer products.
    NRC Response: The NRC agrees that there does not appear to be a 
consolidated source of information concerning radium items, their 
location, or who may be in possession of these items. The NRC staff 
contacted several organizations, such as the National Association of 
Watch & Clock Collectors, to alert them of the publication of the 
proposed rule because they might have an interest in this rulemaking. 
In addition, these organizations might be able to provide further 
information to assist the NRC in making regulatory decisions regarding 
radium items. The NRC staff has also secured the services of a 
contractor to help it better characterize the likely activities and 
potential doses to users, initially, from the proposed exemption for 
radium timepieces, and, at a later date, other radium antiquities that 
will be subject to general licensing. The NRC staff has used NUREG/CP-
0001 as part of its evaluation and has referred the NUREG to its 
contractor for use in its review. Evaluations of previously 
manufactured items would be somewhat different than those in NUREG-1717 
as no new distribution is being allowed for many of these items.
    Comment: In response to the NRC's Issue for Public Comment Q.1, a 
commenter noted that pre-WWII naval warships used radium luminescent 
buttons as deck edge markers. The commenter was concerned that these 
marker buttons may not meet the NRC's descriptions of the various 
radium sources. The commenter suggested that the NRC expand the 
coverage of radium-226 items beyond light sources in aircraft and 
medical uses. The commenter also asked if the NRC will bring 
enforcement actions against

[[Page 55891]]

persons who discover previously unknown radium-226 items, and who would 
be financially responsible for those items.
    NRC Response: The NRC has become aware that radium luminous items 
were also commonly used on military vehicles and naval ships in 
addition to aircraft. The NRC believes that vehicles with radium 
luminous items may be found in military museums and owned by private 
collectors. With regard to ships, it is the NRC's understanding that 
the Navy made a concerted effort years ago to remove and dispose of 
radium luminous items. However, there may be some of these items 
remaining on ``mothballed'' ships. The NRC agrees that the general 
license in 10 CFR 31.12 should be expanded to include additional 
military vehicles. As restructured, the 10 CFR 31.12 general license 
would automatically apply to all possessors of antiquities originally 
intended for use by the general public, nonintact timepieces, and 
timepiece hands and dials no longer installed in timepieces; luminous 
items installed in air, marine, or land vessels or ships (This would 
include airplanes, helicopters, jeeps, trucks, tanks, ships, landing 
vessels, artillery pieces, and any other former military use vehicle no 
longer under the control of the military.) See discussion under New 
General License for Certain Items and Self-Luminous Products Containing 
Radium-226, above; all other luminous products, provided that no more 
than 100 items are used or stored at the same location at any one time; 
and small radium sources containing no more than 0.037 MBq (1 [mu]Ci) 
of radium-226. While the general license does not authorize the 
manufacture, assembly, disassembly, or repair of most of the listed 
items, the disassembly and repair of timepieces would be allowed. The 
general license is automatically granted by NRC regulations to persons 
meeting the general license criteria. No action is required from these 
persons to obtain a general license. The NRC foresees no issue 
regarding possession of these items provided that the restrictions on 
the general license are complied with. The NRC would hold persons who 
possess the items financially responsible for the items with regard to 
such things as disposal or meeting other requirements of the general 
license.
    The general license established in 10 CFR 31.12 is revised from the 
proposed rule as follows: Paragraph (a)(2) is revised to read, 
``Nonintact timepieces and timepiece hands and dials no longer 
installed in timepieces''; paragraph (a)(3) is revised to read, 
``Luminous items installed in air, marine, or land vehicles''; 
paragraph (a)(4) is revised to read, ``All other luminous items, 
provided that no more than 100 are used or stored at the same location 
at any one time''; and paragraph (d) is revised to read, ``The general 
license in paragraph (a) of this section does not authorize the 
manufacture, assembly, disassembly, repair, or import of products 
containing radium-226, except that timepieces may be disassembled and 
repaired''.
    Comment: A commenter asked whether the NRC's reporting requirements 
apply to owners of past accelerators or radium-226 items if they do not 
presently have control over the item. For example, the commenter noted 
that wrecked ships and airplanes could contain radium dials, and 
luminous dial instruments could be disposed of in a sanitary landfill, 
and the original owners of these items would not necessarily have any 
knowledge of their current location.
    NRC Response: The NRC's regulations apply to persons who currently, 
or will in the future, possess byproduct material. The NRC would not 
hold persons responsible for reporting any previous possession, 
transfers, or disposals of materials that may have been disposed into 
locations such as municipal landfills over which they have no control. 
However, while the NRC will not hold anyone accountable for past 
disposals in a landfill, these persons might be accountable under EPA's 
Superfund regulations.
    Comment: In response to the NRC's Issue for Public Comment Q.1, a 
commenter stated that the trade of radium-dial watches has increased in 
the past 10 years with most of these sold through Internet auction 
sites or on personal web sites. The commenter does not believe that the 
majority of the people buying these watches are aware that the watches 
are radioactive or the degree of their radioactivity and is concerned 
about the effect of these watches on people who are inadvertently 
exposed to the watches by their incidental close proximity to someone 
wearing or carrying one. The commenter also noted that most owners of 
these watches are not aware that the radiation is still active because 
the luminous scintillating material in the paint mixture is no longer 
working. In the commenter's opinion, the sale and use of vintage radium 
dial watches is not in keeping with the goal of ``as low as is 
reasonably achievable'' (ALARA).
    The commenter stated that many people open these watches to try to 
repair them, to clean their dials, and to replace hands, that many of 
these watches are bought and sold in poor condition (e.g., open, not 
sealed), and that often a watch is sold with the crystal (glass) 
missing and the radium paint on the dial exposed to the outside air. 
The commenter noted that radium powder/dust can and does flake off of 
exposed dials and broken watch cases.
    The commenter indicated that the NRC should require possessors of 
these kinds of watches to follow the same shipping requirements as 
businesses, because the watches exhibit the same types of hazards. The 
commenter recommended that the NRC consider these concerns in 
connection with defining byproduct material. The commenter does not 
think activity thresholds will be useful or practical, but that any 
rulemaking would have to consider ``radium dial watch'' as an entity.
    NRC Response: To further support the exemption and the related 
general license with regard to timepieces, the NRC conducted a scoping 
study to determine the typical and maximum radium activities used in 
various types of timepieces and the potential exposures that might 
result to users, collectors, and repair technicians. The results of 
this study indicate that the doses expected to an individual user, 
collector, or repair technician are acceptably low.
    As directed by the EPAct, the NRC's development of the proposed 
rule considered the CRCPD's applicable SSRs. As provided in the SSRs, 
the NRC has included an exemption from licensing for persons who 
possess intact timepieces that contain no more than 0.037 megabecquerel 
(1.0 microcurie) of radium. The NRC regulation is more restrictive than 
the SSRs in that the exemption only applies to intact timepieces. In 
the proposed rule, the exemption would also have allowed antique 
collectors and watch repair facilities to repair up to 10 timepieces in 
any year. In the final rule, however, the allowance for repair is 
eliminated from the exemption and is now authorized under the general 
license provision. As noted, the exemption only applies to intact 
timepieces. Possession of nonintact timepieces, or radium luminous 
parts such as hands, dials, or faces, and timepiece disassembly and 
repair would be subject to the general license provided in 10 CFR 
31.12.
    Shipment of radium timepieces are currently and will continue to be 
subject to regulations established by the DOT and the United States 
Postal Service. Such shipments will now also come under the NRC's 
regulations in 10 CFR Part 71.
    The NRC has specifically included radium in the definition of 
Byproduct material. The NRC appreciates that most

[[Page 55892]]

consumers will probably not know how much activity there may be in a 
particular timepiece. However, the NRC's evaluation indicates that most 
timepieces that were produced in the past contained less than the 1-
microcurie (37 kBq) exempt limit. If a particular intact timepiece 
contains more than 1 microcurie (37 kBq), then possession would fall 
under the general license provided in 10 CFR 31.12.
    Comment: In response to the NRC's Issue for Public Comment Q.1, a 
commenter stated that it has never found or been informed of a leak 
from any of the double-encapsulated and welded radium-226/beryllium 
sources in their gauges. The commenter noted that even in some worst-
case accidents that occurred, such as compactors running over gauges, 
no source has leaked radioactive material, and no accident has caused 
the source to be separated from its shield.
    NRC Response: The NRC notes that the commenter appears to be 
describing sources used in portable moisture-density measuring devices 
used in roadbed and other construction activities. Generally, these 
devices are possessed under a specific license, although there is a 
possibility some devices may have been authorized by a State under a 
specific license similar to 10 CFR 32.51 for distribution to general 
licensees under requirements comparable to 10 CFR 31.5. As noted in 
response to another comment, if a device is generally licensed, a label 
on the product should indicate its generally licensed status. In either 
case, the licensing authorization would remain the same. Periodic 
source leak testing is generally required for such devices.
Exemption of Certain Radium-226 Items
    Comment: One commenter recommended that the proposed limit for 
repairing timepieces containing radium-226 be increased from 10 to 18 
units per year. This commenter also suggested that the limitation 
should not be restricted by company, but by the number of qualified 
timepiece repair technicians employed. The commenter suggested that 
this change is needed to provide necessary consideration for industry 
consolidation, the emergence of specialized repair centers, and the 
expansion of geographic markets brought about by the Internet and 
globalization.
    NRC Response: The NRC conducted a scoping study regarding potential 
risk associated with handling timepieces containing radium. Based on 
the results of the scoping study on the potential health and safety 
impacts of repairing timepieces containing radium-226 (including the 
storage of loose parts likely to be associated with repair facilities 
and not covered by the exemption), the Commission has decided not to 
limit the number of repairs. However, the repair will be subject to the 
general license in 10 CFR 31.12. There may be limited circumstances 
where companies with a number of timepiece repair technicians 
specifically involved with handing radium-226 should be specifically 
licensed or may be required to conduct cleanup activities. See 
additional comment and response discussion on General License of 
Certain Radium-226 Items and on Specific Licenses for Radium-226.
    Comment: A commenter disagreed with the NRC's proposal under 10 CFR 
30.20 to exempt smoke detectors containing up to 74 kBq (2 [mu]Ci) of 
radium-226 from the licensing requirements in 10 CFR Parts 20, 30 
through 36, and 39. The commenter stated that radiation detection 
equipment at landfills and scrap facilities are very sensitive and are 
often set to thresholds less than twice the background radiation. The 
commenter noted that low activity sources, such as smoke detectors 
containing up to 74 kBq (2 [mu]Ci) of radium-226, will trigger these 
detectors and cause the arriving load to be rejected. The commenter 
stated that this would increase the number of incidents that the States 
would be required to respond to, which would result in an increased 
expenditure of time, human resources, and funds. The commenter 
recommended that these sources should not be allowed to be disposed of 
in the general waste stream, and that facilities with devices 
containing these levels of activity should be generally licensed and 
should be required to dispose of the sources properly.
    NRC Response: The exemption for smoke detectors is only being 
expanded to cover detectors previously distributed in accordance with a 
specific license issued by a State under comparable provisions to 10 
CFR 32.26 authorizing distribution to persons exempt from licensing. 
Smoke detectors meeting this criteria are already exempted by most 
States. Documentation of the individual safety evaluations made to 
demonstrate that these detectors meet the applicable safety criteria is 
incomplete. However, the Bureau of Radiological Health (BRH) of the 
FDA, in consultation with the States and other Federal agencies 
including the NRC and its predecessor, the Atomic Energy Commission 
(AEC), developed NARM guides in the 1970's, to assist the States to 
develop more uniform regulations for NARM. These guides included one 
for gas and aerosol detectors, which was essentially equivalent to the 
NRC's regulations in 10 CFR 32.26, 32.27 and 32.28. By the late 1970's, 
the SSRs included comparable provisions. The guide and the SSRs also 
included a quantity limit of 3.7 kBq (0.1 [mu]Ci) for radium-226.
    Some information on potential impacts of disposal of these 
detectors is contained in the Nuclear Energy Agency document, 
``Recommendations for ionization chamber smoke detectors in 
implementation of radiation protection standards, 1977,'' and NUREG/CR-
1156, ``Environmental Assessment of Ionization Chamber Smoke Detectors 
Containing Am-241,'' November 1979. According to these documents, 
americium-241 had almost completely replaced radium-226 in smoke 
detectors being sold by the late seventies, and the quantities of 
radium-226 used had generally been reduced to no more than 3 kBq (1 
[mu]Ci), typically 1.8 kBq (0.05 [mu]Ci). It is not expected that there 
are large numbers of smoke detectors with radium-226 still in 
existence, with the smaller quantities being more common among those 
that are. Thus, it is not expected that large numbers of detectors 
containing radium-226 would be disposed of concurrently. The disposal 
of small numbers of such detectors in a landfill or municipal 
incinerator is not expected to result in a significant impact to public 
health and safety or the environment.
    The commenter was particularly concerned with the cost related to 
detectors containing radium being detected at landfills and scrap 
facilities. Exempting from the NRC's regulations those detectors which 
have been previously exempted from regulation by the States will not 
add to the number of these incidents nor will not exempting them be 
able to prevent all such incidents. However, a significant part of the 
cost is incurred after identification of a source, if it requires a 
more expensive disposal route. In many cases, once a radioactive source 
has triggered a monitor, it can still be disposed of at the landfill if 
this is determined to be an acceptable disposal option. Because the 
EPAct allows for the disposal of the newly added byproduct material in 
disposal facilities permitted under Federal or State solid or hazardous 
waste laws, acceptability at landfills for disposal of an exempted 
product or material should be improved. What happens after 
identification will depend, in part, on the label, which would have 
been required by the State at the time of distribution. If intact and 
legible, it would indicate whether the product had been exempted from 
State

[[Page 55893]]

regulations or generally licensed. However, the NRC recognizes, as one 
commenter pointed out, that some landfill operators may not be 
obligated to accept such material at their facilities.
    The Commission continues to consider the exemption of these 
previously distributed detectors to be justified. The final rule 
includes this exemption in revised 10 CFR 30.20.
    Comment: Two of the State commenters stated that the NRC should add 
3.7 kilobecquerel (kBq) [0.1 microcurie ([mu]Ci)] of radium-226 to 10 
CFR 30.19 for self-luminous products or otherwise include exemption 
language from the SSRs for low activity radium-226 sources rather than 
including those sources under a general license. One of these 
commenters specifically mentioned types of products other than self-
luminous products listed in the proposed general license in 10 CFR 
31.12 and indicated that they should also be exempt if containing the 
same low quantity of radium-226. Both of these commenters asserted that 
there are no problems known to exist with these exempt sources so there 
is no sufficient reason for the NRC to not exempt them as the States 
have done for many decades, and stated that if the NRC is aware of some 
risk to public health and safety from these very low activity sources, 
then it should provide the information.
    NRC Response: There is only limited information on these items. 
However, there is some indication that the applied radium may be 
subject to such concerns as flaking off due to aging. The NARM guides 
developed by BRH/FDA in the 1970's included a guide for radioluminous 
products which contained safety criteria for approval of a product for 
use under a general license, but not for use under an exemption. The 
SSRs do not include provisions similar to those in 10 CFR 32.22, 32.23, 
and 32.24, for the manufacture or initial distribution of self-luminous 
products for use under an exemption. The SSR provision similar to 10 
CFR 30.19 covers only previously acquired products in the case of items 
containing radium-226. It appears that these products were generally 
not evaluated under provisions comparable to those in 10 CFR 32.22, 
32.23, and 32.24 for self-luminous products. This SSR provision exempts 
``articles'' containing radium under the heading ``Self-luminous 
products.'' While the quantity limit is less than that for watches, the 
category of product is very open-ended and could include items where 
the radium is not contained.
    For these reasons, the Commission considers it prudent not to 
exempt this category of products that is covered by an exemption in the 
SSRs, or other unspecified products with no more than 3.7 kBq (0.1 
[mu]Ci) of radium-226. In addition, there are many self-luminous 
products containing more than 3.7 kBq (0.1 [mu]Ci) of radium-226 and 
most would not be labeled with the quantity or activity of the radium-
226. It would be difficult to determine which products would fall under 
the exemption and which would fall under the general license in 10 CFR 
31.12.
    Comment: One commenter noted the proposed graded approach for 
different levels of radium-226 sources and also mentioned the 
discussion in the Statements of Consideration of various approaches 
used by the non-Agreement States. This commenter responded to the NRC's 
request for input on whether a general license approach or exemption 
approach would be better for some of the devices containing radium-226, 
by saying that an exemption would gather no data, and therefore not be 
the desired path except for the smallest amounts (e.g., 1 [mu]Ci). This 
commenter also stated that an exemption concentration level of 1 [mu]Ci 
(and an appropriate corresponding exempt quantity limit) could be 
considered with the specific/general license approach for materials 
above that de minis amount.
    NRC Response: The SSRs do not include an exempt quantity or exempt 
concentration for radium-226. With the exception of an exempt quantity 
of polonium-210, these exemptions do not include alpha emitters. Given 
that there are no materials in use that have been previously 
universally exempt from licensing under State regulations, there is no 
justification for adding such exemptions now. Without a demonstrated 
need, the NRC does not consider it prudent to allow introduction of 
radium-226 into materials and products to be used by persons exempt 
from licensing or to allow the distribution of radium-226 as exempt 
quantities.
    The requirements for registration of generally licensed devices 
only apply to those generally licensed under 10 CFR 31.5 and then only 
if the device contains a radium source of 3.7 MBq (0.1 mCi) or greater. 
The new general license in 10 CFR 31.12 will not require registration 
by possessors of the items identified in the regulation nor does the 
NRC believe there is a need to impose such a regulatory burden on the 
general licensee.
    Comment: A commenter recommended that the NRC include an exemption 
in the final rule for Internal Revenue Service (IRS)-designated 
501(c)(3) organizations that existed before the effective date of the 
final rule that operate, in whole or in part, as an accredited school 
of watch and/or clock repair and/or specialty museum with a primary 
focus on housing and exhibiting timepieces and related objects. The 
commenter noted that it is important for students to have access to 
examples of radium parts and watches as part of their training, and 
museums must be able to preserve and present practices and objects 
through exhibits to fulfill their educational mission. The commenter 
stated that without this exemption, the proposed inventory process and 
licensing fees would create an undue burden on these organizations.
    NRC Response: The status of an organization as a nonprofit 
institution and whether its mission is educational are not appropriate 
bases for exemption from licensing requirements. Exemptions from 
licensing are based primarily on findings with respect to health, 
safety, and environmental impacts. It should be noted, however, that 
organizations categorized as small entities in accordance with 10 CFR 
2.810 are eligible for reduced annual licensing fees in accordance with 
10 CFR 171.16. Also, a licensee, such as a nonprofit educational 
institution, may be exempt from application fees under 10 CFR 170.11 
and annual licensing fees under 10 CFR 171.11, depending on the 
licensed activities. Also, a museum or school may possess watches under 
the exemption in 10 CFR 30.15(a)(1) irrespective of whether other 
products or activities require these entities to be a general or 
specific licensee.
General License of Certain Radium-226 Items
    Comment: Several commenters responded to the NRC's Issue for Public 
Comment Q.6 request for information on health and safety impact from 
activities involving radium-226 sources that would support a regulatory 
framework other than general licensing, such as an exemption. In 
general, the commenters agreed that an exemption would be preferable to 
a general license for items containing radium-226; however, most of the 
commenters also agreed that more information on the risks of these 
items is needed before a final decision is made.
    Several of the commenters, citing a number of reasons, recommended 
that the NRC create a time-limited exemption for antiquities containing 
radium-226 until such time as sufficient data are gathered and analyzed 
to determine whether these items exhibit high enough risk to require a 
license rather than a permanent exemption.

[[Page 55894]]

    Two commenters noted that their States have had to respond to scrap 
metal yards, steel mills, and municipal waste sites where radium-226 
items had caused loads to be rejected and noted that this happens 
because possessors of these items do not usually know how to safely 
dispose of them.
    Other commenters suggested that an exemption for items containing 
radium-226 is better as long as enough safety data exist proving a low 
risk level for these items to justify the exemption and recommended 
that more investigation, which might include working groups and a 
public outreach effort, is needed into the safety risks of these items. 
One commenter noted that such an outreach effort would place a burden 
on State financial and human resources, and recommended that the NRC 
conduct a cost-benefit analysis to analyze these impacts on the States.
    While the commenters were in general agreement with the NRC's 
proposed approach regarding the specific constraints in the proposed 
exemption in 10 CFR 30.15(a)(1)(viii), one commenter asked how the NRC 
proposes to regulate radiological antiquities that are bought and sold 
on the Internet.
    NRC Response: The NRC notes that, for the most part, there appears 
to be no existing regulatory approach for many of the radium items 
identified in the 10 CFR 31.12 general license, and that very little 
information exists. Therefore, the NRC believes it is more appropriate 
to regulate the products under a general license until the NRC has had 
the opportunity to further document and evaluate these items and 
practices, and determine whether or not additional exemptions may be 
appropriate. The NRC also recognizes that many individuals may not be 
aware that they possess radium items and that ``incidents'' where these 
items are identified at waste sites may continue into the future.
    Based on its initial evaluations, the NRC has been able to find 
only limited information regarding existing safety data which show a 
low risk level for these items which is necessary to justify an 
exemption. The NRC currently has plans to conduct further evaluations, 
including gathering information concerning the products, to help it 
better characterize the likely activities and potential doses to users 
from radium antiquities that will be subject to general licensing. The 
NRC will consider the commenter's suggestion regarding a public 
outreach program and the program's impact on State and Federal 
resources.
    The general license in 10 CFR 31.12 allows general licensees to 
transfer possession of antiquities and other products between general 
licensees, and this includes antiquities bought and sold over the 
Internet. The NRC believes this is acceptable while the NRC conducts 
evaluations and because the limited information available does indicate 
a low risk associated with these items.
    Comment: Several commenters discussed the appropriate regulation of 
the repair and disassembly of items containing radium-226. One 
commenter stated that it believes a ``prohibition of these activities 
under general licensure'' is appropriate. The commenter recommended 
that disassembly, repair, and assembly work on an antique item should 
be authorized by a specific license, not a general license. Another 
commenter recommended that facilities disassembling or repairing 
timepieces containing radium be generally licensed until a study is 
conducted and completed to assess the potential individual and 
collective (population) radiation doses associated with this industry.
    NRC Response: The NRC agrees that the repair and dissassembly of 
certain items containing radium-226 should only be conducted under a 
specific license and notes that 10 CFR 31.12(d) prohibits these 
activities under the general license. The NRC conducted a scoping study 
on potential exposures regarding activities involving timepieces 
containing radium-226. Based on the results of the scoping study, the 
NRC will allow timepiece disassembly and repair under the general 
license provision.
    Comment: Several commenters were in support of a general license 
for items containing radium. One commenter requested clarification of 
the general license requirements for radium dials, gauges, and buttons 
installed in aircraft used as static displays, in aircraft used in 
museums, in aircraft that are in storage for potential re-use as 
refurbished piloted aircraft, as unmanned drone aircraft (potentially 
used as targets), or as a source for spare parts, and in dials, gauges, 
buttons, and/or painted lettering or numbering that do not have a glass 
or crystal face covering, or for which the covering is damaged or 
broken. The commenter also expressed concern that the transfer 
requirements of proposed 10 CFR 31.12(c)(2) may place an undue burden 
on the licensees and recommended that the NRC should allow for easier 
transfer under the general license from one entity to another.
    One commenter stated that some museums possess devices containing 
radium-226 in gauges and other safety devices installed in ground 
vehicles (e.g., trucks, armored tanks, artillery pieces), portable 
radios, and submarine instrument panels on display and that public 
access to these devices is controlled in the same manner as aircraft at 
these museums. The commenter recommended that the NRC expand the 10 CFR 
30.12 general license to include radium containing devices installed on 
other types of vehicles and equipment besides just aircraft.
    Another commenter stated that a common practice on World War II 
aircraft was to apply radium paint over the words and numbers engraved 
on cockpit instrument panels so that they were visible in the dark. The 
commenter noted that in these cases, the painted surfaces are not 
contained behind glass as in gauges.
    NRC Response: The rule allowing possession under the general 
license rule applies to all luminous items installed in aircraft 
regardless of whether the material is in an intact gauge, a gauge 
missing a face plate, or as luminous paint applied on the outside of a 
gauge. The general license also applies to all aircraft regardless if 
the aircraft is routinely used or in storage.
    Paragraph (a) of 10 CFR 31.12 allows any general licensee to 
transfer any generally licensed item identified in this section to 
another general licensee for possession and use without restriction. 
The provisions in 10 CFR 31.12(c)(2) only restrict transfers to 
specific licensees or as otherwise authorized by the NRC under 10 CFR 
20.2008 when the general licensee is intending to dispose of the item.
    The NRC agrees that the general license should be extended to 
include luminous items installed in additional large military transport 
vehicles no longer under the control of the military and has modified 
10 CFR 31.12 to include marine ships and land vehicles in addition to 
aircraft. The general license also allows for the possession of up to 
100 other luminous items, including uninstalled aircraft safety 
devices.
Specific License for Radium-226
    Comment: A commenter stated that there should be a threshold level 
for possession of radium-226 luminous items that are not contained in 
an intact product beyond which a specific license is preferable, 
whether or not the items are intact. The commenter recommended that the 
NRC consider requiring a specific license for a number

[[Page 55895]]

of items that is at least the exempt quantity value times 10 to 100. 
The commenter also stated that commercial transfers of items containing 
radium-226 should not be treated the same as possession and use and 
recommended that the NRC require a specific license for commercial 
transfers.
    NRC Response: The NRC does not agree, based on other comments and 
the information currently available, that it should impose more 
restrictive requirements beyond those provided in 10 CFR 31.12. 
However, the NRC may consider the commenter's suggestions in a future 
rulemaking should the results from further evaluations, and 
characterization of the likely activities and potential doses to users 
from radium antiquities, indicate a need for additional restrictions in 
these areas.
    Comment: With regard to proposed 10 CFR 31.8(b), which relates to 
the general license for radium-226 in calibration or reference sources, 
one commenter recommended that the NRC provide a ``grandfather clause 
for [radium-226] items'' that were approved for manufacture before 10 
CFR 32.57 was adopted in its current form. The commenter stated that 
the States should be able to simply attest that the calibration or 
reference sources were manufactured to standards or criteria that have 
been demonstrated through years of use to be adequate to protect the 
public health and safety and the users of the sources. The commenter 
asserted that, unless the NRC has knowledge of problems of leaking 
sources of this type, the NRC should provide clarification that these 
sources are acceptable as manufactured.
    NRC Response: ``The general license in 10 CFR 31.8 contains a 
footnote to include any sources labeled in accordance with the 
provisions applicable before January 19, 1975, i.e., with labels 
referring to the AEC before the creation of the NRC. In addition to the 
revision of paragraph (b) of 10 CFR 31.8, this footnote is being 
revised to include a requirement that sources containing radium-226 be 
labeled as required by the authorizing State at the time of 
manufacture. Therefore, the NRC believes that there is no need for any 
further grandfathering. Any calibration and reference source (or its 
container) containing radium-226, that was manufactured or initially 
transferred under requirements comparable to 10 CFR 32.57, would be 
labeled accordingly. As suggested by the commenter, the NRC expects 
that these sources are acceptable as manufactured.
    Comment: A commenter noted that the proposed 10 CFR 32.59 required 
testing for leakage ``with a filter paper'' and ``application of 
moderate finger pressure.'' The commenter believes this is overly 
prescriptive, prohibiting the use of other materials and requiring the 
use of ``the fingers.''
    NRC Response: The requirements referred to by the commenter are the 
existing requirements for distributors of calibration and reference 
sources containing americium-241 for use under the general license in 
10 CFR 31.8 and equivalent general licenses of the Agreement States, to 
which radium-226 is being added. It is consistent with the SSRs. The 
commenter's request for this general revision is outside of the scope 
of this rulemaking.

Comments Related to Accelerator and Accelerator-Produced Radioactive 
Material

    Comment: One commenter believes that the definition of Cyclotron 
was unclear, noting the statement that particles are ``bent''.
    NRC Response: To address the commenter's concern, the NRC is 
revising the definition of Cyclotron to indicate that the charged 
particles travel in an outward spiral or circular path.
    Comment: A commenter stated that the definition of Particle 
accelerator should be revised. The commenter noted that the definition 
currently states that a particle accelerator is a machine capable of 
``discharging the resultant particles or other radiation into a medium 
at energies in excess of 1 megaelectron volt (MeV).'' The commenter 
noted that cathode ray tube television sets were developed from early 
particle accelerators, and that while commercial television sets 
operate at 0.035 MeV, overzealous application of the rule might include 
these and other smaller particle accelerators. The commenter also 
stated that it is possible that any beta-emitting source with energies 
greater than 1 MeV in a vacuum might also be considered an accelerator. 
The commenter noted that the ``NRC is now regulating exotic particles 
such as muons, but that [the commenter's] search of 10 CFR part 20 did 
not find any reference to muons.'' The commenter noted that the NRC 
should also ``expect to see extremity doses approaching 50 REM per year 
for the preparers of the accelerator-produced medical isotope unit 
doses'' and apparently that the NRC should consider those health 
effects in its regulation of NARM.
    NRC Response: The definition of Particle accelerator has been used 
by State radiation control programs for many years. The lower limit of 
1 MeV was chosen to avoid regulation of lower energy accelerators. 
Consistent with the intent of the EPAct, the NRC will regulate 
byproduct material as defined in the EPAct as radioactive material 
produced by use of a particle accelerator. The NRC will not regulate 
the possession or operation of any particle accelerators that will not 
produce the byproduct material that the NRC will regulate. Also, note 
that the NRC will not regulate particles such as protons or electrons, 
or exotic particles such as muons generated in these particle 
accelerators that will not produce byproduct material.
    The NRC is aware that high radiation doses are possible from 
handling accelerator-produced radioactive materials. Because licensees 
are required to comply with the radiation safety program requirements 
in 10 CFR Part 20, the NRC expects that licensees will use handling 
methods and equipment as part of their radiation safety program to 
prevent high radiation doses. No change is made to the definition.
    Comment: A commenter noted that for hadronic beams, measurements of 
energy per nucleon (MeV/nucleon) may provide more useful information 
(apparently rather than the maximum energy of the accelerated 
particles). The commenter gave as an example that a 1-MeV proton will 
have different activation potential than a uranium-238 nucleus with 
(collectively) 1 MeV.
    NRC Response: The commenter's view on energy level is noted. 
Because the NRC only regulates the radioactive material produced by 
using a particle accelerator and not the radiation beam itself, the 
activation potential of the beam or particle has no direct impact in 
the NRC's determination of the regulated material. Radioactive material 
is defined as byproduct material if it is produced for use for 
commercial, medical, or research activities and is produced by 
irradiation or activation in a particle accelerator regardless of the 
type or energy level of the particle.
    Comment: A commenter asked if the NRC's jurisdiction over 
accelerators includes particle beam weapons in space, the ion drive 
technologies being developed for interplanetary use, or laser wake 
field accelerators; or if the NRC's jurisdiction would extend to such 
items and materials as beam energy, interlock requirements, 
minimization of activated/spallated materials, ion species accelerated/
charge state, or minimization of beryllium components (neutron 
spallation targets). The commenter also asked what parts of an 
accelerator (e.g., magnets, power supplies, RF cavities, beam pipe, 
nuts, bolts, wire, shielding, tools) the NRC will regulate. The 
commenter noted that

[[Page 55896]]

these parts are transferred between the DOE-owned/NRC-regulated 
accelerators and worldwide researchers.
    NRC Response: The NRC's authority does not include regulating 
accelerators or parts of an accelerator, nor does it include particles 
or particle beams. The NRC does not regulate accelerator or accelerator 
operating parameters. However, certain Agreement and non-Agreement 
States may regulate accelerators, accelerator operations, and 
accelerator safety requirements within their State's radiation control 
programs. Under the EPAct, the NRC will regulate radioactive materials 
produced in an accelerator used to intentionally produce radioactive 
material for use for commercial, medical, or research activities. This 
will also include any activated radioactive material that may still 
reside within the accelerator as a result of using the accelerator to 
intentionally produce radioactive material. The determination of the 
regulated material is based on whether a radioactive material is 
produced in a particle accelerator for use for commercial, medical, or 
research activities. In addition to regulating the accelerator-produced 
radioactive material, the production facility will also be regulated 
through the NRC or Agreement State licensing process to ensure safe 
handling of the material and to ensure protection of public health and 
safety and the environment.
    Comment: A commenter stated that most activation/spallation in 
accelerators occurs in high loss areas. The commenter noted that beam 
dumps can become very radioactive in higher energy machines. The 
commenter stated that caution should be exercised because the 
efficiency of Geiger-Mueller (GM) photon counters for photon-only 
emitting radionuclides that are common in accelerator environments is 
0.17 percent as opposed to a GM photon-counting efficiency of 30 
percent for medium energy beta emitters.
    NRC Response: The NRC appreciates the commenter's insight. The NRC 
expects licensees to be knowledgeable, based on their qualification 
through training and experience, of the response characteristics of 
survey and measurement instrumentation relative to the radioactive 
material being produced or used. Licensee RSOs are required to show 
evidence of such training and experience as part of the licensing 
process.
    Comment: Two commenters asked if entities other than particle 
accelerator users would be regulated by the NRC. One commenter asked if 
the NRC will license accelerator producers and distributors. Another 
commenter asked who the NRC anticipates will regulate the safety of 
accelerator facilities and their operation in both Agreement and non-
Agreement States. The commenter noted that many States have implemented 
the SSR accelerator regulations. However, the commenter stated that 
``the regulatory responsibility for the radiation safety of the 
accelerator facility, the production of the radionuclides (licensing of 
accelerator targets), and the radioactive waste management 
(specifically, accelerator targets) is unclear in Non-Agreement States, 
particularly in Federal institutions.''
    NRC Response: The NRC has no jurisdiction over accelerators; 
therefore, the NRC will not license or regulate producers, 
distributors, or users of particle accelerators. The NRC will, however, 
regulate persons that handle radioactive material from an accelerator 
that is used to intentionally produce radioactive material for use for 
commercial, medical, or research activities. Although the NRC will not 
license or otherwise regulate the sales or distribution of particle 
accelerators, certain Agreement States and non-Agreement States may 
have regulatory programs for registration, licensing, and/or safe 
operation of accelerators.
    As provided by the EPAct, the NRC or the Agreement States have the 
regulatory authority for regulating the accelerator-produced 
radioactive material, the production of accelerator-produced 
radioactive material, and the associated waste. Once the Agreement 
State certifies, and the NRC determines that the State's program is 
adequate to protect the public health and safety for the newly added 
byproduct material, the State will have regulatory authority over the 
newly added byproduct material. If an Agreement State did not certify 
or the NRC determined that the State's program is inadequate, the NRC 
will retain its regulatory authority over the newly added byproduct 
material. In a non-Agreement State, the NRC has the regulatory 
authority for all AEA materials including the newly added byproduct 
material. As for Federal facilities, the NRC has the regulatory 
authority regardless if the Federal facility is located in an Agreement 
State or in a non-Agreement State.
    Comment: Two commenters agreed with the NRC's proposed delineation 
of particle accelerators into three varieties, especially with the one 
category specific to accelerators that are operated to produce only 
particle beams and not radioactive materials. The commenters agreed 
that these types of accelerators, which include linear accelerators 
used in radiation therapy, should not be regulated. One commenter 
supported the NRC's proposal to not include incidental radioactive 
material produced by medical linear accelerators in the regulation.
    One commenter recommended that the NRC should, in the final rule, 
include a specific exemption for commercially available linear 
accelerators used only for medical purposes to treat patients. The 
commenter recommended modifying the definition of Particle accelerator 
for such exemption and provided specific language for the modification.
    NRC Response: Under the EPAct, the NRC only has regulatory 
authority over accelerator-produced radioactive material and not over 
the accelerator. Because the NRC can only exempt material or activity 
under its jurisdiction, it would not be appropriate for the NRC to 
exempt accelerators in its regulation.
    Comment: A commenter asked if the NRC would regulate neutron 
generators as accelerators. The commenter noted that these neutron 
generators operate by D,T [deuterium, tritium] reactions that use a 4-
MeV (2 MeV per nucleon) deuteron to produce up to a 12-MeV evaporation 
neutron. The commenter stated that confusion will occur if the NRC 
regulates accelerators based on their acceleration potential. As an 
example, the commenter stated that a 4-MeV electron will accelerate a 
nucleon to 4 MeV if only one electron is removed from the electron 
shell (charge state), but if two electrons are stripped, then the 
acceleration energy will be 8 MeV (4 MeV x 2).
    NRC Response: The NRC will not regulate accelerators nor the 
operation of an accelerator. The NRC will only regulate the radioactive 
material produced in an accelerator intentionally operated to produce 
radioactive material for use for commercial, medical, or research 
activities. Therefore, the acceleration potential is irrelevant to the 
NRC's regulatory program. A minimum accelerator potential of 1 MeV is 
specified in the definition of Particle accelerator to be consistent 
with the SSRs.
    If a neutron generated by the accelerator is used to produce 
radioactive material via neutron activation, and the resulting 
radioactive material is used for a commercial, medical, or research 
activity, the radioactive material (and any incidentally produced 
radioactive material) would be regulated as byproduct material under 
Section 11e.(3) of the AEA as amended by the EPAct.

[[Page 55897]]

    Comment: A commenter recommended that the NRC add the definition of 
Particle accelerator to 10 CFR Part 35 in addition to 10 CFR Parts 20 
and 30.
    NRC Response: The NRC Part 35 licensees are required to comply with 
10 CFR Parts 20 and 30, in which the term Particle accelerator is 
defined. Therefore, it is not necessary to repeat this definition. In 
addition, including the definition of Particle accelerator in 10 CFR 
Part 35 may inaccurately reflect that Part 35 includes regulations for 
particle accelerators.
Accelerator-Produced Radioactive Material
    Comment: A commenter stated that certain materials have low nuclear 
binding energy. As with neutron sources using a ``(gamma, N) 
reaction,'' particle beams can produce substantial neutron fluxes if 
they strike a beryllium target. The commenter asked whether the NRC 
would consider the materials activated by these neutrons as byproduct 
material or accelerator-produced material.
    NRC Response: Before the EPAct, the NRC regulated americium/
beryllium neutron generators but not radium/beryllium neutron 
generators because americium-241 was included in the definition of 
Byproduct material, and radium-226 was not. Both generators will now be 
regulated by the NRC because they both contain byproduct material. The 
NRC also considers activation products produced by neutron emissions 
from byproduct material (e.g., californium-252) to be byproduct 
material. The NRC also regulates the tritium targets in well logging 
tools and other accelerators that produced neutron beams because 
tritium is a byproduct material. The EPAct gives the NRC regulatory 
authority over discrete sources of radium-226 and accelerator produced 
radioactive materials. Therefore, the NRC now regulates, as byproduct 
material, the activation products produced by a neutron beam 
accelerator, when the activation products are used for commercial, 
medical or research and development uses.
    Comment: A commenter noted that DOE may begin production of 
radionuclides and radioactive material accelerators [Reference: See 
http://www.eh.doe.gov/nepa/eis/eis0310/eis0310.html Volume l, Chapter 
2a (see page 7 of the first enclosure)]. The commenter asked if this 
would cause any problems.
    NRC Response: As an initial matter, the EPAct did not give the NRC 
jurisdiction over the production of accelerators. Therefore, the 
production of radioactive material accelerators would not impact the 
NRC's regulatory authority. In addition, DOE activities are not subject 
to licensing unless they fall within the purview of certain activities 
specified in Section 202 of the Energy Reorganization Act. The 
production of radionuclides would not fall within the scope of these 
activities. Therefore, DOE would not need a license to produce 
radionuclides. With the exception of restrictions in 10 CFR Part 35 for 
medical use licensees and in 10 CFR Part 30 for general licensees, 
there are no restrictions on who may transfer the radioactive materials 
to the NRC licensees. If DOE were to begin to produce radioactive 
material, it could transfer radionuclides to the NRC licensees provided 
the NRC licensee was specifically authorized to receive the radioactive 
material. However, if DOE pursued production of radioactive drugs or 
sealed sources for direct distribution to medical use licensees, the 
NRC may have to change its regulations because the existing regulations 
only allow medical use licensees to obtain these products from a 10 CFR 
Part 32 licensee. Similar changes may be needed to distribute material 
to general licensees or to persons exempt from licensing.
    Comment: A commenter asked if the NRC will allow the use of the 
most current ANSI/IRCP/NCRP neutron flux to dose conversion factors 
because the accelerator neutron spectrum may exceed the maximum energy 
of only 400 MeV listed in 10 CFR Part 20.
    NRC Response: For those cases in which greater than 400-MeV 
neutrons are encountered during a licensed activity, the licensee can 
request prior approval to use a specific ANSI/ICRP/NCRP neutron flux to 
dose equivalent conversion.
    Comment: Three commenters provided their views on the NRC's 
proposal not to regulate incidental radioactive material produced by 
accelerators that are operated only to produce particle beams.
    Two commenters agreed with the NRC's suggested regulatory approach 
of not regulating incidental radioactive material produced by 
accelerators that are operated only to produce particle beams. One 
commenter indicated agreement with this approach because only small 
amounts of the incidental radioactive materials are produced in the 
particle beam-generating process, and those typically have a short 
half-life. The other commenter agreed because it believed that the 
incidental radioactive materials are indistinguishable from the 
particles produced intentionally in particle beams and would not be an 
undue burden on licensees. A third commenter disagreed with the NRC's 
proposed regulatory approach and recommended that all incidentally 
produced radioactive material be regulated by the NRC regardless of the 
use of the accelerator. The commenter questioned treating incidental 
material that was made radioactive from an accelerator used only to 
produce particle beams differently than incidental material made 
radioactive from an accelerator used to produce both radioactive 
material and particle beams. The commenter stated that the incidental 
accelerator-produced material is radioactive material regardless of the 
purpose for which the accelerator is being used, and that in certain 
situations during disposal of the accelerator, the activated internal 
components of all accelerators will enter the waste stream. 
Furthermore, the commenter noted that in its experience, some 
activation products in the accelerator components were still 
radioactive a month after removal.
    NRC Response: The NRC agrees that there is essentially no 
radiological difference between incidental radioactive material made 
from an accelerator used only to produce particle beams and an 
accelerator used to produce both radioactive material and particle 
beams. However, the NRC's authority under the EPAct does not extend to 
incidentally produced radioactive material unless the incidentally 
produced radioactive material was made during the process of making 
radioactive materials for commercial, medical, or research uses.
    Comment: One commenter agreed with the NRC's proposed approach to 
regulate intentionally and incidentally produced radioactive materials 
without regulating the actual possession or operation of the 
accelerator. However, the commenter requested clarification of the NRC 
regulatory oversight of the radioactive material produced by an 
accelerator and the decommissioning of accelerator facilities in a non-
Agreement State if the NRC does not have the authority under the EPAct 
to regulate the possession and operation of the accelerators that 
produce these materials. The commenter noted that some States do not 
have licensing requirements for operating an accelerator or for the 
material an accelerator produces.
    NRC Response: Although the NRC does not regulate the operation of 
the accelerator, it will regulate the production of byproduct material 
and the byproduct material once it is

[[Page 55898]]

produced. The NRC will also regulate the use of the radioactive 
materials produced by the accelerator including operational steps that 
expose individuals to radioactive materials being produced, or the 
radiation from these materials and maintenance processes that involve 
handling components of the accelerator that have become radioactive. 
The NRC will issue a specific license to any person, as defined in 10 
CFR 30.4, ``Definitions,'' that produces byproduct material with an 
accelerator, provided the person meets the requirements in 10 CFR 
30.33, ``General requirements for issuance of a specific license.'' 
This license will authorize the production of radioactive materials by 
the accelerator and the incidental radioactive materials produced 
during the production process.
    Under the provisions of the waiver that the NRC issued on August 
31, 2005, a person producing byproduct material with an accelerator may 
continue that activity until the waiver is terminated. Under the 
waiver, the person was not required to have a license. When the NRC 
terminates the waiver under which the person is producing byproduct 
material with an accelerator, the person is subject to all the NRC 
regulations pertaining to the production, possession, use, transfer, 
and disposal of the radionuclides produced by the accelerator, and must 
apply for a license or an amendment to continue these activities. The 
person is permitted to continue producing radionuclides with the 
accelerator until the NRC takes final licensing action provided the 
person applies for an NRC license (or an amendment to an NRC license) 
within the time specified in the regulations. Therefore, the NRC's 
authority applies to the owner and operator of the accelerator facility 
in a non-Agreement State, and a license does not have to be in place 
for the transition of authority from a non-Agreement State to the NRC.
    The NRC will regulate all radioactive materials and the disposal of 
components and decommissioning of facilities made radioactive during 
the use of the accelerator if the accelerator is used to produce 
byproduct material for a commercial, medical, or research activity. If 
the accelerator is never used to produce byproduct material for such a 
purpose, then the NRC will not regulate the incidental radioactive 
material produced during the operation of the accelerator.
Regulating Accelerator-Produced Radioactive Material
    Comment: One commenter noted that the NRC has set up a regulatory 
framework that would issue one license for production and distribution 
and another for possession and use. The commenter recommended that the 
NRC continue to allow flexibility for the States to either follow the 
NRC's licensing approach or to streamline the licensing process by 
combining both license authorizations into a single license. Some 
States use the single license approach so facilities are not being 
required to pay multiple fees for multiple licenses or so a single 
facility with a single operator has only one radiation safety program 
for the State to evaluate. The commenter concluded that the additional 
authorizations require only a few extra lines of text in a license 
document, so the licensee should not have to pay separate licensing 
fees.
    Another commenter requested that the NRC clarify whether a single 
license might include authorizations under both 10 CFR Part 30 and 10 
CFR 32.72 or whether separate licenses are required by the NRC.
    NRC Response: Licensing procedures are considered as a matter of 
adequacy for the Agreement States, not compatibility. As long as the 
license or licenses written by an Agreement State are adequate to 
assure that the licensed program will protect public health and safety, 
the licensing procedures need not be the same as those used by the NRC. 
The NRC will continue to consider the adequacy of Agreement State 
licensing procedures for all byproduct licenses, including those for 
the newly added byproduct material, as part of the Integrated Materials 
Performance Evaluation Program (IMPEP) reviews.
    The NRC fees are based on the number of the NRC-regulated 
activities conducted by the licensee. The NRC regulations list fee 
categories for the various activities. A license may include more than 
one fee category, and each fee category has a separate fee to recover 
the budgeted resources associated with that regulated activity.
    The NRC intends to license the production of radionuclides by 
accelerators as a separate Part 30 license and has developed a separate 
licensing guide for this activity (i.e., NUREG-1556, Volume 21, 
``Program Specific Guidance About Possession Licenses for Production of 
Radioactive Materials Using an Accelerator''). Commercial distribution 
will continue to be licensed under 10 CFR 32.72 for radioactive drugs 
and under 10 CFR 32.74 for medical sealed sources. This licensing 
process provides a clear delineation between radionuclide production or 
radioactive drug manufacture and commercial distribution of radioactive 
drugs or medical sealed sources to medical use licensees.
    Historically, a radioactive drug manufacturer has to obtain a Part 
30 license for possession of the licensed material. A Part 30 license 
also authorizes the transfer of byproduct material under 10 CFR 30.41 
to other licensees, but it does not authorize distribution of 
radioactive drugs to medical use licensees. Distribution of radioactive 
drugs containing byproduct material to medical use licensees for 
medical use must be authorized by a ``Medical Distribution'' (MD) 
license under 10 CFR 32.72 or 10 CFR 32.74.
    The NRC issues MD licenses to commercial nuclear pharmacies for 
distribution of radioactive drugs to medical use licensees with a Part 
30 authorization for possession and use. However, the NRC does not 
consider commercial nuclear pharmacies to be drug manufacturers, i.e., 
registered with FDA or a State as a drug manufacturer.
    Comment: A commenter stated that medical radionuclides can 
initially produce very high doses of radiation from the exterior of a 
patient after treatment. The commenter asked whether, because of this, 
there are any patient releasability issues such as those for the 
release of iodine-131 therapy patients. The commenter also asked 
whether there would be any releasability issues for activated or 
spallated patients.
    NRC Response: The requirements in 10 CFR 35.75, ``Release of 
individuals containing unsealed byproduct material or implants 
containing byproduct material,'' apply to all medical uses and all 
medical use licensees. It is the licensee's responsibility for a 
release determination of a patient or human research subject to 
determine whether he or she: (1) cannot be released under 10 CFR 35.75; 
(2) can be released with written instructions; or (3) can be released 
without written instructions. These decisions are based on whether the 
total effective dose equivalent to any other individual is likely to 
exceed certain values. These values apply to the evaluation of all 
patients including activated patients.
    Comment: Several commenters supported the ``grandfathering'' of 
individuals (i.e., not requiring individuals to meet new training and 
experience requirements in order to continue their previous 
responsibilities), discussed in the Statements of Consideration for 
individuals producing accelerator-produced radionuclides and in the 
proposed rule text for ANPs, medical use AUs, and RSOs. These 
commenters wanted a grandfathering provision for

[[Page 55899]]

AUs responsible for the production and use of PET radionuclides 
included in 10 CFR Part 30. Some of these commenters requested that the 
NRC strengthen the language to clarify the extent of the grandfathering 
authorizations. Several commenters requested that the NRC consider 
using this rulemaking to resolve other general issues related to 
grandfathering of AMPs and RSOs. The commenters agreed that individuals 
already authorized to use byproduct materials in 10 CFR Part 35 should 
also be authorized to use the newly covered accelerator-produced 
materials. One commenter wanted the NRC to clarify that the reverse was 
also true, i.e., individuals who previously only used NARM were now 
qualified to use all byproduct material.
    NRC Response: Unlike 10 CFR Part 35 medical use licensees that are 
required to meet specific training and experience requirements, 10 CFR 
Part 30 licensees that use accelerators to produce byproduct material 
are required to meet general performance criteria in 10 CFR 
30.33(a)(3). The training and experience of individuals involved in the 
licensing activities to produce the newly added byproduct material are 
reviewed during the licensing process to ensure that they are qualified 
to perform those activities. Because the NRC does not have specific 
requirements for these individuals, there is no need to provide a 
``grandfather provision'' for them. Applicants with accelerators used 
to produce byproduct material will be required to describe the 
radiation safety training and work experience of those individuals 
using materials that they are seeking authorization to use. It is 
expected that these individuals that used the newly added byproduct 
materials will be able to document that their radiation safety training 
and work experience from using these materials are sufficient to meet 
the general performance criteria and that they be recognized as 
authorized individuals.
    Section 35.57 was amended in the proposed rule to provide that 
certain authorized individuals who used only the newly defined 
byproduct material may be grandfathered (i.e., need not comply with the 
relevant training requirements in Part 35) for performing the same 
uses. The NRC does not believe that the language in the provisions 
should be revised.
    The NRC has determined that revising the regulations to address 
general issues related to the grandfathering of AMPs and RSOs would be 
outside of the scope of this rulemaking. These issues will be addressed 
separately in response to a petition for rulemaking (PRM-35-20) filed 
by the American Association of Physicists in Medicine on September 10, 
2006.
    Comment: There were several comments on the NRC's proposal for the 
noncommercial transfer of PET radionuclides, drugs, and biologics to 
other medical facilities in its consortium by a medical use facility 
that uses its own cyclotron to produce PET radionuclides. One commenter 
stated that it agreed that facilities authorized by a State to produce 
PET radionuclides for noncommercial distribution should be allowed to 
do so without a medical distribution license.
    Generally, the commenters agreed that distribution licenses should 
not be required for distribution of radionuclides from PET facilities 
to medical facilities under contract to them, but thought it was 
unclear which facilities would be included in the definition of 
``medical facilities in its consortium.'' As an example, one commenter 
was not sure whether a cyclotron producing PET radionuclides, that is 
located at a facility owned by Company A but operated under a separate 
license by a different Company B, would need a commercial distribution 
license. The commenter also asked for clarification on whether Company 
B would need a medical distribution license if it also supplied PET 
radionuclides to other facilities in its geographical area under 
contract.
    Another commenter noted that only noncommercial distribution to a 
medical consortium was addressed, and not the noncommercial 
distribution within the consortium in support of research and 
development. The commenter asked that the NRC expand its proposed 
regulatory framework to include authorization for licensees producing 
PET radionuclides, drugs, and biologics to allow noncommercial transfer 
to any licensee approved for research and development uses of these 
materials. This commenter also asked the NRC to provide specific 
guidance on what is considered commercial transfer and noncommercial 
transfer in advance of requiring license application and amendment 
submissions for the production of accelerator-produced radionuclides. 
The commenter's interest was based on its being funded to do research 
involving nonstandard radionuclides and to make the results available 
to the research community and others. The commenter asserted that the 
NRC, in the past, approved similar efforts by universities to produce 
and supply nonstandard radionuclides not otherwise available.
    NRC Response: The NRC recognizes that the PET radionuclide 
production facility may be located in a medical facility, educational 
institution, or Federal facility that has formed a consortium to 
produce PET radioactive drugs for its members. The NRC is adding a 
definition of Consortium in 10 CFR 30.4 to clarify the purpose and 
members of a consortium. In general, the members of the consortium 
jointly own or share in the operation and maintenance cost of the PET 
radionuclide production facility, and the production facility or 
another member of the consortium produces PET radioactive drugs 
(including radioactive biologics) only for its consortium member's 
medical uses. The NRC's authorization for the noncommercial 
distribution of PET radioactive drugs within a medical use consortium 
is not dependent on an authorization by a State to produce PET 
radionuclides for noncommercial distribution. A person or a licensee 
that has or receives PET radionuclides from a PET radionuclide 
production facility may request authorization for noncommercial 
distribution of PET radioactive drugs within its consortium. The NRC 
will review the request along with the description of the consortium 
during the licensing review process to ensure eligibility for 
noncommercial distribution and issuance of the authorization.
    For clarification purposes, the NRC, in the final rule, has moved 
the noncommercial distribution provisions for PET radioactive drugs to 
10 CFR Part 30. For noncommercial distribution of PET radioactive 
drugs, the NRC is applying the same requirements as those included in 
10 CFR 32.72 for commercial distribution of these drugs.
    Regarding different licensing situations, a university that has 
both a 10 CFR Part 30 license and a 10 CFR Part 35 license could 
transfer PET radioactive drugs to its medical facility without a 
commercial distribution license. If the PET radionuclide production 
facility produces PET radioactive drugs and is located at a medical 
facility, but owned, operated, and licensed by another entity under a 
10 CFR Part 30 license, then the PET radionuclide production facility 
licensee would need a 10 CFR 32.72 license to distribute PET 
radioactive drugs to the medical facility for medical use. If a PET 
radionuclide production facility produces PET radioactive drugs and 
wants to distribute excess PET radioactive drugs to other licensees 
outside its consortium, a 10 CFR 32.72 commercial medical distribution 
license would be required. In general, a PET radionuclide production 
facility may transfer excess PET radionuclides to other licensees that 
are authorized to

[[Page 55900]]

receive such PET radionuclide transfer under 10 CFR 30.41. However, if 
a PET radionuclide production facility produces radionuclides for 
commercial distribution, then a distribution authorization would be 
required as well. An applicant's intent regarding noncommercial 
distribution, transfer, or commercial distribution will be evaluated as 
part of the licensing review process to ensure that the proper license 
or authorization is issued.
    A PET radionuclide production facility is required to obtain a 10 
CFR Part 30 license for production, possession, and use of byproduct 
material. Under 10 CFR 30.41, a licensee is allowed to transfer 
byproduct material (including PET radionuclide) to any person 
authorized to receive such byproduct material. However, as required in 
10 CFR Part 35 regulations, medical use licensees can only obtain PET 
radioactive drugs for medical use from persons meeting specific 
requirements for commercial distribution of radioactive drugs in 10 CFR 
32.72. There are no such limitations for nonmedical use. Therefore, a 
specific provision would be needed to allow medical use licensees to 
obtain PET radioactive drugs through noncommercial distribution or from 
persons not covered under 10 CFR 32.72. A new provision is added in 10 
CFR 30.32(j) to allow a PET radionuclide production facility to 
noncommercially distribute PET radioactive drugs to members of its 
consortium. Such a provision is not needed for a PET radionuclide 
production facility to transfer PET radionuclides because transfer is 
already allowed under 10 CFR 30.41.
    Comment: A commenter requested that the NRC clarify whether 
facilities that prepare PET drugs for use in research under 
Investigational New Drug exemptions (INDs) filed with the FDA, or used 
in research conducted under approvals granted by Radioactive Drug 
Research Committees (RDRCs) operating as branches of the FDA under 21 
CFR 361.1, would be considered ``registered'' by the FDA.
    NRC Response: As specified in 10 CFR 30.32(j) and 10 CFR 32.72, 
being registered with the FDA is only one of the five ways that an 
applicant can demonstrate that it is qualified to produce PET 
radioactive drugs for noncommercial or commercial distribution to 
medical use licensees. Because the NRC neither interprets nor enforces 
FDA requirements, it is the applicant's responsibility to provide 
documentation of the proper FDA registration. If there is a question as 
to whether a specific facility that prepares PET drugs under INDs or 
RDRCs is ``registered'' by the FDA, the applicant should contact FDA 
for a determination.
    It is important to note that a 10 CFR Part 35 medical use licensee 
may obtain unsealed byproduct material for uptake, dilution, excretion, 
imaging, or localization from an NRC or Agreement State licensee that 
prepared the material for research in accordance with an RDRC-approved 
protocol or an IND protocol accepted by FDA as permitted in current 
provisions of 10 CFR 35.100 and 35.200. This provision is separate from 
the provision that the byproduct material must be obtained from a 
commercial manufacturer or preparer licensed under 10 CFR 32.72 or by 
noncommercial distribution from a member of its consortium under 10 CFR 
30.32(j).
    Comment: A commenter expressed concern that language in the 
proposed rule could place undue burden on health care providers who use 
cyclotrons for the production of radiotracers by requiring them to meet 
FDA's Good Manufacturing Practices (GMPs) standard that is applied to 
commercial entities producing products for sale to the public. The 
commenter stated that it was inappropriate to apply GMPs to 
noncommercial production of radiotracers. The commenter stated that: 
(1) the EPAct does not give the NRC the authority to require health 
care providers to follow GMPs in their clinical practices; (2) 
enforcing drug production quality standards falls under FDA's 
jurisdiction, and the NRC should not enforce FDA requirements; (3) such 
a requirement would have a detrimental effect on exploration of new 
treatment pathways; and (4) health care providers have not been 
required to apply commercial GMP standards previously. The commenter 
asserted that regulation of cyclotron byproduct material should not 
include processes involving drug production and patient care. The 
commenter further indicated that the production of radiopharmaceuticals 
using a cyclotron is no different than using a molybdenum or rubidium 
generator.
    NRC Response: The NRC disagrees that its regulations would require 
health care providers to follow GMPs in their clinical practice. The 
NRC requires licensees that distribute radioactive drugs (including 
radioactive biologics) to medical use licensees to be qualified to 
produce radioactive drugs for medical use. To demonstrate this 
qualification, the NRC requires in 10 CFR 30.32(j) and 10 CFR 32.72 
that the applicant or licensee submit evidence that it meets at least 
one of the following criteria: (1) be registered with the FDA, (2) be 
registered or licensed with a State agency as a drug manufacturer, (3) 
be licensed as a pharmacy by a State Board of Pharmacy, (4) be 
operating as a nuclear pharmacy within a Federal medical institution, 
or (5) be a PET drug production facility registered with a State 
agency. The FDA's rule on Good Manufacturing Practice for PET drugs 
establishes criteria for the production and process/quality controls of 
PET drugs in PET centers registered with the FDA. While the NRC 
recognizes the FDA registration in the NRC's regulations, registration 
with the FDA is only one of five different criteria that licensees may 
meet to demonstrate they are qualified to distribute radioactive drugs 
to medical use licensees.
    The NRC agrees that the production of radiopharmaceuticals using 
radionuclides from a cyclotron is no different than using molybdenum or 
rubidium generators. The producer of the molybdenum generator is 
registered with the FDA as a drug manufacturer and is licensed by the 
NRC under both 10 CFR Part 30 and 10 CFR 32.72. The use of the 
generator to prepare other radioactive drugs is required in 10 CFR 
32.72 to be done by a commercial nuclear pharmacy or in 10 CFR 35.200 
to be done at the medical use facility by an AU meeting specific 
training and experience criteria or an ANP. The NRC has applied the 
same flexibility in recognizing that certain drugs are produced by 
facilities registered with the FDA or States and that other drugs are 
prepared by or under the supervision of AUs or ANPs.
    Comment: A commenter recommended that the NRC should include an 
exemption for changes that involve the addition or relocation of either 
a PET radionuclide production area or a radionuclide delivery line from 
the PET production area from license amendment or the NRC notification 
requirements for broad scope Type A licenses under 10 CFR 35.15. The 
commenter stated that this allowance is consistent with the level of 
authority the NRC has historically granted under this list of 
exemptions.
    NRC Response: The NRC agrees with the commenter and revised 
proposed 10 CFR 35.15(f) to make it clear that a Type A specific 
license of broad scope is exempt from the notification provisions in 10 
CFR 35.14(b)(5). In this final rule, the NRC's licensing practice for 
Type A specific licenses of broad scope is to have the licensee 
describe significant facilities, such as the PET radionuclide 
production area or radionuclide delivery tube, and provide the NRC its 
criteria for reviewing and approving the addition or relocation of 
these facilities.

[[Page 55901]]

The broad scope licensee with a PET radionuclide production facility 
will need to submit an application to license the production facility 
and, if applicable, increase its radionuclide possession levels.

Comments on Waste and Decommissioning

Decommissioning and Decontamination
    Comment: A commenter noted that under the proposed rule, activities 
under the new definition of Byproduct material would need to be 
licensed within 6 to 12 months after the final rule takes effect. The 
commenter requested clarification as to whether this new requirement 
would result in MML licensees having to permit/license all sites 
containing radium or radium contamination due to radium paint 
operations or gauge maintenance. The commenter noted that current U.S. 
Air Force (USAF) policy is to forgo permitting sites, until intrusive 
characterization of the site has been performed. The commenter 
requested that the NRC state whether this rule would affect the current 
USAF policy.
    NRC Response: As previously discussed, 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 including discrete sources of radium-226. The EPAct covers 
material that is ``produced, extracted, or converted after extraction, 
before, on, or after August 8, 2005, for use for commercial, medical, 
or research activity.'' 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 
under the 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.
    The NRC no longer authorizes specific byproduct material use 
licensees to bury licensed materials at their facility. Although the 
MML licensee cannot issue permits for new burial sites, licensees are 
required under 10 CFR 30.35 to maintain documentation of information 
that is necessary for decommissioning.
    Comment: A commenter stated that Actinide/radium-226 surface 
contamination levels less than 1000-1500 dpm/100cm2 are 
typically not detectable at 1-2 sigma counting statistics. The 
commenter stated that radium-226 captured in clothing/porous materials 
could have much higher counting errors and asked if the NRC has 
accepted the technological shortfall for detection of radium-226 and 
proposed an alternative.
    NRC Response: Licensees are required to ``demonstrate'' to the NRC 
that post remediation contamination levels meet the release criteria 
for their sites. ``Demonstration'' includes specifically addressing 
instrumentation used for detecting and measuring the contamination. If 
instruments can't detect the contamination, other means to identify 
contamination levels must be addressed in the licensee's 
Decommissioning Plan. The NRC guidance documents NUREG-1757, 
``Consolidated NMSS Decommissioning Guidance,'' and NUREG-1575, 
``Multi-Agency Radiological Survey and Site Investigation Manual,'' 
both address instrumentation.
    Comment: Two commenters requested that the NRC modify its 
regulations in 10 CFR 30.36 to allow a longer time frame of at least 10 
years for completion of decommissioning for accelerator production 
facilities. One commenter stated that decommissioning of a particle 
accelerator and its associated facility can range from a return of a 
self-shielded cyclotron unit to the manufacturer to a major cleanup of 
an older accelerator unit and its facility. The commenter stated that 
cost for decommissioning will be significantly impacted by the time 
frame allowed to complete this action. Under the current 10 CFR 30.36 
regulations, completion of decommissioning for an accelerator 
production facility could be required in as little as 48 months 
following cessation of operation. On the other hand, under 10 CFR 
50.82, decommissioning of a power reactor is required to be completed 
within 60 years following cessation of operation. Hence, the commenter 
requested that the NRC modify its regulations in 10 CFR 30.36 to allow 
a longer time frame of at least 10 years for completion of 
decommissioning for accelerator production facilities.
    NRC Response: The NRC's regulations in 10 CFR 30.36 require that 
the site or any separate building or outdoor area that has not been 
used for 2 years must be promptly remediated if the remediation 
activities are allowed by the existing license. If remediation 
activities are not allowed under an existing license, the licensee must 
develop a decommissioning plan and submit a request for a license 
amendment within 1 year. The decommissioning process must be completed 
within 2 years, unless an alternative schedule for completion of 
decommissioning is approved by the Commission.
    The level of effort for decommissioning a radioactive material 
production facility depends on many factors such as the design, age, 
operating condition, and usage of the accelerator and the type of 
facility where the accelerator is located. Decommissioning activity can 
range from simply a return of a self-shielded cyclotron unit to the 
original manufacturer to a more complicated cleanup of an older 
accelerator unit and its facility. Because alternative schedules for 
decommissioning are allowed within the existing regulations, there is 
no need to modify 10 CFR 30.36.
    Comment: In response to the NRC's request for comments on the 
decommissioning of accelerator facilities and accelerator components, 
one commenter requested clarification in Part 35 that the term 
decommissioning does not apply to the removal or replacement of a 
linear accelerator used for medical treatment. Another commenter 
recommended that the NRC include a specific exemption that states that 
``decommissioning'' does not include: (a) replacement of one medical 
accelerator for another; (b) upgrading of a medical accelerator; (c) 
replacement of one cyclotron for

[[Page 55902]]

another within the same facility; or (d) upgrading of an existing 
cyclotron.
    NRC Response: The EPAct gave the NRC the authority to regulate any 
material that has been made radioactive by use of a particle 
accelerator and is produced, extracted, or converted for use for a 
commercial, medical, or research activity. Under the EPAct, the NRC 
only has authority over the radioactive material and not over 
accelerators including linear accelerators used for medical treatment. 
Because linear accelerators used for medical treatment do not produce 
radioactive material that is used for commercial, medical, or research 
activities, the NRC will not be regulating the activated material that 
may be produced during medical treatment.
    Because medical linear accelerators and activated material 
associated with these types of accelerators are not regulated by the 
NRC, no specific exemption is needed for non-NRC regulated material, 
including replacement or upgrade of a medical linear accelerator. 
Decommissioning regulations are not applicable to nonregulated material 
such as a medical linear accelerator.
    Replacement or upgrade of a cyclotron is not typically considered a 
decommissioning activity; therefore, an exemption for such activity 
would not be required. However, if the cyclotron is used to produce 
radioactive material for commercial, medical, or research activities, 
and accelerator components become activated incidental to the 
production of radioactive material, both the radioactive material and 
the components would be regulated as licensed material. The activated 
components would require decommissioning upon cessation of licensed 
activity. If licensed activity continues, the replacement or upgrade of 
a cyclotron or its activated components would be addressed in the 
license. The removed cyclotron and its activated components are 
considered licensed material and would be treated as radioactive waste.
    Comment: A commenter stated that the NRC should address volumetric 
contamination of materials by activation/spallation and recommended 
that the NRC develop release criteria for the various accelerator-
produced radionuclides.
    NRC Response: For decommissioned sites, the release criterion for 
unrestricted use is 25 mrem per year (0.25 mSv per year) as listed 
under 10 CFR Part 20, Subpart E, and 10 CFR 30.36, including all 
radionuclides and all pathways. If an accelerator is used to produce 
regulated material, and accelerator components become activated 
incidental to the production of the regulated material, the activated 
components would be licensed and subject to 10 CFR Part 20, Subpart E, 
and 10 CFR 30.36 requirements.
    Even though the NRC has, in the past, considered exposure criteria 
for release of waste and contaminated scrap, no rule has been adopted 
regarding exposure criteria. Currently, the NRC does not plan to 
develop release criteria for various accelerator-produced 
radionuclides. Activated waste produced in an accelerator will be 
treated like any other radioactive waste. Guidance regarding 
decommissioning and waste disposal can be found in NUREG-1757, 
``Consolidated NMSS Decommissioning Guidance.''
    Comment: Two commenters asked whether the NRC will be proposing 
acceptable de minimus values, release criteria, or remediation 
criterion for surficial and volumetric radium contamination on building 
structures and soil that can be generally applied to decommissioning 
operations. One commenter asked if the NRC accepts 5 pCi/gram of soil 
as volumetric de minimus values that EPA or States have approved for 
radium-226 contamination release value at certain remediation sites.
    NRC Response: Currently, there are no de minimus values or release 
criteria for decommissioning sites. As provided in 10 CFR 20.1402, the 
release criterion for unrestricted use is 25 mrem per year (0.25 mSv 
per year) for all sources and all pathways. The NRC will only accept a 
release value of 5 pCi/gram (0.185 Bq) for radium-226 contamination in 
soil if the site will also meet the NRC's release criterion of 25 mrem 
per year (0.25 mSv per year).
    The NRC does have screening values for building surfaces and 
surface soil concentrations. Screening values are based on the 25-mrem 
per year (0.25-mSv per year) release criterion and can be used to 
simplify decommissioning efforts where low levels of contamination 
exist. Screening values are listed in tables included in Appendix B of 
NUREG-1757, ``Consolidated Decommissioning Guidance-Decommissioning 
Process for Materials Licensees,'' for each radionuclide for building 
surfaces and soil surfaces. These screening values are not de minimus 
values. Unlike de minimus values, the screening values were developed 
under certain site conditions (e.g., type of facility, depth of soil 
contamination, type of surface contamination); therefore, screening 
values may only be used if a site meets these specific conditions. For 
a site with mixed radionuclides, the ``unity rule'' (or sum of the 
fractions rule) applies, and screening values would change depending on 
the site's isotopic mixture. There are only a few sites that can use 
the screening method for decommissioning because sites are very 
different from each other, and most sites do not meet the conditions 
for using screening values.
    Comment: One commenter provided some insight on a radium-226 
dosimeter calibration source breach at a facility in the 1950s and 
indicated that current survey equipment has difficulty detecting 
actinide contamination under 1000-1500 dpm/100cm\2\. The commenter 
stated that if the radium-226 breach occurred before the 1970s, it is 
likely that the contamination still exists. Because the NRC has taken 
authority over all past, present, and future radium-226 sources, the 
commenter asked whether the NRC's authority includes authority over the 
contamination resulting from a radium-226 source breach.
    NRC Response: Under the EPAct, the NRC has the regulatory authority 
over all past, present, and future discrete sources of radium-226 and 
any contamination associated with the discrete sources. However, the 
NRC does not intend to require nonlicensed owners of properties that 
may be contaminated with radium-226 to obtain licenses. If 
contamination is discovered at a nonlicensed person's facility, such as 
contaminated buildings or grounds, the NRC will work with the facility 
owner to perform decommissioning of the site. If the site presents a 
significant threat to the public health and safety, the NRC may order 
the owner to obtain a license and to perform decommissioning of the 
site. In addition, the NRC may seek assistance from EPA to consider 
listing the site on EPA's National Priority List and clean up the site 
under the CERCLA or Superfund Program. Any arrangement between the NRC 
and EPA regarding regulatory authority over decommissioning would be 
agreed upon on a site-specific basis.
    Comment: One commenter indicated that a number of gaslight and 
luminous production sites are abandoned, and some are Superfund sites. 
The commenter asked whether the NRC has the financial ability to clean 
up these sites.
    NRC Response: The NRC does not perform or provide funds for cleanup 
of contaminated sites because the NRC does not have authority in 
spending Federal funds for conducting cleanup activities. The NRC 
relies solely on licensees or property owners to perform

[[Page 55903]]

the necessary cleanup work. Unlike the NRC, EPA has the funds under the 
CERCLA or Superfund Program to evaluate the extent of the contamination 
and to conduct the cleanup efforts. EPA also has the statutory 
authority to recover the cost associated with the cleanup activities 
from the potentially responsible parties.
    Comment: One commenter asked whether there will be any requirements 
for the NRC's review of radium-contaminated sites that have been 
remediated before the effective date of this rule.
    NRC Response: The NRC does not intend to revisit sites that have 
already been remediated. If sites are discovered to be contaminated 
with sufficient quantities of radionuclides to potentially warrant 
additional decommissioning, the NRC will contact and work with the 
owner of the property to re-commence the decommissioning process.
    Comment: One commenter asked how the NRC will review 
decommissioning plans and final status surveys for sites where AEA 
Section 91(b) materials may be the predominant contaminant with respect 
to AEA materials regulated by the NRC and whether there is a limit of 
the NRC's interests in these sites.
    NRC Response: Decommissioning of a licensed facility falls under 
the requirements of 10 CFR part 20, Subpart E, and 10 CFR 30.36. The 
NRC will review decommissioning plans and the final status survey to 
ensure that the licensed facility meets the release criterion of 25 
mrem per year (0.25 mSv per year) for unrestricted use for all 
radionuclides and all pathways. The NRC will use this approach for all 
sites that are contaminated by any licensed material including sites 
where unlicensed radionuclides such as Section 91(b) material 
contribute to the dose estimates in the all-pathway analysis. The NRC 
has no regulatory authority over a site that is contaminated with only 
Section 91(b) material and not licensed material.
    Comment: One commenter raised a question on whether the NRC will 
subsume the predominant regulatory role for remediation of sites that 
predate the USAF MML and were established under AEC purview.
    NRC Response: The NRC has the predominate regulatory role in the 
decommissioning of sites under the MML. Sites containing licensed 
material must be decommissioned under 10 CFR part 20, subpart E, and 10 
CFR 30.36 requirements regardless of whether such sites predate the MML 
or were under the purview of AEC.
    Comment: Two commenters expressed their concern regarding the 
statement in the Statements of Consideration for the proposed rule that 
only radionuclides with a half-life of more than 120 days, that are 
present in sufficient quantities to cause a public health and safety 
concern, need to be addressed for the purpose of establishing adequate 
financial assurances for decommissioning leading to license 
termination. One commenter requested that the final rule include 
specifications of which radionuclides and the threshold amounts would 
be sufficient to lead to license termination. Another commenter 
recommended that the term ``sufficient quantities'' be defined in terms 
of 10 CFR part 20 dose limits.
    NRC Response: In the proposed rule, the term ``sufficient 
quantities'' is referring to quantities of radionuclides with a half-
life of more than 120 days for the purpose of establishing adequate 
financial assurance for decommissioning leading to license termination. 
The specific quantities are established in 10 CFR 30.35. For unsealed 
byproduct material in quantities exceeding 10\5\ times, or for sealed 
sources or plated foils in quantities exceeding 10\12\ times the 
applicable quantities in Appendix B to 10 CFR part 30, the licensee is 
required to submit a decommissioning funding plan. For unsealed 
byproduct material in quantities exceeding 10\3\ but less than or equal 
to 10\5\ times, or for sealed sources or plated foils in quantities 
exceeding 10\10\ but less than or equal to 10\12\ times the applicable 
quantities in Appendix B to 10 CFR part 30, the licensee is required to 
submit either a decommissioning funding plan or a certification that 
financial assurance for decommissioning had been provided in the amount 
prescribed in 10 CFR 30.35(d). Revising the quantities requiring 
financial assurance is beyond the scope of this rule.
    For license termination, the release criterion for unrestricted use 
is 25 mrem per year (0.25 mSv per year) as listed under 10 CFR part 20, 
subpart E, and 10 CFR 30.36. All radionuclides, regardless of the 
quantities present, must be considered in the all-pathway analysis in 
demonstrating compliance with the release criteria.
Waste Disposal
    Comment: One commenter asked whether radioactive waste site 
licenses will need to be changed to reflect the newly regulated 
radioactive materials and whether it is the waste site licensee's 
responsibility to incur the cost of changing the license.
    NRC Response: Waste site licenses may or may not need to be amended 
to include newly regulated radionuclides. The need for amending a 
license will depend on how the existing license identifies the licensed 
material (listed as a group of radionuclides or listed by each 
individual radionuclide). The cost for a license amendment would be the 
responsibility of the licensee.
    Comment: One commenter asked whether there are disposal sites that 
can inexpensively dispose of consumer products and luminous light 
sources. If not, the commenter stated that abandonment may become the 
only method of disposal.
    NRC Response: There are radioactive waste disposal sites, licensed 
by the Agreement States, and hazardous or solid waste disposal sites, 
permitted by the EPA or its authorized States, available for disposal 
of the newly added byproduct material. Disposal charges are set by each 
of the disposal facilities based on the type of material and the 
contamination level. It is the licensee's responsibility to locate a 
disposal facility that could accept the waste and to negotiate disposal 
cost.
    There are also certain manufacturers that accept returned or spent 
sources from their customers. In the past, DOE has, in certain unique 
situations, cooperated with the NRC and the CRCPD in collecting certain 
orphaned sources for storage and/or disposal at DOE facilities due to 
lack of disposal options. However, these programs are typically limited 
in scope and designed for urgent needs.
    In general, consumer products are manufactured by a specific 
license and distributed to consumers as an exempt product. These 
consumer products contain very small amounts of radioactive material in 
order to meet the stringent criteria for an exempt product. There are 
no disposal requirements for exempted products based on the amount of 
the radioactive material present and the negligible impact to public 
health and safety. Hence, exempt products are allowed to be disposed of 
in municipal landfills.
    Comment: One commenter was concerned regarding the disposal of 
exempted smoke detectors containing radium-226.
    NRC Response: This issue is discussed earlier in this document 
under ``Exemption of Certain Radium-226 Items.''
    Comment: One commenter asked if the NRC will accept decay-in-
storage as a method of disposal for accelerator-produced medical 
radionuclides. The commenter also asked whether decay-in-storage could 
also be applied to

[[Page 55904]]

accelerator components that are volumetrically activated or spallated, 
and whether the time period under which the accelerator is turned off 
or in a low energy mode could be counted as the decay-in-storage time.
    NRC Response: Decay-in-storage has been, and will continue to be, 
an accepted means for disposal of radionuclides with short half lives, 
including medical radionuclides. Activated components either within or 
removed from the accelerator will be treated as any other radioactive 
source. Therefore, activated components contaminated with short-lived 
radionuclides with half lives less than 120 days will be allowed to use 
decay-in-storage as a disposal method. Activated components 
contaminated with radionuclides with half lives greater than 120 days 
would either have to be disposed of as radioactive waste or have to be 
addressed later during decommissioning as part of the license 
termination process.
    Comment: For decay-in-storage or disposal, a commenter asked 
whether accelerator-produced medical radionuclide users will be able to 
ignore short-lived radionuclides. As an example, the commenter noted 
that many ``hundreds of thousands'' of fluorine-18 disintegrations on 
the skin surface will produce only microrem doses to the skin or deep 
tissue.
    NRC Response: All accelerator-produced radionuclides, including 
short-lived radionuclides, will be regulated. Licensees may not ignore 
short-lived radionuclides in meeting the NRC's regulatory requirements. 
However, licensees may use decay-in-storage as a means for disposal in 
accordance with the NRC criteria.
    Comment: One commenter stated that decommissioning of accelerator 
facilities can result in the removal of building materials and 
accelerator parts that are activated. Recycling and disposal of 
material that meet the NRC's materials contamination limits may still 
trigger detectors at landfill and scrap facility checkpoints. The 
commenter recommended that the NRC consider exposure criteria for 
release of these materials.
    NRC Response: In the past, the NRC has considered development of 
exposure criteria for release of waste and scrap through the rulemaking 
process. Due to public comments on the rulemaking effort, the NRC 
decided to defer the rulemaking to a later date, and no rulemaking on 
this issue was promulgated.
    Sites released for unrestricted use based on the 25-mrem per year 
(0.25-mSv per year) criterion specified in 10 CFR Part 20, Subpart E, 
have no restrictions placed on the use of the site or disposition of 
material located on the site or disposal of waste or materials from the 
site. If a detector is triggered at a landfill, the operator of the 
landfill should notify the State or another regulatory authority. 
Typically, the NRC would be notified of the event, but, in most cases, 
no action would be taken because the material met the NRC's release 
criteria.
    If the site is discovered to be recontaminated to levels above the 
release criteria, the NRC may contact the site owner or former licensee 
to begin the decommissioning process.
    Comment: A commenter concurred with the NRC's proposed approach 
towards waste disposal to change Part 20 to redefine the definition of 
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. However, the 
commenter questioned whether such an approach may be arbitrary or 
capricious, since other similar low-level wastes may still fall under 
the Compact jurisdiction (i.e., Section 11e.(1) byproduct material). 
The commenter suggested that this situation could be avoided by 
managing the radium as radioactive material instead of byproduct 
material.
    NRC Response: The commenter appears to be concerned that it may be 
arbitrary to treat some byproduct materials as low-level waste and some 
as non-low-level waste and suggested to manage the newly added 
byproduct material as radioactive material instead of as byproduct 
material. However, the EPAct defines the newly added byproduct 
material, i.e., discrete sources of radium-226 and accelerator-produced 
radioactive material, as a byproduct material. Defining the newly added 
byproduct material as radioactive material would be inconsistent with 
the statutory requirement. In addition, the NRC only has authority to 
regulate AEA material and not all radioactive material. Because the 
discrete source of radium-226 is a byproduct material, and byproduct 
material is only a subset of radioactive material, treating radium-226 
as radioactive material instead of byproduct material would have the 
appearance that the NRC has regulatory authority over all radioactive 
material.
    The EPAct provides an additional disposal approach for the newly 
added byproduct material to include disposal at a disposal facility 
permitted under Federal or State solid or hazardous waste laws. This 
approach is consistent with many existing State programs that regulate 
naturally occurring and accelerator-produced radioactive material as 
radioactive material and not as byproduct material. In addition, this 
approach would enhance proper and timely disposal of the newly added 
byproduct material. Similar to low-level waste disposal facilities, 
disposal facilities permitted under Federal or State solid or hazardous 
waste laws also need to consider all radionuclides as source terms in 
conducting the performance assessment and in formulating the waste 
acceptance criteria to ensure protection to public health and safety 
and the environment.
    Comment: One commenter concurred with providing multiple options 
for disposal of the newly added byproduct material but was not sure if 
this is consistent with some compacts' definitions. The EPAct and the 
NRC state that the new byproduct material is not low-level radioactive 
waste (LLW) such that it is not to be impacted by the compact process 
of the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA). The 
commenter stated that this seems ``backward,'' as the Rocky Mountain 
Compact specifically captures radium in its definitions and 
traditionally has treated discrete radium as LLW.
    NRC Response: Although the newly added byproduct material would not 
be considered LLW with respect to the compact process of the LLRWPAA, 
the newly added byproduct material may still be disposed of at an LLW 
disposal site. The EPAct provides additional options for disposal of 
the newly added byproduct material and does not prohibit the existing 
option of LLW disposal.
    Comment: Because the newly added byproduct material would be 
allowed to be disposed of in either the NRC-regulated disposal 
facilities or in a disposal facility permitted under Federal or State 
solid or hazardous waste laws, a commenter asked if waste disposed of 
in a CERCLA site would incur ``potential responsible parties'' (PRP) 
status should the solid or hazardous waste facility fail.
    NRC Response: Currently, disposal sites already dispose of radium-
226 and other accelerator-produced and naturally occurring radioactive 
material as daughter products or as radioactive waste. The EPAct allows 
these disposal sites to continue with their current practice. 
Therefore, nothing would change for these disposal sites under the new 
regulations. The EPA has jurisdiction over any site that becomes a 
CERCLA or a Superfund site, and the EPA has the statutory authority to 
recover cleanup cost from PRPs. Under

[[Page 55905]]

the Superfund, any party who is associated with the site, used the 
site, disposed of material at the site, or contributed to the 
contamination at the site could all be considered as a PRP and liable 
for the cleanup.
    Comment: A commenter indicated that any disposals in solid or 
hazardous waste facilities must take into account potential release of 
radium from the discrete source and therefore radon. The commenter 
suggested that discrete sources can be further encapsulated before 
burial as a treatment to reduce the potential for radium leakage and 
mitigate the potential for radon.
    NRC Response: Disposal facilities need to consider all 
radionuclides and their daughter products when conducting the 
performance assessment and when developing the waste acceptance 
criteria regarding the type of radioactive waste that may be safely 
disposed of at the site. Depending on the performance assessment and 
the waste acceptance criteria, certain disposal facilities may require 
additional treatment of certain wastes to control the daughter products 
or migration of certain radionuclides. However, the NRC sees no reason 
to require further encapsulation of discrete sources before disposal 
because waste forms would depend on site-specific waste acceptance 
criteria for each disposal site.
Financial Assurance
    Comment: Two commenters strongly support an exemption for 
facilities with 18-MeV or less cyclotrons from the requirements of 10 
CFR 30.35 for financial assurance for decommissioning because they do 
not believe these cyclotrons are capable of producing activation 
products in the quantity sufficient to trigger the financial assurance 
requirements. One commenter stated that this approach should be the 
standard in all non-Agreement States. In addition, these commenters 
stated that many burdensome expenditures are associated with 
calculating and securing financial assurance for decommissioning, 
including expensive concrete bunker boring and analysis. These costs 
would inevitably put some existing medical and scientific accelerator 
facilities out of business and would also deter prospective hospitals 
and educational institutions from obtaining onsite cyclotrons, 
potentially impacting patient access to services. In support of an 
exemption, one commenter stated that it could provide data to the NRC 
on incidental activation resulting from a 16.5-MeV cyclotron running at 
maximum beam current at maximum duty cycle.
    NRC Response: Although the commenters do not believe cyclotrons 
operating at 18-MeV or less are capable of producing activation 
products in the quantity sufficient to trigger the financial assurance 
requirements, supporting data have not been provided to the NRC. 
Financial assurance is required for the cost associated with 
decommissioning. Cost for decommissioning a cyclotron depends heavily 
on the complexity of decommissioning activities, which would be 
impacted by multiple factors such as design of the cyclotron, operating 
conditions, maintenance practices, and usage period. A standardized 
approach would not be suitable for all cyclotrons with various designs. 
The NRC's financial assurance regulations require financial assurance 
for decommissioning costs based on the type, quantity, half-life, and 
physical form of the radionuclides authorized in the license. The 
regulations implement a graded approach that requires increased 
financial assurance as the authorized quantity of licensed material 
increases. If the license authorizes a quantity above a threshold 
amount, financial assurance is required. Financial assurance is 
required because the cost of decommissioning should be borne by the 
organization that obtains the benefits of using the licensed material. 
The need for financial assurance increases where the decommissioning 
activities are complex or costly.
    The cost of preparing a cost estimate for decommissioning cannot be 
avoided because the licensee must perform its obligation to 
decommission the facility at the end of licensed operations. Likewise, 
the cost of characterizing the extent of contamination cannot be 
avoided because characterization is necessary to prepare a 
decommissioning plan.
    A licensee can reduce its financial assurance costs in several ways 
allowed by the regulations. The licensee can reduce its licensed 
possession limits to a level below the threshold that requires 
financial assurance, or to a level that allows lower amounts of 
financial assurance. The financial assurance regulations permit a 
licensee to submit a site-specific decommissioning funding plan. If the 
prescribed amounts of financial assurance exceed a reasonable estimate 
of decommissioning costs, the licensee may submit a site-specific 
decommissioning funding plan to justify a lower amount of financial 
assurance. Information relevant to the amount of radioactive material 
that must be removed to permit license termination, and the cost of 
doing so, can be presented in the license application.
    The financial assurance regulations allow for a number of different 
financial instruments to provide financial assurance, which allows the 
licensee to select the lowest cost alternative. Consequently, the NRC 
does not anticipate creating an exception from financial assurance 
requirements for cyclotron licensees.
    Comment: One commenter stated that the NRC should urge the 
Agreement States to adopt their current requirements for 
decommissioning through IMPEP for Agreement States.
    NRC Response: Agreement States are required under AEA Section 274 
b. to adopt the NRC's regulations according to the compatibility 
designations within 3 years. Agreement State programs are regularly 
evaluated through IMPEP reviews. The NRC has worked, and will continue 
to work, closely with the Agreement States to ensure that State 
programs are compatible with the NRC.
    Comment: One commenter indicated that there should also be surety 
requirements for decommissioning of facilities used to manufacture 
sealed sources.
    NRC Response: If the manufacturer of sealed sources has possession 
limits that exceed the threshold amount, it will be required under 
existing NRC regulations to provide financial assurance. Threshold 
quantities are included in 10 CFR 30.35.
    Comment: One commenter stated that decommissioning funding should 
account for activation products because some activation products, such 
as rebar and steel structural components from accelerator facilities, 
have half lives longer than 120 days and could pose a disposal issue. 
Gamma exposure due to activated products could be an issue in certain 
scenarios. If a licensee were to abandon its facility, the potential 
certainly exists for new legacy sites that the NRC is trying to avoid.
    NRC Response: If an accelerator is used to produce regulated 
material, and accelerator components become activated incidental to the 
production of the regulated material, the activated components would be 
licensed and subject to 10 CFR Part 20, Subpart E, and 10 CFR 30.36 
requirements. In accordance with 10 CFR 30.35, financial assurance for 
decommissioning of licensed material is required based on the 
radionuclides and threshold quantities authorized in the license. 
Financial assurance provides funds for the licensee to conduct 
decommissioning activities or to hire a third-party contractor to 
decommission

[[Page 55906]]

a facility. These funds could be used in the event a licensee abandoned 
its facility.

Comments on Other General Requirements

10 CFR Part 20, Appendix B, Derived Air Concentration (DAC)
    Comment: Several commenters recommended that the NRC should use 
specific values for nitrogen-13 and oxygen-15 in 10 CFR part 20, 
appendix B. One commenter stated that the use of default values does 
not allow the licensee to use a risk-based approach for compliance.
    Most of the commenters endorsed the DAC values for nitrogen-13 and 
oxygen-15 calculated by Dr. Michael Stabin at Vanderbilt University. 
The commenters noted that Dr. Stabin based his calculations on EPA 
Federal Guidance Report No. 12 (FGR-12) in conjunction with exposure 
limits and times used by the NRC in other calculated values in 10 CFR 
part 20, Appendix B. The commenters also noted that the dose conversion 
values from FGR-12 are used by the NRC in other applications and for 
other radionuclides currently in 10 CFR part 20, appendix B.
    The commenters recommended that the DAC values for nitrogen-13 and 
oxygen-15 calculated by Dr. Stabin should be rounded to one significant 
number and added to part 20, appendix B.
    NRC Response: In Section G of the proposed rulemaking, the NRC 
requested comments on a number of specific issues, including the 
adequacy of the applicable default ALIs and DACs in 10 CFR part 20, 
appendix B, for oxygen-15 and nitrogen-13, and whether staff should 
develop larger specific values for these radionuclides. All six 
commenters addressing this issue believed that specific values for DAC 
should be used rather than the current default DAC value of 
10-\7\ and 10-\9\ microcuries per milliliter of 
air for occupational and member of the public, respectively. Reasons 
given that the default values in 10 CFR part 20, appendix B, were not 
appropriate included: (1) They are unnecessarily restrictive default 
values that can result in unjustified cost for unnecessary radiological 
monitoring and controls; (2) the use of default values in general does 
not allow the licensee to use a risk-based approach to compliance; (3) 
values in the proposed rule would be unreasonably low; and (4) FGR-12 
dose conversion values are endorsed and used by the NRC in other 
applications, such as dose modeling in support of the License 
Termination Rule.
    One commenter submitted an analysis and DAC values for nitrogen-13 
and oxygen-15 to be incorporated in 10 CFR part 20, appendix B, Table 
1, Column 3, and Table 2, Column 1, for the DAC occupational value and 
air effluent concentration value. This was endorsed by several 
commenters. The analysis used dose equivalent conversion factors for 
submersion in a semi-infinite cloud from FGR-12, ``External Exposure To 
Radionuclides in Air, Water, and Soil,'' along with exposure parameters 
used by the NRC in other calculations in 10 CFR part 20, appendix B.
    Models describing deposition and retention in the respiratory 
tract, levels and times of absorption to blood, and the biokinetics 
involved were not available. The ICRP publications for workers or 
members of the public do not have dose coefficients for radionuclides 
with half-lives less than 10 minutes. ICRP Publication 53, Radiation 
Dose to Patients from Radiopharmaceuticals (1987), does have dose 
coefficients for inhalation of these radionuclides, but the biokinetic 
models generally are not directly applicable to worker intakes or 
environmental emissions. Because information was not available for dose 
conversion factors for intakes of oxygen-15 and nitrogen-13 to compare 
with the dose conversion factors for submersion, the NRC arranged for a 
study during the comment period. The purpose of the study was to 
develop scientifically sound inhalation dose coefficients for 
occupational and public exposures to forms of nitrogen-13 and oxygen-
15, in order to compare DAC values from inhalation with DAC derived 
from submersion in contaminated air. The study developed biokinetic 
models describing deposition and respiratory tract retention, levels 
and time for absorption into blood, and systemic biokinetics of 
absorbed activity. Dose coefficients and derived air concentrations 
were developed for inhalation of nitrogen-13 as a gas and as ammonia, 
and oxygen-15 as molecular oxygen and as water vapor. The dose 
coefficients for submersion in air contaminated with nitrogen-13 and 
oxygen-15 were taken from FGR-12. These coefficients for air submersion 
are virtually identical because of their similar photon emissions.
    The study verified that the limiting dose is from submersion in a 
cloud of the radionuclide and also arrived at limiting values for 
submersion that were submitted by the commenter, above, and that were 
endorsed by three other commenters. In light of the supporting 
documentation and technical basis for providing a specific value for 
the DACs for oxygen-15 and nitrogen-13 from submersion in a semi-
infinite cloud, the NRC is incorporating values of 4E-6 microcuries per 
milliliter for the occupational value in Table 1, Column 3, and 2E-8 
microcuries per milliliter for the effluent concentration in Table 2, 
Column 1, of Appendix B to 10 CFR part 20, for submersion values of 
both radionuclides.
Other Comments on Exemptions and General License
    Comment: Some commenters agreed with the NRC's proposed delineation 
of particle accelerators into three varieties. The commenters agreed 
that the category of accelerators operated to produce only particle 
beams and not radioactive material, which include linear accelerators 
used in radiation therapy, should not be regulated. One commenter 
supported the NRC's proposal not to regulate incidental radioactive 
material produced by medical linear accelerators.
    The commenters recommended that the NRC expand the exclusion in the 
final rule to include a specific exemption for commercially available 
linear accelerators used only for medical purposes to treat patients. 
One of the commenters recommended that the following or similar 
language may be appropriate: ``Particle accelerator means any machine 
capable of accelerating electrons, protons, deuterons, or other charged 
particles in a vacuum and of discharging the resultant particulate or 
other radiation into a medium at energies usually in excess of 1 
megaelectron volt and does not include machines that only produce 
particle beams and not radioactive materials. For purposes of this 
definition, accelerator is an equivalent term.''
    NRC Response: The NRC regulates radioactive material produced by 
using particle accelerators but does not regulate particle 
accelerators, including linear accelerators. Therefore, the NRC cannot 
include in its regulations the exemption suggested by the commenters. 
The definition for particle accelerator incorporated in the NRC 
regulation is the same as the definition found in the SSRs. The 
commenter suggested adding a statement to the definition indicating 
that it does not include machines that produce particle beams and not 
radioactive material. The NRC does not believe this statement needs to 
be added because the NRC does not regulate accelerators and revising 
the definition of Particle accelerator as suggested by the commenter 
would introduce unnecessary confusion and inconsistency with State 
regulations.
    Comment: A commenter noted a potential case in which the use of

[[Page 55907]]

byproduct material may not be covered by the proposed regulations. The 
commenter asked if a person, in an Agreement State who received 
byproduct material before September 25, 1971, for use under an 
Agreement State's general license similar to the general license then 
provided in 10 CFR 31.4, could still possess the radioactive material 
under 10 CFR 30.18(b). The commenter asserted that the new 10 CFR 
30.18(b) should cover the old byproduct material as well as newly 
regulated accelerator-produced radioactive material.
    NRC Response: The Commission agrees that the proposed wording of 10 
CFR 30.18 did not cover materials distributed for use under the 
previous equivalent general license of Agreement States that may now be 
used within the NRC's jurisdiction. The wording has been corrected in 
the final rule to address this comment.
    Comment: A commenter noted that in the Section-by-Section Analysis 
under Section 30.18 exempt quantities, it was stated that Paragraph (b) 
would be revised to include accelerator-produced radioactive material 
that had been received or acquired under the general license in 10 CFR 
31.4. The commenter did not believe that 10 CFR 31.4 provided coverage 
of accelerator-produced radioactive material.
    NRC Response: The Commission agrees that the Section-by-Section 
Analysis on this provision did not appropriately describe the proposed 
change, and this is corrected in this notice.
    Comment: A commenter stated that the discussion for general 
licenses in 10 CFR 31.5 does not address consistency with 10 CFR 35.65, 
which authorizes sealed source possession. The commenter requested 
clarification of regulatory requirements for sealed sources under 10 
CFR part 35 that are also generally licensed under 10 CFR 31.5. A 
similar clarification was also suggested with respect to the general 
license in 10 CFR 31.8.
    In addition, the commenter noted that the proposed rule does not 
address possible alternative licensing methods for a generally licensed 
sealed source that is subject to registration requirements and fees but 
that might also be listed as a sealed source on a specific license and 
achieve the same level of regulatory oversight and tracking. Further, 
the commenter stated that the discussion does not clearly indicate 
whether the requirements in 10 CFR 31.5 are for all sealed sources or 
only registered sealed sources.
    NRC Response: The possession and use of a source or device is not 
authorized by both a general and a specific license concurrently, or by 
more than one general license. The general license in 10 CFR 31.5 only 
covers sealed sources incorporated into a device, although in some 
cases, a specialized source housing may also be considered a device. 
The general license in 10 CFR 31.8 only covers americium-241, and now 
radium-226, calibration and reference sources with a maximum possession 
limit of 5 [mu]Ci (185 kBq) at any one time in any one place. All 
devices under 10 CFR 31.5 and sources under 10 CFR 31.8 must have a 
label that identifies them as generally licensed devices or sources.
    The regulations in 10 CFR 35.65 provide specific authority for 
medical use licensees to receive, possess, and use certain specifically 
licensed sealed sources and other byproduct material. This section does 
not authorize the possession of generally licensed sources or devices. 
Although a 10 CFR part 35 licensee may also possess sealed sources and 
devices as authorized by these general licenses, it does so under the 
general license provisions of 10 CFR 31.5 and 10 CFR 31.8.
    A specific licensee may use a source or device authorized under a 
general license under the authority of its specific license if the 
licensee requests transferring the authority from the general license 
to the specific license and provides assurance that requirements of 
both licenses are met. This practice normally arises because of the 
registration and fees associated with certain devices covered by the 10 
CFR 31.5 general license.
    Devices being authorized for use under 10 CFR 31.5 and equivalent 
Agreement State regulations are evaluated for registration in the SS&D 
registry. In large part, SS&D certificates for devices containing 
radium-226 and accelerator-produced radioactive material have been 
added to the SS&D registry, as a means of sharing this information 
amongst the States, even though NRC did not regulate these materials in 
the past. If these devices have been authorized under State regulations 
that are similar to NRC requirements, the NRC would accept these 
devices containing radium-226 or accelerator-produced radioactive 
material as generally licensed under 10 CFR 31.5, and would also expect 
users to follow the requirements of 10 CFR 31.5 without regard to 
whether or not the State registered the device in the SS&D registry 
before the effective date of this final rule.

Comments on Licensing Fees and Fee Categories

    Comment: One commenter felt that the discussion in the Statements 
of Consideration for the proposed rule related to license application 
and annual fees was not clear in providing the average professional 
staff hours for the licensing categories, and suggested that to assist 
stakeholders in reviewing this proposed rulemaking, the average and 
total professional staff hours be listed by categories. The commenter 
suggested that the breakdown for these categories, and any possible 
changes in the annual fee for existing licenses that might require an 
amendment based on the proposed rule, be in 0.25 full time equivalent 
(FTE) units. The commenter also felt that the discussion related to 
accelerator-produced radioactive material was unclear as to whether the 
discussion applied only to commercial distribution or also applied to 
noncommercial distribution.
    NRC Response: The FTE breakdown for the proposed new fee categories 
could be calculated based on the hourly rate and the time spent in 
reviewing license applications or in conducting inspections. The 
average license application hours used to calculate the license 
application fees (as presented in the proposed rule), for the proposed 
new fee categories 3.R.1, 3.R.2, 3.S., and the proposed revised 3.B. 
fee category, are 2.3, 5.4, 24, and 17.7, respectively. These values 
could be calculated by dividing the FY 2005 application fees by the 
hourly rate of $197, as described in the proposed rule.
    As explained in the proposed rule, the annual fees for the 
materials users fee class are calculated based on the NRC's budgeted 
resources allocated to regulating these types of licensees, less any 
receipts received from this fee class for 10 CFR part 170 activities. 
The net dollar value of budgeted resources for this fee class is 
allocated to all materials users fee categories (subclasses), based on 
the average application and inspection hours associated with each fee 
category. The average inspection hours (associated with the annual fees 
presented in the proposed rule) for the proposed new fee categories 
3.R.1, 3.R.2, 3.S., and revised 3.B. fee category, are 11.2, 12.2, 
21.8, and 18.6, respectively.
    The NRC's fee calculations are described in further detail each 
year in its fee rulemakings and supporting documentation. These 
rulemakings include details on the FTE and contract dollars allocated 
to the materials users fee class, for each agency-planned activity 
level. On February 2, 2007 (72

[[Page 55908]]

FR 5108), the NRC published in the Federal Register its FY 2007 
proposed fee rule. The proposed fee rule, and its supporting 
documentation, presents and explains the fee calculations for all fee 
categories, including the new fee categories included in this rule. The 
final 2007 fee rule was published June 6, 2007 (72 FR 31402). Note that 
the NRC does not plan to assess fees for the new fee categories of 
3.R.1, 3.R.2, and 3.S. until the effective date of this final rule.
    The new fee category 3.S. applies to production of accelerator-
produced byproduct material, i.e., a radionuclide production facility. 
Because specific provisions for noncommercial distribution of PET 
radioactive drugs within a consortium, which includes a PET 
radionuclide production facility, have been added to 10 CFR 30.32(j), 
there is no additional fee for noncommercial distribution of PET 
radioactive drugs. If an accelerator-produced radionuclide production 
facility wants to commercially distribute radioactive drugs, then the 
existing fee categories 3.C. and 3.D. would apply for the commercial 
distribution portion as well as the new fee category 3.S. for the 
radionuclide production portion of the activities.
    Comment: A number of commenters did not agree that there was a need 
to establish the new fee category for the production of accelerator-
produced radioactive materials, 3.S., in Section II.G.(7). These 
commenters felt that the existing fee categories covered byproduct 
materials whose possession, use, processing, manufacturing, 
distribution, and redistribution were similar to accelerator-produced 
byproduct material. One commenter stated further that using these 
existing fee categories was consistent with the NRC's conclusion 
regarding the ``grandfathering'' of medical uses, and that the choice 
of existing fee categories should be based on the type of particle 
accelerators used and the types and quantities of radioactive materials 
being produced. This commenter stated that the establishment of a new 
fee category was inconsistent with the NRC's attempt to minimize impact 
on the noncommercial distribution of PET radionuclides, drugs, and 
biologics.
    While not supporting the 3.S. fee category, another commenter 
requested that, if retained, the language of the final rule explicitly 
state that fee category 3.S. would be applied per facility, not per 
accelerator, and that the NRC should be mindful that additional costs 
would inevitably be passed on to the health care system and patients.
    NRC Response: The NRC is retaining the new fee category 3.S. 
because the NRC incurs budgeted resources in regulating the production 
of accelerator-produced radioactive material, which are in addition to 
the budgeted resources the NRC incurs in regulating the activities 
covered by existing fee categories. Therefore, the NRC believes a 
separate fee for this activity is appropriate. The fee is applicable 
for each licensed facility regardless of how many accelerators reside 
in the facility.
    Comment: One commenter recommended that exceptions be extended to 
IRS-designated 501(c)(3) organizations operating in whole or in part as 
an accredited school of watch and/or clock repair and/or specialty 
museum with a primary focus on housing and exhibiting timepieces and 
related objects.
    NRC Response: Exemptions of persons from the NRC's regulations for 
timepieces and repairs of timepieces are discussed earlier in 
subsection ``Comments Related to Radium-226.'' In 10 CFR 170.11 and 
171.11, the NRC lists fee exemptions for license fees and annual fees 
for certain licensees, including those for nonprofit educational 
institutions. In 10 CFR 170.3 and 171.5, a nonprofit educational 
institution is defined as ``a public or nonprofit educational 
institution whose primary function is education, whose programs are 
accredited by a nationally recognized accrediting agency or 
association, who is legally authorized to provide a program of 
organized instruction or study, who provides an educational program for 
which it awards academic degrees, and whose educational programs are 
available to the public.'' Historically, the NRC has not included any 
fee exemptions for museums. Because the final rule contains exemption 
for intact timepieces containing less than 37 kBq (1 [mu]Ci) of radium-
226 and general license provisions for various items containing radium-
226, the NRC does not expect this rule to have major impacts on museums 
that would necessitate the NRC to establish a fee exemption in its 
regulations. Under 10 CFR parts 170 and 171, an applicant or a licensee 
may file a fee exemption request with the NRC, and the NRC will 
evaluate each request on a case-by-case basis. Requests for a fee 
exemption must be filed with the NRC within 90 days from the effective 
date of this final rule establishing the annual fees for which the 
exemption is sought. However, filing of an exemption request does not 
extend the date on which the bill is payable.

Comments on Waiver Termination and Transitioning

    Comment: A commenter noted that some non-Agreement States may 
continue to require licenses or registration for the production of 
accelerator-produced radioactive materials, along with their associated 
fees. The commenter stated that some States have already indicated that 
they will require a NARM license regardless of whether an NRC license 
is required. The commenter stated that this situation would expand, 
rather than streamline, regulation of radioactive materials.
    The commenter noted that it understood that the States will 
continue to regulate radiation-producing accelerators because the NRC 
will not have jurisdiction over the possession and operation of these 
machines. The commenter stated that the NRC should be aware of its 
concern that some States will not discontinue their current license 
requirements for the resulting accelerator-produced materials and 
recommended that the NRC address this in its Transition Plan.
    NRC Response: Upon expiration of the waiver, non-Agreement States 
will no longer have authority to license the radioactive material 
produced in an accelerator for use for commercial, medical, or research 
activities. The production of the radioactive material, however, is 
only one facet of the operation of the accelerator. Because the NRC 
only has regulatory authority over the radioactive material and not the 
accelerator, some non-Agreement States may continue to license the 
accelerator and its operation. It is possible that certain producers of 
radioactive material may be required to hold two licenses: One from the 
State for possession and operating the accelerator, and one from the 
NRC for the possession and use of the byproduct material produced by 
the accelerator. This would not be an issue for the Agreement States 
because the Agreement State will be the only regulatory authority for 
radiation control within its State.
    The NRC has worked very closely with both Agreement States and non-
Agreement States in developing the Transition Plan. The Transition Plan 
includes various scenarios and implementation guidance to ensure a 
smooth regulatory transition. On October 25, 2006, the NRC transmitted 
the proposed Transition Plan to the States for comments. The NRC will 
consider State comments in finalizing the Transition Plan and plans to 
publish the final Transition Plan subsequent to the publication of the 
final rule but

[[Page 55909]]

before the effective date of this final rule.
    Comment: A commenter requested that to protect the supply chain 
with regard to radiopharmaceuticals, the NRC should work closely with 
OAS and the CRCPD, as well as the States themselves, to address any 
licensing or transactional issues that may arise as a result of the 
transition of authority.
    NRC Response: The NRC has worked closely with OAS and CRCPD and 
involved the Agreement States and non-Agreement States throughout the 
rulemaking process and the development of the Transition Plan. The NRC 
is committed to continued cooperation with the States during the 
transition process.
    Comments: A number of respondents emphasized the importance of 
stakeholder education and guidance to assure a smooth transition to the 
NRC's regulatory control. Two commenters expressed interest in the 
development of a comprehensive guidance document to be released upon 
implementation of the rule, and another commenter mentioned assistance 
to stakeholders through an outline of proposed revisions to the 
existing regulatory guidelines. One commenter also offered its 
organization's publications, websites, and meetings to assist the NRC 
with outreach to the medical user community.
    NRC Response: The NRC is developing guidance in a separate action 
parallel to this rulemaking. A writing team was established in July 
2006 to amend existing guidance and, if necessary, to develop new 
guidance within the NUREG-1556, ``Consolidated Guidance About Materials 
Licenses,'' series of volumes to reflect the new authority over 
discrete sources of radium-226 and the accelerator-produced radioactive 
material. The NRC is in the process of revising Volume 9, 
``Consolidated Guidance About Materials Licenses Program-Specific 
Guidance About Medical Use Licenses'' and Volume 13, ``Consolidated 
Guidance About Materials Licenses Program-Specific Guidance About 
Commercial Radiopharmacy Licenses.'' The NRC is developing new 
guidance, Volume 21, ``Consolidated Guidance About Materials Licenses 
Program-Specific Guidance About Possession Licenses for Production of 
Radioactive Materials Using An Accelerator.'' The NUREG-1556 series 
provides guidance in areas of the NRC's jurisdiction and may be helpful 
to Agreement States. The NRC made the draft final guidance publicly 
available for comment after the draft final rule was made publicly 
available. The draft guidance documents were provided for comment to 
the States and the Advisory Committee on Medical Uses of Radioisotopes 
at that time. The NRC expects to finalize the guidance documents near 
the effective date of this rule (60 days after publication). The 
guidance documents are being published for use by current or potential 
NRC licensees. It is important to note that some Agreement States may 
already have similar guidance documents.
    Comment: A commenter requested the NRC to confirm that on the 
effective date of the proposed rule, holders of licenses that authorize 
the use of licensed material at temporary job sites, where the NRC 
maintains jurisdiction, would be able to amend them to include 
accelerator-produced radionuclides. The commenter also requested the 
NRC to confirm that once such licenses were amended, the licensees 
would be able to perform activities using accelerator-produced 
materials authorized in the licenses, at temporary locations within 
non-Agreement States, upon termination of the waiver period on August 
8, 2009.
    NRC Response: On the effective date of this final rule or on the 
date of waiver termination, if that date is later, persons who use 
accelerator-produced radionuclides at temporary job sites may continue 
those activities regardless of whether they have an NRC license, 
provided that: (1) The person, with an NRC license that does not 
authorize use of byproduct material at temporary job sites where the 
NRC has jurisdiction, applies for an amendment to its license to 
authorize uses at these temporary job sites on or before 6 months from 
the effective date of this final rule or on the date of waiver 
termination, if that date is later; or (2) The person without an NRC 
specific license applies for a license on or before 1 year from the 
effective date of this final rule or on the date of waiver termination, 
whichever is later.
    If the person already has an NRC license authorizing the use of 
byproduct material at temporary job sites where the NRC has 
jurisdiction, the person may continue those activities. With the 
amended definition of Byproduct material in the NRC's regulations, the 
term ``Byproduct material'' in the existing license will be interpreted 
as including accelerator-produced radioactive material. It is possible 
that an amendment may be needed to increase the maximum activity limits 
or add specific sealed sources or devices to the license.
    If the person did not use accelerator-produced materials at 
temporary job sites before the date of waiver termination, and its 
existing license does not authorize the use of byproduct material at 
temporary job sites, the person must apply for and receive a license or 
amendment before using these materials.
    Comment: Two commenters stated that if the NRC required the States 
to change their statutes, then the effective date for the final rule 
should be extended by 5 years in order for Agreement States to amend 
their State statutes and regulations. One commenter stated that it 
agreed with the proposed effective date for the final rule and other 
implementation periods only if the NRC did not require such a change 
from the States.
    NRC Response: The NRC does not believe that changes to the State 
statutes would be required by this rulemaking. The NRC will apply 
existing policies and procedures to work with the Agreement States in 
implementing this rule. These existing policies and procedures allow 
considerable flexibility by the States in meeting the compatibility 
requirements. The Agreement States will have up to 3 years to adopt the 
compatible requirements of this rule. The NRC will continue to work 
with the States to resolve any issues that may arise.
    Comment: A commenter called attention to the discussion in the 
Statements of Consideration for the proposed rule concerning the 
termination of the waiver issued by the NRC on August 31, 2005. The 
commenter noted that the discussion included a reference to a ``special 
arrangement'' that would need to be made between a State and the NRC if 
the State had not become an Agreement State by August 7, 2009, when the 
waiver will terminate. The commenter requested additional information 
on what would constitute a ``special arrangement'' between a State and 
the NRC, and how one could be obtained.
    NRC Response: The NRC has considered this comment and has 
determined that the wording referred to by the commenter did not 
accurately describe the Commission's intent in this regard. What the 
Commission intended to convey was that it understands that situations 
may arise which may delay the completion and effective date of an 
Agreement. If an Agreement cannot be completed for a State before the 
waiver expires on August 8, 2009, the staff will determine, on a case-
by-case basis, options to limit the impact of the transition of 
authority on affected users of the new byproduct material in the State.
    The NRC has been communicating with the non-Agreement States that 
the Commission believes might be seeking

[[Page 55910]]

an Agreement in order to avoid this type of situation. The Commission 
will continue to closely coordinate with these States and monitor the 
process of completing any Agreements with these States in order to 
decrease the likelihood that this type of situation will arise.
    Comment: A commenter recommended that the NRC clarify whether any 
additional actions are needed on the part of licensees that are 
currently covered by the waivers issued to the States.
    NRC Response: The waiver was issued to all persons, including 
individuals and licensees as well as States, that acquire, deliver, 
receive, possess, own, use, or transfer the newly regulated byproduct 
material. No actions are needed on the part of these entities. Once the 
waiver is terminated, these persons or licensees are required to comply 
with the requirements of this rule or the corresponding requirements of 
the Agreement States.
    Comment: A commenter felt that the discussion in the Statements of 
Consideration for the proposed rule under termination of the waiver for 
government agencies was not consistent with an earlier discussion in 
the Supplementary Information that concluded that radioactive materials 
would continue to be used in a manner protective of public health and 
safety. The commenter believed that the later discussion appeared to 
equate regulatory oversight with outcomes more protective of public 
health and safety. The commenter felt that the basis for concluding the 
waivers to be acceptable for a period of time, and then requiring 
termination of those waivers, should be explained.
    NRC Response: The NRC does not agree that there are 
inconsistencies, as stated by the commenter, in the discussion in the 
Statements of Consideration for the proposed rule. As explained in the 
discussion concerning issuance of the waiver on August 31, 2005, the 
NRC was given regulatory authority over the new byproduct material when 
the EPAct became effective. Therefore, although the NRC did not have 
regulations in place that would specifically apply to this material, 
persons continuing to engage in activities involving the newly 
regulated byproduct material, and States seeking to continue to 
regulate this byproduct material would be in technical violation of the 
AEA. The NRC determined that it would be prudent to establish a 
mechanism to allow these activities to continue while the NRC 
established a regulatory framework for the new byproduct material. 
Section 651e(5) of the EPAct provides that the Commission could achieve 
this goal through issuing a waiver of the requirements of Section 
651(e) if the Commission determined that the waiver was in accordance 
with the protection of public health and safety and the promotion of 
the common defense and security. The Commission determined that the 
waiver that it issued on August 31, 2005, met this requirement. 
However, the EPAct also mandated that any such waiver issued would have 
to expire no more than 4 years after the date of the enactment of the 
EPAct. Therefore, the waivers must expire no later than August 8, 2009, 
although under the EPAct, the Commission may terminate waivers at an 
earlier time if it finds such termination is warranted.
    As explained in the discussion concerning the termination of the 
waiver, the NRC established a Transition Plan, as required by Section 
651(e) of the EPAct, to facilitate an orderly transition of regulatory 
authority once the Commission had established a regulatory framework 
for regulating the new byproduct material. This regulatory framework 
has now been established through promulgation of this final rule. In 
accordance with the provisions of the Transition Plan, and to 
facilitate the transition of regulatory authority in an orderly manner, 
the waivers will be terminated in stages for users of the new byproduct 
material. As explained in the discussion for termination of the waiver 
for Government agencies and Federally recognized Indian Tribes, the 
Commission determined to terminate the waiver for these entities on the 
effective date of the final rule because there is currently limited 
regulatory oversight for the newly added byproduct material at these 
facilities. Options will be considered, on a case-by-case basis, to 
limit the impact of the transition of the authority on affected users 
of the new byproduct material in the State. Terminating the waiver for 
these entities at that time will provide for regulatory oversight of 
the newly added byproduct material.
    Comment: A commenter stated that it holds Agreement State licenses 
and licenses from the NRC that authorize ``radioactive material'' for a 
broad range of radionuclides, i.e., any byproduct material with atomic 
numbers 1 through 83 or any byproduct material with atomic numbers 84 
through 102. It also holds NRC licenses that authorize ``byproduct 
material'' for the same broad range of radionuclides. The commenter 
requested that the newly regulated byproduct materials be authorized 
under the current license authorizations until the licenses are renewed 
or amended. The commenter recommended that one way to accomplish this 
would be to provide a general license for specific licensees containing 
broad scope authorizations. As an alternate approach, the commenter 
suggested that the rule could provide that licensees authorized for 
such activities as using, receiving, or possessing radionuclides with a 
range of atomic numbers are similarly authorized with respect to the 
newly regulated radionuclides. The commenter stated that these 
licensees already have the controls in place to allow for safe handling 
of the new radionuclides and that the blanket authorization will save 
the licensees and the NRC paperwork and expenses. The commenter 
suggested that the NRC could request information by letter on which 
licensees are handling the newly regulated radionuclides.
    NRC Response: From the commenter's description of its NRC specific 
license authorization, it should already be authorized to use the newly 
regulated byproduct material. With the amended definition of Byproduct 
material in the NRC regulations via this rule, the use of Byproduct 
material in an existing license will be interpreted as authorizing all 
radioactive materials that fall under the newly expanded definition of 
Byproduct material. With the broad authorization in the specific 
license, a license amendment would only be needed if the quantity 
possessed for one or more particular radionuclides exceeds the 
individual limits specified in the existing license authorization. If 
an amendment is needed, the regulations provide that all licensees have 
6 months from the effective date of this final rule or from the waiver 
termination date to submit an amendment request. In addition, the 
amended regulation would allow licensees to continue to use the newly 
regulated materials until the NRC takes final licensing action provided 
that the amendment request was submitted within the allotted time. The 
NRC believes that it has already provided adequate relief in its 
regulations to assure a smooth transition once the licensee's waiver is 
terminated, and that neither a general license nor a rule change is 
necessary for this purpose.
    Comment: Two commenters requested that the NRC allow sufficient 
time for users to prepare for the regulatory change by simultaneously 
terminating all waivers August 7, 2009, and not chance the supply 
disruption of PET radionuclides, drugs, and biologics. The commenter 
stated that there were many differing State regulations for NARM, and 
that a step-by-step approach to

[[Page 55911]]

terminating State waivers could leave unintended voids in the 
regulations, thus disrupting supplies of PET radionuclides. Another 
commenter requested that the NRC terminate all waivers at the same time 
on August 7, 2009, to avoid disruption. The commenter stated that 
accelerator-production facilities, which were designed and built to 
meet less restrictive State regulations, may require significant time 
to be modified to meet the NRC's regulations, and older facilities may 
require special approvals from the NRC.
    NRC Response: The EPAct requires that all waivers must be 
terminated no later than 4 years after the date of enactment of the 
EPAct. As explained in the discussion concerning the termination of the 
waiver, the NRC established a Transition Plan, as required by Section 
651(e) of the EPAct, to facilitate an orderly transition of regulatory 
authority once the Commission had established a regulatory framework 
for regulating the newly added byproduct material. This regulatory 
framework has now been established through promulgation of this final 
rule.
    The NRC recognizes the importance of minimizing disruption of PET 
radionuclides, drugs, and biologics and that many States have 
regulatory programs for NARM. While all of the waivers cannot be 
terminated in conjunction with the August 7, 2009, statutory deadline, 
the NRC is revising the proposed rule [10 CFR 30.3(c)(2) and (c)(3), 10 
CFR 32.1(c)(2), 10 CFR 35.11(c)(2), and 10 CFR 35.13(a)(2)] to provide 
for some waivers to be terminated in conjunction with the expiration of 
the waiver on August 7, 2009. One aspect of the implementation approach 
in the proposed rule provided that requests for licensing actions 
(e.g., amendments or new applications) would need to be received by the 
NRC on or before August 7, 2009, or earlier, depending upon the date of 
the waiver termination. This would essentially mean waivers would need 
to be terminated in August 2008, in order to provide all affected 
persons the same amount of time, as discussed in the draft Transition 
Plan, to submit licensing actions to the NRC. In response to the 
comment, the NRC is revising the proposed rule to provide for some 
waivers to be terminated in conjunction with the expiration of the 
waiver on August 7, 2009. The NRC plans to terminate waivers in stages 
starting from the effective date of this final rule and ending on 
August 7, 2009. When the waiver is terminated for persons in a State, 
all persons in that State have to comply with the NRC regulations for 
the newly defined byproduct material, regardless of whether a license 
has been issued by the NRC. If the waiver has not been terminated for 
the State, all persons in the State are still permitted under the 
waiver to continue to use the newly defined byproduct material.
    The NRC does not agree that supplies of PET radionuclides will be 
disrupted. Under the waiver, PET radionuclide production facilities can 
continue to produce PET radionuclides. Once the waiver is terminated, a 
PET radionuclide production facility may continue to produce PET 
radionuclides while its license application or amendment request is 
under review, provided that a license application is submitted within 1 
year or an amendment request within 6 months from the date of waiver 
termination. Medical use licensees can continue to receive PET 
radionuclides from these production facilities or PET radioactive drugs 
from drug manufacturers or commercial nuclear pharmacies either under 
the waiver or under the NRC's regulations allowing continued operation 
provided that the license application or amendment request was 
submitted within the allotted time.
    Comments: Two commenters stated that the transition time created by 
the waiver was critical for the non-Agreement States so that patient 
care and research activities could continue without interruption. These 
commenters requested that the NRC maintain the waiver until the local 
medical and scientific communities become fully prepared for the new 
licensing costs and requirements.
    NRC Response: The EPAct authorized the NRC to grant waivers for 4 
years from the date of enactment of the Act; it did not include any 
provisions that would allow the NRC to extend the waiver beyond the 
statutory deadline of August 8, 2009. The NRC recognizes the importance 
of continuing patient care and research activities without interruption 
and the need for local medical and scientific communities to have 
adequate time to become fully prepared for the new licensing costs and 
requirements.
    The NRC has taken several steps to ensure a smooth transition of 
the NRC's regulatory authority over the newly defined byproduct 
material. In addition to preparing a Transition Plan, the NRC has, in 
this rulemaking, included regulatory provisions for persons or 
licensees in a non-Agreement State to continue using the newly defined 
byproduct material after the waiver is terminated for that State 
provided a license application or an amendment request is submitted 
within the allotted time frame. The NRC believes that its transitioning 
approach and the regulatory provisions will provide adequate time for 
licensees to transition to the new regulations without interrupting 
patient care or research for the following reasons: First, most medical 
and scientific communities in the non-Agreement States are already 
using both the traditional byproduct materials and the newly defined 
byproduct materials in similar uses; therefore, regulatory impact, 
including licensing fees and radiation safety programs, to these people 
should be minimal to none. Second, the NRC has made rulemaking-related 
documents and draft rules publicly available to keep stakeholders 
informed. Third, the NRC has allowed time for applicants to prepare new 
license applications or amendment requests in the regulations, during 
which they may continue to use the newly regulated byproduct material 
to provide for a smoother transition.
    Comment: Two commenters were concerned that a ``phased-in'' 
approach for terminating the waivers issued in August 2005 had not been 
structured to allow for the transfer of PET radionuclides, drugs, and 
biologics to an NRC licensee from a radionuclide or drug production 
facility using accelerators that has not yet had the waiver terminated. 
One commenter asked for clarification of potential impacts to the 
medical community due to early termination of the waiver to Federal 
facilities such as Veterans Hospitals (i.e., could Federal facilities 
still accept radioactive drugs from companies that are still covered 
under the waiver).
    NRC Response: The NRC's phased waiver termination plan will not 
affect the transfer of PET radionuclides, drugs, and biologics to an 
NRC licensee from a PET radionuclide production facility that has not 
yet had the NRC waiver terminated. For example, a Government agency 
that is currently receiving PET radionuclides or drugs under the waiver 
may continue to be able to receive PET radionuclides or drugs from a 
PET radionuclide and drug producer or distributor when its waiver is 
terminated. Upon waiver termination, the Government agency's existing 
license or MML permit may already be authorized to receive PET drugs if 
the license or MML permit is for all Byproduct material. If the 
Government agency has used PET radionuclides and drugs under the waiver 
and the license (or MML permit) needs to be amended, the Government 
agency may continue to use the PET radionuclides and drugs while 
preparing the amendment and

[[Page 55912]]

until the NRC (or the MML licensee) makes its final licensing decision, 
provided that an amendment request is submitted within 6 months from 
the date of waiver termination. If the Government agency used PET 
radionuclides and drugs under the waiver and did not have an NRC 
license (or MML permit), the Government agency may still continue to 
use the PET radionuclides and drugs while preparing a new license 
application and until the NRC (or the MML licensee) makes its final 
licensing decision, provided that a license application is submitted 
within 1 year from the date of waiver termination.
    While all of the waivers cannot be terminated in conjunction with 
the August 7, 2009, statutory deadline, the NRC is revising the 
proposed rule [10 CFR 30.3(c)(2) and (c)(3), 10 CFR 32.1(c)(2), 10 CFR 
35.11(c)(2), and 10 CFR 35.13(a)(2)] to provide for some waivers to be 
terminated in conjunction with the expiration of the waiver on August 
7, 2009. The NRC plans to terminate waivers in stages starting from the 
effective date of this final rule and ending on August 7, 2009.
    These same principles would apply to the PET radionuclide and drug 
producers or distributors. After this rule becomes effective, the PET 
radionuclide and drug producers or distributors may continue to operate 
until the waiver is terminated for them. Once the waiver is terminated, 
they may continue to operate if the existing license authorizes all 
``byproduct material'' or as authorized by this rule while preparing a 
new license application or an amendment request or while waiting for 
the NRC's final licensing decision, provided that the license 
application or amendment request is submitted within the allotted time 
as stated in this rule.

IV. Section-by-Section Analysis of Final Revisions

Part 20--Standards for Protection Against Radiation

    The authority citation for this part is revised to reflect the 
EPAct.

Section 20.1003--Definitions

    The definition of Byproduct material is revised to reflect the new 
definition as mandated in Section 651(e) of the EPAct.
    Definitions for Accelerator-produced radioactive material, Discrete 
source, and Particle accelerator are added.
    A definition of Waste is added to clarify that, as mandated by the 
EPAct, byproduct material as defined in Sections 11e.(3) and 11e.(4) of 
the AEA is not low-level radioactive waste as defined in the LLRWPAA.

Section 20.1009--Information Collection Requirements: OMB Approval

    Reference to Sec.  20.2008 is added.

Section 20.2001--General Requirements

    Paragraph (a)(4) is revised to include the new Sec.  20.2008 which 
addresses disposal of waste.

Section 20.2006--Transfer for Disposal and Manifests

    Paragraph (e) is added to require the use of uniform manifests for 
disposal of byproduct material as defined in Sections 11e.(3) and 
11e.(4) of the AEA if intended for ultimate disposal at a land disposal 
facility licensed under 10 CFR Part 61.

Section 20.2008--Disposal of Certain Byproduct Material

    This section is added to part 20 to address disposal requirements 
for byproduct material as defined in Sections 11e.(3) and 11e.(4) of 
the AEA.

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 List of Elements table is revised to include the elements 
nitrogen and oxygen that are now considered byproduct material. Tables 
1, 2, and 3 are revised to specifically include nitrogen-13 and oxygen-
15 and their associated values.

Part 30--Rules of General Applicability to Domestic Licensing of 
Byproduct Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 30.3--Activities Requiring License

    This section is revised to inform Government agencies, Federally 
recognized Indian Tribes, other licensees, and other persons who 
possessed and used byproduct material as defined in Section 11e.(3) of 
the AEA under the provisions of NRC's waiver (70 FR 51581; August 31, 
2005) which sections of the regulations will apply to them when their 
waiver is terminated before issuance of an amendment or new license for 
byproduct material. For the Government agencies and Federally 
recognized Indian Tribes, requirements for the newly added byproduct 
material will apply to them on the effective date of the final rule.
    This section is also revised to allow for transition for Government 
agencies, Federally recognized Indian Tribes, other persons, and other 
licensees, who possessed and used byproduct material as defined in 
Section 11e.(3) of the AEA under the waiver, to continue to use these 
materials while applying for and receiving licenses or amendments to 
existing licenses. This section revises the authority and 
responsibilities of persons or licensees that do not file for the 
license or amendment within the required time with respect to receipt, 
use, possession, and disposal of byproduct material and the 
decommissioning of facilities.

Section 30.4--Definitions

    The definition of Byproduct material is revised to be consistent 
with the new definition in the AEA, with the exception that it does not 
include byproduct material as defined in Section 11e.(2) of the AEA.
    The following definitions are added to this section: Accelerator-
produced radioactive material, Consortium, Cyclotron, Discrete source, 
and Particle accelerator.

Section 30.15--Certain Items Containing Byproduct Material

    This section is revised to add paragraph (a)(1)(viii) to authorize 
0.037 MBq (1 microCi) of radium-226 per timepiece in intact timepieces 
manufactured before the effective date of the final rule.

Section 30.18--Exempt Quantities

    Paragraph (b) is revised to include byproduct material received or 
acquired before September 25, 1971, under a general license provided in 
10 CFR 31.4 or by a State provision similar to 10 CFR 31.4.

Section 30.20--Gas and Aerosol Detectors Containing Byproduct Material

    Paragraph (a) is revised to apply to gas and aerosol detectors 
manufactured or distributed before the effective date of the final rule 
in accordance with a specific license issued by a State with comparable 
provisions to 10 CFR 32.26.

Section 30.32--Application for Specific Licenses

    Paragraph (g) is revised to accept information from sealed source 
or device registrations with regard to NARM issued by the States under 
provisions comparable to 10 CFR 32.210 as a basis for licensing the use 
of sources and devices. The paragraph is also revised to allow a basis 
for licensing sources or devices containing NARM, that were 
manufactured before the effective date of the final rule, are not 
registered with the Commission

[[Page 55913]]

under 10 CFR 32.210 or with an Agreement State, and for which all the 
information identified in 10 CFR 32.210 is unavailable.
    Paragraph (j) is added to this section to inform an educational 
institution, a medical facility, or a Government facility applicant of 
the information required by the NRC to authorize the production of PET 
radioactive drugs used for medical uses under 10 CFR part 35 for the 
noncommercial transfer to medical facilities in its consortium.

Section 30.34--Terms and Conditions of Licenses

    Paragraph (g) is revised to require licensees to measure strontium-
82 and strontium-85 contamination before use of the first eluate when 
eluding strontium-82/rubidium-82 generators.
    Paragraph (j) is added to clarify that nothing in the authorization 
under 10 CFR 30.32(j) relieves the licensee from complying with FDA, 
other Federal, or State requirements for radioactive drugs, and to 
include requirements associated with the labeling and production of PET 
radioactive drugs by licensees authorized under the provisions of 10 
CFR 30.32(j) to produce PET radioactive drugs for the noncommercial 
transfer to medical use licensees in their consortium. This section 
also requires licensees to use the notification process in 10 CFR 32.72 
when permitting qualified authorized nuclear pharmacists to work as 
ANPs.

Section 30.71--Schedule B

    Schedule B is revised to include 13 radionuclides that are now 
considered byproduct material and their associated exempt quantities.

Section 30.72--Schedule C--Quantities of Radioactive Materials 
Requiring Consideration of the Need for an Emergency Plan for 
Responding to a Release

    The table in Schedule C is revised to specifically include radium-
226 and its associated values.

Part 31--General Domestic Licenses For Byproduct Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 31.4--Information Collection Requirements: OMB Approval

    Reference to Sec. 31.12 is added.

Section 31.5--Certain Detecting, Measuring, Gauging, or Controlling 
Devices and Certain Devices for Producing Light or an Ionized 
Atmosphere

    Paragraph (b)(1) is revised to add authority under the general 
license for byproduct material contained in devices which have been 
manufactured or initially transferred and labeled in accordance with 
the specifications contained in an equivalent specific license issued 
by a State with comparable provisions to 10 CFR 32.51.
    Paragraph (c)(13)(i) is revised to add radium-226, with an activity 
of at least 3.7 MBq (0.1 microCi) to the criteria for devices requiring 
registration.

Section 31.8--Americium-241 and Radium-226 in the Form of Calibration 
or Reference Sources

    The section heading and paragraph (a) are revised to include 
radium-226 in a general license for calibration and reference sources.
    Paragraph (b) is revised to recognize sources manufactured or 
initially transferred in accordance with the specifications contained 
in a specific license issued by a State with comparable provisions to 
10 CFR 32.57.
    Paragraph (c)(1) is revised to include an activity limit of 0.185 
MBq (5 microCi) of radium-226.
    Paragraph (c)(2) is revised to include radium-226 in the labeling 
requirement, with the provision added to footnote 1 that, for those 
sources manufactured before the effective date of the final rule, 
sources containing radium-226 shall be labeled in accordance with the 
applicable State regulations at the time of manufacture or import.
    Paragraphs (c)(4), (d), and (e) are revised to include radium-226.

Section 31.11--General License for Use of Byproduct Material for 
Certain In Vitro Clinical or Laboratory Testing

    Paragraphs (a) and (c) are revised to include cobalt-57 in the list 
of authorized byproduct material for use in in vitro clinical or 
laboratory testing.
    Paragraph (d) is revised to allow receipt of prepackaged units that 
are labeled in accordance with a specific license issued by a State 
with comparable provisions to 10 CFR 32.71.

Sections 31.12, 31.13, and 31.14 Are Redesignated as Sec. Sec.  31.21, 
31.22, and 31.23, Respectively

Section 31.12--General License for Certain Items and Self-luminous 
Products Containing Radium-226

    This section is added to the regulations to add a general license 
for certain items and self-luminous products containing radium-226 that 
were manufactured before the effective date of the final rule. The 
general license addresses radium-226 contained in products such as 
antiquities; timepieces; luminous items installed in air, marine, or 
land vehicles; all other luminous products; and small radium sources 
containing no more than 0.037 MBq (1 microCi) of radium-226.
    The general license exempts persons from the provisions of 10 CFR 
parts 19, 20, and 21, and 10 CFR 30.50 and 10 CFR 30.51.
    The general license includes requirements for notification, 
reporting, disposal, and certain prohibitions. However, the general 
license allows timepieces containing radium-226 to be disassembled and 
repaired.

Part 32--Specific Domestic Licenses To Manufacture or Transfer Certain 
Items Containing Byproduct Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 32.1--Purpose and Scope

    A new paragraph (c) is added to inform Government agencies, 
Federally recognized Indian Tribes, other licensees, and other persons 
who manufacture or initially transfer items containing accelerator-
produced radioactive material or discrete sources of radium-226 for 
sale or distribution to persons exempted from the licensing 
requirements of part 30 of this chapter, and persons generally licensed 
under part 31 or part 35 of this chapter, and radioactive drugs and 
sources and devices to medical use licensees, that the requirements in 
part 32 will apply to them when their waiver is terminated before 
issuance of an amendment or new license for such activities. The 
requirements will apply to Government agencies and Federally recognized 
Indian Tribes on the effective date of the final rule.
    This paragraph allows Government agencies, Federally recognized 
Indian Tribes, other persons, and other licensees who manufacture or 
initially transfer items containing accelerator-produced radioactive 
material or discrete sources of radium-226 for sale or distribution to 
persons exempted from the licensing requirements of part 30 of this 
chapter, persons generally licensed under part 31 or part 35 of this 
chapter, and radioactive drugs and sources and devices to medical use 
licensees to continue to manufacture or initially transfer these items 
to such persons when their waiver is terminated before issuance of an 
amendment or new license for such activities.

Section 32.57--Calibration or Reference Sources Containing Americium-
241 or Radium-226: Requirements for License to Manufacture or Initially 
Transfer

    The heading and the section are revised to add radium-226.

[[Page 55914]]

Section 32.58--Same: Labeling of Devices

    This section is revised to include radium-226 in the example label.

Section 32.59--Same: Leak Testing of Each Source

    This section is revised to include radium-226.

Section 32.71--Manufacture and Distribution of Byproduct Material for 
Certain In Vitro Clinical or Laboratory Testing Under General License

    Paragraph (b)(8) is added to include cobalt-57, in units not 
exceeding 0.37 MBq (10 microCi) each, to the list of authorized 
byproduct material approved for distribution.
    Paragraph (c)(1) is revised to include cobalt-57.

Section 32.72--Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under Part 35

    Paragraph (a) is revised to ensure that the NRC's regulation 
encompasses all drug manufacturers that are registered with the FDA or 
a State agency. The description of who is registered with the FDA was 
updated to conform with FDA regulations.
    Paragraph (b) is revised to recognize nuclear pharmacists, who 
prepared only accelerator-produced radioactive drugs, before the 
effective date of the final rule and authorized nuclear pharmacists 
identified on permits issued by master material licensees or by a 
master material permittee of broad scope, to work as authorized nuclear 
pharmacists at a commercial nuclear pharmacy under the notification 
process in 10 CFR 32.72.

Section 32.102--Schedule C--Prototype Tests for Calibration or 
Reference Sources Containing Americium-241 or Radium-226

    The heading and section are revised to include radium-226.

Part 33--Specific Domestic Licenses of Broad Scope for Byproduct 
Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 33.100--Schedule A

    This table is revised to add four additional radionuclides and 
their associated values.

Part 35--Medical Use of Byproduct Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 35.2--Definitions

    The definitions of Cyclotron and Positron Emission Tomography (PET) 
radionuclide production facility are added.

Section 35.10--Implementation

    Paragraph (a) is added to clarify that Government agencies and 
Federally recognized Indian Tribes possessing and using accelerator-
produced radioactive material and discrete sources of radium-226 for 
medical use must comply with the requirements in this part on the 
effective date of the final rule. The paragraph also informs other 
persons using this material for medical use when they must comply with 
the requirements of this part.

Section 35.11--License Required

    Paragraph (a) is revised, and paragraph (c) is added to allow 
Government agencies, Federally recognized Indian Tribes, and other 
persons who possessed and used accelerator-produced radioactive 
materials or discrete sources of radium-226, under the provisions of 
the NRC's waiver (70 FR 51581; August 31, 2005), to have time to apply 
for and receive a new medical use license and allow them to continue to 
use these materials, provided the new license was applied for in the 
time required. This section also provides the time period for applying 
for a new license.

Section 35.13--License Amendments

    Paragraph (a) is modified to allow Government agencies, Federally 
recognized Indian Tribes, and other licensees that possessed and used 
accelerator-produced radioactive materials or discrete sources of 
radium-226, under the provisions of the NRC's waiver (70 FR 51581; 
August 31, 2005), to continue to use this material provided that they 
submit an application to amend their licenses in the specified time 
required. This section also provides the time period for amending 
licenses.
    A new paragraph (b)(5) is added to permit physicians and 
pharmacists who only used accelerator-produced radioactive materials or 
discrete sources of radium-226 during the NRC's waiver (70 FR 51581; 
August 31, 2005) to use the notification process.
    Paragraph (e) is modified to require an amendment before a licensee 
adds to, or changes, areas of use identified in the application or on 
the license, including areas used in accordance with either 10 CFR 
35.100 or 35.200 if the change includes the addition or relocation of 
either an area where PET radionuclides are produced or a PET 
radioactive drug delivery line from the PET radionuclide/PET 
radioactive drug production area. Other areas of use where byproduct 
material is used only in accordance with either 10 CFR 35.100 or 10 CFR 
35.200 continue to be excluded from this requirement.

Section 35.14--Notifications

    Paragraph (a) is revised to address information needed for NRC 
notification of nuclear pharmacists and physicians who used only 
accelerator-produced radioactive materials and discrete sources of 
radium-226 who have not been identified on a license or permit during 
the NRC's waiver (70 FR 51581; August 31, 2005).
    Paragraph (b) is revised to retain, in the notification 
requirements, any additions or changes in 10 CFR 35.100 or 10 CFR 
35.200 areas of use, if the changes do not involve additions or 
relocations of either an area where PET radionuclides are produced or a 
PET radioactive drug delivery line from the PET radionuclide/PET 
radioactive drug production area.

Section 35.15--Exemptions Regarding Type A Specific Licenses of Broad 
Scope

    Paragraph (f) is revised to clarify that the broad scope licensee 
is exempted from making the notification of addition or changes in 10 
CFR 35.100 or 10 CFR 35.200 areas of use.

Section 35.57--Training for Experienced Radiation Safety Officer, 
Teletherapy or Medical Physicist, Authorized Medical Physicist, 
Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist

    A new paragraph (a)(3) is added to grandfather RSOs, medical 
physicists, or nuclear pharmacists who used only accelerator-produced 
radioactive materials or discrete sources of radium-226, or both, 
during the NRC's waiver (70 FR 51581; August 31, 2005) from training 
requirements and to recognize them as RSOs, AMPs, or ANPs for those 
same materials and uses.
    A new paragraph (b)(3) is added to grandfather physicians, 
dentists, or podiatrists who used only accelerator-produced radioactive 
materials or discrete sources of radium-226, or both, under the NRC's 
waiver (70 FR 51581; August 31, 2005) from training requirements and to 
recognize them as AUs for those same materials and uses.

Section 35.63--Determination of Dosages of Unsealed Byproduct Material 
for Medical Use

    This section is revised to add a new provision in paragraphs (b)(2) 
and (c)(3)

[[Page 55915]]

to include PET radioactive drug producers licensed under 10 CFR 
30.32(j) for the production of PET radioactive drugs transferred 
noncommercially to members of their consortium.

Section 35.100--Use of Unsealed Byproduct Material for Uptake, 
Dilution, and Excretion Studies for Which a Written Directive is Not 
Required

    Paragraph (a) is revised to permit medical use licensees to obtain 
PET drugs from PET radioactive drug producers licensed under 10 CFR 
30.32(j) for the production of PET radioactive drugs transferred 
noncommercially to members of their consortium.
    Paragraph (b) is revised to continue to clarify that 10 CFR 35.100 
licensees are not allowed to produce PET radionuclides.

Section 35.200--Use of Unsealed Byproduct Material for Imaging and 
Localization Studies for Which a Written Directive is Not Required

    Paragraph (a) is revised to permit medical use licensees to obtain 
PET drugs from PET radioactive drug producers licensed under 10 CFR 
30.32(j) for the production of PET radioactive drugs transferred 
noncommercially to members of their consortium.
    Paragraph (b) is revised to clarify that 10 CFR 35.200 licensees 
are not allowed to produce PET radionuclides.

Section 35.204--Permissible Molybdenum-99, Strontium-82, and Strontium-
85 Concentrations

    The section heading is revised to add strontium-82 and strontium-
85.
    Paragraph (a) is revised to address acceptable strontium-82 and 
strontium-85 concentrations when eluting strontium-82/rubidium-82 
generators.
    Paragraph (c) is revised and redesignated, and a new paragraph (c) 
is added to address measuring requirements for strontium-82 and 
strontium-85.

Section 35.300--Use of Unsealed Byproduct Material for Which a Written 
Directive is Required

    Paragraph (a) is revised to permit medical use licensees to obtain 
PET drugs from PET radioactive drug producers licensed under 10 CFR 
30.32(j) for the production of PET radioactive drugs transferred 
noncommercially to members of their consortium.
    Paragraph (b) is revised to clarify that 10 CFR 35.300 licensees 
are not allowed to produce PET radionuclides.

Section 35.2204--Records of Molybdenum-99, Strontium-82, and Strontium-
85 Concentrations

    The section heading is revised to add strontium-82 and strontium-
85, and this section is revised to include a recordkeeping requirement 
of the strontium-82 and strontium-85 concentration tests required by 10 
CFR 35.204(b) and (c).

Part 50--Domestic Licensing of Production and Utilization Facilities

    The authority citation for this part is revised to reflect the 
EPAct.

Section 50.2--Definitions

    The definition of Byproduct material is revised to be consistent 
with the new definition as mandated by the EPAct, with the exception 
that it will not include byproduct material as defined in Section 
11e.(2) of the AEA.

Part 61--Licensing Requirements for Land Disposal of Radioactive Waste

    The authority citation for this part is revised to reflect the 
EPAct.

Section 61.2--Definitions

    The definition of Waste is revised to clarify that, as mandated by 
the EPAct, byproduct material, as defined in Sections 11e.(3) and 
11e.(4) of the AEA, is not low-level radioactive waste as defined in 
the LLRWPAA.

Part 62--Criteria and Procedures for Emergency Access to Non-Federal 
and Regional Low-Level Waste Disposal Facilities

    The authority citation for this part is revised to reflect the 
EPAct.

Section 62.2--Definitions

    The definition of Low-level radioactive waste (LLW) is revised to 
clarify that byproduct material, as defined in Sections 11e.(3) and 
11e.(4) of the AEA, is not considered low-level radioactive waste.

Part 72--Licensing Requirements for the Independent Storage of Spent 
Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater 
Than Class C Waste

Section 72.3--Definitions

    The definition of Byproduct material is revised to be consistent 
with the definition in 10 CFR 30.4. This definition is consistent with 
the definition of Byproduct material in the EPAct, with the exception 
that it will not include byproduct material as defined in Section 
11e.(2) of the AEA.

Part 110--Export and Import of Nuclear Equipment and Material

    The authority citation for this part is revised to reflect the 
EPAct.

Section 110.2--Definitions

    Definitions of Accelerator-produced radioactive material, Discrete 
source, and Particle accelerator are added.

Part 150--Exemptions and Continued Regulatory Authority in Agreement 
States and in Offshore Waters Under Section 274

    The authority citation for this part is revised to reflect the 
EPAct.

Section 150.3--Definitions

    The definition of Byproduct material is revised to be consistent 
with the definition in the EPAct.
    A definition of Discrete source is added.

Part 170--Fees for Facilities, Materials, Import and Export Licenses, 
and Other Regulatory Services Under the Atomic Energy Act of 1954, as 
Amended

    The authority citation for this part is revised to reflect the 
EPAct.

Section 170.3--Definitions

    The definition of Byproduct material is revised to be consistent 
with the new definition in the AEA, with the exception that it does not 
include byproduct material as defined in Section 11e.(2) of the AEA.

Section 170.31--Schedule of Fees for Materials Licenses and Other 
Regulatory Services, Including Inspections, and Import and Export 
Licenses

    This section is revised to include licenses that are not included 
in existing fee categories. Fee Category 3.B. is revised to include 
licenses for repair, assembly, and disassembly of products containing 
radium-226. Two new fee categories, 3.R. with additional subcategories 
and 3.S., are added to include fees for possession of items or products 
containing radium-226, which exceed the number of items or limits 
specified in 10 CFR 31.12, and for production of accelerator-produced 
radioactive material.

Part 171--Annual Fees for Reactor Licenses and Fuel Cycle Licenses and 
Materials Licenses, Including Holders of Certificates of Compliance, 
Registrations, and Quality Assurance Program Approvals and Government 
Agencies Licensed by the NRC

    The authority citation for this part is revised to reflect the 
EPAct.

[[Page 55916]]

Section 171.5--Definitions

    The definition of Byproduct material is revised to be consistent 
with the new definition in the AEA, with the exception that it does not 
include byproduct material as defined in Section 11e.(2) of the AEA.

Section 171.16--Annual fees: Materials Licenses, Holders of 
Certificates of Compliance, Holders of Sealed Source and Device 
Registrations, Holders of Quality Assurance Program Approvals, and 
Government Agencies Licensed by the NRC

    This section is revised to include licenses that are not included 
in existing fee categories. Fee Category 3.B. is revised to include 
licenses for repair, assembly, and disassembly of products containing 
radium-226. Two new fee categories, 3.R. with additional subcategories 
and 3.S., are added to include fees for possession of items or products 
containing radium-226, which exceed the number of items or limits 
specified in 10 CFR 31.12, and for production of accelerator-produced 
radioactive material.

V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is amending 10 CFR Parts 20, 30, 31, 32, 33, 35, 50, 61, 62, 
72, 110, 150, 170, and 171 under one or more of Sections 161b, 161i, or 
161o of the AEA. Willful violations of the rule would be subject to 
criminal enforcement.

VI. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register (62 FR 46517; September 3, 1997), 
this rule would be a matter of compatibility between the NRC and the 
Agreement States, thereby providing consistency among the Agreement 
States' and the NRC's requirements. The NRC staff analyzed the rule in 
accordance with the procedure established within Part III, 
``Categorization Process for NRC Program Elements,'' of Handbook 5.9 to 
Management Directive 5.9, ``Adequacy and Compatibility of Agreement 
State Programs'' (a copy of which may be viewed at http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
    The NRC program elements (including regulations) are placed into 
four compatibility categories (See the Compatibility Table in this 
section). In addition, the NRC program elements can also be identified 
as having particular health and safety significance or as being 
reserved solely to the NRC. Compatibility Category A are those program 
elements that are basic radiation protection standards and scientific 
terms and definitions that are necessary to understand radiation 
protection concepts. An Agreement State should adopt Category A program 
elements in an essentially identical manner to provide uniformity in 
the regulation of agreement material on a nationwide basis. 
Compatibility Category B are those program elements that apply to 
activities that have direct and significant effects in multiple 
jurisdictions. An Agreement State should adopt Category B program 
elements in an essentially identical manner. Compatibility Category C 
are those program elements that do not meet the criteria of Category A 
or B, but the essential objectives of which an Agreement State should 
adopt to avoid conflict, duplication, gaps, or other conditions that 
would jeopardize an orderly pattern in the regulation of agreement 
material on a nationwide basis. An Agreement State should adopt the 
essential objectives of the Category C program elements. Compatibility 
Category D are those program elements that do not meet any of the 
criteria of Category A, B, or C, above, and, thus, do not need to be 
adopted by Agreement States for purposes of compatibility.
    Health and Safety (H&S) are program elements that are not required 
for compatibility but are identified as having a particular health and 
safety role (i.e., adequacy) in the regulation of agreement material 
within the State. Although not required for compatibility, the State 
should adopt program elements in this H&S category based on those of 
the NRC that embody the essential objectives of the NRC program 
elements because of particular health and safety considerations. 
Compatibility Category NRC are those program elements that address 
areas of regulation that cannot be relinquished to Agreement States 
under the AEA, as amended, or provisions of Title 10 of the Code of 
Federal Regulations. These program elements are not adopted by the 
Agreement States. The following table lists the parts and sections that 
would be revised and their corresponding categorization under the 
``Policy Statement on Adequacy and Compatibility of Agreement State 
Programs.'' A bracket around a category means that the section may have 
been adopted elsewhere, and it is not necessary to adopt it again.
    The definition of Byproduct material in the AEA was expanded by 
Section 651(e) of the EPAct to incorporate certain discrete sources of 
radium-226 and certain accelerator-produced radioactive materials. The 
definition of Byproduct material in 10 CFR parts 20, 30, 50, 72, 150, 
170, and 171 is amended to reflect the changes to the AEA. The 
definition of Byproduct material in parts 50, 72, 170, and 171 is 
reserved to the NRC. The definition of Byproduct material in 10 CFR 
parts 20, 30, and 150 are categorized as H&S. This designation is for 
regulatory program elements that have particular health and safety 
significance. The H&S designation indicates that the definition is 
needed for purposes of ``adequacy.'' If NARM is included in the 
Agreement between the NRC and the Agreement State, then NARM would be a 
necessary program element of the Agreement State program to adequately 
ensure public health and safety. The definition of Discrete source has 
also been identified in this rule as H&S because it is part of the 
definition of Byproduct material.

                                               Compatibility Table
----------------------------------------------------------------------------------------------------------------
                                                                                       Compatibility
            Section                   Change               Subject        --------------------------------------
                                                                                Existing              New
----------------------------------------------------------------------------------------------------------------
20.1003.......................  Amend............  Definition: Byproduct   [A]...............  [H&S]
                                                    Material (add 11e.(3)
                                                    & 11e.(4) material).
20.1003.......................  Add..............  Definition: Discrete    ..................  H&S
                                                    Source.
20.1003.......................  Add..............  Definition: Particle    ..................  H&S
                                                    Accelerator.
20.1003.......................  Add..............  Definition: Waste.....  ..................  B
20.1009.......................  Amend............  List of OMB approved    D.................  D
                                                    information
                                                    collections.
20.2001(a)(4).................  Amend............  General requirements    C.................  C
                                                    (add reference to new
                                                    Sec.   20.2008).

[[Page 55917]]

 
20.2006(e)....................  Add..............  Transfer for disposal   ..................  B
                                                    and manifests (add
                                                    11e.(3) and 11e.(4)
                                                    byproduct material).
20.2008.......................  Add..............  Disposal of 11e.(3)     ..................  B
                                                    and 11e.(4) byproduct
                                                    material (new
                                                    section).
Appendix B to Part 20.........  Amend............  Add limits for N-13     A.................  A
                                                    and O-15.
30.3(a).......................  Amend............  Activities requiring    C.................  C
                                                    license (add
                                                    reference to
                                                    paragraph (c)).
30.3(b)(1)....................  Add..............  Activities requiring    ..................  NRC
                                                    license (requirements
                                                    that apply to
                                                    Government agencies
                                                    and Federally
                                                    recognized Indian
                                                    Tribes at waiver
                                                    termination).
30.3(b)(2)....................  Add..............  Activities requiring    ..................  NRC
                                                    license
                                                    (authorization for
                                                    Government agencies
                                                    and Federally
                                                    recognized Indian
                                                    Tribes to possess and
                                                    use 11e.(3) materials
                                                    while applying for a
                                                    license amendment).
30.3(b)(3)....................  Add..............  Activities requiring    ..................  NRC
                                                    license
                                                    (authorization for
                                                    Government agencies
                                                    and Federally
                                                    recognized Indian
                                                    Tribes to possess and
                                                    use 11e.(3) materials
                                                    while applying for a
                                                    new license).
30.3(c)(1)....................  Add..............  Activities requiring    ..................  D
                                                    license (requirements
                                                    that apply to all
                                                    other persons at
                                                    waiver termination).
30.3(c)(2)....................  Add..............  Activities requiring    ..................  D
                                                    license
                                                    (authorization for
                                                    all other persons to
                                                    possess and use
                                                    11e.(3) materials
                                                    while applying for a
                                                    license amendment).
30.3(c)(3)....................  Add..............  Activities requiring    ..................  D
                                                    license
                                                    (authorization for
                                                    all other persons to
                                                    possess and use
                                                    11e.(3) materials
                                                    while applying for a
                                                    new license).
30.3(d).......................  Add..............  Activities requiring    ..................  D
                                                    license (continuation
                                                    of authority for
                                                    failure to submit
                                                    amendment or license).
30.4..........................  Add..............  Definition:             ..................  H&S
                                                    Accelerator-produced
                                                    radioactive material.
30.4..........................  Amend............  Definition: Byproduct   [A]...............  [H&S]
                                                    material (add 11e.(3)
                                                    & 11e.(4) material).
30.4..........................  Add..............  Definition: Consortium  ..................  C
30.4..........................  Add..............  Definition: Cyclotron.  ..................  D
30.4..........................  Add..............  Definition: Discrete    ..................  H&S
                                                    source.
30.4..........................  Add..............  Definition: Particle    ..................  H&S
                                                    accelerator.
30.15(a)(1)(viii).............  Add..............  Certain items           B.................  B
                                                    containing byproduct   (all Sec.   30.15)
                                                    material (add radium-
                                                    226 intact timepieces
                                                    and limited repairs).
30.18(b)......................  Amend............  Exempt quantities (add  B.................  B
                                                    11e.(3) material).     (all Sec.   30.18)
30.20(a)......................  Amend............  Gas and aerosol         B.................  B
                                                    detectors containing   (all Sec.   30.20)
                                                    byproduct material
                                                    (grandfather 11e.(3)
                                                    detectors).
30.32(g)......................  Amend............  Application for         C.................  C
                                                    specific licenses.
30.32(j)......................  Add..............  Application for         ..................  B
                                                    specific licenses
                                                    (add noncommercial
                                                    transfer of PET
                                                    drugs).
30.34(g)......................  Amend............  Terms and conditions    D.................  H&S
                                                    of licenses (add
                                                    strontium-82/rubidium-
                                                    82 generators).
30.34(j)......................  Add..............  Terms and conditions    ..................  B
                                                    of licenses (add
                                                    noncommercial
                                                    transfer of PET
                                                    drugs).
30.71.........................  Amend............  Schedule B (add         B.................  B
                                                    11e.(3) material).
30.72.........................  Amend............  Schedule C--Quantities  H&S...............  H&S
                                                    of radioactive
                                                    materials requiring
                                                    consideration of the
                                                    need for an emergency
                                                    plan for responding
                                                    to a release (add
                                                    radium-226).
31.4..........................  Amend............  List of OMB approved    D.................  D
                                                    information
                                                    collections.
31.5(b)(1) & (c)(13)..........  Amend............  Certain detecting,      B.................  B
                                                    measuring, gauging,    (all Sec.   31.5).
                                                    or controlling
                                                    devices and/or an
                                                    ionizing atmosphere
                                                    (add devices with
                                                    NARM approved by
                                                    States).
31.8..........................  Amend............  Americium-241 in the    D.................  D
                                                    form of calibration
                                                    or reference sources
                                                    (add radium-226).
31.11.........................  Amend............  General license for     D.................  D
                                                    use of byproduct
                                                    material for certain
                                                    in vitro clinical or
                                                    laboratory testing
                                                    (add cobalt-57).
31.12.........................  Add..............  General license for     ..................  C
                                                    certain items and
                                                    self-luminous
                                                    products containing
                                                    radium-226 (new
                                                    section).
32.1(c)(1)....................  Add..............  Purpose and scope       ..................  NRC
                                                    (requirements that
                                                    apply to Government
                                                    agencies and
                                                    Federally recognized
                                                    Indian Tribes at
                                                    waiver termination
                                                    and authorization to
                                                    manufacture and
                                                    distribute items with
                                                    11e.(3) material
                                                    while applying for
                                                    amendment or license).

[[Page 55918]]

 
32.1(c)(2)....................  Add..............  Purpose and scope       ..................  D
                                                    (requirements that
                                                    apply to all other
                                                    persons at waiver
                                                    termination and
                                                    authorization to
                                                    manufacture and
                                                    distribute items with
                                                    11e.(3) material
                                                    while applying for
                                                    amendment or license).
32.57.........................  Amend............  Calibration or          B.................  B
                                                    reference sources
                                                    containing americium-
                                                    241: Requirements for
                                                    license to
                                                    manufacture or
                                                    initially transfer
                                                    (add radium-226).
32.58.........................  Amend............  Same: Labeling of       B.................  B
                                                    devices (add radium-
                                                    226).
32.59.........................  Amend............  Same: Leak testing of   B.................  B
                                                    each source (add
                                                    radium-226).
32.71(b)(8) & (c)(1)..........  Add..............  Manufacture and         B.................  B
                                                    distribution of
                                                    byproduct material
                                                    for certain in vitro
                                                    clinical or
                                                    laboratory testing
                                                    under general license
                                                    (add cobalt-57).
32.72(a)(2)(i), (iii), (iv),    Amend............  Manufacture,            B.................  B
 (v), & (b).                                        preparation, or
                                                    transfer for
                                                    commercial
                                                    distribution of
                                                    radioactive drugs
                                                    containing byproduct
                                                    material for medical
                                                    use under part 35
                                                    (recognize FDA and
                                                    State registrations
                                                    of PET facilities and
                                                    pharmacist using
                                                    11e.(3) material).
32.102........................  Amend............  Schedule C--prototype   B.................  B
                                                    tests for calibration
                                                    or reference sources
                                                    containing americium-
                                                    241 (add radium-226).
33.100........................  Amend............  Schedule A (add         D.................  D
                                                    beryllium-7, cobalt-
                                                    57, radium-226, &
                                                    sodium-22).
35.2..........................  Add..............  Definition: Cyclotron.  ..................  D
35.2..........................  Add..............  Definition: Positron    ..................  H&S
                                                    Emission Tomography
                                                    (PET) radionuclide
                                                    production facility.
35.10(a)......................  Add..............  Implementation          ..................  D
                                                    (requirements that
                                                    apply at waiver
                                                    termination).
35.10(g)......................  Redesignated.....  Implementation........  ..................  D
35.11(a)......................  Amend............  License required        C.................  C
                                                    (reference to Sec.
                                                    35.11(c)).
35.11(c)(1)...................  Add..............  License required        ..................  NRC
                                                    (authorize medical
                                                    use of 11e.(3)
                                                    materials by
                                                    Government agencies
                                                    and Federally
                                                    recognized Indian
                                                    Tribes while applying
                                                    for license).
35.11(c)(2)...................  Add..............  License required        ..................  D
                                                    (authorize medical
                                                    use of 11e.(3)
                                                    materials by all
                                                    other persons while
                                                    applying for license).
35.13(a)(1)...................  Amend............  License amendments      ..................  NRC
                                                    (authorize medical
                                                    use of 11e.(3)
                                                    materials by
                                                    Government agencies
                                                    and Federally
                                                    recognized Indian
                                                    Tribes while applying
                                                    for amendment).
35.13(a)(2)...................  Amend............  License amendments      ..................  D
                                                    (authorize medical
                                                    use of 11e.(3)
                                                    materials by all
                                                    other licensees while
                                                    applying for
                                                    amendment).
35.13(b)(5)...................  Add..............  License amendments      D.................  D
                                                    (grandfather
                                                    physicians and
                                                    pharmacists that used
                                                    11e.(3) material).
35.13(e)......................  Amend............  License amendments      D.................  D
                                                    (clarify amendment
                                                    need).
35.14(a) and (b)(5)...........  Amend............  Notifications (using    D.................  D
                                                    notification to allow
                                                    continued operation
                                                    for certain 11e.(3)
                                                    material).
35.15(f)......................  Amend............  Exemptions regarding    D.................  D
                                                    Type A specific
                                                    licenses of broad
                                                    scope (clarify the
                                                    exemption).
35.57(a)(3) & (b)(3)..........  Add..............  Training for            ..................  D
                                                    experienced Radiation
                                                    Safety Officer,
                                                    teletherapy or
                                                    medical physicist,
                                                    authorized user, and
                                                    nuclear pharmacist
                                                    (grandfather RSO,
                                                    AMP, ANP, and AU who
                                                    used only 11e.(3)
                                                    material).
35.63(b)(2)(ii) & (c)(3)......  Amend............  Determination of        H&S...............  H&S
                                                    dosages of unsealed
                                                    byproduct material
                                                    for medical use
                                                    (recognize State
                                                    licenses and State
                                                    requirements).
35.63(b)(2)(iii)..............  Add..............  Determination of        ..................  H&S
                                                    dosages of unsealed
                                                    byproduct material
                                                    for medical use
                                                    (recognize State
                                                    licenses of PET
                                                    facilities).
35.100(a) & (b)...............  Amend............  Use of unsealed         H&S...............  H&S
                                                    byproduct material
                                                    for uptake, dilution,
                                                    and excretion studies
                                                    for which a written
                                                    directive is not
                                                    required (allow use
                                                    of PET radionuclides).
35.200(a) & (b)...............  Amend............  Use of unsealed         H&S...............  H&S
                                                    byproduct material
                                                    for imaging and
                                                    localization studies
                                                    for which a written
                                                    directive is not
                                                    required (allow use
                                                    of PET radionuclides).
35.204(a).....................  Amend............  Permissible molybdenum- H&S...............  H&S
                                                    99 concentrations
                                                    (add strontium-82 &
                                                    strontium-85).
35.204(c).....................  Add..............  Permissible molybdenum- ..................  D
                                                    99 concentrations
                                                    (add strontium-82 &
                                                    strontium-85.

[[Page 55919]]

 
35.204(d).....................  Redesignated.....  Permissible molybdenum- D.................  D
                                                    99 concentrations.
35.300(a) and (b).............  Amend............  Use of unsealed         H&S...............  H&S
                                                    byproduct material
                                                    for which a written
                                                    directive is required
                                                    (allow use of PET
                                                    radionuclides).
35.2204.......................  Amend............  Records of molybdenum-  D.................  D
                                                    99 concentrations
                                                    (add strontium-82 &
                                                    strontium-85).
50.2..........................  Amend............  Definition: Byproduct   NRC...............  NRC
                                                    material (add 11e.(3)
                                                    & 11e.(4) material).
61.2..........................  Amend............  Definition: Waste       B.................  B
                                                    (clarify 11e.(3) &
                                                    11e.(4) material).
62.2..........................  Amend............  Definition: Low-level   NRC...............  NRC
                                                    radioactive waste
                                                    (clarify 11e.(3) &
                                                    11e.(4) material).
72.3..........................  Amend............  Definition: Byproduct   NRC...............  NRC
                                                    material (add 11e.(3)
                                                    & 11e.(4) material).
110.2.........................  Add..............  Definition:             ..................  NRC
                                                    Accelerator-produced
                                                    radioactive material.
110.2.........................  Add..............  Definition: Discrete    ..................  NRC
                                                    source.
110.2.........................  Add..............  Definition: Particle    ..................  NRC
                                                    accelerator.
150.3.........................  Amend............  Definition: Byproduct   A.................  H&S
                                                    material (add 11e.(3)
                                                    & 11e.(4) material).
150.3.........................  Add..............  Definition: Discrete    ..................  H&S
                                                    source.
----------------------------------------------------------------------------------------------------------------
10 CFR Parts 170 and 171 address areas that generally are applicable only to the NRC's regulatory program;
  therefore, no compatibility designation is assigned.

VII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113) requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
the use of such a standard is inconsistent with applicable law or 
otherwise impractical. In this final rule, the NRC is assuming 
regulation of certain discrete sources of naturally occurring 
radioactive material and accelerator-produced radioactive material in 
addition to those byproduct materials already under the NRC's 
jurisdiction. This action does not constitute the establishment of a 
standard that establishes generally applicable requirements.
    The EPAct requires that the NRC use model State standards to the 
maximum extent practicable in developing and issuing regulations for 
the newly expanded definition of Byproduct material. In developing this 
final rule, the NRC has consulted with Agreement and non-Agreement 
States about their regulations. To the maximum extent practicable, the 
NRC has incorporated the CRCPD's SSRs into this final rule.

VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR part 51, that this rule is not a major Federal 
action significantly affecting the quality of the human environment and 
therefore an environmental impact statement is not required. The 
Commission has prepared an environmental assessment for this final 
rule.
    Amendments to the NRC's regulations incorporate new materials into 
the NRC's byproduct material regulatory program and establish new 
program elements where needed. Before the EPAct, the regulation of 
NARM, other than source material, was left primarily to the individual 
States. Although efforts were made by several States to provide a 
uniform regulatory environment, particularly for accelerator-produced 
radioactive material, there is currently no nationwide consistency to 
the regulation of NARM. The amendments to the NRC's regulations will 
provide a uniform regulatory environment for the acquisition, 
possession, use, transfer, and disposal of NARM. This uniform 
regulatory environment has been developed in cooperation with the 
States, using model State standards in existence to the maximum extent 
practicable. Because the approach for developing the generic NRC 
requirements started with the existing generic requirements for 
accelerator-produced radioactive material that had already been 
developed by the States for the SSRs, little change is expected to the 
byproduct material regulatory programs already in place for the 
Agreement States. Consequently, for Agreement States, the primary 
foreseeable impact of the regulatory changes applicable to accelerator-
produced radioactive material is that the regulations will be uniformly 
applied by all Agreement States. Therefore, for the regulation of 
accelerator-produced radioactive material by the Agreement States, 
these amendments to the NRC's regulations are not expected to have any 
adverse environmental impacts.
    In non-Agreement States, these amendments to the NRC's regulations 
generally impose more restrictive requirements on the acquisition, 
possession, use, transfer, and disposal of accelerator-produced 
radioactive materials. In situations where the new NRC requirements are 
more restrictive than those already imposed by individual States' 
existing regulations, the result will likely be a positive impact on 
the environment. In situations where the NRC's requirements are less 
restrictive than the individual State's regulations, it is likely that 
the licensee will, in large part, continue with its current practices, 
and no substantial impact on the environment is anticipated. Therefore, 
it is expected that the overall environmental impacts of the regulation 
of accelerator-produced radioactive material in non-Agreement States 
will be positive.
    The effects of the amendments to the NRC's regulations applicable 
to discrete sources of radium-226 and discrete sources of other 
naturally occurring radioactive material will be greater for the non-
Agreement States than for the Agreement States because certain non-
Agreement States do not have a regulatory program addressing this 
material. The imposition of regulations

[[Page 55920]]

on the acquisition, possession, use, transfer, and disposal of these 
discrete sources of naturally occurring radioactive material will 
provide greater assurance that these activities are performed in a 
manner that is expected to be less harmful to the environment than 
would be assured without these regulations. Therefore, the effect of 
the NRC's regulations applicable to discrete sources of naturally 
occurring radioactive material is anticipated to be beneficial to the 
environment, and it is expected that the overall environmental impacts 
will be positive.
    Therefore, the determination of the environmental assessment is 
that there will be no significant impact to the human environment from 
this action.
    The NRC sent a copy of the environmental assessment and the 
proposed rule to every State Liaison Officer and requested their 
comments on the environmental assessment. No significant comments were 
received that changed this conclusion.

IX. Paperwork Reduction Act Statement

    This final rule amends information collection requirements 
contained in 10 CFR Parts 19, 20, 30, 31, 32, and 35 that are subject 
to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These 
requirements were approved by the Office of Management and Budget, 
approval numbers 3150-0044, -0014, -0017, -0016, -0001, -0010, and -
0120. The changes to 10 CFR Parts 33, 50, 61, 62, 72, 110, 150, 170, 
and 171 do not contain new or amended information collection 
requirements.
    The burden to the public for these information collections is 
estimated to average 24 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of these 
information collections, including suggestions for reducing the burden, 
to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, or by Internet 
electronic mail to [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202 (3150-0044, -
0014, -0017, -0016, -0001, -0010, and -0120, Office of Management and 
Budget, Washington, DC 20503.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

X. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
regulation. The regulatory analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The regulatory analysis is available for inspection in the NRC 
Public Document Room, 11555 Rockville Pike, Rockville, MD, and may be 
downloaded from the rule forum Web site at http://ruleforum.llnl.gov. 
Single copies of the regulatory analysis are available from 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 [email protected].

XI. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule will not have a 
significant economic impact on a substantial number of small entities. 
The majority of companies that own these businesses do not fall within 
the scope of the definition of ``small entities'' set forth in the 
Regulatory Flexibility Act or the Small Business Size Standards set out 
in regulations issued by the Small Business Administration at 13 CFR 
part 121.
    Section 651(e) of the EPAct expanded the definition of Byproduct 
material in Section 11e. of the AEA 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 that 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 is extracted or converted after extraction for use in a 
commercial, medical, or research activity. This rulemaking amends the 
NRC's regulations to include this newly defined byproduct material. 
This amendment will potentially affect large numbers of individuals, 
businesses, or licensees engaged in activities involving discrete 
radium-226 sources or accelerator-produced radioactive material used 
for commercial, medical, or research activities. Many individuals, 
businesses, or licensees qualify as small business entities as defined 
by 10 CFR 2.810. However, the rule is not expected to have a 
significant economic impact on these individuals, businesses, or 
licensees because the NRC is using the existing regulatory framework to 
regulate these materials and is allowing sufficient time for 
individuals, businesses, and licensees to implement the requirements 
for this radioactive material. Based on the regulatory analysis, the 
NRC believes that the selected alternative reflected in the amendment 
is protective of public health and safety and is not overly burdensome 
to accomplish the NRC's regulatory objective. The NRC also notes that 
several Agreement States have imposed similar requirements on their 
licensees either by rule, order, or license condition.

XII. Backfit Analysis

    The NRC has determined that the backfit rule (10 CFR 50.109, 70.76, 
72.62, or 76.76) does not apply to this rule because this amendment 
does not involve any provisions that would impose backfits as defined 
in 10 CFR Chapter 1. Therefore, a backfit analysis is not required.

XIII. Congressional Review Act

    In accordance with the Congressional Review Act of 1996, the NRC 
has determined that this action is not a major rule and has verified 
this determination with the Office of Information and Regulatory 
Affairs of OMB.

List of Subjects

10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, Radiation protection, Reporting and 
recordkeeping requirements, Source material, Special nuclear material, 
Waste treatment and disposal.

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

[[Page 55921]]

10 CFR Part 33

    Byproduct material, Criminal penalties, Nuclear materials, 
Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Medical devices, Nuclear materials, Occupational 
safety and health, Radiation protection, Reporting and recordkeeping 
requirements.

10 CFR Part 50

    Antitrust, Classified information, Criminal penalties, Fire 
protection, Intergovernmental relations, Nuclear power plants and 
reactors, Radiation protection, Reactor siting criteria, Reporting and 
recordkeeping requirements.

10 CFR Part 61

    Criminal penalties, Low-level waste, Nuclear materials, Reporting 
and recordkeeping requirements, Waste treatment and disposal.

10 CFR Part 62

    Administrative practice and procedure, Denial of access, Emergency 
access to low-level waste disposal, Low-level radioactive waste, Low-
level radioactive waste treatment and disposal, Low-level waste policy 
amendments act of 1985, Nuclear materials, Reporting and recordkeeping 
requirements.

10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Manpower 
training programs, Nuclear materials, Occupational safety and health, 
Penalties, Radiation protection, Reporting and recordkeeping 
requirements, Security measures, Spent fuel, Whistleblowing.

10 CFR Part 110

    Administrative practice and procedure, Classified information, 
Criminal penalties, Export, Import, Intergovernmental relations, 
Nuclear materials, Nuclear power plants and reactors, Reporting and 
recordkeeping requirements, Scientific equipment.

10 CFR Part 150

    Criminal penalties, Hazardous materials transportation, 
Intergovernmental relations, Nuclear materials, Reporting and 
recordkeeping requirements, Security measures, Source material, Special 
nuclear material.

10 CFR Part 170

    Byproduct material, Import and export licenses, Intergovernmental 
relations, Nonpayment penalties, Nuclear materials, Nuclear power 
plants and reactors, Source material, Special nuclear material.

10 CFR Part 171

    Annual charges, Byproduct material, Holders of certificates, 
registrations, approvals, Intergovernmental relations, Nonpayment 
penalties, Nuclear materials, Nuclear power plants and reactors, Source 
material, Special nuclear material.

0
For the reasons set out in the preamble and under the authority of the 
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the 
following amendments to 10 CFR parts 20, 30, 31, 32, 33, 35, 50, 61, 
62, 72, 110, 150, 170, and 171.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

0
1. The authority citation for part 20 is revised to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); 
sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. 
L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).


0
2. In Sec.  20.1003, the definition of Byproduct material is revised, 
and definitions of Accelerator-produced radioactive material, Discrete 
source, Particle accelerator, and Waste are added alphabetically to 
read as follows:


Sec.  20.1003  Definitions.

* * * * *
    Accelerator-produced radioactive material means any material made 
radioactive by a particle accelerator.
* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2) The tailings or wastes produced by the extraction or 
concentration of uranium or thorium from ore processed primarily for 
its source material content, including discrete surface wastes 
resulting from uranium solution extraction processes. Underground ore 
bodies depleted by these solution extraction operations do not 
constitute ``byproduct material'' within this definition;
    (3)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (4) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *
    Discrete source means 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.
* * * * *
    Particle accelerator means any machine capable of accelerating 
electrons, protons, deuterons, or other charged particles in a vacuum 
and of discharging the resultant particulate or other radiation into a 
medium at energies usually in excess of 1 megaelectron volt. For 
purposes of this definition, ``accelerator'' is an equivalent term.
* * * * *
    Waste means those low-level radioactive wastes containing source, 
special nuclear, or byproduct material that are acceptable for disposal 
in a land disposal facility. For the purposes of this definition, low-
level radioactive waste means radioactive waste not classified as high-
level radioactive waste, transuranic waste, spent nuclear fuel, or 
byproduct material as defined in paragraphs (2), (3), and (4) of the

[[Page 55922]]

definition of Byproduct material set forth in this section.
* * * * *

0
3. In Sec.  20.1009, paragraph (b) is revised to read as follows:


Sec.  20.1009  Information collection requirements: OMB approval.

    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec. 20.1003, 20.1101, 20.1202, 20.1203, 
20.1204, 20.1206, 20.1208, 20.1301, 20.1302, 20.1403, 20.1404, 20.1406, 
20.1501, 20.1601, 20.1703, 20.1901, 20.1904, 20.1905, 20.1906, 20.2002, 
20.2004, 20.2005, 20.2006, 20.2008, 20.2102, 20.2103, 20.2104, 20.2105, 
20.2106, 20.2107, 20.2108, 20.2110, 20.2201, 20.2202, 20.2203, 20.2204, 
20.2205, 20.2206, 20.2207, 20.2301, and appendix G to this part.
* * * * *

0
4. In Sec.  20.2001, paragraph (a)(4) is revised to read as follows:


Sec.  20.2001  General requirements.

    (a) * * *
    (4) As authorized under Sec. Sec. 20.2002, 20.2003, 20.2004, 
20.2005, or 20.2008.
* * * * *

0
5. In Sec.  20.2006, paragraph (e) is added to read as follows:


Sec.  20.2006  Transfer for disposal and manifests.

* * * * *
    (e) Any licensee shipping byproduct material as defined in 
paragraphs (3) and (4) of the definition of Byproduct material set 
forth in Sec.  20.1003 intended for ultimate disposal at a land 
disposal facility licensed under part 61 of this chapter must document 
the information required on the NRC's Uniform Low-Level Radioactive 
Waste Manifest and transfer this recorded manifest information to the 
intended consignee in accordance with appendix G to this part.

0
6. Section 20.2008 is added to Subpart K--Waste Disposal--to read as 
follows:


Sec.  20.2008  Disposal of certain byproduct material.

    (a) Licensed material as defined in paragraphs (3) and (4) of the 
definition of Byproduct material set forth in Sec. 20.1003 may be 
disposed of in accordance with part 61 of this chapter, even though it 
is not defined as low-level radioactive waste. Therefore, any licensed 
byproduct material being disposed of at a facility, or transferred for 
ultimate disposal at a facility licensed under part 61 of this chapter, 
must meet the requirements of Sec. 20.2006.
    (b) A licensee may dispose of byproduct material, as defined in 
paragraphs (3) and (4) of the definition of Byproduct material set 
forth in Sec.  20.1003, at a disposal facility authorized to dispose of 
such material in accordance with any Federal or State solid or 
hazardous waste law, including the Solid Waste Disposal Act, as 
authorized under the Energy Policy Act of 2005.

0
7. In Appendix B to part 20, the List of Elements table is amended by 
adding Nitrogen and Oxygen in alphabetical order, and page 1 of Tables 
1, 2, and 3 following the List of Elements is revised to read as 
follows:

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

* * * * *

                            List of Elements
------------------------------------------------------------------------
                                                  Atomic
              Name              ----------------------------------------
                                          Symbol                No.
------------------------------------------------------------------------
 
                              * * * * * * *
Nitrogen.......................  N......................               7
 
                              * * * * * * *
Oxygen.........................  O......................               8
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
BILLING CODE 7590-01-P

[[Page 55923]]

[GRAPHIC] [TIFF OMITTED] TR01OC07.055

BILLING CODE 7590-01-C

[[Page 55924]]

* * * * *

Footnotes

    \1\ ``Submersion'' means that values given are for submersion in 
a hemispherical semi-infinite cloud of airborne material.
    \2\ These radionuclides have radiological half-lives of less 
than 2 hours. The total effective dose equivalent received during 
operations with these radionuclides might include a significant 
contribution from external exposure. The DAC values for all 
radionuclides, other than those designated Class ``Submersion,'' are 
based upon the committed effective dose equivalent due to the intake 
of the radionuclide into the body and do not include potentially 
significant contributions to dose equivalent from external 
exposures. The licensee may substitute 1E-7 [mu]Ci/ml for the listed 
DAC to account for the submersion dose prospectively, but should use 
individual monitoring devices or other radiation measuring 
instruments that measure external exposure to demonstrate compliance 
with the limits. (See Sec.  20.1203.)
* * * * *

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

0
8. The authority citation for part 30 is revised to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 
2021, 2021b, 2111).
    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).


0
9. Section 30.3 is revised to read as follows:


Sec.  30.3  Activities requiring license.

    (a) Except as provided in paragraphs (b)(2), (b)(3), (c)(2), and 
(c)(3) of this section and for persons exempt as provided in this part 
and part 150 of this chapter, no person shall manufacture, produce, 
transfer, receive, acquire, own, possess, or use byproduct material 
except as authorized in a specific or general license issued in 
accordance with the regulations in this chapter.
    (b)(1) The requirements, including provisions that are specific to 
licensees, in this part and parts 19, 20, 21, and 71 of this chapter, 
as well as the additional requirements for specific broad scope, 
industrial radiography, irradiator, or well logging uses in 10 CFR 
parts 33, 34, 36, or 39, respectively, shall apply to Government 
agencies or Federally recognized Indian Tribes on November 30, 2007, 
when conducting activities under the authority provided by paragraphs 
(b)(2) and (b)(3) of this section.
    (2) A specifically licensed Government agency or Federally 
recognized Indian Tribe that possesses and uses accelerator-produced 
radioactive material or discrete sources of radium-226 for which a 
license amendment is required to authorize the activities in paragraph 
(a) of this section, may continue to use these materials for uses 
permitted under this part until the date of the NRC's final licensing 
determination, provided that the licensee submits an amendment 
application on or before June 2, 2008.
    (3) A Government agency or Federally recognized Indian Tribe that 
possesses and uses accelerator-produced radioactive material or 
discrete sources of radium-226 for which a specific license is required 
in paragraph (a) of this section, may continue to use such material for 
uses permitted under this part until the date of the NRC's final 
licensing determination provided that the agency or Indian Tribe 
submits an application for a license authorizing activities involving 
these materials on or before December 1, 2008.
    (c)(1) The requirements, including provisions that are specific to 
licensees in this part and parts 19, 20, 21, and 71 of this chapter, as 
well as the additional requirements for specific broad scope, 
industrial radiography, irradiator, or well logging uses in 10 CFR 
parts 33, 34, 36, or 39, respectively, shall apply to all persons, 
other than those included in paragraph (b)(1) of this section, on 
August 8, 2009, or earlier as noticed by the NRC, when conducting 
activities under the authority provided by paragraphs (c)(2) and (c)(3) 
of this section.
    (2) Except as provided in paragraph (b)(2) of this section, all 
other licensees, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a license 
amendment is required to authorize the activities in paragraph (a) of 
this section, may continue to use these materials for uses permitted 
under this part until the date of the NRC's final licensing 
determination, provided that the person submits an amendment 
application within 6 months from the waiver expiration date of August 
7, 2009 or within 6 months from the date of an earlier termination of 
the waiver as noticed by the NRC, whichever date is earlier.
    (3) Except as provided in paragraph (b)(3) of this section, all 
other persons, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a specific license 
is required in paragraph (a) of this section, may continue to use such 
material for uses permitted under this part until the date of the NRC's 
final licensing determination, provided that the person submits a 
license application within 12 months from the waiver expiration date of 
August 7, 2009 or within 12 months from the date of an earlier 
termination of the waiver as noticed by the NRC, whichever date is 
earlier.
    (d) If a person or licensee is required to file an application for 
a license or amendment in accordance with paragraphs (b)(2), (b)(3), 
(c)(2), and (c)(3) of this section, but does not file for the license 
or amendment within the required time, the authority provided by 
paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) of this section to 
receive or use the accelerator-produced radioactive material or 
discrete sources of radium-226 shall expire with respect to the 
person's or licensee's authority to receive and use such byproduct 
material. This authority shall not expire with respect to the 
responsibility of the person or licensee regarding the possession of 
such byproduct material, the decommissioning (including financial 
assurance) of facilities, or the disposal of such byproduct material.
0
10. In Sec.  30.4, the definition of Byproduct material is revised, and 
the definitions of Accelerator-produced radioactive material, 
Consortium, Cyclotron, Discrete source, and Particle accelerator are 
added alphabetically to read as follows:


Sec.  30.4  Definitions.

* * * * *
    Accelerator-produced radioactive material means any material made 
radioactive by a particle accelerator.
* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--

[[Page 55925]]

    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *
    Consortium 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 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.
* * * * *
    Cyclotron means a particle accelerator in which the charged 
particles travel in an outward spiral or circular path. A cyclotron 
accelerates charged particles at energies usually in excess of 10 
megaelectron volts and is commonly used for production of short half-
life radionuclides for medical use.
* * * * *
    Discrete source means 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.
* * * * *
    Particle accelerator means any machine capable of accelerating 
electrons, protons, deuterons, or other charged particles in a vacuum 
and of discharging the resultant particulate or other radiation into a 
medium at energies usually in excess of 1 megaelectron volt. For 
purposes of this definition, accelerator is an equivalent term.
* * * * *

0
11. In Sec.  30.15, paragraph (a)(1)(viii) is added to read as follows:


Sec.  30.15  Certain items containing byproduct material.

    (a) * * *
    (1) * * *
    (viii) 0.037 megabecquerel (1 microcurie) of radium-226 per 
timepiece in intact timepieces manufactured prior to November 30, 2007.
* * * * *

0
12. In Sec.  30.18, paragraph (b) is revised to read as follows:


Sec.  30.18  Exempt quantities.

* * * * *
    (b) Any person, who possesses byproduct material received or 
acquired before September 25, 1971, under the general license then 
provided in Sec.  31.4 of this chapter or similar general license of a 
State, is exempt from the requirements for a license set forth in 
section 81 of the Act and from the regulations in parts 30 through 34, 
36 and 39 of this chapter to the extent that this person possesses, 
uses, transfers, or owns byproduct material.
* * * * *

0
13. In Sec.  30.20, paragraph (a) is revised to read as follows:


Sec.  30.20  Gas and aerosol detectors containing byproduct material.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution gas and aerosol detectors 
containing byproduct material, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from 
the regulations in parts 19, 20, and 30 through 36, and 39 of this 
chapter to the extent that the person receives, possesses, uses, 
transfers, owns, or acquires byproduct material in gas and aerosol 
detectors designed to protect life or property from fires and airborne 
hazards, and manufactured, processed, produced, or initially 
transferred in accordance with a specific license issued under Sec.  
32.26 of this chapter, which license authorizes the initial transfer of 
the product for use under this section. This exemption also covers gas 
and aerosol detectors manufactured or distributed before November 30, 
2007 in accordance with a specific license issued by a State under 
comparable provisions to Sec.  32.26 of this chapter authorizing 
distribution to persons exempt from regulatory requirements.
* * * * *

0
14. In Sec.  30.32, paragraphs (g)(1) and (g)(2) are revised and 
paragraphs (g)(3) and (j) are added to read as follows:


Sec.  30.32   Application for specific licenses.

* * * * *
    (g) * * *
    (1) Identify the source or device by manufacturer and model number 
as registered with the Commission under Sec.  32.210 of this chapter, 
with an Agreement State, or for a source or a device containing radium-
226 or accelerator-produced radioactive material with a State under 
provisions comparable to Sec.  32.210 of this chapter; or
    (2) Contain the information identified in Sec.  32.210(c) of this 
chapter; or
    (3) For sources or devices containing naturally occurring or 
accelerator-produced radioactive material manufactured prior to 
November 30, 2007 that are not registered with the Commission under 
Sec.  32.210 of this chapter or with an Agreement State, and for which 
the applicant is unable to provide all categories of information 
specified in Sec.  32.210(c) of this chapter, the applicant must 
provide:
    (i) All available information identified in Sec.  32.210(c) of this 
chapter concerning the source, and, if applicable, the device; and
    (ii) Sufficient additional information to 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. Such information must include a description of the source 
or device, a description of radiation safety features, the intended use 
and associated operating experience, and the results of a recent leak 
test.
* * * * *
    (j) An application from a medical facility, educational 
institution, or Federal facility to produce Positron Emission 
Tomography (PET) radioactive drugs for noncommercial transfer to 
licensees in its consortium authorized for medical use under part 35 of 
this chapter or equivalent Agreement State requirements shall include:
    (1) A request for authorization for the production of PET 
radionuclides or evidence of an existing license issued under part 30 
of this chapter or Agreement State requirements for a PET radionuclide 
production facility within its consortium from which it receives PET 
radionuclides.
    (2) Evidence that the applicant is qualified to produce radioactive 
drugs for medical use by meeting one of the criteria in Sec.  
32.72(a)(2) of this chapter.

[[Page 55926]]

    (3) Identification of individual(s) authorized to prepare the PET 
radioactive drugs if the applicant is a pharmacy, and documentation 
that each individual meets the requirements of an authorized nuclear 
pharmacist as specified in Sec.  32.72(b)(2) of this chapter.
    (4) Information identified in Sec.  32.72(a)(3) of this chapter on 
the PET drugs to be noncommercially transferred to members of its 
consortium.

0
15. In Sec.  30.34, paragraph (g) is revised and paragraph (j) is added 
to read as follows:


Sec.  30.34  Terms and conditions of licenses.

* * * * *
    (g) Each licensee preparing technetium-99m radiopharmaceuticals 
from molybdenum-99/technetium-99m generators or rubidium-82 from 
strontium-82/rubidium-82 generators shall test the generator eluates 
for molybdenum-99 breakthrough or strontium-82 and strontium-85 
contamination, respectively, in accordance with Sec.  35.204 of this 
chapter. The licensee shall record the results of each test and retain 
each record for 3 years after the record is made.
* * * * *
    (j)(1) Authorization under Sec.  30.32(j) to produce Positron 
Emission Tomography (PET) radioactive drugs for noncommercial transfer 
to medical use licensees in its consortium does not relieve the 
licensee from complying with applicable FDA, other Federal, and State 
requirements governing radioactive drugs.
    (2) Each licensee authorized under Sec.  30.32(j) to produce PET 
radioactive drugs for noncommercial transfer to medical use licensees 
in its consortium shall:
    (i) Satisfy the labeling requirements in Sec.  32.72(a)(4) of this 
chapter for each PET radioactive drug transport radiation shield and 
each syringe, vial, or other container used to hold a PET radioactive 
drug intended for noncommercial distribution to members of its 
consortium.
    (ii) Possess and use instrumentation to measure the radioactivity 
of the PET radioactive drugs intended for noncommercial distribution to 
members of its consortium and meet the procedural, radioactivity 
measurement, instrument test, instrument check, and instrument 
adjustment requirements in Sec.  32.72(c) of this chapter.
    (3) A licensee that is a pharmacy authorized under Sec.  30.32(j) 
to produce PET radioactive drugs for noncommercial transfer to medical 
use licensees in its consortium shall require that any individual that 
prepares PET radioactive drugs shall be:
    (i) an authorized nuclear pharmacist that meets the requirements in 
Sec.  32.72(b)(2) of this chapter, or
    (ii) an individual under the supervision of an authorized nuclear 
pharmacist as specified in Sec.  35.27 of this chapter.
    (4) A pharmacy, authorized under Sec.  30.32(j) to produce PET 
radioactive drugs for noncommercial transfer to medical use licensees 
in its consortium that allows an individual to work as an authorized 
nuclear pharmacist, shall meet the requirements of Sec.  32.72(b)(5) of 
this chapter.

0
16. Section 30.71 is amended by adding Cesium 129 (Cs 129), Cobalt 57 
(Co 57), Gallium 67 (Ga 67), Germanium 68 (Ge 68), Gold 195 (Au 195), 
Indium 111 (In 111), Iodine 123 (I 123), Iron 52 (Fe 52), Potassium 43 
(K 43), Rubidium 81 (Rb 81), Sodium 22 (Na 22), Yttrium 87 (Y 87), and 
Yttrium 88 (Y 88) in alphabetical order by element as follows:


Sec.  30.71  Schedule B.

------------------------------------------------------------------------
                   Byproduct material                       Microcuries
------------------------------------------------------------------------
 
                                * * * * *
Cesium 129 (Cs 129).....................................             100
 
                                * * * * *
Cobalt 57 (Co 57).......................................             100
 
                                * * * * *
Gallium 67 (Ga 67)......................................             100
 
                                * * * * *
Germanium 68 (Ge 68)....................................              10
 
                                * * * * *
Gold 195 (Au 195).......................................              10
 
                                * * * * *
Indium 111 (In 111).....................................             100
 
                                * * * * *
Iodine 123 (I 123)......................................             100
 
                                * * * * *
Iron 52 (Fe 52).........................................              10
 
                                * * * * *
Potassium 43 (K 43).....................................              10
 
                                * * * * *
Rubidium 81 (Rb 81).....................................              10
 
                                * * * * *
Sodium 22 (Na 22).......................................              10
 
                                * * * * *
Yttrium 87 (Y 87).......................................              10
Yttrium 88 (Y 88).......................................              10
 
                                * * * * *
------------------------------------------------------------------------


0
17. Section 30.72 is amended by adding radium-226 in alphabetical order 
to read as follows:


Sec.  30.72  Schedule C--Quantities of radioactive materials requiring 
consideration of the need for an emergency plan for responding to a 
release.

------------------------------------------------------------------------
                                                  Release      Quantity
           Radioactive  material \1\              fraction     (curies)
------------------------------------------------------------------------
 
                                * * * * *
Radium-226....................................        0.001          100
 
                                * * * * *
------------------------------------------------------------------------
\1\For combinations of radioactive materials, consideration of the need
  for an emergency plan is required if the sum of the ratios of the
  quantity of each radioactive material authorized to the quantity
  listed for that material in Schedule C exceeds one.

* * * * *

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

0
18. The authority citation for part 31 is revised to read as follows:

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 
Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), P. Law 109-58, 119 
Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).

0
19. In Sec.  31.4, paragraph (b) is revised to read as follows:


Sec.  31.4  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Sec.  Sec.  31.5, 31.8, 31.11, and 31.12.
* * * * *

0
20. In Sec.  31.5, paragraphs (b)(1)(i), (b)(1)(ii), and (c)(13)(i) are 
revised and paragraph (b)(1)(iii) is added to read as follows:


Sec.  31.5  Certain detecting, measuring, gauging, or controlling 
devices and certain devices for producing light or an ionized 
atmosphere.\2\
---------------------------------------------------------------------------

    \2\ Persons possessing byproduct material in devices under a 
general license in Sec.  31.5 before January 15, 1975, may continue 
to possess, use, or transfer that material in accordance with the 
labeling requirements of Sec.  31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------

* * * * *
    (b)(1) * * *
    (i) A specific license issued under Sec.  32.51 of this chapter; or
    (ii) An equivalent specific license issued by an Agreement State; 
or

[[Page 55927]]

    (iii) An equivalent specific license issued by a State with 
provisions comparable to Sec.  32.51 of this chapter.
* * * * *
    (c) * * *
    (13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) 
and (iii) of this section, devices containing at least 370 
megabecquerels (10 millicuries) of cesium-137, 3.7 megabecquerels (0.1 
millicurie) of strontium-90, 37 megabecquerels (1 millicurie) of 
cobalt-60, 3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 
megabecquerels (1 millicurie) of americium-241 or any other transuranic 
(i.e., element with atomic number greater than uranium (92)), based on 
the activity indicated on the label. Each address for a location of 
use, as described under paragraph (c)(13)(iii)(D) of this section, 
represents a separate general licensee and requires a separate 
registration and fee.
* * * * *

0
21. Section 31.8 is revised to read as follows:


Sec.  31.8  Americium-241 and radium-226 in the form of calibration or 
reference sources.

    (a) A general license is issued to those persons listed in this 
section to own, receive, acquire, possess, use, and transfer, in 
accordance with the provisions of paragraphs (b) and (c) of this 
section, americium-241 or radium-226 in the form of calibration or 
reference sources:
    (1) Any person in a non-Agreement State who holds a specific 
license issued under this chapter which authorizes receipt, possession, 
use, and transfer of byproduct material, source material, or special 
nuclear material; and
    (2) Any Government agency, as defined in Sec.  30.4 of this 
chapter, which holds a specific license issued under this chapter which 
authorizes it to receive, possess, use, and transfer byproduct 
material, source material, or special nuclear material.
    (b) The general license in paragraph (a) of this section applies 
only to calibration or reference sources which have been manufactured 
or initially transferred in accordance with the specifications 
contained in a specific license issued under Sec.  32.57 of this 
chapter or in accordance with the specifications contained in a 
specific license issued to the manufacturer by an Agreement State which 
authorizes manufacture of the sources for distribution to persons 
generally licensed by the Agreement State, or in accordance with a 
specific license issued by a State with comparable provisions to Sec.  
32.57.
    (c) The general license in paragraph (a) of this section is subject 
to the provisions of Sec.  Sec.  30.14(d), 30.34 (a) to (e), and 30.50 
to 30.63 of this chapter, and to the provisions of parts 19, 20, and 
21, of this chapter. In addition, persons who own, receive, acquire, 
possess, use, and transfer one or more calibration or reference sources 
under this general license:
    (1) Shall not possess at any one time, at any one location of 
storage or use, more than 0.185 megabecquerel (5 microcuries) of 
americium-241 or 0.185 megabecquerel (5 microcuries) of radium-226 in 
such sources;
    (2) Shall not receive, possess, use, or transfer a source unless 
the source, or the storage container, bears a label which includes the 
following statement or a substantially similar statement which contains 
the information called for in the following statement: \1\
---------------------------------------------------------------------------

    \1\ Sources generally licensed under this section before January 
19, 1975, may bear labels authorized by the regulations in effect on 
January 1, 1975. Sources containing radium-226 generally licensed 
under this section and manufactured before November 30, 2007 shall 
be labeled in accordance with the applicable State regulations at 
the time of manufacture or import.
---------------------------------------------------------------------------

    The receipt, possession, use, and transfer of this source, Model 
XX, Serial No. XX, are subject to a general license and the regulations 
of the United States Nuclear Regulatory Commission or of a State with 
which the Commission has entered into an agreement for the exercise of 
regulatory authority. Do not remove this label.


CAUTION--RADIOACTIVE MATERIAL--THIS SOURCE CONTAINS AMERICIUM-241 [or 
RADIUM-226, as appropriate]. DO NOT TOUCH RADIOACTIVE PORTION OF THIS 
SOURCE.

-----------------------------------------------------------------------

(Name of manufacturer or initial transferor)

    (3) Shall not transfer, abandon, or dispose of a source except by 
transfer to a person authorized by a license issued under this chapter 
or by an Agreement State to receive the source.
    (4) Shall store a source, except when the source is being used, in 
a closed container adequately designed and constructed to contain 
americium-241 or radium-226 which might otherwise escape during 
storage.
    (5) Shall not use a source for any purpose other than the 
calibration of radiation detectors or the standardization of other 
sources.
    (d) This general license does not authorize the manufacture or 
import of calibration or reference sources containing americium-241 or 
radium-226.
    (e) This general license does not authorize the export of 
calibration or reference sources containing americium-241 or radium-
226.

0
22. In Sec.  31.11, paragraph (a)(8) is added, and paragraphs (c)(1) 
and (d)(1) are revised to read as follows:


Sec.  31.11  General license for use of byproduct material for certain 
in vitro clinical or laboratory testing.

    (a) * * *
    (8) Cobalt-57, in units not exceeding 0.37 megabecquerel (10 
microcuries) each for use in in vitro clinical or laboratory tests not 
involving internal or external administration of byproduct material, or 
the radiation therefrom, to human beings or animals.
* * * * *
    (c) * * *
    (1) The general licensee shall not possess at any one time, under 
the general license in paragraph (a) of this section, at any one 
location of storage or use, a total amount of iodine-125, iodine-131, 
selenium-75, cobalt-57 and/or iron-59 in excess of 7.4 megabecquerels 
(200 microcuries).
* * * * *
    (d) * * *
    (1) Except as prepackaged units which are labeled in accordance 
with the provisions of a specific license issued under the provisions 
of Sec.  32.71 of this chapter or in accordance with the provisions of 
a specific license issued by an Agreement State, or before November 30, 
2007, and the provisions of a specific license issued by a State with 
comparable provisions to Sec.  32.71 that authorize manufacture and 
distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 
(tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for 
distribution to persons generally licensed by the Agreement State or 
the State with comparable provisions to Sec.  32.71.
* * * * *


Sec.  Sec.  31.12, 31.13, and 31.14  [Redesignated]

0
23. Sections 31.12, 31.13, and 31.14 are redesignated as Sec.  31.21, 
Sec.  31.22, and Sec.  31.23, respectively, Sec.  Sec.  31.13 through 
31.20 are reserved, and a new Sec.  31.12 is added to read as follows:


Sec.  31.12  General license for certain items and self-luminous 
products containing radium-226.

    (a) A general license is hereby issued to any person to acquire, 
receive, possess, use, or transfer, in accordance with the provisions 
of paragraphs (b), (c), and (d) of this section, radium-226 contained 
in the following products

[[Page 55928]]

manufactured prior to November 30, 2007.
    (1) Antiquities originally intended for use by the general public. 
For the purposes of this paragraph, antiquities mean products 
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) Intact timepieces containing greater than 0.037 megabecquerel 
(1 microcurie), nonintact timepieces, and timepiece hands and dials no 
longer installed in timepieces.
    (3) Luminous items installed in air, marine, or land vehicles.
    (4) All other luminous products, provided that no more than 100 
items are used or stored at the same location at any one time.
    (5) Small radium sources containing no more than 0.037 
megabecquerel (1 microcurie) of radium-226. For the purposes of this 
paragraph, ``small radium sources'' means discrete survey instrument 
check sources, sources contained in radiation measuring instruments, 
sources used in educational demonstrations (such as cloud chambers and 
spinthariscopes), electron tubes, lightning rods, ionization sources, 
static eliminators, or as designated by the NRC.
    (b) Persons who acquire, receive, possess, use, or transfer 
byproduct material under the general license issued in paragraph (a) of 
this section are exempt from the provisions of 10 CFR parts 19, 20, and 
21, and Sec.  30.50 and 30.51 of this chapter, to the extent that the 
receipt, possession, use, or transfer of byproduct material is within 
the terms of the general license; provided, however, that this 
exemption shall not be deemed to apply to any such person specifically 
licensed under this chapter.
    (c) Any person who acquires, receives, possesses, uses, or 
transfers byproduct material in accordance with the general license in 
paragraph (a) of this section:
    (1) Shall notify the NRC should there be any indication of possible 
damage to the product so that it appears it could result in a loss of 
the radioactive material. A report containing a brief description of 
the event, and the remedial action taken, must be furnished to the 
Director of the Office of Federal and State Materials and Environmental 
Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001 within 30 days.
    (2) Shall not abandon products containing radium-226. The product, 
and any radioactive material from the product, may only be disposed of 
according to Sec.  20.2008 of this chapter or by transfer to a person 
authorized by a specific license to receive the radium-226 in the 
product or as otherwise approved by the NRC.
    (3) Shall not export products containing radium-226 except in 
accordance with part 110 of this chapter.
    (4) Shall dispose of products containing radium-226 at a disposal 
facility authorized to dispose of radioactive material in accordance 
with any Federal or State solid or hazardous waste law, including the 
Solid Waste Disposal Act, as authorized under the Energy Policy Act of 
2005, by transfer to a person authorized to receive radium-226 by a 
specific license issued under part 30 of this chapter, or equivalent 
regulations of an Agreement State, or as otherwise approved by the NRC.
    (5) Shall respond to written requests from the NRC to provide 
information relating to the general license within 30 calendar days of 
the date of the request, or other time specified in the request. If the 
general licensee cannot provide the requested information within the 
allotted time, it shall, within that same time period, request a longer 
period to supply the information by providing the Director of the 
Office of Federal and State Materials and Environmental Management 
Programs, by an appropriate method listed in Sec.  30.6(a) of this 
chapter, a written justification for the request.
    (d) The general license in paragraph (a) of this section does not 
authorize the manufacture, assembly, disassembly, repair, or import of 
products containing radium-226, except that timepieces may be 
disassembled and repaired.

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

0
24. The authority citation for part 32 is revised to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 
(42 U.S.C. 2014, 2021, 2021b, 2111).


0
25. In Sec.  32.1, paragraph (c) is added to read as follows:


Sec.  32.1  Purpose and scope.

* * * * *
    (c)(1) The requirements in this part, including provisions that are 
specific to licensees, shall apply to Government agencies and Federally 
recognized Indian Tribes with respect to accelerator-produced 
radioactive material or discrete sources of radium-226 on November 30, 
2007 except that the agency or tribe may continue to manufacture or 
initially transfer items containing accelerator-produced radioactive 
material or discrete sources of radium-226 for sale or distribution to 
persons exempted from the licensing requirements of part 30 of this 
chapter, and to persons generally licensed under part 31 of this 
chapter, and radioactive drugs and sources and devices to medical use 
licensees, until the date of the NRC's final licensing determination, 
provided that the agency or tribe submits a new license application for 
these activities on or before December 1, 2008 or an amendment 
application for these activities on or before June 2, 2008.
    (2) The requirements in this part, including provisions that are 
specific to licensees, shall apply to all persons other than those 
included in paragraph (c)(1) of this section with respect to 
accelerator-produced radioactive material or discrete sources of 
radium-226 on August 8, 2009, or earlier as noticed by the NRC, except 
that these persons may continue to manufacture or initially transfer 
items containing accelerator-produced radioactive material or discrete 
sources of radium-226 for sale or distribution to persons exempted from 
the licensing requirements of part 30 of this chapter, and to persons 
generally licensed under part 31 of this chapter, and to sell or 
manufacture radioactive drugs and sources and devices to medical use 
licensees until the date of the NRC's final licensing determination, 
provided that the person submits a license application within 12 months 
from the waiver expiration date of August 7, 2009 or within 12 months 
from the date of an earlier termination of the waiver as noticed by the 
NRC, whichever is earlier; or that the person submits an amendment 
request within 6 months from the waiver expiration date of August 7, 
2009 or within 6 months from the date of an earlier termination of the 
waiver as noticed by the NRC, whichever date is earlier.

0
26. In Sec.  32.57, the heading and the introductory text are revised 
to read as follows:

[[Page 55929]]

Sec.  32.57  Calibration or reference sources containing americium-241 
or radium-226: Requirements for license to manufacture or initially 
transfer.

    An application for a specific license to manufacture or initially 
transfer calibration or reference sources containing americium-241 or 
radium-226, for distribution to persons generally licensed under Sec.  
31.8 of this chapter, will be approved if:
* * * * *

0
27. Section 32.58 is revised to read as follows:


Sec.  32.58  Same: Labeling of devices.

    Each person licensed under Sec.  32.57 shall affix to each source, 
or storage container for the source, a label which shall contain 
sufficient information relative to safe use and storage of the source 
and shall include the following statement or a substantially similar 
statement which contains the information called for in the following 
statement: \1\
---------------------------------------------------------------------------

    \1\ Sources licensed under Sec.  32.57 before January 19, 1975, 
may bear labels authorized by the regulations in effect on January 
1, 1975.
---------------------------------------------------------------------------

    The receipt, possession, use, and transfer of this source, Model , 
Serial No., are subject to a general license and the regulations of the 
United States Nuclear Regulatory Commission or of a State with which 
the Commission has entered into an agreement for the exercise of 
regulatory authority. Do not remove this label.

CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or 
RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE

-----------------------------------------------------------------------

(Name of manufacturer or initial transferor)

0
28. Section 32.59 is revised to read as follows:


Sec.  32.59   Same: Leak testing of each source.

    Each person licensed under Sec.  32.57 shall perform a dry wipe 
test upon each source containing more than 3.7 kilobecquerels (0.1 
microcurie) of americium-241 or radium-226 before transferring the 
source to a general licensee under Sec.  31.8 of this chapter. This 
test shall be performed by wiping the entire radioactive surface of the 
source with a filter paper with the application of moderate finger 
pressure. The radioactivity on the paper shall be measured by using 
radiation detection instrumentation capable of detecting 0.185 
kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If 
this test discloses more than 0.185 kilobecquerel (0.005 microcurie) of 
radioactive material, the source shall be deemed to be leaking or 
losing americium-241 or radium-226 and shall not be transferred to a 
general licensee under Sec.  31.8 of this chapter or equivalent 
regulations of an Agreement State.

0
29. In Sec.  32.71, paragraph (b)(8) is added, and paragraph (c)(1) is 
revised to read as follows:


Sec.  32.71  Manufacture and distribution of byproduct material for 
certain in vitro clinical or laboratory testing under general license.

* * * * *
    (b) * * *
    (8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 
microcuries) each.
    (c) * * *
    (1) Identifying the radioactive contents as to chemical form and 
radionuclide, and indicating that the amount of radioactivity does not 
exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, 
selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of 
hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-
59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 
microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of 
americium-241 each; or cobalt-57 in units not exceeding 0.37 
megabecquerel (10 microcuries); and
* * * * *

0
30. In Sec.  32.72, paragraphs (a)(2)(i), (a)(2)(iii), (a)(2)(iv), 
(b)(2)(ii), (b)(4), and (b)(5) are revised, and a new paragraph 
(a)(2)(v) is added to read as follows:


Sec.  32.72  Manufacture, preparation, or transfer for commercial 
distribution of radioactive drugs containing byproduct material for 
medical use under part 35.

    (a) * * *
    (2) * * *
    (i) Registered with the U.S. Food and Drug Administration (FDA) as 
the owner or operator of a drug establishment that engages in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug under 21 CFR 207.20(a);
* * * * *
    (iii) Licensed as a pharmacy by a State Board of Pharmacy;
    (iv) Operating as a nuclear pharmacy within a Federal medical 
institution; or
    (v) A Positron Emission Tomography (PET) drug production facility 
registered with a State agency.
* * * * *
    (b) * * *
    (2) * * *
    (ii) This individual meets the requirements specified in Sec.  
35.55(b) and 35.59 of this chapter, and the licensee has received an 
approved license amendment identifying this individual as an authorized 
nuclear pharmacist; or
* * * * *
    (4) May designate a pharmacist (as defined in Sec.  35.2 of this 
chapter) as an authorized nuclear pharmacist if:
    (i) The individual was a nuclear pharmacist preparing only 
radioactive drugs containing accelerator-produced radioactive material, 
and
    (ii) The individual practiced at a pharmacy at a Government agency 
or Federally recognized Indian Tribe before November 30, 2007 or at all 
other pharmacies before August 8, 2009, or an earlier date as noticed 
by the NRC.
    (5) Shall provide to the Commission:
    (i) A copy of each individual's certification by a specialty board 
whose certification process has been recognized by the Commission or an 
Agreement State as specified in Sec.  35.55(a) of this chapter with the 
written attestation signed by a preceptor as required by Sec.  
35.55(b)(2) of this chapter; or
    (ii) The Commission or Agreement State license, or
    (iii) Commission master materials licensee permit, or
    (iv) The permit issued by a licensee or Commission master materials 
permittee of broad scope or the authorization from a commercial nuclear 
pharmacy authorized to list its own authorized nuclear pharmacist, or
    (v) Documentation that only accelerator-produced radioactive 
materials were used in the practice of nuclear pharmacy at a Government 
agency or Federally recognized Indian Tribe before November 30, 2007 or 
at all other locations of use before August 8, 2009, or an earlier date 
as noticed by the NRC; and
    (vi) A copy of the State pharmacy licensure or registration, no 
later than 30 days after the date that the licensee allows, under 
paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to 
work as an authorized nuclear pharmacist.
* * * * *

0
31. In Sec.  32.102, the heading and the introductory paragraph are 
revised to read as follows:


Sec.  32.102  Schedule C--prototype tests for calibration or reference 
sources containing americium-241 or radium-226.

    An applicant for a license under Sec.  32.57 shall, for any type of 
source which is designed to contain more than 0.185 kilobecquerel 
(0.005 microcurie) of americium-241 or radium-226, conduct prototype 
tests, in the order listed, on each of five prototypes of the source, 
which contains more than 0.185

[[Page 55930]]

kilobecquerel (0.005 microcurie) of americium-241 or radium-226, as 
follows:
* * * * *

PART 33--SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT 
MATERIAL

0
32. The authority citation for part 33 is revised to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 
(42 U.S.C. 2014, 2021, 2021b, 2111).


0
33. Section 33.100 is amended by adding Beryllium-7, Cobalt-57, Radium-
226, and Sodium-22 in alphabetical order to read as follows:


Sec.  33.100  Schedule A.

------------------------------------------------------------------------
           Byproduct material              Col. I curies  Col. II curies
------------------------------------------------------------------------
 
                              * * * * * * *
Beryllium-7.............................           10             0.1
 
                              * * * * * * *
Cobalt-57...............................           10             0.1
 
                              * * * * * * *
Radium-226..............................            0.01          0.0001
 
                              * * * * * * *
Sodium-22...............................            0.1           0.001
------------------------------------------------------------------------

* * * * *

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

0
34. The authority citation for part 35 is revised to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 
(42 U.S.C. 2014, 2021, 2021b, 2111).


0
35. In Sec.  35.2, new definitions for Cyclotron and Positron Emission 
Tomography (PET) radionuclide production facility are added 
alphabetically to read as follows:


Sec.  35.2  Definitions.

* * * * *
    Cyclotron means a particle accelerator in which the charged 
particles travel in an outward spiral or circular path. A cyclotron 
accelerates charged particles at energies usually in excess of 10 
megaelectron volts and is commonly used for production of short half-
life radionuclides for medical use.
* * * * *
    Positron Emission Tomography (PET) radionuclide production facility 
is defined as a facility operating a cyclotron or accelerator for the 
purpose of producing PET radionuclides.
* * * * *

0
36. In Sec.  35.10, paragraph (a) is added to read as follows:


Sec.  35.10  Implementation.

    (a) A Government agency or a Federally recognized Indian Tribe that 
possesses and uses accelerator-produced radioactive material or 
discrete sources of radium-226 for which a specific medical use license 
is required by the Atomic Energy Act of 1954, as amended, must comply 
with the requirements of this part, including provisions that are 
specific to licensees, on November 30, 2007. All other persons who 
possess and use accelerator-produced radioactive material or discrete 
sources of radium-226 for which a specific medical use license is 
required, must comply with the requirements of this part, including 
provisions that are specific to licensees, on August 8, 2009, or 
earlier as noticed by the NRC.
* * * * *

0
37. In Sec.  35.11, paragraph (a) is revised, and paragraph (c) is 
added to read as follows:


Sec.  35.11  License required.

    (a) A person may manufacture, produce, acquire, receive, possess, 
prepare, use, or transfer byproduct material for medical use only in 
accordance with a specific license issued by the Commission or an 
Agreement State, or as allowed in paragraph (b) or (c) of this section.
* * * * *
    (c)(1) A Government agency or a Federally recognized Indian Tribe, 
that possesses and uses accelerator-produced radioactive material or 
discrete sources of radium-226 for which a specific medical use license 
is required in paragraph (a) of this section, may continue to use such 
materials for medical uses until the date of the NRC's final licensing 
determination, provided that the person submits a medical use license 
application on or before December 1, 2008.
    (2) Except as provided in paragraph (c)(1) of this section, all 
other persons, who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 for which a specific medical 
use license is required in paragraph (a) of this section, may continue 
to use this type of material for medical uses permitted under this part 
until the date of the NRC's final licensing determination, provided 
that the person submits a medical use license application within 12 
months from the waiver expiration date of August 7, 2009 or within 12 
months from the date of an earlier termination of the waiver as noticed 
by the NRC, whichever date is earlier.

0
38. In Sec.  35.13, paragraphs (a) and (e) are revised, and paragraph 
(b)(5) is added to read as follows:


Sec.  35.13  License amendments.

* * * * *
    (a) Before it receives, prepares, or uses byproduct material for a 
type of use that is permitted under this part, but is not authorized on 
the licensee's current license issued under this part; except that--
    (1) A Government agency or a Federally recognized Indian Tribe 
licensee who possesses and uses accelerator-produced radioactive 
material or discrete sources of radium-226 may continue to use such 
material for medical uses permitted under this part until the date of 
the NRC's final licensing determination, provided that

[[Page 55931]]

the licensee submits an amendment application on or before June 2, 
2008.
    (2) Except as provided in paragraph (a)(1) of this section, all 
other licensees who possess and use accelerator-produced radioactive 
material or discrete sources of radium-226 may continue to use those 
materials for medical uses permitted under this part until the date of 
the NRC's final licensing determination, provided that the person 
submits a medical use license amendment request within 6 months from 
the waiver expiration date of August 7, 2009 or within 6 months from 
the date of an earlier termination of the waiver as noticed by the NRC, 
whichever date is earlier.
    (b) * * *
    (5) A physician, podiatrist, or dentist who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or 
both, for medical uses or a nuclear pharmacist who used only 
accelerator-produced radioactive materials in the practice of nuclear 
pharmacy at a Government agency or Federally recognized Indian Tribe 
before November 30, 2007 or at all other locations of use before August 
8, 2009, or an earlier date as noticed by the NRC, and for only those 
materials and uses performed before these dates.
* * * * *
    (e) Before it adds to or changes the areas of use identified in the 
application or on the license, including areas used in accordance with 
either Sec.  35.100 or Sec.  35.200 if the change includes addition or 
relocation of either an area where PET radionuclides are produced or a 
PET radioactive drug delivery line from the PET radionuclide/PET 
radioactive drug production area. Other areas of use where byproduct 
material is used only in accordance with either Sec.  35.100 or Sec.  
35.200 are exempt;
* * * * *
0
39. In Sec.  35.14, the introductory text of paragraph (a) and 
paragraph (b)(5) are revised to read as follows:


Sec.  35.14  Notifications.

    (a) A licensee shall provide the Commission a copy of the board 
certification and the written attestation(s), signed by a preceptor, 
the Commission or Agreement State license, the permit issued by a 
Commission master material licensee, the permit issued by a Commission 
or Agreement State licensee of broad scope, the permit issued by a 
Commission master material license broad scope permittee, or 
documentation that only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, were used for medical use or 
in the practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007 or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC, and for each individual no later than 30 days after the 
date that the licensee permits the individual to work as an authorized 
user, an authorized nuclear pharmacist, or an authorized medical 
physicist, under Sec.  35.13(b). For individuals permitted to work 
under Sec.  35.13(b)(4), within the same 30-day time frame, the 
licensee shall also provide, as appropriate, verification of completion 
of;
* * * * *
    (b) * * *
    (5) The licensee has added to or changed the areas of use 
identified in the application or on the license where byproduct 
material is used in accordance with either Sec.  35.100 or Sec.  35.200 
if the change does not include addition or relocation of either an area 
where PET radionuclides are produced or a PET radioactive drug delivery 
line from the PET radionuclide/PET radioactive drug production area.
* * * * *

0
40. In Sec.  35.15, paragraph (f) is revised to read as follows:


Sec.  35.15  Exemptions regarding Type A specific licenses of broad 
scope.

* * * * *
    (f) The provisions of Sec.  35.14(b)(5).
* * * * *

0
41. In Sec.  35.57, paragraphs (a)(3) and (b)(3) are added to read as 
follows:


Sec.  35.57  Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized medical physicist, 
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

    (a) * * *
    (3) A Radiation Safety Officer, a medical physicist, or a nuclear 
pharmacist, who used only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, for medical uses or in the 
practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007 or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC, need not comply with the training requirements of Sec.  
35.50, Sec.  35.51 or Sec.  35.55, respectively, when performing the 
same uses. A nuclear pharmacist, who prepared only radioactive drugs 
containing accelerator-produced radioactive materials, or a medical 
physicist, who used only accelerator-produced radioactive materials, at 
the locations and time period identified in this paragraph, qualifies 
as an authorized nuclear pharmacist or an authorized medical physicist, 
respectively, for those materials and uses performed before these 
dates, for purposes of this chapter.
    (b) * * *
    (3) Physicians, dentists, or podiatrists who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or 
both, for medical uses performed at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007 or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC, need not comply with the training requirements of subparts 
D through H of this part when performing the same medical uses. A 
physician, dentist, or podiatrist, who used only accelerator-produced 
radioactive materials, discrete sources of radium-226, or both, for 
medical uses at the locations and time period identified in this 
paragraph, qualifies as an authorized user for those materials and uses 
performed before these dates, for purposes of this chapter.

0
42. In Sec.  35.63, paragraphs (b)(2)(ii) and (c)(3) are revised, and 
paragraph (b)(2)(iii) is added to read as follows:


Sec.  35.63  Determination of dosages of unsealed byproduct material 
for medical use.

* * * * *
    (b) * * *
    (2) * * *
    (ii) An NRC or Agreement State licensee for use in research in 
accordance with a Radioactive Drug Research Committee-approved protocol 
or an Investigational New Drug (IND) protocol accepted by FDA; or
    (iii) A PET radioactive drug producer licensed under Sec.  30.32(j) 
of this chapter or equivalent Agreement State requirements.
    (c) * * *
    (3) Combination of volumetric measurements and mathematical 
calculations, based on the measurement made by:
    (i) A manufacturer or preparer licensed under Sec.  32.72 of this 
chapter or equivalent Agreement State requirements; or
    (ii) A PET radioactive drug producer licensed under Sec.  30.32(j) 
of this chapter or equivalent Agreement State requirements.
* * * * *

0
43. In Sec.  35.100, paragraph (a) and the introductory text of 
paragraph (b) are revised to read as follows:


Sec.  35.100  Use of unsealed byproduct material for uptake, dilution, 
and excretion studies for which a written directive is not required.

* * * * *

[[Page 55932]]

    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.  32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.  30.32(j) 
of this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:
* * * * *

0
44. In Sec.  35.200, paragraph (a) and the introductory text of 
paragraph (b) are revised to read as follows:


Sec.  35.200  Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.

* * * * *
    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.  32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.  30.32(j) 
of this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:
* * * * *

0
45. In Sec.  35.204, the heading and paragraph (a) are revised, 
paragraph (c) is redesignated as (d) and revised, and a new paragraph 
(c) is added to read as follows:


Sec.  35.204  Permissible molybdenum-99, strontium-82, and strontium-85 
concentrations.

    (a) A licensee may not administer to humans a radiopharmaceutical 
that contains:
    (1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel 
of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of 
technetium-99m); or
    (2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel 
of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per 
millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of 
strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 
microcurie of strontium-85 per millicurie of rubidium-82).
* * * * *
    (c) A licensee that uses a strontium-82/rubidium-82 generator for 
preparing a rubidium-82 radiopharmaceutical shall, before the first 
patient use of the day, measure the concentration of radionuclides 
strontium-82 and strontium-85 to demonstrate compliance with paragraph 
(a) of this section.
    (d) If a licensee is required to measure the molybdenum-99 
concentration or strontium-82 and strontium-85 concentrations, the 
licensee shall retain a record of each measurement in accordance with 
Sec.  35.2204.

0
46. In Sec.  35.300, paragraph (a) and the introductory text of 
paragraph (b) are revised to read as follows:


Sec.  35.300  Use of unsealed byproduct material for which a written 
directive is required.

* * * * *
    (a) Obtained from:
    (1) A manufacturer or preparer licensed under Sec.  32.72 of this 
chapter or equivalent Agreement State requirements; or
    (2) A PET radioactive drug producer licensed under Sec.  30.32(j) 
of this chapter or equivalent Agreement State requirements; or
    (b) Excluding production of PET radionuclides, prepared by:

0
47. Section 35.2204 is revised to read as follows:


Sec.  35.2204  Records of molybdenum-99, strontium-82, and strontium-85 
concentrations.

    A licensee shall maintain a record of the molybdenum-99 
concentration or strontium-82 and strontium-85 concentration tests 
required by Sec.  35.204(b) and (c) for 3 years. The record must 
include:
    (a) For each measured elution of technetium-99m, the ratio of the 
measures expressed as kilobecquerel of molybdenum-99 per megabecquerel 
of technetium-99m (or microcuries of molybdenum per millicurie of 
technetium), the time and date of the measurement, and the name of the 
individual who made the measurement; or
    (b) For each measured elution of rubidium-82, the ratio of the 
measures expressed as kilobecquerel of strontium-82 per megabecquerel 
of rubidium-82 (or microcuries of strontium-82 per millicurie of 
rubidium), kilobecquerel of strontium-85 per megabecquerel of rubidium-
82 (or microcuries of strontium-85 per millicurie of rubidium), the 
time and date of the measurement, and the name of the individual who 
made the measurement.

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION 
FACILITIES

0
48. The authority citation for part 50 is revised to read as follows:

    Authority: Secs. 102, 103, 104, 161, 182, 183, 186, 189, 68 
Stat. 936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 
83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 
2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); 
sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. 
L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111). 
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 (42 U.S.C. 5841). Section 50.10 also issued under secs. 101, 
185, 68 Stat. 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. 
L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), 
and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 
U.S.C. 2138).
    Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 
185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and 
Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 
(42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under sec. 
204, 88 Stat. 1245 (42 U.S.C. 5844). Sections 50.58, 50.91, and 
50.92 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 
2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 
U.S.C. 2152). Sections 50.80-50.81 also issued under sec. 184, 68 
Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

0
49. In Sec.  50.2, the definition of Byproduct material is revised to 
read as follows:


Sec.  50.2  Definitions.

* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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

[[Page 55933]]

    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *

PART 61--LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE 
WASTE

0
50. The authority citation for part 61 is revised to read as follows:

    Authority: Secs. 53, 57, 62, 63, 65, 81, 161, 182, 183, 68 Stat. 
930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2073, 2077, 
2092, st2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 
Stat. 1244, 1246 (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 
95-601, 92 Stat. 2951 (42 U.S.C. 2021a and 5851) and Pub. L. 102-
486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851); sec. 1704, 112 
Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 
Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).


0
51. In Sec.  61.2, the definition for Waste is revised to read as 
follows:


Sec.  61.2  Definitions.

* * * * *
    Waste means those low-level radioactive wastes containing source, 
special nuclear, or byproduct material that are acceptable for disposal 
in a land disposal facility. For the purposes of this definition, low-
level radioactive waste means radioactive waste not classified as high-
level radioactive waste, transuranic waste, spent nuclear fuel, or 
byproduct material as defined in paragraphs (2), (3), and (4) of the 
definition of Byproduct material set forth in Sec.  20.1003 of this 
chapter.

PART 62--CRITERIA AND PROCEDURES FOR EMERGENCY ACCESS TO NON-
FEDERAL AND REGIONAL LOW-LEVEL WASTE DISPOSAL FACILITIES

0
52. The authority citation for part 62 is revised to read as follows:

    Authority: Secs. 81, 161, as amended, 68 Stat. 935, 948, 950, 
951, as amended (42 U.S.C. 211, 2201; secs. 201, 209, as amended, 88 
Stat. 1242, 1248, as amended (42 U.S.C. 5841, 5849); secs. 3, 4, 5, 
6, 99 Stat. 1843, 1844, 1845, 1846, 1847, 1848, 1849, 1850, 1851, 
1852, 1853, 1854, 1855, 1856, 1857 (42 U.S.C. 2021c, 2021d, 2021e, 
2021f; sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), 
Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 
2111).


0
53. In Sec.  62.2, the definition for Low-level radioactive waste (LLW) 
is revised to read as follows:


Sec.  62.2   Definitions.

* * * * *
    Low-level radioactive waste (LLW) means radioactive material that--
    (1) Is not high-level radioactive waste, spent nuclear fuel, or 
byproduct material (as defined in paragraphs (2), (3), and (4) of the 
definition of Byproduct Material set forth in Sec.  20.1003 of this 
chapter); and
    (2) The NRC, consistent with existing law and in accordance with 
paragraph (1) of this definition, classifies as low-level radioactive 
waste.
* * * * *

PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF 
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE AND REACTOR-
RELATED GREATER THAN CLASS C WASTE

0
54. The authority citation for part 72 continues to read as follows:

    Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 
184, 186, 187, 189, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 
954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 
2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 
2234, 2236, 2237, 2238, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 
688, as amended (42 U.S.C. 2021); sec. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); 
Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-
486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 5851); sec. 102, Pub. L. 
91-190, 83 Stat. 853 (42 U.S.C. 4332); secs. 131, 132, 133, 135, 
137, 141, Pub. L. 97-425, 96 Stat. 2229, 2230, 2232, 2241, sec. 148, 
Pub. L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10151, 10152, 10153, 
10155, 10157, 10161, 10168); sec. 1704, 112 Stat. 2750 (44 U.S.C. 
3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 
U.S.C. 2014, 2021, 2021b, 2111).
    Section 72.44(g) also issued under secs. 142(b) and 148(c), (d), 
Pub. L. 100-203, 101 Stat. 1330-232, 1330-236 (42 U.S.C. 10162(b), 
10168(c), (d)). Section 72.46 also issued under sec. 189, 68 Stat. 
955 (42 U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 
U.S.C. 10154). Section 72.96(d) also issued under sec. 145(g), Pub. 
L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10165(g)). Subpart J also 
issued under secs. 2(2), 2(15), 2(19), 117(a), 141(h), Pub. L. 97-
425, 96 Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C. 10101, 
10137(a), 10161(h)). Subparts K and L are also issued under sec. 
133, 98 Stat. 2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 
(42 U.S.C. 10198).


0
55. In Sec.  72.3, the definition for Byproduct material is revised to 
read as follows:


Sec.  72.3  Definitions.

* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *

PART 110--EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL

0
56. The authority citation for part 110 is revised to read as follows:

    Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 81, 82, 103, 104, 
109, 111, 126, 127, 128, 129, 161, 181, 182, 183, 187, 189, 68 Stat. 
929, 930, 931, 932, 933, 936, 937, 948, 953, 954, 955, 956, as 
amended (42 U.S.C. 2071, 2073, 2074, 2077, 2092-2095, 2111, 2112, 
2133, 2134, 2139, 2139a, 2141, 2154-2158, 2201, 2231-2233, 2237, 
2239); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841; sec 5, 
Pub. L. 101-575, 104 Stat 2835 (42 U.S.C.2243); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005; Pub. L. 109-
58, 119 Stat. 594 (2005).
    Sections 110.1(b)(2) and 110.1(b)(3) also issued under Pub. L. 
96-92, 93 Stat. 710 (22 U.S.C. 2403). Section 110.11 also issued 
under sec. 122, 68 Stat. 939 (42 U.S.C. 2152) and secs. 54c and 
57d., 88 Stat. 473, 475 (42 U.S.C. 2074). Section 110.27 also issued 
under sec. 309(a), Pub. L. 99-440. Section 110.50(b)(3) also issued 
under sec. 123, 92 Stat. 142 (42 U.S.C. 2153). Section 110.51 also 
issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). 
Section 110.52 also issued under sec. 186, 68 Stat. 955 (42 U.S.C. 
2236). Sections 110.80-110.113 also issued under 5 U.S.C. 552, 554. 
Sections 110.130-110.135 also issued under 5 U.S.C. 553. Sections 
110.2 and 110.42 (a)(9) also

[[Page 55934]]

issued under sec. 903, Pub. L. 102-496 (42 U.S.C. 2151 et seq.).


0
57. In Sec.  110.2, definitions of Accelerator-produced radioactive 
material, Discrete source, and Particle accelerator are added 
alphabetically to read as follows:


Sec.  110.2  Definitions.

* * * * *
    Accelerator-produced radioactive material means any material made 
radioactive by a particle accelerator.
* * * * *
    Discrete source means 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.
* * * * *
    Particle accelerator means any machine capable of accelerating 
electrons, protons, deuterons, or other charged particles in a vacuum 
and of discharging the resultant particulate or other radiation into a 
medium at energies usually in excess of 1 megaelectron volt. For 
purposes of this definition, ``accelerator'' is an equivalent term.
* * * * *

PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN 
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274

0
58. The authority citation for part 150 is revised to read as follows:

    Authority: Sec. 161, 68 Stat. 948, as amended, sec. 274, 73 
Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 
2014, 2021, 2021b, 2111).
    Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued 
under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84, 
92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 2113, 2114). Section 
150.14 also issued under sec. 53, 68 Stat. 930, as amended (42 
U.S.C. 2073). Section 150.15 also issued under secs. 135, 141, Pub. 
L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 
150.17a also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). 
Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C. 
2282).


0
59. In Sec.  150.3, the definition of Byproduct material is revised, 
and a definition of Discrete source is added alphabetically to read as 
follows:


Sec.  150.3  Definitions.

* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2) The tailings or wastes produced by the extraction or 
concentration of uranium or thorium from ore processed primarily for 
its source material content, including discrete surface wastes 
resulting from uranium solution extraction processes. Underground ore 
bodies depleted by these solution extraction operations do not 
constitute ``byproduct material'' within this definition; (3)(i) Any 
discrete source of radium-226 that is produced, extracted, or converted 
after extraction, before, on, or after August 8, 2005, for use for a 
commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (4) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *
    Discrete source means 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.
* * * * *

PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT 
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT 
OF 1954, AS AMENDED

0
60. The authority citation for part 170 is revised to read as follows:

    Authority: Sec. 9701, Pub. L. 97-258, 96 Stat. 1051 (31 U.S.C. 
9701); sec. 301, Pub. L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w); 
sec. 201, Pub. L. 93-438, 88 Stat. 1242, as amended (42 U.S.C. 
5841); sec. 205a, Pub. L. 101-576, 104 Stat. 2842, as amended (31 
U.S. C. 901, 902); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
sec. 623, Pub. L. 109-58, 119 Stat. 783 (42 U.S.C. 2201(w)); sec. 
651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 
2021(b), 2111).


0
61. In Sec.  170.3, the definition of Byproduct material is revised to 
read as follows:


Sec.  170.3  Definitions.

* * * * *
    Byproduct material means--
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *

0
62. In Sec.  170.31, in the table, ``Schedule of Materials Fees,'' 
paragraph 3.B. is revised, and new categories 3.R. and 3.S. and 
corresponding fees are added to read as follows:


Sec.  170.31  Schedule of fees for materials licenses and other 
regulatory services, including inspections, and import and export 
licenses.

* * * * *

[[Page 55935]]



                       Schedule of Materials Fees
------------------------------------------------------------------------
   Category of materials licenses and type of fees \1\        Fee 2 3
------------------------------------------------------------------------
 
                              * * * * * * *
3. Byproduct material:
 
                              * * * * * * *
    B. Other licenses for possession and use of
     byproduct material issued under part 30 of this
     chapter for processing or manufacturing of items
     containing byproduct material for commercial
     distribution. This category also includes licenses
     for repair, assembly, and disassembly of products
     containing radium-226.
        Application.....................................          $4,600
 
                              * * * * * * *
    R. Possession of items or products containing radium-
     226 identified in 10 CFR 31.12 which exceed the
     number of items or limits specified in that
     section.\6\
    1. Possession of quantities exceeding the number of
     items or limits in 10 CFR 31.12(a)(4), or (5) but
     less than or equal to 10 times the number of items
     or limits specified.
            Application.................................             590
    2. Possession of quantities exceeding 10 times the
     number of items or limits specified in 10 CFR
     31.12(a) (4), or (5).
            Application.................................           1,400
    S. Licenses for production of accelerator-produced
     radionuclides.
        Application.....................................           8,000
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ Types of fees--Separate charges, as shown in the schedule, will be
  assessed for pre-application consultations and reviews; applications
  for new licenses, approvals, or license terminations; possession only
  licenses; issuance of new licenses and approvals; certain amendments
  and renewals to existing licenses and approvals; safety evaluations of
  sealed sources and devices; generally licensed device registrations;
  and certain inspections. The following guidelines apply to these
  charges:
(a) Application and registration fees. Applications for new materials
  licenses and export and import licenses; applications to reinstate
  expired, terminated, or inactive licenses except those subject to fees
  assessed at full costs; applications filed by Agreement State
  licensees to register under the general license provisions of 10 CFR
  150.20; and applications for amendments to materials licenses that
  would place the license in a higher fee category or add a new fee
  category must be accompanied by the prescribed application fee for
  each category.
(1) Applications for licenses covering more than one fee category of
  special nuclear material or source material must be accompanied by the
  prescribed application fee for the highest fee category.
(2) Applications for new licenses that cover both byproduct material and
  special nuclear material in sealed sources for use in gauging devices
  will pay the appropriate application fee for fee Category 1.C. only.
(b) Licensing fees. Fees for reviews of applications for new licenses
  and for renewals and amendments to existing licenses, for
  preapplication consultations and for reviews of other documents
  submitted to the NRC for review, and project manager time for fee
  categories subject to full cost fees are due upon notification by the
  Commission in accordance with Sec.   170.12(b).
(c) Amendment fees. Applications for amendments to export and import
  licenses must be accompanied by the prescribed amendment fee for each
  license affected. An application for an amendment to an export or
  import license or approval classified in more than one fee category
  must be accompanied by the prescribed amendment fee for the category
  affected by the amendment unless the amendment is applicable to two or
  more fee categories, in which case the amendment fee for the highest
  fee category will apply.
(d) Inspection fees. Inspections resulting from investigations conducted
  by the Office of Investigations and nonroutine inspections that result
  from third-party allegations are not subject to fees. Inspection fees
  are due upon notification by the Commission in accordance with Sec.
  170.12(c).
(e) Generally licensed device registrations under 10 CFR 31.5.
  Submittals of registration information must be accompanied by the
  prescribed fee.
\2\ Fees will not be charged for orders related to civil penalties or
  other civil sanctions issued by the Commission under 10 CFR 2.202 or
  for amendments resulting specifically from the requirements of these
  orders. For orders unrelated to civil penalties or other civil
  sanctions, fees will be charged for any resulting licensee-specific
  activities not otherwise exempted from fees under this chapter. Fees
  will be charged for approvals issued under a specific exemption
  provision of the Commission's regulations under Title 10 of the Code
  of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and
  any other sections in effect now or in the future), regardless of
  whether the approval is in the form of a license amendment, letter of
  approval, safety evaluation report, or other form. In addition to the
  fee shown, an applicant may be assessed an additional fee for sealed
  source and device evaluations as shown in Categories 9A through 9D.
\3\ Full cost fees will be determined based on the professional staff
  time multiplied by the appropriate professional hourly rate
  established in Sec.   170.20 in effect at the time the service is
  provided, and the appropriate contractual support services expended.
  For applications currently on file for which review costs have reached
  an applicable fee ceiling established by the June 20, 1984, and July
  2, 1990, rules, but are still pending completion of the review, the
  cost incurred after any applicable ceiling was reached through January
  29, 1989, will not be billed to the applicant. Any professional staff-
  hours expended above those ceilings on or after January 30, 1989, will
  be assessed at the applicable rates established by Sec.   170.20, as
  appropriate, except for topical reports whose costs exceed $50,000.
  Costs which exceed $50,000 for each topical report, amendment,
  revision, or supplement to a topical report completed or under review
  from January 30, 1989, through August 8, 1991, will not be billed to
  the applicant. Any professional hours expended on or after August 9,
  1991, will be assessed at the applicable rate established in Sec.
  70.20.
* * * * * * *
\6\ Persons who possess radium sources that are used for operational
  purposes in another fee category are not also subject to the fees in
  this category. (This exception does not apply if the radium sources
  are possessed for storage only.)


[[Page 55936]]

* * * * *

PART 171--ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES 
AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF 
COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS 
AND GOVERNMENT AGENCIES LICENSED BY THE NRC

0
63. The authority citation for part 171 is revised to read as follows:

    Authority: Sec. 7601, Pub. L. 99-272, 100 Stat. 146, as amended 
by sec. 5601, Pub. L. 100-203, 101 Stat. 1330 as amended by sec. 
3201, Pub. L. 101-239, 103 Stat. 2132, as amended by sec. 6101, Pub. 
L. 101-508, 104 Stat. 1388, as amended by sec. 2903a, Pub. L. 102-
486, 106 Stat. 3125 (42 U.S.C. 2213, 2214); and as amended by Title 
IV, Pub. L. 109-103, 119 Stat. 2283 (42 U.S.C. 2214; sec. 301, Pub. 
L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w); sec. 201, Pub. L. 93-438, 
88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note); sec 651(e), Pub. L. 109-58, 119 Stat. 
806-810 (42 U.S.C. 2014, 2021, 2021(b), 2111).


0
64. In Sec.  171.5, the definition of Byproduct material is revised to 
read as follows:


Sec.  171.5  Definitions.

* * * * *
    Byproduct material means-
    (1) Any radioactive material (except special nuclear material) 
yielded in, or made radioactive by, exposure to the radiation incident 
to the process of producing or using special nuclear material;
    (2)(i) Any discrete source of radium-226 that is produced, 
extracted, or converted after extraction, before, on, or after August 
8, 2005, for use for a commercial, medical, or research activity; or
    (ii) Any material that--
    (A) Has been made radioactive by use of a particle accelerator; and
    (B) Is produced, extracted, or converted after extraction, before, 
on, or after August 8, 2005, for use for a commercial, medical, or 
research activity; and
    (3) Any discrete source of naturally occurring radioactive 
material, other than source material, that--
    (i) The Commission, in consultation with the Administrator of the 
Environmental Protection Agency, 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
    (ii) Before, on, or after August 8, 2005, is extracted or converted 
after extraction for use in a commercial, medical, or research 
activity.
* * * * *

0
65. In Sec.  171.16, paragraph (d), in the table, Schedule of Materials 
Annual Fees and Fees for Government Agencies Licensed by the NRC, 
paragraph 3.B. is revised, and new categories 3.R. and 3.S. and 
corresponding fees are added to read as follows:


Sec.  171.16  Annual Fees: Materials licensees, holders of certificates 
of compliance, holders of sealed source and device registrations, 
holders of quality assurance program approvals, and government agencies 
licensed by the NRC.

   Schedule of Materials Annual Fees and Fees for Government Agencies
                           Licensed by the NRC
------------------------------------------------------------------------
                                                           Annual  fees1
             Category of materials licenses                     2 3
------------------------------------------------------------------------
 
                              * * * * * * *
3. Byproduct material:
 
                              * * * * * * *
    B. Other licenses for possession and use of                   $8,400
     byproduct material issued under part 30 of this
     chapter for processing or manufacturing of items
     containing byproduct material for commercial
     distribution. This category also includes licenses
     for repair, assembly, and disassembly of products
     containing radium-226..............................
 
                              * * * * * * *
    R. Possession of items or products containing radium-
     226 identified in 10 CFR 31.12 which exceed the
     number of items or limits specified in that
     section:\14\
        1. Possession of quantities exceeding the number           2,100
         of items or limits in 10 CFR 31.12(a)(4), or
         (5) but less than or equal to 10 times the
         number of items or limits specified............
        2. Possession of quantities exceeding 10 times             2,700
         the number of items or limits specified in 10
         CFR 31.12(a)(4), or (5)........................
    S. Licenses for production of accelerator-produced            10,800
     radionuclides......................................
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ Annual fees will be assessed based on whether a licensee held a
  valid license with the NRC authorizing possession and use of
  radioactive material during the current fiscal year. However, the
  annual fee is waived for those materials licensees and holders of
  certificates, registrations, and approvals who either filed for
  termination of their licenses or approvals or filed for possession
  only/storage licenses before October 1, 2004, and permanently ceased
  licensed activities entirely by September 30, 2004. Annual fees for
  licensees who filed for termination of a license, downgrade of a
  license, or for a possession only license during the fiscal year and
  for new licenses issued during the fiscal year will be prorated in
  accordance with the provisions of Sec.   171.17. If a person holds
  more than one license, certificate, registration, or approval, the
  annual fee(s) will be assessed for each license, certificate,
  registration, or approval held by that person. For licenses that
  authorize more than one activity on a single license (e.g., human use
  and irradiator activities), annual fees will be assessed for each
  category applicable to the license. Licensees paying annual fees under
  Category 1A(1) are not subject to the annual fees for Category 1.C.
  and 1.D. for sealed sources authorized in the license.
\2\ Payment of the prescribed annual fee does not automatically renew
  the license, certificate, registration, or approval for which the fee
  is paid. Renewal applications must be filed in accordance with the
  requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter.
\3\ Each fiscal year, fees for these materials licenses will be
  calculated and assessed in accordance with Sec.   171.13 and will be
  published in the Federal Register for notice and comment.
* * * * * * *
\14\ Persons who possess radium sources that are used for operational
  purposes in another fee category are not also subject to the fees in
  this category. (This exception does not apply if the radium sources
  are possessed for storage only.)


[[Page 55937]]

* * * * *

    Dated at Rockville, Maryland, this 13th day of September 2007.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 07-4735 Filed 9-28-07; 8:45 am]
BILLING CODE 7590-01-P