Session I – Session I – Strengths and Weaknesses of the EDSP Screening Assays Moderator: Angelina J. Duggan Exponent Health Group September 9, 2009

Session I Objectives EPA EDSP update EPA EDSP update Provide forum to discuss stakeholder’s EDSP perspectives, interpretations and recommendations Provide forum to discuss stakeholder’s EDSP perspectives, interpretations and recommendations

EDSP Tier 1 Development More than 10 years since August 2008 EDSTAC Final Report More than 10 years since August 2008 EDSTAC Final Report Validation was a global effort Validation was a global effort –EPA and international regulators –Academic, industry, government and CRO scientists –Stakeholders recommendations Implementation and interpretation of Phase 1 EDSP screening will present new challenges and expectations for EPA, stakeholders, industry and NGOs Implementation and interpretation of Phase 1 EDSP screening will present new challenges and expectations for EPA, stakeholders, industry and NGOs

Challenges and Expectations Individual and collective interpretation of Tier 1 Phase 1 screening results Individual and collective interpretation of Tier 1 Phase 1 screening results Provide guidance to implement mid-course correctionsProvide guidance to implement mid-course corrections Provide guidance on weight-of-evidence to proceed to Tier 2 testing (EDTP)Provide guidance on weight-of-evidence to proceed to Tier 2 testing (EDTP) Tier 1 lessons learned and expert recommendations (ILSI, NAS) should be applied in Tier 2 testing validation Tier 1 lessons learned and expert recommendations (ILSI, NAS) should be applied in Tier 2 testing validation Can the EDSP accommodate and compliment new technologies Can the EDSP accommodate and compliment new technologies Genomic technologiesGenomic technologies Alternative screening programs (e.g., ToxCast)Alternative screening programs (e.g., ToxCast) NanotechnologyNanotechnology

EPA EDSP Update Gary Timm, EPA OCSP: “ An Update on the Implementation of the EPA’s Endocrine Disruption Screening Program” Gary Timm, EPA OCSP: “ An Update on the Implementation of the EPA’s Endocrine Disruption Screening Program” EDSP background and path forward EDSP background and path forward – ESTAC’s recommendation – Validation criteria – Timelines to implement test orders and Tier 2 testing validation

EDSP Stakeholder Expert Panel CRO perspective CRO perspective –Shelley Tyl, RTI, “Challenges in Conducting and Interpreting Tier 1 EDSP Screening Assays: CRO Perspective ” Registrant /industry assessments Registrant /industry assessments –Sue Marty, Dow Chemical Corp., “Mammalian Tier 1 EDSP Screening Assays: What do they tell us?” –Pat Guiney, SC Johnson, “Wildlife Tier 1 EDSP screening assays: What do they tell us?” –Christopher Borgert, Applied Pharmacology and Toxicology Inc., “Staging Screening and Testing”

Thank You