[Federal Register Volume 71, Number 145 (Friday, July 28, 2006)]
[Proposed Rules]
[Pages 42952-42994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6477]
[[Page 42951]]
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Part IV
Nuclear Regulatory Commission
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10 CFR Part 20, 30, 31 et al.
Requirements for Expanded Definition of Byproduct Material; Proposed
Rule
Federal Register / Vol. 71, No. 145 / Friday, July 28, 2006 /
Proposed Rules
[[Page 42952]]
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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: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations to include jurisdiction over certain radium sources,
accelerator-produced radioactive materials, and certain 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 States and other stakeholders, issue final
regulations establishing requirements that the Commission determines
necessary under the EPAct. This rulemaking effort is being 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., and the Conference of Radiation Control Program
Directors, Inc. (CRCPD). In addition, this proposed rule was informed
and guided by the CRCPD's applicable Suggested State Regulations for
the Control of Radiation. Licensees and individuals who are engaged in
activities involving the newly defined byproduct material in both
Agreement States and non-Agreement States and United States Territories
may be affected by this rulemaking.
DATES: Submit comments on the rule by September 11, 2006. Submit
comments specific to the information collections aspects of this rule
by August 28, 2006. Comments received after the above dates will be
considered if it is practical to do so, but assurance of consideration
cannot be given to comments received after these dates. A copy of the
draft proposed rule was made available on April 7, 2006 on the NRC's
rulemaking Web site at http://ruleforum.llnl.gov.
ADDRESSES: You may submit comments on the rule by any one of the
following methods. Please include the following number (RIN 3150-AH84)
in the subject line of your comments. Comments on rulemakings submitted
in writing or in electronic form will be made available to the public
in their entirety on the NRC rulemaking Web site. Personal information
will not be removed from your comments.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
[email protected]. Comments can also be submitted via the Federal eRulemaking
Portal http://www.regulations.gov.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 am and 4:15 pm Federal workdays (telephone (301)
415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
You may submit comments on the information collections by the
methods indicated in the Paperwork Reduction Act Statement.
Publicly available documents related to this rulemaking may be
examined and copied for a fee at the NRC's Public Document Room (PDR),
Public File Area O-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland. Selected documents, including comments, can be
viewed and downloaded electronically via the NRC rulemaking Web site at
http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of the NRC's public documents. If you do not have access to ADAMS
or if there are problems in accessing the documents located in ADAMS,
contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or
by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Lydia Chang, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone (301) 415-6319, e-mail
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
A. Initiating the Rulemaking Process
B. The New Expanded Definition of Byproduct Material
C. The NRC's Regulatory Approach
D. Changes to Existing NRC Regulations to Accommodate the New
Byproduct Material
E. License Application and Annual Fees
F. Implementation Strategy
G. Summary of Issues for Public Comment
III. Section-by-Section Analysis of Substantive Changes
IV. Criminal Penalties
V. Agreement State Compatibility
VI. Plain Language
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
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
[[Page 42953]]
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). However, the EPAct allowed the NRC 18 months from the date
that the legislation was signed into law by the President to issue
regulations to establish a national program for NARM. The EPAct also
allowed the NRC to issue waivers to States and other entities while a
regulatory framework for NARM was developed. A waiver was issued on
August 31, 2005 (70 FR 51581).
Current Regulatory Structures for NARM
The AEA authorizes States to assume regulatory control of
radioactive materials produced in or by a nuclear reactor, 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, 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 nor regulations for this type of material. Although the NRC has
not regulated NARM in the past, all 33 Agreement States and certain
non-Agreement States have regulatory programs for NARM. The NRC's
current regulations do require licensees to account for dose
contributed from NARM, as well as dose 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 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 NRC
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 NRC authority. In many respects, regulations applicable to NARM
adopted by the Agreement States are compatible with the NRC regulations
for the current materials program, or parallel to 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 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 has greater variation from Agreement State to
Agreement State.
Other Federal Agencies' Regulatory Authority Over NARM
Before the passage of the EPAct, NARM was regulated as a
radioactive material and/or a hazardous substance but was not regulated
by the NRC. Although States had the primary responsibility for
regulating the use of these materials, certain Federal regulations did
and will 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 established programs in regulating
certain aspects of 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
[[Page 42954]]
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 Department of Labor
(DOL) has established regulations addressing the exposure of minors to
radioactive material in the workplace. The Occupational Safety and
Health Administration (OSHA) has the oversight for occupational health
and safety for non-AEA materials. The Department of Commerce (DOC) has
controlled the export of radioactive material. Prior to the enactment
of the EPAct, the DOC regulated the export of all radium-226. With the
enactment of the EPAct, 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 paragraphs 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
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 turn of the 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
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. CRCPD has formed many working groups to
develop a set of SSRs for radioactive material compatible in many
respects to the NRC regulations. Under the SSRs' regulatory framework,
NARM is 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 and currently does not
have 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. Therefore, the NRC determined that
it would be prudent to establish a mechanism to permit individuals
currently engaged in activities involving NARM to continue with their
activities. Although the Commission could have proceeded through
issuing orders on a case-by-case basis to oversee activities involving
NARM while establishing the regulatory framework for regulating this
material, the Commission determined that this would be inefficient and
resource intensive.
Section 651(e)(5) of the EPAct authorizes 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 determines that
the waiver is in accordance with the protection of the public health
and safety, and the promotion of the common defense and security. The
Commission determined that this waiver could be granted to entities
that engaged in activities involving NARM. 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 interests 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.
Therefore, 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
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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.
II. Discussion
A. Initiating 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
and has established the ``Expanded Definition of Byproduct Material
(NARM Rulemaking)'' Web page via the rulemaking Web site http://ruleforum.llnl.gov for posting rulemaking-related documents. In
addition, the NRC has met with other Federal agencies to ensure
coordination regarding this rulemaking, e.g., the NRC met with OSHA on
August 30, 2005. At the meeting, the participants discussed the NRC's
role under the EPAct.
Forming Working Groups
In October 2005, the NRC formed a NARM Rulemaking Working Group for
developing a regulatory framework for the expanded definition of
byproduct material and for drafting this proposed rule. In addition to
the NRC staff, the NARM Working Group also included participants from
the State of Florida and the State of Oregon representing the CRCPD,
the State of Texas representing the OAS, and the State of Michigan.
Weekly meetings were held to take full use of the expert resources
available within the NARM Working Group.
The NRC also established an Office of Nuclear Material Safety and
Safeguards (NMSS) EPAct Task Force with members from the States of
Oregon and North Carolina and with resource members from the States of
Illinois and California. The State participants assisted the NARM
rulemaking by gathering State-specific data, developing certain
technical bases, and formulating certain regulatory approaches for the
proposed rule. The State participants of the NMSS EPAct Task Force have
performed key roles in the proposed rule development and have provided
valuable input to the rulemaking process.
In addition, a Steering Committee was formed to provide oversight
for both the NMSS EPAct Task Force and NARM Rulemaking Working Group.
The Steering Committee is comprised of managers from the affected NRC
program offices and principals from OAS and CRCPD. During the proposed
rule development process, the Steering Committee met weekly to resolve
issues and to provide management direction on the rulemaking. The
Steering Committee plans to continue to meet on a regular basis until
the rule is final.
Roundtable Public Meeting
The NRC held a public meeting on November 9, 2005, to discuss
rulemaking activities to incorporate NARM into its regulatory framework
as mandated by the EPAct. 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 rulemaking website at http://ruleforum.llnl.gov.
During the public meeting, the NRC provided an overview of the
EPAct and discussed the rulemaking process and the role of the NMSS
EPAct Task Force that was established to help implement the
requirements of the EPAct. Other topics that were discussed included
the role of State regulations, potential implications regarding
production of radiopharmaceuticals and availability of
radiopharmaceuticals to patients, definition of discrete source, the
NRC jurisdiction over accelerator-produced radioactive material, and
waste and transportation issues.
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 are
available via the NRC rulemaking Web site at http://ruleforum.llnl.gov
and have been reviewed and considered by the NRC staff in the
development of this proposed rule.
Interface With Other Federal Agencies and States
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 of the Positron Emission
Tomography (PET) drugs in PET centers registered with the FDA. In this
proposed rule, the NRC proposes to recognize the FDA registration in
the NRC's regulations.
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 regulations. The meeting
consisted of members of the NRC's Interagency Coordinating Committee
that had already been established for development of the National
Source Tracking System. Agencies represented at this meeting were DOT,
DOE, including the National Nuclear Security Administration, Department
of Defense, DOC, EPA, and the U.S. Customs and Border Protection. The
participants briefly discussed their agency's jurisdiction over, and
involvement with, radium-226 and other naturally occurring radioactive
materials. At the conclusion of the meeting, 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.
An ad hoc focus group was formed to specifically address issues
related to the broad spectrum of old radium-226 sources and to
formulate a regulatory strategy. The focus group included individuals
from the NRC Headquarters and Regions and representatives from the
States of Florida, North Carolina, Illinois, Michigan, Oregon, and
Texas. Although many of the old discrete radium-226 sources have been
used for decades, no specific quantitative nor
[[Page 42956]]
qualitative technical information was identified during the development
of the proposed rule that would support a broad exemption for these old
discrete radium-226 sources. Because of the lack of specific health and
safety information associated with many of the old radium-226 sources,
the NRC is proposing a graded approach by using a general license to
regulate different groups of radium-226 sources. In addition, in this
proposed rule, the NRC is asking the public for any technical
information that may be available to support an exemption, now or in
the future.
B. 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 proposing a revision of 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 revised definition of Byproduct material will be
promulgated in a separate rulemaking for 10 CFR Part 110. 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 remains
unchanged by this proposed rule.
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, 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. With advertisements proclaiming its special powers,
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. Radium was also used as a radiation source in
needles or as plaques for cancer treatment. 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 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 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.
The two basic designs of particle accelerators are linear and
circular. 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 also be bent into
the circular shaped path. The process of accelerating, focusing, and
bending (if necessary) 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. In some cases, targets
consist of nuclides intended for activation and other nuclides that are
also incidentally activated. Accelerators may also produce a neutron
flux capable of activating materials. The production of incidental
radioactive material is an inextricable part of any accelerator
operation.
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
[[Page 42957]]
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 proposes to 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 does not propose to 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 proposes to 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 are covered by this
proposed rule. The NRC believes very few, if any, accelerators are
operated in this way. NRC is seeking comments on the extent, if any,
that accelerators are used to intentionally produce radioactive
material and to provide beams for basic science research.
The EPAct does not give the NRC authority to regulate the
possession or use of particle accelerators. The NRC does not propose to
adopt 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 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 is considering how 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. Comments are
requested on the decommissioning of accelerator facilities,
specifically addressing the extent to which accelerator components and
facility building materials may become activated, the need to remove
and properly dispose of the activated material during decommissioning
to meet the radiation dose limits in 10 CFR Part 20 Subpart E--
Radiological Criteria for License Termination, the costs of the
decommissioning and disposal, if required, and the need for financial
assurance by accelerator facilities to guarantee sufficient funding for
proper decommissioning.
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 proposed regulatory approach for
manufacturing accelerator-produced radioactive material for industrial
purposes is similar to the proposed 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 is now an
important component of medical specialties for both diagnosis and
therapy purposes. Today, the use of unsealed radioactive materials in
nuclear medicine offers procedures that are essential in many medical
specialties, from pediatrics to cardiology to psychiatry. Approximately
4,000 hospital-based nuclear medicine departments and many freestanding
imaging centers in the U.S. perform millions of nuclear medicine
imaging studies every year. Nuclear medicine is now an integral part of
patient care and is extremely valuable in the early diagnosis and
treatment of medical conditions. Nuclear medicine uses very small
amounts of radioactive materials (radiopharmaceuticals) to diagnose and
treat disease. In diagnosis, the radiopharmaceuticals are used and then
detected by special cameras with the aid of computers in providing very
precise images for the area of interest. In therapeutic nuclear
medicine applications, the radiopharmaceuticals can be directed to the
specific organ being treated. Radiation oncology uses larger amounts of
radioactivity in sealed sources to deliver therapeutic or palliative
radiation doses.
Radiopharmaceuticals could be made from radionuclides produced
either in nuclear reactors or in particle accelerators. Currently,
reactor-produced byproduct radionuclides for radioactive drugs are
imported into the U.S. Although most reactor-produced radionuclides
used in sealed sources are also imported, some are produced in an NRC-
regulated nonpower reactor. Commercial manufacturers use these imported
radionuclides to produce specific sealed sources, radioactive drugs,
and biologics.
The most noteworthy radioactive drug source is the molybdenum-99/
technetium-99m generator since technetium-99m is used in approximately
85 percent of all diagnostic studies in nuclear medicine. Commercial
nuclear pharmacies subsequently use commercially produced radioactive
drugs and drug sources, such as molybdenum-99/technetium-99m
generators, to prepare unit dosages of other radioactive drugs such as
technetium-99m sulfur colloid. The commercial nuclear pharmacy may also
use radiochemicals to prepare radioactive drugs.
There are a limited number of commercial manufacturers in the U.S.
that produce radiopharmaceuticals using radionuclides, such as
thallium-201, iodine-123, indium-111, and gallium-67, that are produced
in particle accelerators. The use of fluorine-18, carbon-11, nitrogen-
13, and oxygen-15 in radiopharmaceuticals, also known as the PET drugs,
has increased in recent years. PET radionuclides and drugs are
primarily produced in cyclotron facilities (often referred to as PET
centers). PET drugs use radionuclides that decay by positron emission,
which provides dual photons traveling in opposite directions that give
a better spacial resolution of images for the area of diagnostic
interest. Due to the relatively short half life (minutes to hours), PET
radionuclides and drugs are produced at locations in close proximity to
the patients (e.g., in hospitals or academic institutions) or at nearby
locations.
[[Page 42958]]
Palladium-103 is the most common accelerator-produced medical use
radionuclide contained in a sealed source. Palladium-103 manual
brachytherapy sources were originally produced at reactor facilities,
but currently all palladium-103 used in the U.S. is commercially
produced by accelerators with a significant amount produced by U.S.
accelerators. Other medical use radionuclides, used in 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 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
proposes to 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 amends 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 such discrete sources would pose a threat
similar to the threat posed by a discrete source of radium-226. At this
time, the proposed rule does not suggest any discrete sources of
naturally occurring radioactive material for inclusion, and the
proposed 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 levels 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. Since this
proposed rule addresses discrete sources of radium-226, the only other
naturally occurring radioactive material similar in hazard to radium-
226 is polonium-210 when using the IAEA criteria. 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,
polonium-210 used for commercial purposes is usually produced by
bombarding bismuth-209 with neutrons in a nuclear reactor. Therefore,
the polonium-210 used in commerce had been regulated by the NRC before
the EPAct. Additionally, polonium-210 is very unlikely to be
commercially used in individual radioactive sources with activity
levels that would place them within IAEA Code of Conduct Category 1 or
2.
As noted previously, the NRC hosted an informal meeting with other
Federal agency representatives on November 22, 2005, to discuss the
development of a definition for discrete source to be added to the NRC
regulations. At this meeting, in a general discussion, the participants
briefly discussed the issue of other naturally occurring radioactive
material that pose a threat similar to discrete sources of radium-226.
Only polonium-210 was considered as a naturally occurring radionuclide
that currently has any commercial importance to generating potentially
significant quantities.
At this time, the NRC staff has determined that no other discrete
sources of naturally occurring radioactive material pose a threat
similar to radium-226-level or IAEA Code of Conduct Category 1 or 2
sources. In developing the proposed rule, and interacting with other
Federal agencies and States, the NRC concluded that 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, this proposed rule does not propose to add any
discrete sources of naturally occurring radioactive material to the
definition of Byproduct material, other than radium-226 and polonium-
210 covered elsewhere in the definition of Byproduct material. 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.
C. The NRC's Regulatory Approach
Consideration of 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 regulations to the maximum extent practicable in issuing
regulations for the expanded definition of byproduct material. CRCPD
published SSRs which included the model regulations for radioactive
materials. Because SSRs are the model regulations that most CRCPD
member States have adopted, or States have issued requirements that are
similar to the SSRs, then the SSRs provide the NRC a model for the
basic regulatory framework for regulating the additional byproduct
materials as defined by the EPAct. The SSRs are available on the CRCPD
Web site at http://www.crcpd.org/free_docs.asp. The majority of
stakeholders at the November 9, 2005, public meeting supported the
recognition of SSRs as the model regulations referred to in the EPAct.
Although varying slightly from State to State, the majority of States
regulating NARM have adopted the guidelines in SSRs.
The NRC considered the SSRs in developing the proposed rule. The
NRC considered the SSRs in evaluating NARM radionuclides for potential
inclusion in radionuclide-specific values listed in 10 CFR Part 20,
Appendices B and C. The NRC found that there are no other radionuclides
identified in comparable provisions in
[[Page 42959]]
Part D of the SSRs that are not already included in 10 CFR Part 20. The
NRC evaluated values in SSRs for exempt concentrations (Schedule A to
10 CFR Part 30) and exempt quantities (Schedule B to 10 CFR Part 30).
These exemption values were carefully reviewed because of their
potential impact on interstate commerce, reciprocity, and other
commercial activities. The NRC determined that these values included in
SSRs were consistent with the existing NRC approach and were derived
using the same methodology. Hence, there is no change needed in the
regulatory approach for exempt concentrations. With respect to the
exempt quantities, the NRC is proposing to adopt the values included in
SSRs into 10 CFR Part 30.
The NRC also evaluated pertinent sections of Part C of the SSRs
that are relevant to control of radium and products containing radium.
In Section C.4.b.ii, the SSRs indicate that the exempt quantity
exemption applicable to radioactive material received under a former
general license does not apply to radium-226. In Section C.4.c, the
SSRs provide an exemption for timepieces or other articles containing
not more than 37 kilobecquerels (kBq) (1 microcurie ([mu]Ci)) of
radium-226, which were previously acquired. In Section C.22, the SSRs
allow a general license, applicable to specifically licensed businesses
and government agencies, to possess and use up to 185 kBq (5 [mu]Ci) of
radium as calibration sources. The use of radium sources in industrial
gauging devices may also be authorized under a general license
specified in this section. In Section C.28, the SSRs allow up to 3.7
kBq (0.1 [mu]Ci) of radium-226 that may be incorporated into smoke
detectors distributed under an exempt license. Some Agreement States
also include radium-226 in their exempt concentration and exempt
quantities regulations.
The NRC evaluated certain sections of the SSRs regarding
radioactive material used in medical activities. Section C.22(i) of the
SSRs includes a general license for use of radioactive material for
certain in vitro clinical or laboratory testing that is comparable to
the requirements in 10 CFR 31.11 for the same type of general license.
The SSRs indicated that cobalt-57, in units not exceeding 370 kBq (10
[mu]Ci) each, could be used under this general license. In this
proposed rule, the use of cobalt-57 was added to the general license
requirements in 10 CFR 31.11, and the cobalt-57 products included in
the general license were added to 10 CFR 32.71 requirements, which
provide the licensing criteria for the manufacturer and distributor of
the products used under the general license. Section 32.71 of the NRC
regulations is comparable with Section C.28(h) of the SSRs.
Paragraphs (j) and (k) of Section C.28 of the SSRs were reviewed
for specific information on NARM radiopharmaceuticals or PET drugs, but
no such information was found. Section G.48 of the SSRs includes
contamination limits for strontium-82/rubidium-82 generators. The
contamination limits from the SSRs are 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). In this proposed rule, the contamination
limits and requirements to measure the contamination limits were added
to 10 CFR 35.204 with corresponding recordkeeping requirements added to
10 CFR 35.2204. There were no additional regulatory requirements in the
SSRs applicable to medical use licensees.
In developing this proposed rule, and as specifically discussed at
the November 9, 2005, roundtable public meeting, the NRC learned that
few SSRs specifically address accelerator-produced radioactive
material. Because most Agreement States have regulated accelerator-
produced radioactive material in a manner similar to and under the same
requirements as reactor-produced radioactive material, few SSRs exist
solely to address accelerator-produced radioactive material. While SSRs
do exist that address naturally occurring radioactive material issues,
there appear to be few model State regulations specific to accelerator-
produced radioactive material upon which the NRC can base this proposed
rule. However, there is general agreement among the States, and
reflected in the SSRs, that accelerator-produced radioactive material
should be regulated under the same requirements as reactor-produced
radioactive material. This proposed rule takes the same regulatory
approach.
Common Defense and Security Considerations
The NRC has supported efforts to establish international guidance
for the safety and security of radioactive materials of concern. This
effort has resulted in a major revision of the IAEA Code of Conduct.
The revised Code of Conduct was approved by the IAEA Board of Governors
in September 2003, and is available on the IAEA Web site at http://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf. Table 1 of the
Code of Conduct lists those radionuclides that pose a significant risk
to individuals, society, and the environment. While the Code of Conduct
initially focused on sealed source management and control from a safety
perspective, terrorist events have caused the scope to be broadened to
include a security consideration. The Code of Conduct included 26
radionuclides with quantities that could be fatal or cause permanent
injury to a person if not safely managed or securely protected. Of
these 26 radionuclides, only two naturally occurring radionuclides are
listed: radium-226 and polonium-210. With the passage of the EPAct, the
NRC has regulatory authority over each of the radionuclides listed in
Table 1 of the Code of Conduct. Radium-226 is one of the isotopes of
concern for use in a radiological dispersal device, and it is on the
list of radioactive sources in the IAEA Code of Conduct that could pose
a significant risk.
The NRC has published a final rule relating to the export and
import of radioactive materials for certain radionuclides listed in the
Code of Conduct (70 FR 37985; July 1, 2005) and a proposed rule for
national source tracking of sealed sources (70 FR 43646; July 28,
2005). In a separate rulemaking, the NRC will amend its regulations in
10 CFR Part 110 on export and import of radioactive material to address
discrete sources of radium-226 in a manner consistent with the Code of
Conduct.
Definition of Discrete Sources
The EPAct extended the definition of Byproduct material to include
any discrete source of radium-226 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 EPAct gives the NRC authority over discrete sources of
radium-226 but not over diffuse sources of radium-226. The result did
not extend the NRC's authority over radium-226 as it occurs in nature,
nor over other processes where radium-226 may be unintentionally
concentrated. Scale from pipes used in the fossil fuel industry, fly
ash from coal power plants, phosphate fertilizers, or residuals from
treatment of water to meet drinking water standards are not considered
as discrete sources; however, uranium and thorium within these
materials may become licensable source material
[[Page 42960]]
depending upon their concentration. To more clearly establish the limit
of its authority regarding radium-226, the NRC was tasked with defining
what constitutes a discrete source. The NRC is defining the term in
this proposed rule.
The term Discrete source is not defined in the EPAct, and the EPAct
specifically indicates that the final regulations, in establishing
requirements necessary to carry out the amendment, shall include a
definition of the term Discrete source. This definition of Discrete
source will be 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.
The NRC believes that this new authority over radium-226 and other
naturally occurring radioactive material was not intended to extend to
all naturally occurring radioactive material. 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. The authority does not extend to naturally
occurring radioactive material that is found in nature in its original
form and location, nor to naturally occurring radioactive material
moved or concentrated inadvertently in some man-made process. The
intent of the NRC in developing the definition of Discrete source for
radium-226 and other naturally occurring radioactive material was to
better define the materials covered by the new authority.
In defining radium-226 and other naturally occurring radioactive
material as byproduct material, Discrete source means ``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.'' The discrete source will have the same
radiological characteristics (type of radiation, half-life, etc.) as
the radionuclide found in nature, but will have been concentrated and
purposefully used for its radiological properties, after it has been
removed from its original location in nature. This excludes the NRC
jurisdiction over inadvertent movement or concentration of naturally
occurring radioactive material. It does not change the NRC's authority,
in any manner, over source material. This definition of Discrete source
clarifies those radium-226 sources and other naturally occurring
radioactive material, other than source material, that will be
delineated as byproduct material and will fall under the expanded
definition of Byproduct material as mandated in the EPAct. This
definition of Discrete source does not include material encapsulated or
sealed only for disposal. However, it should be noted that once a
radioactive material, as defined under this definition of Discrete
source, becomes a byproduct material, it will continue to be regulated
as a byproduct material even if the discrete radioactive source is
leaking or broken, or no longer has a physical boundary.
D. 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 States for use under an exemption from
licensing and under a general license. Generally, the NRC's intent in
this proposed 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 proposed
rule are only intended to accommodate items manufactured in the past,
which may still be in use or in storage. For example, radium-226 was
used in timepieces and other self-luminous products, and in smoke
detectors. Some time ago, promethium-147 and tritium replaced radium-
226 in self-luminous products. For many years, americium-241 has been
the primary radionuclide used in smoke detectors; consequently, the use
of radium-226 in the manufacture of smoke detectors stopped several
years ago.
The bases of these proposed provisions are primarily the SSRs and
also information in the 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 States. While this is not a complete
database with respect to NARM, it includes detailed information about
many products containing NARM previously evaluated by States. In
addition to SSRs and the information in the SS&D registry, the specific
provisions of the various States also have been considered in
developing this proposed rule.
Exemptions From Licensing
Part 30 of Title 10 of the Code of Federal Regulations includes a
number of exemptions from licensing requirements. 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 and 10 CFR 30.20, Self-luminous products
and Gas and aerosol detectors, respectively, 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. Sections 30.14
and 30.18 of NRC's regulations, Exempt concentrations and Exempt
quantities, respectively, 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
[[Page 42961]]
10 CFR 30.71, respectively. The remaining exemptions from licensing are
product specific, for which many assumptions can and have been made
concerning how the product is distributed, used, and disposed of. The
proposed rule would add some products and materials containing NARM to
some of the current exemptions. The table of exempt concentrations in
10 CFR 30.70 already includes all of the radionuclides and associated
limits contained in the equivalent section of the SSRs. Thus, the NRC
is not proposing to revise the exempt concentration table in this
proposed 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. The proposed rule would
add these 13 radionuclides and their respective quantities, as
currently 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 State's 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 proposing to add only the 13 radionuclides and values from
the SSRs, and no further additions to 10 CFR 30.71 are included in the
proposed rule. It is noted, however, that for other byproduct material,
excluding alpha emitters, which is the last item on the list in 10 CFR
30.71, Schedule B, allows for 3.7 kBq (0.1 [mu]Ci) to be used as an
exempt quantity. This would apply to accelerator-produced radionuclides
as well.
Timepieces Containing Radium-226
The exemption in 10 CFR 30.15(a)(1) would be revised to include
timepieces (including dials, watch faces, and hands) that were
manufactured prior to the effective date of the rule and containing no
more than 37 kBq (1 [mu]Ci) of radium-226. This limit is consistent
with the SSRs. However, as the hazard of handling non-intact timepieces
and hands and dials, particularly the repair, may be more significant
because of the effects of aging on the radium-containing paint, the
exemption in the proposed rule would be limited to ``intact''
timepieces, with an exception to allow for repairing a limited number
of timepieces, per year, proposed as ten. This latter exception is
intended to recognize historical practices and minimize impacts on
small businesses and antique collectors, while NRC gathers data to
determine if more specific requirements should be placed on the
possession and repair of antiques containing radium-226. It is believed
that the incidence of handling of watch and other timepiece parts and
the repair of timepieces containing radium-226 is generally limited;
however, the Commission requests input regarding the appropriateness of
this number and other comments concerning how active the repair of
radium timepieces may be, the safety significance of this exemption,
alternatives to potential regulations, or justification for continuing
the exemption in this area. As discussed later, the possession, but not
the repair, of a larger number of timepiece parts would be covered by a
proposed new general license. However, if a significant number of such
items are being handled in a facility, the controls associated with a
specific license would be appropriate. As noted elsewhere in this
Federal Register notice, the Commission will be gathering additional
information about the quantities of radium-226 in products in order to
better evaluate the health and safety implications associated with the
various products and activities involving radium-226.
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 would not be
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. Instead, the possession, use, and transfer of these items would
be subject to the general license for certain previously manufactured
items and self-luminous products containing radium-226 established in
10 CFR Part 31. The NRC plans to further evaluate the health and safety
implications of self-luminous products to determine if exemptions may
be appropriate.
Smoke Detectors
Smoke detectors are included in the class exemption in 10 CFR 30.20
for gas and aerosol detectors. This exemption is revised in the
proposed rule 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 in smoke detectors was, in fact, a past
practice. The proposed provision added to 10 CFR 30.20 for detectors
containing radium-226 would be 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
would have been used in approving distribution of these detectors for
use under an exemption from licensing. This exemption would 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 continues to retain 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). The current 10 CFR 150.15(a)(6) 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 and
regulatory requirements must have a license from the NRC authorizing
these activities.
[[Page 42962]]
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, States have only authorized a
few distribution licensees for distribution to persons exempt from
licensing requirements of exempt quantities of accelerator-produced
radioactive material. These distribution licensees already have an NRC
license under 10 CFR 32.18 authorizing the distribution of exempt
quantities of pre-EPAct byproduct material. Thus, only a simple
amendment of those NRC licenses will be required as a result of this
aspect of this proposed 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: those ``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
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
proposed rule would accommodate generally licensed devices meeting the
restrictions of the general license that were previously approved by
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 changes in response to this proposed rule. 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) would be 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
registration is separate and quite different from the SS&D registration
by the distributors. 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 would come under
10 CFR 31.5 include devices with 37 MBq (1 mCi) or more of radium-226.
These devices would be subject to the registration requirement. Other
certificates, which include devices with radium-226, allow only much
smaller quantities. These devices would 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. At this
time, 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. Information
available from States will also be added. 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 would need to add devices containing radium-226
during the registration process.
Calibration and Reference Sources in 10 CFR 31.8
Section 31.8 of 10 CFR Part 31 currently provides a general license
for the use of up to 185 kBq (5 [mu]Ci) of americium-241 in calibration
and reference sources. The SSRs and many State regulations also include
radium-226 in their comparable provisions to the general license. This
proposed rule would add 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.
General License for in vitro Test Kits in 10 CFR 31.11
The general license for in vitro test kits in 10 CFR 31.11 would
also be revised. In vitro test kits are discussed later under
``Regulatory Framework for Accelerator-Produced Radioactive Material
Used in Medical Activities.''
New General License for Certain Items and Self-Luminous Products
Containing Radium-226
A new section would be added to 10 CFR Part 31 to provide a general
license to any person for other products and discrete sources
containing radium-226 which are apparently in the public domain but may
not be otherwise covered under a license and are not specifically
addressed in the SSRs. The general license would include: (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, healing pads, etc.; (2) luminous
hands and dials not contained in timepieces and other luminous items,
provided that no more than 50 are used or stored at the same location
at any one time; (3) luminous gauges and other aircraft safety items
containing radium-226 installed in aircraft; (4) luminous aircraft
gauges and other aircraft safety items containing radium-226 no longer
installed in aircraft, 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 [mu]Ci) of radium-226 as
discrete survey instrument calibration sources, sources contained in
radiation measuring instruments, sources used in educational
demonstrations (such as cloud chambers, spinthariscopes, etc.),
electron tubes, lightning rods, ionization sources, and static
eliminators.
[[Page 42963]]
The general license would allow any person to acquire, receive,
possess, use, or transfer radium-226 contained in the aforementioned
products. Persons who receive, possess, use, or transfer the radium-226
items under the general license would be exempt from the provisions of
10 CFR Parts 19, 20, and 21 to the extent that the receipt, possession,
use, or transfer is within the terms of the general license.
The proposed general license would prohibit the manufacture,
assembly, disassembly, repair, or import of products containing radium-
226; prohibit export under the general license; and require that the
product is only to be disposed of by transfer to a specific licensee
authorized to receive it or to a disposal facility authorized to
dispose of the material in accordance with any Federal or State solid
or hazardous waste law. The proposed general license would also
prohibit abandonment of the product. The general license would require
notifying the NRC or the Agreement State 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 would require persons possessing
these devices under a general license to respond to written requests
for information from the NRC or the appropriate Agreement States.
The Commission intends to conduct an evaluation to better
understand the products, determine the extent to which radium may have
been used in the products, the activities or quantities of radium-226
that might have been used or remain in the products, and determine any
health and safety or environmental impacts that the products pose. It
is anticipated, based on the information developed from this
evaluation, that the Commission may determine that it is appropriate to
exempt additional products from further regulatory control, or modify
the general license. Meanwhile, it is the NRC's intent, to a large
extent, to maintain the existing ``status quo'' with Agreement State
regulation of NARM through the imposition of minor restrictions on
transfer and possession, except when larger numbers of products may be
involved or significant contamination of property has resulted.
The Commission specifically requests comments to provide
information that may assist the NRC to more fully evaluate potential
impact to public health and safety and the environment due to
activities involving radium-226 sources. In particular, the Commission
requests input on any quantitative or qualitative health and safety
information regarding radium-226 sources that may be used to support a
regulatory framework other than general licensing, such as an
exemption. The Commission also requests comments regarding the specific
constraints in the proposed exemption in 10 CFR 30.15(a)(1)(viii) and
in its general license approach for certain items and self-luminous
products containing radium-226 that were manufactured prior to the
effective date of the rule, regarding under what circumstances an
exemption is a more effective and viable approach, and requests
additional information for the technical basis supporting an exemption
in lieu of a general license. In particular, the Commission would
appreciate input on whether this general license approach, and its
allowances and restrictions, is reasonable while the Commission
evaluates the products; whether the general license should allow
possession of radium-226 luminous items, such as individual watch
hands, dials, gauge indicators and faces, which are not contained in an
intact finished product regardless of number; whether commercial
transfers should be restricted and require a specific license; or
whether data are available to justify an exemption for certain types of
radium-226 sources, now or in the future.
Regulatory Framework for Accelerator-Produced Radioactive Material Used
in Medical Activities
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. The NRC has a well established regulatory
framework for the commercial production, distribution, and use of in
vitro test kits, radioactive drugs, biologics, and SS&Ds for medical
activities involving byproduct material yielded in, or made radioactive
by, exposure to the radiation incident to the process of producing or
using special nuclear material. The NRC believes this existing
regulatory framework is also applicable to the commercial producers,
distributors, and medical users of in vitro test kits, radionuclides,
radioactive drugs, biologics, and SS&Ds containing NARM that are now
included in the EPAct's expanded definition of byproduct material. The
NRC also believes this framework will minimize the impact of its
regulations on the availability of radioactive drugs containing
accelerator-produced radionuclides.
This regulatory framework for the commercial radioactive drug
manufacturer and the commercial nuclear pharmacy consists of licenses
(or authorizations) issued under 10 CFR Part 30 to possess and use the
radioactive materials, 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
license issued under 10 CFR 32.72 to distribute radioactive drugs to
medical use licensees. While the medical SS&D manufacturers also have
licenses (or authorizations) issued under 10 CFR Part 30, their medical
distribution licenses are issued under 10 CFR 32.74. The medical
distribution licenses (or authorizations) issued under 10 CFR 32.72 and
10 CFR 32.74 authorize distribution to medical use licensees, but do
not authorize the possession and use of byproduct material.
This regulatory framework is directly applicable to longer half-
life NARM radionuclides, e.g., thallium-201, cobalt-57, and palladium-
103, that are produced in a few accelerator facilities for import by,
or transfer to, drug manufacturers, in vitro kit manufacturers,
commercial nuclear pharmacies, and sealed source producers. It is also
applicable to the commercial production and distribution of PET
radionuclides, e.g., fluorine-18, oxygen-15, and carbon-11, which are a
special subset of NARM radionuclides. The NARM (including PET)
radionuclide producers will be licensed for the production and
subsequent possession and use of the NARM (or PET) radionuclides under
10 CFR Part 30. The NARM (including PET) radionuclide producer can
transfer these radionuclides to other licensees under the provisions of
10 CFR 30.41. This includes distribution of NARM (or PET) radionuclides
to individuals, including universities and research laboratories, for
basic research but not medical use. If the NARM (including PET)
radionuclide producer also uses these radionuclides to make radioactive
drugs (including PET drugs) or medical sealed sources that are
distributed directly to medical use licensees, then the NARM
radionuclide producer also needs a 10 CFR 32.72 or 10 CFR 32.74 medical
distribution license for this purpose. These medical use licensees are
authorized to use these materials on patients or human research
subjects. The commercial NARM (including PET) radioactive drug or
biologic manufacturer and commercial nuclear pharmacy preparing NARM
(including PET) radioactive drugs and biologics will need a license (or
authorization) issued under 10 CFR Part 30 and another issued under 10
CFR 32.72.
[[Page 42964]]
PET drugs are a special subset of NARM drugs that are characterized
by the radiation they emit and usually have very short half lives.
Individual hospitals and academic institutions, in addition to the
commercial drug manufacturers and commercial nuclear pharmacies, may
also have cyclotrons that are used to produce PET radionuclides and may
prepare PET drugs from these nuclides. Although PET drugs have very
short half lives, certain PET radionuclides with longer half lives can
be transported from the production facility to the user's site. This
permits the commercial distribution of some PET drugs (e.g., fluorine-
18 glucose) to medical users that do not have a cyclotron. Even medical
users with cyclotrons may purchase widely used PET drugs from
commercial manufacturers or nuclear pharmacies so their cyclotrons can
be used to produce other PET radionuclides. The longer half-life PET
radionuclides may also be combined with nonradioactive chemicals and
biologics to produce new PET drugs and biologics.
The extremely short half-life radionuclides used for medical use
have to be administered immediately after production and would
essentially necessitate that the cyclotron be located in the medical
facility. Some hospitals form ``consortiums'' with adjacent or nearby
hospitals to make PET radionuclides and drugs available to these
associated facilities through noncommercial distributions. While the
NRC's existing regulatory framework works for the commercial production
and distribution of PET radionuclides and drugs, it was not developed
to handle the noncommercial distribution between medical use licensees.
Failure to address noncommercial distribution would impact the
availability of these radioactive 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 radionuclides, drugs, and biologics among medical use licensees.
In accordance with this process, a medical use facility, which uses its
own cyclotron to produce PET radionuclides for use under its own
medical use license, would not need a medical distribution license, but
it would need to have either a separate 10 CFR Part 30 license for the
PET radionuclide production facility or a 10 CFR Part 30 authorization
for this production facility on its medical use license. As with other
radionuclide production facilities, the radiation safety program will
be reviewed in accordance with the criteria in 10 CFR 30.33. If the
licensee has a broad scope authorization for 10 CFR Part 30 uses, then
the program also will be reviewed in accordance with 10 CFR Part 33.
Under the new regulatory framework, if the medical use facility
does not intend to commercially distribute the PET radionuclides,
drugs, or biologics, but intends to transfer them to other medical
facilities in its consortium, a medical distribution license is not
needed, but an authorization for the noncommercial transfer of the
radionuclides, drugs, and biologics to other medical use licensees is
needed. With minor revisions to 10 CFR Part 35, the consortium medical
use facilities would be authorized by regulation to receive these PET
drugs.
The NRC is distinguishing between the ``production'' of PET
radionuclides which requires the presence of the cyclotron and the
``preparation'' of PET drugs which may occur at another location. To
ensure the continued availability of PET drugs, all PET centers (i.e.,
facilities with cyclotrons used to produce PET radionuclides),
including commercial nuclear pharmacies, that are registered with FDA
or a State will be authorized to produce PET radionuclides under their
10 CFR Part 30 license or 10 CFR Part 30 authorization. The NRC will
review the radiation safety programs of these facilities in accordance
with the criteria in 10 CFR 30.33.
To ensure availability of PET drugs from commercial nuclear
pharmacy PET centers that are not registered with the FDA or a State,
these pharmacies will be authorized for PET radionuclide production if
their radiation safety programs meet the criteria in 10 CFR 30.33,
which includes individuals with training and experience in the
production of PET radionuclides, i.e., the processes from insertion of
targets in the accelerator/cyclotron beam to radiochemical isolation,
purification, and testing, so that the requirements in 10 CFR
30.33(a)(3) are met. Individuals, such as radiochemists, physicists,
engineers, and others with appropriate training and experience, will be
recognized as authorized users under the pharmacy's 10 CFR Part 30
authorization for the production of PET radionuclides and other
radionuclides using cyclotrons and other types of accelerators. This
training and experience will be evaluated by the NRC through reviewing
and processing of a license application on a case-by-case basis.
Authorized nuclear pharmacists will continue to be authorized to
use already produced reactor-produced radionuclides, PET radionuclides,
and other accelerator-produced radionuclides to prepare PET drugs and
other radioactive drugs, i.e., compound PET drugs and other radioactive
drugs, under the practice of pharmacy. Medical use licensees that
receive PET radionuclides that are added to ``cold kits'' may 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.
Further, to ensure the availability of NARM (which includes PET)
radioactive drugs and biologics, individuals who may include nuclear
pharmacists among others, responsible for the production of PET
radionuclides at the cyclotron facilities under the NRC waiver issued
on August 31, 2005, will be ``grandfathered'' and will not be required
to meet new training and experience requirements as long as their
duties and responsibilities under the new license do not significantly
change. When adding these individuals to a license, the applicant will
be required to document that these individuals were responsible for the
production of PET radionuclides using a cyclotron or accelerator during
the period the waiver was in effect.
To ensure a smooth transition and availability of NARM (which
includes PET) radioactive drugs, biologics, and sealed source use in
medical facilities, those individuals that used only NARM byproduct
materials for medical uses under the NRC's August 31, 2005, waiver will
be ``grandfathered'' in the regulations with appropriate changes to 10
CFR Part 35.
The radiation safety knowledge needed to safely use the newly added
byproduct material radionuclides for medical uses is similar to that
for the existing byproduct radionuclides used in medicine. Individuals
already authorized to use byproduct material in 10 CFR Part 35 are
therefore authorized to use the newly added byproduct material for
medical use. Further, no changes were made to the training and
experience criteria in 10 CFR Part 35 for any authorized individual.
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 noncommercial distribution of these drugs by
medical use licensees; (3) expanding the authorization for commercial
nuclear pharmacies to
[[Page 42965]]
produce PET radionuclides; (4) ``grandfathering'' current users of
accelerator-produced radioactive drugs; (5) retaining the existing
training and experience criteria in 10 CFR Part 35 for authorized
individuals; and (6) permitting individuals to continue to prepare and
use radioactive drugs while they are applying for new licenses or
amendments.
The medical use of extremely short half-life radionuclides, e.g.,
oxygen-15, requires the radionuclide to be administered in the imaging
and localization medical use area (10 CFR 35.200) immediately after the
radionuclide is produced by the cyclotron. This necessitates the
medical use area to be co-located with the cyclotron or to have a
radionuclide delivery line from the PET radionuclide production area.
This introduces the potential for a high radiation area in a medical
use area that is normally considered a low radiation area. This is a
unique situation and was not envisioned when 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. These
requirements are found in 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 proposed rule clarifies that
an amendment would be required in the unique situation described
previously if the changes involved movement of the cyclotron or a
radionuclide delivery line from the PET radionuclide production area.
Changes to the typical 10 CFR 35.100 and 10 CFR 35.200 medical use
areas are not affected.
Consideration of NARM in 10 CFR Part 20, Appendix B
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. Since 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. 123I 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 4 x 10-6 microcurie per milliliter (1.48 x
10-2 becquerels per milliliter) for occupational exposure
and a corresponding effluent concentration of 2 x 10-8
microcurie per milliliter (7.4 x 10-4 becquerels per
milliliter) for exposure of members of the public. The above 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 is not
proposing to add specific values for these radionuclides in this
rulemaking at this time. Since certain medical communities have
expressed the desire of having specific DACs for these two
radionuclides, the Commission specifically requests public comment on
the default values, and whether it should include larger specific
values for oxygen-15 and nitrogen-13 in the final 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 (1 rem) effective dose equivalent or 0.05
sievert (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 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 proposed rule would
add 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.
Although 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, the requirement includes the use of the ``rule of ratios'' (See
Footnote 1 to 10 CFR 30.72), so that licenses authorizing other
byproduct material, in quantities approaching values that would require
emergency planning 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 policy and requires only a minor change to the regulations to
ensure that the term ``low-level radioactive waste,'' when used in the
NRC 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
[[Page 42966]]
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 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 proposing any
changes to 10 CFR Part 61 at this time, 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.
Section 651(e)(3) of the EPAct also allows that, notwithstanding
the previously mentioned provisions that require the NRC licensing of
the disposal of the newly added byproduct material, 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, is not
affected. 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
proposing a change to its regulations in 10 CFR Part 20 that would
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.
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. 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 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 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 to cause a public health and safety concern,
need to be addressed for the purposes of establishing adequate
financial assurances for decommissioning leading to license
termination.
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 proposed
by the NRC, a general licensee may become subject to specific licensing
if a large number of discrete sources of radium-226 are accumulated
(e.g., more than 50 luminous products in one location). 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 individuals 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 proposing
any changes in the financial assurance of the decommissioning
regulation.
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 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
[[Page 42967]]
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. 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). There is not enough known about the
breadth or depth of these potential radium-226 contamination
situations, and how many of them exist at facilities that will apply
for specific licenses, to propose any additional requirements to
address them at this time. Therefore, the NRC proposes to address these
situations on a case-by-case basis as they are identified following
issuance of the new requirements for the newly added byproduct
material.
E. 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.
Persons applying for a license with the NRC, or requesting an
amendment to their current licenses that may result in 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 Materials Program hourly rate
in 10 CFR 170.20 (currently $197). An application fee must generally be
paid for each applicable fee category.
Additionally, all persons who hold licenses issued by NRC are
subject to annual fees under 10 CFR Part 171, unless exempt under the
provisions of 10 CFR 171.11. The 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
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 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), which is indicative of the safety risk and
resulting regulatory costs associated with these categories of
licenses. The annual fees for a materials users license (other than a
master materials license) currently range from $750 for fee category
2.B (shielding) to $27,300 for fee category 7.B (broad-scope medical).
The license application fees schedule is in 10 CFR 170.31. The
annual fees schedule is in 10 CFR 171.16. The fee amounts noted in this
section are the FY 2005 fees which may change in July 2006, once the FY
2006 Fee Rule becomes effective.
The NRC believes that the majority of NRC licensees affected by
this 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 proposing three new fee categories for activities that
are currently not covered by its regulations, but are covered under
this proposed rule. The new fee categories would apply to certain
previously manufactured items 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 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 collecting items containing radium-226 are
expected to be eligible for a general license under the proposed 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 31.12 (e.g. proper disposal of the radioactive
material). However, if an individual collects more than the number of
items or limits specified in this section, that individual would be
required to obtain a specific license and be subject to the regulations
regarding license application and annual fees. The NRC is proposing a
new fee category, 3.R., with a two-tiered fee level, for those
individuals 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)(3), (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 proposed 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 proposed new fee category, 3.R.1., is for individuals
possessing quantities greater than the number of items or limits in 10
CFR 31.12(a)(3), (4), or (5), but less than or equal to 10 times these
quantities. Since 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. would be $450 and
$1,600, respectively. The second proposed new fee category, 3.R.2., is
for individuals possessing quantities greater than 10 times the number
of items or limits in 10 CFR 31.12(a)(3), (4), or (5). The license
application and annual fees for this new category, 3.R.2., would be
$1,100 and $2,500, 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 would be required to obtain a specific license
and would be subject to the applicable license application and annual
fees. The NRC is proposing to include 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
[[Page 42968]]
manufacturing of items containing byproduct material for commercial
distribution. The license fee for this category is currently $3,500,
and the annual fee is currently $8,200.
The NRC is proposing to add a new fee category, 3.S., for the
production of accelerator-produced radioactive materials. The NRC is
proposing this new fee category because these production activities
need to be distinguished from those activities that only involve use of
already prepared radionuclides. The estimated regulatory effort for the
proposed new fee category, 3.S., would be comparable to that for fee
category 3.C. The license application and annual fees for this new
category would be $4,700 for the application fee and $10,200 for the
annual fee.
The NRC is specifically requesting comments on the proposed fee
categories and amounts. The NRC is requesting these comments based upon
its assumption that the majority of existing NRC licensees covered by
this rulemaking will not be impacted because the existing fee
categories remain sufficient to cover all regulated activities. The NRC
would like to receive comments from current NRC licensees who believe
they will need to amend their licenses. Some amendments will be needed
to add the new fee categories, with the attendant Parts 170 and 171
fees as a result of this rulemaking. The NRC is currently assuming that
approximately 75 requests for a new license or an amendment will
contain one of the new fee categories.
Additionally, the NRC requests comments from potential licensees
currently not regulated by the NRC, but who may be required to obtain
an NRC license as a result of this rulemaking. The NRC is interested in
information on whether these licenses would fall under the current fee
categories, and/or the new fee categories proposed in this rulemaking.
Regarding the regulation of radium-226, the NRC is specifically
requesting comments from private collectors of items or products
containing radium-226 as to whether private collectors believe that
they will remain within the boundaries of the proposed general license
in 10 CFR 31.12 and whether there are private collectors who believe
that they will be required to obtain a specific license.
The NRC would also like to receive comments on the proposed two-
tiered fee level under fee category 3.R. Currently, the NRC estimates
receiving approximately 20 new applications for tier one fee category
and one new application for the tier two fee category.
The NRC would like to receive comments on the proposed new fee
category, 3.S., for the production of accelerator-produced radioactive
materials. The NRC is currently assuming that approximately 25 new
applications will be received for this fee category. Specifically, the
NRC requests comments on whether operators of production facilities
agree that a new category is needed or believe that they fall into
existing categories.
F. Implementation Strategy
Several actions are planned or must occur coincident with, or
following, the NRC issuance of final rules covering the newly added
byproduct material, including:
(1) Issuance and publication of a transition plan for the orderly
transition of regulatory authority for the newly added byproduct
material for Agreement and non-Agreement States;
(2) Termination of the waiver issued by the NRC (70 FR 51581;
August 31, 2005) for States and users of the newly added byproduct
material; and
(3) An implementation period for users of the newly added byproduct
material to come 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 intends to
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 effective through 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 States to continue to regulate this material
during the applicable waiver period. All individuals 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 NRC regulatory authority for the
material on August 8, 2009. The waiver may also be terminated earlier
than August 8, 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 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
[[Page 42969]]
those States that desire to establish such an agreement for the newly
added byproduct materials to develop a program. To establish such an
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 three or more
years to complete. If a State requests an agreement with the
Commission, but the agreement cannot be established while the waiver is
in effect, i.e., through August 7, 2009, a special arrangement would
need to be made with the Commission for the State to continue its
regulatory program over the newly added byproduct material. Without an
agreement or special arrangement, regulatory authority over the newly
added byproduct material will automatically remain with the Commission
on the date the waiver expires, or is terminated earlier by the
Commission.
If an Agreement or non-Agreement State notifies the Commission,
during the waiver period, that it does not intend to continue with its
regulatory program with respect to the newly added byproduct material,
the NRC, in coordination with the State, will determine an appropriate
date to terminate the waiver for the State. Users of the material in
the State will be subject to NRC regulatory authority on the
termination date of the waiver. Specific actions for users in the State
to comply with the new requirements of the rule will be noticed in the
Federal Register (Notification of Waiver Termination and Implementation
Dates of Rule). 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 Commission intends to terminate the waiver for Government
agencies and Federally recognized Indian Tribes on the effective date
of the final rule because there is currently limited regulatory
oversight for the newly added byproduct material at these facilities.
Waiver termination is necessary in order to require Government agencies
and Federally recognized Indian Tribes to comply with the new
requirements and for NRC to ensure protection of public health and
safety for the newly added byproduct material.
The purpose of the waiver is to allow time for the States and
individuals to have an orderly transition of the regulatory authority
for NARM. Terminating the waiver for the Government agencies and
Federally recognized Indian Tribes on the effective date of the final
rule provides for regulatory oversight of the newly added byproduct
material. A ``Notification of Waiver Termination and Implementation
Dates of Rule'' applicable to Government agencies and Federally
recognized Indian Tribes will be included with the publication of the
final rule.
Implementation Period
Although Government agencies and Federally recognized Indian Tribes
are already being regulated by NRC for the AEA 11e.(1) and 11e.(2)
byproduct material, the NRC is proposing a transitional period for them
to submit a license amendment or a new license application for the
newly added byproduct material. The proposed rule would allow 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. In
addition, the proposed rule contains specific provisions that would
give Governmental agencies and Federally recognized Indian Tribes
authority to continue to use the newly added byproduct material during
the period when the waiver is terminated until the date of 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 the final
rule.
For individuals owning, using, and otherwise engaging in activities
involving the newly added byproduct material, the date on which
compliance with the rule will be required will depend on the date of
waiver termination. For certain States and individuals, 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. The NRC plans to terminate the waiver for Government
agencies and Federally recognized Indian Tribes on the effective date
of the final rule, and these users will be subject to the new
requirements on that date. The effective date of the rule will be 60
days after the date of publication of the final rule to give the
Government agencies and Federally recognized Indian Tribes time to
comply with the requirements. The NRC is proposing to provide
Government agencies and Federally recognized Indian Tribes 6 months
from the effective date (or 8 months from the date of publication of
the final rule) to apply for a license amendment for the newly added
byproduct material if they hold an NRC specific byproduct materials
license, and 12 months from the effective date of the final rule to
submit a new license application for the newly added byproduct material
if a new NRC specific byproduct materials license is needed. 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.
The NRC plans to separately solicit information from the States on
their intentions concerning continuing with, or establishing new,
regulatory programs for the newly added byproduct material. Users will
be subject to NRC regulatory authority upon expiration or termination
of the waiver if they are located either in an Agreement State that
does not intend to continue its regulatory program with respect to the
newly added byproduct material or in a non-Agreement State that does
not enter into an agreement with the Commission under section 274b. of
the AEA that covers the newly added byproduct material. For these
users, the waiver termination process, specific authority, and
condition to continue activities involving the newly added byproduct
material will be described in the Commission's transition plan,
required by Section 651(e) of the EPAct. Specific actions for these
users to comply with the new requirements of the rule will be noticed
in the Federal Register (Notification of Waiver Termination and
Implementation Dates of Rule). For users of the material who transition
from a State regulatory program to NRC's regulatory program, the NRC
expects to provide, in the notification, a similar provision allowing a
6-month period for submitting an amendment and a 12-month period for
submitting a new license application provided that a license amendment
or license application is submitted on or before August 7, 2009. At
this time, the NRC is not aware of any Agreement State that does not
intend to continue its regulatory program with respect to the newly
added byproduct material. The NRC requests comments on the
[[Page 42970]]
proposed effective date for the final rule and other implementation
periods, to ensure that the affected individuals have sufficient time
to come into compliance with the new requirements.
G. Summary of Issues for Public Comment
The NRC is requesting additional information or comments on
multiple topics. The issues and sections of this document where these
issues are explained are as follows:
(1) Technical information that may be available to support an
exemption for old discrete radium-226 sources. (See Section II, Item A,
``Interface With Other Federal Agencies and States.'')
(2) The extent that accelerators are used to intentionally produce
radioactive material and provide beams for basic science research. (See
Section II, Item B, subsection ``Particle Accelerators.'')
(3) The decommissioning of accelerator facilities including
accelerator components and facility building materials that may become
activated. (See Section II, Item B, subsection ``Particle
Accelerators.'')
(4) The adequacy of the applicable default ALIs and DACs in
Appendix B to 10 CFR 20 for oxygen-15 and nitrogen-13, and whether
staff should develop larger specific values for these radionuclides.
(5) The appropriateness of the number of timepieces containing
radium-226 (proposed as ten per year) for an exemption to allow
repairing and other comments concerning how active the repair of
timepieces containing radium-226 may be, the safety significance of
this proposed exemption, alternatives to potential regulations or
justification for continuing the exemption in this areas. (See Section
II, Item D, Subsection, ``Timepieces containing radium-226.'')
(6) The health and safety impact from activities involving radium-
226 sources, in particular, an alternative to the general licensing
approach, such as an exemption. A technical basis supporting an
exemption. (See Section II, Item D, ``New General License for Certain
Items and Self-Luminous Products Containing Radium-226.'')
(7) Whether the majority of licensees believe they will remain in
their existing fee categories. Whether potential licensees currently
not regulated by NRC, but who may be required to obtain an NRC license
as a result of this rulemaking, believe their licenses would fall under
the current fee categories and/or the proposed fee categories. (See
Section II, Item E, ``License Application and Annual Fees.'')
(8) Whether private collectors of items or products containing
radium-226 believe these items or products will remain within the
boundaries of the proposed general license and whether private
collectors believe they will be required to obtain a specific license.
(See Section II, Item E, ``License Application and Annual Fees.'')
(9) Proposed fee categories and amounts and the two-tiered fee
level. (See Section II, Item E, ``License Application and Annual
Fees.'')
(10) The proposed effective date for the final rule and other
implementation periods. (See Section II, Item F, subsection
``Implementation Period.'')
(11) The compatibility category designations and, in particular, on
the compatibility designation of the definition of Discrete source.
(See Section V.)
(12) The environmental assessment. (See Section VIII.)
(13) Information collections aspects. (See Section IX.)
(14) Draft regulatory analysis. (See Section X.)
(15) Impacts on small businesses. (See Section XI.)
III. Section by Section Analysis of Substantive Changes
Part 20--Standards for Protection Against Radiation
The authority citation for this part would be revised to reflect
the EPAct.
Section 20.1003 Definitions
The definition of Byproduct material would be 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 would be added.
A definition of Waste would be 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 20.2001 General requirements
Paragraph (a)(4) would be revised to include the new 10 CFR 20.2008
which addresses disposal of waste.
Section 20.2006 Transfer for disposal and manifests
Paragraph (e) would be added to require the use of uniform
manifests for disposal of 11e.(3) and 11e.(4) byproduct material 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 would be added to Part 20 to address disposal
requirements for byproduct material as defined in Sections 11e.(3) and
11e.(4) of the AEA.
Part 30--Rules of General Applicability to Domestic Licensing of
Byproduct Material
The authority citation for this part would be revised to reflect
the EPAct.
Section 30.3 Activities requiring license
This section would be 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 the NRC's waiver of 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 such
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 rule.
This section would also be 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 would revise 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 would be revised to be
consistent with the new definition in the AEA, with the exception that
it would not include byproduct material as defined in Section 11e.(2)
of the AEA.
The following definitions would be added to this section:
Accelerator-produced radioactive material, Cyclotron, Discrete source,
and Particle accelerator.
Section 30.15 Certain items containing byproduct material
This section would be revised to add paragraph (a)(1)(viii) to
authorize 0.037 MBq (1 [mu]Ci) of radium-226 per
[[Page 42971]]
timepiece in intact timepieces manufactured before the effective date
of the rule, and limited repair activities involving non-intact
timepieces.
Section 30.18 Exempt quantities
Paragraph (b) would be revised to include accelerator-produced
radioactive material, now considered byproduct material, that might
have been distributed under an authorization of a State, that was
received or acquired before September 25, 1971, under the general
license then provided in 10 CFR 31.4 or similar general license of a
State.
Section 30.20 Gas and aerosol detectors containing byproduct material
Paragraph (a) would be 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)(1) would be revised to accept information from sealed
source or device registrations with regard to NARM issued by States
under provisions comparable to 10 CFR 32.210 as a basis for licensing
the use of sources and devices.
Section 30.34 Terms and conditions of licenses
Paragraph (g) would be 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.
Section 30.71 Schedule B
Schedule B would be revised to include 13 radionuclides, that are
now considered byproduct material, and their associated activities.
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 would be revised to specifically include
radium-226 and its associated values.
Part 31--General Domestic Licenses for Byproduct Material
The authority citation for this part would be revised to reflect
the EPAct.
Section 31.5 Certain detecting, measuring, gauging, or controlling
devices and certain devices for producing light or an ionized
atmosphere
Paragraph (b)(1) would be 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) would be revised to add radium-226, with an
activity of at least 3.7 MBq (0.1 mCi) to the criteria for devices
requiring registration.
Section 31.8 Americium-241 and radium-226 in the form of calibration or
reference sources
The heading and paragraph (a) would be revised to include radium-
226 in this general license for calibration and reference sources.
Paragraph (b) would be revised to include radium-226 calibration or
reference 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) would be revised to include an activity limit of
0.185 MBq (5 [mu]Ci) of radium-226.
Paragraph (c)(2) would be 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) would be 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) would be revised to include cobalt-57 to the
list of authorized byproduct material for use in in vitro clinical or
laboratory testing.
Paragraph (d) would be 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 would be 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
A new section, 10 CFR 31.12, would be added to the regulations to
add a general license for certain items and self-luminous products
containing radium-226 that were manufactured prior to the effective
date of the rule. The general license addresses radium-226 contained in
products such as antiquities originally intended for use by the general
public, luminous items installed in aircraft, luminous items no longer
installed in aircraft, other luminous products including timepiece
hands and dials no longer installed in timepieces, and small radium
sources containing no more than 0.037 MBq (1 [mu]Ci) of radium-226.
The general license would exempt persons from the provisions of 10
CFR parts 19, 20, and 21 to the extent that receipt, possession, use,
or transfer are within the terms of the general license. However, the
exemption shall not be deemed to apply to any person who is also
specifically licensed by the Commission.
The general license would include requirements for notification,
reporting, and disposal. The general license would prohibit abandoning
the device, and it would not authorize the manufacture, assembly,
disassembly, repair, or import of products containing radium-226.
Export shall only be in accordance with 10 CFR part 110.
Part 32--Specific Domestic Licenses To Manufacture or Transfer Certain
Items Containing Byproduct Material
The authority citation for this part would be revised to reflect
the EPAct.
Section 32.1 Purpose and scope
A new paragraph (c) would be 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
[[Page 42972]]
agencies and Federally recognized Indian Tribes on the effective date
of the final rule.
This paragraph would allow 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 would be revised to add radium-226.
Section 32.58 Same: Labeling of devices
This section would be revised to include radium-226 in the example
label.
Section 32.59 Same: Leak testing of each source
This section would be 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) would be added to include cobalt-57, in units not
exceeding 0.37 MBq (10 [mu]Ci), each, to the list of authorized
byproduct material approved for distribution.
Paragraph (c)(1) would be 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 10 CFR part 35
Paragraph (a) would be revised to ensure that the NRC regulation
encompasses all byproduct, non-PET accelerator-produced radioactive
material, and PET drug production facilities registered with the FDA or
a State agency.
Paragraph (b) would be revised to authorize PET radionuclide
production, if under the supervision of an authorized user; to
recognize nuclear pharmacists who, before the effective date of the
final rule, prepared only accelerator-produced radioactive drugs as
authorized nuclear pharmacists under the NRC's waiver of August 31,
2005; and to allow the use of the notification process as specified in
10 CFR 35.14 for authorized nuclear pharmacists who, before the
effective date of the final rule, prepared accelerator-produced
radioactive drugs, and who were identified on permits issued by the
master materials licensees, or on permits issued by master materials
permittees of broad scope, to also work as authorized nuclear
pharmacists at a commercial nuclear pharmacy under the notification
process.
Section 32.102 Schedule C--prototype tests for calibration or reference
sources containing americium-241 or radium-226
The heading and section would be revised to include radium-226.
Part 33--Specific Domestic Licenses of Broad Scope for Byproduct
Material
The authority citation for this part would be revised to reflect
the EPAct.
Section 33.100 Schedule A
This table would be revised to add four additional radionuclides
and their associated values.
Part 35--Medical Use of Byproduct Material
The authority citation for this part would be revised to reflect
the EPAct.
Section 35.2 Definitions
The definitions of Authorized nuclear pharmacists and Authorized
user would be revised to encompass those individuals who, before the
EPAct, only used accelerator-produced radioactive material and discrete
sources of radium-226 in non-Agreement States, Agreement States, or
Federal facilities that may have never been identified on a license or
a permit.
The definitions of Cyclotron and Positron Emission Tomography (PET)
radionuclide production facility would be added.
Section 35.10 Implementation
A new paragraph (a) would be 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 individuals using this material for medical use on when
they must comply with the requirements of this part.
Section 35.11 License required
A new paragraph (a), with the remaining paragraphs redesignated,
would be 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 of August 31, 2005, to have time to
apply for and receive a new medical use license. This section would
provide the time period for applying for a new license.
Section 35.13 License amendments
Paragraph (a) would be 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 of August 31,
2005, to continue to use this material provided that they submit
application to amend their licenses. This section would provide the
time period for amending licenses.
A new paragraph (b)(4)(v) would be added to grandfather physicians
and pharmacists who only used accelerator-produced radioactive
materials or discrete sources of radium-226 during the NRC's waiver of
August 31, 2005.
Paragraph (e) would be 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
radionuclide delivery line from the PET radionuclide 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 would continue to be
excluded from this requirement.
Section 35.14 Notifications
Paragraph (a) would be revised to address 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 of
August 31, 2005.
Paragraph (b) would be 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
[[Page 42973]]
relocations of either an area where PET radionuclides are produced or a
radionuclide delivery line from the PET radionuclide production area.
Section 35.15 Exemptions regarding Type A specific licenses of broad
scope
Paragraph (f) would be revised to retain the existing notification
exemption for addition 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 radionuclide
delivery line from the PET radionuclide production area.
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) would be added to grandfather Radiation
Safety Officers, medical physicists, or nuclear pharmacists who only
used accelerator-produced radioactive materials or discrete sources of
radium-226 during the NRC's waiver of August 31, 2005.
A new paragraph (b)(3) would be added to grandfather physicians,
dentists, or podiatrists who only used accelerator-produced radioactive
materials or discrete sources of radium-226 under the NRC's waiver of
August 31, 2005.
Section 35.63 Determination of dosages of unsealed byproduct material
for medical use
This section would be revised to add a new provision in paragraphs
(b)(2) and (c)(3) to include an NRC or Agreement State medical use
licensee with a PET radionuclide production facility.
Section 35.69 Labeling of vials and syringes and transport radiation
shields
The heading would be revised to add transport radiation shields,
and the section would be revised to reorganize existing text and add a
new provision to address labeling requirements for medical use
licensees that are authorized for noncommercial distribution of PET
drugs.
Section 35.100 Use of unsealed byproduct material for uptake, dilution,
and excretion studies for which a written directive is not required
Paragraph (a) of this section would be revised to permit medical
use licensees to obtain PET radionuclides and drugs by noncommercial
transfer from an NRC or Agreement State medical use licensee with a PET
radionuclide production facility.
Paragraph (b) of this section would be revised to continue to allow
medical use licensees to obtain unsealed byproduct material for uptake,
dilution, and excretion studies from individuals listed within this
paragraph, with the exception of obtaining PET radionuclides produced
by these individuals.
Section 35.200 Use of unsealed byproduct material for imaging and
localization studies for which a written directive is not required
Paragraph (a) of this section would be revised to permit medical
use licensees to obtain PET radionuclides and drugs by noncommercial
transfer from an NRC or Agreement State medical use licensee with a PET
radionuclide production facility.
Paragraph (b) of this section would be revised to continue to allow
medical use licensees to obtain unsealed byproduct material for uptake,
dilution, and excretion studies from individuals listed within this
paragraph, with the exception of obtaining PET radionuclides produced
by these individuals.
Section 35.204 Permissible molybdenum-99, strontium-82, and strontium-
85 concentrations
The heading of this section would be revised to add strontium-82
and strontium-85.
Paragraph (a) of this section would be revised to address
acceptable strontium-82 and strontium-85 concentrations when eluting
strontium-82/rubidium-82 generators.
Paragraph (c) of this section would be revised and redesignated,
and a new paragraph (c) would be 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) of this section would be revised to permit medical
use licensees to obtain PET radionuclides and drugs by noncommercial
transfer from an NRC or Agreement State medical use licensee with a PET
radionuclide production facility.
Paragraph (b) of this section would be revised to continue to allow
medical use licensees to obtain unsealed byproduct material for uptake,
dilution, and excretion studies from individuals listed within this
paragraph, with the exception of obtaining PET radionuclides produced
by these individuals.
Section 35.2204 Records of molybdenum-99, strontium-82, and strontium-
85 concentrations
The heading would be revised to add strontium-82 and strontium-85,
and this section would be 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 would be revised to reflect
the EPAct.
Section 50.2 Definitions
The definition of Byproduct material would be 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 would be revised to reflect
the EPAct.
Section 61.2 Definitions
The definition of Waste would be 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 would be revised to reflect
the EPAct.
Section 62.2 Definitions
The definition of Low-level radioactive waste would be revised to
correct a cross reference and 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
The authority citation for this part would be revised to reflect
the EPAct.
Section 72.3 Definitions
The definition of Byproduct material would be revised to be
consistent with the definition in 10 CFR 30.4. This definition would be
consistent with the definition of Byproduct material in the EPAct, with
the exception that it will
[[Page 42974]]
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 would be revised to reflect
the EPAct.
Section 110.2 Definitions
Definitions of Accelerator-produced radioactive material, Discrete
source, and Particle accelerator would be added.
Part 150--Exemptions and Continued Regulatory Authority in Agreement
States and in Offshore Waters Under Section 274
The authority citation for this part would be revised to reflect
the EPAct.
Section 150.3 Definitions
The definition of Byproduct material would be revised to be
consistent with the definition in the EPAct.
A definition of Discrete source would be 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 would be revised to reflect
the EPAct.
Section 170.3 Definitions
The definition of Byproduct material would be revised to be
consistent with the new definition in the AEA, with the exception that
it would 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 would be revised to include licenses that would not be
included in existing fee categories. Fee Category 3.B. would be revised
to include licenses for repair, assembly, and disassembly of products
containing radium-226. Two new fee categories, 3.R. and 3.S., would be
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 would be revised to reflect
the EPAct.
Section 171.5 Definitions
The definition of Byproduct material would be revised to be
consistent with the new definition in the AEA, with the exception that
it would not include byproduct material as defined in Section 11e.(2)
of the AEA.
Section 171.16 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
This section would be revised to include licenses that would not be
included in existing fee categories. Fee Category 3.B. would be revised
to include licenses for repair, assembly, and disassembly of products
containing radium-226. Two new fee categories, 3.R. and 3.S., would be
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.
IV. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 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.
V. 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 proposed rule would be a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency among the
Agreement States and the NRC requirements. The NRC staff analyzed the
proposed 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/).
NRC program elements (including regulations) are placed into four
compatibility categories (See the Draft 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 Atomic Energy Act, as amended, or provisions of Title 10 of
the Code of Federal Regulations. These program elements are not adopted
by Agreement States.
[[Page 42975]]
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 NRC invites comment on the compatibility category designations
in the proposed rule and suggests that commenters refer to Handbook 5.9
of Management Directive 5.9 for more information. The NRC notes that,
like the rule text, the compatibility category designations can change
between the proposed rule and final rule, based on comments received
and Commission decisions regarding the final rule. The NRC encourages
anyone interested in commenting on the compatibility category
designations in any manner to do so during the comment period.
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 would be amended to reflect the changes to the AEA. The
definition of Byproduct material in Parts 50, 72, 170, and 171 is
reserved to NRC. For the definition of Byproduct material in 10 CFR
Parts 20, 30 and 150, the NRC proposes to identify it 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,'' since 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 proposed rule as
H&S since it is a part of the definition of Byproduct material. NRC
specifically requests comments on the compatibility designations. In
particular, NRC requests comments on whether the definitions of
Byproduct material and Discrete source are correctly identified as H&S,
considering the procedures in Management Directive 5.9 and considering
that the EPAct redefined the term byproduct material and required the
NRC to include a definition of Discrete source in its final
regulations. If commenters believe that these definitions should not be
identified as H&S, the NRC requests comment and justification for a
different compatibility category under Management Directive 5.9.
Draft 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 Source ........................... H&S
20.1003............................. Add........................ Definition: Waste.......... ........................... B
20.2001(a)(4)....................... Amend...................... General requirements (add C.......................... C
reference to new Sec.
20.2008).
20.2006(e).......................... Add........................ Transfer for disposal and ........................... B
manifests (add 11e.(3) and
11e.(4) byproduct
material).
20.2008............................. Add........................ Disposal of 11e.(3) and ........................... B
11e.(4) byproduct material
(new section).
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: Accelerator- ........................... H&S
produced radioactive
material.
30.4................................ Amend...................... Definition: Byproduct [A]........................ [H&S]
material (add 11e.(3) &
11e.(4) material).
30.4................................ Add........................ Definition: Cyclotron...... ........................... D
30.4................................ Add........................ Definition: Discrete source ........................... H&S
30.4................................ Add........................ Definition: Particle ........................... H&S
Accelerator.
30.15(a)(1)(viii)................... Add........................ Certain items containing B (all Sec. 30.15)....... B
byproduct material (add
radium-226 intact
timepieces and limited
repairs).
30.18(b)............................ Amend...................... Exempt quantities (add B (all Sec. 30.18)....... B
11e.(3) material).
30.20(a)............................ Amend...................... Gas and aerosol detectors B (all Sec. 30.20)....... B
containing byproduct
material (grandfather
11e.(3) detectors).
[[Page 42976]]
30.32(g)(1)......................... Amend...................... Application for specific C.......................... C
licenses.
30.34(g)............................ Amend...................... Terms and conditions of D.......................... H&S
licenses (add strontium-82/
rubidium-82 generators).
30.71............................... Amend...................... Schedule B (add 11e.(3) B.......................... B
material).
30.72............................... Amend...................... Schedule C--Quantities of H&S........................ H&S
radioactive materials
requiring consideration of
the need for an emergency
plan for responding to a
release (add radium-226).
31.5(b)(1) & (c)(13)................ Amend...................... Certain detecting, B (all Sec. 31.5)........ B
measuring, gauging, or
controlling devices and/or
an ionizing atmosphere
(add devices with NARM
approved by States).
31.8................................ Amend...................... Americium-241 in the form D.......................... D
of calibration or
reference sources (add
radium-226).
31.11............................... Amend...................... General license for use of D.......................... D
byproduct material for
certain in vitro clinical
or laboratory testing (add
cobalt-57).
31.12............................... Add........................ General license for certain ........................... C
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).
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 reference B.......................... B
sources containing
americium-241:
Requirements for license
to manufacture or
initially transfer (add
radium-226).
32.58............................... Amend...................... Same: Labeling of devices B.......................... B
(add radium-226).
32.59............................... Amend...................... Same: Leak testing of each B.......................... B
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), (v), & Amend...................... Manufacture, preparation, B.......................... B
(b). 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 tests B.......................... B
for calibration or
reference sources
containing americium-241
(add radium-226).
33.100.............................. Amend...................... Schedule A (add beryllium- D.......................... D
7, cobalt-57, radium-226,
& sodium-22).
35.2................................ Amend...................... Definition: Authorized B.......................... B
nuclear pharmacist
(recognize pharmacist, who
used 11e.(3) material).
35.2................................ Amend...................... Definition: Authorized user B.......................... B
(recognize authorized
user, who used 11e.(3)
material).
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 (reference C.......................... C
to 35.11(c).
35.11(c)(1)......................... Add........................ License required (authorize ........................... NRC
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 (authorize ........................... D
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 materials while
applying for amendment).
35.13(b)(4)(v)...................... Add........................ License amendments D.......................... D
(grandfather physicians
and pharmacists that used
11e.(3) material).
35.13(e)............................ Amend...................... License amendments (clarify D.......................... D
amendment need).
35.14(a) and (b)(4)................. Amend...................... Notifications (using D.......................... D
notification to allow
continued operation for
certain 11e.(3) material).
[[Page 42977]]
35.15(f)............................ Amend...................... Exemptions regarding Type A D.......................... D
specific licenses of broad
scope (clarify the
exemption).
35.57(a)(3) & (b)(3)................ Amend...................... Training for experienced B.......................... B
Radiation Safety Officer,
teletherapy or medical
physicist, authorized
user, and nuclear
pharmacist (grandfather
RSO, who used 11e.(3)
material).
35.63(b)(2)(ii) & (c)(3)............ Amend...................... Determination of dosages of H&S........................ H&S
unsealed byproduct
material for medical use
(recognize State licenses
and State requirements).
35.63(b)(2)(iii).................... Add........................ Determination of dosages of ........................... H&S
unsealed byproduct
material for medical use
(recognize State licenses
of PET facilities).
35.69(b)............................ Add........................ Labeling of vials and H&S........................ H&S
syringes (to include PET
drugs).
35.100(a) & (b)..................... Amend...................... Use of unsealed byproduct H&S........................ H&S
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 byproduct H&S........................ H&S
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-99 H&S........................ H&S
concentrations (add
strontium-82 & strontium-
85).
35.204(c)........................... Add........................ Permissible molybdenum-99 ........................... D
concentrations (add
strontium-82 & strontium-
85.
35.204(d)........................... Redesignated............... Permissible molybdenum-99 D.......................... D
concentrations.
35.300(a) and (b)................... Amend...................... Use of unsealed byproduct H&S........................ H&S
material for which a
written directive is
required (allow use of PET
radionuclides).
35.2204............................. Amend...................... Records of molybdenum-99 D.......................... D
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 (clarify B.......................... B
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: Accelerator- ........................... NRC
produced radioactive
material.
110.2............................... Add........................ Definition: Discrete source ........................... NRC
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 source ........................... H&S
--------------------------------------------------------------------------------------------------------------------------------------------------------
10 CFR Part 170 address areas that generally are applicable only to NRC's regulatory program; therefore, no compatibility designation is assigned.
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.3............................... Amend...................... Definition: Byproduct
material (add 11e.(3) &
11e.(4) material).
170.31 Table: 3B.................... Amend...................... Other licenses for
possession and use of
byproduct material issued
under Part 30 (revise to
include radium-226).
170.31 Table: 3R.1.................. Add........................ Possession of items or
products containing radium-
226 (add a new fee
category).
170.31 Table: 3R.2.................. Add........................ Possession of items or
products containing radium-
226 (add a new fee
category).
170.31 Table: 3S.................... Add........................ License for production of
accelerator-produced
radionuclides (add a new
fee category).
--------------------------------------------------------------------------------------------------------------------------------------------------------
10 CFR Part 171 address areas that generally are applicable only to NRC's regulatory program; therefore, no compatibility designation is assigned.
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.5............................... Amend...................... Definition: Byproduct
material (add 11e.(3) &
11e.(4) material).
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.16 Table: 3B.................... Amend...................... Other licenses for
possession and use of
byproduct material issued
under part 30 (revise to
include radium-226).
171.16 Table: 3R.................... Add........................ Possession of items or
products containing radium-
226 (add a new fee
category).
171.16 Table: 3S.................... Add........................ License for production of
accelerator-produced
radionuclides (add a new
fee category).
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 42978]]
VI. Plain Language
The Presidential Memorandum dated June 1, 1998, entitled ``Plain
Language in Government Writing,'' directed that the Government's
writing be in plain language. The NRC requests comments on this
proposed rule specifically with respect to the clarity and
effectiveness of the language used. Comments should be sent to the
address listed under the heading ADDRESSES above.
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 proposed rule, the NRC would assume
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 required 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
proposed 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 the proposed rule.
VIII. Environmental Assessment and Finding of No Significant
Environmental Impact: Availability
The Commission is preparing an environmental assessment to
determine if an environmental impact statement would be required for
this proposed rule. Under the National Environmental Policy Act of
1969, as amended, and the Commission's regulations in Subpart A of 10
CFR Part 51, an environmental impact statement is required if this
proposed rule, if adopted, is likely to be a major Federal action
significantly affecting the quality of the human environment.
Amendments to the NRC's regulations would incorporate new materials
into the NRC's byproduct material regulatory program or establish new
program elements, if needed. Before the EPAct, the regulation of
naturally occurring and accelerator-produced radioactive material
(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 proposed amendments to the
NRC regulations would provide a uniform regulatory environment for the
acquisition, possession, use, transfer, and disposal of NARM. This
uniform regulatory environment would be 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 would start with the existing generic requirements for
accelerator-produced radioactive material that had already been
developed by the States for the SSRs, little, if any, change is
expected to the byproduct material regulatory programs already in place
for Agreement States. Consequently, for Agreement States, the primary
foreseeable impact of the regulatory changes applicable to accelerator-
produced radioactive material is that the regulations would be
uniformly applied by all Agreement States. Therefore, for the
regulation of accelerator-produced radioactive material by the
Agreement States, the proposed amendments to the NRC regulations, if
adopted, are not expected to have any adverse environmental impacts.
In non-Agreement States, the proposed amendments to the NRC
regulations would most likely 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, if any, the result would most
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 would most likely continue
with its current practice, and no substantial impact on the environment
would be anticipated. Therefore, it is expected that the overall
environmental impacts of the proposed regulation of accelerator-
produced radioactive material by non-Agreement States, if adopted,
would be positive.
The effects of the proposed amendments to the NRC regulations
applicable to discrete sources of radium-226 and discrete sources of
other naturally occurring radioactive material would 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 on the acquisition, possession,
use, transfer, and disposal of these discrete sources of naturally
occurring radioactive material would 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 proposed NRC regulations
applicable to discrete sources of naturally occurring radioactive
material, if adopted, is anticipated to be beneficial to the
environment, and it is expected that the overall environmental impacts
would be positive.
Therefore, the preliminary determination of this environmental
assessment is that there will be no significant impact to the public
from this action. However, the general public should note that the NRC
welcomes public participation. Comments on any aspect of the
environmental assessment may be submitted to the NRC as indicated under
the ADDRESSES heading.
The NRC has sent a copy of the environmental assessment and this
proposed rule to every State Liaison Officer and request their comments
on the environmental assessment. The environmental assessment may be
examined at the NRC Public Document Room, O-1F21, 11555 Rockville Pike,
Rockville, MD. Single copies of the environmental assessment will be
available from Lydia Chang, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-6319, e-mail [email protected].
IX. Paperwork Reduction Act Statement
This proposed 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
information collection requirements have been submitted to the Office
of Management and Budget for review and approval. The proposed changes
to 10 CFR parts 33, 50, 61, 62, 72, 110, 150, 170 and 171 do not
contain new or amended information collection requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR parts 20, 30, 31,
32, 33, 35, 50, 61, 62, 72, 110, 150, 170, and 171, ``Requirements for
Expanded Definition of Byproduct Material.''
[[Page 42979]]
The form number if applicable: NRC Forms 4, 5, 313, 313A, 314, and
664.
How often the collection is required: Initially, periodically based
on regulated activity, quarterly, annually, and at license termination.
Who will be required or asked to report: New licensees that operate
certain linear accelerators or cyclotrons for the purposes of producing
radionuclides, new licensees that manufacture or transfer certain items
containing discrete radium-226 sources, or that possess products that
contain radium-226 sources, and existing licensees that may have
additional testing, labeling, or reporting requirements due to their
possession of radioactive material that fits the expanded definition of
byproduct material.
An estimate of the number of annual responses: 5,258 (10 CFR part
19--350 responses; 10 CFR 20--511 responses; 10 CFR 30--250 responses;
10 CFR part 31--540 responses; 10 CFR 32--220 responses; 10 CFR 35--759
responses; NRC Form 4--30 responses; NRC Form 5--1,030 responses; NRC
Form 313--1,250 responses; NRC Form 313A--300 responses; NRC Form 314--
1 response; NRC Form 664--15 responses).
The estimated number of annual respondents: 2,358 (10 CFR 19--200
respondents; 10 CFR 20--250 respondents; 10 CFR 30--10 respondents; 10
CFR 31--40 respondents; 10 CFR 32--110 respondents; 10 CFR 35--122
respondents; NRC Form 4--30 recordkeepers; NRC Form 5--30 respondents;
NRC Form 313--1,250 respondents; NRC Form 313A--300 respondents; NRC
Form 314--1 respondent; NRC Form 664--15 respondents).
An estimate of the total number of hours needed annually to
complete the requirement or request: The total burden increase for this
rulemaking is 110,600 hours (10 CFR part 19 --4,811 hours; 10 CFR 20--
8,843 hours; 10 CFR 30--5,393 hours; 10 CFR part 31--200 hours; 10 CFR
32--43,019 hours; 10 CFR 35--29,526 hours; NRC Form 4--21 hours; NRC
Form 5--2,231 hours; NRC Form 313--15,550 hours; NRC Form 313A--1,000
hours; NRC Form 314--1 hour; NRC Form 664--5 hours).
Abstract: The NRC is proposing to amend its regulations to include
jurisdiction over certain radium sources, accelerator-produced
radioactive materials, and certain naturally occurring radioactive
material, as required by the EPAct, which was signed into law on August
8, 2005. Section 651(e) of the EPAct expanded the AEA's 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, 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 in a commercial, medical, or research activity. In so doing,
these materials were placed under the NRC's regulatory authority.
Section 651(e) of the EPAct also mandated that the Commission, after
consultation with States and other stakeholders, issue final
regulations establishing requirements that the Commission determines
necessary to carry out this section and the amendments made by this
section. This proposed rule would establish licensing requirements with
associated recordkeeping and reporting requirements that would be
applied to licensees that possess, transfer, manufacture or distribute
these radioactive materials newly placed under NRC jurisdiction. The
NRC has used to the maximum extent practicable the CRCPD's applicable
SSRs in developing this proposed rule. The U.S. Nuclear Regulatory
Commission is seeking public comment on the potential impact of the
information collections contained in the proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and
rule are available at the NRC worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the
signature date of this notice and are also available at the rule forum
site, http://ruleforum.llnl.gov.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
above issues, by August 28, 2006 to the Records and FOIA/Privacy
Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail to
[email protected] and to the Desk Officer, John A. Asalone, Office
of Information and Regulatory Affairs, NEOB-10202 (3150-0044, -0014, -
0017, -0016, -0001, -0010, -0005, -0006, -0120, -0028, and -0198),
Office of Management and Budget, Washington, DC 20503. Comments
received after this date will be considered if it is practical to do
so, but assurance of consideration cannot be given to comments received
after this date. You may also e-mail comments to [email protected] or comment by telephone at (202) 395-4650.
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 draft regulatory analysis on this
proposed regulation. The draft regulatory analysis examines the costs
and benefits of the alternatives considered by the Commission.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft regulatory analysis may be submitted to
the NRC as indicated under the ADDRESSES heading. The draft 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 website at http://ruleforum.llnl.gov. Single copies of the
regulatory analysis are available from Lydia Chang, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone (301) 415-6319, 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 would not, if
promulgated, 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
[[Page 42980]]
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 would amend
the NRC regulations to include this newly defined byproduct material.
This amendment would 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 would qualify as small business entities as
defined by 10 CFR 2.810. However, the proposed 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 draft regulatory analysis,
the NRC believes that the selected alternative reflected in the
proposed 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.
Because of the broad spectrum of products and uses for this newly
defined byproduct material and the potential impact to a wide
population of individuals, businesses, and licensees, the NRC is
specifically requesting public comment concerning the impact of the
proposed regulation. The NRC particularly desires comment from
individuals, businesses, or licensees, who qualify as small businesses,
as to how the proposed regulation will affect them and how the
requirements imposed on small entities may be modified to be less
stringent while still adequately protecting the public health and
safety. Comments on how the regulation could be modified to take into
account the differing needs of small entities should specifically
discuss:
1. Are small businesses likely to be affected by the proposed
regulations? If so, for what types of material and/or equipment that
are currently, or may potentially be, used (e.g., accelerators,
cyclotrons, radium sources)? How many small businesses would be
affected by the proposed regulations?
2. If small businesses are likely to be affected by the proposed
regulations, is the significance of the potential economic burden
related to the size of the business? If so, how? How does this burden
compare to larger organizations in the same business community?
3. How could the proposed regulations be modified to take into
account the differing needs or capabilities of small businesses while
maximizing potential benefits and minimizing the potential economic
burden? What would be the approximate level of benefits to your entity
if this change was made in the proposed rule?
4. How would these modifications to the proposed regulations (from
question 3) act to more closely equalize the impact of the regulations
or create more equal access to the benefits as opposed to providing
special advantages to any individuals or groups?
5. Would these modifications (from question 3) act to increase,
maintain, or decrease the NRC's ability to adequately protect public
health and safety? How?
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 proposed rule because this
amendment would not involve any provisions that would impose backfits
as defined in 10 CFR Chapter 1. Therefore, a backfit analysis is not
required.
List of Subject
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.
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
[[Page 42981]]
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.
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. 553; the NRC is proposing to
adopt 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
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).
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 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 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.
* * * * *
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
definition of Byproduct material set forth in this section.
* * * * *
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, 20.2102, 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, 20.2008, 20.2301, and appendix G to this part.
* * * * *
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.
* * * * *
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 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.
6. Section 20.2008 is added to Subpart K--Waste Disposal--to read
as follows:
[[Page 42982]]
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.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
7. 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).
8. 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 [date 60 days after
date of publication of final rule], 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 [date 8 months after date of publication of
final rule].
(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 tribe submits an
application for a license authorizing activities involving these
materials on or before [date 1 year and 2 months after date of
publication of final rule].
(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 individual submits an amendment
application on or before August 7, 2009, or earlier as noticed by the
NRC.
(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 individual submits a
license application on or before August 7, 2009, or earlier as noticed
by the NRC.
(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.
9. In Sec. 30.4, the definition of Byproduct material is revised,
and the definitions of Accelerator-produced radioactive material,
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--
(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
[[Page 42983]]
(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.
* * * * *
Cyclotron means a circular particle accelerator in which charged
particles are bent traveling through the accelerator. 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 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.
* * * * *
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.
* * * * *
10. 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 [date 60 days
after the date of publication of the final rule]. However,
notwithstanding the requirement that timepieces be intact, antique
collectors and watch repair facilities may repair no more than 10
timepieces in any one year.
* * * * *
11. 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 for accelerator-produced radioactive material, 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 of this chapter to the extent
that this person possesses, uses, transfers, or owns byproduct
material.
* * * * *
12. 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 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 manufactures, processes, produces, or initially transfers 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 [date 60 days after the
date of publication of the final rule] 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.
* * * * *
13. In Sec. 30.32, paragraph (g)(1) is revised 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 with a State regarding source or device
containing radium-226 or accelerator-produced radioactive material
under provisions comparable to Sec. 32.210 of this chapter; or
* * * * *
14. In Sec. 30.34, paragraph (g) is revised 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.
* * * * *
15. Section 30.71 is revised 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
[[Page 42984]]
* * * * *
Yttrium 87 (Y 87)....................................... 10
Yttrium 88 (Y 88)....................................... 10
* * * * *
------------------------------------------------------------------------
16. Section 30.72 is revised 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
17. 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), Pub. L. 109-58, 119
Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).
18. 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.
* * * * *
19. 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.
* * * * *
(b)(1) * * *
(i) A specific license issued under Sec. 32.51 of this chapter;
(ii) An equivalent specific license issued by an Agreement State;
or
(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.
* * * * *
20. 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
these 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 [DATE 60 DAYS AFTER THE
DATE OF PUBLICATION OF THE FINAL RULE] 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
[[Page 42985]]
reference sources containing americium-241 or radium-226.
21. 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 [date 60
days after the date of publication of the final rule], 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]
22. Sections 31.12, 31.13, and 31.14 are redesignated as Sec.
31.21, Sec. 31.22, and Sec. 31.23, respectively, and new Sec. Sec.
31.13 through 31.20 are added and 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 manufactured prior to [date 60 days after
date of publication of final rule]:
(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) Luminous items installed in aircraft.
(3) Luminous items no longer installed in aircraft, provided that
no more than 100 are used or stored at the same location at any one
time.
(4) Other luminous products including timepiece hands and dials no
longer installed in timepieces, provided that no more than 50 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
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, 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 parts 19, 20, and 21, 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 Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30
days.
(2) Shall not abandon the device containing radium-226. The
product, and any radioactive material from the product, may only be
disposed of according to Sec. 20.2008 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 the device containing radium-226 except in
accordance with part 110 of this chapter.
(4) Shall dispose of the product containing radium-226 by export
only as provided by paragraph (c)(3) of this section, 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 Nuclear Material Safety and Safeguards, 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.
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
23. 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).
24. 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
[[Page 42986]]
discrete sources of radium-226 on [date 60 days after date of
publication of final rule] 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 or part 35 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 [date 1 year and 2 months after date of publication of final
rule] or an amendment application for these activities on or before
[date 8 months after date of publication of final rule].
(2) The requirements in this part, including provisions that are
specific to licensees, shall apply to all persons other than those
included in (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 or part 35 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 individual submits a license
application or amendment on or before August 7, 2009, or earlier as
noticed by the NRC.
25. In Sec. 32.57, the heading and the introductory text are
revised to read as follows:
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:
* * * * *
26. 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 licensd 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)
27. 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.
28. 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
* * * * *
29. In Sec. 32.72, paragraphs (a)(2)(i), (a)(2)(iii), (a)(2)(iv),
and (b) 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) A licensee described by paragraph (a)(2)(iii) or (iv) of this
section:
(1) May produce Positron Emission Tomography (PET) radionuclides
provided that the PET radionuclide production is under the supervision
of an authorized user who meets the requirements of Sec. 30.33(a)(3)
of this chapter.
(2) May prepare radioactive drugs for medical use, as defined in
Sec. 35.2 of this chapter, provided that the radioactive drugs are
prepared by either an authorized nuclear pharmacist, as specified in
paragraphs (b)(3) and (b)(5)
[[Page 42987]]
of this section, or an individual under the supervision of an
authorized nuclear pharmacist as specified in Sec. 35.27 of this
chapter.
(3) May allow a pharmacist to work as an authorized nuclear
pharmacist if:
(i) This individual qualifies as an authorized nuclear pharmacist
as defined in Sec. 35.2 of this chapter;
(ii) This individual meets the requirements specified in Sec. Sec.
35.55(b) and 35.59, and the licensee has received an approved license
amendment identifying this individual as an authorized nuclear
pharmacist; or
(iii) This individual is designated as an authorized nuclear
pharmacist in accordance with paragraph (b)(5) of this section.
(4) The actions authorized in paragraphs (b)(1), (b)(2), and (b)(3)
of this section are permitted in spite of more restrictive language in
license conditions.
(5) 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 [date 60 days after date of
publication of final rule] or at all other pharmacies before August 8,
2009, or an earlier date as noticed by the NRC.
(6) Shall provide to the Commission a copy of each individual's
certification by the Board of Pharmaceutical Specialties, the
Commission or Agreement State license, Commission master materials
licensee permit, 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, and a copy of the state pharmacy licensure or
registration, no later than 30 days after the date that the licensee
allows, pursuant to paragraphs (b)(3)(i) and (b)(3)(iii) of this
section, the individual to work as an authorized nuclear pharmacist.
* * * * *
30. 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 kilobecquerel (0.005 microcurie) of
americium-241 or radium-226, as follows:
* * * * *
PART 33--SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT
MATERIAL
31. 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).
32. Section 33.100 is revised by adding Beryllium-7, Cobalt-57,
Radium-226, and Sodium-22 in alphabetical order to read as follows:
Sec. 33.100 Schedule A.
------------------------------------------------------------------------
Col. I Col. II
Byproduct material curies 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
33. 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).
34. In Sec. 35.2, the definitions for Authorized nuclear
pharmacist and Authorized user are revised, and new definitions for
Cyclotron and Positron Emission Tomography (PET) radionuclide
production facility are added alphabetically to read as follows:
Sec. 35.2 Definitions.
* * * * *
Authorized nuclear pharmacist means a pharmacist who--
(1) Meets the requirements in Sec. Sec. 35.55(a) and 35.59; or
(2) Is identified as an authorized nuclear pharmacist on--
(i) A specific license issued by the Commission or Agreement State
that authorizes medical use or the practice of nuclear pharmacy;
(ii) A permit issued by a Commission master material licensee that
authorizes medical use or the practice of nuclear pharmacy;
(iii) A permit issued by a Commission or Agreement State broad
scope medical use licensee that authorizes medical use or the practice
of nuclear pharmacy; or
(iv) A permit issued by a Commission master material license broad
scope medical use permittee that authorizes medical use or the practice
of nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist by a
commercial nuclear pharmacy that has been authorized to identify
authorized nuclear pharmacists; or
(4) Is designated as an authorized nuclear pharmacist in accordance
with Sec. 32.72(b)(5) of this chapter; or
(5) Prepared only radioactive drugs containing accelerator-produced
radioactive materials at a pharmacy at a Government agency or Federally
recognized Indian tribe before [date 60 days after date of publication
of final rule] or at all other pharmacies before August 8, 2009, or an
earlier date as noticed by the NRC.
Authorized user means a physician, dentist, or podiatrist who--
(1) Meets the requirements in Sec. Sec. 35.59 and 35.190(a),
35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or
35.690(a); or
(2) Is identified as an authorized user on--
(i) A Commission or Agreement State license that authorizes the
medical use of byproduct material;
(ii) A permit issued by a Commission master material licensee that
is authorized to permit the medical use of byproduct material;
(iii) A permit issued by a Commission or Agreement State specific
licensee of broad scope that is authorized to permit the medical use of
byproduct material; or
(iv) A permit issued by a Commission master material license broad
scope permittee that is authorized to permit the medical use of
byproduct material; or
(3) Used only accelerator-produced radioactive materials, discrete
sources of radium-226, or both, for medical uses at a Government agency
or Federally recognized Indian tribe before [date 60 days after date of
publication of final rule] or at all other locations of use before
August 8, 2009, or an earlier date
[[Page 42988]]
as noticed by the NRC, and for only those materials and uses performed
before these dates.
* * * * *
Cyclotron means a circular particle accelerator in which charged
particles are bent traveling through the accelerator. 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.
* * * * *
35. 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 [date 60 days after date of publication of
final rule]. 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.
* * * * *
36. 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 individual submits a medical use
license application on or before [date 1 year and 2 months after date
of publication of final rule].
(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 individual submits a medical use license application on or before
August 7, 2009, or earlier as noticed by the NRC.
37. In Sec. 35.13, paragraphs (a) and (e) are revised and
paragraph (b)(4)(v) 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 the licensee
submits an amendment application on or before [date 8 months after date
of publication of final rule].
(2) Except as provided in (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 individual submits a
medical use license application on or before August 7, 2009, or earlier
as noticed by the NRC.
(b) * * *
(4) * * *
(v) An individual who uses only accelerator-produced radioactive
materials, discrete sources of radium-226, or both, for medical use or
in the practice of nuclear pharmacy at a Government agency or Federally
recognized Indian tribe before [date 60 days after date of publication
of final rule] 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
radionuclide delivery line from the PET radionuclide production area.
Other areas of use where byproduct material is used only in accordance
with either Sec. 35.100 or Sec. 35.200 are exempted;
* * * * *
38. In Sec. 35.14, the introductory text of paragraph (a) and
paragraph (b)(4) 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 [date 60 days after date of publication
of final rule] 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) * * *
(4) 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 radionuclide delivery line
from the PET radionuclide production area.
* * * * *
39. In Sec. 35.15, paragraph (f) is revised to read as follows:
[[Page 42989]]
Sec. 35.15 Exemptions regarding Type A specific licenses of broad
scope.
* * * * *
(f) The provisions of Sec. 35.14(b)(4) regarding additions to or
changes in 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 radionuclide delivery line from the PET radionuclide production area.
* * * * *
40. 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 [date 60 days after date of publication
of final rule] 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. Sec. 35.50, 35.51, or 35.55,
respectively, when performing the same uses.
(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 [date 60 days after date of publication
of final rule] 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.
41. 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) An NRC or Agreement State medical use licensee with a PET
radionuclide production facility.
(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) An NRC or Agreement State medical use licensee with a PET
radionuclide production facility.
* * * * *
42. Section 35.69 is revised to read as follows:
Sec. 35.69 Labeling of vials and syringes and transport radiation
shields.
(a) Each syringe and vial used for medical use that contains
unsealed byproduct material must be labeled to identify the radioactive
drug. Each syringe shield and vial shield must also be labeled unless
the label on the syringe or vial is visible when shielded.
(b) Each label affixed to a transport radiation shield or syringe,
vial, or other container used to hold a PET drug to be transferred for
noncommercial distribution by the medical use licensee shall meet the
requirements in 10 CFR 32.72(a)(4).
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.
* * * * *
(a) Obtained from:
(1) A manufacturer or preparer licensed under Sec. 32.72 of this
chapter or equivalent Agreement State requirements;
(2) The licensee's noncommercial PET radionuclide production
facility; or
(3) The noncommercial transfer of a PET radionuclide or drug from
an NRC or Agreement State medical use licensee with a PET radionuclide
production facility; or
(b) Excluding production of PET radionuclides, prepared by:
* * * * *
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;
(2) The licensee's noncommercial PET radionuclide production
facility; or
(3) The noncommercial transfer of a PET radionuclide or drug from
an NRC or Agreement State medical use licensee with a PET radionuclide
production facility; or
(b) Excluding production of PET radionuclides, prepared by:
* * * * *
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.
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;
[[Page 42990]]
(2) The licensee's noncommercial PET radionuclide production
facility; or
(3) The noncommercial transfer of a PET radionuclide or drug from
an NRC or Agreement State medical use licensee with a PET radionuclide
production facility; or
(b) Excluding production of PET radionuclides, prepared by:
* * * * *
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
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).
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
(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
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, 2093, 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).
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
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,
2021); 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).
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.
* * * * *
[[Page 42991]]
PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE AND REACTOR-
RELATED GREATER THAN CLASS C WASTE
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).
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
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 issued under sec. 903, Pub. L. 102-496
(42 U.S.C. 2151 et seq.).
57. In Sec. 110.2, definitions of Accelerator-produced radioactive
material, Discrete source, and Particle accelerator are added 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 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.
* * * * *
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
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).
59. In Sec. 150.3, the definition of Byproduct material is
revised, and a definition of Discrete source is added 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
[[Page 42992]]
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 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.
* * * * *
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
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).
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.
* * * * *
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.
* * * * *
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..................................... $3,500.
* * * * * * *
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.\5\
1. Possession of quantities exceeding the number
of items or limits in 10 CFR 31.12(a)(3), (4),
or (5) but less than or equal to 10 times the
number of items or limits specified.
Application................................. $450.
2. Possession of quantities exceeding 10 times
the number of items or limits specified in 10
CFR 31.12(a)(3), (4), or (5).
Application................................. $1,110.
S. Licenses for production of accelerator-produced
radionuclides.
Application..................................... $4,700.
* * * * * * *
------------------------------------------------------------------------
* * * * * * *
[[Page 42993]]
\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 1C 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 NRC for review, and for project manager time for fee
categories subject to full cost fees (fee Categories 1A, 1B, 1E, 2A,
4A, 5B, 10A, 11, 12, 13A, and 14) 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 a 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.
* * * * * * *
\5\ 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.)
* * * * * * *
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
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).
62. 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.
* * * * *
63. In Sec. 171.16, paragraph (d), in the table, Schedule of
Materials Annual Fees and Fees for Government Agencies Licensed by 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 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.
* * * * *
[[Page 42994]]
Schedule of Materials Annual Fees and Fees for Government Agencies
Licensed by NRC
------------------------------------------------------------------------
Annual fees
Category of materials licenses \1\ \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..................................... 8,200
* * * * * * *
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 1,600
of items or limits in 10 CFR 31.12(a)(3), (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 2,500
the number of items or limits specified in 10
CFR 31.12(a)(3), (4), or (5)...................
S. Licenses for production of accelerator-produced 10,200
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 licenses 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 1C and
1D 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.)
* * * * * * *
Dated at Rockville, Maryland, this 20th day of July, 2006.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
[FR Doc. 06-6477 filed 7-27-06; 8:45 am]
BILLING CODE 7590-01-P