SETAC Focused Topic Meeting On Endocrine Disrupting Chemicals Outreach Statement
Jane Staveley, Exponent, Inc., Glen van der Kraak, University of Guelph, and Vickie Wilson, USEPA
More than 200 participants representing business, government and academia from ten countries attended a SETAC North America Focused Topic Meeting (FTM) from 4–6 February 2014, dealing with the issue of “Endocrine Disruption: Chemical Testing, Risk Assessment Approaches and Implications.” The primary focus of the FTM was to address the dichotomy of approaches evolving for the management of endocrine disrupting chemicals (EDCs). EDCs are defined as exogenous chemicals or mixtures that can alter the function(s) of the endocrine system and consequently cause adverse health effects in an intact organism, its progeny or (sub)populations (see also SETAC technical issue paper).
It is possible that as many as 50,000 chemicals could require assessment for their endocrine disruption potential. Results from those assessments will influence decisions concerning new chemical approvals and the handling of existing chemicals in commerce. In the US, Canada and Japan, the approach is risk-based, incorporating both the inherent hazards and exposure potential when determining risks posed by suspected EDCs. In contrast, in Europe a hazard-based approach is being discussed because there is concern among some toxicologists and endocrinologists that traditional risk assessment may not always be appropriate when considering unresolved issues including low-dose or non-threshold effects and portions of the life cycle sensitive to exposure. In the hazard-based approach, the primary focus is the intrinsic endocrine hazard of a chemical and not the effect concentration or environmental concentrations of the chemical in question.
Some attendees supported the hazard-based approach because it is precautionary in nature. They were not convinced that traditional risk assessment covers the uncertainties connected to potential no-threshold, low dose or sensitive periods of exposure and response to endocrine disruptors. However, the majority of attendees at the FTM supported the concept that EDC assessments should consider environmentally relevant exposures. It was also recognized that interactions of chemicals with endocrine receptors or alterations in endocrine response do not always result in irreversible adverse outcomes and that linkages between endocrine mediated responses and adverse outcomes such as malformations, growth, reproduction and development must be established. This was considered important despite the fact that these assessments are more costly and time consuming to conduct.
The FTM presented an opportunity to publically recognize some of the controversies surrounding the developing science around EDCs and to further the debate concerning hazard- and risk-based approaches. At this time, there is no agreement on the manner by which EDCs should be regulated, although most participants were convinced that efforts to advance our understanding of the potential impacts of EDCs need to be based on a systematic review of all available information and that agreed upon criteria be developed to evaluate these data. In the end, the FTM recommended the need for meaningful dialog between the proponents of risk- and hazard-based approaches to evaluate EDCs as this will be critical in assisting both the public and regulators on an issue that may effect both humans and wildlife.
As a follow up to the discussions held at the FTM and a preceding meeting in Brussels in 2012, a SETAC Pellston workshop is being organized for early 2016 in Pensacola, Florida, to develop scientific case studies of both environmental hazard and risk assessment approaches applied to EDCs. These will use real-world data to evaluate different assessment methods which, conducted rigorously by global experts on EDCs, would give rise to authoritative guidance to regulators.
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