Beyond Science and Decisions: Problem Formulation to Dose Response

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): www.allianceforrisk.org

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.

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.

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.

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

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

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

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

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 10