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National Toxicology Program; Workshop

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SUMMARY:

National Toxicology Program (NTP); National Institute of Environmental Health Sciences (NIEHS); Announces a Workshop on the “Assessment of the Allergenic Potential of Genetically Modified Foods,” September 24-26, 2001, Durham Marriott at the Civic Center, 201 Foster Street, Durham, NC.

Background

There is growing concern among the general public and the scientific community regarding the potential toxicity of genetically modified (GM) foods. Of specific interest is the ability of GM proteins to elicit potentially harmful immunologic responses including hypersensitivity and/or autoimmunity. The lack of information on the potential toxicity of these products has created a considerable backlash against the producers and users of these crops. This workshop will gather experts in food allergy, GM crops, and the regulatory aspects of these products, along with bench scientists and clinicians, to examine the current state of knowledge in the area, identify the critical issues regarding these materials, and develop testing strategies to examine the allergenicity of these compounds.

Sponsors for the workshop include the Office of Research and Development, U.S. Environmental Protection Agency; National Toxicology Program, Department of Health and Human Services; National Institute of Environmental Health Sciences, National Institutes of Health; Office of Rare Diseases, National Institutes of Health; Center for Food Safety and Nutrition, U.S. Food and Drug Administration. The workshop is organized by the National Institute of Environmental Health Sciences and the National Toxicology Program, Research Triangle Park, North Carolina.

Preliminary Meeting Agenda

Monday, September 24, 2001

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

12:00 p.m.

Lunch

Post-Marketing Surveillance—Dr. Carol Rubin

Session II: Toxicological Evaluation of Novel Proteins

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

Session III: Regulatory Considerations

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 Start Printed Page 43022safety of exposure to potentially allergenic substances and what are the biggest uncertainties.

Speaker/Panelist—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, 2001

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 Allergencity Using Swine Models—Dr. Ricki Helm

Serum Screening & Challenges for Allergenicity Safety Assessment—Dr. Susan Hefle

12: 00 p.m.

Lunch

Charge to Breakout Groups:

The afternoon of the 25th will be devoted to breakout sessions. Breakout group reports will be presented the morning of the 26th. 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, 2001

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

Open to the Public/Registration Information

The public is invited to attend the workshop as observers. The number of observers will be limited only by the space available. An open discussion session is scheduled each day to provide an opportunity for observers to contribute to the scientific discussion. Due to space limitations, advance registration is requested by August 31, 2001. For registration information, contact Ms. Angie Sanders, NTP Office of Liaison and Scientific Review, 111 T.W. Alexander Drive, NIEHS, MD A3-02, Research Triangle Park, NC 27709: sanders5@niehs.nih.gov; 919-541-0530 (telephone); 919-541-0295 (fax). For additional information or to view the registration package, please access the meeting web page located on the NTP web site: http://ntp-server.niehs.nih.gov/​htdocs/​Liason/​GMFoodPg.html. For scientific information, contact Dr. Dori Germolec: germolec@niehs.nih.gov; 919-541-3230 (telephone); 919-541-0870 (fax).

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Dated: August 6, 2001.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 01-20599 Filed 8-15-01; 8:45 am]

BILLING CODE 4140-01-P