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New Approach Methodologies for Developmental Neurotoxicity Hazard: A case-study with glufosinate.
Citation:
Shafer, T. New Approach Methodologies for Developmental Neurotoxicity Hazard: A case-study with glufosinate. Food and Drug Administration Center for Food Safety and Applied Nutrition, Division of Toxicology (Virtual Presentation), RTP (Virtual), NC, February 14, 2023. https://doi.org/10.23645/epacomptox.22732418
Impact/Purpose:
Presentation to the Food and Drug Administration Center for Food Safety and Applied Nutrition, Division of Toxicology (Virtual Presentation) February 2023. Assessment of Developmental Neurotoxicity (DNT) using animal-based Guideline studies is expensive, time consuming, and does not always yield actionable data. Further, DNT assessment is not required under TSCA and the Guideline DNT study is a triggered study under FIFRA. Consequently, few of the tens of thousands of chemicals to which humans may be exposed have been evaluated for DNT hazard. To address this issue, New Approach Methodologies (NAMs) are being developed that can help provide data for risk decisions under FIFRA and TSCA. As these methods become more widely utilized, they can also provide information for other types of environmental decision-making as well.
Description:
Developmental neurotoxicity (DNT) hazard information is lacking for tens of thousands of chemicals that are present in the environment, which hinders regulatory evaluation of exposure risks for developing individuals. Because guideline DNT studies are expensive and slow, obtaining DNT hazard information efficiently with in vivo approaches for these chemicals is not feasible. To address this issue, new approach methodologies have been developed over the last 15 years that assess the effects of chemicals on key neurodevelopmental processes including proliferation, apoptosis, neurite outgrowth, synaptogenesis and network formation. A battery of these assays is now being used to evaluate sets of chemicals for DNT hazard, and some data is being used to inform decision-making on environmental chemicals including pesticides and other compounds. This presentation will present an overview of DNT NAMs and the information that they can provide for environmental decision-making. A recently published example with DL- and L-glufosinate will be used as a case-study to illustrate how data from DNT NAMs can be incorporated into environmental decision-making and the impact that such data can have. (This abstract does not reflect EPA Policy).
URLs/Downloads:
DOI: New Approach Methodologies for Developmental Neurotoxicity Hazard: A case-study with glufosinate.
SHAFER_FDA_2023_FINAL.PDF (PDF, NA pp, 9566.807 KB, about PDF)