site-logo

Promoting the Use of Relevant Field Trial Data Across Geographies

Overview

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 scientific basis for requiring duplicative trials is questionable, but policy and perception issues make accepting data from other countries difficult for many regulators.

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.

Collaborators & Partners

  • Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA)
  • Common Market for Eastern and Southern Africa (COMESA)
  • International Food Policy Research Institute (IFPRI)
  • University of British Columbia
  • University of Edinburgh
We developed a tool for visualizing agroclimatic zonations & their relationships to CFT locations.

Current Work

Global Environmental Zones Explorer (GEnZ)

Since the Agriculture & Food Systems Institute’s publication of a conceptual framework for data transportability in the journal Transgenic Research in 2014, it has continued to make significant effort to progress this work beyond theory to practical application. In particular, our Global Environmental Zones (GEnZ) Explorer is a simple-to-use online tool that allows users to visualize agroclimatic zonations and their relationships to CFT locations.

Our Successes

Objective

The African agricultural biotechnology community seeking to make more efficient use of resources to evaluate the biosafety of genetically engineered plants could benefit from the data transportability conceptual framework and its practical application using the GEnZ Explorer. One way to avoid the unnecessary cost of duplicating CFT data is to use pre-existing CFT data obtained from a similar environment outside of a host country. The GEnZ Explorer, an online tool that allows CFT locations to be characterized with respect to agroclimatic zones to facilitate CFT data transportability, will enable users to identify the locations of CFT data generated in environments outside of a host country that are similar and relevant to the environments found within the host country.

Outcome

In 2018, supported by a grant from the United States Department of Agriculture Foreign Agricultural Service (USDA FAS) Emerging Markets Program (EMP), the Agriculture and Food Systems Institute (AFSI) conducted the following outreach activities related to the practical application of data transportability into regional risk assessment policy for stakeholders in Africa, in partnership with the Common Market for Eastern and Southern Africa (COMESA) and the Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA):

At these workshops, attendees were introduced to and gained hands-on experience with the GEnZ Explorer. They learned how to use the online tool to identify the location of CFT data generated outside of their country that were conducted in similar environments to those found in their country. Participants also shared updates on the regulatory systems and approval process in their countries, as well as discussed how data transportability concepts could be applied in the region.

  • Project Name:
    Applying the Results of the Data Transportability Conceptual Framework in Partnership with the Common Market for Eastern and Southern Africa (COMESA)
  • Years:
    2018-2020
  • Funding:
    United States Department of Agriculture Foreign Agricultural Service (USDA FAS) Emerging Markets Program (EMP)
  • Partners and Collaborators:
    ssociation for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA), Common Market for Eastern and Southern Africa (COMESA), International Food Policy Research Institute (IFPRI) Program for Biosafety Systems (PBS), United States Department of Agriculture (USDA), United States Agency for International Development (USAID)
  • Countries of Participants:
    Burkina Faso, Eswatini, Ethiopia, Ghana, Kenya, Malawi, Morocco, Nigeria, Senegal, South Africa, Tanzania, Uganda, Rwanda, Zambia

Discover

Publications

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.

Transportability of Confined Field Trial Data for Environmental Risk Assessment of Genetically Engineered Plants: A Conceptual Framework
Transgenic Research | April 21, 2014

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.

Search Resources