AGENDA ITEMS - DAY 2

Should the FDA take measures to insure that sheep and goats originating from or residing in high risk countries where BSE occurs are safe sources of materials for the manufacture of FDA regulated products? (14 x yes = unanimous)
Should the FDA take measures to insure that sheep and goats originating from or residing in high risk countries where Scrapie occurs are safe sources of materials for the manufacture of FDA regulated products? (14 x yes = unanimous)
Meeting Details
Attendees
Dr Freas
     Proceedings
Dr Brown
     Introduction
Dr. Charles Durfor, Ph.D. Center for Devices and Radiological Health in the FDA
     Status of revising the guidance for the preparation of a pre-market notification
     application for processed human dura mater
Dr David Asher, M.D. Center for Biologics Evaluation and Research of the FDA
     Safe sourcing of materials from sheep and goats in countries not free of ruminant TSEs
Professor Almond, Ph.D. Pasteur-Marieux Connaught
     The Potential Risk of Introducing BSE Agent into Sheep and Goats in Europe
Dr Richard Race, C.V.M. Rocky Mountain Laboratory
     Infectivity in sheep tissues
Dr. Diane Sutton, D.V.M. USDA
     Potential for Human and Animal Exposures to Animal TSE Agents in the USA
Dr, John Honstead, D.V.M. FDA
     The briefest summary of the FDA regulation that's ever been given in history
Dr Lisa Ferguson, D.V.M. USDA
     Measures for consideration in assuring scrapie free sources of sheep and goat derived
     materials
Dr Kiki B Hellman, Ph.D. Center for Diseases and Radiological Health in the FDA
     Committee charge and presentation of questions,
All Participants
     Discussion