[Federal Register Volume 72, Number 102 (Tuesday, May 29, 2007)]
[Notices]
[Pages 29555-29556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10261]


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NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 21, ``Consolidated Guidance About Materials 
Licenses Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator''; Draft 
Guidance Document for Comment

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability for public comment.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has amended its 
regulations to include jurisdiction over certain radium sources, 
accelerator-produced radioactive materials, and certain naturally 
occurring radioactive material, as required by the Energy Policy Act of 
2005 (EPAct), which was signed into law on August 8, 2005. The EPAct 
expanded the Atomic Energy Act of 1954 definition of byproduct material 
to include these radioactive materials. Subsequently, these radioactive 
materials were placed under NRC's regulatory authority. NRC is revising 
its regulations to provide a regulatory framework that includes these 
newly added radioactive materials. See SECY-07-0062, ``Final Rule: 
Requirements for Expanded Definition of Byproduct Material,'' dated 
April 3, 2007, for information on that rulemaking.
    Two licensing guidance documents in the NUREG-1556 series are being 
revised along with these new regulations to provide guidance related to 
the new requirements: (1) NUREG-1556, Volume 13, Revision 1, 
``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Commercial Radiopharmacy Licenses,'' and (2) NUREG-1556, 
Volume 9, Revision 2, ``Consolidated Guidance About Materials 
Licenses--Program Specific Guidance About Medical Use Licenses.'' A new 
volume in the NUREG-1556 series is also being developed to address the 
production of radioactive material using an accelerator. This NUREG is 
entitled, ``NUREG-1556, Volume 21, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Possession Licenses 
for Production of Radioactive Material Using an Accelerator.''
    This notice is announcing the availability of one of these three 
licensing guidance documents for public comment: NUREG-1556, Volume 21. 
NUREG-1556, Volume 13, Revision 1, and NUREG-1556, Volume 9, Revision 
2, will be available for public comment in the near future by separate 
notices in the Federal Register.

DATES: Please submit comments by June 28, 2007. Comments received after 
this date will be considered if practical to do so, but the NRC staff 
is able to ensure consideration only for those comments received on or 
before this date.

ADDRESSES: Volume 21, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator'' is available 
for inspection and copying for a fee at the NRC's Public Document Room 
(PDR), Public File Area O-1F21, One White Flint North, 11555 Rockville 
Pike, Rockville, Maryland. Publicly available documents created or 
received at the NRC after November 1, 1999, are available 
electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this site, the public can gain 
entry into the NRC's Agencywide Document Access and Management System 
(ADAMS), which provides text and image files of the NRC's public 
documents. The ADAMS Accession Number for NUREG-1556, Volume 21 is 
ML071410035. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC 
PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
[email protected]. The document will also be posted on NRC's public Web site 
at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ 
on the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' 
Web site page.
    A free single copy, to the extent of supply, may be requested by 
writing to Office of the Chief Information Officer, Reproduction and 
Distribution Services, U.S. Nuclear Regulatory Commission, Printing and 
Graphics Branch, Washington, DC 20555-0001; facsimile: 301-415-2289; e-
mail: [email protected].
    Please submit comments to Chief, Rulemakings, Directives, and 
Editing Branch, Division of Administrative Services, Office of 
Administration, U.S. Nuclear Regulatory Commission, Washington, DC, 
20555-0001. You may also deliver comments to 11545 Rockville Pike, 
Rockville, MD, between 7:30 a.m. and 4:30 p.m. Federal workdays, or by 
e-mail to: [email protected].

FOR FURTHER INFORMATION CONTACT: Torre Taylor, Division of 
Intergovernmental Liaison and Rulemaking, Office of Federal and State 
Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
7900, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    On August 8, 2005, the President signed into law the EPAct. Among 
other provisions, Section 651(e) of the EPAct expanded the definition 
of byproduct material as defined in Section 11e. of the Atomic Energy 
Act of 1954 (AEA), placing additional byproduct material under the 
NRC's jurisdiction, and required the Commission to provide a regulatory 
framework for licensing and regulating these additional byproduct 
materials.
    Specifically, Section 651(e) of the EPAct expanded the definition 
of byproduct material by: (1) adding any discrete source of radium-226 
that is produced, extracted, or converted after extraction, before, on, 
or after the date of enactment of the EPAct for use for a commercial, 
medical, or research activity; or any material that has been made 
radioactive by use of a particle accelerator and is produced, 
extracted, or converted after extraction, before, on, or after the date 
of enactment of the EPAct for use for a commercial, medical, or 
research activity (Section 11e.(3) of the AEA); and (2) adding any 
discrete source of naturally occurring radioactive material, other than 
source material, that the Commission, in consultation with the 
Administrator of the Environmental Protection Agency (EPA), the 
Secretary of the Department of Energy (DOE), the Secretary of the 
Department of Homeland Security (DHS), and the head of any other 
appropriate Federal agency, determines would pose a threat similar to 
the threat posed by a discrete source of radium-226 to the public 
health and safety or the common defense and security; and is extracted 
or converted after extraction before, on, or after the date of 
enactment of the EPAct for use in a commercial, medical, or research 
activity (Section 11e.(4) of the AEA).
    NRC is revising its regulations to provide a regulatory framework 
that includes these newly added radioactive materials. See SECY-07-
0062, ``Final

[[Page 29556]]

Rule: Requirements for Expanded Definition of Byproduct Material,'' 
dated April 3, 2007, for information on that rulemaking.

Discussion

    As part of the rulemaking effort to address the mandate of the 
EPAct, the NRC also evaluated the need to revise certain licensing 
guidance to provide necessary guidance to applicants in preparing 
license applications to include the use of the newly added radioactive 
materials as byproduct material. Two NUREG-1556 documents are being 
revised to provide additional guidance to licensees: (1) NUREG-1556, 
Volume 13, Revision 1, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Commercial Radiopharmacy 
Licenses,'' and (2) NUREG-1556, Volume 9, Revision 2, ``Consolidated 
Guidance About Materials Licenses--Program-Specific Guidance About 
Medical Use Licenses.'' Additionally, a new NUREG-1556 volume is also 
being developed to address production of radioactive material using an 
accelerator. This NUREG-1556 volume is entitled: Volume 21, 
``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Possession Licenses for Production of Radioactive 
Material Using an Accelerator.''
    At this time, NRC is announcing the availability for public comment 
NUREG-1556, Volume 21, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator.'' The 
remaining two NUREG-1556 volumes, (1) NUREG-1556, Volume 13, Revision 
1, ``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Commercial Radiopharmacy Licenses,'' Draft Report for 
Comment, and (2) NUREG-1556, Volume 9, Revision 2, ``Consolidated 
Guidance About Materials Licenses--Program-Specific Guidance About 
Medical Use Licenses,'' will be available for public comment in the 
near future.
    NUREG-1556, Volume 21, provides guidance on preparing a license 
application for the production of radioactive material using an 
accelerator(s). It also includes the criteria that NRC staff will use 
in evaluating license applications for this use. This document includes 
guidance that is specific to the activities that take place once 
radioactive materials are produced by the accelerator, which include 
material in the target and associated activation products. This 
document does not include information for the operation of the 
accelerator as NRC does not regulate the accelerator or its operation.
    Volume 21 provides guidance related to each of the items that 
applicants should address in their materials license application, which 
includes items such as radioactive material that will be produced and 
its purpose; information on individuals responsible for the radiation 
safety program; training for individuals that will handle radioactive 
material; description of the facilities and equipment used; and the 
radiation safety program. There are some aspects of producing 
radioactive materials using an accelerator that are unique to this type 
of use and are discussed in the document. Some examples include 
training and experience for individuals who will handle radioactive 
material during the maintenance and repair of the accelerator and other 
associated equipment, and guidance on the facility design and type of 
equipment needed to transfer and handle large radioactive materials 
with high activities. This document will also include guidance on the 
production and noncommercial distribution of positron emission 
tomography radioactive drugs to consortium members.

    Dated at Rockville, Maryland, this 22nd day of May 2007.

    For the Nuclear Regulatory Commission.
Dennis K. Rathbun,
Division Director, Division of Intergovernmental Liaison and 
Rulemaking, Office of Federal and State Materials and Environmental 
Management Programs.
 [FR Doc. E7-10261 Filed 5-25-07; 8:45 am]
BILLING CODE 7590-01-P