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National Institute of Environmental Health Sciences (NIEHS)

Immunologic Issues Concerning Genetically Modified Food
September 24 – 26, 2001 Research Triangle Park, NC


Monday, September 24
8:30 a.m. Meeting Begins/Welcome


What are the issues?
Dr. Dean Metcalfe

National Center for Food Safety and Technology Conference Conclusion, November 2000
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

The Role of Eosinophils in Food Allergy
Dr. Marc Rothenberg
12:00 p.m.  Post-Marketing Surveillance
Dr. Carol Rubin
  Session II: Toxicological Evaluation of Novel Proteins

Assessment of Protein Structure, Sequence Homology, and Stability
Dr. Tong-Jen Fu, Dr. Gary Bannon
  Session III: Regulatory Consideration

Panel Discussion:
This session will consist of short presentations from regulatory and industry scientists followed by a panel discussion. Panelists will consider what studies (data) are most useful in assessing the safety of exposure to potentially allergenic substances and what are the biggest uncertainties.
Speakers/Panelists: Dr. Laura Tarantino (FDA), Dr. John Kough (EPA), Dr. James Astwood (Monsanto), Dr. Katherine Sarlo (Proctor and Gamble), Dr. Val Giddings (Biosys)
  Session IV: Risk Communication

Biotechnology and How the Public Perceives It
Dr. Thomas Hoban, Dr. Rebecca Goldburg
5:00 p.m.  Open Discussion
Tuesday, September 25
  Session V: Toxicologic Methods of Safety Assessment
8:30 a.m.  Meeting Begins/Overview

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 in Dogs
Dr. Robert Buchanan

Assessment of Allergenicity Using Swine Models
Dr. Ricki Helm

Serum Screening & Challenges for Allergenicity Safety Assessment
Dr. Susan Hefle
12:00 p.m.  Charge to Breakout Groups:
The afternoon of the 25 will be devoted to breakout sessions. Breakout group reports will be presented the morning of the 26. Meeting participants will divide into breakout groups that will address questions and evaluate research needs as listed below. It is anticipated that each breakout group will consist of 8–10 individuals with varied expertise. On the final day of the meeting, each breakout group will report on their discussions of the state of the science, the research gaps in the specific area, and approaches to address these gaps.

What are the research needs in the areas of:
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
  Session VI: Breakout Group Meetings

Address Questions, Research Needs, and Areas of Particular Focus Observer Question and Discussion Session (Within Breakout Groups)
5:00 p.m.  Adjourn
Wednesday, September 26
  Session VII: Breakout Group Presentations
8:30 a.m.  Meeting Begins/Presentations

Meeting Summary and Discussion

Consensus Building and Agreement on the Way Forward
12:30 p.m.  Adjourn

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Last Reviewed: August 24, 2005
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