[Federal Register Volume 66, Number 219 (Tuesday, November 13, 2001)]
[Notices]
[Pages 56839-56840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program (NTP); National Institute of 
Environmental Health Sciences (NIEHS); Notice of the Rescheduled Date, 
New Location, and Revised Agenda for the Workshop, ``Assessment of the 
Allergenic Potential of Genetically Modified Foods''

Background

    The NIEHS and the NTP are organizing a workshop to bring together 
experts in food allergy, genetically modified crops, and the regulatory 
aspects of these products, along with bench scientists and clinicians. 
The workshop's focus is to examine the current state of knowledge in 
this area, identify the critical issues regarding genetically modified 
foods, and develop testing strategies to examine the allergenicity of 
these compounds.
    This meeting was previously announced in the Federal Register 
[August 16, 2001, Volume 66, Number 159, Pages 43201-43022]. The 
workshop was postponed and is now rescheduled for December 10-12, 2001 
at the Sheraton, 1 Europa Drive, Chapel Hill, NC (919-968-4900). This 
meeting is open to the public.

[[Page 56840]]

Revised Tentative Meeting Agenda

Assessment of the Allergenic Potential of Genetically Modified 
Foods

December 10-12, 2001

Sheraton, 1 Europa Drive, Chapel Hill, NC

Monday, December 10, 2001

7:30-8:30 a.m.  Registration
  Welcome
  Introduction
     What are the Issues?--Dr. Dean Metcalfe
     Conclusions from the November 2000 National Center for 
Food Safety & Technology Conference--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
     Serum Screening and Challenges for Allergenicity Safety 
Assessment--Dr. Robert Hamilton
12-1:00 p.m.  Lunch
     Post-Marketing Surveillance--Dr. Carol Rubin
Session II: Toxicological Evaluation of Novel Proteins
     Assessment of Protein Structure, Sequence Homology and 
Stability--Drs. Tong-Jen Fu and Gary Bannon
Session III: Regulatory Considerations
Panel Discussion
     A Viewpoint from the U.S. Food and Drug Administration--
Dr. Kathleen Jones
     A Viewpoint from the U.S. Environmental Protection 
Agency--Dr. John Kough
     A Viewpoint from Industry--Drs. Katherine Sarlo, Val 
Giddings, and James Astwood
Session IV: Risk Communication
     Biotechnology and How the Public Perceives It--Drs. Thomas 
Hoban and Rebecca Goldburg
5:00 p.m.  Open Discussion

Tuesday, December 11, 2001

7:30-8:30 a.m.  Registration
Session V: Toxicologic Methods of Safety Assessment
     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 Using Swine Models--Dr. Ricki 
Helm
     Assessment of Allergenicity in Dogs I--Dr. Robert Buchanan
     Assessment of Allergenicity in Dogs II--Dr. Bruce 
Hammerberg
12-1:00 p.m.  Lunch
  Charge to Breakout Groups
Session VI--Breakout Group Meetings
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
    Invited meeting participants will divide into these six breakout 
groups. The public can attend breakout groups as observers, as space 
permits, and time will be available for observer questions and 
discussion. Information about breakout groups registration is available 
in the meeting registration packet (see below).
5:00 p.m.  Adjourn

Wednesday, December 12, 2001

7:30-8:30 a.m.  Registration
Session VII--Breakout Group Presentations
     Individual Group Presentations

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

Meeting Registration Information

    This meeting is open to the public and the public is invited to 
attend as observers. The number of observers will be limited only by 
the space available. Time will be provided for open discussion each 
day. Due to space limitations, advance registration is requested by 
November 30, 2001.
    Registration materials as well as further details about the 
workshop are available on the NTP meeting Web site (http://ntp-server.niehs.nih.gov/htdocs/Liason/GMFoodPg.html). For questions about 
registration information, contact the 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).

    Dated: October 31, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 01-28309 Filed 11-9-01; 8:45 am]
BILLING CODE 4140-01-P