ToxRefDB - OPP Source Documents

Public Release of DNT DERs from EPA-OPP

Development of NAMs to evaluate Developmental Neurotoxicity Data for Human Health Risk Assessment As part of an international effort, the Office of Research and Development has been developing in vitro assays to evaluate key neurodevelopmental processes for inclusion in a NAM battery for evaluating developmental neurotoxicity (DNT). In September 2020, a FIFRA SAP Peer Review meeting was held on “The Use of NAMs to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity (DNT) for Human Health Risk Assessments”. At this meeting, technical presentations were given by members of OPP and ORD on the assay development and regulatory use of the available DNT-NAM battery along with a case study demonstrating its potential application. The meeting materials are available in the Federal Register Docket Number (EPA-HQ-OPP-2020-0263) and the SAP’s report (https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0054) was released in December 2020. Currently, ORD is collaborating with European Food Safety Authority (EFSA) and other international partners to further evaluate the DNT-NAM battery. To support this work, the Agency is releasing 127 data evaluation records (DERs) of DNT potential for the chemicals studied. The DERs are publicly available here in this repository. For more information on these DERs, please see: Adopting 21st-Century Science Methodologies - Replacement Strategies | US EPA (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/adopting-21st-century-science-methodologies-0). The documents in this Clowder repository were also publicly released via the public docket located at: https://www.regulations.gov/document/EPA-HQ-OPP-2016-0093-0183