Endocrine Disruptors - Chem

2nd International Conference
Endocrine Disruptors
Hot Topics
Presenting Institutions and Companies
• Commission’s Proposal for the Criteria to Identify
• European Commission, Directorate Joint Research
Centre, Health, Consumers and Reference Materials,
Unit: Chemicals Safety and Alternative Methods
Endocrine Disruptors
• Report from the Competent Authorities
• Screening Methodology for Identification of Potential
Endocrine Disrupting Substances
• Risk Assessment of Endocrine Disruptors in the US
• Adverse Outcome Pathways (AOPs) Focusing on
• Swedish Chemicals Agency (KEMI)
• American Chemistry Council (ACC)
• Czech National Institute for Public Health (NIPH)
• Environment Agency Austria (UBA)
• U.S. Environmental Protection Agency (EPA)
Endocrine Active Chemicals
• Bayer AG
• Dow AgroSciences Ltd
Workshop
• Charité Universitätsmedizin Berlin
Alternative and New Methods in Endocrine Toxicity Testing
Dr Majorie B.M. van Duursen, Institute for Risk
Assessment Sciences (IRAS), Utrecht University
• Uppsala University
• Dr. Knoell Consult GmbH
• Utrecht University
• Wageningen University
• LyondellBasell Industries N.V.
Sponsored by
• BASF SE
24th and 25th October 2016, Conference
26th October 2016, Workshop
Vienna, Austria
www.chem-academy.com/endocrine-disruptors
Presented by
Scientific Criteria for the
Monday, 24th October 2016
8.30
Registration and Coffee
8.50
Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik
Industries AG, Germany
9.00
Endocrine Disruptors: A Regulatory Update from the Industry’s Point of View
• Update on the definition of science-based criteria for Endocrine
Disruptors
• The race for leadership and “expert knowledge”: what is reasonable
and why?
• Impact of ED criteria on related regulation
• Case study with natural substances
Ellen Dhein, Corporate Environmental Affairs, Bayer AG, Germany
9.45
Report from the Competent Authorities
• Sweden’s approach in dealing with EDs – medium and long term
actions regarding Endocrine Disruptors
• Challenges for EU
• Development and validation of tests and test strategies
• International exchange and coordination
Dr Gregory Moore, Swedish Chemicals Agency (KEMI), Sweden
10.30
Networking and Coffee Break
11.00
Scientific Principles for the Identification of Endocrine Disrupting Chemicals
• Does this statement improve the regulation of Endocrine Disruptors?
• Which important issues were not addressed in the statement?
• Is there a need for more experimental testing or do we know enough?
Professor Ibrahim Chahoud, Institute of Clinical Pharmacology and Toxicology,
Charité Universitätsmedizin Berlin, Germany
11.45
Global Perspectives on Endocrine Disruptor Assessment and Testing
Requirements
• Current regulatory developments worldwide: Europe, Americas, Asia,
Australia
• Related testing requirements in various regulatory programs and
guidances
• Impact on global registrations and recommendations
Dr Martina Duft, Ecotoxicology, Industrial Chemicals & Biocides, Dr. Knoell
Consult GmbH, Germany
12.30
Lunch Break
13.45
Screening Methodology for Identification of Potential Endocrine Disrupting
Substances
• Screening methodology in the context of impact assessment –
collecting and assessing available evidence regarding potential
endocrine disrupting effects of selected substances
• PPPR, BPR, REACH and Cosmetic Products Regulation
Sharon Munn, European Commission, Directorate Joint Research Centre,
Health, Consumers and Reference Materials, Unit: Chemicals Safety and
Alternative Methods , Italy
14.30
Endocrine Disruptors: The Point of View of Ecotoxicology
• Ecotoxicology vs. toxicology: definition
• Key elements of ecotox testing
• EU impact assessment and ED criteria in regard to ecotoxicology
• Drivers for testing within the plant protection industry
• Hazard characterisation
Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany
15.15
Networking and Coffee Break
15.45
Human Pharmaceuticals and their Environmental Effects
• Adverse effects of human pharmaceuticals in aquatic wildlife species
• Recent data on specific pharmaceuticals perturbing reproductive and
developmental processes
• Androgenic and gestagenic activity of progestagens at environmentally
relevant exposure concentrations
Professor Ingvar Brandt, Department of Environmental Toxicology, Uppsala
University, Sweden
16.30
Assessment and Application of Adverse Outcome Pathways (AOPs) Relevant
to the Endocrine System
• Overview of the current state of the science with respect to AOPs
relevant to the endocrine system and how they are currently being
developed and assessed
• Suggested key elements to be considered when evaluating the utility
of these AOPs for different, defined purposes
• Consideration of how these AOPs may be used in the future, e.g.
identification of Endocrine Disruptors for regulatory purposes
Dr Richard Green, Toxicologist and Risk Assessor, Human Health Assessment,
Dow AgroSciences Ltd., presenting on behalf of an ECETOC Task Force,
United Kingdom
17.15
Chairman’s Closing Remarks
18.00
Evening Reception
Following the official part of the conference, Chem-Academy invites
you to a social evening reception at an atmospheric local restaurant.
Benefit from the informal surrounding to intensify business contacts
and extend your network.
Identification of Endocrine Disruptors
Tuesday, 25th October 2016
8.20
Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik
Industries AG, Germany
8.30
Weight of Evidence: Evaluating Results from Tier-1 Screening for the U.S. EPA
Endocrine Disruptor Screening Program (EDSP)
• Brief history on the U.S. EPA EDSP
• The weight of evidence (WoE) process used to evaluate Tier-1
screening data
• Findings of the first set of chemicals evaluated under the Tier-1
WoE process
• Next steps and on-going activities within the EDSP
Amy Blankinship, Senior Scientist, Environmental Fate and Effects Division,
Office of Pesticide Programs, Office of Chemical Safety and Pollution
Prevention, U.S. Environmental Protection Agency, USA
9.15
Environmental Hazard and Risk Assessment Approaches for Endocrine-Active
Chemicals
• Background and set-up of the SETAC Pellston Workshop
• Aims and summary results from assorted case studies
• Risk or hazard assessment – when to do what?
• Cross-cutting issues highlighted by the workshop, areas of scientific
concern and future research
Annegaaike Leopold, Wageningen University, Co-Chair SETAC Pellston
Workshop on Endocrine Disruption Hazard and Risk Assessment, the
Netherlands
10.00
13.15
Industry View on Endocrine Disruption
• Industry’s view on the criteria and methods
• Comments on ED Regulation in General
• Challenges Anticipated with Classification
Dr Erik K. Rushton, DABT, Senior Toxicologist, Corporate HSE/Product Safety,
LyondellBasell Industries N.V., the Netherlands
14.00
Screening of Endocrine Disruption in the Czech Republic
• Impact of endocrine disruption on public health in the Czech Republic
• Biomonitoring studies of endocrine disruption in the Czech Republic
• Introducing in vitro screening methods of endocrine disruption
• Screening of analogous substances of bisphenol A
Markéta Dvoráková, Centre of Toxicology and Health Safety, Unit for
Alternative Toxicological Methods, NRL of Experimental Immunotoxicology,
National Institute for Public Health, Czech Republic
14.45
Networking and Coffee Break
15.15
Endocrine Disruptors in the Context of REACH
• Roadmap 2020 – Identification of SVHCs because of their ED
properties
• Screening and substance evaluation of potential EDs
• Restriction & authorisation of (potential) EDs
Mag. Simone Mühlegger, Chemicals & Biocides, Environment Agency, Austria
16.00
Chairman’s Closing Remarks
16.15
End of the 2nd International Conference
“Endocrine Disruptors”
Networking and Coffee Break
10.30
Risk-Based Science in the U.S.: The Critical Role of Endocrine Potency and
Exposure
• Importance of potency and exposure for identifying potential EDCs
• New research on estrogenic potency thresholds
• Implications for other global regulatory approaches
Conference Element: Visualisation of Content
Dr Christopher J. Borgert, President & Principal Scientist, Applied
Pharmacology and Toxicology, Inc., American Chemistry Council, USA
11.15
Developmental Origin of Health and Disease (DOHaD): the Role of Early Life
Exposures
• Understanding the pathophysiological basis – the DOHaD approach
• New strategies for research and disease prevention: windows of
exposure, study design and impact of EDs
• Non-communicable diseases and dysfunction: testing environmental
chemical exposures
• Data gaps and challenges
Dr Majorie B.M. van Duursen, Senior Researcher and Lecturer, Endocrine
Toxicology, Institute for Risk Assessment Sciences (IRAS), Utrecht University,
the Netherlands
12.00
Lunch Break
Graphic Recording of conference «Product Safety in the Chemical Industry»
www.chem-academy.com/graphic-recording-produktsicherheit
Workshop
Wednesday, 26th October 2016
8.30
Reception and Coffee
9.00 to 16.30
Alternative and New Methods in Endocrine Toxicity
Testing
Coffee breaks will be arranged flexibly.
About Your Workshop Leader
Dr Majorie B.M. van Duursen, Senior Researcher and Lecturer, Endocrine
Toxicology, Institute for Risk Assessment Sciences (IRAS), Utrecht
University, the Netherlands
Dr. Majorie van Duursen is associate professor at the Toxicology and
Pharmacology Division of the Institute for Risk Assessment Sciences at
the Utrecht University (the Netherlands). Her research focuses on the
effects of natural compounds and environmental contaminants on the
endocrine system. For that, she works with complex cell culture (in
vitro) systems to better mimic the interactions and architecture of a
tissue. She is involved in many national and international (EU-funded)
research projects on the toxicological impact of endocrine disruptors.
Majorie is participant of the Endocrine Disruptor Expert Group of ECHA
and member of the WHO Collaborative Center for Children’s
Environmental Health.
Content of Workshop
New EDC Criteria in the Light of the Scientific Debate
• General introduction of the EDC criteria
• Scientific debate issues involved and possible solutions
• EU impact assessment
There is general consensus on the World Health Organisation (WHO)
definition of an Endocrine Disruptor: "an exogenous substance or mixture that alters function(s) of the endocrine system and consequently
causes adverse health effects in an intact organism, or its progeny, or
(sub-) populations". This introductory part summarises key parts of the
scientific debate around EDC criteria and their possible solutions. In a
next step the workshop looks deeper into the EU impact assessment
and the consequences for the scientific debate.
Practical Impact on Related Regulatory Areas
• What do the criteria for BP and PPP mean for other regulatory areas
such as REACH?
• How should EDCs be identified in the regulatory context?
• Addressing crucial (toxicological) principles
On June 15 2016, the European Commission formally proposed criteria
to assess Endocrine Disruptors under Biocidal Products and Plant
Protection Products legislation. The question remains how Endocrine
Disrupting Chemicals should be identified in this regulatory context.
The second part of the course focuses on the crucial toxicological
principles and their practical impact on other regulatory areas like
REACH. It addresses the direction ED scientific research is taking.
Application of Alternative Test Methods into Practice
• Hazard vs. risk, potency and relevant life-stage (timing of the dose)
• How can non-animal methods be applied in light of the new criteria?
• Implementation of alternative test methods
- in silico
- in vitro
- in chemico
- read-across
A group of scientists agreed in an international expert meeting organized
by the German Federal Institute for Risk Assessment (BfR) the following:
criteria for identifying chemicals as Endocrine Disruptors would need to
be accompanied by the implementation of relevant test systems in EU
regulations. The Commission requires that animal testing should be
reduced and avoided where possible. But what kind of alternative test
methods can be applied in practice? What does this mean for hazard
versus risk assessments or relevant life-stages and timing of the dose?
This part of the workshop takes a deeper look into the various alternative
testing methods and ways to find possible solutions.
Advance Notice
Course
REACH Registration 2018
26th to 27th September, 2016
Cologne, Germany
www.chem-academy.com/reach-registration
8th Annual Conference
CLP
7th to 9th November, 2016
Dusseldorf, Germany
www.chem-academy.com/ghs
Conference Language German
10th Annual Conference
Product Safety in the Chemical Industry
23th to 25th January, 2017
Bonn, Germany
www.chem-academy.com/produktsicherheit
Conference Language German
2nd International Conference
Continued and On-Going Process Verification
20th to 22nd March, 2017
Berlin, Germany
www.chem-academy.com/cpv
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Impressions
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Session
Graphic Recording
Evening Reception
Case
Studies
Networking
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2nd International Conference Endocrine Disruptors
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24th to 26th October 2016
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Conference
24th and 25th October 2016
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Workshop*
26th October 2016
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