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Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants: Phase II Technical Workshop

    June 17, 2019-June 21, 2019
    Washington, DC
    Ashland, OH, USA

The Agriculture & Food Systems Institute, in collaboration with ILSI Focal Point in China, conducted the first phase of our Technical Training Program on Safety Assessment of Foods and Feeds Derived from Genetically Engineered (GE) Plants on March 5-7, 2019 in Langfang, China. Aimed at providing Chinese public-sector scientists with in-depth information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE crops, Phase I of the program established a baseline understanding of the food safety assessment paradigm, toxicity and allergenicity testing, compositional assessment, and animal testing.

Phase II of the technical training, comprised of laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted, took place on July 17-21, 2019 in Washington, DC and Ashland, OH, USA. The training included a review of the concepts from Phase I, with an additional focus on critical reading and a review of study reports.

Participants were asked to complete the eLearning module “Application of Problem Formulation for Food and Feed Safety Assessment” in advance of the Phase II workshop.

Speakers

Dr. Bhavneet Bajaj
Agriculture & Food Systems Institute
Dr. Patrick Cournoyer
US Food and Drug Administration
Dr. Cara Cuite
Rutgers University
Dr. Mònica García-Alonso
Estel Consult, Ltd.
Dr. Xu Hu
Corteva Agrisciences
Dr. Xenia Morin
Rutgers University
Dr. Jason Roper
Corteva Agrisciences
Dr. Chris A. Wozniak
US Environmental Protection Agency

Agenda

Day 1 - Monday, June 17, 2019 · 09:30-16:30

Agriculture & Food Systems Institute · Washington, DC

Welcome, Introduction, and Overview of the Workshop
Dr. Bhavneet Bajaj, Agriculture & Food Systems Institute

Recap of Phase I: Basic Concepts in the Safety Assessment of Novel Foods and Feeds, Problem Formulation Methodology, and Guidelines and Methods
Dr. Mònica García-Alonso, Estel Consult, Ltd.

Review of eLearning Modules
Dr. Mònica García-Alonso, Estel Consult, Ltd.

FDA Regulation of Food from New Plant Varieties: An Overview
Dr. Patrick Cournoyer, US Food & Drug Administration

EPA Regulation of Plant-Incorporated Protectants
Dr. Chris A. Wozniak, US Environmental Protection Agency

Day 2 - Tuesday, June 18, 2019 · 08:30-16:00

Agriculture & Food Systems Institute · Washington, DC

Understanding the American Public’s Perceptions of Genetically Modified Food
Dr. Cara L. Cuite, Rutgers University

Public Opinion on GE Plants and Food and Feed Derived from Them: China
Dr. Xenia Morin, Rutgers University

Breakout Groups: Exercise 1 – Risk Communication Group Discussion and Q&A on Public Perception and Communication
Dr. Xenia Morin, Rutgers University

New Plant Breeding Techniques: Global Status of Regulation of Products for Food and Feed Use
Dr. Bhavneet Bajaj, Agriculture & Food Systems Institute

Breakout Groups: Exercise 2 -Safety Assessment of Provided Case Studies (Case 1: Cry1Ac, Case 2: IPD072Aa), Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd.

Day 3 - Wednesday, June 19, 2019 · 08:30-17:30

Charles River Laboratories · Ashland, OH

Introduction to CRL and Rules
Leanne Silvis, Charles River Laboratories

Animal Welfare, Human Health, and Safety Considerations for Animal Testing Facilities
Leanne Silvis, Charles River Laboratories

Acute Oral Toxicity Studies – (a) Design, Guidelines, and Doses, (b) Surrogate Species, (c) Interpreting Results and Writing Reports
Dr. Jason Roper, Corteva Agrisciences

Breakout Groups Exercise 3: Critical Review of Acute Oral Toxicity Studies Data, Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd.

Discussion and Q&A
Dr. Jason Roper, Corteva Agriscience

Quality Assurance & Good Laboratory Practices
Ms. Carrie James and Mr. Kelvin Mentzer, Charles River Laboratories

Role of a Study Director
Dr. JoAnna Bultman, Charles River Laboratories

Biosecurity, Laboratory, and Vivarium Safety
Leanne Silvis, Charles River Laboratories

CRL Facility Tour

Day 4 - Thursday, June 20, 2019 · 08:30-17:00

Charles River Laboratories · Ashland, OH

Presentation on Pathology
Dr. Gary Coleman, Charles River Laboratories

CRL In-Depth Facility Tour and Demonstration
Ms. Susana Rodriguez, Mr. William Miller, and Mr. Matthew Bennett, Charles River Laboratories

  • Histology
  • Necropsy
  • Neurobehavioral Testing Suite
  • Inlife Dosing and Blood Collection Demonstration

90-Day Sub-Chronic Studies
Dr. Jason Roper, Corteva Agriscience

Breakout Groups: Exercise 4 – Critical Review of 90-Day Feeding Studies Data, Group Presentations, and Discussion
Dr. Jason Roper, Corteva Agriscience

Discussion and Q&A

Day 5 - Friday, June 21, 2019 · 08:30-14:30

Charles River Laboratories · Ashland, OH

Bringing It All Together: Writing Relevant and Informative Risk Assessment Summaries
Dr. Mònica García-Alonso, Estel Consult, Ltd.

RNAi Food and Feed Safety Assessment
Dr. Xu Hu and Dr. Jason Roper, Corteva Agriscience

Investigation of an In Vitro Method for Protein Hazard Characterization
Dr. Jason Roper, Corteva Agriscience

Presentation of Completion Certificates and Workshop Closure