Pesticide registration in the United States: overview and new directions.

This paper provides an overview of EPA's pesticide registration program and a discussion of recent activities. The registration of pesticides is the responsibility of the Office of Pesticide Programs, an office of the U.S. Environmental Protection Agency (EPA). EPA's pesticide regulatory authority derives from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). FIFRA governs the registration or licensing of pesticide products including insecticides, herbicides, fungicides, rodenticides, disinfectants, plant growth regulators, and biological agents. FFDCA governs pesticide residue levels in food and feed crops. FIFRA gives EPA authority for registering pesticides to ensure that when used according to label directions, they will not pose unreasonable adverse effects to the environment. FIFRA requires EPA to balance the risks and benefits of a pesticide in deciding whether or not to grant a pesticide registration. In a typical year EPA reviews over 5000 registration submissions that vary from routine label amendments to the review of a new active ingredient. About 20 applications for registration of a new active ingredient are received each year. Registration for a new active ingredient requires a significant investment in time and money by the registrant. Data development for a major agricultural chemical can cost 10 million dollars or more and take several years to complete. EPA is embarking on a number of new initiatives in the registration program designed to reduce the use of chemical pesticides, limit the regulatory burden on lower risk and reduced risk products, and streamline the review process generally.