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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

EDSP Phase I: Challenges and Lessons Learned

Erik R. Janus

Technical & Regulatory Analyst

this morning s program
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

edsp phase i challenges and lessons learned1
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”
edsp as a novel program
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
technical challenges
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
regulatory policy challenges
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
edsp tiered approach
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
the clock keeps ticking
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
test development validation
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
stakeholder outreach communication
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”
harmonization with other regulatory programs
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
effects of aging
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