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