Chapter 31 - Risk Assessment and Risk Management: The Regulatory Process

Abstract

This chapter describes the federal regulatory processes in the United States for risk assessment and management of pesticides. In the United States, primary authority for pesticide regulation resides with the US Environmental Protection Agency (EPA), under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA, EPA registers pesticides for use. This law also authorizes the Agency to prescribe the conditions of use of pesticide products. Under FFDCA, EPA establishes maximum allowable levels of pesticide residues in foods and animal feeds, which are enforced by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The chapter describes some of the changes in the federal regulations on pesticides over the years since the Federal Insecticide Act of 1910, and discusses the current state of pesticide related regulations in the United States. The major changes in FIFRA caused by amendments and the passage of The Food Quality Protection Act (FQPA), include power of EPA to suspend a pesticide registration in an emergency situation, formation of the FIFRA Science Review Board, tolerance re-evaluation as part of re-registration, requirement for periodic registration review, additional incentives for the development and maintenance of minor use registrations, and special provisions for antimicrobial pesticides. The most significant changes in pesticide regulation resulting from the passage of FQPA impact the tolerance-setting process described in FFDCA.