Answer to Question #6996 Submitted to "Ask the Experts"
Category: Medical and Dental Equipment/Shielding — Equipment
The following question was answered by an expert in the appropriate field:
Q
- What type of license does a facility need if it is considering using PET (positron emission tomography) and CT (computed tomography) scanning technology for research purposes (nonhuman), assuming various isotopes such as 18F, 15O, and 99Tcm will be used?
- Would the Nuclear Regulatory Commission or the state be the regulator?
- Do the certifications for human use apply to research-based use?
- If a local hospital agrees to provide the radionuclide, what are the requirements for shipping? Can a company vehicle be used to transport across town?
A
- If the radionuclides are to be used for nonhuman research, then a specific license would be issued by the regulatory agency, such as for an academic or research and development application of the licensed material. A medical license would not be issued if the radionuclides, or their radiations, are not applied to humans.
- The agency issuing a specific license depends on the location of the facility. States will issue licenses in agreement states (34 of them); the NRC issues licenses in nonagreement states (16 of them) or to facilities located on federally owned property or on tribal lands.
- The qualifications of an individual to be authorized use of licensed material will be determined during the license application review. The experience and training in the use of the radionuclides requested in the license application of the certified individual will be considered during the application review.
- A local hospital may provide the radionuclide, but may need a distribution license if the hospital is providing the radionuclide for commercial purposes. The shipping and transport of radioactive material on public highways is governed by the regulation of the Department of Transportation (DOT). All pertinent DOT requirements must be met. A company vehicle may be used if the radioactive material has the proper transport manifest and the vehicle is placarded appropriately.
Joe DeCicco, CHP
Cynthia Jones, PhD, ATE Editor
Answer posted on 12 March 2008. The information and material posted on this website is intended as general reference information only. Specific facts and circumstances may alter the concepts and applications of materials and information described herein. The information provided is not a substitute for professional advice and should not be relied upon in the absence of such professional advice specific to whatever facts and circumstances are presented in any given situation. Answers are correct at the time they are posted on the Website. Be advised that over time, some requirements could change, new data could be made available, or Internet links could change. For answers that have been posted for several months or longer, please check the current status of the posted information prior to using the responses for specific applications.
