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Confined Field Trial (CFT) Data Transportability Workshop

    March 12, 2019-March 13, 2019
    8:30 am - 3:30 pm
    Addis Ababa, Ethiopia

Confined field trials (CFTs) provide a means to determine whether a genetic modification within a genetically engineered (GE) plant results in unintended effects that could pose a risk to the environment. CFTs are usually performed locally within each individual ”host” country that is considering cultivation of the GE plant, and the CFT data collected is used to inform an environmental risk assessment used for regulatory decision-making. Since the data collected from a CFT involves a comparative assessment of the GE crop to its non-GE comparator, data collected from each new host country CFT is duplicative of prior CFT results and does not further inform risk assessment. One way to avoid the needless cost of duplicating CFT data is to make use of pre-existing CFT data obtained from a similar environment outside of a host country.

The Agriculture & Food Systems Institute has developed an online tool that allows CFT locations to be characterized with respect to agroclimatic zones to facilitate CFT data transportability. This tool allows users to identify the locations of CFT data generated in environments outside of a host country, which are similar and relevant to the environments found within the host country. To introduce the CFT data transportability tool to members of the African agricultural biotechnology community seeking to make more efficient use of resources for evaluating GE plant biosafety, the Agriculture & Food Systems Institute conducted the CFT Data Transportability Workshop in Addis Ababa, Ethiopia on March 12-13, 2019.

Agenda

Day 1 - March 12, 2019

8:30 am

Opening Remarks

8:45 am

Introductions

Session 1: Overview of the Environmental Risk Assessment (ERA) Paradigm

9:00 am

The Global ERA Paradigm

Common elements in approaches taken for environmental risk assessment for GE plants

John Teem
Agriculture & Food Systems Institute

9:30 am

The Regulatory Context for GE Plant Approvals in Africa

Activity within existing regulatory frameworks, applications that are being processed, and GE plants that have been released.

Margaret Karembu
International Service for the Acquisition of Agri-biotech Applications (ISAAA)

10:00 am

Tea Break

10:30 am

Data Elements of a GE Plant Application

Components of a dossier used to fulfill ERA requirements

Karen Hokanson
University of Minnesota

11:00 am

Confined Field Trials

Types of data collected in CFTs, criteria for selecting sites, and updates on local CFTs in progress.

Barbara Mugwanya-Zawedde
Uganda Biosciences Information Center (UBIC)

11:30 am

Discussion

12:30 pm

Lunch Break

Session 2: Concepts in Data Transportability

2:00 pm

Introduction to Concepts of Data Transportability

What kinds of data are generally considered transportable? What types of data collected from CFTs are transportable? Variety registration as a regional example of data transportability.

John Teem
Agriculture & Food Systems Institute

2:45 pm

Identification of Agroclimatic Zones Relevant to In-Country CFTs and an Online Tool for Identification of Surrogate Environments for Obtaining CFT Data

Application of the GEnS system for identifying agroclimate zones and a web-based software tool for assigning CFT locations to agroclimate zones.

Larissa Jarvis
University of Montreal

3:30 pm

Tea Break

4:00 pm

Discussion

5:00 pm

Adjourn Day 1

Day 2 - March 13, 2019

9:00 am

Welcome and Review of Day 1

John Teem
Agriculture & Food Systems Institute

Session 3: Regional Regulatory Updates

9:15 am

Uganda

A focus on the Ugandan regulatory system and approval process.

Charles Mugoya
National Agricultural Research Organisation (NARO)

9:45 am

Ethiopia

A focus on the Ethiopian regulatory system and approval process.

Assefa Gudina
Ministry of Environment, Forest, and Climate Change (MOEFCC)

10:15 am

Kenya

A focus on the Kenyan regulatory system and approval process.

Dorington Ogoyi
National Biosafety Authority (NBA)

10:45 am

Tea Break

11:15 am

Case Studies for Data Transportability

Applications of the GEnS System to CFT Data Transportability for Maize, Cassava, and Cotton.

John Teem
Agriculture & Food Systems Institute

12:00 pm

Lunch Break

1:30 pm

Practical Exercise of the Online Data Transportability Tool

Demonstration of the features of the online tool for identifying agroclimate zones for CFT locations in COMESA countries.

Larissa Jarvis
University of Montreal

2:30 pm

Final Discussion

3:30 pm

Adjourn Day 2

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