Assessment of the U.S. 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 the 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 protect infants and children from environmental toxins. For this task, the Agency relies heavily on scientific data obtained by manufacturers of industrial chemicals and pesticides following protocols collected under EPA's Health Effects Test Guidelines.


RESULTS
This article reviews the protocols included in the EPA guidelines to assess developmental toxicity, which are required for food-use pesticides under the core testing battery. We reviewed these protocols on the basis of their adequacy for identifying hazards to infants and children. Our analysis found limitations in the protocols that hinder their potential for identifying developmental hazards.


CONCLUSIONS
Methods that the EPA currently depends upon to identify developmental toxicity of chemicals have limitations that impede obtaining complete and reliable data on which to base regulatory decisions that protect children. Other methodological approaches need to be explored as alternatives or supplements to the current protocols. Until more accurate testing protocols 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 stages of development.
Claudio
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Division of Environmental and Occupational Medicine, Mount Sinai Medical Center, New York, NY 10029-6574, USA. Luz.Claudio@mssm.edu
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D000818:Animals; D002648:Child; D002675:Child, Preschool; D005314:Embryonic and Fetal Development / Q000187:drug effects*; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007223:Infant; D010575:Pesticides / Q000592:standards / Q000633:toxicity; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D013723:Teratogens; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards; D014481:United States; D014484:United States Environmental Protection Agency / Q000592:standards*; D014982:Xenopus laevis
D010575:Pesticides; D013723:Teratogens