Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

July 17, 2003


Questions on Safety of Bovine Bone Gelatin in Oral and Topical Drugs, Foods and Cosmetics (HTM) (PPT)

U.S. Market Dynamics for Bovine Bone Gelatin, George Mason, GMIA (HTM) (PPT)

Bovine Bone Sourcing Practices and Bone Gelatin Manufacturing Processes in the United States, Dr. Michael Dunn, PhD, FDA (HTM) (PPT)

Raw Materials Sourcing and Bone Gelatin Manufacturing Practices in Europe, GME (HTM) (PPT)

TSE Infectivity Reduction During Gelatine Extraction Processes, Ad Grobben, (HTM) (PPT)

vCJD Risk to Consumers Eating Foods Containing Small Amounts of Processed Ruminant Product - Modelling and Assumptions, FDA (PDF)

USDA Gelatin Policy, Terry A. Morris, USDA (HTM) (PPT)

The Canadian BSE Case and Publich Health, Health Canada (PDF)

Transmissible Spongiform Encephalopathies: Decontamination of Agent and FDA-Regulated Products, Dr. David Asher, MD (HTM) (PPT)

CJD: Recommendations for Disinfection and Sterilization in Health Care, Dr. William Rutala, PhD, MPH, University of North Carolina (HTM) (PPT)

Studies on the Inactivation of Scrapie-Infected Brain Tissue by Incineration, Paul Brown, Edward Rau and Paul Lemieux (PDF)

Transmissible Spongiform Encephalopathies: Two Models for Evaluating Effects of Cleaning and Decontamination Measures on Residual Agent Infectivity, Dr. David Asher, MD, FDA (HTM) (PPT)

CDRH - CBER TSE Instrument Decontamination Project, Stanley Brown,, FDA (HTM) (PPT)

Open Public Hearing

Requests and Comments for Open Public Hearing (HTM) (PDF) (Word)

The TSE-Safety of Serologicals Products: Use in Global Healthcare, Wayne Vaz, Serologicals Corporation (HTM) (PPT)

Letter From David Bieging on Behalf of Gelatin Manufacturers of Europe (GME) and the Gelatin Manufacturers Institute of America (GMIA) (PDF)

Some Observations on the Deferral of Volunteer Blood Donors for nvCJD Risk, Dr. Merlyn H. Sayers, MB, BCh., P.D, UT Southwestern Medical Center (HTM) (PPT)

Letter Regarding the Ban on Canadian Ruminants and Ruminant Products, Dr. Peter Lurie, MD, MPH,, Public Citizen (PDF)