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International Consortium to Advance Cross Species Extrapolation in Regulation (ICACSER)
Citation:
LaLone, C., N. Basu, P. Browne, S. Edwards, M. Embry, F. Sewwll, AND G. Hodges. International Consortium to Advance Cross Species Extrapolation in Regulation (ICACSER). Informal meeting with SETAC and SOT leadership, Duluth, MN, November 29, 2021. https://doi.org/10.23645/epacomptox.18737201
Impact/Purpose:
Presentation to an informal meeting with SETAC and SOT leadership (December 2021). This presentation will provide an overview of a developing International Consortium to Advance Cross Species Extrapolation in Regulation (ICACSER) to the leadership of the Society of Environmental Toxicology and Chemistry and Society of Toxicology Specialty Sections. The presentation is intended to inform the professional societies of the objectives of ICACSER and develop a collaboration between the societies in advancing these objectives.
Description:
Regulatory decisions surrounding chemical safety include human and environmental protection. Historically, there has been a reliance on animal toxicity testing to inform hazard and risk assessment. Typically, mammalian data drive human health considerations and studies from select non-mammalian species representing different taxa drive environmental considerations, with little if any crosstalk between the knowledge-streams. The global regulatory landscape is experiencing an evolution in thinking surrounding animals in toxicity testing, eliminating or greatly reducing their use in toxicology. Therefore, the data landscape is also changing, requiring greater use of mechanistic, cell-based, and computationally derived information for consideration as alternatives to animal testing. To establish confidence in mechanistic data and provide evidence as to how it relates to apical level changes at an individual or population level, the adverse outcome pathway (AOP) framework is being adopted. The AOP framework has been described as an approach for developing causal linkages between levels of biological organization allowing for prediction of adverse effects. Such pathway-based approaches provide opportunities to incorporate data generated from all species to understand the biology to mutually inform both human and environmental safety, using mammalian data to provide insights to non-mammalian species and vice versa. In fact, a critical component of the AOP framework is determining the taxonomic domain of applicability. There are several parameters that dictate the sensitivity of an organism to perturbation at the various levels of biological organization, such as pathway conservation, toxicokinetics/toxicodynamics, life history, life stage, etc. Therefore, an emphasis on conservation (or lack thereof) of the biology across species for the purpose of understanding how broadly available knowledge can be extrapolated is a logical first step in addressing this challenge. Fortunately, the shifting paradigm in toxicity testing has inspired the use of bioinformatics and specifically the development of tools and workflows for computationally exploring and predicting the taxonomic relevance of existing and newly generated toxicity data and knowledge across species. To date, a number of these methods/tools (e.g., SeqAPASS, EcoDrug, phylogenetic workflows) have been released to the public, peer-reviewed, and published. However, there is a growing recognition that although each tool brings important information to the challenge of cross-species extrapolation, no individual method is capable of advancing the science and use of these types of data in regulatory decision-making if created in a silo. Therefore, an expert consortium has been established to advance the science of cross-species extrapolation using bioinformatic techniques, as a critical first step, to inform regulatory needs. Mission Statement Advance cross species extrapolation to inform regulation with the specific goal to deliver a platform for sharing and integrating data-streams from bioinformatic approaches enabling the creation of a toolbox, aligning with the existing adverse outcome pathway (AOP) framework and developing AOP Knowledgebase Characteristics of consortium The consortium aims to incorporate a diversity of expertise that represent the tripartite nature of the challenges faced in species extrapolation. Participants will be those motivated to advance this area of science in a collaborative and inclusive manner. It is anticipated that participants will be representatives from government (researchers, regulators, policy-makers), academia, industry, non-government organizations, communicators and social scientists.
URLs/Downloads:
DOI: International Consortium to Advance Cross Species Extrapolation in Regulation (ICACSER)
INTERNATIONAL CONSORTIUM TO ADVANCE CROSS SPECIES EXTRAPOLATION.PDF (PDF, NA pp, 679.294 KB, about PDF)