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National Advisory Council for Environmental Policy and Technology (NACEPT)
Endocrine Disruptor Methods Validation Subcommittee (EDMVS)
Plenary Meeting - June 5-6, 2003

RESOLVE
1255 23rd Street, N.W., Suite 275
Washington, DC 20037
(202) 944-2300

Meeting Objectives:

Review and discuss the status/results of the prevalidation work on the aromatase assay, steroidogenesis assay, the one generation extension study, and the mammalian two generation assay; and

Provide input and advice on the EDSP’s validation plans for the steroidogenesis assay and mammalian two generation assay.

Thursday,  June 5, 2003

9:00 – 9:10 Welcome and Opening Comments 

Joe Merenda, EDMVS Chair and Director, Office of Science Coordination and Policy (OSCP), EPA

9:10 – 9:30 Introduction, Agenda Review, and Review of Previous Meeting Summary

Paul De Morgan, Facilitator, RESOLVE

9:30 – 10:00   Review of EDMVS Work Plan

Jane Smith, EDMVS Designated Federal Official (DFO), OSCP, EPA

10:00 – 10:15  Review of EDMVS Member Selection Process

Jane Smith, EDMVS DFO, OSCP, EPA

10:15 – 10:30  Break

10:30 – 11:30  Presentation on Status of Aromatase Assay (Tier I): Optimization and Performance Comparison of the Assay Using Placental Tissues (Porcine, Human, Bovine) and Human Recombinant Receptor

Jim Matthews, Ph.D., Research Triangle Institute (RTI)

11:30 – 12:30  Update of OECD EDTA Activities

Gary Timm and Les Touart, Ph.D., OSCP, EPA

12:30 – 1:45    Lunch

1:45 – 2:30    Presentation and Discussion of Steroidogenesis Assay (Tier I): Preliminary Results of the Optimization of the Protocol using Sliced Testes

Carol Sloan, Ph.D., RTI

2:30 – 3:15 Presentation and Discussion of EDSP’s Prevalidation and Validation Plans for Steroidogenesis

Gary Timm, OSCP, EPA

3:15 – 3:30 Break

3:30 – 4:30  Discussion of Steroidogenesis Plans and Related Issues

4:30 – 5:00 Public Comment

Members of the public will be given an opportunity to comment on any aspect of the EDMVS work.  The amount of time given to each individual will depend on the number of people wishing to provide comment.

5:00 Adjourn

Friday,  June 6, 2003

8:30 – 8:45  Settling In

8:45 – 10:30 Study Results, Comments, and Discussion of One Generation Extension

Julia George, Ph.D., RTI and Paul Foster, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

10:30 – 10:45  Break

10:45 – 12:00  Presentation and Discussion of EDSP Validation Plan for the Mammalian Two Generation Assay

Jim Kariya, OSCP, EPA

12:00 – 1:15    Lunch

1:15 – 2:30  Continued Discussion of EDSP Validation Plan for Mammalian Two Generation Assay

2:30 – 3:00  Next Steps and Agenda for August Meeting

3:00 Adjourn


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