The Endocrine Disruptor Screening Program Developed by the U.S. Environmental Protection Agency

Abstract

The Food Quality Protection Act (FQPA) was signed into law on 3 August 1996. FQPA amended both laws under which the Environmental Protection Agency manages the regulatory process for pesticide registration and use in the United States. Many new requirements were incorporated into these two laws, including the development of “a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect....” “Certain substances” includes all pesticides (both active and other ingredients of pesticide formulations) as well as “any other substance that may have an effect cumulative to an effect of a pesticide chemical if...a substantial population may be exposed to such substance.” With the assistance of an advisory committee made up of 40 members representing several other agencies of the Federal government, States, chemical manufacturers and users, public interest groups, and the public health and academic communities, EPA has developed, and is currently implementing, such a screening program. The initial program, as proposed, consists of two tiers, a screening tier containing eight assays, and a testing tier, containing five multigeneration tests. The screening battery is designed to determine whether or not the agent being evaluated has the potential to interact not only with the estrogen-hormone system, but also the androgen- and thyroid-hormone systems, as well. The testing tier is designed to provide definitive characterization of an agent's inherent ability to disrupt one or more of the three hormone systems. This presentation will describe, in detail, the status of development and validation of each component of the proposed screening program, including possible alternatives; the universe of chemical agents that are candidates for inclusion in the program, the priority-setting process to be used for chemical selection and the relationship between EPA's program and the OECD effort to develop a program for use by its member countries.