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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 the 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

USDA Foreign Agricultural Service, 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, and Estel Consult Ltd.

Current Work

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 ILSI Focal Point in China, the ILSI Research Foundation is organizing a food safety training program that 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 near Beijing, while the second phase will be conducted at a research center in the United States, where participants will be 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 we are doing by reading our monthly newsletter.

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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Overview

Agenda

Overview

Crop composition is an essential component of the food safety assessment for GE crops that are intended to be used as food. However, it is important to understand the purpose of the data and its context in the safety assessment. Open to attendees of the 15th ISBR Symposium, this workshop will provide an opportunity to briefly discuss the rationale for considering crop composition data, how that data is interpreted in the context of the safety assessment, and what the limitations are to compositional studies.

The workshop will also introduce participants to a resource for assisting in the interpretation of compositional studies—the ILSI Crop Composition Database. Participants will see a demonstration of the database and its features, highlighting updates and additions to Version 7.0, the latest iteration of the database that was launched in January 2019. Then, participants will be provided with a series of exercises designed to help them understand the search reporting function of the ILSI Crop Composition Database, which they can walk through using their personal laptop during the workshop.

In order to ensure that organizers can provide assistance to participants while conducting the practical exercises, the workshop is limited to 20 participants and will be conducted twice (at 2:00 pm and 4:00 pm). More information about the workshop and how to register for the symposium is available from the International Society for Biosafety Research.

Agenda

Welcome and Introduction

Compositional Assessment as a Component of Food Safety Assessment for GE Plants
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation

Introduction to the ILSI Crop Composition Database
Dr. Bhavneet Bajaj, Scientific Program Manager, ILSI Research Foundation

Practical Exercises

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By Invitation Only. 

The ILSI Research Foundation, 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. Planned for June 2019, Phase II of the training will include laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted.

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

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 Regulation of Genetically Engineered Foods and Livestock Feeds in China
Mr. Peilei Liu, Ministry of Agriculture and Rural Affairs International Guidance for Assessing Foods and Feeds Derived from Genetically Engineered Plants
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI) Key Concepts in the Risk Assessment of Genetically Engineered Crops
Dr. Monica Garcia-Alonso, Estel Consult, Ltd.

Question & Answer Session

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

Breakout Exercise 1

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

Breakout Exercise 2

Day 2

Delving into Food and Feed Safety Assessments (I)

Recap and Questions from Day 1

Key Concepts in Genetically Engineered Food/Feed Assessment: Compositional Analyses
Dr. Monica Garcia-Alonso, Estel Consult, Ltd. Accessing Crop Compositional Data to Inform Genetically Engineered Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation

Breakout Exercise 3

Characterization of the Genetic Modification and the Novel Protein(s)
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Breakout Exercise 4

Assessing Potential Toxicity of Proteins Expressed in Genetically Engineered Crops
Dr. Jason Roper, Corteva Agrisciences

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. Understanding Animal Feeding Studies in the Context of Genetically Engineered Food/Feed Safety Assessments
Dr. Jason Roper, Corteva Agrisciences

Plenary Group Discussion

Assessing Potential Allergenicity
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Breakout Exercise 6

Risk Communication
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI) Feedback, Discussion, and Review
Dr. Monica Garcia-Alonso, Estel Consult, Ltd. Preparing for the Phase II Workshop
Dr. Monica Garcia-Alonso, Estel Consult, Ltd.

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.

Speakers

Dr. Mònica García-Alonso, Estel Consult, Ltd.

Dr. Mònica García-Alonso is an independent consultant and director at Estel Consult, Ltd. She has been working in the area of risk assessment of genetically modified crops and regulatory affairs for more than 20 years. She holds a bachelor’s degree in biology, with a specialty in zoology and entomology, and a master’s degree in insect physiology and ecology from the University of Barcelona, as well as a doctorate in neurobiology from the University of Reading. She worked for Syngenta for 19 years and set up her own consultancy eight years ago. She now supports private and public research activities aimed at developing GM crop solutions and provides training on risk assessment to regulators and developers around the world.

Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Dr. Donald MacKenzie is the Executive Director of the Institute for International Crop Improvement (IICI). He manages the IICI’s programs and partnerships dedicated to translating key discoveries in plant health, disease and pest management, genomics, advanced breeding, and nutrition to staple crops that impact food security around the globe. Don also provides guidance on navigating through the practical, safety, and regulatory processes necessary to demonstrate that new crop varieties are proven safe and effective for the farmers who will benefit from them.

Don is an international expert in regulatory systems for agriculture, including environmental risk assessment, biosafety, and food safety assessments. His extensive experience in plant product development and global regulatory processes aligns with the Institute’s commitment to collaborate with international and local partner organizations to deliver crops with improved nutritional content and disease resistance to places where people are in most need. In addition to feeding the hungry, these efforts have the potential to contribute to environmental health and empower farmers to become more self-sufficient.

Dr. Jason Roper, Corteva Agrisciences

Dr. Jason Roper earned his B.S. in Biomedical Science with a minor in Chemistry from Western Michigan University in 1997. He then completed his M.S. and Ph.D. in Molecular Toxicology and Environmental Medicine at the University of Rochester School of Medicine and Dentistry in 2004 and 2005, respectively. Following his post-graduate studies, Jason worked for six years as Senior Toxicologist and Study Director at a contract research organization specializing in GLP mammalian toxicology studies. He joined DuPont Pioneer in 2011 as Research Scientist and Toxicologist, managing a team of scientists responsible for the planning and execution of mammalian, livestock, and avian toxicology studies to support product safety evaluations for global regulatory submissions of genetically modified organisms (GMOs), including insect-resistant and herbicide-tolerant maize, soybean, rice, and canola products.

Jason joined the DuPont Central Research and Development (CR&D) group at Haskell Global Centers for Health and Environmental Sciences in 2013 as Principal Investigator and Senior Research Toxicologist, providing consulting services for the several DuPont businesses in the agricultural, biotechnology, and food industries. Following the merger of DOW with DuPont in 2017, Jason led the general, neuro- and inhalation toxicology competencies at Haskell Global Centers until transitioning to the Corteva Agrisciences (a division of DowDuPont) seeds business in 2019, as a subject-matter expert for regulatory toxicology and product safety. Jason has served as Chair of the CropLife International Toxicology Expert Team (2016-2018) and the DuPont Agricultural Animal Resource Committee (2016-present), Vice-Chair of the Haskell Animal Welfare Committee (2013-2017), and is a member of the HESI Protein Allergen, Toxin, and Bioinformatics (PATB) group and the Haskell Contract Laboratory Evaluation and Approval Team (2015-present).

Dr. Bhavneet Bajaj, ILSI Research Foundation

Dr. Bhavneet Bajaj joined the ILSI Research Foundation as Scientific Program Manager in July 2018. She has worked in academia, the biotechnology industry, and the US Department of Agriculture (USDA) and has a combined research and teaching experience of 12 years.

Dr. Bajaj has worked on plant secondary metabolites of nutritional, agricultural, and medicinal importance. Prior to joining the ILSI Research Foundation, Dr. Bajaj held the position of Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in high polyamine containing tomatoes. Before then, she was an Associate Investigator with the Plant Protection Group at DuPont, where she worked on metabolic engineering as a strategy for insect control in soybean. During her postdoctoral training, she worked on targeted metabolite profiling of triterpene glycosides and phenolic acids in cell suspensions of black cohosh and developed an in vitro protocol for accelerating its seed germination. Dr. Bajaj has also worked as an Assistant Professor at Jaipur National University, India, where she taught genetic engineering, enzymology, and biochemistry courses to masters level students.

Dr. Bajaj received her M.Sc. and Ph.D. in Biotechnology from Guru Jambheshwar University of Science and Technology, India. Her graduate level research comprised of genetic diversity studies on bacterial blight pathogen of clusterbean using molecular markers.

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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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eLearning

The ILSI Research Foundation has developed eLearning courses that focus on food safety.

Seven Food System Metrics of Sustainable Nutrition Security

Sustainability considerations have been absent from most food security assessments conducted to date, despite the tremendous economic, environmental, and social implications of meeting accelerating food demand in the face of water shortages and climate change.

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DOI: 10.3390/su8030196

Background: The world faces an escalating challenge to meet accelerating demand for sustainably-produced, nutritious food in the face of human population pressure, resource scarcity, ecosystem degradation, and climate change. As the ambitious Millennium Development Goals (MDGs) give way to the Sustainable Development Goals (SDGs), about 795 million people globally are still without sufficient calories and at least two billion lack sufficient nutrients.  The ILSI Research Foundation has developed and published a new paper giving a unique set of metrics for measuring food system performance.  The metrics make it possible to set meaningful goals, track progress, and evaluate the potential impact of food system interventions intended to improve sustainability and human nutrition outcomes.

Abstract: Sustainability considerations have been absent from most food security assessments conducted to date, despite the tremendous economic, environmental, and social implications of meeting accelerating food demand in the face of water shortages and climate change. In addition, previous food security work has generally focused only on achieving adequate calories, rather than addressing dietary diversity and micronutrient adequacy, both of which are critical to maintaining a healthy overall nutritional status. In response to the limitations of previous assessments, a new methodology is proposed here based on the concept of “sustainable nutrition security” (SNS). This novel assessment methodology is intended to remedy both kinds of deficiencies in the previous work by defining seven metrics, each based on a combination of multiple indicators, for use in characterizing sustainable nutrition outcomes of food systems: (1) food nutrient adequacy; (2) ecosystem stability; (3) food affordability and availability; (4) sociocultural wellbeing; (5) food safety; (6) resilience; and (7) waste and loss reduction. Each of the metrics comprises multiple indicators that are combined to derive an overall score (0–100). A novel SNS assessment methodology based on these metrics can be deployed by decision-makers and investors to set meaningful goals, track progress, and evaluate the potential impact of food system interventions intended to improve sustainability and human nutrition outcomes.

Download the journal article here.

Resources

Download the metric paper news release here.

Download the 7 food system metrics of sustainable nutrition security infographic available in English or Spanish.

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