Food & Feed
Safety Assessment

Providing Training & Resources Needed to Assess the Safety of Foods & Feeds Derived from Genetically Engineered 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

Karen Hokanson, Ph.D.

Karen 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

Indonesia & Philippines

China & Korea

IICA

European Union

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
Inter-American Institute for Cooperation on Agriculture (IICA)
Rutgers University
Stine Haskell Research Center
Thailand Department of Agriculture
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 genetically engineered foods.

Programs

Genetically Engineered 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 genetically engineered 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

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

Educating Regulators & Scientists About Safety Assessment of Genetically Engineered Foods

Outcome

The safety assessment of genetically engineered 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 genetically engineered 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 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 genetically engineered 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 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 genetically engineered 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 genetically engineered 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

Towards a Harmonised Approach to Food Safety Assessment of Genetically Engineered Plants in South Asia – Expert Working Group Report

December 20, 2021

The harmonisation initiative in South Asia was formally undertaken in 2020 by the Agriculture & Food Systems Institute (AFSI) by convening an Expert Working Group (EWG) constituted of senior experts and regulators identified from agencies in Bangladesh, Bhutan, India, and Sri Lanka that are relevant to the safety assessment of foods derived from rDNA plants. This report was systematically drafted by the EWG.

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).

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