State of the Science on Assessing Developmental Neurotoxicity Using New Approach MethodsUS FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
Swiss Ctr Appl Human Toxicol, Basel, Switzerland.;DNTOX GmbH, Dusseldorf, Germany.;IUF, Leibniz Res Inst Environm Med, Dusseldorf, Germany..
Univ Washington, Seattle, WA USA..
Johns Hopkins Univ, Ctr Alternat Anim Testing CAAT, Baltimore, MD USA.;Univ Konstanz, CAAT Europe, Constance, Germany..
Natl Inst Environm Hlth Sci, NIH, Durham, NC USA..
US FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
European Food Safety Author, Pesticides Peer Review Unit, Parma, Italy..
Dow Chem Co USA, Midland, MI 48674 USA..
US FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
US Environm Protect Agcy, Off Pesticide Programs, Washington, DC USA..
US FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
Org Econ Cooperat & Dev, Environm Directorate, Environm Hlth & Safety Div, Paris, France..
US Environm Protect Agcy, Ctr Computat Toxicol & Exposure, Off Res & Dev, Res Triangle Pk, NC USA..
Johns Hopkins Univ, Ctr Alternat Anim Testing CAAT, Baltimore, MD USA..
US FDA, Natl Ctr Toxicol Res, JEFFERSON, AR 72079 USA..
Oregon State Univ, Sinnhuber Aquat Res Lab, Corvallis, OR USA..
European Food Safety Author, Pesticides Peer Review Unit, Parma, Italy..
US FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
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2025 (English)In: Altex, ISSN 1868-596X, E-ISSN 1868-8551, Vol. 42, no 1, p. 121-144
Article in journal (Refereed) Published
Abstract [en]
The workshop titled State of the Science on Assessing Developmental Neurotoxicity Using New Approach Methods was co-organized by University of Maryland’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN; now called the Human Foods Program), and was hosted by FDA in College Park, MD on November 14-15, 2023. This event convened experts from international organizations, governmental agencies, industry, and academia to explore the transition from traditional in vivo tests to innovative new approach methods (NAMs) in developmental neurotoxicity (DNT) testing. The discussions emphasized the heightened vulnerability of the developing human brain to toxic exposures and the potential of NAMs to provide more ethical, economical, and scientifically robust alternatives to traditional testing. Various NAMs for DNT were discussed, including in silico, in chemico, in vitro, non-mammalian whole organisms, and novel mammalian approaches. In addition to progress in the field, the workshop discussed ongoing challenges such as expectations to perfectly replicate the complex biology of human neurodevelopment and integration of DNT NAMs into regulatory frameworks. Presentations and panel discussions provided a comprehensive overview of the state of the science, assessed the capabilities and limitations of current DNT NAMs, and outlined critical next steps in advancing the field of DNT testing.
Place, publisher, year, edition, pages
ALTEX Edition , 2025. Vol. 42, no 1, p. 121-144
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-551603DOI: 10.14573/altex.2410231ISI: 001416960200009PubMedID: 39675048Scopus ID: 2-s2.0-85215668052OAI: oai:DiVA.org:uu-551603DiVA, id: diva2:1941175
Funder
EU, Horizon 2020, 825759EU, Horizon 2020, 963845EU, Horizon Europe, 101057014German Research Foundation (DFG), 507269789NIH (National Institutes of Health), K99 ES031050NIH (National Institutes of Health), R35 ES0317092025-02-272025-02-272025-02-27Bibliographically approved