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Objective

Food safety is recognized as a universal public health concern. Enormous economic and human 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. The ILSI Research Foundation addresses this challenge by providing information resources and capacity building activities for scientists, regulators, and the public, focusing particularly on the safety assessment of foods and feeds derived from GE plants.

Collaborators & Partners

USDA Foreign Agricultural Service, CropLife International, CropLife China, ILSI Focal Point in 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 Activity

The ILSI Research Foundation's concluded projects in the area of food and feed safety assessment include:

GE Food Safety Capacity Building

Understanding the need for technical capacity building for food safety assessment, the ILSI Research Foundation shares its knowledge and scientific expertise by facilitating regional workshops and developing and disseminating reference materials.

Crop Composition Database

The ILSI Research Foundation’s CCDB is a curated, open resource that provides data on the natural variability in the nutritional composition (e.g., nutrients, anti-nutrients, and secondary metabolites) of key crop species.

Past Work

The ILSI Research Foundation's concluded projects in the area of food and feed safety assessment include:

Resources

Newsletters

Find out about the work we are doing by reading our monthly newsletter.

OECD Working Group 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 provided 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 also introduced participants to a resource for assisting in the interpretation of compositional studies—the ILSI Crop Composition Database. Participants saw 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 were provided with a series of exercises designed to help them understand the search reporting function of the ILSI Crop Composition Database, which they were able to walk through using their personal laptop during the workshop.

In order to ensure that organizers could provide assistance to participants while conducting the practical exercises, the workshop was limited to 20 participants and was conducted twice (at 2:00 pm and 4:00 pm). More information about the workshop 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

Phase II of the workshop took place June 17-21, 2019 in Washington, DC and Ashland, OH. It focused on laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted. Phase II also included a review of the concepts from Phase I, with an additional focus on critical reading and 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. 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.

Group Photo of Phase I & II Participants and Key Faculty (Langfang, China,  March 5, 2019) Group Photo of Phase I & II Participants and Key Faculty (Langfang, China, March 5, 2019) [post_title] => Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants: Phase I Technical Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => china-phase1 [to_ping] => [pinged] => [post_modified] => 2019-06-25 17:11:05 [post_modified_gmt] => 2019-06-25 17:11:05 [post_content_filtered] => [post_parent] => 0 [guid] => http://ilsirf.org/?post_type=event&p=9982 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 8651 [post_author] => 65 [post_date] => 2018-10-25 19:34:42 [post_date_gmt] => 2018-10-25 19:34:42 [post_content] =>

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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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.

Read more

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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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