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Objective

Field studies are conducted to inform the environmental risk assessments required by regulatory authorities prior to the approval of genetically engineered crops. It’s common practice for regulators to require such trials on a country-by-country basis. This results in duplication of trials that do not provide any additional data in support of risk assessments. Among other things, this duplication makes it especially difficult and expensive for public sector researchers to obtain approvals for the novel crops they develop. The ILSI Research Foundation developed a conceptual framework that describes how agro-climatic zones can be used to determine if there is sufficient similarity between trial locations such that duplicate trials can be avoided.

Collaborators & Partners

Common Market for Eastern and Southern Africa (COMESA), Kenya National Biosafety Authority, USDA Foreign Agricultural Service, International Food Policy Research Institute (IFPRI), University of British Columbia, University of Edinburgh

Areas of Focus

By convening experts in agronomy, agro-ecology, agrometeorology, plant breeding and risk assessment, the ILSI Research Foundation identified the key components of the environment that influence the outcome of field trials.

Once it became clear that climatic and abiotic characteristics were the drivers, we convened a group of climate modeling and global information system experts to identify criteria for a global stratification scheme that could be developed into a tool for identifying environments with similar agroclimatic conditions.

Further efforts have focused on the correlation of global strata with crop growing regions for major crops. These correlations can help breeders and crop developers rationally select field trial sites, as well as allow regulators to make better use of data generated in other countries.

Current Activity

The ILSI Research Foundation is currently working with the Common Market for Eastern and Southern Africa (COMESA) to turn this concept into a practical tool for application in regional risk assessments in Eastern and Southern Africa, and that will also be useful for planning field trials in other parts of the world. The ILSI Research Foundation is committed to making this resource available to benefit public and private sector crop development.

Resources

Newsletters

Find out about the work being done by the ILSI Research Foundation by reading our monthly e-newsletter.

Transportability of Confined Field Trial Data for Environmental Risk Assessment of Genetically Engineered Plants: A Conceptual Framework

It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere.

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