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Applying ‘omics technologies in chemicals risk assessment: Report of an ECETOC workshop
Citation:
Buesen, R., B. Chorley, B. da Silva Lima, G. Daston, L. Deferme, T. Ebbels, T. Gant, A. Goetz, J. Greally, L. Gribaldo, J. Hackermuller, B. Hubesch, D. Jennen, K. Johnson, J. Kanno, H. Kauffmann, M. Laffont, P. McMullen, R. Meehan, M. Pemberton, S. Perdichizzi, A. Piersma, U. Sauer, K. Schmidt, H. Seitz, K. Sumida, K. Tollefsen, W. Tong, T. Tralau, B. VanRavenzwaay, R. Weber, A. Worth, C. Yauk, AND A. Poole. Applying ‘omics technologies in chemicals risk assessment: Report of an ECETOC workshop. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 91:s3-s13, (2017). https://doi.org/10.1016/j.yrtph.2017.09.002
Impact/Purpose:
’Omics technologies hold the promise of generating comprehensive toxicologically relevant information on molecular changes in cells and tissues more quickly, more accurately and with less resources than ever before. They provide approaches to precisely measure substance-induced molecular perturbations that are associated with adverse outcomes in animals and humans. Thereby, these emerging technologies have the potential to improve chemical safety assessment and, at the same time, to refine and reduce animal testing in regulatory toxicology. However, in addition to prevailing knowledge gaps in linking specific molecular changes to apical outcomes, current methodological uncertainties in interpreting and assessing data limit the application of ‘omics technologies in regulatory toxicology. This includes issues surrounding the generation, storage, processing, and interpretation of ‘omics data, as well as a lack of experience with such kind of data across the regulatory community. Hence, best practices for generating, storing, processing, and interpreting ‘omics data are needed as one starting point so that the outcomes of ‘omics-based studies can be reliably verified and confidently integrated into regulatory hazard and risk assessment. Against this background, the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) convened a workshop entitled Applying ‘omics technologies in chemicals risk assessment that took place from 10-12 October 2016 in Madrid, Spain. Thirty-six invited experts from Europe, Canada, Japan, and the United States, attended this workshop representing the European Commission; the Organisation for Economic Cooperation and Development (OECD); national authorities from EU Member States, EU associated countries and North America; academia; industry and independent consultants. The 2016 ECETOC workshop, reported in this paper, was conceived to contribute to fulfilling the recommendations from previous ECETOC workshops on the Application of ‘omic technologies in toxicology and ecotoxicology: Case studies and risk assessment (ECETOC, 2008), ‘Omics in (eco)toxicology: case studies and risk assessment (ECETOC, 2010), and ‘Omics and risk assessment science (ECETOC, 2013). The recommendations from these workshops addressed the need to define quality standards on the design and performance of ‘omics-based studies and to communicate these quality standards as best practices. Such guidance would serve to enhance the regulatory acceptance and use of ‘omics data.
Description:
Prevailing knowledge gaps in linking specific molecular changes to apical outcomes and methodological uncertainties in the generation, storage, processing, and interpretation of 'omics data limit the application of 'omics technologies in regulatory toxicology. Against this background, the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) convened a workshop Applying 'omics technologies in chemicals risk assessment that is reported herein. Ahead of the workshop, multi-expert teams drafted frameworks on best practices for (i) a Good-Laboratory Practice-like context for collecting, storing and curating 'omics data; (ii) the processing of 'omics data; and (iii) weight-of-evidence approaches for integrating 'omics data. The workshop participants confirmed the relevance of these Frameworks to facilitate the regulatory applicability and use of 'omics data, and the workshop discussions provided input for their further elaboration. Additionally, the key objective (iv) to establish approaches to connect 'omics perturbations to phenotypic alterations was addressed. Generally, it was considered promising to strive to link gene expression changes and pathway perturbations to the phenotype by mapping them to specific adverse outcome pathways. While further work is necessary before gene expression changes can be used to establish safe levels of substance exposure, the ECETOC workshop provided important incentives towards achieving this goal.
URLs/Downloads:
DOI: Applying ‘omics technologies in chemicals risk assessment: Report of an ECETOC workshop