2010 Endocrine Workshop: EDSP Compliance

December 13, 2010

steptoe.com

EDSP Phase I: Challenges and Lessons LearnedErik R. JanusTechnical & 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 - 11:25 Ellen 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The “checklist approach” is outdated!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