October 08 and 09, 2018 - Conference
October 10, 2018 - Workshop
Berlin, Germany

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Wednesday, 18th October 2017

8.30 Reception and Coffee

9.00 to 16.30
Gaining Experience with the Performance of Hazard Assessment of Endocrine Active Substances

Breaks will be arranged flexibly.

About Your Workshop Leaders

Annegaaike Leopold is an ecotoxicologist, now working as a consultant in the field of science communication as well as endocrine and regulatory ecotoxicology, building on 25 years of involvement in ecotoxicology and contract laboratory research with a specific focus on birds and the development of scientifically sound, ethically defensible, resource friendly test methods. Her previous roles have included that of Director of European and subsequently Global Business Development at Wildlife International, now part of EAG, Inc. Preceding these roles she set up and ran the avian toxicology laboratory at NOTOX (now WIL Research) and managed the aquatic toxicology laboratory before that. She has been heavily involved in developing (endocrine) test methods in birds, fish and terrestrial organisms as a member of OECD working groups. Annegaaike has organised and co-chaired a SETAC Europe Special Symposium (in 2012) and a SETAC North America Focused Topic Meeting (in 2014) on Endocrine Testing and Evaluation and a SETAC Pellston Workshop on Environmental Hazard and Risk Assessment of Endocrine Active Substances in 2016. She was corresponding guest editor of the 5 papers that emanated from this workshop and were published in IEAM in March of 2017.

Peter Matthiessen is a UK-based self-employed consultant in aquatic ecotoxicology with 40 years of experience in conducting research on, and providing advice about, the effects of aquatic pollution. His major research interests are endocrine disruption and its ecosystem impacts. Peter is the author of about 140 research publications and major reports, and has experience both in the environmental risk assessment of pesticides and other chemicals and in design and operation of environmental monitoring for chemical effects, and in the development of environmental quality standards. He has owned a strong advisory role in bodies such as Defra, EA, HSE, OECD and EFSA.

Content of the Workshop

The purpose of the workshop is to make participants familiar with the steps that need to be taken when evaluating an endocrine disrupting substance (EDS). Participants will be guided through the process of making a scientifically sound decision on whether an EDS can be safely regulated in the basis of risk assessment or alternatively, whether a more conservative approach is required in the form of regulation on the basis of hazard alone.

During the first part of the day the steps to be gone through from data collection to weight of evidence assessment to hazard characterisation will be dealt with. After exposure estimates have been incorporated differences are then discussed between hazard and risk-based decisions. One or more of the case studies worked through in preparation of the SETAC Pellston workshop on Endocrine Hazard and Risk Assessment of Endocrine Active Substances (EHRA) will be used as examples.

During the second part of the workshop participants will learn to work with a series of questions that need to be answered in order to determine whether there is a sufficiently sound scientific basis to perform an ecotoxicological risk assessment whether a hazard assessment only should be undertaken.

The subject of the third part of the workshop will be examples of uncertainties that may influence a hazard or risk assessment and hence the regulation of an EDC and how to deal with these uncertainties. Examples of uncertainties that will be discussed include 1) in vivo studies with apical endpoints: delayed effects; 2) in vitro and in vivo studies: non-monotonic dose relationships and the presence or absence of thresholds; extrapolation from studies in individual organisms to the population level.

The final part of the workshop will deal with examples of one or more data sets in which we do not have sufficient data to make a firm judgement about the feasibility of doing a risk assessment.


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