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. 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 value of data, the Agriculture & Food Systems Institute continues its longstanding commitment to serve as a scientific resource for governments, academic institutions, and private sector organizations.

Collaborators & Partners

USDA Foreign Agricultural Service, International Food Policy Research Institute (IFPRI), Foundation for the National Institutes of Health (FNIH), New Partnership for African Development (NEPAD), Common Market for Eastern and Southern Africa (COMESA), Organisation for Economic Co-operation and Development (OECD), and the Government of Australia

Current Actvity

The Agriculture & Food Systems Institute's active programs related to environmental risk assessment (ERA) include:

Data Transportability for Field Trial Research

Confined field trials (CFTs) are conducted to inform environmental risk assessments that are required by regulatory authorities before genetically engineered crops can be approved and released for cultivation. Many countries expect CFTs to be conducted as a matter of course, even if satisfactory data are already available from trials conducted elsewhere. The primary variable that differentiates CFT locations is agroclimate, which means that data from trials cultivated in like agroclimates should be considered relevant and sufficient to satisfy regulatory requirements, irrespective of the country where the CFTs are conducted.

ERA for the Use of Gene Drive

According to the World Health Organization’s 2017 World Malaria Report, an estimated 216 million cases of malaria occurred worldwide in 2016, with 90% of this total concentrated in the African region. Alarmingly, and despite an increased public health focus on the elimination of malaria, it is becoming clear that many countries will not be able to achieve this goal without considering novel management approaches. One control strategy in the early stages of development is the use of gene drive mechanisms to suppress or replace vector mosquito populations.

Past Work

The Agriculture & Food Systems Institute's concluded projects in the area of environmental risk assessment include:



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


The Agriculture & Food Systems Institute has developed eLearning courses that focus on environmental risk assessment.

Data Transportability for COMESA Workshop

Hosted by the Agriculture & Food Systems Institute, in partnership with COMESA and ASARECA, this workshop introduced the online GEnZ Explorer tool, which allows confined field trial (CFT) locations to be characterized with respect to agroclimatic zones to facilitate data transportability of CFTs.

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Moving Research from the Laboratory for Field Trials: Regulatory Pathway for Genetically Engineered Organisms and their Derived Products

Dr. Andrew Roberts, Deputy Executive Director, conducted a guided problem formulation exercise during a workshop organized by the Foundation for the National Institutes of Health (FNIH).

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4th International Conference of Biotechnology on Health and Agriculture

The Agriculture & Food Systems Institute’s South Asia Biosafety Program sponsored a technical session on Biosafety and the Environment at the 4th International Conference of Biotechnology on Health and Agriculture, which was organized jointly by the Global Network of Bangladeshi Biotechnologists and Innovation in Plant and Food Sciences.

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Symposium on Risk Assessment of Plants Developed Using New Breeding Technologies

Dr. Morven McLean, Agriculture & Food Systems Institute Executive Director, delivered a presentation on Environmental Risk Assessment of Gene Edited Plants at the Symposium on Risk Assessment and Regulation of Genome Edited Plants, in Manila, the Philippines.

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7th Annual South Asia Biosafety Conference (SABC2019)

Under the auspices of the South Asia Biosafety Program, the Agriculture & Food Systems Institute and Biotech Consortium India Limited organized the 7th Annual South Asia Biosafety Conference (SABC 2019), the premier biosafety meeting in South Asia.

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

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.

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Genetic Biocontrol for Invasive Species

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.

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

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.

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Agricultural Biotechnology and Biosafety in South Asia: Progress and Prospects

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.

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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.

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