July 4, 2010 by Melanie Gross
A shift from fundamental research on endocrine disruption (ED) to a regulatory context was evident at SETAC Europe this year, with only one plenary and accompanying poster session dedicated to regulatory developments in environmental risk assessment of endocrine disruptors. Presentations and posters on more fundamental research were fitted in under other relevant sessions, such as fate and effects of pharmaceuticals or pesticides.
This shift is not surprising given the amount of research already invested into endocrine disrupting effects, and in particular the inclusion of endocrine disruption as a hazard based cut-off criterion for the approval of active substances in the revised regulations regarding the authorisation of plant protection products (Regulation (EC) No 1107/2009). However, the fundamental scientific criteria necessary to define endocrine disrupting properties are not defined yet. The new regulation specifies that the Commission shall present a draft of the measures concerning specific scientific criteria for the assessment of endocrine disrupting properties to be adopted by 14 December 2013.
In the meantime various organisations have organised workshops to develop such criteria and make recommendations. ECETOC presented an initial proposal at a workshop of invited regulatory, academic and industry scientists (Barcelona; June 29-30, 2009) to evaluate the approach as a concept for identifying endocrine disrupting properties within a regulatory context (ECETOC 2009a, b). wca were contracted to help refine the guidance following input from the workshop and prepare the guidance for publication in the open literature. The ECETOC task force presented the refined guidance for the assessment of ED in wildlife at SETAC, which was well received. This presentation was followed by the joint views developed by the German Umweltbundesamt and the Fraunhofer Institute. Although there were differences in their approach compared to that presented by ECETOC, there were also some important common elements. Specifically, these included waiving the cut-off criterion for active substances with intended endocrine mode of actions (such as insect growth regulators), the requirement to link any adverse effects on apical endpoints (such as reproduction) to a mechanistic understanding of endocrine disruption, as well as the need to consider the potency and specificity of endocrine effects.
We also presented a poster at SETAC on a practical weight of evidence evaluation for endocrine disrupting properties of plant protection products, which can be used within a framework such as that proposed by ECETOC. The WoE evaluation consists of four evaluation steps: a) Study reliability & quality of work undertaken, b) Study relevance & endpoint relevance to endocrine disruption, c) Study significance & based on the earlier assessments made for reliability and relevance, and d) Balance of the weight of evidence, coherence and gap assessment.
The German Bundesinstitut für Risikobewertung (BfR; Federal Institute for Risk Assessment) has also been active in this field and has developed a draft concept paper on “The development of a stepwise procedure for the assessment of substances with endocrine disrupting properties according to the Plant Protection Products Regulation (Regulation (EC) No 1107/2009)” based on the results of a workshop held in Berlin in 2009. BfR provided this paper as a first input for the development of a harmonised European guidance document for use by Member State authorities and EC peer review groups.
This is a developing area and the criteria that are ultimately endorsed by the EU Parliament can have serious impacts on the registration, use, trade and transport of active substances in plant protection products and it is therefore critical that these issues are addressed in a scientifically sound way. Based on the proposed revisions to the regulations concerning biocidal products [COM(2009) 267 final from 12.6.2009], the same measures addressed under Regulation (EC) No 1907/2006 concerning specific scientific criteria for the assessment of endocrine disrupting properties should be applied as cut off criteria for the approval of biocidal active substances and their products. It is therefore also important that any guidance developed is applicable under various pieces of EC legislation (chemicals under REACH, as well as active substances in pesticides and biocides).