[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]



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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

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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