Chapter 62 - Risk Assessment and Risk Management: The Regulatory Process

Abstract

This chapter evaluates the present risk assessment and risk management scenario prevalent worldwide, especially in the United States. The tolerances for most raw and processed foods are enforced by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS). In the United States, primary authority for pesticide regulation resides with the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA authorizes EPA to prescribe the conditions of use of pesticide products. Amendments to FIFRA and FFDCA in 1996 brought both incremental and broad changes to the legal foundation for pesticide regulation in the United States. EPA may now suspend a pesticide registration in an emergency situation without simultaneously issuing a notice of intent to cancel, a change from the previous requirement for simultaneous action. There also must be a lack of efficacious alternatives or the alternatives must pose a greater risk to human health or the environment than does the pesticide under evaluation. The law provides additional incentives for the development and maintenance of minor use registrations in a number of ways: extension of time to generate residue data and for exclusive use of these data; greater flexibility to waive data requirements; the option to waive some or all of the fees usually charged to support and maintain registration; and expedited review of minor-use applications by the agency. The most significant changes in pesticide regulation resulting from the passage of FQPA impact the tolerance-setting process described in FFDCA.