Beyond Science and Decisions: Problem Formulation to Dose Response

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

2. Beyond Science and Decisions, Problem Formulation to Dose Response Stakeholder Process ARA* Process Steering Committee 25 Groups: Led by Texas Commission on Environmental Quality (TCEQ) Risk Document Development Training and Certification Workshop 1 Report Available Non-profit Collaborators Risk Communication Workshop Reports 2 & 3 Expected January & May 2011 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): www.allianceforrisk.org

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 www.allianceforrisk.org/workshop/selections.htm • Summaries of breakout group discussions and suggestions for team members will be posted at http://www.allianceforrisk.org/Workshop/Workshop1MeetingReport.doc • 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, Dourson@tera.org • Roberta Grant, Rgrant@tceq.state.tx.us • Lynne Haber, Haber@tera.org • Michael Honeycutt, MHoneycu@tceq.state.tx.us