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Objective

New technologies have the promise to transform agricultural productivity and nutrition. However, many governments lack the risk assessment resources and experience needed to assure decision-makers and the public that environmental and food safety concerns posed by products of these technologies have been adequately addressed. The ILSI Research Foundation is developing risk assessment resources, and providing training to scientists, risk assessors and regulators, to promote science-based risk assessments of products of biotechnology.

Collaborators & Partners

US Agency for International Development (USAID), US Department of Agriculture (USDA), UNEP-GEF, Organisation for Economic Co-operation and Development (OECD), International Food Policy Research Institute (IFPRI), Indian Council of Agricultural Research and governmental ministries and departments in India, Bangladesh and Indonesia

Areas of Focus

In 2016, the ILSI Research Foundation undertook biosafety-related activities in India, Bangladesh, China, Japan, Korea, Mexico and Paraguay. In 2017, the ILSI Research Foundation is continuing its biosafety capacity building through:

eLearning Courses

Self-paced and interactive courses developed by the ILSI Research Foundation serve as supplemental training resources to in-person workshops.

South Asia Biosafety Program

Managed by the ILSI Research Foundation, SABP assists India and Bangladesh in further strengthening institutional governance of biotechnology.

UNEP-GEF Phase II Project

The ILSI Research Foundation provides technical support on risk assessment and risk management in South Asia.

Resources

Newsletters

Find out about the work being done through the South Asia Biosafety Program by reading our monthly newsletter.

eLearning

eLearning courses have been developed by the ILSI Research Foundation that focus on biosafety and biotechnology.

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

7th Training Workshop for Institutional Biosafety Officers on the Conduct and Monitoring of Confined Field Trials of Regulated Genetically Engineered (GE) Plants

New Delhi, India

ILSI Research Foundation, in collaboration with the Indian Council of Agricultural Research and Biotech Consortium India Limited, co-organized the 7th Training Workshop for Institutional Biosafety Officers on the Conduct and Monitoring of Confined Field Trials of Regulated Genetically Engineered Plants.

Read more

Gene Drive: 21st Century Genetic Control of Agricultural and Public Health Pests

Vancouver, Canada

Dr. Andrew Roberts, Deputy Executive Director, delivered the presentation Environmental Risk Assessment of Gene Drive Insects at the Section Symposium: Gene Drive: 21st Century Genetic Control of Agricultural and Public Health Pests, which took place during the 2018 Entomology Society of America Annual Meeting in Vancouver, Canada.

Read more

Environmental Risk Assessment of Genetically Modified Crops and Insects: Lessons Learned from the Past and Next Steps in a Changing World

Vancouver, Canada

Dr. Andrew Roberts, Deputy Executive Director, delivered the presentation The Global Perspective on ERA Regulations for GE Crops and Insects at the Section Symposium: Environmental Risk Assessment of Genetically Modified Crops and Insects: Lessons Learned from the Past and Next Steps in a Changing World, which took place during the 2018 Entomology Society of America Annual Meeting in Vancouver, Canada.

Read more

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Biotech Consortium India Ltd. and the ILSI Research Foundation co-organized the 7th Training Workshop for Institutional Biosafety Officers on Confined Field Trials of Genetically Engineered Plants on December 10-11 in New Delhi. The workshop, part of ICAR’s Program on Biosafety Compliance and Readiness, provided training to 20 participants, including institutional biosafety officers and scientists engaged in the development of GE plants under the ICAR Network Project of Transgenics in Crops.

Agenda

December 10, 2018

December 11, 2018

Photos

December 10, 2018

Welcome and Introductions
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Opening Remarks
Dr. N.K. Singh, Project Director, National Research Center on Plant Biotechnology (NRCPB) and Coordinator, ICAR Network Project of Transgenics in Crops (NPTC)

Overview of the Program
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation

Session 1: Regulatory Framework and Guidelines for the Conduct of CFTs

Regulatory framework for CFTs of GE Crops
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Guidelines for the Conduct of Confined Field Trials of Regulated, GE Plants
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Exercise 1: Workbook Questions on CFT Regulations and Guidelines

Q&A and Review of Session 1

Session 2: Application and Conduct of CFTs for GE Plants

Application for Seeking Permission for Confined Field Trials of Regulated GE Plants
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Exercise 2: Using Plant Biology Documents to Complete Part E of CFT Applications

Interactive Walkthrough: Annotations to the CFT Application Form
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation

Conducting a CFT: Handling Material, Maintaining Isolation, Harvest, and Termination
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation

Exercise 3: Workbook Questions on Conducting a CFT

December 11, 2018

Session 2: Application and Conduct of CFTs for GE Plants (continued)

Demonstrating Compliance with Regulatory Requirements
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Interactive Walkthrough: Recording Formats
Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited (BCIL)

Non-Compliance and Corrective Actions for CFTs
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation

Exercise 4: Workbook Questions on Compliance

Open Discussion

Adjournment 

Photos

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Dr. Andrew Roberts, Deputy Executive Director, delivered the presentation Environmental Risk Assessment of Gene Drive Insects at the Section Symposium: Gene Drive: 21st Century Genetic Control of Agricultural and Public Health Pests, which took place during the 2018 Entomology Society of America Annual Meeting in Vancouver, Canada.

More detailed information about the session is available on the Entomological Society of America website

Agenda

Abstract & Presentation

Agenda

Introductory Remarks
David A. O'Brochta, Foundation for the National Institutes of Health (Organizer)
Blair D. Siegfried, University of Florida (Organizer)
Scott T. O'Neal, Virginia Polytechnic Institute and State University (Moderator)
Peter D. Jensen, Monsanto Company (Moderator)

Natural Selfish Genetic Elements and Gene Drive - Their Relevance to Evolution
Gerald S. Wilkinson, University of Maryland
Kimberly Paczolt, University of Maryland
Josephine Reinhardt, University of New York

Engineered Gene Drives - Types and Mechanisms
Omar Akbari, University of California, San Diego

Gene Drives for Public Health - Modifying Vector Populations
Rebeca Carballar-Lejarazú, University of California, Irvine

Gene Drive Performance - Insights from Modeling
Alun Lloyd, North Carolina State University

Gene Drives for Agricultural Insect Control
Max Scott, North Carolina State University

Ethics, Social, and Community Considerations Raised by Gene Drives
Claudia Emerson and Aaron Roberts, McMaster University

Environmental Risk Assessment of Gene Drive Insects
Andrew F. Roberts, ILSI Research Foundation

Gene Drives for Public Health - Suppressing Vector Populations
Austin Burt, Imperial College of London
Tony Nolan, Imperial College of London

Abstract & Presentation

Environmental Risk Assessment of Gene Drive Insects
Andrew F. Roberts, ILSI Research Foundation

The potential to use gene drive mechanisms to address intractable public health problems caused by vector-borne diseases has been of interest to scientists for decades, but recent advances in molecular biology have brought this idea closer to feasibility and consequently into the public consciousness. To begin discussions in Africa that will facilitate the consideration of potential future use of gene drive technologies to control malaria, the New Partnership for African Development (NEPAD) organized a series of regional consultations taking place in 2016-2018. Drawing from his experience in facilitating problem formulation exercises at these consultations, as well as other sources, I will share some of my own conclusions about the utility (and the necessity) of applying an organized scoping process like problem formulation to better inform the risk assessment process, especially as it relates to new technologies or new uses of technology. I will also review commonly identified assessment endpoints that can provide guidance to future risk assessments for gene drive mosquitoes. These include potential alterations to vectorial capacity that might impact human or animal health, the potential for aquatic larvae to influence water quality, and the potential for harm resulting from altered ecosystem interactions.

Download Presentation

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Dr. Andrew Roberts, Deputy Executive Director, delivered the presentation The Global Perspective on ERA Regulations for GE Crops and Insects at the Section Symposium: Environmental Risk Assessment of Genetically Modified Crops and Insects - Lessons Learned from the Past and Next Steps in a Changing World, which took place during the 2018 Entomoloagy Society of America Annual Meeting in Vancouver, Canada.

More detailed information about the session is available on the Entomological Society of America website.

Agenda

Abstract & Presentation

Agenda

Introductory Remarks
Tony Shelton, Cornell University (Organizer)
Jörg Romeis, Agroscope (Organizer)
Ana Maria Velez, University of Nebraska (Organizer)

Evolution of Environmental Risk Assessment for GM Crops
Paul Jepson, Oregon State University

Assessing the Risk of Bt Crops to Arthropod Natural Enemies: A Tri-Trophic Perspective
Steven Naranjo, USDA - ARS
Tony Shelton, Cornell University
Junce Tian, Zhejiang University
Jörg Romeis, Agroscope
Richard Hellmich, USDA - ARS

Systematically Reviewing Non-Target Effects of Bt Maize on Arthropods in Field Studies: Pitfalls and Opportunities of Meta-Analysis
Michael Meissle, Agroscope
Steven Naranjo, USDA - ARS
Jörg Romeis, Agroscope

Risk Assessment of RNAi and Gene Editing in Pest Management
Ana Velez, University of Nebraska, Lincoln

Gene Drive: An Overview for Pest Management
Timothy Harvey-Samuel, Pirbright Institute

Role of Population Modification in the Malaria Eradication Agenda
Anthony James and Rebeca Carballar-Lejarazú, University of California, Irvine

The US System for Regulating GE Organisms in Agriculture
Lisa Knolhoff, USDA - APHIS

The Global Perspective on ERA Regulations for GE Crops and Insects
Andrew F. Roberts, ILSI Research Foundation

The Cornell-Oxitec Project: The First Release of Self-Limiting Insects in North America
Tony Shelton, Cornell University
Neil Morrison, Oxitec Ltd.

Fall Armyworm in Africa: Can GE Technologies Be Part of the Solution?
Joseph E. Huesing and Regina Eddy, United States Agency for International Development

Biological Control of Human Diseases and Crop Pests with GM Insects
Brad Shurdut, Intrexon Corporation
Neil Morrison, Oxitec Ltd.
Catherine Reavey, Oxitec Ltd.

Managing GM Crop Dominated Landscapes: Case of the Monarch Butterfly
Richard Hellmich, USDA - ARS

Panel Discussion

Abstract & Presentation

The Global Perspective on ERA Regulations for GE Crops and Insects
Andrew F. Roberts, ILSI Research Foundation

Global experience with environmental risk assessment (ERA) for genetically engineered (GE) organisms has focused almost exclusively on considerations for GE crops. Up until now, only a small number of cases featuring a handful of other organisms (including trees, fish, microorganisms and insects) have received regulatory ERA for release to the environment. However, new and emerging technologies are bringing GE insects into the spotlight. This talk will review the current global experience with regulatory ERA of GE insects, identify relevant international treaties (such as the Convention on Biological Diversity and its Cartagena Protocol on Biosafety), and offer some insight on how regulatory ERA for GE insects is likely to move forward as these technologies are deployed around the world.

Download Presentation

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OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Volume 8 of the series Safety Assessment of Transgenic Organisms in the Environment contains the first OECD biosafety consensus document to deal with the biology of an insect, the mosquito Aedes aegypti.

Read more

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Legacy Work

Strengthening the Capacity of Developing Countries in Biosafety Risk Assessment and Regulation

The Partnership for Biosafety Risk Assessment and Regulation (PBRAR) was active from 2011-2014, and was supported by a US $1.2 million grant from the Development Grant Facility of the World Bank. The Partnership was comprised of the ILSI Research Foundation, the Environment Directorate of the Organisation for Economic Co-operation and Development (OECD), the World Bank, and eight developing countries that have adopted, or are considering the adoption of, agricultural biotechnology.

In each of the partner countries, the PBRAR sought to strengthen the technical capacity of stakeholders engaged in biosafety risk assessment and regulation so as to facilitate evidence-based decision making.

Pakistan Grants Program: Scientific Support for Regulatory Decision Making

The Biosafety Research in Pakistan Grants Program, managed by the ILSI Research Foundation, supported research projects designed to improve understanding about environmental impacts of genetically engineered crops relevant to agricultural production in Pakistan.

Active from 2012-2014, 16 grantees from academic institutions worked to investigate the potential effects of genetically engineered crops on the agro-ecosystem, and build a knowledgeable community of practice to facilitate regulatory decision-making in Pakistan.