The U.S. Nuclear Regulatory Commission (NRC) is authorizing the University of Pittsburgh, License No. 37-00245-09, an exemption to 10 CFR 35.615(f)(3), to permit the licensee to have a qualified neurosurgeon physically present in place of an Authorized User (AU) during the use of its gamma stereotactic radiosurgery (GSR) units.
Identification of the Proposed Action
The University of Pittsburgh has a NRC license (License No. 37-00245-09) which authorizes the medical use of three GSR units. The licensee has requested, in a letter dated April 9, 2004, that NRC grant a exemption to 10 CFR 35.615(f)(3), which requires an AU and Authorized Medical Physicist (AMP) to be physically present throughout all patients treatments with a GSR unit.
Need for the Proposed Action
The licensee has three GSR units located in the same wing of the hospital. Because of its expanding patient workload, the licensee states that there will be times when it will need to be able to perform simultaneous treatments with the GSR units. The licensee is requesting an exemption to 10 CFR 35.615(f)(3) to allow the use of a qualified neurosurgeon, instead of an AU, to be present throughout patients treatments involving the GSR units, in addition to the presence of the AMP. The AU will be immediately available to respond to an emergency at any of the units.
The exemption is needed so that University of Pittsburgh can continue to provide optimum medical treatment to its patients. The exemption would allow the University of Pittsburgh to perform simultaneous treatments with the GSR units. The exemption would allow better participation of the AU in dose treatment planning and patient set-up, without requiring the addition of a second AU. In evaluating the licensee's performance conforming to the current requirements in 10 CFR 35.615(f)(3), NRC inspections since April 2000 have not identified any violations nor medical events associated with the use of the GSR units.
Environmental Impacts of the Proposed Action
The gamma stereotactic radiosurgery sources are sealed sources and no material will be released to the environment. All the sources are contained within the unit, as verified by periodic spot checks 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 USC 4322(2)(E)), a possible alternative to the final action has been considered. The alternative is to deny the exemption request, which would require the licensee to have at least two AUs and two AMPs physically present when simultaneous treatments are conducted at the licensed facility, which would significantly increase the cost of patient care. The alternative option would not produce a gain in protecting the human environment, and it would negatively impact the licensee's provision of medical care to it patients.
Alternative Use of Resources
No alternative use of resources was considered because of the reasons stated above.
Agencies and Persons Consulted
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) has been consulted to evaluate this exemption request. ACMUI's recommendation has been considered in responding to the licensee's request.
Identification of Source Used
Letters from the University of Pittsburgh, to NRC, Region I, dated April 9, 2004, and June 3, 2004.
Finding of No Significant Impact
Based on the above environmental assesment, the Commission has concluded that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, 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 letters are available for inspection, and/or copying for a fee, in the NRC Region I, Public Document Room, 475 Allendale Road, King of Prussia, PA 19406. The documents are available electronically for public inspection from the Publicly Available Records (PARS) component of NRC's Documents Access and Management System (ADAMS), accession numbers ML041190282 and ML041620397, respectively. ADAMS is accessible from the NRC Web site at: http://www.nrc.gov/reading-rm/adams.html.Start Signature
Dated at Rockville, Maryland, this 24th day of September, 2004.
For the Nuclear Regulatory Commissinon.
Section Chief, Material Safety and Inspection Branch, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 04-22197 Filed 10-1-04; 8:45 am]
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