Agenda
FOOD AND DRUG ADMINISTRATION
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
July 17 & 18, 2003
Holiday Inn Select
8120 Wisconsin Avenue
Bethesda, MD 20814
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
TSEAC AGENDA
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
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
8:00 a.m. Administrative
Remarks
8:10 TSEs
and Decontamination: Introductory Presentations (continued)
A Model for Evaluating TSE Decontamination of Metal Objects: Recent
Progress
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
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