You are here:
Challenges with Guideline DNT Studies Facilitate the Application of DNT NAMs by the US EPA
Citation:
Shafer, T. Challenges with Guideline DNT Studies Facilitate the Application of DNT NAMs by the US EPA. National Academies Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment, RTP, NC, May 12, 2022. https://doi.org/10.23645/epacomptox.19699777
Impact/Purpose:
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:
Presentation to the National Academies Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment Workshop May 2022. The presentation is a short summary of the challenges with conventional guideline DNT studies and presents a case-study for the use of NAMs in a weight-of- evidence decision on waiving of a guideline DNT requirement.
URLs/Downloads:
DOI: Challenges with Guideline DNT Studies Facilitate the Application of DNT NAMs by the US EPA
SHAFER_NAS WORKSHOP.PDF (PDF, NA pp, 886.401 KB, about PDF)