Assessment of the US Environmental Protection Agency methods for identification of hazards to developing organisms - Part I: The reproduction and fertility testing guidelines

Background Successful reproduction depends on the coordination of many proc esses, particularly the normal development and subsequent maturation of the sexual organs. The Food Quality Protection Act of 1996 mandates that the U .S. Environmental Protection Agency must protect infants and children from the effects of toxins, including those that affect the reproductive system. Therefore, the Agency finds itself at a critical juncture to make sure tha t the methods it requires for toxicity testing, the Health Effects Test Gui delines or Series 870 Guidelines, are adequate to determine possible toxici ty to children. Methods and Results We found that two testing protocols included in the cor e guidelines assess toxicological effects on developing animals. This artic le aims to provide a detailed analysis of the protocols included in the Rep roduction and Fertility Effects Test Guideline. An accompanying article ass esses the Developmental Toxicity Testing Guideline. We conducted this analy sis on the basis of whether the test would yield the information needed to adequately determine risk to infants and children. Conclusions Our analysis concludes that given the limitations inherent in t esting for reproduction and fertility effects during development, it is nec essary to include a safety factor during risk assessment of chemicals. This action will fulfill the mandate expressed in the FQPA to protect infants a nd children from environmental hazards. Am. J. Ind. Med. 35:543-553, 1999. (C) 1999 Wiley-Liss, Inc.