Regulatory authority over the use of ionizing radiation in veterinary use is shared among several federal, state, and local government agencies. NRC (or the responsible Agreement State) has regulatory authority over the possession and use of byproduct or source material in veterinary medicine. Byproduct material is used in some calibration sources, radioactive drugs, bone mineral analyzers, portable fluoroscopic imaging devices, brachytherapy sources and devices, and teletherapy units used in veterinary medicine. Source material is used for radiation shielding and counterweights in therapy devices.
NRC's byproduct material veterinary use licenses are issued pursuant to NRC regulations in 10 CFR Part 30, "Rules of general applicability to domestic licensing of byproduct material." Because NRC has fewer veterinary licenses and does not have regulations specific to veterinary medical uses, it does not distinguish between different types of veterinary practices the way it does for medical use.
Veterinary use includes diagnostic, therapeutic, and research veterinary uses of radioactive drugs and devices. These licenses usually are issued for the treatment of domestic pets and non-food animals. At the present time, no radioactive veterinary drugs have been approved for use in animals intended for the human food supply.
Any animal that has been injected with a radioactive compound or has had radioactive sources implanted cannot be released until the researcher or veterinarian ensures that the dose that members of the public will receive from the animal is within limits of 10 CFR 20.1301, "Dose limits for individual members of the public." Regulations in 10 CFR 20.1301 require that the total effective dose equivalent to an individual member of the public from the licensed operation does not exceed 1 millisievert (mSv) [0.1 rem or 100 millirem (mrem)] in a year and that the dose in any unrestricted area from external sources does not exceed 0.02 mSv [0.002 rem or 2 mrem] in any 1 hour. A member of the public is any individual, except when that individual is receiving an occupational dose. Members of the public, therefore, include bystanders, pet owners, family members, or other caretakers of the animal after the researcher or veterinarian has released it.
Some veterinary practices only have regulated material in the form of prepackaged in vivo diagnostic test kits. The amount of nuclear material used these practices determines whether possession and use of the kits is authorized by specific license pursuant to 10 CFR Part 30 or a general license pursuant to 10 CFR 31.11. See the general license section for those materials generally licensed pursuant to 10 CFR 31.11. See 10 CFR 31.11, "General License for Use of Byproduct Material for Certain In Vitro Clinical or Laboratory Testing" for the registration requirements and the materials that can be used under this general license.
The Food and Drug Administration oversees the good manufacturing practices in manufacture of radio-pharmaceuticals, clinical tests materials and radiation-producing x-ray machines and accelerators. The states regulate the practices of veterinary medicine and pharmacy and administer programs associated with radiation-producing x-ray machines and accelerators.
Page Last Reviewed/Updated Wednesday, December 02, 2020