July 17 & 18, 2003

Holiday Inn Select

8120 Wisconsin Avenue

Bethesda, MD 20814



First Day, Thursday, July 17, 2003


 8:00  a.m.            Administrative Remarks

 8:10                 Opening Remarks

                                    Dr. Suzette Priola, Chairperson


 8:20    Topic # 1 - Safety of Bovine Bone Gelatin in Oral and Topical Drugs, Food and Cosmetics


Background and Introduction

Dr. Morrie Potter, CFSAN, FDA (15’)           

Questions to the Committee

Dr. Yuan-yuan Chiu, CDER, FDA (10’)             

Market Trend in United States

Mr. George Masson, President GMIA (20’)               

Manufacturing Process for Bone Gelatin – Industry Practices in United States

Dr. Michael Dunn, Vice President, Chairman of the Regulatory Committee, GMIA (20’)

Manufacturing Process for Bone Gelatin – Industry Practices in Europe

Mr. Reinhard Schrieber, Chief Manufacturing Officer, Deutsche Gelatine-Fabriken Stoess AG, Gelita Group  (20’)

 9:45                 Break

10:00                Reports of Three GME Validation Studies on Bone Gelatin

Dr. Robert Sommerville, IAH Edinburgh, UK (60’)

Risk Analysis of Infectivity

Dr. Ron Rogers, Health Canada, Ottawa (15’)           

USDA Gelatin Policy

Dr. Terry Morris, APHIS (20’)           

11:35                Open Public Hearing                                                                      

11:55                Committee Discussion and Voting  

12:25 p.m.            Lunch





First Day, Thursday, July 17, 2003 (continued)


  1:25 p.m.            Topic # 2 - BSE in Canada                                  


                        Potential Exposure of Blood Donors in North America to the BSE Agent

                                    Dr. Jay Epstein, Director, OBRR, CBER, FDA (5’)

Review of Bovine Spongiform Encephalopathy in Canada (15’)

Dr. Robert Hills, Health Canada, Ottawa

 1:45                 Open Public Hearing

 2:15                 Committee Discussion


Topics # 3 and # 4: General Introduction


TSEs and Decontamination of Medical Equipment and Facilities


2:45                 TSEs, Decontamination and FDA Regulated Products

Dr. David M. Asher, OBRR, CBER, FDA (10’)                                   


2:55                  Invited Speakers


            Principles of TSE Inactivation: Validation and Use of Infectivity Assays and Assays for Abnormal Prion Proteins,

Dr. Robert Rohwer, Director Molecular Neurovirology Unit, VA Medical Center, Baltimore             (20’)           

Review of Effective Decontamination of TSE Agents: Basis for WHO Recommendations,

Dr. David Taylor, SEDECON 2000, UK            (30’)           

3:45                  Questions for Previous Speakers

3:55                  Reducing the Risk of CJD Transmission through Surgical Procedures: Experience in UK, (30’)

Dr. Philippa Edwards, Principal Scientist, CJD Policy Team, UK

TSE Agents and Infection Control in Hospitals: Experience in USA

Dr. William Rutala, UNC             (20’)                       

 4:45                 Break


5:00                 Preliminary Results: Infectivity of Air Emissions and Residues from Simulated Incineration of Scrapie Tissues

Capt. Edward Rau, Environmental Health Officer, NIH            (30’)           

TSE Infectivity: Experience with Models for Validating Decontamination of Surfaces and Effects of Decontamination on Materials (30’)

Drs. David M. Asher, CBER and Stanley Brown, CDRH

 6:00 p.m.            Adjourn






Second Day, Friday, July 18, 2003


 8:00 a.m.            Administrative Remarks

 8:10                TSEs and Decontamination: Introductory Presentations (continued)

A Model for Evaluating TSE Decontamination of Metal Objects: Recent


                                    Dr. C. Weissmann, MRC Prion Unit, Imperial Coll., London  (30’)

TSE Decontamination: Studies Relevant to Facility and Equipment Cleaning

Dr. Cristoph Kempf, Plasma Protein Therapeutics Association (PPTA) (15’)


8:55    Topic # 3 – Reprocessing of Medical Devices, Contaminated or Potentially Contaminated with TSE agents


                        Introduction  (10’)

Ms. Lillian Gill, CDRH, Senior Associate Director for Science

Background: Validating Sterilization of Medical Devices (20’) 

                        CDR Martha O’Lone, Infection Control Devices Branch, CDRH

 9:25                 Open Public Hearing

10:20                BREAK

10:35                Presentation of Topic 3 Questions        

Dr. Charles Durfor, CDRH, FDA                                               

Committee Discussion and Voting on Topic 3 Questions

11:50                Lunch


12:50   Topic # 4 - Methods to Decontaminate Facilities and Equipment Used to Prepare Human Cells, Tissue & Cellular and Tissue-Based Products (HCT/Ps), and Human Blood Products, Including Plasma Derivatives, to Reduce the Theoretical Risk of Transmitting TSE Agents.


Methods used in Human Cells, Tissues & Cellular and Tissue-Based Product (HCT/P) Establishments

Dr. R. Solomon  (10’)           

Methods used in Eye Banks

                                    Ellen Heck, UT Southwestern Medical Center  (10’)

Methods used in Plasma Derivative Manufacturing

Dr. D. Scott, OBRR, CBER, FDA  (10’)           

Decontamination Practices for Plasma Product Facilities

Dr. Christoph Kempf , PPTA  (10’)

Proposed PPTA-Sponsored Collaborative Study on Inactivation of TSE Agents with Sodium Hydroxide and Sodium Hypochlorite, commonly used to clean and decontaminate facilities and equipment in manufacture of plasma derivatives

Dr. Andrew Bailey, PPTA  (15’)

 1:45                 Open Public Hearing  (30’)

 2:15                 Presentation of Topic 4 Questions 

Committee Discussion and Voting on Topic 4 Questions 

 4:15 p.m.               Adjourn