[Federal Register Volume 66, Number 159 (Thursday, August 16, 2001)]
[Notices]
[Pages 43021-43022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Workshop

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

[[Page 43022]]

safety 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: [email protected]; 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: [email protected]; 919-541-3230 (telephone); 919-541-
0870 (fax).

    Dated: August 6, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 01-20599 Filed 8-15-01; 8:45 am]
BILLING CODE 4140-01-P