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Providing Training & Resources Needed to Assess the Safety of Foods & Feeds Derived from GE Plants

The Issue

Food safety is recognized as a universal public health concern. Enormous resources are invested globally to ensure that there is a safe food supply. However, most of these resources are focused on improving food safety through the reduction of harm from chemical and microbial contaminants present in foods, rather than on the safety of the foods themselves.

What We Are Doing

The Agriculture & Food Systems Institute addresses this challenge by providing information resources and capacity building activities for scientists and regulators, focusing particularly on the safety assessment of foods and feeds derived from genetically engineered plants.

Why It’s Important

Evidence-based food safety assessments conducted using internationally accepted best practices help reduce complexity, time, and costs for all stakeholders. They also contribute to regulatory and trade cooperation between countries.

Program Staff

Rachel Melnick , Ph.D.
Rachel contributes to the development and implementation of AFSI’s current and future applied research and capacity building programs. She is responsible for developing strategies and budgets for these projects, identifying associated personnel requirements, and is accountable for ensuring the program/project meets its stated objectives. She also serves as liaison between AFSI management and staff, implementing partners, and other applicable parties.
Bhavneet Bajaj, Ph.D., PMP
Bhavneet contributes to the continued development and implementation of AFSI’s applied research and capacity building programs related to agricultural and other biotechnologies. Additionally, she manages AFSI’s highly acclaimed open access databases – the Crop Composition Database and the World Nutrient Databases for Dietary Studies. In these roles, she works closely with AFSI’s scientific staff and external partners to ensure that programs are science-focused, have broad participation from multiple sectors and disciplines, and are directed toward concrete and achievable outcomes.

Where We Operate

Collaborators & Partners

  • Biotech Consortium India Limited
  • Charles River Laboratories
  • China Center for Disease Control and Prevention
  • China Ministry of Agriculture and Rural Affairs
  • Chinese National Institute for Nutrition and Health
  • Chinese Society of Agricultural Biotechnology
  • Corteva Agrisciences (formerly DuPont Pioneer)
  • CropLife China
  • Estel Consult Ltd.
  • ILSI Focal Point in China
  • Indonesian National Agency for Food and Drug Control (BPOM)
  • Indonesian Center for Animal Research and Development (ICARD)
  • Institute for International Crop Improvement, Donald Danforth Plant Science Center
  • Rutgers University
  • Stine Haskell Research Center
  • USDA Foreign Agricultural Service
  • U.S. Environmental Protection Agency
  • U.S. Food and Drug Administration
Explore our resources and programs on science-based safety assessments of GE foods.

Programs

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GE Food Safety Capacity Building

Sharing Knowledge & Expertise

Understanding the need for technical capacity building for food safety assessment, the Agriculture & Food Systems Institute shares its knowledge and scientific expertise by facilitating regional training workshops and developing and disseminating reference materials.

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Crop Composition Database (CCDB)

Understanding Crop Composition as a Basis for Comparative Assessment

Our Crop Composition Database is a curated, open access resource that provides data on the natural variability in the nutrients, anti-nutrients, and secondary metabolites of key crop species. This information is critical to inform comparative assessments of GE foods and feeds, but it can also inform research that promotes the healthy growth of livestock, as well as improving food security and nutrition modeling.

VISIT DATABASE
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Protein Monographs

Providing Risk Assessors with Centralized Food Safety Information

The Agriculture & Food Systems Institute has prepared a series of monographs that provide comprehensive reviews of publicly available food safety information and data for the novel proteins found in some genetically engineered plants.

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Our Successes

Outcome

The safety assessment of genetically engineered (GE) foods is heavily informed by internationally agreed guidelines developed under the Codex Alimentarius Commission, including Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. Together, these documents describe a safety assessment process for whole foods, rather than food additives or ingredients that have traditionally been the subject of safety assessments.

To support the practical application of these guidelines, the Agriculture & Food Systems Institute has developed a comprehensive training program, delivering experiential learning to regulators from across the globe. The program, which covers the key elements used in GE food safety assessment, was developed by AFSI scientific staff in collaboration with internationally recognized subject matter experts, in response to needs identified by:

  • Regulators and scientists from the public sector who are called upon to conduct safety assessments
  • Public sector scientists engaged in GE product development
  • Scientists from public institutions that provide testing services

The multi-phased program helps participants:

  • Establish a baseline understanding of the concepts and principles of GE food safety assessment (Phase I)
  • Observe and understand acute and sub-chronic toxicity testing protocols, reporting formats, and results interpretation (Phase II)

The program combines introductory e-learning modules, classroom training, and practical exercises (Phase I) with laboratory visits, discussions with the technicians and supervisors who generate safety data, and observation of testing and data collection (Phase II). Participants come away with a deep understanding of the rationale behind the safety assessment framework, the practical realities of laboratory testing, and the context needed to understand and interpret the data they see as part of regulatory submissions, as well as to better interpret and understand published literature.

The program has been conducted three times since 2014, including over 50 participants from 9 countries.

  • 2014: Bangladesh, Ghana, India Kenya Nigeria, Pakistan, and Paraguay
  • 2017: Indonesia
  • 2019: China

A “refresher” training program planned in cooperation with the Government of Indonesia to take place in 2020 was turned into a virtual training course (Phase III), featuring fully-voiced interactive training sessions prepared by AFSI staff and GE food safety experts from Australia, the Philippines, and the United States. It revisits the comprehensive food safety assessment paradigm presented in Phases I and II and expands these concepts into considerations for plants containing multiple GE traits. The training was capped off by an interactive session with expert faculty so that participants could ask follow-up questions and provide program feedback.

  • Project Name:
    Comprehensive GE Food Safety Assessment Training for Foods Derived from GE Plants
  • Years:
    2014-2020
  • Partners:
    Biotech Consortium India Limited, Charles River Laboratories, China Center for Disease Control and Prevention, China Ministry of Agriculture and Rural Affairs, Chinese National Institute for Nutrition and Health, Chinese Society of Agricultural Biotechnology, Corteva Agrisciences (formerly DuPont Pioneer), CropLife China, Estel Consult Ltd., ILSI Focal Point in China, Indonesian National Agency for Food and Drug Control (BPOM), Indonesian Center for Animal Research and Development (ICARD), Institute for International Crop Improvement, Donald Danforth Plant Science Center Rutgers University, Stine Haskell Research Center, USDA Foreign Agricultural Service, U.S. Environmental Protection Agency, U.S. Food and Drug Administration
  • Countries:
    Bangladesh, China, Ghana, India, Indonesia, Kenya, Nigeria, Pakistan, and Paraguay
“I used the databases I learned about in the training when I conducted a food safety assessment of GE maize.”
Prof. Dr. Qin Zhuo, Chinese Center for Disease Control and Prevention
“The problem formulation framework was used in my work related to risk assessment of food chemicals.”
Prof. Zhaoping Liu, China National Center for Food Safety Risk Assessment (CFSA)

Discover

Publications

A Review of the Food and Feed Safety of the PAT Protein
| December 31, 2016

This document provides a comprehensive review of information and data relevant to the assessment of the protein PAT for food and feed safety.

A Review of the Food and Feed Safety of the Cry1Ac Protein
| December 31, 2016

This document provides a comprehensive review of information and data relevant to the assessment of the protein Cry1Ac for food and feed safety.

A Review of the Food and Feed Safety of the Cry1Ab Protein
| December 31, 2016

This document provides a comprehensive review of information and data relevant to the assessment of the protein Cry1Ab for food and feed safety.

A Review of the Food and Feed Safety of the EPSPS Protein
| December 31, 2016

This document provides a comprehensive review of information and data relevant to the assessment of the EPSPS protein for food and feed safety.

Information Tools for Environmental Risk Assessment of Low Level Presence
| December 31, 2011

In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.

A Review of the Environmental Safety of the PAT Protein
| December 31, 2011

This document provides a comprehensive review of information and data relevant to the environmental risk assessment of the protein phosphinothricin-N-acetyl transferase (PAT) produced in genetically engineered (GE) plants by genes isolated from Streptomyces viridochromogenes (pat gene) or Streptomyces hygroscopicus (bar gene) and presents a summary statement about the environmental safety of this protein.

Low Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment
| March 31, 2014

The Agriculture & Food Systems Institute organized a workshop held in Buenos Aires, Argentina on December 18-19, 2013 on low level presence (LLP) in seed. This document contains the conference proceedings to address the potential adverse environmental impacts that might arise from an LLP in seed situation using a consistent and scientifically defensible approach to environmental risk assessment.

The Use of Whole Food Animal Studies in the Safety Assessment of Genetically Modified Crops: Limitations and Recommendations
Critical Reviews in Toxicology | January 1, 2013

This manuscript by Bartholomaeus et al., published in Critical Reviews in Toxicology, focuses on the relevance and utility of whole food animal studies in safety assessments of GM crops (Task Force #10).

Natural Variation in Grain Composition of Wheat and Related Cereals
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Shewry et al. 2013;61(35):8295-8303) (Task Force #12).

How Composition Methods Are Developed and Validated
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Rogers. 2013;61(35):8312-8316) (Task Force #12).

Bringing a Transgenic Crop to Market: Where Compositional Analysis Fits
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Privalle et al. 2013;61(35):8260-8266) (Task Force #12).

Application of Laws, Policies, and Guidance From the United States and Canada to the Regulation of Food and Feed Derived From Genetically Modified Crops: Interpretation of Composition Data
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Price and Underhill. 2013;61(35):8349-8355) (Task Force #12).

Biological Importance and Statistical Significance
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Lovell. 2013;61(35):8340–8348) (Task Force #12).

Availability and Utility of Crop Composition Data
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (KItta. 2013;61(35):8304–8311) (Task Force #12).

Food Safety: Importance of Composition for Assessing Genetically Modified Cassava (Manihot esculenta Crantz)
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Jansen van Rijssen et al. 2013;61(35):8333-8339) (Task Force #12).

Compositional Analysis of Genetically Modified (GM) Crops: Key Issues and Future Needs
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Hoekenga et al. 2013;61(35):8248–8253) (Task Force #12).

Evaluation of Endogenous Allergens for the Safety Evaluation of Genetically Engineered Food Crops: Review of Potential Risks, Test Methods, Examples and Relevance
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Goodman et al. 2013;61(35):8317–8332).

Genetics and Consequences of Crop Domestication
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Flint-Garcia et al. 2013;61(35):8267-8276).

Safety of GM Crops: Compositional Analysis
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Brune et al. 2013;61(35):8243-8247) (Task Force #12).

Traditional and Modern Plant Breeding Methods With Examples in Rice (Oryza sativa L.).
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Breseghello et al. 2013;61(35):8277–8286) (Task Force #12).

Evaluating the Potential for Adverse Interactions Within Genetically Engineered Breeding Stacks
Plant Physiology | January 1, 2013

This article, published in Plant Physiology, discusses evaluation of the potential for interactions between the products of the events in a GE stack that impact food and feed safety in the context of conventional breeding of non-GE plants (Task Force #9).

Mineral Biofortification Strategies for Food Staples: The Example of Common Bean
Journal of Agricultural and Food Chemistry | January 1, 2013

Proceedings from the 2012 IFBiC Plant Compositional Analysis Workshop, published in the Journal of Agricultural and Food Chemistry (Blair et al. 2013;61(35):8287-8294).

Crop Genome Plasticity and Its Relevance to Food and Feed Safety of Genetically Engineered Breeding Stacks
Plant Physiology | January 1, 2012

This article, published in the December 2012 issue of Plant Physiology, draws on insights from plant breeding, describes the plasticity of conventional plant genomes over generations of crossing and selection, and considers the implications of event stacking on food and feed safety in the context of normal plant genome behavior (Task Force #9).

Improvements to the International Life Sciences Institute Crop Composition Database
Journal of Food Composition and Analysis | January 1, 2010

This article in the Journal of Food Composition and Analysis describes enhancements made in Version 4.0 of the Crop Composition Database.

Application of Food and Feed Safety Assessment Principles to Evaluate Transgenic Approaches to Gene Modulation in Crops
Food and Chemical Toxicology | January 1, 2010

Published in Food and Chemical Toxicology (2010;48:1773-1790), this article reviews the main aspects of the current safety assessment paradigm and to recommends scientifically sound principles for conducting a safety assessment for GM crops that are developed by technologies that modify endogenous plant gene expression (Task Force #8).

The Use of 35S and Tnos Expression Elements in the Measurement of Genetically Engineered Plant Materials
Analytical and Bioanalytical Chemistry | January 1, 2009

An original paper in Analytical and Bioanalytical Chemistry by Marcia Holden et al. (Sampling and Detection).

Evaluation of Protein Safety in the Context of Agricultural Biotechnology
Food and Chemical Toxicology | January 1, 2008

This document puts forth a scientifically based two-tiered, weight-of evidence strategy to assess the safety of novel proteins (Task Force #6).

Sampling and Detection Methods for Products of Modern Agricultural Biotechnology in NAFTA Countries
| January 1, 2007

This document provided background information for an October 11- 12, 2007 ILSI IFBiC discussion workshop on specific issues and viewpoints related to harmonization of sampling and detection methods for GM foods in NAFTA countries (Sampling and Detection).

October 2007 Workshop Background Paper on Sampling and Detection Methods
| January 1, 2007

This report represents a unique survey of the present status of GMO activities in the North American Free Trade Agreement region. Available in English, Portuguese, and Spanish.

Nutritional and Safety Assessments of Food and Feeds Nutritionally Improved through Biotechnology: Case Studies
Comprehensive Reviews in Food Science and Food Safety | January 1, 2008

An IFBiC report published in Comprehensive Reviews in Food Science and Food Safety  (Task Force #4).

Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved Through Biotechnology: Case Studies (Executive Summary)
Journal of Food Science | January 1, 2007

Executive Summary published in Journal of Food Science (Task Force #4).

Best Practices for the Conduct of Animal Studies to Evaluate Crops Genetically Modified for Output Traits
| January 1, 2007

An IFBiC/FASS reference publication scientists who conduct bioavailability, performance, processing, and animal-derived food product studies with nutrientenhanced crops and their coproducts (Task Force #5).

Evaluación de Inocuidad y Aptitud Nutricional de Alimentos y Forrajes Mejorados Nutricionalmente a Través de la Biotecnología
| January 1, 2005

This is a Spanish-language report from an ILSI biotech workshop held in Argentina from October 6-8 2005. It describes the participants and includes a summary of the various talks held during the workshop (Task Force #4).

Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology: An Executive Summary
Concise Reviews in Food Science | January 1, 2004

An IFBiC report in Concise Reviews in Food Science. Available in English, Spanish, and Korean (Task Force #4).

Development of the International Life Sciences Institute Crop Composition Database
Journal of Food Composition and Analysis | January 1, 2004

A journal article describing the development and usefulness of the IFBiC Crop Composition Database (Task Force #7).

Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology
Comprehensive Reviews in Food Science and Food Safety | January 1, 2004

An IFBiC report published in Comprehensive Reviews in Food Science and Food Safety (Task Force #4).

Best Practices for the Conduct of Animal Studies to Evaluate Crops Genetically Modified for Input Traits
| January 1, 2003

IFBiC/FASS recommendations on guidelines for the production, harvest, sampling, and analysis of GM plants containing input traits and for the conduct of animal experiments using these plants (Task Force #5).

Biotechnology-Derived Nutritious Foods for Developing Countries: Needs, Opportunities, and Barriers
| January 1, 2002

This is a discussion summary and expanded abstracts from a workshop organized by the Agriculture & Food Systems Institute (the ILSI Human Nutrition Institute) and International Food Biotechnology Committee, the International Food Policy Research Institute, and the Joint Institute for Food Safety and Applied Nutrition.

Assessment of the Allergenic Potential of Foods Derived from Genetically Engineered Crop Plants
Critical Reviews in Food Science and Nutrition | January 1, 1996

This article by Metcalfe et al. was published in a special supplement to Critical Reviews in Food Science and Nutrition (1996;36(Suppl):S165-S186).

Editorial: Biotechnologies and Food: Assuring the Safety of Foods Produced by Genetic Modification
Regulatory Toxicology and Pharmacology | January 1, 1990

This editorial by Coulston et al. was published in Regulatory Toxicology and Pharmacology (1990;12(3):213).

1990 Report on Biotechnology
Regulatory Toxicology and Pharmacology | January 1, 1990

1990 Historical Document in Regulatory Toxicology and Pharmocology prepared by the ILSI International Food Biotechnology Council, the precursor to the ILSI International Food Biotechnology Committee.

Monographs on Pathology of Laboratory Animals: Endocrine System
| January 1, 1983

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Respiratory System
| January 1, 1985

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Genital System
| January 1, 1987

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Nervous System
| January 1, 1988

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Hemopoietic System
| January 1, 1991

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Integument and Mammary Glands
| January 1, 1990

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Cardiovascular and Musculoskeletal Systems
| January 1, 1991

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Eye and Ear
| January 1, 1991

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Monographs on Pathology of Laboratory Animals: Nonhuman Primates II
| January 1, 1993

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998.

Monographs on Pathology of Laboratory Animals: Nonhuman Primates I
| January 1, 1993

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing.

Monographs on Pathology of Laboratory Animals: Digestive System
| January 1, 1997

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998.

Monographs on Pathology of Laboratory Animals: Urinary System
| January 1, 1998

This book is part of the series “Monographs on Pathology of Laboratory Animals,” sponsored by the Agriculture & Food Systems Institute between 1985 and 1998. The series was intended for pathologists, toxicologists, and other interested in evaluating and harmonizing toxicological testing. Its goal was to provide useful information to pathologists involved in studies of foods, drugs, chemicals, and other substances found in the environment.

Events

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