What are Confined Field Trials –

and why are they needed?

Thanks to:
Drs. Donald MacKenzie, Lawrence Kent & Karen Hokanson

Environmental Biosafety Workshop

Michigan State University – August 2012
 First , we’ll talk about…
•  What are confined field trials and why are
they needed?
•  How are confined field trials different from a
commercial release?
•  How is biosafety ensured for a confined field
trial?
–  Pillars of Confinement
•  Control the plant material
•  Prevent Gene Flow
•  Prevent Persistence
Why do we regulate GM Crops?
 Why do we regulate GM Crops?
•  New technology, no established history
•  Assure safety – food, feed, environmental

•  Cartagena Protocol requires

•  Public perception requires

•  Defined regulatory system can facilitate

technology transfer
What are Confined Field Trials?
 What are Confined Field Trials?
•  They are field experiments done to evaluate the
performance of GM plants.
•  They are small-scale.

•  They are done under terms and conditions of

authorization that confine the experimental material

•  They are similar to field experiments done for

conventional breeding, but plant material and genes
are confined to a limited area.
•  They are an essential step for technology
assessment and development
 What is the Difference between
“Confined” and “Contained” ?
•  ‘Contained’ means ----

•  ‘Confined’ means ----

•  Both are research

experiments
 What is the Difference between
“Confined” and “Contained” ?
•  ‘Contained’ means
enclosed within a container
such as a laboratory or
greenhouse.

•  ‘Confined’ means that

genes and plant material are
kept (confined) in a specific
area.

•  Both are research

experiments
Confined field trials in Africa
Why are Confined Field Trials
Needed?
 Why are Confined Field Trials
Needed?
•  Test the GM plants under real field conditions – proof of
concept for new trait

•  Test the efficacy & value of a trait in local environment

•  Select the best lines for further development

•  Breed a biotech trait into local varieties

•  Generate safety data needed for subsequent risk assessment

and approval
–  Gererate plant material for feeding studies
–  Conduct environmental safety assessment

•  Scale-up of production material, prior to regulatory approval

The development and
deployment of a GM crop
move through different
stages General
release

Full safety
assessment

Confined
Field Trials
Growth
Chamber or Approval
greenhouse
General Release
CFT Application
Lab Application
 Why Confine?
•  Risk assessment has not yet been done
•  No regulatory approval for general release

•  CFTs: Limit Risk by Controlling Exposure

–  Risk is ‘the probability of harm’
–  Risk = hazard x likelihood of exposure
–  the likelihood of event (exposure) x the impact of event
(hazard)

•  General Release: Evaluate ‘Hazard’ with full scale

risk assessment
 Stages of Development

Risk Mitigation Risk Assessment

Research Production

Contained use
(laboratory, Confined Unconfined release
greenhouse, release (commercial use)
screenhouse) (field test)
Field Trials vs. Commercialization
•  Risks associated with field trials can be
mitigated than those associated with
commercial releases
–  Trial area is small
–  Limited numbers
–  Good control:
•  Restricted access
•  Surrounding crops
•  Good disposal
•  Good documents
 The Pillars of Confinement
•  Control the Plant Material: Maintain control of the GM
plant material at all times,
•  to prevent eating by humans or livestock,
•  to prevent mixing it with non-GM material,
•  to prevent escape into the environment.

•  Prevent Gene Flow: Keep new genes on the trial site by

controlling pollen-mediated gene flow.

•  Prevent Persistence: Prevent gene flow and maintain

control in following year by eliminating volunteers.
 Material Confinement
Things to consider :
•  Seed/plant material shipping/storage
•  Trial site – security
•  Equipment
•  Termination Procedures
•  Post-harvest Site Management

GM Cassava Field Trial

Columbia, South America
 Genetic Confinement
•  Prevent gene flow in pollen
–  between other plantings of the same crop,
–  between related species

•  Prevent gene flow via dispersal of seed or

vegetative propagules
–  Appropriate material confinement is also important
to prevent gene flow
GM Cassava Field
Trial Site in Kenya
 Confined Trial of GM Wheat
Manitoba, Canada

• Open Field
• For Research Purposes
• Like Breeders Trials
• Experimental
 Do Confinement Measures Make
GM Field Trials Safe?
•  Science-based confinement measures and
adequate inspections have ensured the safe
conduct of confined field trials of GM crops
worldwide.

•  Over the last 18 years (since 1987), more than

15,000 field trials have been conducted in
over 50 countries.
•  There is not a single documented example of
actual “harm” to the environment or to people or
animals.
 2003 Burkina Faso Bt Cotton Field Trial
Near Fada N’Gourma

Local Cotton Variety GM Cotton

No sprays No sprays
Yield: 735 kg/ha Yield: 1102 kg/ha

Field test conducted on 0.6 ha. Guard row (15 m depth) of conventional cotton around the trial.
Following harvest, all plant material on the trial site will be destroyed by burning on site.
 Closing the Loop
Appropriate confinement requires:
•  Appropriate practices for material and genetic
confinement - depends on crop
•  Trial personnel must be trained and equipped --
routine and emergency procedures
•  Good record keeping & documentation
•  Inspection-- internal and/or regulatory authority
•  Contingency planning -- for emergency
Confined field trials remain confined
 Final Messages
•  Field trials are ESSENTIAL for the development of
GM (and conventional) crops adapted for local
environment.

•  Confined field trials are very different from general

releases. There are different questions, separate
review and approval processes

–  Confined Field Trials >> Confinement measures

–  Unrestricted release >> Full risk assessment

•  Confined field trials CAN be performed safely and

routinely by focusing on confinement measures
Thank You!