[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Notices]
[Pages 77817-77818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31943]


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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