Heintz MM, Kennedy SB, Brown L, Fender CL, Hecker M, Hughes SA, Naile J, DeLeo P. Toxicogenomics in ecological risk assessment: Current landscape, research gaps and recommendations to increase confidence across sectors. Abstract 1.02.T-01, SETAC North America 46th Annual Meeting, Portland, OR, November 2025.
Abstract
In recent years, toxicogenomic-based approaches (especially transcriptomics) in human health risk assessment of chemicals have been progressing rapidly. For example, the United States Environmental Protection Agency (EPA) is employing approaches such as high-throughput transcriptomics profiling and the EPA Transcriptomic Assessment Product (ETAP) for chemical prioritization and development of reference values for data-poor chemicals, respectively. In contrast, toxicogenomic applications in ecological risk assessment of chemicals are less established but there has been increasing focus on this topic in the last 5-10 years. Thus, to increase confidence and advance toxicogenomic approaches in ecological risk assessment, a landscape review of grey and peer-reviewed literature was conducted to understand current frameworks and applications for toxicogenomics in ecological risk assessment and identify research gaps that need to be addressed. To date, there are no published regulatory frameworks that call for the integration of toxicogenomics data in ecological risk assessment, albeit several jurisdictions are now allowing for inclusion of such data as additional lines of evidence. The types of toxicogenomic applications in ecological risk assessment identified during the landscape review included derivation and evaluation of the protectiveness of transcriptomic points of departure (tPODs), Adverse Outcome Pathway (AOP) refinement, chemical grouping and read-across, and hazard classification. These toxicogenomic applications were primarily published by academic and government research organizations, whereas publications from industry, contract researchers and government regulatory departments were not identified. Research on these applications has mainly focused on the incorporation of tPODs in ecological risk assessment, which show significant promise to reasonably accurately estimate apical PODs. However, critical sources of uncertainty regarding the application of tPODs to ecological risk assessment remain, including the reproducibility and variability within and across species, life stages, exposure regimens, and transcriptomic technologies. Based on learnings from this review, a case study is being developed to address some of the research gaps identified, the status of which will be presented. For the gaps not addressed by the case study, a prioritization process is underway and will be presented as a topic of discussion. Disclaimer/Disclosure: This work was supported by the American Chemistry Council.
