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Endocrine Disruptors: International Fresenius Conference discusses test methods and legal regulations both inside and outside Europe

The effects of endocrine disruptors – chemicals that can influence the hormone system – have been a topic of discussion for quite some time. In July, the EU Member States agreed on a proposal presented by the European Commission that deals with the identification of endocrine disruptors in connection with plant protection and biocidal products. So what exactly does this mean for the consumer, the operator and the pesticide industry? The international Akademie Fresenius “Endocrine Disruptors” conference, which took place in Cologne on 29 and 30 November, set out to find answers to just this question. The organisers had succeeded in signing up a range of high-profile experts from the industry, the European Commission, the Organisation for Economic Co-operation and Development (OECD) and the United States Environmental Protection Agency (EPA).

This international Fresenius conference provided an overview of the legal situation and the varying positions to be found in the different industries, fields of application and Member States. Apart from the latest reports from Brussels, the presentations focussed on the discussions surrounding new test and calculation methods.

Laura Fabrizi of the European Commission provided a summary of where the European regulatory framework for dealing with endocrine disruptors within the EU regulation for pesticides and biocides currently stands. The scientific criteria to identify endocrine disruptors for biocides will enter into force on 7 December and become applicable on 7 June 2018. At the Standing Committee for Plant, Animal, Food and Feed meeting the 12 and 13 December, the criteria to identify endocrine disruptors for pesticides will be tabled for discussion and possible vote. For Fabrizi, the European Commission is pioneering this topic: It is the first time worldwide that criteria identifying endocrine disruptors are set for regulatory purposes. The draft guidance to identify endocrine disruptors, which is being developed by the European agencies ECHA and EFSA with the support of the European Commission Joint Research Centre, is expected to be published for public consultation on 7 December 2017.

Revision of OECD’s guidance document on endocrine disruptors to be published in 2018

Guidance document 150, developed by the OECD (Organisation for Economic Co-operation and Development) in 2012, is an important decision-making aid for scientists and the authorities when examining chemicals for endocrine disruptors. The OECD has defined an approach to assessing endocrine disruptors (The OECD Conceptual Framework) which is divided into five different levels. The test guidelines for endocrine disruption are contained within the Conceptual Framework, which is designed to be flexibly interpreted within the context of the many different legal provisions, policies and practices. OECD Guidance Document 150 provides guidance on the test guidelines, including recommendations and descriptions of the test methods, thus contributing to the harmonisation of testing requirements at supranational level. This year, Guidance Document 150 has been revised. A new version is due to be published in 2018. During the Fresenius conference, Patience Browne of the OECD and the British consultant, Jenny Odum, reported on the revision status and the changes that are going to be taking effect in the new version. This new version will also be including numerous new analytical approaches. Patience Browne pointed out that the large number of new test procedures had also considerably helped to improve the general understanding of the effects of endocrine disruptors. She said that the nations now faced the joint task of ensuring that new, alternative approaches were compatible with the OECD resolution on the Mutual Acceptance of Data (MAD) for assessing chemical substances. 

SeqAPASS: Online tool of the United States Environmental Protection Agency aimed at facilitating the extrapolation of results across species

Carlie A. LaLone of the United States Environmental Protection Agency (EPA) presented the online screening tool SeqAPASS (= Sequence Alignment to Predict Across Species Susceptibility) at the Fresenius conference. This tool is aimed at helping researchers and regulators to extrapolate toxicity information across species. For some species, such as humans, mice, rats, and zebrafish, the EPA has a large amount of data regarding their toxicological susceptibility to various chemicals.  However, there is still not enough data available for other plants and animals. SeqAPASS allows extrapolation to other species in order to evaluate their chemical susceptibility. SeqAPASS achieves this by evaluating the similarities of amino acid sequences and protein structures to identify whether a protein target is present for a chemical interaction. 

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