# Presentation: 009834

## The EDMVS’Draft Work Plan

- Presentation to the EDMVS,
-  December 10, 2001

##  Today’s talk will identify

- the assays
- the major milestones for each assay
- when the assay milestones will be reviewed by EDMVS
- the OECD interactions

## Tier I Screening Battery recommended for consideration by EDSTAC 

- Steroidogenesis  (EPA)
- Pubertal - female  (EPA)
- Fish reproduction  (EPA lead for OECD)
- Frog Thyroid  (EPA lead for OECD)
- Estrogen/Androgen receptor/ binding & reporter gene (ICCVAM for EPA)
- Hershberger   (OECD)
- Uterotrophic   (OECD)

## Alternative Assays recommended for consideration by EDSTAC 

- Tier I
- Aromatase (EPA)
- Pubertal male (EPA)
- Adult 14 –day intact male (Industry)
- Tier ?
- In Utero through Lactation (EPA)

## Tier II Assays recommended for consideration by EDSTAC

- Mammalian 2-generation (EPA / OECD)
- Avian 2-generation (EPA lead for OECD)
- Amphibian chronic (EPA lead for OECD)
- Invertebrate Chronic (EPA lead for OECD)
- Fish Chronic (EPA lead for OECD)

## Steroidogenesis (Tier I)

-    _Milestone _                                  _Meeting Date_
- DRP  				March 2002
- Prevalidation Report	Oct 2002
- Validation Report		May 2003
- Integrated Summary	May 2003

## Pubertal – female (Tier I)

-      _Milestone _                                 _Meeting Date_
- DRP equivalent		Dec 2001
- Prevalidation Report	Oct 2002
- Validation Report		July 2003
- Integrated Summary	July 2003

## Fish Reproduction (Tier I)

-      _Milestone _                                _Meeting Date_
- DRP                             March 2002
- Prevalidation Report 	Dec 2002
- Validation Report 		July 2003
- Integrated Summary	July 2003
- OECD interaction: US lead within OECD.  Timelines Pending.

## Frog Thyroid (Tier I)

-      _Milestone_			_Meeting Date_
- DRP                  	June 2002
- evaluate utility & future of assay before setting milestone dates

## ER/AR binding/reporter gene (Tier I)

**ICCVAM **
- DRP, Prevalidation, Validation & Integrated Summary Reports
- Expert Consultation            May 2002
- Peer Review                       Fall  2002
**EDMVS **
- reviews ICCVAM Peer Review Report Spring 2003
- provides recommendation on Tier I battery                        Oct 2003

## Hershberger (Tier I)

**OECD**
- Completed prevalidation
- Validation Fall 2002
**EDMVS**
- reviews Integrated Summary Report Feb 2003
- provides recommendation on Tier I battery                            Oct 2003

## Uterotrophic (Tier I)

**OECD**
- Validation process completed
**EDMVS**
- reviews Integrated Summary  Feb 2003
- provides recommendation on Tier I battery	                  Oct 2003

## Aromatase (Tier I)

-      _Milestone _                                 _Meeting Date_
- DRP  				March 2002
- Prevalidation Report	Oct 2002
- Validation Report		May 2003
- Integrated Summary	May 2003

## Pubertal – male (Tier I)

-      _Milestone _                                 _Meeting Date_
- DRP equivalent		Dec 2001
- Prevalidation Report	Oct 2002
- Validation Report		July 2003
- Integrated Summary	July 2003

## Adult 14-day intact male (Tier I)

- Development supported by Industry
- EDMVS reviews EPA paper comparing results of adult 14-day intact male,  pubertal male, and OECD 407  July 2003

## In Utero through Lactation (Tier ?)

-      _Milestone _                                 _Meeting Date_
- DRP				Today
- Prevalidation Report	Dec 2002
- Validation Report		Oct 2003
- Integrated Summary 	Oct 2003

## Tier II Assays

## Mammalian 2-generation (Tier II) 

-       _Milestone _                                            _Meeting Date_
- DRP                            none planned
- Prevalidation Report     Feb 2003
- Validation Report              2004
- Integrated Summary         2004
- OECD interaction:     Likely to be US lead within OECD.  Timelines     pending:  OECD acknowledges need to revise     guideline, but will finish revisions currently in
-          process first.

## Avian 2-generation (Tier II)  

-      _Milestone _                                             _Meeting Date_
- DRP                                    March 2002
- Prevalidation Report             2004
- Validation Report                  2004
- Integrated Summary             2004
- OECD interaction: 	US lead within OECD.  Timelines pending.

## Amphibian Chronic (Tier II) 

-      _Milestone _                                _Meeting Date_
- DRP                                  Oct 2002
- Prevalidation Report         May 2003
- Validation Report                   2004
- Integrated Summary              2004
- OECD interaction: 	US lead within OECD.  Timelines pending.

## Invertebrate Chronic (Tier II) 

-      _Milestone _                                   _Meeting Date_
- DRP                                     June 2002
- Prevalidation Report            May 2003
- Validation Report                   2004
- Integrated Summary              2004
- OECD interaction: US lead within OECD.  Timelines pending.

## Fish Chronic  (Tier II)

-      _Milestone _                                     _Meeting Date_
- DRP			    March 2002
- Prevalidation		    May 2003
- Validation		            2004
- Integrated Summary             2004
- OECD interaction: 	US lead within OECD.  Timelines pending.

## Assays and Milestones for Future EDMVS Meetings

**March 2002**
- Steroidogenesis DRP
- Fish Reproduction DRP
- Aromatase DRP
- Avian  2-gen DRP
- Fish Chronic DRP

## June 2002

- Frog Thyroid DRP
- Invertebrate DRP

## October 2002

- Steroidogenesis  Preval. Report
- Pubertal - female Preval. Report
- Pubertal - male Preval. Report
- Aromatase Preval. Report
- Amphibian DRP

**December 2002**
- Fish repro. Preval. Report
- In utero  Lactation Preval. Report
**February 2003**
- Hershberger Integrated Summary
- Uterotrophic Integrated Summary
- Mammalian 2-gen Preval. Report

## May 2003

- Validation & Integrated Summary Reports:
- Steroidogenesis
- Aromatase
- Prevalidation Reports:
- Amphibian Chronic
- Invertebrate Chronic
- Fish Chronic

## July 2003

- Validation & Integrated Summary Reports:
- Pubertal - male
- Pubertal - female
- Fish Reproduction
-  Comparison Paper – adult 14-day intact male, pubertal male, and OECD 407

## October 2003

- In Utero through Lactation Validation & Integrated Summary Report
- Tier I Screening Battery Composition Review

## - 2004 -

- Validation & Integrated Summary Reports:
- Mammalian 2-gen
- Amphibian Chronic
- Invertebrate Chronic
- Fish Chronic
- Avian 2-gen Preval., Validation & Integrated Summary  Reports

## March Agenda

- Steroidogenesis DRP
- Fish Reproduction DRP
- Aromatase DRP
- Avian  2-gen DRP
- Fish Chronic DRP
- Other Issues: Low dose