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Revision of OECD Guidelines for Genotoxicity Testing: Current Status and Next Steps
Citation:
Schoeny, R., V. Thybaud, J. Van benthem, N. Delrue, G. Douglas, E. Lorge, D. Lovell, AND T. Singer. Revision of OECD Guidelines for Genotoxicity Testing: Current Status and Next Steps. Environmental Mutagenesis and Genomics Society 45th Annual Meeting, Orlando, FL, September 13 - 17, 2014.
Impact/Purpose:
EPA has a long history of active collaboration in the development of the Organisation for Economic Co-operation and Development (OECD) Test Guidelines (TG) and other products. This abstract describes the process of updating several TG as well as the progress in producing new TG and guidance documents.
Description:
Over the past 30 years, assays have been developed to evaluate chemical genotoxicity. OECD Genotoxicity Test Guidelines (TG) describe assay procedures for regulatory safety testing. Since the last OECD TG revision (1997), there has been tremendous scientific and technological progress on assay performance and understanding of underlying mechanisms. To improve regulatory assay performance and data interpretation, OECD began updating TGs in 2010. OECD identified Canada, Netherlands, France and USA as lead countries and established an international Expert Group (EG). The EG recommended deletion of several TGs, including assays in yeast and Drosophila, as mammalian cell assays are considered more relevant. TG were revised to 1) improve clarity and consistency; 2) improve statistical power; 3) refine methodology to improve relevance of results; and 4) provide up-to-date recommendations for acceptability criteria and data interpretation. In April 2014 the OECD Working group of National Coordinators of the Test Guidelines Programme approved revised TGs for in vitro and in vivo micronucleus (TG487, TG474), and chromosomal aberration tests (TG473, TG475), and a new TG for in vivo Comet assay. Next steps are these: 1) revision of TGs for in vivo germ cell and in vitro mammalian gene mutation tests; 2) updating the Introduction Document, providing a TG overview and background for the recent updates; 3) a Guidance Document on assay strengths and weaknesses, weight of evidence approaches, and data interpretation; 4) a new TG on in vitro TK mutation assay. The opinions are the authors and do not necessarily reflect policies of US EPA.