INFORMATION NEEDS FOR PESTICIDE REGISTRATION IN THE UNITED STATES

Abstract

Historically, the tiered data-gathering process of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP) relied on aquatic field studies in its highest tier to complete an ecological risk assessment. A 1992 policy decision deemphasized requirements for field testing and placed greater emphasis on more realistic exposure estimates, laboratory-derived risk criteria, and early risk mitigation. Currently, ecological risk assessments of pesticides as performed by the OPP require two fundamental components: (1) an effects dose–response profile for selected species, and (2) an exposure profile for representative species relevant to the endpoints being considered. Additional information, though useful, is not generally considered essential for effective risk management decisions. It is the existing policy of the OPP to make expeditious decisions to attempt to mitigate the risk concerns identified with laboratory-derived data rather than postpone action until these risks are further characterized by field data. Experimental field studies and bio-monitoring studies can still be used in both prospective and ongoing assessments of pesticide risks. Such studies provide useful information for risk assessment and subsequent risk-management decisions. Since the original presentation in August 1994, the OPP brought its risk assessment methodology to the FIFRA Scientific Advisory Panel. In May 1996, this panel advised the OPP to reconsider its 1992 policy regarding field studies. The OPP is in the process of re-evaluating this policy.