02-31943. 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 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.