Federal Register: November 13, 2001 (Volume 66, Number 219)

DOCID: FR Doc 01-28309

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

NOTICE: NOTICES

ACTION: Meetings:

SUBJECT CATEGORY:

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''

DOCUMENT SUMMARY:

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 4320143022]. The workshop was postponed and is now rescheduled for December 1012, 2001 at the Sheraton, 1 Europa Drive, Chapel Hill, NC (9199684900). This meeting is open to the public.
[[Page 56840]]
Revised Tentative Meeting Agenda
Assessment of the Allergenic Potential of Genetically Modified Foods
December 1012, 2001
Sheraton, 1 Europa Drive, Chapel Hill, NC
Monday, December 10, 2001
7:308:30 a.m. Registration
Welcome
Introduction

  • What are the Issues?Dr. Dean Metcalfe
  • Conclusions from the November 2000 National Center for Food Safety & Technology ConferenceDr. 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
  • Serum Screening and Challenges for Allergenicity Safety AssessmentDr. Robert Hamilton
    121:00 p.m. Lunch
  • PostMarketing SurveillanceDr. Carol Rubin
    Session II: Toxicological Evaluation of Novel Proteins
  • Assessment of Protein Structure, Sequence Homology and StabilityDrs. TongJen 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 AgencyDr. John Kough
  • A Viewpoint from IndustryDrs. Katherine Sarlo, Val Giddings, and James Astwood
    Session IV: Risk Communication
  • Biotechnology and How the Public Perceives ItDrs. Thomas Hoban and Rebecca Goldburg
    5:00 p.m. Open Discussion
    Tuesday, December 11, 2001
    7:308:30 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 MiceDr. Ian Kimber
  • Assessment of Allergenicity Using Swine ModelsDr. Ricki Helm
  • Assessment of Allergenicity in Dogs IDr. Robert Buchanan
  • Assessment of Allergenicity in Dogs IIDr. Bruce Hammerberg
    121:00 p.m. Lunch
    Charge to Breakout Groups
    Session VIBreakout 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. Postmarket 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
    7:308:30 a.m. Registration
    Session VIIBreakout 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 A302, Research Triangle Park, NC 27709: liaison@starbase.niehs.nih.gov; 9195410530 (telephone); 9195410295 (fax).

    Dated: October 31, 2001.
    Samuel H. Wilson,
    Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0128309 Filed 11901; 8:45 am] BILLING CODE 414001P

    SUMMARY:

    National Toxicology Program—; Genetically modified foods; allergenic potential assessment; workshop,

    DOCUMENT BODY 2:

    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 4320143022]. The workshop was postponed and is now rescheduled for December 1012, 2001 at the Sheraton, 1 Europa Drive, Chapel Hill, NC (9199684900). This meeting is open to the public.
    [[Page 56840]]
    Revised Tentative Meeting Agenda
    Assessment of the Allergenic Potential of Genetically Modified Foods
    December 1012, 2001
    Sheraton, 1 Europa Drive, Chapel Hill, NC
    Monday, December 10, 2001
    7:308:30 a.m. Registration
    Welcome
    Introduction

  • What are the Issues?Dr. Dean Metcalfe
  • Conclusions from the November 2000 National Center for Food Safety & Technology ConferenceDr. 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
  • Serum Screening and Challenges for Allergenicity Safety AssessmentDr. Robert Hamilton
    121:00 p.m. Lunch
  • PostMarketing SurveillanceDr. Carol Rubin
    Session II: Toxicological Evaluation of Novel Proteins
  • Assessment of Protein Structure, Sequence Homology and StabilityDrs. TongJen 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 AgencyDr. John Kough
  • A Viewpoint from IndustryDrs. Katherine Sarlo, Val Giddings, and James Astwood
    Session IV: Risk Communication
  • Biotechnology and How the Public Perceives ItDrs. Thomas Hoban and Rebecca Goldburg
    5:00 p.m. Open Discussion
    Tuesday, December 11, 2001
    7:308:30 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 MiceDr. Ian Kimber
  • Assessment of Allergenicity Using Swine ModelsDr. Ricki Helm
  • Assessment of Allergenicity in Dogs IDr. Robert Buchanan
  • Assessment of Allergenicity in Dogs IIDr. Bruce Hammerberg
    121:00 p.m. Lunch
    Charge to Breakout Groups
    Session VIBreakout 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. Postmarket 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
    7:308:30 a.m. Registration
    Session VIIBreakout 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 A302, Research Triangle Park, NC 27709: liaison@starbase.niehs.nih.gov; 9195410530 (telephone); 9195410295 (fax).

    Dated: October 31, 2001.
    Samuel H. Wilson,
    Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0128309 Filed 11901; 8:45 am] BILLING CODE 414001P

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