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Pubertals and One-generation Extension

Pubertals and One-generation Extension. Overview of questions. Does the fire raise significant concerns? Should the EPA bring the pubertal and one-gen extension study designs to EDMVS before moving forward?

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Pubertals and One-generation Extension

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  1. Pubertals andOne-generation Extension

  2. Overview of questions • Does the fire raise significant concerns? • Should the EPA bring the pubertal and one-gen extension study designs to EDMVS before moving forward? • Should EPA halt prevalidation studies that have been begun in parallel with DRP development, until EDMVS approves the DRPs?

  3. Does the fire raise significant concerns? • Is Bisphenol A an issue? • Does EDMVS wish to see the final report of the independent review panel? • yes, before moving forward • yes, but go ahead in the meantime • no, the fire is not a significant issue

  4. Fire considerations • If fire report is brought to EDMVS • one-gen study will not start Nov. 14 • pubertal array study may not begin in early January

  5. Pubertals • Single-dose data • Multi-dose • study design, chemical & dose selection • Multiple-chemical array • study design, chemical & dose selection

  6. Pubertal considerations • December agenda, unavailability of alternative dates. Extend Dec. meeting? • Review time for single-dose data • (not available in soft copy) • Study design is currently based on the expert advice of developers of assay (EPA/RTP)

  7. One-generation extension • New protocol, never performed • Developed by EPA/RTP • Reviewed by P. Foster, CIIT • Proof-of-concept only; multi-chemical study will be done later

  8. Details: Pubertals (1)

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

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

  11. 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

  12. 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

  13. 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?

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