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.
Andrew Roberts, Ph.D.
Rachel Melnick , Ph.D.
Collaborators & Partners
- Australian Government
- Common Market for Eastern and Southern Africa (COMESA)
- Foundation for the National Institutes of Health (FNIH)
- International Food Policy Research Institute (IFPRI)
- 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
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 GE crop might be grown, data from previous trials, including those cultivated in similar agroclimates, may provide all that is necessary.LEARN MORE
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
Identifying Priorities for Risk Assessment
With 228 million cases of malaria worldwide in 2018, 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.LEARN MORE
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 (GE) 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 & Food Systems Institute facilitated expert working groups, training workshops, and publications addressing the proper use of surrogate species for testing in support of environmental risk assessment of GE crops.
- In 2016, the Agriculture & Food Systems 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, as well as facilitating the transportability of existing datasets across geographies and regulatory regimes.
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. In order to facilitate risk assessments for the use of these GE mosquitoes, regulators need access to succinct, summary information of biosafety-relevant aspects of the biology of the species.
The OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology (WGHROB) develops and publishes consensus documents that provide internationally agreed upon baseline information for understanding key aspects about 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 & Food Systems Institute approached the OECD Environment Secretariat about developing a biology document for Aedes aegypti, the first insect species and only the second animal species to be the subject of an OECD biology document. The idea was put to the WGHROB and agreed, with the Governments of Brazil and Mexico as convening leads together with the Agriculture & Food Systems Institute. The OECD Consensus Document on the Biology of Mosquito Aedes aegypti was declassified in July 2018 and is now available on the OECD website.
RNA interference, or RNAi, refers to a set of biological processes that make use of conserved cellular machinery to silence genes. The use of RNAi to develop plants with desirable traits has fueled a discussion about how best to address environmental considerations that might arise with these products.
The Agriculture & Food Systems Institute convened a multi-sectoral, multi-disciplinary team of scientists to help identify and clarify the relevant safety considerations and risk assessment methodologies for environmental risk assessment of plants with RNAi traits.
- This resulted in the publication of a peer-reviewed paper that identifies research informative for environmental risk assessments of these plants, with a particular focus on non-target organism assessment.
- This important work was highlighted during scientific sessions at the 2012 Entomological Society of America Annual Meeting and the 13th International Symposium for the Biosafety of Genetically Modified Organisms.
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.
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.
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.
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.
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.
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.
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.
American Journal of Tropical Medicine and Hygiene | November 29, 2016
Reducing the incidence of malaria has been a public health priority for nearly a century. However, before new technologies and associated vector control strategies can be developed and exploited, it will be necessary to understand and assess the likelihood of any potential harms to humans or the environment. To begin this process, the Foundation for the National Institutes of Health and the Agriculture & Food Systems Institute organized an expert workshop to consider the potential risks related to the use of gene drives in Anopheles gambiae for malaria control in Africa.
| December 31, 2011
In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.
Recommendations for the Design of Laboratory Studies on Non-Target Arthropods for Risk Assessment of Genetically Engineered Plants
Transgenic Research | October 13, 2010
This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs).
Genetically Modified Crops and Aquatic Ecosystems: Considerations for Environmental Risk Assessment and Non-Target Organism Testing
Transgenic Research | November 26, 2011
The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study.
January 27, 2021
Tangail, Bangladesh (Virtual)
December 9, 2020
Dhaka, Bangladesh (Virtual)
December 8, 2020
Jakarta, Indonesia (Virtual)
November 14, 2020