Low Dose Effects and Non-monotonic Dose Responses for Endocrine Active Chemicals: Science to Practice Workshop

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1 Low Dose Effects and Non-monotonic Dose Responses for Endocrine Active Chemicals: Science to Practice Workshop Agenda Tuesday, September 11 Thursday, September 13, 2012 Charité Medical University of Berlin, Campus Benjamin Franklin (CBF), Hindenburgdamm 30, 12203, Hörsaal West, Lecture Hall Workshop Goal: To determine whether the current data on low dose effects and non-monotonic dose response curves for EACs are sufficient to re-examine the ways in which chemicals are tested for endocrine disrupting properties and how risk to human health is managed. Workshop Objectives: 1. To present and discuss the state of the science for low dose effects and non-monotonic dose response curves for chemicals with endocrine activity. 2. To define research needs required to move closer to scientific agreement on low dose effects and non-monotonic dose responses for endocrine active substances. 3. To define how research programs, especially those funded by public agencies, could support studies that would produce data most useful for a science-based risk assessment. 4. To start a discussion on the implications of low dose effects and non-monotonic dose response curves to risk assessment. 5. To develop a plan to continue discussions between basic researchers and risk assessment scientists beyond the current workshop. Low Dose Workshop Agenda - FINAL Sep 03.docx Page 1 of 5

2 Day 1 Tuesday, September 11, 2012 Opening: Welcome and Meeting Goals 8:30 8:45 Welcome Sharon Munn, Joint Research Centre- Institute for Health and Consumer Protection, European Commission, Italy Jerry Heindel, The National Institute of Environmental Health Sciences (NIEHS), USA Detlev Ganten, Chairman of the Board of the Charité Foundation and President of the World Health Summit, Germany 8:45 9:00 Opening Comments Linda Birnbaum, Director NIEHS, USA (via video) Elke Anklam, Director, Joint Research Centre-Institute for Health and Consumer Protection, European Commission, Italy 9:00 9:10 Meeting Goals Sharon Munn, European Commission, Italy Jerry Heindel, NIEHS, USA Session I: Update on Recent Workshops/Activities 9:10 9:25 EC Update on EDC activities Peter Korytar, DG Environment, European Commission, Belgium 9:25 9:40 April 2012 Workshop Sponsored by The Pew Charitable Trusts, Nature Journal, and the Institute of Food Technologists Tom Neltner, The Pew Charitable Trusts, USA 9:40 10:05 June 2012 Colloquium Sponsored by European Food Safety Authority (EFSA) Iona Pratt, Food Safety Authority of Ireland 10:05 10:25 Break Session II: Setting the Stage: Developing a Common Language and Understanding 10:25 10:55 How Hormones and Endocrine Disruptors Act Fred vom Saal, University of Missouri, USA 10:55 11:15 Principles of Pharmacology Related to Low Dose Effects and Non-Monotonic Dose Responses Scott Belcher, University of Cincinnati, USA 11:15 11:45 Practical Principles of Risk Assessment Theo Vermeire, National Institute for Public Health and the Environment (RIVM), Netherlands 11:45 12:15 Facilitated Discussion Led by RESOLVE 12:15 13:15 Lunch Low Dose Workshop Agenda - FINAL Sep 03.docx Page 2 of 5

3 Session III: Occurrence of Low Dose Effects and Non-monotonic Dose Responses for Endocrine Active Chemicals 13:15 13:55 State of the Science of Low Dose Effects of Endocrine Active Chemicals Tyrone Hayes, University of California Berkeley, USA 13:55 14:35 State of the Science of Non-Monotonic Dose Responses in Animal and Human Studies Laura Vandenberg, Tufts University, USA 14:35 15:00 Break 15:00 15:30 Computational Modeling of Non-monotonic Dose-Responses: Insights into Minimum Requirements Rory Conolly, US Environmental Protection Agency (US EPA), USA 15:30 15:45 An Example that Shows the Need to Develop a Strategy for Interpreting Non- Monotonic Responses in Guideline Studies Heather Patisaul, North Carolina State University, USA 15:45 16:15 Mechanisms for Non-monotonic Dose Responses Ana Soto, Tufts University, USA 16:15 17:00 Facilitated Discussion Led by RESOLVE 17:00 17:30 Introduction to Break-out Sessions and Polling Paul De Morgan, RESOLVE, USA Evening Reception Time: Location: 19:00 p.m. 22:30 p.m. Henry Ford Bau of the Freie Universität Berlin Low Dose Workshop Agenda - FINAL Sep 03.docx Page 3 of 5

4 Day 2 Wednesday, September 12, 2012 Session IV: Report on Current Activities 8:30 8:45 French Agency for Food, Environmental and Occupational Health (ANSES) Activities Related to Low Dose/Non-monotonic Dose Responses for EDCs Claire Beausoleil, ANSES, France 8:45 9:10 U01 BPA consortium/tox 21 Kembra Howdeshell, NIEHS/National Toxicology Program (NTP), USA 9:10 9:25 Endocrine Society Statement of Principles Ana Soto, Tufts University, USA (on behalf of The Endocrine Society) 9:25 9:40 US EPA Update on Low Dose-related Activities Mark Miller, US EPA, USA 9:40 10:00 Break Session V: Implications of Low Dose and Non-Monotonic Dose Responses for Risk Assessment 10:00 10:20 How EFSA Works and Performs Risk Assessment Alexandre Feigenbaum, EFSA, Italy 10:20 10:50 Impact of Low Dose and Non-Monotonic Dose Responses on Risk Assessment Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks, European Commission 10:50 11:10 OECD Test Guidelines and Endocrine Endpoints Olwenn Martin, Brunel University, UK 11:10 11:40 Facilitated Discussion Led by RESOLVE Session VI: Day 2 Breakout Session 11:40 12:00 Charge to Breakout Groups Paul De Morgan, RESOLVE 12:00 16:00 Breakout Groups (working lunch) Each breakout group has a RESOLVE facilitator, a chair who will lead discussion, and a rapporteur who will report results 16:00 16:30 Break 16:30 18:15 Reports from Day 2 Breakout Groups in General Session Evening Poster Session on Site with Refreshments Time: 18:30-20:00 Location: Südfoyer of the Campus Benjamin Franklin of the Charité Low Dose Workshop Agenda - FINAL Sep 03.docx Page 4 of 5

5 Day 3 Thursday, September 13, 2012 Session VII: Day 3 Breakout Session 8:30 8:50 Charge to Breakout Groups Paul De Morgan, RESOLVE 9:00 12:00 Breakout Groups Each breakout group has a RESOLVE facilitator, a chair who will lead discussion, and a rapporteur who will report results 12:00 13:00 Lunch 13:00 15:00 Reports from Day 3 Breakout Groups in General Session Session VIII: Wrap-up 15:00 15:30 Overall Summary and Path Forward to Continue the Dialogue Sharon Munn, European Commission, Italy Jerry Heindel, NIEHS, USA 15:30 Meeting Adjourns Sponsoring Organizations: Charité Medical University of Berlin European Commission Danish Ministry of the Environment Danish Technical University, National Food Institute French Agency for Food, Environmental and Occupational Health (ANSES) German Federal Environment Agency (UBA) The National Institute of Environmental Health Sciences/NIH The Oak Foundation Special Thanks to Gilbert Schönfelder, Charité University, for his hard work organizing the local arrangements and logistical support, Andreas Gies and UBA for their overall workshop support, and The Pew Charitable Trusts for its assistance in planning, arranging for the expert facilitators, and providing for the polling system. Low Dose Workshop Agenda - FINAL Sep 03.docx Page 5 of 5

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