[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Pages 63942-63943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22157]


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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''

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the 
completion and availability of NUREG-1556, Volume 21, ``Consolidated 
Guidance About Materials Licenses, Program-Specific Guidance About 
Possession Licenses for Production of Radioactive Material Using an 
Accelerator,'' dated October 2007.

ADDRESSES: Copies of NUREG-1556, Volume 21, may be purchased from the 
Superintendent of Documents, U.S. Government Printing Office, P.O. Box 
37082, Washington, DC 20402-9328; www.access.gpo.gov/su_docs, 202-512-
1800 or The National Technical Information Service, Springfield, 
Virginia 22161-0002; www.ntis.gov; 1-800-533-6847 or, locally, 703-805-
6000.
    A copy of the document is also available for inspection and/or 
copying for a fee in the NRC Public Document Room, 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 
ML072900058. 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, and on the Office of Federal and State Materials and 
Environmental Management Programs' NARM (Naturally-Occurring and 
Accelerator-Produced Radioactive Material) Toolbox Web site page at: 
http://nrc-stp.ornl.gov/

[[Page 63943]]

narmtoolbox.html under the heading of ``Licensing Guidance.'' Some 
publications in the NUREG series that are posted at NRC's Web site 
address www.nrc.gov are updated regularly and may differ from the last 
printed version.
    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].

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]; or Duane White, Division of Materials Safety 
and State Agreements, Office of Federal and State Materials and 
Environmental Management Programs, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6272, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: On August 8, 2005, the President signed into 
law the Energy Policy Act of 2005 (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 revised its regulations to provide a regulatory framework that 
includes these newly added radioactive materials. See Federal Register 
notice 72 FR 55864, dated October 1, 2007. 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 was 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.''
    NUREG-1556, Volume 21, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator'' was noticed 
for public comment on May 29, 2007 (72 FR 29555). Six comment letters 
were received and these comments were considered by the staff as this 
NUREG was finalized.
    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 also includes guidance on the 
production and noncommercial distribution of positron emission 
tomography radioactive drugs to consortium members.
    The remaining two NUREG-1556 volumes were noticed separately: (1) 
NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72 FR 36526), and 
(2) NUREG-1556, Volume 9, Revision 2, on August 2, 2007 (72 FR 42442). 
These two NUREGs are being finalized and will be available in the near 
future.

    Dated at Rockville, Maryland, this 1st day of November, 2007.

    For the Nuclear Regulatory Commission.

Patrice M. Bubar,
Deputy Director, Division of Intergovernmental Liaison and Rulemaking, 
Office of Federal and State Materials and Environmental Management 
Programs.
 [FR Doc. E7-22157 Filed 11-9-07; 8:45 am]
BILLING CODE 7590-01-P