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

An International Workshop

September 11-13, 2012

Charité Universitätsmedizin, Berlin, Germany

 

Background

There have been extensive discussions in Europe and the United States to identify and develop methods to translate scientific findings of endocrinology to human health risk assessment. A recent review paper ( http://edrv.endojournals.org/content/early/2012/03/14/er.2011-1050.abstract ) in Endocrine Reviews suggests that low dose effects and non-monotonic dose responses are to be expected for chemicals with endocrine disrupting activity and that these responses may occur frequently enough to be a concern. This review focuses in part on the many observations of the link between current human exposures to various chemicals and specific diseases and contends that these observations are supported by mechanistic and animal studies.

 

This workshop seeks to lay out the evidence for low dose effects and non-monotonic dose responses in relation to endocrine active chemicals, with the goal of establishing whether the current observations are sufficient to re-examine the ways in which chemicals are tested for endocrine disrupting properties and how risk to human health may be managed.

 

Within this context the goals of this workshop are the following:

  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.

 

The workshop is sponsored by The National Institute of Environmental Health Sciences (NIEHS)/ NIH, The Oak Foundation, the European Commission, The French Agency for Food, Occupational and Environmental Health (ANSES) , The Federal Environment Agency (UBA) in Germany, the Danish Ministry of the Environment and National Food Institute from Denmark and Charite Medical University, Berlin.

 

Who should attend: Toxicologists, environmental health scientists, regulatory agencies and risk assessors interested in all aspects of endocrine disruptors/endocrine disruption.

 

Meeting Location

The meeting will be hosted by Prof. Dr. Gilbert Schönfelder of the Institute of Clinical Pharmacology and Toxicology of the Charié-Universitätsmedizin Berlin.

 

The meeting will be held in south Berlin at Campus Benjamin Franklin (CBF) of the Charié-Universitätsmedizin Berlin:

Address: Campus Benjamin Franklin (CBF), Hindenburgdamm 30, 12203 Berlin

 

Contacts

 

Meeting Organizers:

  • Jerrold J. Heindel, NIEHS, USA
  • Sharon Munn, European Commission, Ispra, Italy
  • John Bucher, NIEHS, USA
  • Thaddeus Schug, NIEHS, USA
  • Tom Zoeller, University of Massachusetts, USA
  • John Peterson Myers, Environmental Health Sciences, USA
  • Laura Vandenberg, Tufts University, USA
  • Andreas Kortenkamp, Brunell, UK
  • Andreas Gies, Wolfgang Straff, UBA, Germany
  • Gilbert Schonfelder, Charite University, Germany
  • Ulla Hass, National Food Institute, Denmark
  • Claire Beausoleil and Jean-Nicolas Ormsby, ANSES, France
  • Bernd Schaefer, BfR, Germany
  • Marie Louis Holmer, Danish Ministry of the Environment
  • Tom Neltner, Maricell Maffini, Pew Trust, USA

 

Scientific Contacts:

 

Local Arrangement Contact:

 

Agenda

 

Day 1: 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: 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
  • Discussion Leader: RESOLVE
12:15 - 13:15
Lunch (on site)

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
  • Discussion Leader: RESOLVE
17:00-17:30
Introduction to Break-out Sessions and Polling
  • Paul De Morgan, RESOLVE, USA

Evening Reception

19:00
Henry Ford Bau of the Freie Universität Berlin

 

Day 2: 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
  • Discussion Leader: 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

18:30-20:00
Location: Südfoyer of the Campus Benjamin Franklin of the Charité

 

Day 3: 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 VII: 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

 

Sponsors

NIEHS, EC, Danish Ministry of the Environment, DTU Food, Umwelt Bundes Amt, Anses, Charite

 

 


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