1. Beyond Science and Decisions: Problem Formulation to Dose Response

2. Beyond Science and Decisions, Problem Formulation to Dose Response
Stakeholder Process
ARA* Process
25 Groups: Led by Texas Commission on Environmental Quality (TCEQ)
Steering
Committee
Risk Document
Development
Workshop 1 Report
Available
Training and
Certification
Non-profit
Collaborators
Risk
Communication
Workshop Reports
2 & 3 Expected January
& May 2011
The list of sponsors currently includes 2 CONSULTING GROUPS, 6 government agencies, 6 industry groups, 5 non-profit organizations, and 6 scientific societies/sections:   Sponsors now include: American Chemistry Council    
American Petroleum Institute
CONSORTIUM FOR ENVIRONMENTAL RISK MANAGEMENT LLC (CERM)
Dose Response Specialty Group (Society for Risk Analysis)
Georgia Department of Natural Resources (EPD)
Illinois Environmental Protection Agency
Indiana Department of Environmental Management
Hamner Institutes
Hawai’i Department of Health (HEER)
International Society of Regulatory Toxicology and Pharmacology
Mickey Leland National Urban Air Toxics Research Center
Naphthalene Council
New Zealand Ministry of Health
Noblis
NSF International
Regulatory and Safety Evaluation Specialty Section (Society of Toxicology)
Risk Assessment Specialty Section (Society of Toxicology)
SAPPHIRE GROUP
Society for Risk Analysis
Society of Toxicology
Texas Association of Business
Texas Chemical Council
Texas Commission on Environmental Quality
Texas Industry Project
Toxicology Excellence for Risk Assessment
Risk Research
And Tools
Methods Text
Expected Summer 2011
Risk Information
Exchange (RiskIE)
Peer Review &
Consult
All information
To be web posted
* Alliance for Risk Assessment (ARA):

3. Workshop Series Objectives
Additionally develop content of the NAS (2008) report on improving the risk assessment process to develop practical guidance for:
Risk assessment techniques applicable to specific issue identification (e.g., prioritization, screening and full assessment);
Use by risk managers at a variety of levels (e.g., states, regional managers, people in a variety of agencies, and in the private sector)
Implement a multi-stakeholder approach to share information, ideas and techniques in support of developing practical problem-driven risk assessment guidance.

4. Specific Workshop Objectives
Identify useful dose-response techniques for specific issues, including:
Consideration of relevant data,
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 and toxicology
Mode of action information, at a level of detail appropriate for the identified issue.

5. Specific Workshop Objectives (continued)
Provide methods to explicitly address:
Human variability in cancer assessment, and
Enhance the consideration of human variability in noncancer assessment, including underlying diseases.
Identify methods for calculating the probability of response for noncancer endpoints.
Develop guidance for regulators and scientists for applying selected dose- response techniques.

6. Workshop Approach
Workshop 1: Presentations that highlight relevant work in issue identification and assessment methods, followed by brainstorming on purpose-focused methods and selection of case studies. [Talks from March 16–18, 2010 meeting & report now available.]
Workshop 2 (October/November, 2010): Case study presentations and evaluation by science panel selected by ARA Steering Committee
Workshop 3 (April, 2011): Panel builds consensus on purpose-specific dose-response methods

7. Why is this Approach Useful?
Multi-stakeholder approach, with input from experts in risk assessment, biology/toxicology, and mathematical analysis
Case-studies to test principles and methods against real-world data & review by expert panel
Integration of risk management-driven problem formulation with mode of action and biology
Methods covering a range of
problem formulations,
risk management needs, and
informed by state-of-the science guidance and frameworks

8. Path Forward
Workshop 1 participants evaluated and recommended case study proposals, including new proposals. Case studies are listed at
Summaries of breakout group discussions and suggestions for team members will be posted at
Case study leaders are currently assembling teams; additional participants are welcome.
Additional case studies may also be brought forward to the second workshop

9. How Can You Participate?
Participate in a case study or bring forward a new one
Participate in workshops 2 or 3, either in person or via webcast
Be a sponsor of the workshop series

10. For More Information Please visit www.allianceforrisk.org
TCEQ Workshop series contact:
Michael Dourson,
Roberta Grant,
Lynne Haber,
Michael Honeycutt, 10