[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Production of Radioactive Material Using an Accelerator''; Draft
Guidance Document for Comment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