[Federal Register: December 19, 2002 (Volume 67, Number 244)]
[Notices]
[Page 77817-77818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de02-110]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 30-30097]
Dr. Ilia Ruiz Gandulla, Environmental Assessment and Final
Finding of No Significant Impact; Exemption
The U. S. Nuclear Regulatory Commission is authorizing Ilia Ruiz
Gandulla, M.D., License No. 52-24929-01, an exemption to 10 CFR 35.432,
for 90 days to permit the licensee to continue the medical use of its
strontium-90 eye applicator without determining the source output or
activity based on a calibration performed as required by 10 CFR 35.432.
During this period, the licensee shall use the activity value
(corrected for decay) provided by the strontium-90 eye applicator
brachytherapy 1988 calibration certificate for ophthalmic treatment.
Environmental Assessment
Identification of the Proposed Action
Ilia Ruiz Gandulla, M.D., has a United States Nuclear Regulatory
Commission (NRC) license (License No. 52-24929-01) that authorizes the
use, for medical therapeutic patient treatment purposes, of a
strontium-90 eye applicator sealed source. The licensee has requested,
in a letter dated November 21, 2002, that the NRC grant her an
exemption for a limited period of time from the source calibration
requirement in 10 CFR 35.432, in order to use the licensed source for
patient treatment until a laboratory authorized to calibrate the source
can provide the calibration required by 10 CFR 35.432. This requirement
became effective on October 24, 2002.
10 CFR section 35.432 specifies that licensees may only use
brachytherapy sources on or after October 24, 2002, if the licensee
shall have determined the source output or activity using a dosimetry
system that meet the requirements of 10 CFR 35.630(a). To meet this
requirement, a licensee may perform the measurements, or use
measurements provided by the source manufacturer or by a calibration
laboratory accredited by the American Association of Physicists in
Medicine that are made in accordance with the referenced section of the
rule.
Since the 1988 calibration of the source was not performed in
accordance with the requirements of 10 CFR 35.432, Dr. Gandulla, an
opthamologist practicing in Mayaguez, Puerto Rico, has not been able to
use the source since October 24, 2002. She requested recalibration of
her strontium-90 eye
[[Page 77818]]
applicator source by an accredited calibration laboratory, but the
calibration laboratory has a backlog of requests and cannot send the
transportation container needed to ship the source at this time. The
calibration is expected to be completed by December 31, 2002. Dr.
Gandulla does not have the authorization or equipment to perform the
calibration and the strontium-90 source manufacturer cannot provide the
calibration because the manufacturer is no longer in business. Dr.
Gandulla requested an exemption that would permit her to continue to
perform patient treatments until the required recalibration can be
performed.
Need for the Proposed Action
The exemption is needed so that Dr. Gandulla can continue to
provide optimum medical treatment to her patients. The exemption would
allow Dr. Gandulla to use the activity from the 1988 calibration
certificate (corrected for decay) to determine the treatment times for
ophthalmic conditions. This would permit continued use of the source
prior to its recalibration and provide needed timely patient
therapeutic services without interruption. Recalibration of the
licensed strontium-90 eye applicator is expected to be performed by
December 31, 2002. The 90-day duration of the exemption allows for
flexibility if there is a delay in the calibration laboratory's ability
to supply the transportation container necessary to ship the source.
NRC inspections since 1988 have not identified any medical events
associated with the use of the source or the treatment times developed
using the existing activity values.
Environmental Impacts of the Proposed Action
The strontium-90 eye applicator source is a sealed source and no
material will be released into the environment. All the strontium-90 is
contained within the brachytherapy source, 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.
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. The
alternatives are to deny the exemption request and to require the
licensee to: (1) return the source for calibration to the manufacturer,
(2) have another calibration laboratory perform the measurements, (3)
perform the calibration measurements, or (4) put the sources in storage
until the calibration can be performed. The sources cannot be returned
to the manufacturer because the manufacturer is no longer in business.
Dr. Gandulla has already requested calibration by an accredited
calibration laboratory. The licensee does not have the qualifications,
authorization, or equipment to perform the calibration. The only other
possible option is to require that the licensee place the source in
storage. This option would not produce a gain in protecting the human
environment, and it would negatively impact the licensee-physician's
provision of medical care to her 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 Ilia Ruiz Gandulla, M.D., to U.S. Nuclear Regulatory
Commission, Region II, dated November 21, 2002.
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 is available for inspection, and/or copying
for a fee, in the Region II Public Document Room, Atlanta Federal
Center, 61 Forsyth Street, SW., Atlanta, GA 30303 The document is
available electronically for public inspection from the Publically
Available Records (PARS) component of NRC's Documents Access and
Management System (ADAMS), accession number ML023250443. ADAMS is
accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html
.
Dated in Rockville, Maryland, this 13th day of December, 2002.
For the Nuclear Regulatory Commission.
Frederick Brown,
Section Chief, Material Safety and Inspection Branch, Division of
Industrial and Medical Nuclear Safety, Office of Nuclear Material
Safety and Safeguards.
[FR Doc. 02-31943 Filed 12-18-02; 8:45 am]
BILLING CODE 7590-01-P