Notification of the Plan for the Transition of Regulatory Authority Resulting From the Expanded Definition of Byproduct Material, 59157-59162 [07-5120]
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Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Rules and Regulations
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Notification of the Plan for the
Transition of Regulatory Authority
Resulting From the Expanded
Definition of Byproduct Material
Nuclear Regulatory
Commission.
ACTION: Notice of publication of
transition plan.
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AGENCY:
SUMMARY: In accordance with Section
651e of the Energy Policy Act of 2005,
the U.S. Nuclear Regulatory
Commission is publishing a ‘‘Plan for
the Transition of Regulatory Authority
Resulting from the Expanded Definition
of Byproduct Material’’ (transition plan)
to facilitate an orderly transition of
regulatory authority with respect to the
byproduct material defined in
paragraphs (3) and (4) of section 11e. of
the Atomic Energy Act of 1954, as
amended. A copy of the final transition
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plan is provided as Appendix A to this
document.
FOR FURTHER INFORMATION CONTACT: Kim
K. Lukes, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, telephone (301) 415–
6701 or e-mail KXK2@NRC.GOV.
Dated at Rockville, Maryland, this 11th day
of October, 2007.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
Appendix A—A Plan for the Transition
of Regulatory Authority Resulting From
the Expanded Definition of Byproduct
Material
I. Introduction
The Energy Policy Act of 2005
(EPAct) expanded U.S. Nuclear
Regulatory Commission (NRC or
Commission) regulatory authority over
radioactive materials to include new
byproduct material, as defined in
paragraphs (3) and (4) of section 11e. of
the Atomic Energy Act of 1954, as
amended (AEA), hereinafter referred to
as the new byproduct material. The
expanded NRC authority pre-empted
existing State regulatory authority over
the subject materials. NRC is authorized,
however, to discontinue its regulatory
authority over the new byproduct
material under certain conditions,
allowing States to exercise regulatory
authority over these materials.
The EPAct requires the Commission
to prepare and publish a transition plan
to facilitate an orderly transition of
regulatory authority with respect to the
new byproduct material. The plan must
address States that have, before the date
on which the plan is published, entered
into agreements with the Commission,
under section 274b. of the AEA 1
(Agreement States), and States that have
not entered into such agreements (nonAgreement States). The plan must also
include a description of the conditions
under which a State may exercise
regulatory authority over the new
byproduct material.
To meet the requirements of the
EPAct, the transition plan must include
a statement of the Commission that any
Agreement between the Commission
and a State 2 under section 274b. of the
1 Section 274b. of the AEA authorizes the
Commission to enter into an agreement with the
Governor of a State that provides for discontinuance
of the Commission’s regulatory authority in the
State over byproduct material as defined in section
11e., source materials, and special nuclear materials
in quantities not sufficient to form a critical mass.
2 Section 274n. of the AEA defines the term
‘‘State’’ to mean any State, Territory, or possession
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AEA, covering byproduct material and
entered into before the date of
publication of the transition plan, must
be considered to include the new
byproduct material, if the Governor of
the State certifies to the Commission, on
the date of the publication of the
transition plan that: (1) The State has a
program for licensing the new
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 new
byproduct material. This transition plan
is being promulgated in response to
those requirements.
II. Background
On August 8, 2005, the President
signed into law the Energy Policy Act of
2005. Public Law No. 109–58, 119 Stat
594 (2005). Before then, byproduct
material had been defined in section
11e. of the AEA as: (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; and (2) the
tailings or wastes produced by the
extraction or concentration of uranium
or thorium from any ore processed
primarily for its source material content.
Section 651(e) of the EPAct, among
other things, expanded the definition of
byproduct material in section 11e. of the
AEA, thereby placing additional
byproduct material under NRC’s
jurisdiction. Section 651(e) further
required the Commission to provide a
regulatory framework for licensing and
regulating this additional byproduct
material.
In particular, section 651(e) of the
EPAct expanded the definition of
byproduct material by adding
paragraphs (3) and (4) to the definition
of byproduct material in section 11e.
Section 11e.(3) defines, as byproduct
material:
‘‘(A) any discrete source of radium-226 that
is produced, extracted, or converted after
extraction, before, on, or after the date of
enactment of this paragraph for use for a
commercial, medical, or research activity; or
(B) any material that—
(i) has been made radioactive by use of a
particle accelerator; and
(ii) is produced, extracted, or converted
after extraction, before, on, or after the date
of enactment of this paragraph for use for a
commercial, medical, or research activity.
Section 11e.(4) defines, as byproduct
material, any discrete source of
of the United States, the Canal Zone, Puerto Rico,
and the District of Columbia.
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naturally occurring radioactive material
(NORM),3 other than source material,
that—
(A) 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
(B) before, on, or after the date of
enactment of this paragraph is extracted or
converted after extraction for use in a
commercial, medical, or research activity.’’
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III. The Agreement State Program
In 1959, the AEA was amended to
adopt section 274, Cooperation with
States. As provided in section 274b., the
Governor of a State may request an
Agreement with the Commission in
which NRC discontinues, and the State
assumes, regulatory authority over
categories of materials, that may include
source, byproduct, and special nuclear
materials (in quantities insufficient to
form a critical mass). Collectively, the
materials that are authorized for
regulation by States under such
Agreements are known as ‘‘AEA
materials’’ or ‘‘Agreement materials.’’
The Commission may enter into an
Agreement if it finds that the State
program is compatible with the
Commission’s program for regulation of
such materials, and that it is adequate
to protect the public health and safety
with respect to the materials covered by
the proposed Agreement. Under section
274j.(1) of the AEA, the Commission
must periodically review Agreement
State programs and the actions the
States take under the Agreements, to
ensure compliance with the provisions
of that section.
A. Concept of Compatibility
In 1997, the Commission adopted a
Policy Statement declaring that an
Agreement State radiation control
program is compatible with the
Commission’s regulatory program when
the State program does not create
conflicts, duplications, gaps, or other
conditions that jeopardize an orderly
pattern in the regulation of agreement
material Nationwide [see Statement of
Principle and Policy for the Agreement
State Program; Policy Statement on
Adequacy and Compatibility of
Agreement State Programs, (62 FR
46517; September 3, 1997)]. Thus,
compatibility focuses primarily on the
3 Note: At this time, NRC has not identified any
NORM currently in use that would meet the
definition of section 11e.(4).
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potential effects of a State action or
inaction either on a Nationwide basis or
on interstate commerce crossing into
other jurisdictions.
Generally, a State program is
compatible if the elements of the
program are similar to the
corresponding elements of the NRC
program. Some elements, such as basic
radiation protection standards and
program elements with transboundary
implications, should be essentially
identical, whereas other elements may
need only to meet the same essential
objectives. The detailed criteria for
Agreement State compatibility are set
out in NRC Management Directive 5.9,
Adequacy and Compatibility of
Agreement State Programs.
B. Concept of Adequacy
The 1997 Commission Policy
Statement declares that an Agreement
State radiation control program is
adequate to protect public health and
safety if administration of the program
provides reasonable assurance that the
level of protection afforded by the State
program is at least as protective as
NRC’s materials regulatory program.
The continuing adequacy and
compatibility of an Agreement State
radiation control program is determined
through the Integrated Materials
Performance Evaluation Program
(IMPEP). NRC periodically reviews the
adequacy and compatibility of each
Agreement State’s radiation protection
program using the same set of
performance criteria used to evaluate
the equivalent NRC licensing and
inspection programs. For further
information on this program, please see
NRC Management Directive 5.6,
Integrated Materials Performance
Evaluation Program (IMPEP), on the
NRC Web site (https://www.nrc.gov).
IV. Regulation of Radioactive Materials
Before the EPAct
For the purposes of this discussion,
before the EPAct, radioactive materials
could be divided into three groups:
those regulated only by NRC (e.g.,
formula quantities of special nuclear
material); those regulated only by State
or local agencies [e.g., Naturally
Occurring and Accelerator-Produced
Radioactive Material (NARM)]; and
those radioactive materials that may be
regulated by NRC, or by a State under
an Agreement pursuant to section 274b.
of the AEA.
Since 1954, NRC (and its predecessor
agency, the U.S. Atomic Energy
Commission) has regulated the nonmilitary use of a limited set of
radioactive materials. Collectively, the
set of regulated materials is known as
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AEA material. The basis for assertion of
Federal authority over the AEA
materials was the belief that they posed
(at that time) a new hazard beyond the
ability of the States to control. NORM
(mostly radium-226) and acceleratorproduced radioactive materials (ARM)
were relatively rare and did not pose an
overwhelming problem for the States to
control.
AEA material originally consisted of
source and special nuclear materials,
and byproduct materials as now defined
in section 11e.(1). In 1978, the AEA
definition of ‘‘byproduct material’’ was
amended to add section 11e.(2), that
included the tailings from uranium or
thorium ore processed primarily for
their source material content. Other
NORM and ARM were not included in
the definition of byproduct material
before enactment of the EPAct, and thus
were not AEA materials and were not
subject to NRC regulation. These
radioactive materials were under
individual State regulatory authority.
V. Regulatory Changes Required by
Section 651(e) of the EPAct
By amending the definition of
‘‘byproduct material’’ to include certain
ARM and NORM, including radium226, the EPAct has made these
radioactive materials AEA materials
subject to NRC regulation. Note that
only certain ARM and NORM that meet
the criteria set out in the EPAct are
byproduct material. The criteria for
ARM that is defined as byproduct
material are that the material: (1) Is
made radioactive by use of a particle
accelerator; (2) is produced, extracted,
or converted after extraction, before, on,
or after the enactment date of the EPAct;
and (3) is produced, extracted, or
converted after extraction, for use for a
commercial, medical, or research
activity. For radium-226 and other
NORM to be byproduct material, it must
meet the last two criteria, plus be a
‘‘discrete source.’’ ARM and NORM that
do not meet these criteria are not AEA
byproduct material.
Independent State regulation of the
new byproduct material is pre-empted
by the EPAct. States now may only
regulate the materials through an
agreement with the Commission, under
section 274b. of the AEA. Other ARM
and NORM that do not meet the
definition of byproduct material could
continue to be regulated under
individual State authority.
This transition plan addresses only
transitions of authority related to the
newly defined byproduct material
described in Section 651(e) and not to
issues raised in other sections of the
EPAct.
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VI. Transition of Authority
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A. Preliminary Activities
At the time the EPAct was signed into
law, NRC did not have regulations in
place that would specifically apply to
the new byproduct material. Time was
needed for the development of a revised
regulatory program, to allow for the
orderly transition of regulatory authority
over this material.
Section 651(e)(5) of the EPAct
authorizes the Commission to issue
waivers of the requirements of section
651(e) for up to 4 years, if the
Commission determines that the waiver
is in accordance with the protection of
the public health and safety and
promotion of the common defense and
security. The Commission determined
that such a waiver should be granted to
entities engaging in activities involving
the new byproduct material, and it
would be in the best interests of the
public to allow the continued use of the
new byproduct material, and to allow
the States to continue to regulate the
new byproduct material until the
Commission could codify new
regulations for these materials. The
Commission issued such a waiver on
August 31, 2005 (70 FR 51581). As
required by section 651(e) of the EPAct,
the Commission must terminate any
waiver issued under section 651(e),
regarding a State, on determining that:
(1) The State has entered into an
agreement with the Commission under
section 274b. of the AEA; (2) the
Agreement covers section 11e.(3) or
11e.(4) byproduct material; and (3) the
State’s program for licensing such
byproduct material is adequate to
protect the public health and safety. In
addition, any waiver issued under
section 651(e) may be effective only
through August 7, 2009, unless the
Commission terminates it earlier.
NRC conducted a rulemaking to cover
the new byproduct materials. The final
rule was published on October 1, 2007
(72 FR 55864), in accordance with the
EPAct requirements. The rule is to
become effective 60 days after
publication for some licensees, and later
for others, as described in this transition
plan and the Federal Register Notice for
the final rule. Revisions to NRC Policy
and Guidance documents were
undertaken in parallel with the
rulemaking.
B. Conditions Under Which a State May
Exercise Authority Over 11e.(3) and
11e.(4) Byproduct Material
A State may exercise regulatory
authority over the new byproduct
material in one of two ways: (1) Under
the Commission-issued waiver; or (2)
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under an AEA section 274b. Agreement.
Starting on August 8, 2009, or earlier if
the waiver is terminated for the State
under EPAct section 651(e)(5)(B)(ii), the
State may exercise its own authority
over the new byproduct material only
under an AEA section 274b. Agreement.
If the State does not already have such
an Agreement, the Governor of the State
may request an Agreement with the
Commission. The Commission may
enter into an Agreement if the
documentation supporting the
Governor’s request demonstrates that:
(1) The State has a program to regulate
the materials covered by the proposed
Agreement; and (2) the State program is
adequate to protect the public health
and safety and is compatible with the
Commission’s program for byproduct
material.
NRC staff will evaluate the Governor’s
request using NRC/Office of Federal and
State Materials and Environmental
Management Programs (FSME)
Procedure SA–700, Processing an
Agreement. This procedure is posted on
the NRC Web site (https://www.nrc.gov).
Printed hard copies may also be
obtained from the NRC Public
Document Room.
The Commission may enter into an
Agreement covering one or more of the
following categories of materials: source
material; special nuclear material in
quantities not sufficient to form a
critical mass; byproduct material as
defined in section 11e.(1), 11e.(2),
11e.(3), or 11e.(4); the regulation of the
land disposal of byproduct, source, or
special nuclear waste materials received
from other persons; and the safety
evaluation of sealed sources or devices
containing sealed sources.
1. Transition of Authority in States That
Have Entered Into Agreements With the
Commission Under AEA Section 274b.,
Before Publication of This Plan
There are two ways an existing
Agreement State may include the new
byproduct material in its AEA section
274b. Agreement: (1) The Governor of
the State provides the certification
described in section 651(e)(4)(C)(iii)(II)
of the EPAct on the date of publication
of the transition plan; or (2) using the
standard process, whereby the Governor
requests an amendment to the State’s
Agreement, as provided in section 274
of the AEA.
The Governor’s certification avoids
the need to amend the State’s
Agreement in accordance with the
formal requirements of section 274 of
the AEA. If a Governor chooses not to
provide the certification described in
the EPAct, NRC will assert its authority
to regulate the new byproduct material.
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2. Basis for Finding Adequacy in
Reviewing Governor Certifications
For Agreement States whose
Governors provide a certification, the
Commission will find the States’
programs adequate to protect health and
safety if the criteria of NRC Management
Directive 5.6, Integrated Materials
Performance Evaluation Program
(IMPEP), are satisfied. For an Agreement
State whose program for licensing
11e.(1) byproduct material has been
previously evaluated under IMPEP, the
Commission will base its determination
of adequacy on the State’s prior IMPEP
findings if: (1) The State’s program for
licensing 11e.(3) and 11e.(4) byproduct
material is not separate and distinct 4
from its program for licensing 11e.(1)
byproduct material; (2) the State intends
to continue to license the new
byproduct material under its existing
program; and (3) no changes have been
made to the State’s licensing program
that would impact the previous IMPEP
finding of adequacy. If the State
provides confirmation that these criteria
are met, the Commission will consider
a finding of adequate performance from
the State’s last IMPEP review as an
indicator that the State’s program for
licensing section 11e.(3) and 11e.(4)
byproduct material is adequate to
protect health and safety.
For a new Agreement State that has
not yet had a program review under
IMPEP, the Commission will base its
determination of adequacy on the
following: (1) The State’s program for
licensing 11e.(3) and 11e.(4) byproduct
material is not separate and distinct
from its program for licensing 11e.(1)
byproduct material; (2) the State intends
to continue to license the new
byproduct material under its existing
program; and (3) no changes have been
made to the State’s licensing program
that would impact the Commission’s
decision to enter into the AEA section
274b. Agreement.
The Governor’s certification should be
addressed to the Chairman of the
Commission. On receipt, the Chairman
or his designee will review the
certification. If the Governor’s
certification contains the statements
required by the EPAct, and the
Commission determines that the State’s
program to license the new byproduct
material is adequate to protect health
and safety, the Chairman will accept the
Governor’s certification on behalf of the
Commission, and the Governor will be
notified of the acceptance. As of the
4 The Commission understands that the
Agreement States license NARM and section 11e.(1)
byproduct material without distinguishing between
the materials.
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date that the certification is accepted by
the Commission, the State’s Agreement
will be considered to include AEA
section 11e.(3) and 11e.(4) byproduct
material, and the waiver will be
terminated for the State. The
certification will become a part of the
Agreement, but the Agreement
document will not be otherwise
amended.
The NRC will verify the adequacy of
the State’s program to license the new
byproduct material during subsequent
IMPEP reviews.
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3. Agreement States That Elect Not To
Include AEA Section 11e.(3) and 11e.(4)
Byproduct Material in Their Agreements
If an Agreement State elects not to
continue to regulate the new byproduct
material under an existing section 274b.
Agreement, the State should notify the
Commission that it intends to
discontinue its regulatory authority for
the new byproduct material. NRC is
requesting that such an Agreement State
also provide NRC with a list of affected
users/licensees, in its notification.
To facilitate an orderly transition of
regulatory authority for an Agreement
State that does not intend to continue to
regulate the new byproduct material,
NRC intends to terminate the waiver for
the State, and all individuals in the
State, before August 8, 2009. The timing
of the waiver termination for the State
will be determined in consultation with
representatives of the State’s regulatory
program.
NRC plans to use the phased
approach for earlier waiver terminations
described in Section VI.C.1., ‘‘NonAgreement States That Do Not Request
an Agreement,’’ for Agreement States
that do not intend to continue to
regulate the new byproduct material.
This approach will prevent an abrupt
transition of authority on the date the
waiver expires. Likewise, NRC plans to
notice waiver terminations in the
Federal Register, for Agreement States
that do not intend to continue to
regulate the new byproduct material, in
the same manner as described in
Section VI.C.1., for non-Agreement
States that do not request Agreements.
Also, the actions with which users of
the new byproduct material in such
Agreement States will be required to
comply will be the same as those
described in Section VI.C.1., for users in
non-Agreement States that do not
request Agreements.
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4. Agreement States That Do Not, on the
Date of Publication of the Transition
Plan, Certify Adequacy for 11e.(3) and
11e.(4) Byproduct Material
Section 651(e) of the EPAct provides
that any Agreement covering byproduct
material, as defined in paragraph (1) or
(2) of section 11e. of the AEA, entered
into between the Commission and a
State under section 274b. of that Act
before the date of publication of this
transition plan shall be considered to
include byproduct material, as defined
in paragraph (3) or (4) of section 11e. of
the AEA, if the Governor of the State
certifies to the Commission on the date
of publication of this transition plan
that: (a) The State has a program for
licensing byproduct material, as defined
in paragraph (3) or (4) of section 11e. of
the AEA, that is adequate to protect the
public health and safety, as determined
by the Commission; and (b) the State
intends to continue to implement the
regulatory responsibility of the State
with respect to the byproduct material.
If the Governor of a State has not
made such a certification to the
Commission, and the State intends to
continue to implement its regulatory
authority over these materials, the State
may be required to amend its AEA
section 274b. Agreement to include the
new byproduct material.
C. Transition of Authority in States That
Have Not Entered Into an Agreement
With the Commission Under AEA
Section 274b. (Non-Agreement States)
Before Publication of This Plan
1. Non-Agreement States That Do Not
Request an Agreement
Any State that, on August 8, 2009,
does not have an Agreement with the
Commission under section 274b. of the
AEA, which covers 11e.(3) or 11e.(4)
new byproduct material, must
discontinue its regulatory authority over
the byproduct material.
To facilitate an orderly transition of
regulatory authority for States that do
not intend to establish AEA section
274b. Agreements with the Commission
before August 8, 2009, NRC intends to
terminate the waiver for such States,
and all individuals in such States,
before August 8, 2009. NRC plans to use
a phased approach for the earlier waiver
terminations, to prevent an abrupt
transition of authority on the date the
waiver expires. The timing of waiver
terminations for the States will be
determined in consultation with
representatives of the States’ regulatory
programs. Waiver terminations will be
executed for groups of States, at
periodic intervals occurring between the
effective date of the rule and August 7,
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2009. Starting at Midnight, local time,
on the effective date of the waiver
termination, NRC will assume
regulatory authority over section 11e.(3)
and 11e.(4) byproduct material within
the States.
Each waiver termination for a group
of States will be noticed in the Federal
Register as a ‘‘Notification of Waiver
Termination and Implementation Dates
of Rule.’’ To the extent possible, each
waiver termination will be noticed
approximately 6 months before the
effective date of the waiver termination.
The notifications will provide the
effective date of the waiver
terminations, and will identify the
States to which the waiver terminations
will apply. The notifications also will
provide specific actions with which
users of the newly added byproduct
material in the affected States will need
to comply to continue to use the
material. The actions with which the
users will be required to comply are
expected to be similar to those provided
for Government agencies and federally
recognized Indian Tribes in NRC’s
amended rules applicable to the new
byproduct material October 1, 2007 (72
FR 55864), which become effective on
November 30, 2007. In a manner similar
to the process outlined in Section VI.F.,
if non-Federal entities in these States
wish to continue using the new
byproduct material, they will either: (1)
Be required to apply for license
amendments for the new byproduct
material, within 6 months from the date
the waiver is terminated for their State,
if they hold an NRC specific byproduct
materials license; or (2) submit a license
application for the new byproduct
material, within 12 months from the
date the waiver is terminated for their
State.
NRC plans to terminate the waiver no
later than August 7, 2009, for all
individuals in States that do not plan to
establish AEA section 274b. Agreements
with NRC. This should allow all users
in States sufficient time to submit
license applications within the periods
described above.
NRC will cooperate with States for
which the waiver will be terminated to
identify users of the byproduct material
within the States, and provide
notifications to the users of the
impending transition of authority. In
addition to the notifications described
above, NRC may issue press releases,
and initiate interactions with industry
groups and other stakeholders in an
effort to ensure that all users in the
affected States are aware of the
transition of authority and requirements
for continued use of the new byproduct
material.
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NARM to persons who were exempt
from licensing and regulatory
requirements. With the expansion of the
definition of byproduct material, NRC
authority pre-empts the States’ authority
The Governor of any State that does
to issue such licenses.
not have an Agreement with the
NRC understands that there are a
Commission under section 274b. may
limited number of State issued exempt
request an Agreement that covers
distribution licenses for the new
section 11e.(3) or 11e.(4) byproduct
byproduct material, which will transfer
material, and also may request an
to NRC on termination of the waiver for
Agreement that covers any or all of the
the State. The specifics of the transfer
other materials and activities as
will be addressed directly with the
described in the discussion in Section
VI.B., ‘‘Conditions Under Which a State involved States and distributors, on a
May Exercise Authority over 11e.(3) and case-by-case basis. On expiration or
earlier termination of the waiver, NRC
11e.(4) Byproduct Material.’’ The
will issue licenses for the distribution of
request should follow the NRC/FSME
products containing AEA section 11e.(3)
Procedure SA–700, Processing an
Agreement, starting with a request for an and 11e.(4) byproduct material to
persons who are exempt from licensing
Agreement as soon as practical. A copy
of the procedure is available on the NRC and regulatory requirements.
Web site (https://www.nrc.gov).
E. Transition of Sealed Source or Device
The NRC staff will recommend that
Registration Certificates for NARM From
the Commission approve an Agreement
State Jurisdiction to NRC Jurisdiction
if the State’s Program for regulating the
Since, previously, the States had
requested byproduct materials meets the
jurisdiction over NARM (including the
criteria in NRC/FSME Procedure SA–
new byproduct material), the States also
700, Processing an Agreement. If the
had authority for the evaluation of
Commission approves, the Agreement
will become effective on a date selected radiation safety information on sealed
sources or devices (SSDs) containing
by the State, and specified in the
Agreement. If the effective date is before NARM, and the registration of such
SSDs for distribution. Most Agreement
August 8, 2009, the Commission will
States’ section 274b. Agreements
terminate the waiver for all persons in
provide for the Commission to
that State on the effective date of the
discontinue its authority for the
Agreement.
evaluation of radiation safety
Requests from States to enter into
information on SSDs containing
274b. Agreements before the timebyproduct materials, and for the
limited waiver expires on August 7,
registration of the SSDs for distribution.
2009, will be reviewed in accordance
with the NRC/FSME Procedure SA–700, An Agreement State whose section
274b. Agreement provides for the
Processing an Agreement. Every effort
will be made to complete an Agreement Commission to discontinue its SSD
authority shall retain this authority and
as soon as practical, without
responsibility for SSDs containing the
compromising quality and
new byproduct material, after the
completeness. The Commission
waiver expires on August 7, 2009, or on
understands that situations may arise
earlier waiver termination by the
that may delay the completion and
Commission, if the State’s 274b.
effective date of Agreements. If any
Agreement includes the new byproduct
Agreements cannot be completed before
material.
the waiver expires on August 7, 2009,
After the waiver expires on August 7,
the Commission may consider, on a
2009, or on earlier waiver termination
case-by-case basis, options to limit the
by the Commission, NRC will assume
impact on affected users of 11e.(3) and
11e.(4) byproduct material in the States. regulatory authority over radiation
safety evaluations and registration of
D. Transition of Exempt Distribution
SSDs containing the new byproduct
Licenses for NARM From State
material in non-Agreement States, and
Jurisdiction to NRC Jurisdiction
in Agreement States whose section
The Commission, pursuant to 10 CFR 274b. Agreements do not provide for the
Commission to discontinue its authority
150.15, retains the authority to license
the distribution of byproduct material to for radiation safety evaluations and
persons who are exempt from regulatory registration of SSDs containing
byproduct material. In addition, NRC
requirements. Since the Commission
will also assume regulatory authority
did not have jurisdiction over section
over all radiation safety evaluations and
11e.(3) and 11e.(4) byproduct material
registrations of exempt distribution
previously, the States had the authority
devices containing the new byproduct
to issue licenses for the distribution of
sroberts on PROD1PC70 with RULES
2. Non-Agreement States That Request
AEA Section 274b. Agreements
Covering Section 11e.(3) or 11e.(4)
Byproduct Materials
VerDate Aug<31>2005
17:03 Oct 18, 2007
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Fmt 4700
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59161
material that previously may have been
licensed by the States.
NRC will cooperate with States for
which the regulatory authority over
radiation safety evaluations and
registrations of SSDs containing the new
byproduct material will transfer from
the State to the NRC, to provide a
notification to affected holders of active
SSD registrations in the States, of the
impending transition of authority. NRC
is also requesting that such States
provide NRC with copies of affected
SSD registrations.
F. Federal Entity Licensees of the
Commission and Unlicensed Federal
Users
Under the AEA byproduct, source,
and special nuclear material, licenses
for Government agencies and federally
recognized Indian Tribes are issued by
the Commission, and are not subject to
State regulation. Since NRC was not
previously authorized to license NARM,
these entities may not have an NRC
license authorizing the new byproduct
material. NRC plans to terminate the
waiver for Government agencies and
federally recognized Indian Tribes on
the effective date of the final rule, which
is November 30, 2007, and these users
will be subject to the new requirements
on that date. Such entities who wish to
continue to use the new byproduct
material must either: (1) Apply for
license amendments for the new
byproduct material, within 6 months
from the effective date of the rule, if
they hold NRC specific byproduct
materials licenses; or (2) submit license
applications for the new byproduct
material, within 12 months from the
effective date of the rule, if new NRC
specific byproduct materials licenses are
needed.
G. Notification of Transition Actions
Section 651(e)(5)(c) of the EPAct
requires NRC to publish a notice of any
waiver granted under section 651(e)(5)
in the Federal Register. As described
above, NRC published such a waiver on
August 31, 2005. NRC is required by
section 274e.(1) of the AEA to notice in
the Federal Register any new or
amended AEA section 274b.
Agreements. Any new or amended
Agreements will be published as
required by section 274e.(1) of the AEA.
Although the EPAct does not
specifically require NRC to notice a
waiver termination, NRC will publish in
the Federal Register any ‘‘Notification
of Waiver Termination and
Implementation Dates of Rule.’’ NRC
will also make publicly available the
acceptance of a Governor’s certification.
E:\FR\FM\19OCR1.SGM
19OCR1
59162
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Rules and Regulations
NRC normally provides notifications
of any new AEA section 274b.
Agreements to Congress, Federal
Agencies, and States. NRC plans to also
notify these entities of any waiver
termination.
References
1. Atomic Energy Act of 1954, as amended.
2. Conference of Radiation Control Program
Directors, Inc. (CRCPD), ‘‘Suggested State
Regulations for Control of Radiation,’’
available at the CRCPD Web site https://
www.crcpd.org/free_docs.asp.
3. Energy Policy Act of 2005, Pub. L. 109–
58, 119 Stat. 594 (2005).
4. U.S. Nuclear Regulatory Commission,
Management Directive 5.6, ‘‘Integrated
Materials Performance Evaluation Program
(IMPEP),’’ available in the Electronic Reading
Room on the NRC Web site https://
www.nrc.gov.
5. U.S. Nuclear Regulatory Commission,
Management Directive 5.9, ‘‘Adequacy and
Compatibility of Agreement State Programs,’’
available in the Electronic Reading Room on
the NRC Web site https://www.nrc.gov.
6. U.S. Nuclear Regulatory Commission,
Office of Federal and State Materials and
Environmental Management Programs,
Procedure SA–700, ‘‘Processing an
Agreement,’’ available at the NRC, Office of
Federal and State Materials and
Environmental Management Programs Web
site https://nrc-stp.ornl.gov/.
7. U.S. Nuclear Regulatory Commission,
‘‘Statement of Principle and Policy for the
Agreement State Program; Policy Statement
on Adequacy and Compatibility of
Agreement State Programs,’’ 62 FR 46517,
September 3, 1997.
8. U.S. Nuclear Regulatory Commission,
Guidance on New Agreements, NRC
Handbook 5.8, ‘‘Proposed Section 274b.
Agreements With States,’’ available in the
Electronic Reading Room on the NRC Web
site https://www.nrc.gov.
[FR Doc. 07–5120 Filed 10–18–07; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 20
RIN 3150–AI22
National Source Tracking of Sealed
Sources; Revised Compliance Dates
Nuclear Regulatory
Commission.
ACTION: Final rule.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: The Nuclear Regulatory
Commission (NRC) is amending its
regulations to revise the compliance
dates for licensees to begin reporting
source transactions and initial source
inventory information to the National
Source Tracking System for nationally
tracked sources. No other requirements
VerDate Aug<31>2005
16:59 Oct 18, 2007
Jkt 214001
related to the National Source Tracking
System are being revised by this rule.
DATES: Effective Date: This final rule is
effective October 19, 2007. Compliance
Dates: Compliance with the reporting
provisions in 10 CFR 20.2207 is
required by January 31, 2009 for both
Category 1 sources and Category 2
sources.
FOR FURTHER INFORMATION CONTACT:
Merri Horn, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone (301) 415–
8126, e-mail, mlh1@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Discussion and Need for the Rule
The President signed the Energy
Policy Act of 2005 (Pub. L. 109–58, 119
Stat. 594) into law on August 8, 2005.
It contains a provision on national
source tracking that requires the NRC to
issue regulations establishing a
mandatory tracking system for radiation
sources in the United States. The NRC
issued the final rule for the National
Source Tracking System on November 8,
2006 (71 FR 65686).
The National Source Tracking System
rule requires licensees to report
information on the manufacture,
transfer, receipt, disassembly, and
disposal of nationally tracked sources.
This information will be entered into a
computerized data base. The National
Source Tracking System will capture
information on the origin of each
nationally tracked source (manufacture
or import), all transfers to other
licensees, all receipts of nationally
tracked sources, and endpoints of each
nationally tracked source (disassembly,
disposal, decay, or export). Ultimately,
the National Source Tracking System
will be able to provide a domestic life
history account of all nationally tracked
sources.
The compliance dates for licensees to
report initial source inventories was
November 15, 2007, for Category 1
sources and November 30, 2007, for
Category 2 sources. These were also the
dates to start reporting source
transactions for entry into the system.
The NRC anticipated that system
development and all testing would be
complete and the National Source
Tracking System would be operational
by November 2007. However, system
development has taken longer than
anticipated and the system will not be
ready to accept data by November 2007.
Therefore, the NRC is revising the
compliance dates for which reporting is
to start.
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
The requirements for Category 1
nationally tracked sources will now be
implemented by January 31, 2009. This
means that by this date any licensee that
possesses a Category 1 level source must
have reported its initial inventory and
must begin reporting all transactions
involving Category 1 sources to the
National Source Tracking System. The
requirements for Category 2 nationally
tracked sources will also be
implemented by January 31, 2009. By
this date, all licensees must have
reported their initial inventories of
Category 2 nationally tracked sources
and begin reporting all transactions to
the National Source Tracking System.
II. Section by Section Analysis of
Substantive Changes
Section 20.2207—Reports of
Transactions Involving Nationally
Tracked Sources
Paragraph (h) is revised to require a
licensee to report its initial inventory of
Category 1 nationally tracked sources by
January 31, 2009, and the inventory of
Category 2 nationally tracked sources by
January 31, 2009.
III. Bases and Findings for Dispensing
With Notice and Comment and for
Making Rule Immediately Effective
Generally, NRC rulemaking involves
issuing rules using the public notice and
comment procedures set forth in the
Administrative Procedure Act (APA).
Typically, a proposed rule is issued for
comment and any comments submitted
are evaluated in the agency’s
development of the final rule. But under
5 U.S.C 553(b)(3)(B), a Federal agency
such as the NRC may dispense with
those procedures where it finds for
‘‘good cause’’ that notice and public
procedures thereon are ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ In this case, notice-andcomment procedures are not required
because the usual public rulemaking
procedures are impracticable. The
National Source Tracking System will
not be ready to accept data received
from licensees by the original
compliance dates in the final rule.
Compliance with the rule by those dates
is not feasible, and no purpose would be
served by seeking public comment on
whether to extend the compliance dates.
Therefore, under 5 U.S.C. 553(b)(3)(B),
good cause exists to dispense with
notice and comment procedures.
In addition, this rule is immediately
effective upon publication in
accordance with 5 U.S.C. 553(d)(1)
because it is a substantive rule granting
or recognizing an exemption or relieving
a restriction. Specifically, the rule
E:\FR\FM\19OCR1.SGM
19OCR1
]]>Agencies
[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Rules and Regulations]
[Pages 59157-59162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5120]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Chapter I
RIN 3150-AH84
Notification of the Plan for the Transition of Regulatory
Authority Resulting From the Expanded Definition of Byproduct Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of publication of transition plan.
-----------------------------------------------------------------------
SUMMARY: In accordance with Section 651e of the Energy Policy Act of
2005, the U.S. Nuclear Regulatory Commission is publishing a ``Plan for
the Transition of Regulatory Authority Resulting from the Expanded
Definition of Byproduct Material'' (transition plan) to facilitate an
orderly transition of regulatory authority with respect to the
byproduct material defined in paragraphs (3) and (4) of section 11e. of
the Atomic Energy Act of 1954, as amended. A copy of the final
transition plan is provided as Appendix A to this document.
FOR FURTHER INFORMATION CONTACT: Kim K. Lukes, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6701 or e-mail KXK2@NRC.GOV.
Dated at Rockville, Maryland, this 11th day of October, 2007.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
Appendix A--A Plan for the Transition of Regulatory Authority Resulting
From the Expanded Definition of Byproduct Material
I. Introduction
The Energy Policy Act of 2005 (EPAct) expanded U.S. Nuclear
Regulatory Commission (NRC or Commission) regulatory authority over
radioactive materials to include new byproduct material, as defined in
paragraphs (3) and (4) of section 11e. of the Atomic Energy Act of
1954, as amended (AEA), hereinafter referred to as the new byproduct
material. The expanded NRC authority pre-empted existing State
regulatory authority over the subject materials. NRC is authorized,
however, to discontinue its regulatory authority over the new byproduct
material under certain conditions, allowing States to exercise
regulatory authority over these materials.
The EPAct requires the Commission to prepare and publish a
transition plan to facilitate an orderly transition of regulatory
authority with respect to the new byproduct material. The plan must
address States that have, before the date on which the plan is
published, entered into agreements with the Commission, under section
274b. of the AEA \1\ (Agreement States), and States that have not
entered into such agreements (non-Agreement States). The plan must also
include a description of the conditions under which a State may
exercise regulatory authority over the new byproduct material.
---------------------------------------------------------------------------
\1\ Section 274b. of the AEA authorizes the Commission to enter
into an agreement with the Governor of a State that provides for
discontinuance of the Commission's regulatory authority in the State
over byproduct material as defined in section 11e., source
materials, and special nuclear materials in quantities not
sufficient to form a critical mass.
---------------------------------------------------------------------------
To meet the requirements of the EPAct, the transition plan must
include a statement of the Commission that any Agreement between the
Commission and a State \2\ under section 274b. of the AEA, covering
byproduct material and entered into before the date of publication of
the transition plan, must be considered to include the new byproduct
material, if the Governor of the State certifies to the Commission, on
the date of the publication of the transition plan that: (1) The State
has a program for licensing the new 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 new
byproduct material. This transition plan is being promulgated in
response to those requirements.
---------------------------------------------------------------------------
\2\ Section 274n. of the AEA defines the term ``State'' to mean
any State, Territory, or possession of the United States, the Canal
Zone, Puerto Rico, and the District of Columbia.
---------------------------------------------------------------------------
II. Background
On August 8, 2005, the President signed into law the Energy Policy
Act of 2005. Public Law No. 109-58, 119 Stat 594 (2005). Before then,
byproduct material had been defined in section 11e. of the AEA as: (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; and (2) the
tailings or wastes produced by the extraction or concentration of
uranium or thorium from any ore processed primarily for its source
material content.
Section 651(e) of the EPAct, among other things, expanded the
definition of byproduct material in section 11e. of the AEA, thereby
placing additional byproduct material under NRC's jurisdiction. Section
651(e) further required the Commission to provide a regulatory
framework for licensing and regulating this additional byproduct
material.
In particular, section 651(e) of the EPAct expanded the definition
of byproduct material by adding paragraphs (3) and (4) to the
definition of byproduct material in section 11e. Section 11e.(3)
defines, as byproduct material:
``(A) any discrete source of radium-226 that is produced,
extracted, or converted after extraction, before, on, or after the
date of enactment of this paragraph for use for a commercial,
medical, or research activity; or (B) any material that--
(i) has been made radioactive by use of a particle accelerator;
and
(ii) is produced, extracted, or converted after extraction,
before, on, or after the date of enactment of this paragraph for use
for a commercial, medical, or research activity.
Section 11e.(4) defines, as byproduct material, any discrete source
of
[[Page 59158]]
naturally occurring radioactive material (NORM),\3\ other than source
material, that--
---------------------------------------------------------------------------
\3\ Note: At this time, NRC has not identified any NORM
currently in use that would meet the definition of section 11e.(4).
(A) 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
(B) before, on, or after the date of enactment of this paragraph
is extracted or converted after extraction for use in a commercial,
medical, or research activity.''
III. The Agreement State Program
In 1959, the AEA was amended to adopt section 274, Cooperation with
States. As provided in section 274b., the Governor of a State may
request an Agreement with the Commission in which NRC discontinues, and
the State assumes, regulatory authority over categories of materials,
that may include source, byproduct, and special nuclear materials (in
quantities insufficient to form a critical mass). Collectively, the
materials that are authorized for regulation by States under such
Agreements are known as ``AEA materials'' or ``Agreement materials.''
The Commission may enter into an Agreement if it finds that the
State program is compatible with the Commission's program for
regulation of such materials, and that it is adequate to protect the
public health and safety with respect to the materials covered by the
proposed Agreement. Under section 274j.(1) of the AEA, the Commission
must periodically review Agreement State programs and the actions the
States take under the Agreements, to ensure compliance with the
provisions of that section.
A. Concept of Compatibility
In 1997, the Commission adopted a Policy Statement declaring that
an Agreement State radiation control program is compatible with the
Commission's regulatory program when the State program does not create
conflicts, duplications, gaps, or other conditions that jeopardize an
orderly pattern in the regulation of agreement material Nationwide [see
Statement of Principle and Policy for the Agreement State Program;
Policy Statement on Adequacy and Compatibility of Agreement State
Programs, (62 FR 46517; September 3, 1997)]. Thus, compatibility
focuses primarily on the potential effects of a State action or
inaction either on a Nationwide basis or on interstate commerce
crossing into other jurisdictions.
Generally, a State program is compatible if the elements of the
program are similar to the corresponding elements of the NRC program.
Some elements, such as basic radiation protection standards and program
elements with transboundary implications, should be essentially
identical, whereas other elements may need only to meet the same
essential objectives. The detailed criteria for Agreement State
compatibility are set out in NRC Management Directive 5.9, Adequacy and
Compatibility of Agreement State Programs.
B. Concept of Adequacy
The 1997 Commission Policy Statement declares that an Agreement
State radiation control program is adequate to protect public health
and safety if administration of the program provides reasonable
assurance that the level of protection afforded by the State program is
at least as protective as NRC's materials regulatory program.
The continuing adequacy and compatibility of an Agreement State
radiation control program is determined through the Integrated
Materials Performance Evaluation Program (IMPEP). NRC periodically
reviews the adequacy and compatibility of each Agreement State's
radiation protection program using the same set of performance criteria
used to evaluate the equivalent NRC licensing and inspection programs.
For further information on this program, please see NRC Management
Directive 5.6, Integrated Materials Performance Evaluation Program
(IMPEP), on the NRC Web site (https://www.nrc.gov).
IV. Regulation of Radioactive Materials Before the EPAct
For the purposes of this discussion, before the EPAct, radioactive
materials could be divided into three groups: those regulated only by
NRC (e.g., formula quantities of special nuclear material); those
regulated only by State or local agencies [e.g., Naturally Occurring
and Accelerator-Produced Radioactive Material (NARM)]; and those
radioactive materials that may be regulated by NRC, or by a State under
an Agreement pursuant to section 274b. of the AEA.
Since 1954, NRC (and its predecessor agency, the U.S. Atomic Energy
Commission) has regulated the non-military use of a limited set of
radioactive materials. Collectively, the set of regulated materials is
known as AEA material. The basis for assertion of Federal authority
over the AEA materials was the belief that they posed (at that time) a
new hazard beyond the ability of the States to control. NORM (mostly
radium-226) and accelerator-produced radioactive materials (ARM) were
relatively rare and did not pose an overwhelming problem for the States
to control.
AEA material originally consisted of source and special nuclear
materials, and byproduct materials as now defined in section 11e.(1).
In 1978, the AEA definition of ``byproduct material'' was amended to
add section 11e.(2), that included the tailings from uranium or thorium
ore processed primarily for their source material content. Other NORM
and ARM were not included in the definition of byproduct material
before enactment of the EPAct, and thus were not AEA materials and were
not subject to NRC regulation. These radioactive materials were under
individual State regulatory authority.
V. Regulatory Changes Required by Section 651(e) of the EPAct
By amending the definition of ``byproduct material'' to include
certain ARM and NORM, including radium-226, the EPAct has made these
radioactive materials AEA materials subject to NRC regulation. Note
that only certain ARM and NORM that meet the criteria set out in the
EPAct are byproduct material. The criteria for ARM that is defined as
byproduct material are that the material: (1) Is made radioactive by
use of a particle accelerator; (2) is produced, extracted, or converted
after extraction, before, on, or after the enactment date of the EPAct;
and (3) is produced, extracted, or converted after extraction, for use
for a commercial, medical, or research activity. For radium-226 and
other NORM to be byproduct material, it must meet the last two
criteria, plus be a ``discrete source.'' ARM and NORM that do not meet
these criteria are not AEA byproduct material.
Independent State regulation of the new byproduct material is pre-
empted by the EPAct. States now may only regulate the materials through
an agreement with the Commission, under section 274b. of the AEA. Other
ARM and NORM that do not meet the definition of byproduct material
could continue to be regulated under individual State authority.
This transition plan addresses only transitions of authority
related to the newly defined byproduct material described in Section
651(e) and not to issues raised in other sections of the EPAct.
[[Page 59159]]
VI. Transition of Authority
A. Preliminary Activities
At the time the EPAct was signed into law, NRC did not have
regulations in place that would specifically apply to the new byproduct
material. Time was needed for the development of a revised regulatory
program, to allow for the orderly transition of regulatory authority
over this material.
Section 651(e)(5) of the EPAct authorizes the Commission to issue
waivers of the requirements of section 651(e) for up to 4 years, if the
Commission determines that the waiver is in accordance with the
protection of the public health and safety and promotion of the common
defense and security. The Commission determined that such a waiver
should be granted to entities engaging in activities involving the new
byproduct material, and it would be in the best interests of the public
to allow the continued use of the new byproduct material, and to allow
the States to continue to regulate the new byproduct material until the
Commission could codify new regulations for these materials. The
Commission issued such a waiver on August 31, 2005 (70 FR 51581). As
required by section 651(e) of the EPAct, the Commission must terminate
any waiver issued under section 651(e), regarding a State, on
determining that: (1) The State has entered into an agreement with the
Commission under section 274b. of the AEA; (2) the Agreement covers
section 11e.(3) or 11e.(4) byproduct material; and (3) the State's
program for licensing such byproduct material is adequate to protect
the public health and safety. In addition, any waiver issued under
section 651(e) may be effective only through August 7, 2009, unless the
Commission terminates it earlier.
NRC conducted a rulemaking to cover the new byproduct materials.
The final rule was published on October 1, 2007 (72 FR 55864), in
accordance with the EPAct requirements. The rule is to become effective
60 days after publication for some licensees, and later for others, as
described in this transition plan and the Federal Register Notice for
the final rule. Revisions to NRC Policy and Guidance documents were
undertaken in parallel with the rulemaking.
B. Conditions Under Which a State May Exercise Authority Over 11e.(3)
and 11e.(4) Byproduct Material
A State may exercise regulatory authority over the new byproduct
material in one of two ways: (1) Under the Commission-issued waiver; or
(2) under an AEA section 274b. Agreement. Starting on August 8, 2009,
or earlier if the waiver is terminated for the State under EPAct
section 651(e)(5)(B)(ii), the State may exercise its own authority over
the new byproduct material only under an AEA section 274b. Agreement.
If the State does not already have such an Agreement, the Governor
of the State may request an Agreement with the Commission. The
Commission may enter into an Agreement if the documentation supporting
the Governor's request demonstrates that: (1) The State has a program
to regulate the materials covered by the proposed Agreement; and (2)
the State program is adequate to protect the public health and safety
and is compatible with the Commission's program for byproduct material.
NRC staff will evaluate the Governor's request using NRC/Office of
Federal and State Materials and Environmental Management Programs
(FSME) Procedure SA-700, Processing an Agreement. This procedure is
posted on the NRC Web site (https://www.nrc.gov). Printed hard copies
may also be obtained from the NRC Public Document Room.
The Commission may enter into an Agreement covering one or more of
the following categories of materials: source material; special nuclear
material in quantities not sufficient to form a critical mass;
byproduct material as defined in section 11e.(1), 11e.(2), 11e.(3), or
11e.(4); the regulation of the land disposal of byproduct, source, or
special nuclear waste materials received from other persons; and the
safety evaluation of sealed sources or devices containing sealed
sources.
1. Transition of Authority in States That Have Entered Into Agreements
With the Commission Under AEA Section 274b., Before Publication of This
Plan
There are two ways an existing Agreement State may include the new
byproduct material in its AEA section 274b. Agreement: (1) The Governor
of the State provides the certification described in section
651(e)(4)(C)(iii)(II) of the EPAct on the date of publication of the
transition plan; or (2) using the standard process, whereby the
Governor requests an amendment to the State's Agreement, as provided in
section 274 of the AEA.
The Governor's certification avoids the need to amend the State's
Agreement in accordance with the formal requirements of section 274 of
the AEA. If a Governor chooses not to provide the certification
described in the EPAct, NRC will assert its authority to regulate the
new byproduct material.
2. Basis for Finding Adequacy in Reviewing Governor Certifications
For Agreement States whose Governors provide a certification, the
Commission will find the States' programs adequate to protect health
and safety if the criteria of NRC Management Directive 5.6, Integrated
Materials Performance Evaluation Program (IMPEP), are satisfied. For an
Agreement State whose program for licensing 11e.(1) byproduct material
has been previously evaluated under IMPEP, the Commission will base its
determination of adequacy on the State's prior IMPEP findings if: (1)
The State's program for licensing 11e.(3) and 11e.(4) byproduct
material is not separate and distinct \4\ from its program for
licensing 11e.(1) byproduct material; (2) the State intends to continue
to license the new byproduct material under its existing program; and
(3) no changes have been made to the State's licensing program that
would impact the previous IMPEP finding of adequacy. If the State
provides confirmation that these criteria are met, the Commission will
consider a finding of adequate performance from the State's last IMPEP
review as an indicator that the State's program for licensing section
11e.(3) and 11e.(4) byproduct material is adequate to protect health
and safety.
---------------------------------------------------------------------------
\4\ The Commission understands that the Agreement States license
NARM and section 11e.(1) byproduct material without distinguishing
between the materials.
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For a new Agreement State that has not yet had a program review
under IMPEP, the Commission will base its determination of adequacy on
the following: (1) The State's program for licensing 11e.(3) and
11e.(4) byproduct material is not separate and distinct from its
program for licensing 11e.(1) byproduct material; (2) the State intends
to continue to license the new byproduct material under its existing
program; and (3) no changes have been made to the State's licensing
program that would impact the Commission's decision to enter into the
AEA section 274b. Agreement.
The Governor's certification should be addressed to the Chairman of
the Commission. On receipt, the Chairman or his designee will review
the certification. If the Governor's certification contains the
statements required by the EPAct, and the Commission determines that
the State's program to license the new byproduct material is adequate
to protect health and safety, the Chairman will accept the Governor's
certification on behalf of the Commission, and the Governor will be
notified of the acceptance. As of the
[[Page 59160]]
date that the certification is accepted by the Commission, the State's
Agreement will be considered to include AEA section 11e.(3) and 11e.(4)
byproduct material, and the waiver will be terminated for the State.
The certification will become a part of the Agreement, but the
Agreement document will not be otherwise amended.
The NRC will verify the adequacy of the State's program to license
the new byproduct material during subsequent IMPEP reviews.
3. Agreement States That Elect Not To Include AEA Section 11e.(3) and
11e.(4) Byproduct Material in Their Agreements
If an Agreement State elects not to continue to regulate the new
byproduct material under an existing section 274b. Agreement, the State
should notify the Commission that it intends to discontinue its
regulatory authority for the new byproduct material. NRC is requesting
that such an Agreement State also provide NRC with a list of affected
users/licensees, in its notification.
To facilitate an orderly transition of regulatory authority for an
Agreement State that does not intend to continue to regulate the new
byproduct material, NRC intends to terminate the waiver for the State,
and all individuals in the State, before August 8, 2009. The timing of
the waiver termination for the State will be determined in consultation
with representatives of the State's regulatory program.
NRC plans to use the phased approach for earlier waiver
terminations described in Section VI.C.1., ``Non-Agreement States That
Do Not Request an Agreement,'' for Agreement States that do not intend
to continue to regulate the new byproduct material. This approach will
prevent an abrupt transition of authority on the date the waiver
expires. Likewise, NRC plans to notice waiver terminations in the
Federal Register, for Agreement States that do not intend to continue
to regulate the new byproduct material, in the same manner as described
in Section VI.C.1., for non-Agreement States that do not request
Agreements. Also, the actions with which users of the new byproduct
material in such Agreement States will be required to comply will be
the same as those described in Section VI.C.1., for users in non-
Agreement States that do not request Agreements.
4. Agreement States That Do Not, on the Date of Publication of the
Transition Plan, Certify Adequacy for 11e.(3) and 11e.(4) Byproduct
Material
Section 651(e) of the EPAct provides that any Agreement covering
byproduct material, as defined in paragraph (1) or (2) of section 11e.
of the AEA, entered into between the Commission and a State under
section 274b. of that Act before the date of publication of this
transition plan shall be considered to include byproduct material, as
defined in paragraph (3) or (4) of section 11e. of the AEA, if the
Governor of the State certifies to the Commission on the date of
publication of this transition plan that: (a) The State has a program
for licensing byproduct material, as defined in paragraph (3) or (4) of
section 11e. of the AEA, that is adequate to protect the public health
and safety, as determined by the Commission; and (b) the State intends
to continue to implement the regulatory responsibility of the State
with respect to the byproduct material.
If the Governor of a State has not made such a certification to the
Commission, and the State intends to continue to implement its
regulatory authority over these materials, the State may be required to
amend its AEA section 274b. Agreement to include the new byproduct
material.
C. Transition of Authority in States That Have Not Entered Into an
Agreement With the Commission Under AEA Section 274b. (Non-Agreement
States) Before Publication of This Plan
1. Non-Agreement States That Do Not Request an Agreement
Any State that, on August 8, 2009, does not have an Agreement with
the Commission under section 274b. of the AEA, which covers 11e.(3) or
11e.(4) new byproduct material, must discontinue its regulatory
authority over the byproduct material.
To facilitate an orderly transition of regulatory authority for
States that do not intend to establish AEA section 274b. Agreements
with the Commission before August 8, 2009, NRC intends to terminate the
waiver for such States, and all individuals in such States, before
August 8, 2009. NRC plans to use a phased approach for the earlier
waiver terminations, to prevent an abrupt transition of authority on
the date the waiver expires. The timing of waiver terminations for the
States will be determined in consultation with representatives of the
States' regulatory programs. Waiver terminations will be executed for
groups of States, at periodic intervals occurring between the effective
date of the rule and August 7, 2009. Starting at Midnight, local time,
on the effective date of the waiver termination, NRC will assume
regulatory authority over section 11e.(3) and 11e.(4) byproduct
material within the States.
Each waiver termination for a group of States will be noticed in
the Federal Register as a ``Notification of Waiver Termination and
Implementation Dates of Rule.'' To the extent possible, each waiver
termination will be noticed approximately 6 months before the effective
date of the waiver termination. The notifications will provide the
effective date of the waiver terminations, and will identify the States
to which the waiver terminations will apply. The notifications also
will provide specific actions with which users of the newly added
byproduct material in the affected States will need to comply to
continue to use the material. The actions with which the users will be
required to comply are expected to be similar to those provided for
Government agencies and federally recognized Indian Tribes in NRC's
amended rules applicable to the new byproduct material October 1, 2007
(72 FR 55864), which become effective on November 30, 2007. In a manner
similar to the process outlined in Section VI.F., if non-Federal
entities in these States wish to continue using the new byproduct
material, they will either: (1) Be required to apply for license
amendments for the new byproduct material, within 6 months from the
date the waiver is terminated for their State, if they hold an NRC
specific byproduct materials license; or (2) submit a license
application for the new byproduct material, within 12 months from the
date the waiver is terminated for their State.
NRC plans to terminate the waiver no later than August 7, 2009, for
all individuals in States that do not plan to establish AEA section
274b. Agreements with NRC. This should allow all users in States
sufficient time to submit license applications within the periods
described above.
NRC will cooperate with States for which the waiver will be
terminated to identify users of the byproduct material within the
States, and provide notifications to the users of the impending
transition of authority. In addition to the notifications described
above, NRC may issue press releases, and initiate interactions with
industry groups and other stakeholders in an effort to ensure that all
users in the affected States are aware of the transition of authority
and requirements for continued use of the new byproduct material.
[[Page 59161]]
2. Non-Agreement States That Request AEA Section 274b. Agreements
Covering Section 11e.(3) or 11e.(4) Byproduct Materials
The Governor of any State that does not have an Agreement with the
Commission under section 274b. may request an Agreement that covers
section 11e.(3) or 11e.(4) byproduct material, and also may request an
Agreement that covers any or all of the other materials and activities
as described in the discussion in Section VI.B., ``Conditions Under
Which a State May Exercise Authority over 11e.(3) and 11e.(4) Byproduct
Material.'' The request should follow the NRC/FSME Procedure SA-700,
Processing an Agreement, starting with a request for an Agreement as
soon as practical. A copy of the procedure is available on the NRC Web
site (https://www.nrc.gov).
The NRC staff will recommend that the Commission approve an
Agreement if the State's Program for regulating the requested byproduct
materials meets the criteria in NRC/FSME Procedure SA-700, Processing
an Agreement. If the Commission approves, the Agreement will become
effective on a date selected by the State, and specified in the
Agreement. If the effective date is before August 8, 2009, the
Commission will terminate the waiver for all persons in that State on
the effective date of the Agreement.
Requests from States to enter into 274b. Agreements before the
time-limited waiver expires on August 7, 2009, will be reviewed in
accordance with the NRC/FSME Procedure SA-700, Processing an Agreement.
Every effort will be made to complete an Agreement as soon as
practical, without compromising quality and completeness. The
Commission understands that situations may arise that may delay the
completion and effective date of Agreements. If any Agreements cannot
be completed before the waiver expires on August 7, 2009, the
Commission may consider, on a case-by-case basis, options to limit the
impact on affected users of 11e.(3) and 11e.(4) byproduct material in
the States.
D. Transition of Exempt Distribution Licenses for NARM From State
Jurisdiction to NRC Jurisdiction
The Commission, pursuant to 10 CFR 150.15, retains the authority to
license the distribution of byproduct material to persons who are
exempt from regulatory requirements. Since the Commission did not have
jurisdiction over section 11e.(3) and 11e.(4) byproduct material
previously, the States had the authority to issue licenses for the
distribution of NARM to persons who were exempt from licensing and
regulatory requirements. With the expansion of the definition of
byproduct material, NRC authority pre-empts the States' authority to
issue such licenses.
NRC understands that there are a limited number of State issued
exempt distribution licenses for the new byproduct material, which will
transfer to NRC on termination of the waiver for the State. The
specifics of the transfer will be addressed directly with the involved
States and distributors, on a case-by-case basis. On expiration or
earlier termination of the waiver, NRC will issue licenses for the
distribution of products containing AEA section 11e.(3) and 11e.(4)
byproduct material to persons who are exempt from licensing and
regulatory requirements.
E. Transition of Sealed Source or Device Registration Certificates for
NARM From State Jurisdiction to NRC Jurisdiction
Since, previously, the States had jurisdiction over NARM (including
the new byproduct material), the States also had authority for the
evaluation of radiation safety information on sealed sources or devices
(SSDs) containing NARM, and the registration of such SSDs for
distribution. Most Agreement States' section 274b. Agreements provide
for the Commission to discontinue its authority for the evaluation of
radiation safety information on SSDs containing byproduct materials,
and for the registration of the SSDs for distribution. An Agreement
State whose section 274b. Agreement provides for the Commission to
discontinue its SSD authority shall retain this authority and
responsibility for SSDs containing the new byproduct material, after
the waiver expires on August 7, 2009, or on earlier waiver termination
by the Commission, if the State's 274b. Agreement includes the new
byproduct material.
After the waiver expires on August 7, 2009, or on earlier waiver
termination by the Commission, NRC will assume regulatory authority
over radiation safety evaluations and registration of SSDs containing
the new byproduct material in non-Agreement States, and in Agreement
States whose section 274b. Agreements do not provide for the Commission
to discontinue its authority for radiation safety evaluations and
registration of SSDs containing byproduct material. In addition, NRC
will also assume regulatory authority over all radiation safety
evaluations and registrations of exempt distribution devices containing
the new byproduct material that previously may have been licensed by
the States.
NRC will cooperate with States for which the regulatory authority
over radiation safety evaluations and registrations of SSDs containing
the new byproduct material will transfer from the State to the NRC, to
provide a notification to affected holders of active SSD registrations
in the States, of the impending transition of authority. NRC is also
requesting that such States provide NRC with copies of affected SSD
registrations.
F. Federal Entity Licensees of the Commission and Unlicensed Federal
Users
Under the AEA byproduct, source, and special nuclear material,
licenses for Government agencies and federally recognized Indian Tribes
are issued by the Commission, and are not subject to State regulation.
Since NRC was not previously authorized to license NARM, these entities
may not have an NRC license authorizing the new byproduct material. NRC
plans to terminate the waiver for Government agencies and federally
recognized Indian Tribes on the effective date of the final rule, which
is November 30, 2007, and these users will be subject to the new
requirements on that date. Such entities who wish to continue to use
the new byproduct material must either: (1) Apply for license
amendments for the new byproduct material, within 6 months from the
effective date of the rule, if they hold NRC specific byproduct
materials licenses; or (2) submit license applications for the new
byproduct material, within 12 months from the effective date of the
rule, if new NRC specific byproduct materials licenses are needed.
G. Notification of Transition Actions
Section 651(e)(5)(c) of the EPAct requires NRC to publish a notice
of any waiver granted under section 651(e)(5) in the Federal Register.
As described above, NRC published such a waiver on August 31, 2005. NRC
is required by section 274e.(1) of the AEA to notice in the Federal
Register any new or amended AEA section 274b. Agreements. Any new or
amended Agreements will be published as required by section 274e.(1) of
the AEA.
Although the EPAct does not specifically require NRC to notice a
waiver termination, NRC will publish in the Federal Register any
``Notification of Waiver Termination and Implementation Dates of
Rule.'' NRC will also make publicly available the acceptance of a
Governor's certification.
[[Page 59162]]
NRC normally provides notifications of any new AEA section 274b.
Agreements to Congress, Federal Agencies, and States. NRC plans to also
notify these entities of any waiver termination.
References
1. Atomic Energy Act of 1954, as amended.
2. Conference of Radiation Control Program Directors, Inc.
(CRCPD), ``Suggested State Regulations for Control of Radiation,''
available at the CRCPD Web site https://www.crcpd.org/free_docs.asp.
3. Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594
(2005).
4. U.S. Nuclear Regulatory Commission, Management Directive 5.6,
``Integrated Materials Performance Evaluation Program (IMPEP),''
available in the Electronic Reading Room on the NRC Web site https://
www.nrc.gov.
5. U.S. Nuclear Regulatory Commission, Management Directive 5.9,
``Adequacy and Compatibility of Agreement State Programs,''
available in the Electronic Reading Room on the NRC Web site https://
www.nrc.gov.
6. U.S. Nuclear Regulatory Commission, Office of Federal and
State Materials and Environmental Management Programs, Procedure SA-
700, ``Processing an Agreement,'' available at the NRC, Office of
Federal and State Materials and Environmental Management Programs
Web site https://nrc-stp.ornl.gov/.
7. U.S. Nuclear Regulatory Commission, ``Statement of Principle
and Policy for the Agreement State Program; Policy Statement on
Adequacy and Compatibility of Agreement State Programs,'' 62 FR
46517, September 3, 1997.
8. U.S. Nuclear Regulatory Commission, Guidance on New
Agreements, NRC Handbook 5.8, ``Proposed Section 274b. Agreements
With States,'' available in the Electronic Reading Room on the NRC
Web site https://www.nrc.gov.
[FR Doc. 07-5120 Filed 10-18-07; 8:45 am]
BILLING CODE 7590-01-P
