01-28309. National Toxicology Program (NTP); National Institute of Environmental Health Sciences (NIEHS); Notice of the Rescheduled Date, New Location, and Revised Agenda for the Workshop, “Assessment of the Allergenic Potential of Genetically ...

Background

The NIEHS and the NTP are organizing a workshop to bring together experts in food allergy, genetically modified crops, and the regulatory aspects of these products, along with bench scientists and clinicians. The workshop's focus is to examine the current state of knowledge in this area, identify the critical issues regarding genetically modified foods, and develop testing strategies to examine the allergenicity of these compounds.

This meeting was previously announced in the Federal Register [August 16, 2001, Volume 66, Number 159, Pages 43201-43022]. The workshop was postponed and is now rescheduled for December 10-12, 2001 at the Sheraton, 1 Europa Drive, Chapel Hill, NC (919-968-4900). This meeting is open to the public.

Revised Tentative Meeting Agenda

Assessment of the Allergenic Potential of Genetically Modified Foods

December 10-12, 2001

Sheraton, 1 Europa Drive, Chapel Hill, NC

Monday, December 10, 2001

7:30-8:30 a.m. Registration

 Welcome

 Introduction

• What are the Issues?—Dr. Dean Metcalfe
• Conclusions from the November 2000 National Center for Food Safety & Technology Conference—Dr. Steven Gendel

Session I: Clinical Aspects and Clinical Investigation of Food Allergy

• Clinical Spectrum of Food Allergy—Dr. Hugh Sampson
• Clinical Assessment of Food Allergy to Novel Proteins—Dr. Sam Lehrer
• Contribution of Inhalation Allergenicity—Occupational / Rural Exposures—Dr. Leonard Bernstein
• Serum Screening and Challenges for Allergenicity Safety Assessment—Dr. Robert Hamilton

12-1:00 p.m. Lunch

• Post-Marketing Surveillance—Dr. Carol Rubin

Session II: Toxicological Evaluation of Novel Proteins

• Assessment of Protein Structure, Sequence Homology and Stability—Drs. Tong-Jen Fu and Gary Bannon

Session III: Regulatory Considerations

Panel Discussion

• A Viewpoint from the U.S. Food and Drug Administration—Dr. Kathleen Jones
• A Viewpoint from the U.S. Environmental Protection Agency—Dr. John Kough
• A Viewpoint from Industry—Drs. Katherine Sarlo, Val Giddings, and James Astwood

Session IV: Risk Communication

• Biotechnology and How the Public Perceives It—Drs. Thomas Hoban and Rebecca Goldburg

5:00 p.m. Open Discussion

Tuesday, December 11, 2001

7:30-8:30 a.m. Registration

Session V: Toxicologic Methods of Safety Assessment

• Oral and Intraperitoneal Exposure of Brown Norway Rats—Dr. Andre Penninks
• Oral and Systemic Exposure of BALB/c Mice—Dr. Ian Kimber
• Assessment of Allergenicity Using Swine Models—Dr. Ricki Helm
• Assessment of Allergenicity in Dogs I—Dr. Robert Buchanan
• Assessment of Allergenicity in Dogs II—Dr. Bruce Hammerberg

12-1:00 p.m. Lunch

 Charge to Breakout Groups

Session VI—Breakout Group Meetings

1. Use of Human Clinical Data for Risk Assessment

2. Animal Models to Assess Food allergy

3. Biomarkers of Exposure and Effect

4. Sensitive Populations

5. Models of Dose Response

6. Post-market Surveillance

Invited meeting participants will divide into these six breakout groups. The public can attend breakout groups as observers, as space permits, and time will be available for observer questions and discussion. Information about breakout groups registration is available in the meeting registration packet (see below).

5:00 p.m. Adjourn

Wednesday, December 12, 2001

7:30-8:30 a.m. Registration

Session VII—Breakout Group Presentations

• Individual Group Presentations

Meeting Summary and Discussion

Consensus Building and Agreement on the Way Forward

12:30 p.m. Adjourn

Meeting Registration Information

This meeting is open to the public and the public is invited to attend as observers. The number of observers will be limited only by the space available. Time will be provided for open discussion each day. Due to space limitations, advance registration is requested by November 30, 2001.

Registration materials as well as further details about the workshop are available on the NTP meeting Web site (http://ntp-server.niehs.nih.gov/​htdocs/​Liason/​GMFoodPg.html). For questions about registration information, contact the NTP Office of Liaison and Scientific Review, 111 T.W. Alexander Drive, NIEHS, MD A3-02, Research Triangle Park, NC 27709: [e-mail]; 919-541-0530 (telephone); 919-541-0295 (fax).

Dated: October 31, 2001.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.