State of the science on assessing developmental neurotoxicity using new approach methods
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Abstract
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.
Plain language summary
Chemicals present in the environment that result in human exposure may alter key biological processes during the development of the human brain. This may contribute to learning disabilities, behavioral disorders, and neurological impairments that are associated with conditions such as autism and attention deficit hyperactivity disorder. Only a few chemicals have been evaluated for such effects in animals, and it is unclear how well animal studies predict human conditions. The workshop brought together stakeholders from international organizations, governmental agencies, industry, and academia to discuss the transition to non-animal tests and other novel approaches to evaluate potential neurodevelopmental effects of chemicals which are more ethical and provide more human-relevant information. The capabilities and limitations of current alternative tests were discussed, and critical next steps to advance the field were outlined.
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