A Decision Support Tool for Determining Federal Regulatory Authority over Products for Vertebrate Animals

Author(s): Ruell, Emily W.; Gatewood, Donna M.; O'Hare, Jeanette R.; Eisemann, John D. | Abstract: Products developed for vertebrate animals, including toxicants, repellents, contraceptives, vaccines, drugs, antimicrobials, diagnostic kits, and some devices, are regulated under a suite of federal laws. Authorization for the production, sale, and use of these products is primarily controlled by three federal agencies: the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine, and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). Furthermore, regulatory oversight of these products extends to research activities conducted during their development. However, determining the regulatory jurisdiction of new products can be confusing for researchers and product developers. In fact, the same product could be regulated under different laws and by more than one agency depending on its intended target population, function, product claims, and route of administration. Adding to this complexity, EPA, FDA, and APHIS have reached a series of formal and informal agreements on which agency will have primary oversight for a number of novel product types that do not clearly fall into established product categories. Here, we present a decision support tool that helps researchers and product developers identify the regulatory jurisdiction of new products, allowing them to comply with federal laws and consult with the appropriate agency early in the research and development phase. Such consultations ensure that resources are spent on studies that satisfy agency-specific data requirements for product registration, approval, and licensing.