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Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances

March 1, 2017

A SETAC Pellston Workshop® “Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)” was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS—not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk assessment of EDS is scientifically sound and sufficiently reliable and protective of the environment. In the absence of such data, assessment on the basis of hazard is scientifically justified until such time as relevant new information is available.

Publication Year 2017
Title Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances
DOI 10.1002/ieam.1885
Authors Peter Matthiessen, Gerald T. Ankley, Ronald C. Biever, Poul Bjerregaard, Christopher Borgert, Kristin Brugger, Amy Blankinship, Janice Chambers, Katherine K. Coady, Lisa Constantine, Zhichao Dang, Nancy D. Denslow, David Dreier, Steve Dungey, L. Earl Gray, Melanie Gross, Patrick D. Guiney, Markus Hecker, Henrik Holbech, Taisen Iguchi, Sarah Kadlec, Natalie K. Karouna-Renier, Ioanna Katsiadaki, Yukio Kawashima, Werner Kloas, Henry Krueger, Anu Kumar, Laurent Lagadic, Annegaaike Leopold, Steven L. Levine, Gerd Maack, Sue Marty, James P. Meador, Ellen Mihaich, Jenny Odum, Lisa Ortego, Joanne L. Parrott, Daniel Pickford, Mike Roberts, Christoph Schaefers, Tamar Schwarz, Keith Solomon, Tim Verslycke, Lennart Weltje, James R. Wheeler, Mike Williams, Jeffery C. Wolf, Kunihiko Yamazaki
Publication Type Article
Publication Subtype Journal Article
Series Title Integrated Environmental Assessment and Management
Index ID 70194268
Record Source USGS Publications Warehouse
USGS Organization Patuxent Wildlife Research Center