CODE 4160
A1 AGENDA
Food and Drug
Administration
Center for Food Safety
and Applied Nutrition
|
Food
Advisory Committee Meeting July
13-15, 2005 Advice
on CFSAN’s Draft Report: Approaches
to Establish Thresholds for Major Food Allergens and for Gluten in Food |
Wednesday, July 13, 2005: Approaches to
Establish Thresholds for Food Allergens
8:30 Call
to Order, Welcome, and Introductions
Charge
to the Food Advisory Committee
Richard
Durst, Ph.D.
Acting Chairman,
Food Advisory Committee
8:40 Conflict
of Interest Statement & Other Instructions
Marcia Moore
Executive Secretary,
Food Advisory Committee, FDA
8:45 Opening
Statement
Michael M. Landa, Esq.
Deputy Director for Regulatory Affairs, CFSAN,
FDA
8:50 Use
of Food Allergen Thresholds
Catherine L. Copp, Esq.
Policy Advisor, CFSAN, FDA
9:00 Introduction
to Food Allergens
Robert Wood, M.D.
Professor, Johns Hopkins
University School of Medicine
9:40 Patient
Perspectives on Food Allergies
Anne Munoz-Furlong
Director, Food Allergy
& Anaphylaxis Network
10:00 Allergenicity:
Analytical Methods
Susan Hefle, Ph.D.
Associate Professor and Co-Director, Food
Processing Center, University of Nebraska
10:30 Break
10:40 Clinical
Studies: Interpreting Oral Challenge Studies
Stefano Luccioli, M.D.
Senior Medical Advisor,
CFSAN, FDA
11:30 Threshold
Modeling Approach
Rene Crevel, Ph.D.
Senior Scientist, Unilever, Safety and
Environmental Assurance Centre, United Kingdom
12:00 Food
Allergen Thresholds
Steve Taylor, Ph.D.
Maxcy Distinguished Professor & Director, Food
Processing Center, University of Nebraska
12:30 Lunch
2:00 Overview
of Approaches to Establishing Thresholds: Allergens
Steven M. Gendel, Ph.D.
Senior Scientist, National
Center for Food Safety and Technology, FDA
2:15 Public
Comments (Pre-registration is required)
3:15 Break
3:30 Committee
Discussion
Review
of the charge and questions from FDA
Thursday, July 14, 2005: Approaches to
Establishing Thresholds for Gluten
8:30 Call
to Order and Welcome and Introductions
Richard
Durst, Ph.D.
Acting Chairman,
Food Advisory Committee
8:40 Use
of Gluten Thresholds
Catherine L. Copp, Esq.
Policy Advisor, CFSAN, FDA
8:45 Introduction
to Celiac Disease
Joseph Murray, M.D.
Professor of Medicine, the
Mayo Clinic of Rochester, Minnesota
9:30 Patient
Perspectives on Celiac Disease
Cynthia Kupper, R.D., C.D.
Executive Director
Gluten Intolerance Group
of North America
9:50 Grains
Donald Kasarda, Ph.D.
Consultant and Retired
Senior Scientist, Agricultural Research Service, USDA
10:30 Break
10:45 Prospective
Studies on Celiac Disease
Alessio Fasano, M.D.
Professor of Pediatrics, Medicine &
Physiology and Director, the Mucosal Biology Research Center, Center for Celiac
Research, University of Maryland School of Medicine
11:25 Retrospective
Studies
Pekka Collin, M.D., M.P.H.
Professor, University of Tampere, Medical
School, Finland
12:05 International
Perspectives on Gluten-Free
Rhonda
R. Kane, M.S., R.D.
Consumer Safety Officer,
CFSAN, FDA
12:30 Lunch
2:00 Overview
of Approaches to Establishing Thresholds: Gluten
Steven M. Gendel, Ph.D.
Senior Scientist, National
Center for Food Safety and Technology, FDA
2:15 Public
Comments (Pre-registration is required)
3:15 Break
3:30 Committee Discussion
Review of the charge and questions from FDA
(Please note that the
meeting begins at 8:00a.m. tomorrow, July 15, 2005.)
Friday, July 15, 2005: Discussion and
Response
8:00 Call
to Order and Welcome and Introductions
Richard
Durst, Ph.D.
Acting Chairman,
Food Advisory Committee
8:10 Committee’s Discussion
and Response to FDA’s Charge and Questions
11:55 Closing
Comments
Michael M. Landa, Esq.
Deputy Director for Regulatory Affairs, CFSAN,
FDA
12:00 Adjourn
Richard
Durst, Ph.D.
Chairman,
Food Advisory Committee