DIE AKADEMIE FRESENIUS Where Experts Meet! 12 and 13 November 2019 in Frankfurt/Germany Endocrine Disruptors 10 th International Akademie Fresenius Conference The Experts Andrew Adams ECPA ED Expert Group | Alan Breen Irish Department of Agriculture, Food and the Marine | Natalie Burden British National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) | Antonio Conto Chemsafe | ZhiChao Dang Dutch National Institute for Public Health and the Environment (RIVM) | Milou Dingemans KWR Watercycle Research Institute | Martina Duft knoell Germany | Annegaaike Leopold Calidris Environment | Melanie Lichtenberger ibacon | Emily McVey Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Katie Paul Friedman U.S. Environmental Protection Agency (EPA) | Maristella Rubbiani European Commission | Susanne Smolka Pesticide Action Network (PAN) Germany | Gerard Swaen Maastricht University | Lennart Weltje BASF | Michael Werner Consultant | James Wheeler Shell International | Daniel Zalko French National Institute for Agricultural Research (INRA) Highlights Regulation on Biocides and Pesticides in Europe • Latest updates from the EU Commission and the ECHA ED Expert Group • Implementation of the ED criteria: Member State, industry and NGO view • Practical experiences and recommenda- tions for applicants Endocrine Testing in Aquatic Vertebrates • Overview on test methods: FSTRT, MEOGRT and LAGDA • Effects of thyroid disruption in fish including AOPs Human Health Aspects • U.S. EPA on predictions of endocrine hazard and risk based on ToxCast • ED assessment from a human health perspective – actual vs target conditions Pharmaceuticals • ED properties assessment for drug actives Communication and Monitoring • Understanding the challenges of communicating the risks of endocrine disrupting chemicals and a way towards more transparency • Water quality management in the Netherlands and innovative monitoring approaches
Transcript
DIE AKADEMIE FRESENIUS Where Experts Meet!
12 and 13 November 2019 in Frankfurt/Germany
Endocrine Disruptors10th International Akademie Fresenius Conference
The Experts
Andrew Adams ECPA ED Expert Group | Alan Breen Irish Department of Agriculture, Food and the Marine | Natalie Burden British National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) | Antonio Conto Chemsafe | ZhiChao Dang Dutch National Institute for Public Health and the Environment (RIVM) | Milou Dingemans KWR Watercycle Research Institute | Martina Duft knoell Germany | Annegaaike Leopold Calidris Environment | Melanie Lichtenberger ibacon | Emily McVey Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Katie Paul Friedman U.S. Environmental Protection Agency (EPA) | Maristella Rubbiani European Commission | Susanne Smolka Pesticide Action Network (PAN) Germany | Gerard Swaen Maastricht University | Lennart Weltje BASF | Michael Werner Consultant | James Wheeler Shell International | Daniel Zalko French National Institute for Agricultural Research (INRA)
Highlights
Regulation on Biocides and Pesticides in Europe
• Latest updates from the EU Commission and the ECHA ED Expert Group
• Implementation of the ED criteria: Member State, industry and NGO view
• Practical experiences and recommenda-tions for applicants
Endocrine Testing in Aquatic Vertebrates
• Overview on test methods: FSTRT, MEOGRT and LAGDA
• Effects of thyroid disruption in fish including AOPs
Human Health Aspects
• U.S. EPA on predictions of endocrine hazard and risk based on ToxCast
• ED assessment from a human health perspective – actual vs target conditions
Pharmaceuticals
• ED properties assessment for drug actives
Communication and Monitoring
• Understanding the challenges of communicating the risks of endocrine disrupting chemicals and a way towards more transparency
• Water quality management in the Netherlands and innovative monitoring approaches
Tuesday, 12 November 2019
8.30 Registration and coffee
9.00 Welcome address by Akademie Fresenius and introduction by the Chair
Lennart Weltje, BASF, Germany
Regulation on Biocides and Pesticides in Europe9.10 Criteria for ED identification under EU Regulations on plant protection products and on biocidal products – implementation and current status
• The European Commission strategy for ED • Application of the guideline• Next steps and future perspective
Maristella Rubbiani, European Commission, DG SANTE, Belgium
9.35 Member State view on the implementation of the criteria for endocrine disruptors
Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands
10.00 Implementation of ED criteria in the ECHA ED Expert Group
• Rigid application of the guidance or weight of evidence
• ECHA vs EFSA similar approaches? • REACH and future prospects
Alan Breen, Department of Agriculture, Food and the Marine, Ireland
10.25 Coffee break
10.55 Effective regulation of endocrine disruptors? A critical view after one year of implementation
• Implementation of ED criteria in EU legislation • Priorities for improving and speeding up ED regulation• Beyond pesticide & biocide policy – the need for a
11.20 Implementation of the new criteria for endocrine disruptors – industry view
• Learning from experience• Weighing the evidence – the heart of the matter• Communication and transparency
The Programme• Future prospects and implications for other chemical
sectors
Andrew Adams, ECPA ED Expert Group, France
11.45 Practical experiences with the implementation of the ED guidance
• Requirements, challenges and first experiences• ED assessment of actives and biocidal products,
co-formulant screening approach• Testing vs non-testing – what is “sufficiently investi-
gated”?• Practical implications and regulatory consequences• Recommendations for applicants
Martina Duft, knoell Germany
12.10 Panel discussion13.00 Lunch
Endocrine Testing in Aquatic Vertebrates14.30 The Fish Short Term Reproduction Test (FSTRT): performance, interpretation and limitations
• The FSTRT as a key assay for the detection of estrogen, androgen and steroidogenic activity
• Analysis of a historical control database of 49 studies • Elements of test design and interpretation in context
with the historical data
James Wheeler, Shell International, The Netherlands
14.55 Effects of thyroid disruption in fish
• Central and peripheral control of thyroid hormones • Effects of thyroid disruption in fish including AOPs• Testing and identification of thyroid disruptors
ZhiChao Dang, National Institute for Public Health and the Environment (RIVM), The Netherlands
15.20 Coffee break
15.50 Experiences in conducting amphibian assays
• Insight into practical experiences in conducting tests on Xenopus laevis
• Limits and possibilities for each test design
Melanie Lichtenberger, ibacon, Germany
16.15 Conducting MEOGRT and LAGDA: challenges and 3Rs implications
• Why consider the 3Rs?• Implications of conducting MEOGRT and LAGDA on
animal use• Addressing the challenges
Natalie Burden, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), United Kingdom
16.40 Panel discussion17.10 End of first day
Get-together on Monday,11 November 2019Will you arrive on Monday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.
18.15 Departure time for the evening event
Wednesday, 13 November 2019
8.30 Welcome address by the Chair
Emily McVey, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands
Human Health Aspects8.40 An update on public tools for prediction of endocrine hazard and risk
• Assessment of available in silico and in vitro data and predictions based on ToxCast
• Use of high-throughput toxicokinetic data and models • Endocrine bioactivity exposure ratio (BER)
Katie Paul Friedman, U.S. Environmental Protection Agency (EPA), United States of America
9.05 ED assessment from a human health perspective – actual vs target conditions
• Requirements of the ECHA/EFSA ED guidance document• Update of information requirements using biocides as
an example• Tiered testing strategies: another “mega mouse study“
vs animal welfare?• Considerations on mode of action and AOPs
Michael Werner, Consultant, Germany
9.30 The real causes for the risen trends in endocrine related diseases
• Overview on increased diseases and health parameters• Endocrine disruption theory• Impact of changes in human reproduction
Gerard Swaen, Maastricht University, The Netherlands
9.55 Coffee break
Risk Communication10.25 The challenges of communicating about risk in relation to (environmental) endocrine disrupting substances
• Who communicates to/with whom in the science – policy – public interface and how?
• Conflicting views among endocrine disruptor experts: a major challenge to effective stakeholder communication
• Working towards more transparency for the benefit of better communication
Annegaaike Leopold, Calidris Environment, The Netherlands
10.50 Panel discussion
Pharmaceuticals11.20 Environmental impact of active pharmaceutical ingredients (API) and their ED properties
• Pharmaceuticals in the environment (PIE): a matter of concern
• Environmental risk assessment (ERA) of active pharmaceutical ingredients: the scientific approach
• European Medicines Agency (EMA) guidance 2006 and its ongoing revision
• ED properties assessment for drug actives
Antonio Conto, Chemsafe, Italy
11.45 Short break
Monitoring12.00 Contaminants of emerging concern in the water cycle
• Water quality management in the Netherlands• Risk-based monitoring and innovative monitoring
approaches• Bioassays for water quality
Milou Dingemans, KWR Water Research Institute, The Netherlands
Outlook on new Research Projects12.25 New EU Horizon 2020 ED projects: GOLIATH and the EURION Cluster• Overview and objectives of the EURION Cluster• The GOLIATH project• First research outcomes
Daniel Zalko, French National Institute for Agricultural Research (INRA), France
12.50 Panel discussion13.20 Lunch and end of the conference
At the end of the first conference day Akademie Fresenius invites you to a leisurely evening at the restaurant “Daheim im Lorsbacher Thal” in Frankfurt. You have the opportunity of better getting to know other participants you met during the day over a relaxed meal. Don’t miss out on this opportunity!
Information available online at: www.akademie-fresenius.com/2719
The ExpertsAndrew Adams has many years of
experience working in European regulatory affairs for biocides and moved into a public and governmental affairs role at Bayer CropSci-ence in 2014 where he is
now the Global Issues Lead for Insecti-cides and Fungicides. With specific focus on endocrine disruptors, he currently represents Crop Life International and the ECPA as Chair of their ED Expert Groups.
Alan Breen is a Regulatory Toxicologist working with the Department of Agriculture, Food and the Marine of Ireland. He has 25 years of experience in the area of chemical safety
evaluation and risk assessment and is also a member of the ECHA ED Expert Group.
Natalie Burden has led a programme of work at the NC3Rs dedicated to advancing the application of the 3Rs in toxicology and regulatory sciences since 2014. She leads projects to support
changes in policy and practice and identify opportunities within regulatory frameworks to reduce, refine and replace animal use.
Antonio Conto is the founder of Chemsafe and has over 28 years of post-gradu-ate experience, mainly in risk assessment and regulatory toxicology for chemical and pharmaceutical
companies. Nowadays, his role is mainly focused on managing Chemsafe and reviewing toxicology/safety expert reports.
ZhiChao Dang is an EU Registered Toxicologist and works as a Senior Risk Assessor and Project Leader at RIVM. He has been involved in the development of EU and OECD documents on
endocrine disruptors as well as the development of OECD test guidelines.
Milou Dingemans has over 15 years of experience in scientific research on the harmful effects of the exposure to chemicals on health and has been a Researcher and Toxicologist in the
Chemical Water Quality and Health Team at KWR Watercycle Research Institute since 2016. She is active in the develop-ment, validation and implementation of innovative test methods (such as bioassays) and risk assessment tech-niques.
Martina Duft is a Senior Expert Regulatory Ecotoxicolo- gist at knoell Germany and is the coordinator of the knoell ED expert team and key contact for the topic endocrine disruptors. After several
years in ED related research, she has worked for over 15 years in various regulatory sectors with a focus on ecotoxicology and regulatory affairs.
Annegaaike Leopold is a Biologist by training and has 30 years of experience in the applied regulatory ecotoxicology field. She has contributed to environmental endocrine disruptor test
guidelines and has worked on hazard and risk assessment of endocrine disruptors.
Melanie Lichtenberger holds a PhD in biology with a focus on ecotoxicology. During her PhD and work as a Study Director in aquatic ecotoxicology she was involved in conducting endocrine
studies in the lab. Currently she works at ibacon as Head of Test Facility and is also involved in the hazard identification of endocrine disruptors.
Emily McVey is an experienced Regulatory Toxicologist and works as a Risk Assessor in ecotoxicolo-gy at the Ctgb. Her specialties include environmental toxicology, wild
vertebrates, molecular mechanisms of toxicity, neurodevelopmental toxicity and endocrine disruption testing and assessment.
Katie Paul Friedman joined the National Center for Computa-tional Toxicology in the Office of Research and Development at the U.S. EPA in August 2016, where she is currently focused on integration
of multiple information streams to address the needs of preliminary risk assessment, with additional interests in uncertainty in alternative and traditional toxicity information, endocrine bioactivity prediction and in vitro kinetics.
Maristella Rubbiani is Policy Officer at the European Commis-sion and responsible for ED issues and coformu-lants. Previously, she worked at the Italian Competent Authority in charge of the imple-
mentation of the regulation for biocides and PPPs.
Susanne Smolka is an Ecotoxicologist and works as a Senior Policy Advisor for the German Pesticide Action Network (PAN Germany). She accompanied the revision and implemen-
tation of the EU pesticide and biocide legislation over the past 17 years with the main focus on improving the regulation of substances of high concern such as endocrine disruptors.
Gerard Swaen is an Associate Professor at Maastricht University and an Occupational Epidemiologist with a specific interest in the potential health effects from exposure to chemicals. He has
conducted epidemiology studies on chemicals such as acrylonitrile, carbon disulphide, coal tar, coke factories.
Lennart Weltje holds a PhD in ecotoxico- logy and environmental chemistry and currently works as a Senior Ecotoxicologist at BASF conducting risk assessments for PPPs and biocides. His former
stations include the Dutch National Institute for Public Health and the Environment (RIVM).
Michael Werner is a Chemist and Eurotox Registered Toxicologist with an over 20 years track record in hazard, exposure and risk assessments. In his present role as a Senior
Expert Regulatory Toxicology Biocides and Assistant to the Managing Director, he leads a small biocides group and provides regulatory as well as scientific/technical advice to clients for the preparation of biocidal active substance/product dossiers.
James Wheeler works as an Ecotoxicolo-gist for Shell Interna-tional. His work focuses on environmental risk assessment and ecotoxicology testing. He has a particular interest in fish
endocrine test methods and is a member of several industry and OECD work groups active in this area.
Daniel Zalko is a Research Director at the French National Institute for Agricultural Research (INRA) and heads the “Metabolism and Xenobiotics” team of the TOXALIM research center in food
toxicology. His research focuses on the metabolism of food and environmental contaminants, with an emphasis on the relationship between specific bioactiva-tion pathways and adverse toxicological outcomes.
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