EDSP Phase I: Challenges and Lessons Learned

This mornings program8:45 - 11:45 am: Morning Session EDSP Phase I: Challenges and Lessons Learned8:45 - 9:00 Erik Janus, Steptoe & Johnson LLP (Session Chair) Introduction/Overview 9:00 - 9:15 Erik Janus, Steptoe & Johnson LLP Procedural and Legal Issues9:15 - 9:50 Terry Quill, Quill Law GroupUpdate/Status on Other Scientifically Relevant Info9:50 10:30 Barbara Neal, Exponent

Morning Break & Exhibit Viewing10:30 - 10:45

Test Guidelines and Guideline Modifications 10:45 - 11:25 Ellen Mihaich, Environmental and Regulatory ResourcesDiscussion / Audience Q&A / Introduction of Exhibitors

EDSP Phase I: Challenges and Lessons LearnedEDSP Tiered Approach & Initial Policy DecisionsTest Method Development & ValidationStakeholder Outreach & CommunicationHarmonization with Other Regulatory ProgramsEffects of Aging

EDSP as a novel programDeveloping and validating a new chemical screening and testing program is very resource intensive and requires effective stakeholder input as well as dedicated leadership throughout the processThe EDSP policy microcosm has highlighted some key technical and regulatory issues which continue to require challenging solutions

Technical ChallengesOSRI: acceptance of info, processing of info, rendering determinations from infoWoE: a priori hypothesis testing and/or decision-making frameworks versus learning by doingTest Guideline validation: interlaboratory performance, industry standards, implementation in different countries

Regulatory & Policy ChallengesStakeholder input: WoE guidance, peer review of TGs, OSRI guidanceHarmonization with other legislative initiativesInerts, drinking water compound order recipient identification and data compensationPublic communication of scientific and regulatory program needs

EDSP Tiered ApproachThe checklist approach is outdated!Current science has moved beyond inflexible one size fits all testing batteries that cannot incorporate 21st century tox methods and ideasFinal process is not quick, simple and cheapSelection of chemicals is still on potential for exposure, not toxicity

The clock keeps ticking Perhaps most importantly, the EDSP timeline keeps moving forward while major issues remain unresolved:Standard Evaluation ProceduresWeight of Evidence MethodologyOSRI DeterminationsOver 200 chemicals identified for screening almost 140 are pesticide activesALL pesticides must be tested per FQPAOver 1000 common chemical names in NPIRS

Test Development & ValidationCost and time estimates were quite low even lower when paired with high rejection rate of OSRI and overly prescriptive Test GuidelinesTension between modern comprehensive and redundant screening battery and stakeholder and procedural issuesValidation of battery as a whole was not performedInterpretation of battery suffers from lack of detailed guidanceLack of core set of test compounds and designated positive and negative controls

Stakeholder Outreach & CommunicationHighly visible, politically chargedSusceptible to the problem child of the week responseVery long development timelineRapidly changing knowledgeChange of administration and preferred stakeholders

Harmonization with Other Regulatory ProgramsTSCA (or whatever the reform will look like)OECD endocrine frameworkEuropean legislation: REACh, plant protection products, biocides, new drugs, cosmeticsSafe Drinking Water ActCalifornia Green Chemistry program

Effects of AgingOriginal FQPA mandate = 1996!The numbers game: 2 centuries, 3 Presidents, 5 EPA Administrators, 8 Sessions of Congress, 14 calendar years of Congressional appropriations (up to $10 million per year?)Leadership issuesHas this impacted the timeline or vice versa?Who is in charge? (OSCP vs OPP)Forward progress has been more stochastic than sustained - often driven by external, non-scientific issuesScience has rapidly outpaced regulation