[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Rules and Regulations]
[Pages 51581-51582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17293]


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NUCLEAR REGULATORY COMMISSION

10 CFR Chapter I


Energy Policy Act of 2005 Requirements; Treatment of Accelerator-
Produced and Other Radioactive Material as Byproduct Material; Waiver

AGENCY: Nuclear Regulatory Commission.

ACTION: Time-limited waiver of Energy Policy Act of 2005 requirements.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is issuing a time-
limited waiver of the requirements enacted by section 651(e) of the 
Energy Policy Act of 2005, titled ``Treatment of Accelerator-Produced 
and Other Radioactive Material as Byproduct Material'', as they pertain 
to byproduct material as defined in paragraphs (3) and (4) of section 
11 e. of the Atomic Energy Act of 1954, as added by section 651(e). The 
waiver will allow persons owning, using, and otherwise engaging in 
activities involving the material to continue with their activities and 
States to continue to regulate this material during the applicable 
waiver period.

DATES: This waiver is effective August 31, 2005. This waiver is 
effective through August 7, 2006, for the import and export of 
materials covered by the waiver, unless terminated sooner if the 
Commission determines that an earlier termination is warranted. For all 
other matters, it is effective through August 7, 2009, unless 
terminated sooner if the Commission determines that an earlier 
termination is warranted or required.

FOR FURTHER INFORMATION CONTACT: Susan Chidakel, Office of the General 
Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, 
telephone (301) 415-1535, e-mail [email protected] or Merri Horn, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-8126, e-
mail, [email protected].

SUPPLEMENTARY INFORMATION: The President of the United States signed 
the Energy Policy Act of 2005 on August 8, 2005. The provisions of the 
Act became effective immediately, unless another effective date was 
expressly provided. Since no effective date was stated for the 
provisions of section 651(e) of the Act, section 651(e) became 
effective immediately, and brought byproduct material, as defined in 
paragraphs (3) and (4) of section 11 e. of the Atomic Energy Act of 
1954 (42 U.S.C. 2201 et seq.), as added by section 651(e)(1), under the 
immediate regulatory authority of the Nuclear Regulatory Commission.
    Section 11 e.(3) of the Atomic Energy Act of 1954 now includes as 
byproduct material: (i) any discrete source of radium-226 that is 
produced, extracted, or converted after extraction (before, on, or 
after the date of enactment of section 651(e) of the Energy Policy Act 
of 2005), for use for a commercial, medical, or research activity; and 
(ii) any material that has been made radioactive by use of a particle 
accelerator and is produced, extracted, or converted after extraction 
(before, on, or after the date of enactment of section 651(e) of the 
Energy Policy Act of 2005), for use for a commercial, medical, or 
research activity. Section 11 e.(4) expands the definition to include 
any discrete source of naturally occurring radioactive material, other 
than source material, if certain conditions are met. Section 11 e.(4) 
is considered to be a place-holder and NRC staff does not anticipate a 
need for active regulation of the latter material at this time.
    Prior to enactment of the Energy Policy Act of 2005, the NRC did 
not have authority over the newly covered byproduct material, and it 
fell under the authority of the States. Therefore, the NRC does not 
currently have regulations in place that would specifically apply to 
the material. With the enactment of the Energy Policy Act of 2005, the 
States may no longer assert the authority to regulate the newly covered 
byproduct material, except as authorized to do so by the Act.
    The Energy Policy Act of 2005 allows the Commission up to 18 months 
after the date of enactment to issue final regulations for the newly 
covered byproduct material. To facilitate an orderly transition of 
regulatory authority with respect to the newly defined byproduct 
material, the Act also provides for preparation and publication of a 
transition plan for States that have not previously entered into an 
Agreement with the Commission under section 274 b of the Atomic Energy 
Act and for those States that have entered into such an Agreement. 
However, neither the regulations nor the transition plan have yet been 
developed. Until such time as the regulations and transition plan have 
been completed and are in place, persons that engage in activities 
involving the material will want to continue with their activities.
    To ease the transition period from individualized State programs to 
a more uniform regulatory program developed under the Atomic Energy Act 
and its section 274b Agreement State Program, section 651(e) of the 
Energy Policy Act of 2005 authorizes the Commission to issue waivers of 
its authority. Waivers of the Commission's jurisdiction will permit 
existing State authorities to continue. Ultimate transition from NRC to 
State authority for those States with an existing Agreement State 
program is expected to proceed easily. For States without such programs 
currently, that want to enter into an agreement with the NRC, this 
waiver period will permit them to go through the processes necessary to 
establish and carry out an Agreement State program to regulate this 
material after the waiver period expires.
    Section 651(e)(5) authorizes the Commission to grant a waiver to 
any entity of any requirement under section 651(e) with respect to a 
matter relating to the newly defined byproduct material, except as 
required by section 651(e)(5)(B)(i)(l). Thus, such a waiver can also be 
granted to entities that engage in activities involving the material. 
Without the waiver, States that seek to continue regulation of the 
material would be, and persons that carry on activities involving the 
newly defined byproduct material could be, in technical violation of 
the Atomic Energy Act of 1954, as amended by section 651(e) of the 
Energy Policy Act of 2005.

[[Page 51582]]

    The authorization to grant waivers is subject to the Commission's 
determination that the waiver is in accordance with the protection of 
the public health and safety and the promotion of the common defense 
and security. The Commission has determined that there is no basis on 
which to conclude that these materials will not continue to be used in 
a manner that ensures that the public health and safety will be 
protected while this waiver is in effect. The Energy Policy Act of 2005 
also specifically requires the Commission to consider, in promulgating 
regulations, the impact on the availability of radiopharmaceuticals to 
physicians and to patients the medical treatment of which relies on 
radiopharmaceuticals. The Commission believes that it is in the best 
interests of the country to allow continued use of the newly defined 
byproduct material in radiopharmaceuticals for medical purposes, and to 
allow the States to continue to regulate the newly defined byproduct 
material until the Commission can codify new regulations for these 
materials.
    In sum, the Commission currently does not have in place a specific 
set of regulations to oversee the use of byproduct material as defined 
in paragraphs (3) and (4) of section 11 e. of the Atomic Energy Act of 
1954, as added by section 651(e) of the Energy Policy Act of 2005. 
Granting of the waiver set forth at the end of this document will 
allow, for the applicable waiver period, States to continue with their 
programs, persons engaged in activities involving the newly defined 
Atomic Energy Act byproduct material to continue their operations in a 
safe manner, and continued access to medical radiopharmaceuticals. This 
will also permit the Commission and States that currently do not have 
Sec.  274i Agreement State regulatory programs, but wish to enter into 
an agreement with the NRC, to appropriately address the newly defined 
byproduct material. The Commission has determined that issuance of this 
waiver is in accordance with the protection of the public health and 
safety and the promotion of the common defense and security.

Waiver

    Except as required by section 651(e)(5)(B)(i)(I), the Commission 
hereby grants a waiver from the requirements of section 651(e) of the 
Energy Policy Act of 2005, titled, ``Treatment of Accelerator-Produced 
and Other Radioactive Material as Byproduct Material'', as follows:
    (1) To all persons engaged in export from or import into the United 
States of byproduct material as defined in section 11 e.(3) and (4) of 
the Atomic Energy Act 1954, through August 7, 2006, unless terminated 
sooner if the Commission determines that an earlier termination is 
warranted; except that the requirements of the Department of Commerce 
relating to export of such material will continue to apply to such 
material during the waiver period;
    (2) To all persons that acquire, deliver, receive, possess, own, 
use, or transfer byproduct material as defined in section 11 e.(3) and 
(4) of the Atomic Energy Act 1954, through August 7, 2009, unless 
terminated sooner if the Commission determines that an earlier 
termination is warranted; and
    (3) To all States that have entered into an agreement with the 
Commission under section 274 b. of the Atomic Energy Act of 1954 (42 
U.S.C. 2014(e)) and to States that have not entered into such an 
Agreement, through August 7, 2009, unless terminated sooner if the 
Commission determines that an earlier termination is warranted; except 
that such a waiver for an Agreement State will be terminated by the 
Commission, if the Commission makes the determinations required by 
section 651(e)(5)(B)(ii) of the Energy Policy Act of 2005.

    Dated at Rockville, Maryland, this 25th day of August, 2005.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-17293 Filed 8-30-05; 8:45 am]
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