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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

EDSP’sTest Protocol Validation Program

Status and Timeline

presentation to the Endocrine Disruptor Methods Validation Subcommittee, October 30, 2001

today s talk will include
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
settlement agreement
Settlement Agreement
  • Only the milestones related to validation of assays are shown
work to date tier 1 assays
Work to date: Tier 1 assays

* OECD  in progress completed

work to date tier 2 assays
Work to date: Tier 2 assays

* OECD  in progress completed

about the detailed timelines
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
details receptor binding
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
details uterotrophic
Details: Uterotrophic*
  • Data being presented FYI to EDMVS today
  • Peer review currently under discussion with OECD
details hershberger
Details: Hershberger*
  • May be able to provide data on an FYI basis to EDMVS in fall of 2002
details pubertals 2
Details: Pubertals (2)
  • Male and female are parallel but separate
  • Potential delay due to recent fire in lab
details mammalian 2 gen
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
details fish chronic plc
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
details frog chronic plc
Details: Frog chronic/PLC*
  • Separate but parallel
details episodic exposure
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

upcoming edmvs meetings december 2001
Upcoming EDMVS meetings:December 2001
  • Detailed Review Papers
    • aromatase
    • steroidogenesis
    • in utero through lactation
  • Need for pubertal DRP?
  • Low dose
upcoming edmvs meetings march 2002
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
upcoming edmvs meetings june 2002
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
questions for discussion tomorrow
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?
slide29

This presentation will be available on the

Endocrine Disruptor Method Validation Subcommittee Web site:

http://www.epa.gov/scipoly/oscpendo/edmvs.htm