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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.

eLearning

The ILSI Research Foundation has developed eLearning courses 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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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. 

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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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.

Read more

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