On December 6, 2016 European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) informed about the release of their “Guidance on assessment and application of Adverse Outcome Pathways (AOPs) relevant to the endocrine system.” The Adverse Outcome Pathway (AOP) framework is used to organize data on the sequence of biological events leading to adverse effects (more information on AOPs: FPF background article). The ECETOC guidance document sees AOPs as a potential tool to identify and regulate endocrine disruptors by linking observed adverse outcomes with endocrine mechanisms and by predicting “the potential for an adverse outcome in vivo based on the results of in vitro mechanistic data.” AOPs that are able to fulfill these requirements need to be sufficiently robust and fit for purpose, the authors of the report claim. This report also provides a list of key elements and the minimum scientific standards allowing the use of a defined AOP in e.g. hazard identification, read-across and risk assessment, illustrated by a case study.
On December 7, 2016 the Pesticide Action Network (PAN) Europe announced the publication of their new report on non-animal testing prediction systems (NATPS) entitled “AOP, the Trojan horse for industry lobbying tools?”. The AOP concept is valuable for scientific research and our understanding of toxicity and diseases by linking the effect of a chemical on a biological target with certain defined key events and finally an adverse outcome, PAN Europe summarizes. However, the report strongly advises against the use of AOPs as a final decision-taking tool in risk assessment, because in the foreseeable future AOPs cannot guarantee the high level of protection that is required under EU law. PAN Europe lists examples of “actual use and misuse of AOP,” covers possible conflicts of interest, and warns of industry lobbying in favor of AOPs. The report finishes with a list of 12 recommendations regarding the correct use of the AOP concept.
ECETOC (December, 2016). “Guidance on assessment and application of Adverse Outcome Pathways (AOPs) relevant to the endocrine system.” Technical Report No. 128 (pdf)
PAN Europe (December 7, 2016). “Misuse of new non-animal testing strategy’s, PAN Europe report warns.”
PAN Europe (December, 2016). “AOP, the Trojan horse for industry lobbying tools?” (pdf)