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Endocrine Disruptors 2011
Smithers Information Ltd, June 2011
The possible effects of chemicals on the endocrine systems of humans and the wider environment are hotly debated topics covered here.
As such, regulatory bodies around the world have been tasked with finding a workable system to identify and validate 'endocrine active disruptive substances' and to assess their effects using appropriate risk-based approaches. This has not been without controversy and the Holy Grail, it seems, is a set of clearly defined, integrated and globally harmonised test methods that minimise the need for animal testing.
According to the REACH Regulations in Europe, an Annex XV dossier has to be prepared for compounds that are carcinogenic, mutagenic, reproductively toxic, respiratory sensitisers, persistent / bioaccumulative / toxic (PBT) or of equivalent concern. While equivalent concern is somewhat unspecified, chemicals that could interact with the endocrine system would fall into that category.
In the United States, the US Congress enacted in 1996 Section 408(p) of the Food Quality Protection Act (FQPA) which directed the US Environmental Protection Agency (EPA) to develop and implement a screening program using 'validated test systems' to investigate the potential of chemicals to induce adverse health effects through endocrine pathways. This endocrine disruptor screening program (EDSP) is now underway and the manufacturers of 67 pesticides and chemicals have to date received test orders for the completion of tier 1 screening tests to be done according to the EPA's 890 test guidelines.
Since an Annex XV dossier or a positive finding from the EDSP will have far reaching consequences including use restrictions up to a total ban, the assessment of endocrine activity needs to be based on solid science starting from reliable, robust, validated and internationally harmonised screening tests up to and including an agreed upon assessment of the available data considering a weight of evidence approach.
These proceedings cover all the presentations from iSmithers’ inaugural Endocrine Disruptors 2011 conference which addressed key topics related to the evaluation of adverse effects on the endocrine system and corresponding regulatory requirements.
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