# Presentation: 035765

## 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
- questions for your consideration
- upcoming EDMVS meeting topics

## Settlement Agreement

- Only the milestones related to validation of assays are shown

## Work to date: Tier 1 assays

|  | Detailed Review Paper | Pre-validation | Validation |
| --- | --- | --- | --- |
| ER/AR binding |  |  |  |
| Uterotrophic* |  |  |  |
| Hershberger* |  |  |  |
| Pubertals |  |  |  |
| Frog metamorphosis |  |  |  |
| Fish repro screen* |  |  |  |
| Steroidogenesis |  |  |  |
| Aromatase |  |  |  |

- *  OECD          in progress       completed

## Work to date: Tier 2 assays

|  | Detailed Review Paper | Pre-validation | Validation |
| --- | --- | --- | --- |
| Mammalian 2-gen* |  |  |  |
| Avian 2-gen* |  |  |  |
| Amphibian chronic* |  |  |  |
| Invertebrate chronic*? |  |  |  |
| Fish chronic* |  |  |  |
|  |  |  |  |
| In utero/lactation |  |  |  |

- *  OECD          in progress       completed

## Overview of plans: Tier 1

## Overview of plans: Tier 2

## 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

- 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: Aromatase and Steroidogenesis

- Separate but parallel

## Details: Uterotrophic*

- Data being presented FYI to EDMVS today
- Peer review currently under discussion with OECD

## Details: Hershberger*

- May be able to provide data on an FYI basis to EDMVS in fall of 2002

## Details: Fish reproduction

## Details: Pubertals (1)

## Details: Pubertals (2)

- Male and female are parallel but separate
- Potential delay due to recent fire in lab

## Details: In utero/lactation

## Tier 2 assays

## 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: Avian 2-generation*

## 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*

- Separate but parallel

## Details:  Invertebrate chronic*?

## 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

## End of detailed plans

## 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

- 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

- 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

- 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?

## 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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