Endocrine Disruptors

October 16 and 17, 2017 - Conference
October 18, 2017 - Workshop
Berlin, Germany

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Monday, 16th October 2017

8.30 Registration and Coffee

Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany

Regulatory Status Quo – Challenges for the Industry
• Definition of science-based criteria for ED: impact on the industry
• Risk characterisation as a means to deal with ED
• What do the ED criteria mean for related regulation?
• Key elements of the EFSA/ECHA guidance
• Industry’s view on political and public debates on ED
Ellen Dhein, Corporate Environmental Affairs, Bayer AG, Germany

Criteria for ED Identification Under EU Regulations on Plant Protection Products and on Biocidal Products: an Update
• Content
• Process for adoption
• Where do we stand?
Dr Karin M. Nienstedt, Policy Officer, Unit E4 – Pesticides and Biocides, DG Health and Food Safety, European Commission, Belgium

Activities under the EU Strategy for EDs: Towards Better Identification of Endocrine Disruptors - Focus for the Future
• Gaps in test methods
• Approach to address gaps
• Factors for prioritising further TG development
Dr Peter Korytar, DG Environment, Unit B2 – Sustainable Chemicals, European Commission Belgium

10.40 Networking and Coffee Break

Activities under the EU Strategy for EDs: Towards Better Identification of Endocrine Disruptors – Addressing the Gaps
• Recommendations from recent EC funded workshops regarding:
   - Thyroid disruption
   - Retinoid signalling pathway
   - Temporal aspects
   - Other aspects
Dr Elise Grignard, Scientific Officer, European Commission, Joint Research Centre (JRC), Italy

An Industry View of the Criteria for Identifying Endocrine Disruptors
• Regulatory criteria: where science meets politics and emotions run high
• What about REACH: how could progress look like even without criteria?
• Biocides – Substances or Active Substances: what’s all the fuss about?
• Guidance next up: what to expect
• What is the rest of the world going to do?
Peter Smith, Executive Director of the Product Stewardship Programme, European Chemical Industry Council (Cefic), Belgium

Endocrine Disruptors: On the Way to a Harmonised Approach
• Current regulatory framework and its implications
• Scientific discussion concerning EDs
• The European Commission´s Proposals, 2016
• EFSA/ECHA draft guidance document
Dr Glenn Lurman, Scientist, Federal Institute for Risk Assessment (BfR), Germany

13.10 Lunch Break

Endocrine Disruptors – Global Requirements and Challenges
• Current regulatory developments worldwide: Europe vs the Americas and Asia
• Keys to understand hazard and risk assessment in varying regulatory frameworks
• Testing requirements and related efforts
• Implications of the EU ED draft criteria on global registrations
• Recommendations for managing potential EDs on a global scale
Dr Martina Duft, Ecotoxicology/Regulatory Affairs, Industrial Chemicals & Biocides, Dr. Knoell Consult GmbH, Germany

Industry View on Endocrine Disruptor Assessments
• ED Regulation – challenges during ECHA’s substance evaluation
   - Proposing a pro-active industry approach
• Balancing research and regulatory science
   - Pros and cons for requesting limits
• Getting back to the basics of regulatory assessment
   - How does the LOAEL/NOAEL fit into natural variation?
   - Data assessment in light of biological and statistical significance
Dr Erik K. Rushton, DABT, Senior Toxicologist, Corporate HSE/Product Safety, LyondellBasell Industries N.V., the Netherlands

15.50 Networking and Coffee Break

Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Chemicals
• What’s so difficult about environmental safety assessment of endocrine disrupting substances?
• Background and set-up of the SETAC Pellston Workshop
• Risk or hazard assessment – when to do what?
• Remaining areas of scientific concern and future research
• Issues of concern in the need for improved methods of assessment
• How can we find a broader consensus on key scientific questions?
Annegaaike Leopold, Consultant, Calidris Environment B.V., the Netherlands

Endocrine Disruptors within the REACH Authorisation Framework
• Regulatory requirements for EDs under the REACH authorisation regime
• Consequence of the threshold discussion for the affected companies (e.g. pharmaceutical    industry)
• Outcome of the ECHA/CEFIC workshop
• Effects of analytical constraints
Dr Martina Vosteen, Principal, Ramboll Environ Germany GmbH, Germany

17.40 Chairman’s Closing Remarks

17.45 End of Day 1

18.15 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.


Tuesday, 17th October 2017

8.20 Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany

Testing Strategy for Endocrine Disruptors: Environmental Perspective
• Overview of the EU regulations addressing Endocrine Disruptors from an environmental    perspective
• Hazard vs risk-based approaches to chemical regulation
• Considerations for endocrine disruption testing in different legal frameworks
• Case study on fish toxicity testing
Prof Dr ZhiChao Dang, Senior Risk Assessor, Centre for Safety of Substances and Products, RIVM - National Institute for Public Health and the Environment, the Netherlands

Endocrine Disruptors: the Point of View of Ecotoxicology
• Definition: ecotoxicology and toxicology and how they work together
• Challenges for regulatory ecotoxicology
• Key elements of ecotox testing
• The ED criteria in regard to ecotoxicology
• Hazard characterisation - how to assess effects?
Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany

9.50 Networking and Coffee Break

The Application of Adverse Outcome Pathways (AOPs) for the Identification of Endocrine Disruptors
• Application of AOPs in the identification of Endocrine Disruptors in the context of emerging EU    criteria (EFSA/ECHA)
• The importance of considering both endocrine and non-endocrine AOPs
• How much data is needed to be able to make decisions?
• How can Aggregated Exposure Pathways (AEPs) be used in combination with AOPs?
Dr Richard Green, Toxicologist and Risk Assessor, Human Health Assessment, Dow AgroSciences Ltd., presenting on behalf of an ECETOC Task Force, United Kingdom

Human-Relevant Potency-Threshold (HRPT) for Estrogen Receptor Alpha Agonists - Prototype for Hazard Identification of EDCs
• Methodology for development of HRPTs
• Basis of the HRPT for ER-alpha agonists
• Case study chemical showing consistency with other regulatory approaches
• Implications for other endocrine pathways: efficient hazard
Identification of EDCs
Dr Christopher J. Borgert, President & Principal Scientist, Applied Pharmacology and Toxicology, Inc., USA

Considerations in Identifying Thyroid Active Chemicals as Endocrine Disruptors - Potential Impacts under 1107/2009
• Thyroid-active chemicals and endocrine disruption
• Adversity of effects on the thyroid hormone system
• Human and wildlife population relevance of thyroid axis disruption
• Specific vs non-specific effects on thyroid hormone system
• Adequacy of test methods
Dr Daniel B. Pickford, Senior Technical Expert and Lead Ecotoxicologist, Syngenta, United Kingdom

12.20 Lunch Break

The Challenges Facing the Crop Protection Industry
• EU’s approach in dealing with EDs – medium and long term actions
• Challenges of providing sufficient, safe and affordable food for an evergrowing world    population: with or without pesticides?
• Ban on glyphosate: why does this question divide Europe?
• Ensuring consumers’ safety: how to turn into action
• Implications of the current ED approach on crop protection and society
• Which scientific principles could be acceptable for all parties?
Graeme Taylor, Director of Public Affairs, European Crop Protection Association (ECPA), Belgium

ED Criteria: Application, Burden of Proof and Potential Impact on Health and Agriculture
• Criteria for regulatory purposes or political compromise?
• Guilty until proven innocent?
• Which improvements in human and environmental safety will the proposed criteria deliver?
• What do we need for our food supply to be safe, plentiful and affordable?
Dr Andy Adams, Global Agricultural Policy and Stakeholder Affairs, BayerS.A.S., France

15.00 Networking and Coffee Break

Endocrine Disruptor Testing Needs for the Protection of Public Health: Progress and Challenges
• Developing and using test guidelines: strengths and limitations
   - Short term goals with developing in vitro tests
   - Additions of ED endpoints to current in vivo TGs
   - Difficulties with potency comparisons
• Potential implications of IATA, ITS and Defined Approaches developments
   - Role for epigenetics in reproductive toxicity and carcinogenicity testing
Dr Miriam Jacobs, Principal Toxicologist, Public Health England, United Kingdom

16.10 An Epidemiological Perspective on Endocrine Disruption
• Current state of affairs on the human health field
• Increasing level of available information vs real increase in ED related health outcomes?
• How reliable are the epidemiologic studies on exposure to chemicals and ED related health    outcomes?
• Which other factors can explain the changing incidences?
• How can epidemiology be brought even more thoroughly into the debates on ED?
Dr Gerard Swaen, Senior Epidemiologist, Department of Complex Genetics, Maastricht University, The Netherlands

16.50 Chairman’s Closing Remarks

17.00 End of the conference


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