Environmental
Risk Assessment

Creating Confidence in Biosafety Assessments to Inform Reliable and Predictable Regulatory Outcomes

The Issue

Developing and applying sound science to the environmental risk assessment (ERA) of biotechnologies is crucial for safely realizing their contributions to human health and sustainable production of food, fuel, and fiber.

What We Are Doing

Whether it be through improving systematic approaches to inform understanding of plausible risks associated with the use of gene drive strategies or working to maximize the utility of confined field trial data, we serve as a scientific resource for governments, academic institutions, and private sector organizations.

Why It’s Important

Any new technology comes with potential benefits and potential risks for the environment. Understanding these is essential to making informed decisions about what should or should not move from research to field to market.

Program Staff

Andrew Roberts, Ph.D.

Andrew leads the development and management of AFSI’s extensive international portfolio of biotechnology-related analytical and capacity building programs, open access resources, and relationships with key partner organizations and stakeholder groups.

Karen Hokanson, Ph.D.

Karen contributes to the development and implementation of AFSI’s current and future applied research and capacity building programs. She is responsible for developing strategies and budgets for these projects, identifying associated personnel requirements, and is accountable for ensuring the program/project meets its stated objectives. She also serves as liaison between AFSI management and staff, implementing partners, and other applicable parties.

Where We Operate

COMESA

IICA Countries

Collaborators & Partners

Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA)
Australian Government
Common Market for Eastern and Southern Africa (COMESA)
Foundation for the National Institutes of Health (FNIH)
International Food Policy Research Institute (IFPRI)
Instituto Interamericano de Cooperación para la Agricultura (IICA)
New Partnership for African Development (NEPAD)
Organisation for Economic Co-operation and Development (OECD)
University of British Columbia
University of Edinburgh
USDA Foreign Agricultural Service

Rationalizing the use of field trial data to inform ERA.

Programs

Data Transportability for Field Trial Research

Promoting Use of Relevant Field Trial Data Across Geographies

Confined field trials (CFTs) are conducted to inform environmental risk assessments of genetically engineered crops. But instead of repeating trials in every country where a genetically engineered crop might be grown, data from previous trials, including those cultivated in similar agroclimates, may provide all that is necessary.

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Global Environmental Zones (GEnZ) Explorer

Rationalizing the Location of CFTs to Maximize Data Utility

Our online tool allows users to visualize agroclimatic zonations and their relationships to CFT locations in order to help determine where to best locate CFTs and maximize data utility. This can be used by CFT managers and risk assessors to provide context for the relevance of CFT data produced at remote locations.

VISIT TOOL

Gene Drives in Mosquitoes

Identifying Priorities for Risk Assessment

With almost 263 million estimated cases of malaria worldwide in 2023, novel approaches to managing this debilitating disease are needed. We are advancing understanding of the underlying technology and helping stakeholders identify priorities for risk assessment of the use of gene drive to control the mosquito vectors that spread this disease.

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Our Successes

Improving Understanding of How to Assess the Effects of Genetically Engineered Crops on Non-Target Organisms

Objective

Because it is not possible to measure, monitor, and test every organism in every environment, surrogate species play an important role in evaluating the potential for adverse environmental impacts of new technologies. This includes assessing the potential effects of genetically engineered crops on non-target organisms (NTOs). Surrogate species must be selected appropriately to represent key taxonomic or functional groups, and testing must be done with sufficient rigor to ensure that tests address the potential impact being investigated. The Agriculture and Food Systems Institute (AFSI) recognized the benefits of providing technical training to regulatory scientists and risk assessors on non-target organism testing of transgenic crops.

Outcome

AFSI facilitated multiple expert working groups and publications addressing the proper use of surrogate species for testing in support of environmental risk assessment of genetically engineered crops, and in 2016, the institute produced a peer-reviewed publication that provides an overview of the history of regulatory approaches to NTO assessments and analyzes current regulatory practices. The paper proposes recommendations to improve the predictive value and efficiency of NTO testing and to facilitate the transportability of existing datasets across geographies and regulatory regimes.

Supported by a grant from the United States Department of Agriculture Foreign Agricultural Service (USDA FAS) Emerging Markets Program (EMP) and in cooperation with the USDA Agricultural Research Service (ARS), Iowa State University, and Corteva Agriscience, AFSI organized technical trainings on non-target organism testing of transgenic crops for two different cohorts on June 26-30, 2023 and June 24-28, 2024. These by-invitation-only workshops provided regulatory scientists and environmental risk assessors from Ghana, India, Indonesia, Kenya, Malawi, Nigeria, the Philippines, the USA and Vietnam with an experiential learning opportunity in laboratory and field testing of non-target organisms.

During the technical training program, through group work, presentations, and facilitated exchanges, participants:

Learned how insect populations are assessed in agroecosystems using two common insect collection techniques: sticky cards to collect flying insects and pitfall traps to collect ground-dwelling insects.
Gained first-hand experience setting up traps in established fields of insect-resistant and conventional corn.
Received the opportunity to review and critique data generated by commercial laboratories, which are typically provided to government regulators in support of applications to authorize commercial planting of insect-resistant crops.
Improved their understanding of the limits of NTO testing in environmental risk assessment.

Dynamic Role and Importance of Surrogate Species for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Insect-Resistant Plants on Non-Target Organisms

Project Name:
Environmental Risk Assessment Workshop: Non-Target Organism Testing
Years:
2023-2024
Funding:
United States Department of Agriculture Foreign Agricultural Service (USDA FAS) Emerging Markets Program (EMP)
Parties:
Regulatory Scientists, Environmental Risk Assessors
Geography:
Ghana, India, Indonesia, Kenya, Malawi, Nigeria, the Philippines, the USA and Vietnam

OECD Consensus Document on the Biology of Mosquito Aedes Aegypti

Objective

Genetically engineered Ae. aegypti have been developed to control populations of this mosquito, which is the main vector of yellow fever, dengue fever, Zika, and chikungunya. To facilitate risk assessments for the use of these genetically engineered mosquitoes, regulators need access to succinct, summary information on biosafety-relevant aspects of the biology of the species. Biosafety consensus documents published by the Organisation for Economic Co-operation and Development (OECD) Working Group on Harmonization of Regulatory Oversight in Biotechnology (WG-HROB) provide internationally agreed-upon baseline information for understanding key aspects of the biology of specific organisms. Each document identifies and describes important characteristics of its subject, usually a plant species, which are typically considered when undertaking a comparative risk assessment of its genetically engineered counterpart. The Agriculture and Food Systems Institute (AFSI) recognized the benefits of developing an OECD Consensus Document of the Biology of mosquito Aedes aegypti to serve as a public resource.

Outcome

As a recognized observer organization and having consistently attended meetings for many years, AFSI approached the OECD Environment Secretariat about developing a biology document for Aedes aegypti. The idea was put to the WG-HROB, and, with the governments of Brazil and Mexico as convening leads together with AFSI, the project was launched at a workshop hosted by the government of Mexico in May 2014. During this workshop, experts developed a detailed outline of the document and committed to an action plan.

The OECD Consensus Document on the Biology of Mosquito Aedes aegypti was declassified in July 2018 as Volume 8 of the series on Safety Assessment of Transgenic Organisms in the Environment. It is the first OECD biosafety consensus document to:

Deal with the biology of an insect.
Focus on an organism for which biotechnological applications are not aimed at an increase in production or the quality of the product, but are driven by health considerations, specifically to reduce the health burden associated with diseases vectored by mosquitoes, such as yellow fever, dengue, Zika and Chikungunya.

The biology document provides the following information on Ae. aegypti:

Taxonomy
Morphology
Life Cycle
Reproductive Biology
Genetics
Ecology
Interactions with Other Species and the Environment

Preparation of the OECD Consensus Document of the Biology of Mosquito Aedes aegypti was co-led by Mexico, Brazil, and AFSI, with additional expertise provided by Australia, France, India, Kenya, and the United States, as well as inputs from private sector entities.

OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Project Name:
OECD Consensus Document on the Biology of Mosquito Aedes Aegypti
Years:
2014-2018
Co-Leads:
Governments of Mexico and Brazil
Additional Expertise:
Governments of Australia, France, India, Kenya, and the United States, as well as experts from private sector entities
Publisher:
OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology (WG-HROB)

Clarifying the Protection Goals and Information Needs for Environmental Risk Assessment of RNAi Plants

Objective

Historically, genetically engineered (GE) plants incorporating genes conferring insect protection have primarily used Cry proteins derived from Bacillus thuringiensis (Bt) to achieve their insecticidal phenotype. As a result, regulators have developed familiarity and confidence in reviewing plants incorporating these insecticidal proteins. However, new technologies have been developed to produce genetically engineered plants that incorporate pest protection by triggering an RNA interference (RNAi) response or proteins other than Bt Cry proteins. With increasing attention being paid to the use of sublethal endpoints and their value for environmental risk assessment (ERA), the Agriculture and Food Systems Institute (AFSI) recognized a need to clarify the protection goals and information needs for the ERA of RNAi Plants.

Outcome

To address this need, AFSI:

Highlighted the benefits of clarifying protection goals and information needs for the ERA of RNAi Plants at the 2012 Entomological Society of America Annual Meeting, which took place on November 11-14, 2012, in Knoxville, Tennesee.
Organized a scientific session on RNAi and environmental risk assessment of genetically engineered plants at the 13^th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO), which took place on November 9-13, 2014 in Cape Town, South Africa. During this event, a multi-sectoral, multi-disciplinary team of scientists worked together to help identify and clarify the relevant safety considerations and risk assessment methodologies for environmental risk assessment of plants with RNAi traits.
Led a joint effort to draft a manuscript based on presentations and discussions at the 13^th ISBGMO scientific session, which proposes research areas that may be beneficial for future environmental risk assessments of RNAi-based genetically modified plants, with a particular focus on non-target organism assessment. This peer-reviewed paper was published in Frontiers in Plant Science on November 10, 2015.

Biosafety Research for Non-Target Organism Risk Assessment of RNAi-based GE Plants, Frontiers in Plant Science, 2015.

Project Name:
Biosafety Research for Non-Target Organism Risk Assessment of RNAi-based Genetically Engineered Plants
Years:
2012-2015
Funding:
United States Department of Agriculture National Institute for Food and Agriculture (USDA NIFA) Biotechnology Risk Assessment Grants (BRAG) Program

Discover

Publications

Frequently Asked Questions: Genome Edited Plants

Biosafety Resource Book Series | April 4, 2024

Published by the South Asia Biosafety Program, this booklet provides information about genome edited plants in a simple language, so readers may better understand the science, applications, and policies at the global and national levels.

GEnZ Explorer: A Tool for Visualizing Agroclimate to Inform Research and Regulatory Risk Assessment

Transgenic Research | June 6, 2023

This paper describes the development of an open-source tool, the GEnZ Explorer, that provides agroclimate together with overall crop production information to assist regulators and applicants in making informed choices on whether data from previous CFTs can inform an environmental risk assessment in a new country, as well as help developers determine optimal locations for planning future CFTs. The GEnZ Explorer allows users to identify the agroclimate zones that are relevant for the production of 21 major crops and crop categories.

New Applications of Insecticidal RNAi

Frontiers in Agronomy | May 27, 2022

Reduced reliance on synthetic chemical pesticides that may negatively impact pollinators and other beneficial insects is an aim of both private industry and governmental agencies alike. The need for environmentally sound methods of insect control has inspired research into a wide range of bio-based technologies. RNA interference has emerged as a highly effective tool with inherent potential to control a wide range of insects.

Frequently Asked Questions: Genetically Engineered Plants and Biosafety

Biosafety Resource Book Series | March 30, 2021

The South Asia Biosafety Program designed this booklet to address some of the questions the general public may have about the safety of genetically engineered plants, with explanations in easy and understandable language.

Biosafety Regulation and Processes in Bangladesh: A Guide for Researchers in Agricultural Biotechnology

Biosafety Resource Book Series | November 19, 2020

Part of the South Asia Biosafety Program’s capacity development interventions, this publication aims to inform researchers about the prevailing regulatory administrative system of Bangladesh and outlines the regulatory processes functioning at different stages of research and development of GE crops.

Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops

Frontiers in Bioengineering and Biotechnology | August 18, 2020

This paper presents the recent evolution of the regulatory system in Paraguay toward the establishment of a simplified procedure for GE crops that have been already assessed by sound and experienced regulatory systems, taking into account several scientific criteria. Dr. Carmen Vicién, Agriculture & Food Systems Institute in-country partner, was a co-author of this paper, which references the Agriculture & Food Systems Institute’s involvement in the Partnership for Biosafety Risk Assessment and Regulation in Paraguay.

Sublethal Endpoints in Non-Target Organism Testing for Insect-Active GE Crops

Frontiers in Bioengineering and Biotechnology | June 9, 2020

This review paper focuses on the current status and history of sublethal endpoint use in insect-active GE crops and evaluates the future use of sublethal endpoints for new and emerging technologies.

Genetic Biocontrol for Invasive Species

Frontiers in Bioengineering and Biotechnology | May 25, 2020

This publication provides an overview of the state of genetic biocontrol, focusing on several approaches that were the subject of presentations at the Genetic Biocontrol for Invasive Species Workshop, which was sponsored by the OECD’s Co-operative Research Program on Biological Resource Management for Sustainable Agricultural Systems.

Agricultural Biotechnology and Biosafety in South Asia: Progress and Prospects

SAARC Agriculture Centre | September 30, 2019

This book contains the papers and proceedings of the SAARC Regional Consultative Meeting on the Progress and Prospects of Agricultural Biotechnology and Biosafety in South Asia, which took place on June 18- 20, 2019 in Dhaka, Bangladesh.

Problem Formulation for Gene Drive Mosquitoes Designed to Reduce Malaria Transmission in Africa: Results from Four Regional Consultations 2016–2018

Malaria Journal | October 15, 2019

This summary publication captures the findings from four African consultations organized by the New Partnership for Africa’s Development (NEPAD) to identify risk hypotheses and data needs for future environmental risk assessment of gene drives in the mosquito Anopheles gambiae.

OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Safety Assessment of Transgenic Organisms in the Environment (Volume 8) | June 23, 2018

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.

Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems

Frontiers in Bioengineering and Biotechnology | April 5, 2018

The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. Dr. Carmen Vicién, Agriculture & Food Systems Institute in-country partner, was a co-author of this paper, which references the Agriculture & Food Systems Institute’s involvement in the Partnership for Biosafety Risk Assessment and Regulation in Paraguay and the use of Agriculture & Food Systems Institute eLearning courses in Kenya.

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