ELSEVIER Reproductive Toxicology, Vol. 11, Nos. 2/3, pp. 443-45 1, 1997 Copyright 0 1997 Elsevier Science Inc. Printed in the USA. All nghts reserved 0890-6238197 $17.00 + .oO PI1 SOS90-6238(96)00159-2 NEW APPROACHES FOR ASSESSING THE ETIOLOGY AND RISKS OF DEVELOPMENTAL ABNORMALITIES FROM CHEMICAL EXPOSURE LYNN R. GOLDMAN Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency, Washington, D.C. Abstract - Developmental toxicants, insidious in modes of action and effects, strike the very origin of our lives: the developing embryo, fetus, neonate, and child; they cause spontaneous abortions, stillbirths, malformations, early postnatal mortality, reduced birth weight, mental retardation, sensory loss as well as other functional or physical changes, including subclinical effects having far reaching social and economic impacts. The large majority of developmental defects have unknown etiologies. With this uncertainty, EPA and the scientific community world-wide give high priority to finding new approaches for assessing etiology and risks of devel- opmental effects. The United Nations Conference on Environment and Development (UNCED) and Agenda 21 mobilized the international community to focus on risks posed by chemicals in the environment, including developmental risks. The international harmonization of test and risk assessment guidelines for developmental effects are priorities. Lead, persistent organic pollutants (POPS), endocrine disruptors, and the improvement of quantitative risk assessment methodologies, particularly for children, are priorities. EPA reinvented its research agenda to assure wide involvement of the National Science Foundation, other federal agencies, and national experts in research to address the U.S.% public health and environmental priorities. 0 1997 Elsevier Science Inc. Key zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Words: developmental abnormalities; chemical exposure. INTRODUCTION It is appropriate that we meet this December to examine new approaches for assessing the etiology and risk of developmental effects from chemical exposure. Twenty- five years ago this month, a Republican President and Democratic majority in the Congress founded the Envi- ronmental Protection Agency (EPA). Over the past quar- ter century we have accomplished much to protect the public health and the environment, thanks to dedicated people, strong environmental laws, and an evolving sci- ence base for sound decision making. Together, we have made strong progress. For example: l Today we use safer chemicals than we did in 1970, and in safer ways. The most highly toxic and persistent pesticides threatening human health, nontarget species, and ecosystems have been either banned or severely restricted (1). Pollution Prevention, including source reduction, is now a core strategy for the EPA and for producers and users of pesticides and other chemicals (2). 0 The air is cleaner. Severe smog episodes of the 70s are largely a relic. Since 1984, emissions of the toxic metal lead have decreased 75% and concentrations in urban areas decreased 86% (3). Between 1976 and 1991, av- erage blood lead levels in children have decreased from 0.62 to 0.14 pmol/L (4). Toxic emissions from the chemical industry have been cut 49% and from all industries cut 43% since 1988 (5). Fifty million more Americans in 55 cities are breathing cleaner air today than in 1990-air that meets public health standards (6). l Rivers, streams, and lakes are cleaner than they were in 1970. The National Pollutant Discharge Elimination System permits have been effective in reducing point discharges of pollutants into the nation’s waters (7). The municipal wastewater treatment standard has been met across the U.S. by most municipalities (8). Vol- untary partnerships between EPA and the states are reducing pesticides in ground water (9). l The rate of Superfund site cleanups has increased with more cleanups in the past 3 years than in the previous 12 (10). Brownfields redevelopments are successfully reclaiming once polluted hazardous waste sites for safe, productive uses for business and municipalities (11). l Waste disposal is handled more responsibly than in 1970. We now have safeguards to ensure that solid waste and toxic wastes are handled in ways that reduce risks to health and the environment and avoid costly waste cleanups. At home, school, and work, the prin- ciples of pollution prevention-reduce, reuse, or re- cycle-have taken hold firmly in less than a decade. The Clinton Administration is committed to the 443