Canadian Food Inspection Agency
Science Branch
Office of Biotechnology

Confined Research Field Trials for Plants With Novel Traits (PNTs)

What are Plants with Novel Traits (PNTs)?

PNTs are plants with novel traits. These plants have traits which (1) are not present in plants of the same species that already exist in Canada or (2) are expressed outside the normal range of similar existing traits already in the plant species. Details on definitions for PNTs and biotechnology are available in the factsheet “Biotechnology? Modern Biotechnology? GM? GMO? GE? PNTs? What do these terms mean?” found on the Web site of the Office of Biotechnology, Canadian Food Inspection Agency (CFIA).

What are confined research field trials?

In the early stages of PNT development, the plants are grown in fields in a confined area for research purposes. The CFIA’s Plant Biosafety Office (PBO) assesses applications for these confined research field trials and sets out the rules for how they are to be done.

No matter what method has been used to put the new trait into the plant, all confined research field trials of PNTs in Canada are evaluated by government scientists to determine that the trials will not harm the environment.

Why do developers of PNTs conduct confined research field trials?

Confined research field trials for PNTs have several purposes. They:

• give scientists opportunities to study the environmental safety of the modified plants
• give developers an opportunity to evaluate the performance of the plants in the natural environment (instead of a lab or greenhouse)
• provide information that the CFIA requires to complete an environmental assessment, livestock feed assessment, and food safety assessment if a developer later submits an application for unconfined release
• generate data that can be used for variety registration

Are there rules for conducting confined research field trials?

Developers must meet strict conditions before conducting a confined research trial in Canada. Developers of PNTs have to provide government evaluators with information about the plants (such as where they are being grown and the procedures being used) and must also work with the CFIA both during the field trial and after harvest. Some other requirements are:

• providing a detailed map of where the plants are being grown
• giving the CFIA information on endangered species at or near the trial site
• following rules about the distance a field trial must be from other plants (this is called “minimum isolation distance” and is used, in part, to reduce the possibility of pollen flow to other plants); the CFIA can increase the minimum isolation distances for specific field trials
• monitoring trial sites according to the schedule the CFIA has determined for each crop
• following rules about the amount of time after the trial is over that the land cannot be used to plant similar species (“post-harvest land use restriction”)
• giving access to CFIA inspectors who inspect trials during the growing season and after the harvest to check that the terms and conditions that were set for the trial are being complied with
• providing to the CFIA, upon request, records regarding all the confined research field trials (including information about current season and post-harvest site monitoring, the disposal of all plant material, and experimental data)

Additional details on requirements for confined research field trials can be found in the “Directive 2000-07 (Dir2000-07): Conducting Confined Research Field Trials of Plants with Novel Traits in Canada” and in Appendix 2 (“Minimum Isolation Distances And Periods of Post-harvest Land Use Restriction”) and Appendix 4 (“General And Species-specific Terms And Conditions For Confined Field Trials”) of Directive 2000-07.

Are these requirements reviewed and updated?

In February 2002, the CFIA made changes to the guidelines for confined field trials in Canada (Directive 2000-07). Some of these are:

• changes for record keeping and reporting of confined research field trials (the changes provide details on what needs to be recorded and reported, such as transporting the seeds, storing and disposing surplus and harvested seeds, cleaning the machinery used, and monitoring).
• changes to isolation distances, such as increased isolation for some crops and more specific rules for certain species (canola in particular)
• using global positioning satellite (GPS) co-ordinates, in addition to the maps mentioned above
• increases in the frequency of monitoring after the PNTs have been harvested, while the site is still subject to land-use restrictions
• further guidance on removing volunteer plants and related species before the plants flower
• posting summaries of authorized confined research field trials on the CFIA Web site

What if any of these plants pollinate other plants?

Applicants are required to monitor their fields frequently. If related species are found within the trial's isolation zone, the applicant must remove and destroy these plants before seeds are produced. After harvest, any volunteers or related species found in the area that is covered by the post-harvest land use restriction must be removed before flowering occurs. If pollination, hybridization, or seed production do occur, additional post-harvest restrictions and monitoring requirements will be imposed on the trial.

What happens if developers don’t follow the rules for confined field trials?

The CFIA has the authority to revoke the authorization for the trial, and the trial may have to be destroyed or other measures taken to bring it into compliance.

What happens to the plant after the research trial is over?

After the confined research field trial, the PNT is destroyed. Nothing that is harvested from a confined field trial may be used as human food or livestock feed.

Unless the CFIA authorizes developers to keep seeds for future research trials, the seeds and other plant material harvested from confined trials must be disposed of by an approved method. Examples include incineration, using superheated steam under high pressure (autoclaving), deep burial, or other means that will make the seed or plant material unable to live. Composting is not allowed as a disposal method.

Does the CFIA limit the number of confined research field trials that are held in Canada?

Yes. The CFIA restricts the size and number of the trials. The CFIA may consider an exception to this but the developer has to give a scientific reason to justify the request, and the reason must be for research purposes only.

Who else reviews the information the applicant submits?

The CFIA’s Plant Biosafety Office will distribute copies of received field trial applications to the Agency’s livestock feed evaluators (Feed Section), if the applicant wants to use material from the trial in a research feeding study. The PBO also gives information to the Pest Management Regulatory Agency (PMRA) in cases involving testing novel herbicide tolerance or insect resistance.

The CFIA also sends non-confidential information about each new trial to designated provincial government contacts, in those provinces where proposed trials are going to be done. The federal Access to Information Act sets out what information is considered to be “confidential business information.” For details on this, please refer to the CFIA factsheet “Finding Out about the Regulatory Decisions Made for Products Derived through Biotechnology”.

As well, the CFIA sends non-confidential information on authorized field trials to the BioTrack database of the Organisation of Economic Co-operation and Development (OECD).

You can request general information from the CFIA about confined trials it authorizes, or you can find it in the Summary of Confined Research Field Trials section of the CFIA's Web site.

More information on confined field research trials and unconfined release of PNTs is available in the “How To Apply For Confined or Unconfined Release of PNTs” section of the CFIA’s Plant Biosafety Office Web site, and in the CFIA factsheets called “The CFIA Assessment Process and What is Expected from Industry” and “Regulating Agricultural Biotechnology in Canada: Environmental Questions”.