Assessment of the US Environmental Protection Agency methods for identification of hazards to developing organisms - Part II: The developmental toxicity testing guideline

Background The effects of toxins on developing animals depend not only on t he nature of the chemical but also on the timing of exposure and assessment of outcomes. This complicates the task of regulatory agencies such as the U.S. Environmental Protection Agency (EPA), which must comply with the 1996 Food Quality Protection Act to ensure that their standards and policies pr otect infants and children from environmental toxins. For this task, the Ag ency relies heavily on scientific data obtained by manufacturers of industr ial chemicals and pesticides following protocols collected under EPA's Heal th Effects Test Guidelines. Methods and Results This article reviews the protocols included in the EPA guidelines to assess developmental toxicity, which are required for food-us e pesticides under the core testing battery. We reviewed these protocols on the basis of their adequacy for identifying hazards to infants and childre n. Our analysis found limitations in the protocols that hinder their potent ial for identifying developmental hazards. Conclusions Methods that the EPA currently depends upon to identify develop mental toxicity of chemicals have limitations that impede obtaining complet e and reliable data on which to base regulatory decisions that prefect chil dren. Other methodological approaches need to be explored as alternatives o r supplements to the current protocols, Until more accurate resting protoco ls become available, it may well be necessary under existing laws to employ safety factors that are more protective of the health of children at all s tages of development. Am. J. Ind. Med. 35:554-563, 1999. (C) 1999 Wiley-Lis s, Inc.