This presentation will highlight the types of studies that are increasingly becoming important for the assessment of the safety of chemicals. In contrast to the currently required studies (such as those in Section 158 for pesticides) that have been the subject of guidelines for carrying them out for a number of years, these new studies are often not fully validated, are subject to modification by the laboratories performing the studies, and are not presently carried out under strict Good Laboratory Practice (GLP) conditions. Nonetheless many of these studies are essential for making informed decisions about the safety of chemicals. In addition, given the National Academy of Sciences Toxicity Testing in the 21st Century report (Tox21), issued in 2007, the traditional studies will become less important in the future as new testing methodologies emerge and are used for regulatory decisions. The Council for the Advancement Pyrethroid Human Risk Assessment (CAPHRA) has undertaken a multi-year research program designed to examine whether children are more sensitive to the neurotoxicity of pyrethroid insecticides than adults. Although many of these studies appear to be within the realm of academic research, they embrace the essence of the Tox21 approach, and the data derived has important applications for the safety assessment of chemicals currently in use. The program will lead to the development of a physiologically-based pharmacokinetic model to allow the prediction of brain levels of pyrethroids in humans. Because of this, CAPHRA has developed a careful, well-considered approach to ensuring data quality for studies conducted outside of traditional GLP facilities. Examples of the studies being conducted by CAPHRA, as well as other studies that are consistent with the Tox21 regimen will be discussed. An approach to ensuring data quality will be presented.

Twenty-first century toxicology and risk assessment: Going beyond guideline studies

246th National Meeting (2013)

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