FIFRA-88, GLP, and QA: pesticide registration.

Abstract

The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has decreased the number of pesticide registrations in the United States. Subsequent implementation of the U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased costs of maintaining these registrations. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) maintains approximately 30 Section 3 (federal) or Section 24c (state) vertebrate pesticide registrations for the Wildlife Services (WS) program to control wild mammals and birds that damage crops, impact endangered species, or pose human health risks. Under FIFRA-88, APHIS summarized, performed, and submitted or gained waivers for > 500 studies requested by the U.S. EPA to assess potential hazards/effects of these pesticides. A summary of FIFRA-88 milestones for registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient (AI) in a "low-volume, minor-use" avicide (DRC-1339, Starlicide), is used to illustrate GLP/QA/animal welfare issues involved in this process. Trends in the development of new pesticides and veterinary drugs are compared to provide some perspectives on future career paths for QA professionals.