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EDSP’s Test Protocol Validation Program

EDSP’s Test Protocol Validation Program. Status and Timeline presentation to the Endocrine Disruptor Methods Validation Subcommittee, October 30, 2001. Today’s talk will include. an overview of work to date an overview of future plans detailed plans for each assay

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EDSP’s Test Protocol Validation Program

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  1. EDSP’sTest Protocol Validation Program Status and Timeline presentation to the Endocrine Disruptor Methods Validation Subcommittee, October 30, 2001

  2. Today’s talk will include • an overview of work to date • an overview of future plans • detailed plans for each assay • questions for your consideration • upcoming EDMVS meeting topics

  3. Settlement Agreement • Only the milestones related to validation of assays are shown

  4. Work to date: Tier 1 assays * OECD  in progress completed

  5. Work to date: Tier 2 assays * OECD  in progress completed

  6. Overview of plans: Tier 1

  7. Overview of plans: Tier 2

  8. About the detailed timelines: • Some dates are approximate due to • Uncertainty about length of in-lab phases, report writing, etc. • Meeting dates and procedures not final (can OECD meetings be scheduled when needed? can EDMVS review be coordinated with OECD schedule? etc.) • Detailed steps have not been broken out yet for assay steps relatively far in the future. • ICCVAM review is explicitly shown in some timelines; will be included in all • This is the first draft, subject to change

  9. Details: Receptor binding • Goal: Performance criteria rather than test guideline • May be able to provide draft Background Review Document to EDMVS on an FYI basis in March

  10. Details: Aromatase and Steroidogenesis • Separate but parallel

  11. Details: Uterotrophic* • Data being presented FYI to EDMVS today • Peer review currently under discussion with OECD

  12. Details: Hershberger* • May be able to provide data on an FYI basis to EDMVS in fall of 2002

  13. Details: Fish reproduction

  14. Details: Pubertals (1)

  15. Details: Pubertals (2) • Male and female are parallel but separate • Potential delay due to recent fire in lab

  16. Details: In utero/lactation

  17. Tier 2 assays

  18. Details: Mammalian 2-gen* • PTU demo and one-gen demo will be brought to EDMVS for June 2002 review, but … • possible delay of one-gen due to fire in lab

  19. Details: Avian 2-generation*

  20. Details: Fish chronic/PLC* • Chronic and partial life cycle are separate but parallel • PLC being considered due to difficulty maintaining constant exposures in chronic aquatic studies

  21. Details: Frog chronic/PLC* • Separate but parallel

  22. Details: Invertebrate chronic*?

  23. Details: (Episodic exposure) • General issue, not specific assay • To investigate short-term exposures at critical periods • Mammalian issue paper has started; eco has not begun yet

  24. End of detailed plans

  25. Upcoming EDMVS meetings:December 2001 • Detailed Review Papers • aromatase • steroidogenesis • in utero through lactation • Need for pubertal DRP? • Low dose

  26. Upcoming EDMVS meetings:March 2002 • Detailed Review Papers on OECD assays • Fish reproduction • Fish chronic • Avian chronic • Invertebrate • Frog screen and chronic (?) • Fish repro screen vs. vitellogenin • Dose-setting in validation studies • Restricted feeding study protocol

  27. Upcoming EDMVS meetings:June 2002 • Pubertal prevalidation • single-dose • multiple-dose • array of chemicals • Mammalian two-gen prevalidation • thyroid study • one-gen extension • Steroidogenesis prevalidation • Aromatase prevalidation

  28. Questions for discussion tomorrow • Is the logic of the plan sound? • Are the time estimates reasonable? • Is a Mammalian 2-gen DRP needed? • Is a Mammalian 2-gen practicality study needed? • Should we be concerned about the fire in the lab?

  29. This presentation will be available on the Endocrine Disruptor Method Validation Subcommittee Web site: http://www.epa.gov/scipoly/oscpendo/edmvs.htm

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