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The use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment
Citation:
The use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.
Impact/Purpose:
The Agency is interested in using in vitro data to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment. Specifically, the Agency is seeking advice and recommendation from the FIFRA SAP on scientific issues associated with the evaluation and utility of NAMs as part of a weight of evidence evaluation of developmental neurotoxicity potential and the use of in vitro acetylcholinesterase inhibition data to develop interspecies and/or intraspecies data-derived extrapolation factors for organophosphate pesticides.
Description:
In 2007, the National Research Council (NRC)'s report on Toxicity Testing in 21st Century: A Vision and a Strategy was published which encouraged a new paradigm in toxicity testing that reduces the reliance on laboratory animals while moving towards in vitro and in silico predictive approaches that are more efficient and human relevant. EPA's Office of Pesticide Programs (OPP) has developed a strategic vision for implementing the 2007 NRC report that has multiple components involving a combination of computational and predictive modeling approaches, in vitro techniques, and limited, targeted in vivo testing. EPA is actively engaged in numerous activities with respect to reducing laboratory animal use and implementing in vitro and computational approaches. As NAMs can provide human relevant information that may be challenging to obtain with whole animal testing. EPA is also interested in using in vitro and computational approaches for reducing the reliance on default assumptions for risk assessment, including the application of 10X uncertainty factors for inter- and intra-species extrapolation.
URLs/Downloads:
Transmission of Background materials and Charge to the panel for the September 15-18, 2020 Session of the FIFRA Scientific Advisory Panel (FIFRA SAP) reviewing the use of new approach methodologies (N (PDF, NA pp, 171 KB, about PDF)FIFRA Scientific Advisory Panel Meeting Minutes and Final Report No. 2020-02 Peer Review of the Use of New Approach Methodologies (NAMs) (PDF, 58 pp, 1499 KB, about PDF)
The Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment, Charge Questions (PDF, NA pp, 197 KB, about PDF)
The use of new approach methodologies (NAMs) to derive extrapola
Revised Charge Questions NAMs to Derive Extrapolation Factors (PDF, NA pp, 169 KB, about PDF)
Agency Issue Paper: Use of NAMs to Derive Extrapolation Factors (PDF, NA pp, 3604 KB, about PDF)