Beyond Science and Decisions: From Problem Formulation to Dose-Response. Workshop III Date: May 4-6th, 2011 Location:

1. Beyond Science and Decisions: From Problem Formulation to Dose-Response. Workshop III Date: May 4-6th, 2011 Location: Noblis, Falls Church, VA ARA Workshop III

2. Introduction • Dose-Response Advisory Committee (DRAC) • Alliance for Risk Assessment (ARA) Steering Committee • Sponsors

3. Dose-Response Advisory Committee • Rick Becker, American Chemistry Council • Michael Dourson, Toxicology Excellence for Risk Assessment (TERA) • Julie Fitzpatrick, Environmental Protection Agency • Roberta Grant, Texas Commission on Environmental Quality (TCEQ) • Lynne Haber, TERA • Michael Honeycutt, TCEQ • Lynn H. Pottenger, The Dow Chemical Company • Jennifer Seed, Environmental Protection Agency

4. ARA Steering Committee • Barbara Harper, Confederated Tribes of the Umatilla Indian Reservation • William Hayes, State of Indiana • Bette Meek, University of Ottawa/Health Canada (liaison with the DRAC) • Anita Meyer, United States Army Corps of Engineers • Edward Ohanian, United States Environmental Protection Agency • Ruthann Rudel, Silent Spring • Phil Wexler, National Library of Medicine • Michael Dourson, Toxicology Excellence for Risk Assessment (recused) • Michael Honeycutt, Texas Commission on Environmental Quality (recused)

5. 45 sponsors and collaborators: • 11 government agencies • 11 industry groups • 7 scientific societies • 8 non-profit organizations/consortia • 8 consulting groups Thanks to our sponsors!

6. Purpose • Through the development and application of case studies, to additionally evolve the methodologies in specific areas and crosscutting issues raised by Science and Decisions Advancing Risk Assessment

7. Series of Three Workshops • Workshop I • Texas Commission on Environmental Quality, March 16-18, 2010 • Workshop II • Crystal City, Virginia (in tandem with the Federal & State Risk Assessment & Toxicology Committee), October 11-13, 2010 • Workshop III • Noblis; Falls Church, Virginia, May 4-6, 2011

8. Overview of Workshop Objectives • Build off the NAS (2009) report • to develop practical guidance for use by risk managers at a variety of levels • states, regional managers, a variety of agencies, and industry • for risk assessment techniques applicable to specific problem formulations. • Implement a multi-stakeholder approach to share information, ideas, and techniques in support of developing practical, problem-driven risk assessment guidance.

9. Workshop Materials • Workshop Notebook • Background • Agenda and Logistics • Bios • Case Study Summaries • Online • Framework • Full Case Studies • Presentation Slides

10. Housekeeping • Look around now for exits in case of fire • Cell phone reminder.... • Mid-morning and afternoon breaks • Lunch speakers scheduled and lunches provided on Wednesday and Thursday • The sessions are being webcast so remember there is a second audience listening on the phone. Please be mindful of their participation: • Use the mics to facilitate listening for those on webcast • Only one person speaking at a time • Identify yourself with name and affiliation when speaking

11. Beyond Science and Decisions: From Problem Formulation to Dose-Response. Workshop I Date: March 16-18, 2010 Location: Texas Commission on Environmental Quality

12. Workshop I Summary • 60 participants with more than 100 participants via webcast • Brainstorming • Ongoing risk assessment activities • Perspectives on the NAS (2008) Silver Book • Selection of case studies • Consideration and selection of case studies • Focus on the principles of the methodology, not specific chemicals

13. Workshop II/III Expert Panel • Provide guidance during the workshops • Evaluate the case studies during Workshop II/III • Use case studies to evolve methodologies and address cross-cutting issues raised in NAS Science & Decisions report • Balance across affiliation & expertise • Risk assessment and Toxicology

14. Panel Selection Process • Announcement of workshops, with a call for Panel nominations • DRAC also nominated panel member candidates • ARA Steering Committee reviewed candidates and developed a prioritized list of nominees • Invitations were sent to a total of 27 people • Particular effort was made to include people from the NAS, 2009 Panel & environmental NGOs

15. Workshop II/III Expert Panel • 3 from the US Federal Government, with 2 from EPA • 2 from industry • 2 from academia • 1 from state government, and 1 state government emeritus • 2 from nonprofit groups • 1 consultant • 2 are members of the NAS Science & Decisions Panel

16. Expert Panel for Workshop III • Michael Bolger, U.S. Food and Drug Administration (FDA) • James S. Bus, The Dow Chemical Company • John Christopher, CH2M/Hill • Rory Conolly, U.S EPA National Health and Environmental Effects Research Laboratory • Mike Dourson, Toxicology Excellence for Risk Assessment (TERA) • Adam M. Finkel, UMDNJ School of Public Health (NAS 2009 Panel) • R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc. • Randy Manning,Georgia Department of Natural Resources (Environmental Protection Division) • Bette Meek, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa (Chairperson) • Greg Paoli, Risk Sciences International (NAS 2009 Panel) • Rita Schoeny, U.S. EPA Office of Water

17. Activities between Workshops II & III • Panel reviewed the case studies • A draft risk framework was developed and posted on the ARA website • New case studies were proposed and submitted to the Panel for consideration • Panel used  framework to identify areas and methodological issues where additional illustrative case studies were needed • Those case studies were invited to be brought to Workshop III

18. Organizational Framework: Dose-Response Methods Presented ARA Workshop II

19. In-Depth Dose-Response Assessment ARA Workshop II

20. Workshop Agenda: Day 1(8:15 am-5:30 pm) • Welcome and Introduction: • Dr. David Evans, Noblis, and Dose-Response Advisory Committee members • Keynote Address: Rita Schoeny, EPA • Presentation of Framework & Cross-Cutting NAS Issues: Lynne Haber, TERA • Lunch speaker: Bette Meek, University of Ottawa • Science Panel Discussion Questions related to MOA • Observer Comments • Review of New Case Studies

21. Workshop Agenda: Day 2 (Thursday, May 5) Day 2(8 am-5:30 pm) • Review of New Case Studies (Cont’d) • Keynote Talk: Resha Putzrath, U.S Navy • Report on Case Study Progress from Workshop II • Lunch speaker: James Swenberg, University of North Carolina • Science Panel Discussion Questions related to Background & Endogenous Exposure and Background Response • Science Panel Discussion of Additional Cross-Cutting NAS Issues

22. Workshop Agenda: Day 3(Friday, May 6) Day 3(8:30 am -noon) • Science Panel Discussion • Observer Comments/Open Discussion • Closing Remarks ARA Workshop II

23. ACC Center for Advancing Risk Assessment Science & Policy (ARASP) Perspective • Group of chemical-specific groups working towards improving risk assessment science and policy, given changing world of toxicology. • Accelerate the development, evaluation and use of weight-of-evidence frameworks, MOA analysis, & quantitative uncertainty methods in chemical risk assessments. • Support ARA-sponsored workshops to broaden & deepen scientific discussion on dose-response assessment & MOA • Contribute case studies / scientific data & analyses and actively participate in the scientific discourse of the ARA project.

24. TCEQ’s Perspective • Commissioner’s and executive management of the Texas Commission on Environmental Quality support these series of workshops • Environmental regulations should be meaningful and provide the most benefit to those who need help • Good science should lead the way and improve the process

25. EPA Perspective • The case studies being developed by this workshop series will be useful to the Agency as it moves forward in addressing the recommendations presented in Science and Decisions.

26. Beyond Science and Decisions: From Problem Formulation to Dose-Response. Workshop III Date: May 4-6th, 2011 Location: Noblis, Falls Church, VA ARA Workshop III