Federal Register: August 16, 2001 (Volume 66, Number 159)
DOCID: FR Doc 01-20599
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program; Workshop
DOCUMENT 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 2426, 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 2000Dr. Steven Gendel
Session I: Clinical Aspects and Clinical Investigation of Food Allergy
Clinical Spectrum of Food AllergyDr. Hugh Sampson
Clinical Assessment of Food Allergy to Novel ProteinsDr. Sam Lehrer
Contribution of Inhalation AllergenicityOccupational/Rural ExposuresDr. Leonard Bernstein
The Role of Eosinophils in Food AllergyDr. Marc Rothenberg 12:00 p.m.
Lunch
PostMarketing SurveillanceDr. Carol Rubin
Session II: Toxicological Evaluation of Novel Proteins
Assessment of Protein Structure, Sequence Homology and Stability Dr. TongJen 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
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safety of exposure to potentially allergenic substances and what are the biggest uncertainties.
Speaker/PanelistDr. 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 ItDr. 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 RatsDr. Andre Penninks
Oral and Systemic Exposure of BALB/c MiceDr. Ian Kimber
Assessment of Allergenicity in DogsDr. Robert Buchanan
Assessment of Allergencity Using Swine ModelsDr. 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 810 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. Postmarket Surveillance
Session VIBreakout 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 VIIBreakout 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; 919541
0530 (telephone); 9195410295 (fax). For additional information or to
view the registration package, please access the meeting web page
located on the NTP web site: http://ntpserver.niehs.nih.gov/htdocs/
Liason/GMFoodPg.html. For scientific information, contact Dr. Dori
Germolec: germolec@niehs.nih.gov; 9195413230 (telephone); 919541 0870 (fax).
Dated: August 6, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 0120599 Filed 81501; 8:45 am]
BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; Genetically modified foods; allergenic potential assessment; workshop,