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Monday,
October 1, 2007
Part II
Nuclear Regulatory
Commission
10 CFR Parts 20, 30, et al.
Requirements for Expanded Definition of
Byproduct Material; Final Rule
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NUCLEAR REGULATORY DATES: Effective Date: This final rule is medical, or research activity (Section
COMMISSION effective on November 30, 2007. 11e.(3) of the AEA); and (2) adding any
FOR FURTHER INFORMATION CONTACT: discrete source of naturally occurring
10 CFR Parts 20, 30, 31, 32, 33, 35, 50, Lydia Chang, Office of Federal and State radioactive material, other than source
61, 62, 72, 110, 150, 170, and 171 Materials and Environmental material, that the Commission, in
Management Programs, U.S. Nuclear consultation with the Administrator of
RIN 3150–AH84 Regulatory Commission, Washington, the Environmental Protection Agency
DC 20555–0001, telephone (301) 415– (EPA), the Secretary of the Department
Requirements for Expanded Definition 6319, e-mail lwc1@nrc.gov; or Catherine of Energy (DOE), the Secretary of the
of Byproduct Material R. Mattsen, Office of Federal and State Department of Homeland Security
AGENCY: Nuclear Regulatory Materials and Environmental (DHS), and the head of any other
Commission. Management Programs, U.S. Nuclear appropriate Federal agency, determines
Regulatory Commission, Washington, would pose a threat similar to the threat
ACTION: Final rule.
DC 20555–0001, telephone (301) 415– posed by a discrete source of radium-
SUMMARY: The Nuclear Regulatory 6264, e-mail crm@nrc.gov. 226 to the public health and safety or
Commission (NRC) is amending its SUPPLEMENTARY INFORMATION:
the common defense and security; and
regulations to include jurisdiction over is extracted or converted after extraction
I. Background before, on, or after the date of enactment
discrete sources of radium-226, II. Discussion
accelerator-produced radioactive of the EPAct for use in a commercial,
A. The New, Expanded Definition of
materials, and discrete sources of Byproduct Material medical, or research activity (Section
naturally occurring radioactive material, B. The NRC’s Regulatory Approach 11e.(4) of the AEA).
C. Changes to Existing NRC Regulations to Although Section 651(e) of the EPAct
as required by the Energy Policy Act of
Accommodate the New Byproduct became effective on August 8, 2005, the
2005 (EPAct), which was signed into
Material NRC did not have regulations in place
law on August 8, 2005. The EPAct
D. License Application and Annual Fees that would specifically apply to this
expanded the Atomic Energy Act of E. Implementation Strategy newly covered byproduct material
1954 definition of Byproduct material to III. Summary and Analysis of Public (hereafter referred to as NARM). The
include any discrete source of radium- Comments on the Proposed Rule EPAct also allowed the NRC to issue
226, any material made radioactive by IV. Section-by-Section Analysis of Final
waivers to States and other entities
use of a particle accelerator, and any Revisions
V. Criminal Penalties while developing final regulations for
discrete source of naturally occurring NARM. A waiver was issued on August
radioactive material, other than source VI. Agreement State Compatibility
VII. Voluntary Consensus Standards 31, 2005 (70 FR 51581).
material, that the Commission, in
VIII. Environmental Assessment and Finding
consultation with other Federal officials Previous Regulatory Structures for
of No Significant Environmental Impact:
named in the EPAct, determines would Availability NARM
pose a similar threat to the public health IX. Paperwork Reduction Act Statement The AEA authorizes the States to
and safety or the common defense and X. Regulatory Analysis assume regulatory control of certain
security as a discrete source of radium- XI. Regulatory Flexibility Certification radioactive materials provided the State
226, that are extracted or converted after XII. Backfit Analysis has an adequate program to protect the
extraction for use for a commercial, XIII. Congressional Review Act
public health and safety and is
medical, or research activity. In so I. Background compatible with the NRC’s program for
doing, these materials were placed regulation of these materials and enters
under the NRC’s regulatory authority. The Energy Policy Act of 2005 into an agreement with the NRC. As
The EPAct also mandated that the On August 8, 2005, the President authorized by Section 274b of the AEA,
Commission, after consultation with the signed into law the EPAct. Among other 34 States have assumed responsibility
States and other stakeholders, issue provisions, Section 651(e) of the EPAct for regulating certain activities related to
final regulations establishing expanded the definition of Byproduct radioactive material by entering into
requirements that the Commission material as defined in Section 11e. of agreements with the NRC. The activities
determines necessary under the EPAct. the Atomic Energy Act of 1954 (AEA), regulated by these ‘‘Agreement States’’
This rulemaking effort has been placing additional byproduct material include the use of byproduct material,
undertaken in response to that mandate under the NRC’s jurisdiction, and source material, and special nuclear
and includes significant contributions required the Commission to provide a material. Each Agreement State issues
from many States that have regulated regulatory framework for licensing and licenses to persons who use these
the naturally occurring and accelerator- regulating this additional byproduct materials in that State except for DOE,
produced radioactive material, the material. other Government agencies, and
Organization of Agreement States, Inc., Specifically, Section 651(e) of the Federally recognized Indian Tribes. The
the Conference of Radiation Control EPAct expanded the definition of NRC issues licenses to persons using
Program Directors, Inc. (CRCPD), and Byproduct material by: (1) Adding any these materials in non-Agreement
other stakeholders. In addition, this discrete source of radium-226 that is States.
final rule was informed and guided by produced, extracted, or converted after Before enactment of the EPAct, the
the CRCPD’s applicable Suggested State extraction, before, on, or after the date NRC did not have authority over NARM
Regulations for the Control of Radiation. of enactment of the EPAct for use for a or regulations for this type of material.
Licensees, individuals, and other commercial, medical, or research Although the NRC has not regulated
entities who are engaged in activities activity; or any material that has been NARM in the past, all 34 Agreement
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involving the newly defined byproduct made radioactive by use of a particle States and certain non-Agreement States
material in both Agreement States and accelerator and is produced, extracted, have regulatory programs for NARM.
non-Agreement States and United States or converted after extraction, before, on, The NRC’s regulations did require
Territories will be affected by this or after the date of enactment of the licensees to account for dose
rulemaking. EPAct for use for a commercial, contributed from NARM, as well as dose
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contributed from other byproduct, respect to NARM, including those Department of Labor has the oversight
source, or special nuclear material, aspects relating to receipt, possession, for occupational health and safety for
because the definition of Occupational use, storage, transfer, transportation, radiation protection. It has regulations
dose encompasses both licensed and disposal of NARM. This regulatory governing radiation protection in the
material and nonlicensed material such structure also subjects NARM users in workplace, including provisions
as NARM sources at a licensed facility. the Agreement States to the same addressing the exposure of minors to
In addition, the NRC requires in its licensing, inspection, and enforcement radioactive material in the workplace,
radiological criteria for license policies as those using other byproduct, but defers to the NRC on AEA materials.
termination that licensees consider source, or special nuclear materials. In The Department of Commerce (DOC)
other nondiscrete sources, including addition, this regulatory structure has controlled the export of radioactive
radium, during decommissioning allows for both specific and general material. Before the enactment of the
activities at sites contaminated with licensing of various NARM products, EPAct, the DOC regulated the export of
source material, such as rare-earth the distribution of certain NARM items all radium-226. With the enactment of
processing facilities. to persons exempt from regulation and, the EPAct, the NRC will regulate the
Currently, there are 16 non- in most cases, includes provisions to export of discrete sources of radium-
Agreement States plus United States review and approve proposals for sealed 226; DOC retains jurisdiction to regulate
(U.S.) Territories. Although most non- sources and devices containing NARM. the export of nondiscrete sources of
Agreement States and U.S. Territories The Agreement States have regulated radium-226. The Consumer Product
have some type of programs for NARM, a vast array of NARM produced for Safety Commission regulations have
the regulatory structures vary greatly. medical, industrial, research and addressed hazardous substances other
Certain non-Agreement States have development, commercial, and than byproduct, source, and special
established a licensing structure for consumer purposes. In many Agreement nuclear materials currently regulated by
regulating their NARM users. As such, States, this regulatory structure also the NRC. The Food and Drug
the regulatory structure could parallel captures some types of nondiscrete Administration (FDA) regulates all
the NRC regulations issued in Title 10 sources found in the oil and gas drugs (including drugs containing
of the Code of Federal Regulations (10 industry or mining industry; moreover, radioactive materials) by requiring good
CFR) applicable to the current materials it captures inadvertently produced manufacturing practices to assure the
program, or it could parallel the activation products from the use of purity, potency, and consistency of
Suggested State Regulations for the proton beams for medical radiation finished drugs with their labeling in
Control of Radiation (SSRs) developed therapy. However, the regulation of establishing the safety and effectiveness
by the CRCPD. Other non-Agreement these nondiscrete sources and activation of these drugs.
States or U.S. Territories have elected to products varies from Agreement State to Section 651(e)(3) of the EPAct
use registration as their regulatory Agreement State. provides that byproduct material, as
structure for managing the NARM users. defined by Section 11e.(3) or 11e.(4) of
Other Federal Agencies’ Regulatory
Some States register facilities; others the AEA, may only be transferred to and
Authority Over NARM
register both facilities and devices. disposed of in a disposal facility that is
Some States use registration information Although the States had the primary adequate to protect public health and
to conduct inspections; others use responsibility for regulating the use of safety, and is licensed by either the NRC
registration to identify facility locations NARM before the passage of the EPAct, or a State that has entered into an
for security purposes. In general, there certain Federal regulations continue to agreement with the Commission under
is limited regulatory oversight where apply under some circumstances, such Section 274b of the AEA or at a disposal
registration is used in non-Agreement as environmental protection, workplace facility in accordance with any Federal
States. It was, in part, due to this lack safety, drug safety, transportation, and or State solid or hazardous waste law,
of national consistency, that the EPAct disposal. With the passage of the EPAct, including the Solid Waste Disposal Act,
placed these materials under the NRC’s the NRC will have primary also known as the Resource
jurisdiction. responsibility for radiation safety and in Conservation and Recovery Act (RCRA).
Agreement States have regulated regulating the use of these materials in
NARM use for many decades in a fairly cooperation with the States, with the Development of the Suggested State
uniform and consistent manner. The exception of those activities that are Regulations (SSRs)
Agreement States have accomplished self-regulated by the DOE. Since enactment of the AEA in 1954,
this by using the same standards to Other Federal agencies have scientists continue to develop new
regulate NARM as those used to regulate regulations or have established technologies in producing
other byproduct, source, and special programs for self-regulating certain radionuclides, such as the use of
nuclear material under the NRC’s activities involving NARM. The particle accelerators. At the beginning of
authority. In many respects, regulations Department of Transportation (DOT) the 20th century, naturally occurring
applicable to NARM adopted by the regulates interstate transport of NARM. radioactive material, including radium-
Agreement States are compatible with In cooperation with DOT, the NRC 226, was routinely used in consumer
the NRC’s regulations for the current approves Type B packages through products and in cancer treatment.
materials program, or parallel the regulations in 10 CFR Part 71. The EPA Because there was no Federal mandate
CRCPD’s SSRs. has established controls for certain to regulate these materials, most States
Although Agreement States do have NARM through several authorities, have since established regulatory
some provisions specifically for NARM, including the Clean Air Act, the Safe structures for both accelerator-produced
in general, the regulatory structure used Drinking Water Act, the Toxic radioactive material and naturally
by Agreement States does not Substances Control Act, the Resource occurring radioactive material,
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distinguish between NARM and other Conservation and Recovery Act, and the including radium-226.
radioactive material. NARM users in the Comprehensive Environmental In 1968, CRCPD was chartered as a
Agreement States are expected to Response, Compensation, and Liability nonprofit organization to provide a
implement all aspects of standards for Act. The Occupational Safety and forum for enhancing communication
their radiation protection programs with Health Administration (OSHA) of the among States and Federal agencies
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regarding radiation regulations and to The Commission believed that committee forming a partnership with
promote a uniform radiation protection granting the waiver would allow the the NRC in making rulemaking
environment for all radioactive material. States to continue with their regulatory decisions. In an effort to keep
Throughout the years, CRCPD programs, allow persons engaged in stakeholders informed, the NRC held a
developed policies and guidance for its activities involving NARM to continue public roundtable meeting in early
member States. In addition, CRCPD is their operations in a safe manner, and November. In addition, the NRC has met
responsible for the development of allow continued access to medical with other Federal agencies to ensure
model regulations, known as the SSRs. radiopharmaceuticals. In addition, it coordination regarding this rulemaking.
Under the SSRs’ regulatory framework, would enable the Commission to work The NRC held a public meeting on
NARM has been a regulated radioactive with the States in developing November 9, 2005, to discuss
material comparable to byproduct appropriate regulations for NARM and rulemaking activities to incorporate
material. Nearly all of the Agreement in formulating a sound Transition Plan NARM into its regulatory framework.
States have based their regulations on for implementation of these regulations. The public meeting was in a
this model for NARM. It would also provide an opportunity for ‘‘roundtable’’ format to allow
For NARM regulation only, CRCPD non-Agreement States that currently do stakeholders an opportunity to discuss
also established ‘‘Licensing States’’ not have Agreement State regulatory concerns and to enhance interaction
similar to the Agreement State Program programs under Section 274b. of the among all interested parties on the
under Section 274 of the AEA. AEA to consider entering into an subject of the NRC regulating NARM.
Licensing States recognized by CRCPD agreement with the NRC. The Representatives from other Federal
under criteria found in Publication 94– Commission determined that issuance agencies, States, and a broad spectrum
8, ‘‘CRCPD Recognition of Licensing of the waiver would be in accordance of interest groups were invited to
States for the Regulation and Control of with the protection of public health and participate in the ‘‘roundtable’’
NARM,’’ are those States that have safety and the promotion of the common discussion. A transcript of this meeting
demonstrated an adequate and defense and security. is available via the NRC’s and other
consistent regulatory control program The Commission granted a waiver (70 related documents are available from
for NARM. Licensing State designation FR 51581; August 31, 2005) from the (see FOR FURTHER INFORMATION CONTACT
assures comparable regulatory requirements of Section 651(e) of the section of this document.)
structures with respect to NARM, and EPAct to: (1) All persons engaged in Following the public meeting, the
other States may grant reciprocal export from or import into the U.S. of NRC received five written comments
recognition of their licenses or byproduct material through August 7, from interested parties related to the
acceptance of their licensees’ 2006, unless terminated sooner if the discussion at the meeting and the
manufactured products. Commission determined that an earlier rulemaking activities. These comment
termination was warranted; and except letters were reviewed and considered by
Issuance of Waiver on August 31, 2005 the NRC staff in the development of the
with regard to the requirements of the
Section 651(e) of the EPAct became DOC relating to export of byproduct proposed rule.
effective immediately upon signature by material; (2) all persons acquiring, In addition to the public meeting, the
the President on August 8, 2005. Before delivering, receiving, possessing, NRC interacted and met with FDA staff
enactment of the EPAct, the NRC did owning, using, or transferring byproduct to exchange information regarding the
not have authority over NARM or material through August 7, 2009, unless NRC’s NARM rulemaking efforts and the
regulations in place that would terminated sooner if the Commission FDA’s regulations for accelerator-
specifically apply to this material. determined that an earlier termination produced drugs. The primary objective
Nonetheless, persons engaged in was warranted; and (3) all States that of the FDA’s regulations is to ensure
activities involving NARM could be, had entered into an agreement with the medical safety, purity, potency, and
and States seeking to continue Commission under Section 274b. of the effectiveness of the drugs, and that of
regulation of NARM would be, in AEA, and States that had not entered the NRC’s regulations is to ensure
technical violation of the AEA. into such an Agreement, through August radiation safety. During the meeting,
Section 651(e)(5) of the EPAct 7, 2009, unless terminated sooner if the areas of potential dual regulation were
authorized the Commission to issue a Commission determined an earlier discussed. Because the NRC and the
waiver of the requirements of Section termination was warranted, or for an FDA have different missions, the
651(e) to any entity with respect to Agreement State if the Commission associated regulations are more
NARM for specified periods of time if made certain determinations required complementary than duplicative. FDA
the Commission determined that the by Section 651(e)(5)(B)(ii) of the EPAct. has published a proposed rule (70 FR
waiver was in accordance with the 55038; September 20, 2005), ‘‘Current
protection of the public health and Stakeholder Involvement in the Good Manufacturing Practice for
safety and the promotion of the common Rulemaking Process Positron Emission Tomography Drugs,’’
defense and security. The Commission The NRC took several initiatives in an and expects to finalize the rule soon.
determined that there was no basis to effort to enhance stakeholder The FDA’s final rule will establish
conclude that these materials would not involvement and to improve efficiency criteria for the production and process/
continue to be used in a manner that is during the rulemaking process. With quality controls for the Positron
protective of public health and safety assistance from the Organization of Emission Tomography (PET) drugs in
while the waiver is in effect. The Agreement States (OAS) and CRCPD, PET centers registered with the FDA.
Commission also determined that it the NRC was able to obtain participation The NRC hosted a meeting of Federal
would be in the best interest of the of several State representatives in agency representatives on November 22,
public to allow continued use of NARM, various working groups in the 2005, to discuss the development of a
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especially for medical purposes, and to development of the proposed rule. definition of Discrete source to be added
allow the States to continue to regulate Principals from OAS and CRCPD, to the NRC’s regulations. Agencies
NARM until the Commission could representing interests for both represented at this meeting were DOT,
codify new regulations for these Agreement States and non-Agreement DOE, including the National Nuclear
materials. States, also participated in the steering Security Administration, Department of
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Defense, DOC, EPA, and the U.S. definition of Byproduct material in that used for military operations but is no
Customs and Border Protection. A draft Part remains unchanged by this rule. longer under the control of the military,
definition was formulated. This Since the publication of the proposed has been sold, or is in the possession of
definition formed the basis for the rule, and after considering the private individuals, is also within the
definition in the proposed rule, with comments on the new definition of coverage of this rule.
only minor changes and text byproduct material, the Commission has The NRC intends to interact with the
rearrangement for clarity. taken a closer look at the scope of the Department of Defense to obtain a
Commission’s jurisdiction over the common understanding of the uses of
The NRC published the proposed rule
newly added byproduct material. The radium-226 and accelerator-produced
to establish the regulatory framework for
EPAct covers discrete sources of radioactive material by the military to
the newly defined byproduct material
radium-226 and accelerator-produced resolve any potential issues regarding
on July 28, 2006 (71 FR 42952). Thirty-
radioactive material that is ‘‘produced, the application of the Commission’s
nine comment letters were received.
extracted, or converted after extraction, interpretation of the EPAct in regard to
The commenters included a number of
before, on, or after August 8, 2005, for any specific case of military use.
States, Federal agencies, professional
use for commercial, medical, or research
organizations, universities, medical Radium-226
activity’’ (emphasis added).
communities, industries, and Notwithstanding that a discrete source
individuals. Radium is a chemically reactive,
of radium-226 may have originated from silvery white, radioactive, metallic
II. Discussion a commercial supplier, the Commission element with an atomic number of 88
has determined that discrete sources of and symbol of Ra. Radium-226, the most
A. The New, Expanded Definition of radium-226 still in control of the
Byproduct Material abundant and most stable isotope of
military do not constitute ‘‘commercial radium, is formed by the radioactive
use’’ under the EPAct, and are therefore, disintegration of thorium-230 in the
Section 651(e) of the EPAct expanded
outside the Commission’s jurisdiction. decay series starting with uranium-238.
the definition of Byproduct material to
Defining ‘‘commercial use’’ to include Radium-226 can be found in all
include: (1) Any discrete source of
all material supplied to the military uranium ores. The half-life of radium-
radium-226 that is produced, extracted,
from a commercial supplier would 226 is 1599 years. Radium-226 emits
or converted after extraction, before, on,
result in virtually all military use of this alpha particles and gamma radiation
or after the date of enactment of the material to be ‘‘commercial use.’’ This
EPAct for use for a commercial, and decays to radon gas.
would vitiate any distinction that the
medical, or research activity; (2) any Although radium was discovered in
EPAct intended to make for military
material that has been made radioactive the ore pitchblende by the chemists
use, as opposed to commercial use, by
by use of a particle accelerator and is Marie and Pierre Curie in 1898, no one
excluding military use from its
produced, extracted, or converted after understood the dangers of radium until
coverage.
extraction, before, on, or after the date However, this exclusion from the later in the twentieth century. Based on
of enactment of the EPAct for use for a coverage of the EPAct only applies to a radium’s properties, especially its
commercial, medical, or research certain type of military use, i.e., NARM ability to stimulate luminescence,
activity; and (3) any discrete source of used for ‘‘military operations.’’ The term industries started manufacturing
naturally occurring radioactive material, ‘‘military operations’’ covers what is hundreds of consumer products
other than source material, that the traditionally understood as the containing radium. Radium was added
Commission, in consultation with the military’s primary mission for national to products such as hair tonic,
Administrator of the EPA, the Secretary defense, including warfare, combat, and toothpaste, ointments, and elixirs.
of DOE, the Secretary of DHS, and the battlefield missions, and, of course, Radium paint was used in the mid-
head of any other appropriate Federal training for battlefield missions. NARM 1900s to paint the hands and numbers
agency, determines would pose a threat used, or available for use, for these of some clocks, watches, doorknobs, and
similar to the threat posed by a discrete purposes would be excluded from the other objects to make them glow in the
source of radium-226 to the public coverage of the EPAct and from the dark. Glow-in-the-dark watch and clock
health and safety or the common coverage of this rule. If the material is faces were particularly popular. Most of
defense and security, and that is intended for use in military operations, these uses were eventually discontinued
extracted or converted after extraction, it is excluded from the coverage of this for health and safety reasons, but its
before, on, or after the date of enactment rule notwithstanding the fact that it was wide use in luminescent paints
of the EPAct for use in a commercial, originally produced by a commercial continued through World War II
medical, or research activity. The NRC supplier. In addition, ‘‘military because radium’s luminescent glow
is revising the definition of Byproduct operational’’ material includes material made aircraft and vehicle dials, gauges,
material in 10 CFR Parts 20, 30, 50, 72, still under the control of the military, and other instruments visible at night.
150, 170, and 171 to be consistent with i.e., in storage, or material that may be Many of these early products still
the EPAct. The same revision to the subject to decontamination and remain in the possession of museums
definition of Byproduct material was disposal. and individual collectors. Large
made in a separate rulemaking for 10 Other use of NARM by the military inventories of radium-226 luminescent
CFR Part 110 (April 20, 2006; 71 FR would be covered by this rule. Under military and aircraft devices remain and
20336). A different definition for the the Commission’s interpretation of the periodically turn up in repair shops,
term Byproduct material is used in 10 EPAct, NARM, whether discrete sources and have resulted in contamination
CFR Part 40, because 10 CFR Part 40 or accelerator material, that is produced, incidents.
regulations are limited to source extracted, or converted for use or has In more recent times, radium sources
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material and the tailings or wastes been used, in medical or research were used in industrial radiography and
associated with the extraction or activities, or in a manner similar to a industrial smoke detectors. Currently,
concentration of source material. commercial activity, e.g., military radium sources are still being used in
Therefore, 10 CFR Part 40 regulations museums, is covered by the EPAct and some industrial products, such as
are not impacted by the EPAct, and the this rule. Furthermore, NARM that was industrial gauges, that measure certain
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physical properties such as moisture basic physics research facilities reach has not adopted any rule regarding the
and density. energies in excess of 1000 MeV. operation of a particle accelerator or the
For the purposes of this rulemaking, qualification of any person maintaining
Accelerator-Produced Radioactive the NRC divided particle accelerators or operating a particle accelerator.
Material into three groupings: (1) Those that are However, nothing in the EPAct directs
Particle Accelerators always operated to intentionally the NRC to change the policy that
produce radioactive materials in radiation safety standards must consider
A particle accelerator is a device that
quantities useful for their radioactive unregulated as well as regulated sources
imparts kinetic energy to subatomic
properties for a commercial, medical, or of radiation. The NRC will continue to
particles by increasing their speed
research activity; (2) those that are require any person subject to the dose
through electromagnetic interactions.
operated to produce only particle beams limits in 10 CFR Part 20 to continue to
Particle accelerators are used to produce
and not radioactive materials; and (3) include the radiation dose from the
radioactive material by directing a beam
accelerators that are used to produce operation of a particle accelerator in
of high speed particles at a target
both radioactive materials and particle meeting the dose limitations. The NRC
composed of a specifically selected
beams for other uses. Examples of is aware that the operation of a particle
element, which is usually not accelerators that are operated to produce accelerator may activate materials in the
radioactive. Nuclei in the target are only particle beams and not radioactive structure of the building and facilities
struck by the high speed particles and materials include linear accelerators housing the accelerator. The NRC
undergo a nuclear transformation. A used for medical treatment of cancer intends to assure the safe
nuclide that is struck is transformed and other health-related conditions. decommissioning of particle accelerator
into a different nuclide. By careful Other examples include the buildings and facilities, including the
selection of the target element, the experimental particle physics research removal and disposal of activated
particles accelerated, and the operating colliders used to probe the fundamental building materials, to assure that the
parameters of the accelerator (e.g., beam properties of nature (as long as that is dose limits to members of the public are
energy), a resultant proton-heavy their only use) and electron not exceeded. The decommissioning of
nuclide can be produced. Usually the microscopes, i.e., particle accelerators these facilities will be required to meet
nuclide produced is radioactive and is that probe the structure of materials at the radiation dose limits in 10 CFR Part
created for the use of its radiological a very small dimension (high 20 Subpart E—Radiological Criteria for
properties. The process of transforming magnification). Ion implanters are License Termination.
nuclei from a stable element into a particle accelerators used to modify the The majority of accelerator-produced
radionuclide is called activation. In electrical properties of materials in radioactive material is now created for
some cases, the target is selected so that semiconductor fabrication. In these use in medicine. The NRC is aware of
the accelerator produces a neutron beam activities, no radioactive material is only two operations in the U.S. and a
that is, in turn, used to activate nuclides intentionally created; all activation is few importers, mostly from Europe and
that are then used for their radioactive incidental to the intended use of the Canada, that are commercial producers
properties. Some particle accelerators accelerator. of accelerator-produced radioactive
are not used to produce radioactive The NRC will regulate the radioactive material for use in industrial activities.
material, but instead the high energy material both intentionally and The regulatory approach for
beam produced by the particle incidentally produced by all manufacturing accelerator-produced
accelerator is used directly, for example, accelerators that are intentionally radioactive material for industrial
to treat cancer patients. operated to produce a radioactive purposes is similar to the regulatory
The two basic designs of particle material for its radioactive properties. approach for manufacturing accelerator-
accelerators are linear and circular, also The NRC will not regulate the incidental produced radioactive material for
known as cyclotron. In either case, radioactive material produced by medical purposes.
charged particles are injected into the accelerators that are operated to produce
accelerator to form a beam. The beam is only particle beams and not radioactive Accelerator-Produced Radioactive
accelerated and focused onto the target. materials for use for a commercial, Material Used in Medical Activities
In the circular designs, the beam must medical, or research activity. For those Medical use of radioactive material
be directed to travel in a circular shaped accelerators that are used to produce began over 50 years ago. The medical
path. For all accelerators, the process of both radioactive material and particle use of sealed and unsealed radioactive
accelerating, focusing, and directing the beams, the NRC will regulate the materials continues to be an important
beam is accomplished by a combination intentionally produced radioactive component of medical specialties for
of electrically charged structures and material and all of the incidentally both diagnosis and therapy purposes.
magnetic fields in the accelerator. produced radioactive material, The use of small quantities of unsealed
During operation, these internal including incidental radioactive radioactive materials
structures will be struck by particles material produced when the accelerator (radiopharmaceuticals) in nuclear
from the beam and activated is operated to produce radioactive medicine is an integral part of patient
incidentally. material, as well as incidental care and is extremely valuable in the
Particle accelerators are often radioactive material produced when it is early diagnosis and treatment of medical
classified by the maximum energy of the operated to produce only a particle conditions. Radiation oncology uses
accelerated particles, expressed in beam. The incidental radioactive larger amounts of radioactivity in sealed
megaelectron-volts (MeV). An electron- materials produced in these accelerators sources to deliver therapeutic or
volt is the amount of energy imparted to are indistinguishable, so both will be palliative radiation doses.
an electron by an accelerating potential considered byproduct material. The Almost all reactor-produced
jlentini on PROD1PC65 with RULES2
of one volt. The small cyclotrons that NRC believes very few, if any, byproduct radionuclides for radioactive
produce radionuclides used in PET accelerators are operated in this way. drugs are imported into the U.S., as well
nuclear medicine usually operate at The EPAct does not give the NRC as most reactor-produced radionuclides
energies of up to about 30 MeV. By authority to regulate the possession or used in sealed sources, although some
comparison, the accelerators used in use of particle accelerators. The NRC used in radioactive drugs and sealed
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sources are also produced in an NRC- the EPA, the Secretary of Energy, the discrete sources of naturally occurring
regulated nonpower reactor. Secretary of Homeland Security, and the radioactive material pose a threat
Commercial manufacturers primarily head of any other appropriate Federal similar to the radium-226-level or IAEA
use the imported radionuclides to agency, determines would pose a threat Code of Conduct Category 1 or 2
produce specific sealed sources, similar to the threat posed by a discrete sources.
radioactive drugs, and biologics. source of radium-226 to the public Through interaction with other
Commercial nuclear pharmacies may health and safety or the common Federal agencies and States during
use radiochemicals to prepare defense and security, and is extracted or development of the rule, the NRC
radioactive drugs, as well as converted after extraction, before, on, or concluded that, at this time, only
commercially produced radioactive after the date of enactment of the EPAct polonium-210 has the potential to pose
drugs and drug sources, such as for use in a commercial, medical, or a threat similar to the threat posed by a
molybdenum-99/technetium-99m research activity. discrete source of radium-226 to the
generators, to prepare unit dosages of The inclusion of discrete sources of public health and safety or the common
other radioactive drugs. naturally occurring radioactive material defense and security. The NRC had
The U.S. has a limited number of into the definition of Byproduct already been regulating the use and
commercial radionuclide production material is contingent on the possession of polonium-210 because it
facilities that use accelerators to Commission’s determination, in is produced in nuclear reactors and is
produce radionuclides, such as consultation with other Federal rarely extracted as naturally occurring
thallium-201, iodine-123, indium-111, agencies, that these discrete sources radioactive material. Therefore,
and gallium-67 used in radioactive although this rule adds this category of
would pose a threat similar to the threat
drugs. A larger number of radionuclide byproduct material to the definitions in
posed by a discrete source of radium-
production facilities (often referred to as the regulations, at this time, the NRC’s
226. The NRC has not currently
PET centers) use cyclotrons to produce regulations will not apply to any
identified any discrete sources of
the PET radionuclides fluorine-18, discrete sources of naturally occurring
naturally occurring radioactive material
carbon-11, nitrogen-13, and oxygen-15 radioactive material, other than radium-
under this provision, and the rule does
for use in PET radioactive drugs. PET 226. The EPAct has provided a
not contain criteria for making such a
radionuclides decay by positron mechanism for the Commission to
determination. For comparison, the
emission and, because of their relatively include additional discrete sources of
International Atomic Energy Agency
short half-life (minutes to hours), are naturally occurring radioactive material
produced at locations in close proximity (IAEA) has identified a list of sources
that are considered to pose a high risk in the future following consultation
to the patients (e.g., in hospitals or with other Federal agencies, if the need
academic institutions) or at nearby to human health and safety if not
managed safely and securely. The IAEA arises to consider other naturally
locations. occurring radioactive material as
Palladium-103, the most common Code of Conduct on the Safety and
Security of Radioactive Sources (Code of byproduct material. No further revision
accelerator-produced medical use to the regulations will be necessary to
radionuclide contained in a sealed Conduct) identified certain quantities of
26 radionuclides that pose a significant begin regulating a material identified
source, was originally produced at through this mechanism. However, the
reactor facilities. Other radionuclides risk to individuals, society, and the
environment. The activity of these NRC will provide an opportunity for
used in medical radiation therapy can public input before applying its
also be produced with either reactors or radionuclides at the IAEA Code of
Conduct Category 1 or 2 level could be regulations to other naturally occurring
accelerators. With the new definition of radionuclides that the NRC determines
Byproduct material, sealed sources that fatal or cause permanent injury to a
person who handled them or was in consultation with other federal
can be produced from either pathway agencies, pose a threat similar to the
will be uniformly regulated. At this otherwise in contact with them for a
short time, if not safely managed or threat posed by discrete source of
time, there are no teletherapy or remote radium-226.
afterloader or gamma stereotactic securely protected. Of these 26 sources,
radiosurgery units with accelerator- only two naturally occurring B. The NRC’s Regulatory Approach
produced sources. radionuclides are listed: Radium-226
and polonium-210. Because this rule Consideration of Suggested State
Because production accelerators for
addresses discrete sources of radium- Regulations for the Control of Radiation
medical radionuclides (e.g., PET
226, the only other naturally occurring (SSRs)
production facilities) and industrial
radionuclides are used to intentionally radioactive material similar in hazard to All 34 Agreement States have
produce radioactive material for use of radium-226 when using the IAEA regulations for NARM. Twelve non-
its radioactive properties for a criteria is polonium-210. However, Agreement States and certain U.S.
commercial, medical, or research naturally occurring polonium is scarce. Territories have some type of regulatory
activity, the NRC will regulate both the One ton of uranium ore contains only structure for NARM, while four non-
radionuclides produced in these about 100 micrograms (0.0001 grams) of Agreement States have no program for
accelerators as well as the incidentally polonium. Due to its scarcity in nature, regulating NARM. The EPAct mandated
activated radioactive material. polonium-210 used for commercial that the NRC use model State standards
purposes is usually produced by to the maximum extent practicable in
Other Naturally Occurring Radioactive bombarding bismuth-209 with neutrons issuing regulations for the expanded
Material With Similar Risk as Radium- in a nuclear reactor and had been definition of Byproduct material. The
226 regulated by the NRC before the EPAct. NRC considered the SSRs published by
The EPAct amended the definition of Additionally, polonium-210 is unlikely CRCPD (http://www.crcpd.org/
jlentini on PROD1PC65 with RULES2
Byproduct material to include any to be commercially used in individual free_docs.asp) as the model State
discrete source of naturally occurring radioactive sources with activity levels standard in developing this rule. Most
radioactive material, other than source that would place them within the IAEA Agreement States have regulated
material, that the Commission, in Code of Conduct Category 1 or 2. Hence, discrete sources of radium and
consultation with the Administrator of the NRC has determined that no other accelerator-produced radioactive
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material in a manner similar to and amendments satisfy the requirements of is separate and distinct from the
under the same requirements as reactor- Section 651(d) of the EPAct pertaining radioactivity present in nature, and in
produced radioactive material. Few to the export or import of Category 1 or which the radionuclide concentration
provisions in the SSRs exist solely to Category 2 radiation sources as defined has been increased by human processes
address these materials. Where specific by the IAEA Code of Conduct. By this with the intent that the concentrated
provisions do exist in the SSRs for these final rule, the NRC is again amending is radioactive material will be used for its
materials, they have been evaluated for regulations in 10 CFR Part 110 to radiological properties.’’ As a result of
possible inclusion in the NRC’s include a definition of Discrete source. public comments on the proposed rule,
regulations. Section 651(d) of the EPAct also the NRC changed the wording of the
For radionuclide-specific values listed requires the NRC to issue regulations definition of Discrete source from that
in 10 CFR part 20, Appendices B and C, establishing a mandatory tracking in the proposed rule. Discrete source is
the NRC found that there are no other system for radiation sources, including defined in this final rule as ‘‘a
radionuclides identified in the SSRs radium-226, in the U.S. The NRC issued radionuclide that has been processed so
that are not already included in 10 CFR a final rule for national source tracking that its concentration within a material
part 20. As discussed further in this of sealed sources (71 FR 65686; has been purposely increased for use for
document under Section C., ‘‘Changes to November 8, 2006) that included commercial, medical, or research
Existing NRC Regulations to radium-226 sources. activities.’’ The changes are for
Accommodate the New Byproduct clarification purposes only and do not
Definition of Discrete Source
Material,’’ most of the specific change the original intent of the
provisions related to NARM The EPAct extended the definition of proposed definition of Discrete source
radionuclides in the SSRs have been Byproduct material in the AEA to or the scope of the NRC’s regulation of
adopted in this rule. These include include any discrete source of radium- radium-226 or other naturally occurring
exempt quantities in 10 CFR 30.18 and 226 and certain other naturally
radioactive materials identified in the
10 CFR 30.71, an exemption for occurring radioactive material that is
future. The intent of the revised
timepieces in 10 CFR 30.15, a general produced, extracted, or converted after
definition continues to be consistent
license for calibration and reference extraction, before, on, or after the date
with the proposed rule in that the NRC’s
sources in 10 CFR 31.8, a general license of the enactment of the EPAct, for use
authority is not intended to extend to all
for use of radioactive material for for a commercial, medical, or research
naturally occurring radioactive material,
certain in vitro clinical or laboratory activity. The term Discrete source is not
specifically not to naturally occurring
testing in 10 CFR 31.11, contamination defined in the EPAct, and the EPAct
radioactive material that is found in
limits for strontium-82/rubidium-82 specifically mandates that the final
nature in its original form and location,
generators, and requirements to measure regulations, in establishing
requirements necessary to carry out the or that which is moved or concentrated
the contamination limits in 10 CFR inadvertently by some man-made
35.204 with corresponding amendment, shall include a definition
of the term Discrete source. The process. A discrete source will have the
recordkeeping requirements in 10 CFR same radiological characteristics (e.g.,
35.2204. definition of Discrete source is used for
purposes of the new definition of type of radiation, half-life) as the
While SSRs do exist that address
Byproduct material in the case of radionuclide found in nature but will
other types of naturally occurring
radium-226 and other naturally have been purposefully concentrated for
radioactive material that are not covered
occurring radioactive material other use for its specific properties after it has
by the EPAct or these new regulations,
than source material. The term Discrete been removed from its original location
discrete sources of radium and
source is not used in conjunction with in nature. This definition excludes the
accelerator-produced radioactive
material are covered under the same accelerator-produced radioactive NRC’s jurisdiction over inadvertent
provisions of the SSRs that apply to material in the EPAct language. movement or concentration of naturally
reactor-produced radioactive material. Thus, the EPAct gave the NRC occurring radioactive material such as
There is general agreement among the authority over discrete sources of scale from pipes used in the fossil fuel
States, reflected in the SSRs, that the radium-226 but not over diffuse sources industry, fly ash from coal power plants,
new categories of byproduct material of radium-226. The EPAct did not or phosphate fertilizers. It also excludes
should be regulated under the same extend the NRC’s authority over radium- NRC jurisdiction over residuals from
requirements as reactor-produced 226 as it occurs in nature, or over other treatment of water. While radium, in
radioactive material. This rule takes the processes where radium-226 may be particular, may be intentionally
same regulatory approach. Most of the unintentionally concentrated. The focus concentrated in this case, it is not for
requirements that will apply to users of was on those materials that presented a the purpose of using the radium, but to
the newly regulated material are threat to public health and safety or to improve water quality. Only if, and
preexisting NRC requirements. the common defense and security when, this radium were further
similar to the threat posed by discrete processed for use would it be
Other Related Rulemakings radium-226 sources. Scale from pipes considered a discrete source, and thus
The NRC amended its regulations in used in the fossil fuel industry, fly ash byproduct material. Neither the changes
10 CFR Part 110 revising the definition from coal powerplants, phosphate to the AEA as a result of the EPAct, nor
of Byproduct material to include fertilizers, or residuals from treatment of anything in this rulemaking changes the
discrete sources of radium-226, water to meet drinking water standards NRC’s authority, in any manner, over
accelerator-produced radioactive are not considered discrete sources. source material.
material, and discrete sources of However, uranium and thorium within The words ‘‘a radionuclide that has
naturally occurring radioactive material these materials may become licensable been processed so that its concentration
jlentini on PROD1PC65 with RULES2
(71 FR 20336; April 20, 2006). In source material depending upon their within a material has been purposely
addition, an earlier amendment (70 FR concentration. increased’’ are intended to further
37985; July 1, 2005) added discrete The definition of Discrete source in clarify that the extraction or processing
sources of radium to 10 CFR Part 110, the proposed rule was ‘‘a radioactive relates to the intent to use the
Appendix P. Together, the two source with physical boundaries, which radionuclide itself, and not a material
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that happens to contain the The bases of these exemptions and largely as collectors’ items and only
radionuclide, such as fertilizer. The general licenses are primarily the SSRs infrequently used by consumers as
addition of the phrase ‘‘for use for and also information in NRC’s sealed timepieces. When originally
commercial, medical, or research source and device (SS&D) registry. The manufactured, the quantity of radium-
activities’’ repeats a constraint that also SS&D registry is the NRC’s national 226 employed in watch and clock dials
appears in the definition of Byproduct database of technical information on and hands varied by timepiece size,
material. The NRC has repeated this sealed sources and devices. manufacturer, model, and from item to
constraint in order to ensure that when Manufacturers or distributors may item. While the quantity of radium-226
the term ‘‘discrete source’’ is used submit a request to the NRC for an varied in the timepieces, there is a
separately from the term ‘‘byproduct evaluation of a product’s radiation general agreement for typical average
material,’’ it will not be interpreted safety information and for registration of and upper bound quantities. Based
more broadly, but it will be clear that the product. After satisfactory upon the spectrum of timepiece sizes,
only material which is intended for use completion of the evaluation, the NRC wristwatches have the smallest quantity,
for commercial, medical, or research issues a certificate of registration to the with pocket watches and clocks having
activities is being referenced. person making the request, and this quantities several times higher than
It should also be noted that in certificate is added to the SS&D registry. wristwatches. The radioactivity
accordance with this definition of Many Agreement States have similar associated with wristwatches is
Discrete source, once a discrete source registration procedures, and registration generally on the order of several
meets the definition of Byproduct certificates for the sources and devices kilobecquerel (kBq) (tenths of a
material, any contamination resulting they review are added to the national microcurie (µCi)) with an average of 5.6
from the use of such discrete sources of SS&D registry. The NRC also has kBq (0.15 (µCi)). Pocket watches may
this byproduct material will also be included SS&D certificates for NARM, have radioactivity of about 13 kBq (0.35
considered byproduct material. This which have been issued by the States. µCi), and clocks are typically 18 kBq
issue is discussed further in this While this is not a complete database (0.5 µCi). However, collections of pocket
document under ‘‘Summary and with respect to NARM, it includes watches and clocks are rare when
Analysis of Public Comments on the detailed information about many compared to wristwatches.
Proposed Rule.’’ products containing NARM previously Before the discontinuation of the
evaluated by the States. In addition to manufacturing of timepieces containing
C. Changes to Existing NRC Regulations SSRs and the information in the SS&D radium-226 in the 1970s, radium-226-
To Accommodate the New Byproduct registry, the specific provisions of the illuminated timepieces were widely
Material various States also were considered in distributed throughout the country as a
developing this rule. common consumer product. To date, a
The Commission has authority to
large number of radium-226 timepieces
issue both general and specific licenses Regulating Items Containing Radium- are still owned by individuals as valued
for the use of byproduct material and to 226 heirlooms or collectors’ items or are on
exempt byproduct material from Currently, items or products display in museums. Because museums
regulatory control under Section 81 of containing radium-226 are unique in and collectors normally collect a wide
the AEA. A general license, as provided that there are no new items in consumer range of timepieces, a portion of their
by regulation, grants authority to a commerce using radium-226 byproduct collection may contain radium-226
person for certain activities involving material. Although certain industrial timepieces. Some businesses and a few
byproduct material and is effective devices such as moisture density gauges collectors are also engaged in repairing
without the filing of an application with containing radium-226 are still in use, and refurbishing timepieces either as a
the Commission or the issuance of a most radium-226 articles have not been hobby or professionally, and these
licensing document to a particular produced for at least 20 years. activities may occasionally involve
person. Requirements for general Beginning in the early 1900s, radium- timepieces containing radium-226.
licensees appear in the regulations and 226 was used to make self-luminescent Because these timepieces were
are designed to be commensurate with paint and incorporated in watch and manufactured before the NRC assumed
the specific circumstances covered by clock dials and hands and later used to regulatory authority over radium-226,
each general license. illuminate airplane instrumentation and because these timepieces are
In considering the expansion of the dials and gauges as well as markers and already in public possession, the NRC
definition of Byproduct material to signs. Beginning in the 1950s, other intends to minimize regulatory impact
include discrete sources of radium-226 radionuclides began to replace radium- to individuals, museums, or other
and accelerator-produced radioactive 226 as a self-luminescent material due entities in possession of these
material, the NRC has evaluated to the recognition of the radiological timepieces. In finalizing the rule, the
products and materials previously hazard associated with radium-226. NRC made its determination based on
approved by the States for use under an Currently, the radionuclides of choice no significant risk to public health and
exemption from licensing and under a for self-luminescent applications are safety and the environment.
general license. Generally, the NRC’s promethium-147 and tritium due to the In the proposed rule, the NRC
intent in this rule is to accommodate much reduced radiological hazard vis-a- proposed to exempt intact timepieces
existing products and materials that vis radium-226. containing no more than 37 kBq (1 µCi)
were previously regulated by the States Based on the National Council on of radium-226 per timepiece and repair
under similar provisions, if the potential Radiation Protection and Measurements of no more than 10 timepieces in any
doses are similar to those expected from in Report 95, ‘‘Radiation Exposure of the one year. In addition, the NRC proposed
other currently regulated products and U.S. Population from Consumer to generally license no more than 50
jlentini on PROD1PC65 with RULES2
materials. Many of these products have Products and Miscellaneous Sources,’’ timepiece hands and dials used or
not been made for some time, so some radium-226 has not been used in stored at the same location at any one
of the provisions in this rule are limited radioluminescent watches since 1968 time. Due to lack of sufficient health
to items manufactured in the past, and clocks since 1978. In fact, radium- and safety information to make a final
which may still be in use or in storage. 226 timepieces are currently kept regulatory decision, the NRC conducted
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