[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Rules and Regulations]
[Pages 59157-59162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5120]


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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.

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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 <a href="/cdn-cgi/l/email-protection#470c1f0c750709150469000811"><span class="__cf_email__" data-cfemail="a8e3f0e39ae8e6faeb86efe7fe">[email protected]</span></a>.

    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.
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    \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.
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    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.
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    \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.
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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--
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    \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 (http://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 (http://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.
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    \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 (http://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 http://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 http://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 http://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 http://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 http://www.nrc.gov.


[FR Doc. 07-5120 Filed 10-18-07; 8:45 am]
BILLING CODE 7590-01-P


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