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Objective

While the majority of governments design safety assessments of genetically engineered (GE) foods around the Codex Alimentarius’ principles and guidelines, there remain significant differences in the practical application of Codex and other international guidance. This adds complexity, time, and cost to the regulatory process, further exacerbates asynchronous authorizations, and stands in the way of achieving regional or sub-regional regulatory cooperation. The ILSI Research Foundation’s efforts focus primarily on technical training of regulators and public sector scientists who are called upon to inform risk assessments on behalf of institutional or national biosafety committees. This includes training around concepts and principles of GE food safety assessment, and, where necessary, turning this into experiential understanding.

Collaborators & Partners

ILSI Focal Point in China, CropLife China, China Center for Disease Control and Prevention (CDC), Chinese Society of Agricultural Biotechnology, Chinese National Institute for Nutrition and Health, DuPont Pioneer, Estel Consult Ltd., Indonesian National Agency for Food and Drug Control, Indonesian Center for Animal Research and Development, International Food Policy Research Institute (IFPRI), Badan Pengawas Obat dan Makanan (Indonesia), USDA Foreign Agricultural Service

Areas of Focus

The ILSI Research Foundation is implementing food safety activities in China and Indonesia as well as preparing a reference book that describes how and why safety assessments of foods derived from genetically engineered crops are undertaken, while placing these in the context of overall conventional food safety.

Current Activity

The ILSI Research Foundation is engaged in outreach and capacity building on GE food safety assessment in China, in collaboration with ILSI Focal Point in China, CropLife China, and other Chinese academic and government stakeholders. An initial workshop was convened in 2016, with presentations on the GE food safety assessment paradigm, regulation of biotechnology in China, and considerations for new agricultural biotechnologies. A follow-up workshop was organized by the ILSI Research Foundation in May 2017, together with ILSI Focal Point in China, the National Institute for Nutrition and Health at China CDC, and the Chinese Society of Agricultural Biotechnology.

Supported by a grant from the USDA’s Foreign Agricultural Service and in collaboration with the Government of Indonesia, the ILSI Research Foundation is organizing a food safety training program which focuses on providing practical instruction in the technical aspects of food safety testing and evaluation for foods derived from GE plants. The first phase of the program involves classroom and case study training in Jakarta, while the second phase is being conducted in cooperation with the DuPont Stine Haskell Research Center in Wilmington, Delaware. Participants will receive classroom and practical training, in addition to being able to observe studies being conducted in laboratory facilities to improve practical understanding of just how and why these studies are carried out.

Resources

Newsletters

Find out about the work being done by the ILSI Research Foundation by reading our monthly e-newsletter.

e-Learning

e-Learning courses have been developed by the ILSI Research Foundation that focus on food safety.

OECD Task Force on the Safety of Novel Foods and Feeds

Paris, France

The OECD Task Force on the Safety of Novel Foods and Feeds, for which the ILSI Research Foundation is a recognized observer organization, works on technical issues related to the food safety of novel foods and feeds, including the products of agricultural biotechnology.

Read more

2nd Asia Forum on Genome Editing

Gangneung, Korea

Dr. Morven McLean, Executive Director, chaired the session Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in the USA, EU, and Germany at the 2nd Asia Forum on Genome Editing

Read more

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By Invitation Only. 

Implemented by the ILSI Research Foundation, this technical training program is structured to provide Chinese public-sector scientists in-depth technical information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from genetically engineered (GE) crops. The program is designed using a phased approach, with Phase I being a workshop aimed at establishing a baseline understanding of the concepts and principles of GE food and feed safety assessment. Topics will include the whole food safety assessment paradigm, as well as discussion of toxicity and allergenicity testing, compositional assessment, and animal testing.

Participants are asked to complete the eLearning module “Concepts in the Safety Assessment of Novel Food and Feed” in advance of the Phase I workshop.

Provisional Agenda

Day 1

Day 2

Day 3

Day 1

Introduction of Key Concepts and Regulatory Landscape

Welcome and Overview of the Workshop
Dr. Bhavneet Bajaj, ILSI Research Foundation, USA

Regulation of Genetically Engineered Foods and Livestock Feeds in China
TBD

International Guidance for Assessing Foods and Feeds Derived from Genetically Engineered Plants
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Key Concepts in the Risk Assessment of Genetically Engineered Crops
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Question & Answer Session

Applying Problem Formulation to the Safety Assessment of Genetically Engineered Foods and Feeds
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Breakout Exercise 1

Accessing Information: Useful Resources for GE Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation, USA

Breakout Exercise 2

Day 2

Delving into Food and Feed Safety Assessments (I)

Recap and Questions from Day 1
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Key Concepts in GE Food/Feed Assessment: Compositional Analyses
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Accessing Crop Compositional Data to Inform GE Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation, USA

Breakout Exercise 3

Characterization of the Genetic Modification and the Novel Protein(s)
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 4

Assessing Potential Toxicity
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

Breakout Exercise 5

Day 3

Delving into Food and Feed Safety Assessments (II)

Recap and Questions from Day 2
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Understanding Animal Feeding Studies in the Context of GE Food/Feed Safety Assessments
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

Plenary Group Discussion

Assessing Potential Allergenicity
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 6

Explaining the Safety Assessment to Others
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Feedback, Discussion, and Review

Preparing for the Phase II Workshop
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Presentation of Completion Certificates & Workshop Closure

Phase II

A five-day workshop is planned for June 2019, focusing on laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted. Phase II will include a review of the concepts from Phase I, with an additional focus on critical reading and review of study reports. Participants will be asked to complete the eLearning module “Application of Problem Formulation for Food and Feed Safety Assessment” in advance of the Phase II workshop.

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Dr. Morven McLean, Executive Director, chaired the session Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in the USA, EU, and Germany at the 2nd Asia Forum on Genome Editing held November 1-2 in Gangneung, South Korea. Launched in 2017, the Asia Forum is a unique platform for sharing ideas related to the management of potential risks resulting from genome editing technologies with a focus on Asian countries.

Agenda

November 1, 2018

November 2, 2018

November 1, 2018

Registration and Opening Ceremony

Session 1: Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in the USA, EU, and Germany

Chair: Morven McLean, ILSI Research Foundation

Speaker - USA:
Ibrahim M. Shaqir, USDA APHIS Biotechnology Regulatory Services

Speaker - EU & Germany:
Jens Kahrmann, Federal Office of Consumer Protection and Food Safety, Department of Genetic Engineering

Session 2: Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in Malaysia and India

Chair: Huy Ham Le, Institute of Agricultural Genetics

Speakers - Malaysia:
Raimi Rosmin, Department of Biosafety, Ministry of Natural Resources and Environment
Mohd Faiz Foong Abdullah, Faculty of Applied Sciences, Universiti Teknologi Mara

Speakers - India:
Ponnuswami Balasubramanian, Tamil Nadu Agricultural University
Vibha Ahuja, Biotech Consortium India Limited

Session 3: Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in Cambodia, the Philippines, and Vietnam

Chair: Letchumanan Ramatha

Speaker - Cambodia:
Pisey Oum, Ministry of Environment

Speaker - The Philippines:
Julieta Estacio, National Committee on Biosafety of the Philippines

Speaker - Vietnam:
Huy Ham Le, Institute of Agricultural Genetics

Comprehensive Discussion
Chairs: Homin Jang & Heidi Michell

Welcome Reception

November 2, 2018

Session 4: Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in Japan and Australia

Chair: Jens Kahrmann, Federal Office of Consumer Protection and Food Safety, Department of Genetic Engineering

Speaker - Japan:
Masashi Tachikawa, Graduate School of Environmental Studies, Nagoya University

Speaker - Australia:
Heidi Mitchell, Plant Evaluation Section, Office of the Gene Technology Regulator, Australian Government Department of Health

Session 5: Advances in Genome Editing and Related Regulation with Recent GMO Safety Issues in Korea

Chair: Ibrahim M. Shaqir, USDA APHIS Biotechnology Regulatory Services

Speaker - Korea:
Okjae Koo, ToolGen
Ancheol Jang, Biosafety Division, National Institute of Agricultural Science/Rural Development Administration

Comprehensive Discussion
Chairs: Homin Jang & Vibha Ahuja

Closing Remarks

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Dr. Andrew Roberts co-chaired the scientific session: Advances in Molecular Biology as Relevant to Food Technology alongside Dr. Michael Knowles at the 19th World Congress of Food Science and Technology (IUFoST2018).

IUFoST2018 brought together researchers, academics, professionals, policymakers, food scientists, and private sector representatives to exchange ideas, share innovations, showcase new research, and discuss policy issues. Global developments in all the facets of food science and technology were showcased through over 60 parallel scientific sessions, with more than 250 speakers participating. ILSI, ILSI India, ILSI Europe, and ILSI North America also participated in the event.

Scientific Session: Advances in Molecular Biology as Relevant to Food Technology

Overview Abstracts & Presentations Speakers Photos Overview

Abstracts & Presentations

History and Context for Food Safety Assessment of Foods Derived from Genetically Engineered Plants (Download Presentation)
Dr. Andrew F. Roberts, ILSI Research Foundation

When genetically engineered plants were being developed in the late 1980s and early 1990s, food safety regulators were faced with a unique challenge.  Prior to this point risk assessments for foods focused on the presence of chemical and microbial contaminants while the foods themselves were considered to be safe.  But in response to public policy initiatives to require pre-market safety assessment for novel foods, assessors had to develop a paradigm for assessing the safety of whole foods for the first time.  This presentation will walk through some of the landmark early documents that developed the paradigm which has since been incorporated into the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL45-2003).

Food Safety Assessment for Genetically Engineered Plants in South Asia
Dr. Vibha Ahuja, Biotech Consortium India Ltd.

Foods derived from genetically engineered (GE) plants are widely consumed across many countries. In 2017, GE plants were grown by 24 countries in approximately 190 million hectares and imported by additional 43 countries for food and feed use. Countries in South Asian region are in varying stages of development and use of  GE plants. National biosafety frameworks and guidelines for food safety assessment are in place in these countries to regulate activities involving GE plants and derived food/feed products. Authorizations for the use of GE plants/foods are currently made at the national level. Regional harmonization for safety assessment guidance will ensure that foods derived from GE plants in any South Asian  country will meet the standard for safety, preventing disruptions to trade, ensuring the safety of foods for travelers between countries, and building a foundation for regional recognition of food safety authorizations, in future

Methods for the Detection, Identification, and Quantification of GM-Material in Food (Download Presentation)
Dr. Lalitha R. Gowda, CSIR-Central Food Technological Research Institute (retired)

Consequent to global commercialization of genetically modified (GM) crops, these crops and their products have been regulated by many countries requiring market traceability and labeling above an established threshold. The success of any regulatory and labeling scheme depends upon the efficiency with which a genetically modified material can be reliably detected and quantified. Detection of GMOs is focused on either identifying the altered gene(s) or their proteins product(s). The methods rely either on the polymerase chain reaction (PCR) to amplify the transgene sequence(s), or on immunological methods (primarily ELISA, the enzyme-linked immunosorbent assay) to bind to the transgene gene product(s). Both methods have their place and are both qualitative and quantitative. These molecular techniques form the foundation for GMO analyses. Owing to the increase in number and divergence of GMOs developed and commercialized, most GM detection laboratories now predominantly apply initial PCR based screenings followed by (when appropriate) more specific PCR based identification and quantification. Before PCR techniques can be used by official authorities in routine analysis, they must be validated. The potential and practicality of PCR for GM material detection are discussed in the light of actual legislation and of the constraints imposed by food production and processing.

*The authors of these abstracts declare no conflict of interest, in terms of scientific, financial, and personal.

Speakers

Dr. Michael Knowles
Governing Council Member, IUFoST

Dr. Michael Knowles is a pharmacist and medicinal chemist who spent the first half of his career with the UK Ministry of Agriculture, Fisheries, and Food where he became Chief Scientist (Fisheries & Food) and Under-Secretary, Head of the Food Science Group. The latter half of his career he spent with The Coca-Cola Company, eventually becoming Vice-President of Global Scientific and Regulatory Affairs, from which he retired in 2013. He is a Fellow of several scientific societies, former Global President of the International Life Sciences Institute, a Liveryman of the Society of Apothecaries, London, and a Freeman of the City of London. His scientific publications are mainly in the area of food safety, and he is joint-founding editor of the Journal of Food Additives and Contaminants. He has been a member and/or chaired scientific and regulatory committees in EU food and drink trade associations, and he is the past-Chairman of the Board of the European Technology Platform, “Food for Life,” and a member of IUFoST’s Governing Council.


Dr. Andrew Roberts
Deputy Executive Director, ILSI Research Foundation

Dr. Andrew Roberts is the Deputy Executive Director of the ILSI Research Foundation, where he is responsible for programs addressing environmental risk assessment and food safety assessment for biotechnology. Prior to joining the Research Foundation, Dr. Roberts worked at the U.S. Department of Agriculture in several different capacities, all related to the regulation of agricultural biotechnology.


Dr. Vibha Ahuja
Chief General Manager, Biotech Consortium India Ltd.

Dr. Vibha Ahuja holds a Ph.D. in Microbiology and is an expert on biosafety and regulatory aspects, particularly with reference to genetically modified organisms, having more than 25 years of experience. She is experienced in issues related to the Indian biosafety regulatory framework and has been part of formulation and dissemination of guidelines. She has been actively involved in capacity building initiatives in the country and throughout South Asia.


Dr. Lalitha R. Gowda
Former Chief Scientist, CSIR-Central Food Technological Research Institute

Dr. Lalitha R. Gowda obtained her Ph. D in Biochemistry from Baylor University, Texas, USA and had post-doctoral training at the Department of Biochemistry, University of Cambridge, UK. Her research and teaching career spans over 35 years in the areas of structural biology of plant proteins, food science, detail-focused analytical food safety, and a solid understanding of food safety regulations. She is a member of the Scientific Committee of FSSA(I), and Genetic Engineering Appraisal Committee (GEAC) under the Ministry of Environment, Forests & Climate Change.

Photos

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Crop Health and Its Global Impacts on the Components of Food Security

This article attempts to develop a framework that would enable assessment of the impacts of plant diseases, referred collectively to as crop health, on food security via its components. Given the number of components and interactions at play, a systems modelling approach is required to address the functioning of food systems exposed to plant disease risks.

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