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Developmental Neurotoxicity Study Guidance

EPA and Health Canada have developed new guidance for interpreting developmental neurotoxicity (DNT) data in support of a pesticide registration. The DNT study assesses behavioral and neurobiological parameters to ascertain the effects of chemicals on the developing animal. The basic purpose of DNT guideline testing is to screen for the potential of chemicals to cause adverse neurodevelopmental outcomes.

This document was developed to resolve some inconsistencies in the way U.S. and Canadian regulators were evaluating DNT studies and provides guidance on how to evaluate the quality, conduct, and resulting data derived from the behavioral methods employed in the Organization for Economic Cooperation (OECD) and/or EPA DNT Guidelines. It may be useful for other international regulatory agencies or those interpreting data generated under the auspices of the OECD or EPA DNT guidelines. While it was meant for government scientists, we are posting it in the interest of transparency and to ensure everyone (regulated community and NGOs alike) knows how we are evaluating the data.

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