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Quantitative Integration of NAMs into Regulatory Decision-Making: Current State of the Science
Citation:
Lambert, J. Quantitative Integration of NAMs into Regulatory Decision-Making: Current State of the Science. SOT 60th Annual Meeting and ToxExpo Virtual Meeting, N/A, N/A, March 12 - 26, 2021. https://doi.org/10.23645/epacomptox.14681145
Impact/Purpose:
This presentation is part of a session pertaining to development and application of molecular points-of-departure (PODs) in decision-based contexts (e.g., human health risk assessment). The presentation is designed to illustrate potential areas of assessment application for New Approach Methodologies (NAM) in general, and for molecular PODs (i.e., transcriptomic pathway-based). Any NAM results presented are already available in peer-reviewed publications.
Description:
The diversity of chemicals found in commerce and the environment presents a unique challenge as the vast majority have little-to-no human epidemiological or traditional experimental animal toxicity information in the public domain to support hazard identification and quantitative dose-response assessment. Specifically, data-poor chemicals are commonly unaccounted for in formal evaluations of health risks to human populations due to the lack of available points-of-departure (POD) for use in derivation of non-cancer or cancer values. New Approach Methodologies (NAM), such as structure-activity/read-across, transcriptomics, in vitro cell bioactivity, high-throughput toxicokinetics, and several other NAM platforms and approaches present a significant opportunity to expedite the assessment of chemicals both qualitatively and quantitatively. Leveraging NAM data that can readily provide structural, physicochemical, and biological information associated with pathways and processes respondent to exposure to parent chemicals and/or their metabolite(s) may facilitate hazard identification ranging from data-gap filling to pathway-based inferences for organ or tissue-based toxicity. More importantly, several NAMs provide a rapid mechanism in which in vivo dose and/or in vitro concentration-response data can be used to generate PODs for potential risk assessment applications, from basic screening and prioritization, up to NAM-based human health risk assessment. This presentation will provide current state of the science and future opportunities for applications of NAM-based PODs in regulatory chemical decision-making in the U.S. EPA. The views expressed in this presentation are those of the author and do not necessarily represent the views or policies of the U.S. EPA. The author has no conflicts of interest to disclose.
URLs/Downloads:
DOI: Quantitative Integration of NAMs into Regulatory Decision-Making: Current State of the Science
SOT 2021_MOL POD SESSION_LAMBERT_V3.PDF (PDF, NA pp, 1851.452 KB, about PDF)