[Federal Register Volume 68, Number 232 (Wednesday, December 3, 2003)]
[Notices]
[Pages 67704-67705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30091]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 030-34629]


Gamma Knife Center of the Pacific Environmental Assessment and 
Final Finding of No Significant Impact; Exemption

    The U.S. Nuclear Regulatory Commission is authorizing the Gamma 
Knife Center of the Pacific, License No. 53-11966-02, an exemption to 
10 CFR 35.655, for 120 days to permit the licensee to continue the 
medical use of its gamma stereotactic radiosurgery unit beyond the 
interval specified in the regulation for full inspection and servicing.

Environmental Assessment

Identification of the Proposed Action

    The Gamma Knife Center of the Pacific has a United States Nuclear 
Regulatory Commission (NRC) license (License No. 53-11966-02) that 
authorizes the medical use of a Leksell Gamma Stereotactic Radiosurgery 
unit. The licensee has requested, in a letter dated September 8, 2003, 
that the NRC grant a temporary exemption from the requirements of 10 
CFR 35.655(a) in order to continue treating patients until the 
manufacturer's scheduled source replacement in February 2004. This 
regulation requires that all stereotactic radiosurgery units be fully 
inspected and serviced at source replacement or at intervals not to 
exceed 5 years whichever comes first.
    The licensee had the Leksell Gamma Stereotactic Radiosurgery unit 
installed in October 1998 and treated the first patient December 1, 
1998. The period of time between manufacturer's scheduled source 
exchange and the last full inspection service before treatment of the 
first patient exceeds the required 5 year interval. The licensee in e-
mails dated September 11 through 18 clarifies that the manufacturer has 
indicated the semiannual service, which was last performed July 29, 
2003 on the licensee's unit, includes all the tests that can be 
performed without disassembly of the unit. Such disassembly is not 
advised at any time other than source replacement because a new Leksell 
Gamma Stereotactic Radiosurgery unit can contain 6,000 curies of cobalt 
60 and disassembly can create high radiation fields unless it is 
performed at source replacement.

Need for the Proposed Action

    The exemption is needed so that Gamma Knife Center of the Pacific 
can continue to provide medical treatment to its patients. The 
exemption would allow the Gamma Knife Center of the Pacific to use the 
gamma stereotactic radiosurgery unit until the manufacturer can remove 
the sources and perform the full inspection and servicing during source 
replacement. This inspection and service can only be performed after 
source removal during source replacement. The exemption would permit 
continued use of the unit and provide needed timely patient therapeutic 
services without interruption. The source exchange and inspection 
service is scheduled for February 2004. The 120-day duration of the 
exemption allows for flexibility if there is a delay in the 
manufacturer's ability to ship the sources and perform the source 
exchange. NRC inspections since 1999 have not identified any violations 
or medical events associated with the use of the gamma stereotactic 
radiosurgery unit.

Environmental Impacts of the Proposed Action

    The gamma stereotactic radiosurgery unit contains 201 cobalt 60 
sealed sources and no material will be released into the environment. 
All the cobalt-60 is contained within the gamma stereotactic 
radiosurgery unit, as verified by periodic source leak tests performed 
by the licensee. The proposed action does not increase public radiation 
exposure. There will be no impact on the environment as a result of the 
proposed action.

[[Page 67705]]

Alternatives to the Proposed Action

    As required by Section 102(2)(E) of NEPA (42 U.S.C. 4322(2)(E)), 
possible alternatives to the final action have been considered. Only 
the manufacturer can perform the source exchange and the licensee has 
already scheduled the source exchange at the manufacturer's earliest 
available time. The only alternative is to deny the exemption request 
and to require the licensee to put the sources in storage until the 
source exchange and full inspection service can be performed. This 
option would not produce a gain in protecting the human environment, 
and it would negatively impact the licensee's provision of medical care 
to its patients.

Alternative Use of Resources

    No alternative use of resources was considered due to the reasons 
stated above.

Agencies and Persons Consulted

    No other agencies or persons were contacted regarding this proposed 
action.

Identification of Source Used

    Letter from the Gamma Knife Center of the Pacific, to U.S. Nuclear 
Regulatory Commission, Region IV, dated November September 8, 2003.
    E-mails from Ronald Flick to Jackie Cook, NRC, dated September 11, 
12, and 18, 2003.

Finding of No Significant Impact

    Based on the above environmental assessment, the Commission has 
concluded that the proposed action will not have a significant effect 
on the quality of the human environment. Accordingly, the NRC has 
determined that a Finding of No Significant Impact is appropriate and 
preparation of an environmental impact statement is not warranted.
    The licensee's letter and e-mails are available for inspection, 
and/or copying for a fee, in the Region IV Public Document Room, 611 
Ryan Plaza Drive, Suite 400, Arlington Texas 76011. The documents are 
available electronically for public inspection from the Publically 
Available Records (PARS) component of NRC's Documents Access and 
Management System (ADAMS), accession number ML03300150. ADAMS is 
accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.

    Dated at Rockville, Maryland, this 26th day of November, 2003.

    For the Nuclear Regulatory Commission.
Roberto J. Torres,
Section Chief, Material Safety and Inspection Branch, Division of 
Industrial and Medical Nuclear Safety, Office of Nuclear Material 
Safety and Safeguards.
[FR Doc. 03-30091 Filed 12-2-03; 8:45 am]
BILLING CODE 7590-01-P