Requirements for Expanded Definition of Byproduct Material, 42952-42994 [06-6477]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 71, Number 145 (Friday, July 28, 2006)]
[Proposed Rules]
[Pages 42952-42994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6477]



[[Page 42951]]

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

Part IV





Nuclear Regulatory Commission





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



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]]


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

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.

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

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 https://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: SECY@nrc.gov. 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 https://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
cag@nrc.gov. Comments can also be submitted via the Federal eRulemaking 
Portal https://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 
https://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 https://www.nrc.gov/NRC/ADAMS/. 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 pdr@nrc.gov.

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 
lwc1@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background
II. Discussion
    A. Initiating the Rulemaking Process
    B. The New Expanded Definition of Byproduct Material
    C. The NRC's Regulatory Approach
    D. Changes to Existing NRC Regulations to Accommodate the New 
Byproduct Material
    E. License Application and Annual Fees
    F. Implementation Strategy
    G. Summary of Issues for Public Comment
III. Section-by-Section Analysis of Substantive Changes
IV. Criminal Penalties
V. Agreement State Compatibility
VI. Plain Language
VII. Voluntary Consensus Standards
VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability
IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis

I. Background

The Energy Policy Act of 2005

    On August 8, 2005, the President signed into law the EPAct. Among 
other provisions, Section 651(e) of the EPAct expanded the definition 
of byproduct material as defined in Section 11e. of the Atomic Energy 
Act of 1954 (AEA), placing additional byproduct material under the 
NRC's jurisdiction, and required the Commission to provide a regulatory 
framework for licensing and regulating this additional byproduct 
material.
    Specifically, Section 651(e) of the EPAct expanded the definition 
of byproduct material by: (1) Adding any discrete source of radium-226 
that is produced, extracted, or converted after extraction, before, on, 
or after the date of enactment of the EPAct for use for a commercial, 
medical, or research activity; or any material that has been made 
radioactive by use of a particle accelerator and is produced, 
extracted, or converted after extraction, before, on, or after the date 
of enactment of the

[[Page 42953]]

EPAct for use for a commercial, medical, or research activity (Section 
11e.(3) of the AEA); and (2) adding any discrete source of naturally 
occurring radioactive material, other than source material, that the 
Commission, in consultation with the Administrator of the Environmental 
Protection Agency (EPA), the Secretary of the Department of Energy 
(DOE), the Secretary of the Department of Homeland Security (DHS), and 
the head of any other appropriate Federal agency, determines would pose 
a threat similar to the threat posed by a discrete source of radium-226 
to the public health and safety or the common defense and security; and 
is extracted or converted after extraction before, on, or after the 
date of enactment of the EPAct for use in a commercial, medical, or 
research activity (Section 11e.(4) of the AEA).
    Although Section 651(e) of the EPAct became effective on August 8, 
2005, the NRC did not have regulations in place that would specifically 
apply to this newly covered byproduct material (hereafter referred to 
as NARM). However, the EPAct allowed the NRC 18 months from the date 
that the legislation was signed into law by the President to issue 
regulations to establish a national program for NARM. The EPAct also 
allowed the NRC to issue waivers to States and other entities while a 
regulatory framework for NARM was developed. A waiver was issued on 
August 31, 2005 (70 FR 51581).

Current Regulatory Structures for NARM

    The AEA authorizes States to assume regulatory control of 
radioactive materials produced in or by a nuclear reactor, provided the 
State has an adequate program to protect the public health and safety 
and is compatible with the NRC's program for regulation of these 
materials and enters into an agreement with the NRC. As authorized by 
Section 274b of the AEA, 34 States have assumed responsibility for 
regulating certain activities related to radioactive material by 
entering into agreements with the NRC. The activities regulated by 
these ``Agreement States'' include the use of byproduct material, 
source, and special nuclear material. Each Agreement State issues 
licenses to persons who use these materials in that State except for 
DOE, other Government agencies, and Federally recognized Indian Tribes. 
The NRC issues licenses to persons using these materials in non-
Agreement States.
    Before enactment of the EPAct, the NRC did not have authority over 
NARM nor regulations for this type of material. Although the NRC has 
not regulated NARM in the past, all 33 Agreement States and certain 
non-Agreement States have regulatory programs for NARM. The NRC's 
current regulations do require licensees to account for dose 
contributed from NARM, as well as dose contributed from other 
byproduct, source, or special nuclear material, because the definition 
of occupational dose encompasses both licensed material and nonlicensed 
material such as NARM sources at a licensed facility. In addition, the 
NRC requires, in its radiological criteria for license termination, 
that licensees consider other nondiscrete sources including radium 
during decommissioning activities at sites contaminated with source 
material, such as rare-earth processing facilities.
    Currently, there are 16 non-Agreement States plus United States 
(U.S.) Territories.Although most non-Agreement States and U.S. 
Territories have some type of programs for NARM, the regulatory 
structures vary greatly. Certain non-Agreement States have established 
a licensing structure for regulating their NARM users. As such, the 
regulatory structure could parallel the NRC regulations issued in Title 
10 of the Code of Federal Regulations applicable to the current 
materials program, or it could parallel the Suggested State Regulations 
for the Control of Radiation (SSRs) developed by the CRCPD. Other non-
Agreement States or U.S. Territories have elected to use registration 
as their regulatory structure for managing the NARM users. Some States 
register facilities; others register both facilities and devices. Some 
States use registration information to conduct inspections; others use 
registration to identify facility locations for security purposes. In 
general, there is limited regulatory oversight where registration is 
used in non-Agreement States. It was, in part, due to this lack of 
national consistency, that the EPAct placed these materials under NRC 
jurisdiction.
    Agreement States have regulated NARM use for many decades in a 
fairly uniform and consistent manner. The Agreement States have 
accomplished this by using the same standards to regulate NARM as those 
used to regulate other byproduct, source, and special nuclear material 
under NRC authority. In many respects, regulations applicable to NARM 
adopted by the Agreement States are compatible with the NRC regulations 
for the current materials program, or parallel to the CRCPD's SSRs.
    Although Agreement States do have some provisions specifically for 
NARM, in general, the regulatory structure used by Agreement States 
does not distinguish between NARM and other radioactive material. NARM 
users in Agreement States are expected to implement all aspects of 
standards for their radiation protection programs with respect to NARM, 
including those aspects relating to receipt, possession, use, storage, 
transfer, transportation, and disposal of NARM. This regulatory 
structure also subjects NARM users in the Agreement States to the same 
licensing, inspection, and enforcement policies as those using other 
byproduct, source, or special nuclear materials. In addition, this 
regulatory structure allows for both specific and general licensing of 
various NARM products, the distribution of certain NARM items to 
persons exempt from regulation and, in most cases, includes provisions 
to review and approve proposals for sealed sources and devices 
containing NARM.
    The Agreement States have regulated a vast array of NARM produced 
for medical, industrial, research and development, commercial, and 
consumer purposes. In many Agreement States, this regulatory structure 
also captures some types of nondiscrete sources found in the oil and 
gas industry or mining industry; moreover, it captures inadvertently 
produced activation products from the use of proton beams for medical 
radiation therapy. However, the regulation of these nondiscrete sources 
and activation products has greater variation from Agreement State to 
Agreement State.

Other Federal Agencies' Regulatory Authority Over NARM

    Before the passage of the EPAct, NARM was regulated as a 
radioactive material and/or a hazardous substance but was not regulated 
by the NRC. Although States had the primary responsibility for 
regulating the use of these materials, certain Federal regulations did 
and will continue to apply under some circumstances, such as 
environmental protection, workplace safety, drug safety, 
transportation, and disposal. With the passage of the EPAct, the NRC 
will have primary responsibility for radiation safety and in regulating 
the use of these materials in cooperation with the States, with the 
exception of those activities that are self-regulated by the DOE.
    Other Federal agencies have established programs in regulating 
certain aspects of activities involving NARM. The Department of 
Transportation (DOT) regulates interstate transport of NARM. In 
cooperation with DOT, the NRC approves Type B packages through 
regulations in 10 CFR Part 71. The EPA has established controls for 
certain

[[Page 42954]]

NARM through several authorities, including the Clean Air Act, the Safe 
Drinking Water Act, the Toxic Substances Control Act, the Resource 
Conservation and Recovery Act, and the Comprehensive Environmental 
Response, Compensation, and Liability Act. The Department of Labor 
(DOL) has established regulations addressing the exposure of minors to 
radioactive material in the workplace. The Occupational Safety and 
Health Administration (OSHA) has the oversight for occupational health 
and safety for non-AEA materials. The Department of Commerce (DOC) has 
controlled the export of radioactive material. Prior to the enactment 
of the EPAct, the DOC regulated the export of all radium-226. With the 
enactment of the EPAct, NRC will regulate the export of discrete 
sources of radium-226; DOC retains jurisdiction to regulate the export 
of nondiscrete sources of radium-226. The Consumer Product Safety 
Commission regulations have addressed hazardous substances other than 
byproduct, source, and special nuclear materials currently regulated by 
the NRC. The Food and Drug Administration (FDA) regulates all drugs 
(including drugs containing radioactive materials) by requiring good 
manufacturing practices to assure the purity, potency, and consistency 
of finished drugs with their labeling in establishing the safety and 
effectiveness of these drugs.
    Section 651(e)(3) of the EPAct provides that byproduct material, as 
defined by paragraphs 11e.(3) or 11e.(4) of the AEA, may only be 
transferred to and disposed of in a disposal facility that is adequate 
to protect public health and safety, and is licensed by either the NRC 
or a State that has entered into an agreement with the Commission under 
Section 274b of the AEA or at a disposal facility in accordance with 
any Federal or State solid or hazardous waste law, including the Solid 
Waste Disposal Act, also known as the Resource Conservation and 
Recovery Act (RCRA).

Development of the Suggested State Regulations

    Since enactment of the AEA in 1954, scientists continue to develop 
new technologies in producing radionuclides, such as the use of 
particle accelerators. At the turn of the century, naturally occurring 
radioactive material, including radium-226, was routinely used in 
consumer products and in cancer treatment. Because there was no Federal 
mandate to regulate these materials, most States have since established 
regulatory structures for both accelerator-produced radioactive 
material and naturally occurring radioactive material, including 
radium-226.
    In 1968, CRCPD was chartered as a nonprofit organization to provide 
a forum for enhancing communication among States and Federal agencies 
regarding radiation regulations and to promote a uniform radiation 
protection environment for all radioactive material. Throughout the 
years, CRCPD developed policies and guidance for its member States. In 
addition, CRCPD is responsible for the development of model 
regulations, known as the SSRs. CRCPD has formed many working groups to 
develop a set of SSRs for radioactive material compatible in many 
respects to the NRC regulations. Under the SSRs' regulatory framework, 
NARM is a regulated radioactive material comparable to byproduct 
material. Nearly all of the Agreement States have based their 
regulations on this model for NARM.
    For NARM regulation only, CRCPD also established ``Licensing 
States'' similar to the Agreement State Program under Section 274 of 
the AEA. Licensing States recognized by CRCPD under criteria found in 
Publication 94-8, ``CRCPD Recognition of Licensing States for the 
Regulation and Control of NARM,'' are those States that have 
demonstrated an adequate and consistent regulatory control program for 
NARM. Licensing State designation assures comparable regulatory 
structures with respect to NARM, and other States may grant reciprocal 
recognition of their licenses or acceptance of their licensees' 
manufactured products.

Issuance of Waiver on August 31, 2005

    Section 651(e) of the EPAct became effective immediately upon 
signature by the President on August 8, 2005. Before enactment of the 
EPAct, the NRC did not have authority over NARM and currently does not 
have regulations in place that would specifically apply to this 
material. Nonetheless, persons engaged in activities involving NARM 
could be, and States seeking to continue regulation of NARM would be, 
in technical violation of the AEA. Therefore, the NRC determined that 
it would be prudent to establish a mechanism to permit individuals 
currently engaged in activities involving NARM to continue with their 
activities. Although the Commission could have proceeded through 
issuing orders on a case-by-case basis to oversee activities involving 
NARM while establishing the regulatory framework for regulating this 
material, the Commission determined that this would be inefficient and 
resource intensive.
    Section 651(e)(5) of the EPAct authorizes the Commission to issue a 
waiver of the requirements of Section 651(e) to any entity with respect 
to NARM for specified periods of time if the Commission determines that 
the waiver is in accordance with the protection of the public health 
and safety, and the promotion of the common defense and security. The 
Commission determined that this waiver could be granted to entities 
that engaged in activities involving NARM. The Commission determined 
that there was no basis to conclude that these materials would not 
continue to be used in a manner that is protective of public health and 
safety while the waiver is in effect. The Commission also determined 
that it would be in the best interests of the public to allow continued 
use of NARM, especially for medical purposes, and to allow the States 
to continue to regulate NARM until the Commission could codify new 
regulations for these materials.
    The Commission believed that granting the waiver would allow the 
States to continue with their regulatory programs, allow persons 
engaged in activities involving NARM to continue their operations in a 
safe manner, and allow continued access to medical 
radiopharmaceuticals. In addition, it would enable the Commission to 
work with the States in developing appropriate regulations for NARM and 
in formulating a sound transition plan for implementation of these 
regulations. It would also provide an opportunity for non-Agreement 
States that currently do not have Agreement State regulatory programs 
under Section 274b. of the AEA to consider entering into an agreement 
with the NRC. The Commission determined that issuance of the waiver 
would be in accordance with the protection of public health and safety 
and the promotion of the common defense and security.
    Therefore, the Commission granted a waiver (70 FR 51581; August 31, 
2005) from the requirements of Section 651(e) of the EPAct to: (1) All 
persons engaged in export from or import into the U.S. of byproduct 
material through August 7, 2006, unless terminated sooner if the 
Commission determined that an earlier termination was warranted; and 
except with regard to the requirements of the DOC relating to export of 
byproduct material; (2) all persons acquiring, delivering, receiving, 
possessing, owning, using, or transferring byproduct material through 
August 7, 2009, unless terminated sooner if the Commission determined 
that an earlier termination

[[Page 42955]]

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 https://
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 https://
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 https://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 https://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 https://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 ex