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EDSP Phase I: Challenges and Lessons Learned

EDSP Phase I: Challenges and Lessons Learned. Erik R. Janus Technical & Regulatory Analyst. This morning’s program. 8:45 - 11:45 am: Morning Session EDSP Phase I: Challenges and Lessons Learned 8:45 - 9:00 Erik Janus, Steptoe & Johnson LLP (Session Chair)

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EDSP Phase I: Challenges and Lessons Learned

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  1. EDSP Phase I: Challenges and Lessons Learned Erik R. Janus Technical & Regulatory Analyst

  2. This morning’s program 8:45 - 11:45 am: Morning Session EDSP Phase I: Challenges and Lessons Learned 8:45 - 9:00 Erik Janus, Steptoe & Johnson LLP (Session Chair) Introduction/Overview 9:00 - 9:15 Erik Janus, Steptoe & Johnson LLP Procedural and Legal Issues 9:15 - 9:50 Terry Quill, Quill Law Group Update/Status on Other Scientifically Relevant Info 9:50 – 10:30Barbara Neal, Exponent Morning Break & Exhibit Viewing 10:30 - 10:45 Test Guidelines and Guideline Modifications 10:45 - 11:25Ellen Mihaich, Environmental and Regulatory Resources Discussion / Audience Q&A / Introduction of Exhibitors

  3. EDSP Phase I: Challenges and Lessons Learned • EDSP Tiered Approach & Initial Policy Decisions • Test Method Development & Validation • Stakeholder Outreach & Communication • Harmonization with Other Regulatory Programs • Effects of “Aging”

  4. EDSP as a novel program • Developing 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 process • The EDSP policy microcosm has highlighted some key technical and regulatory issues which continue to require challenging solutions

  5. Technical Challenges • OSRI: acceptance of info, processing of info, rendering determinations from info • WoE: a priori hypothesis testing and/or decision-making frameworks versus “learning by doing” • Test Guideline validation: interlaboratory performance, industry standards, implementation in different countries

  6. Regulatory & Policy Challenges • Stakeholder input: WoE guidance, peer review of TGs, OSRI guidance • Harmonization with other legislative initiatives • Inerts, drinking water compound order recipient identification and data compensation • Public communication of scientific and regulatory program needs

  7. EDSP Tiered Approach • The “checklist approach” is outdated! • Current science has moved beyond inflexible “one size fits all” testing batteries that cannot incorporate 21st century tox methods and ideas • Final process is not “quick, simple and cheap” • Selection of chemicals is still on potential for exposure, not toxicity

  8. The clock keeps ticking … • Perhaps most importantly, the EDSP timeline keeps moving forward while major issues remain unresolved: • Standard Evaluation Procedures • Weight of Evidence Methodology • OSRI Determinations • Over 200 chemicals identified for screening – almost 140 are pesticide actives • ALL pesticides must be tested per FQPA • Over 1000 “common chemical names” in NPIRS

  9. Test Development & Validation • Cost and time estimates were quite low – even lower when paired with high rejection rate of OSRI and overly prescriptive Test Guidelines • Tension between modern comprehensive and redundant screening battery and stakeholder and procedural issues • Validation of battery as a whole was not performed • Interpretation of battery suffers from lack of detailed guidance • Lack of core set of test compounds and designated positive and negative controls

  10. Stakeholder Outreach & Communication • Highly visible, politically charged • Susceptible to the “problem child of the week” response • Very long development timeline • Rapidly changing knowledge • Change of administration and “preferred stakeholders”

  11. Harmonization with Other Regulatory Programs • TSCA (or whatever the reform will look like) • OECD endocrine framework • European legislation: REACh, plant protection products, biocides, new drugs, cosmetics • Safe Drinking Water Act • California Green Chemistry program

  12. Effects of “Aging” • Original 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 issues • Has 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 issues • Science has rapidly outpaced regulation

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