1. Location: Noblis, Falls Church, VA
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
Dose-Response Advisory Committee (DRAC). The workshop sponsors are composed of federal, state, industry, and NGO organizations.  The Dose-Response Advisory Committee interacts with these various sponsors in the development of workshop structure and charge questions, and recruitment of presenters. The DRAC will have the final decision on workshop structure, presenters, and content, after consultation with the ARA Steering Committee.

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)
Steering Committee. The Alliance for Risk Assessment Steering Committee (SC) will provide oversight of the workshop series.  The Steering Committee will advise the DRAC on charge questions and will have the final decision on members of the Expert Panel after a review of all nominations.  The SC consists of a broad range of representatives from state, tribal, and federal government, academia, and environmental NGOs.

5. 45 sponsors and collaborators: 11 government agencies
Thanks to our sponsors!
45 sponsors and collaborators:
11 government agencies
11 industry groups
7 scientific societies
8 non-profit organizations/consortia
8 consulting groups
Sponsors:
  Academy of Toxicological Sciences
•             American Chemistry Council    
•             American Petroleum Institute
•             American Water Works Association
•             Center for Food Safety and Applied Nutrition (US Food and Drug Administration)
•             CONSORTIUM FOR ENVIRONMENTAL RISK MANAGEMENT, LLC (CERM)
•             CropLife America
•             Dose Response Specialty Group (Society for Risk Analysis)
•             ENVIRON
•             Georgia Department of Natural Resources (EPD)
•             Georgia Pacific
•             GRADIENT
•             Hamner Institutes
•             Hawai’i Department of Health (HEER)
•             Human Toxicology Project Consortium
•             Illinois Environmental Protection Agency
•             Indiana Department of Environmental Management
•             INDUSTRIAL ECONOMICS, INCORPORATED  
•             International Copper Association
•             International Society of Regulatory Toxicology and Pharmacology
•             The LifeLine Group
•             Mickey Leland National Urban Air Toxics Research Center
•             Minnesota Pollution Control Agency (Environmental Analysis & Outcomes Division)
•             Naphthalene Council
•             National Center for Toxicological Research
•             New Zealand Ministry of Health
•             Nickel Producers Environmental Research Association
•             Noblis
•             NSF International
•             Ohio Environmental Protection Agency
•             PASTOR, BEHLING & WHEELER, LLC
•             Regulatory and Safety Evaluation Specialty Section (Society of Toxicology)
•             Risk Assessment Specialty Section (Society of Toxicology)
•             SAPPHIRE GROUP
•             SC Johnson & Son
•             Society for Risk Analysis
•             Society of Toxicology
•             SUMMIT TOXICOLOGY
•             TED SIMON, LLC
•             Texas Association of Business
•             Texas Chemical Council
•             Texas Commission on Environmental Quality
•             Texas Industry Project
•             Toxicology Excellence for Risk Assessment
•             U.S. Environmental Protection Agency
*With financial support from Health Canada

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
Workshop Background & Purpose
This workshop series is a continuation of the discussion set forth by the National Academy of Science (2009) Science and Decisions: Advancement of Risk Assessment, toward a unified approach to dose response assessment. Conducted under the aegis of the Alliance for Risk Assessment (ARA), a series of three workshops is underway. The workshops will be lead by an Expert Panel, and will focus on biological and statistical issues that relate to dose-response assessment. Evaluation of dose-response assessment techniques will be based on case studies. The first workshop was devoted to brainstorming and selection of case studies to evaluate proposed dose-response assessment techniques and utility in different problem formulations. In the second workshop, the Expert Panel will lead a discussion and evaluation of case study results. A third workshop scheduled for March of 2011 will seek consensus on a guidance document highlighting key considerations for applying dose-response techniques for common risk assessment applications.

7. Series of Three Workshops
Workshop I
Texas Commission on Environmental Quality, March , 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.
Specific Workshop Objectives:
Identify useful dose-response techniques for specified problem formulations, including characterization of assumptions, strengths and limitations, and how the techniques address key considerations in the dose-response.
These techniques should appropriately reflect the relevant biology (including the biology of thresholds), and mode of action information, at a level of detail appropriate for the problem formulation.
Provide methods to explicitly address human variability in cancer assessment, and enhance the consideration of human variability in noncancer assessment, including explicit consideration of underlying disease processes.
Identify methods for calculating the probability of response for noncancer endpoints.
Develop peer reviewed publications and/or a guidance document that will serve as a resource for regulators and scientists to refer to for guidance on key considerations for applying selected dose-response techniques for various problem formulations, with suggested techniques and resources.

9. Workshop Materials Workshop Notebook Online 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
Paul Moyer, Minnesota Department of Health (MDH) and William Hayes, Indiana Department of Environmental Management were originally on the panel, but had to withdraw due to new job responsibilities

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. Location: Noblis, Falls Church, VA
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