National Institute of Environmental Health Sciences (NIEHS)
Immunologic Issues Concerning Genetically Modified Food
September 24 – 26, 2001 • Research Triangle Park, NC
Agenda
| Monday, September 24 |
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| 8:30 a.m. | Meeting Begins/Welcome
Introduction: 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 |
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| 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 |
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| 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) |
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| Session IV: Risk Communication
Biotechnology and How the Public Perceives It Dr. Thomas Hoban, Dr. Rebecca Goldburg |
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| 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) |
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| 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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