Endocrine Disruptors

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Monday, 8th October 2018

8.15 Registration and Coffee

8.50
Chairman’s Opening Remarks
Dr Volker J. Soballa, Vice President, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany

9.00
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
• Hazard vs risk/potency
• What do the ED criteria mean for related regulation?
• Industry’s view on political and public debates on ED
Ellen Dhein, Manager Regulatory and Environmental Affairs, Bayer AG, Germany

9.45
Criteria for ED Identification under EU Regulations on Plant Protection Products and on Biocidal Products: an Update
• Content: what do the criteria apply to or not?
• Timeline and process for the adoption
• Where do we stand?
• How do criteria and guidelines go together
• How will the EU deal with natural EDs?
• Implementation challenges for biocides and plant products
• Consequences for active substances under review
Laura Fabrizi, Policy Officer, Unit E4 – Pesticides and Biocides, DG Health and Food Safety, European Commission, Belgium

10.30 Coffee Break

11.00
The Guidance document for the implementation of the New Criteria on Endocrine Disruptors for Biocides and Pesticides
• ECHA’s activities regarding Endocrine Disruptors
• Key points of the Guidance Document and the proposed assessment strategy
• Some reflections on the concerns raised in the course of the public consultation
• Implications of the guidance document for other regulatory frameworks
Francesca Pellizzato, Substance Evaluation Team, European Chemicals Agency (ECHA), Finland

11.45
Endocrine Disruptors – Global Requirements and Challenges
• Current regulatory developments worldwide: Europe vs the Americas and Asia
• Practical implications
• Keys to understand hazard and risk assessment in varying regulatory frameworks
• Testing requirements and related efforts
• Recommendations for managing potential EDs on a global scale
• Conclusion: case by case assessment
Dr Martina Duft, Ecotoxicology/Regulatory Affairs, Industrial Chemicals & Biocides, knoell Germany GmbH, Germany

12.30 Lunch Break

13.45
Approaching ED – a Competent Authority’s Point of View
• Report on ongoing activities in Sweden and other European actors
• National lists of chemicals compared with the ECHA ED-list
• The role of REACH as a centrepiece of European chemicals regulation
• How much harmonisation do we need?
• Overview of OECD work - the importance of test methods and Guidance
Dr Gregory Moore Swedish Chemicals Agency (KEMI), Sweden

14.30
ED Guidance Document: Participation of the BfR in the Development and Feedback from its Application
• EFSA/ECHA ED Guidance Document (ED GD)
• BfR contribution to the ED GD
• BfR experience in application of the ED GD in practice
Olena Kucheryavenko, Research Associate, Federal Institute for Risk Assessment (BfR), Germany

15.15 Coffee Break

15.45
Commission Proposal for ED Regulatory Criteria – Views from the Crop Protection Industry
• Views of the crop protection industry on the Commission proposal for ED regulatory criteria
• Possible consequences – examples
• Industry proposed amendments
Jean-Pierre Busnardo, European Regulatory Affairs Manager, DuPont Crop Protection, Belgium

16.30
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, Bayer S.A.S., France

17.15 Chairman’s Closing Remarks

17.30 End of Day 1

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.

Tuesday, 9th October 2018

8.40
Chairman’s Opening Remarks
Dr Volker J. Soballa, Vice President, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany

8.45
The US EPA’s Endocrine Disruptor Screening Program
• EPA’s statutory authority for endocrine testing
• Program’s scope and structure
• Approach to screening and testing
• Implementation of computational toxicology tools
• Incorporation of alternative methods
• Preview of future activities
Seema Schappelle, Ph.D., Director, Exposure Assessment Coordination & Policy Division, Office of Science Coordination & Policy, Office of Chemical Safety & Pollution Prevention, US EPA (United States Environmental Protection Agency), USA

9.30
Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Chemicals: Canadian Regulatory Perspective
• Consideration of endocrine effects in prioritization and risk assessment in the Canadian context
• Risk assessment considerations
• Research and monitoring of endocrine disrupting substances in Canada
• International engagement
Magdalena Jagla, Unit Head, Science and Technology Branch, Environment and Climate Change Canada/Government of Canada, Canada

10.15 Coffee Break

10.45
OECD Test Guidelines and Methods
• The OECD’s tools for evaluating chemicals for endocrine disruption
• New approaches for endocrine safety screening
• Applying Adverse Outcome Pathways (AOPs) for ED evaluation
• Consideration of additional endocrine pathways
Patience Browne, OECD, Test Guidelines Programme, Environmental Directorate, France

11.30
EDs in the REACH Restriction and Authorisation Process
• ED identification under REACH
• Implication of the threshold discussion
• Reproducibility of test results
• Development of new analytical test methods
• Challenges with exemptions
• Strategies for the Pharmaceutical & Medical Device Sector
Dr Martina Vosteen, Principal, Ramboll Environment & Health GmbH

12.15 Lunch Break

13.30
Assessing Endocrine Disrupting Properties of Substances in Ecotoxicology
• Regulatory requirements for pesticide active substances
• Current activities within ecotox in the US and the EU
• Triggering endocrine testing in ecotoxicology
• How to assess population relevance of adverse effects
• Review of endocrine disruption in wildlife populations from current-use chemicals
Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany

14.15
Considerations in Identifying Thyroid Active Chemicals as Endocrine Disruptors – Consequences of the New Criteria
• Thyroid-active chemicals and endocrine disruption
• Adversity of effects on the thyroid hormone system
• Specific vs non-specific effects on thyroid hormone system
Dr Daniel B. Pickford, Senior Technical Expert and Lead Ecotoxicologist, Syngenta, United Kingdom

15.00 Coffee Break

15.30
Endocrine Disruptor Issues in Japan
• Japan’s role within the international framework of researching endocrine effects
• Results of Japan’s previous programme on ED (EXTEND2010)
• Key elements of the new project on endocrine disrupting chemicals by the Japanese Ministry of    the Environment (EXTEND2016)
• A path forward in the debate over health impacts of endocrine disrupting chemicals
Dr Kunihiko Yamazaki, Environmental Health Department, Ministry of Environment (MOE) Japan, Japan

16.15
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 ever-growing 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

17.00 Chairman’s Closing Remarks

17.15 End of the Conference

 

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