How to Apply for Confined or Unconfined Environmental Release of PNTs in Canada

Applying for a Confined Research Field Trial in Canada

The confined research field trial program provides developers with an opportunity to grow PNTs for research purposes under terms and conditions of confinement which are designed to minimize any impact the PNT may have on the environment. These research trials allow developers to evaluate the field performance of their PNT, to collect information to address the environmental safety criteria necessary for an application for unconfined release, or to undertake academic research.

Instructions, information requirements, and terms and conditions can be found in the following links:

Applicants wishing to submit an application to conduct field trials of PNTs intended for PMF are subject to information requirements found in Dir2000-07.

Applying for an Unconfined Release in Canada

The Plant Biosafety Office of the Canadian Food Inspection Agency is responsible for the regulation of PNTs in Canada in regards to environmental safety. Before a PNT can be authorized for unconfined environmental release, a determination on the risk to the environment, including to human health, is required. Unconfined release involves the release into the environment with limited or no restrictions, generally towards commercialisation.

The following documents define the criteria and information requirements for the environmental safety assessment of a PNT intended for unconfined release:

Importing Plants with Novel Traits to Canada

PNTs (and/or products derived from them) to be imported into Canada are subject to the CFIA regulatory review under the Plant Protection Act and Regulations. PNTs (and/or the products derived from them) that have been authorized for unconfined release into the Canadian environment may not require an Import Permit. PNTs that have not been authorized for unconfined release into the Canadian environment require an Import Permit issued under the Plant Protection Act and Regulations. In addition, these PNTs (and/or products derived from them) are subject to the same phytosanitary import requirements as their unmodified counterparts.

Managing Cases of Non-compliance of Unauthorized Plant Products Derived through Biotechnology

Under Canadian legislation, the presence of an unauthorized product in the marketplace or environment constitutes regulatory non-compliance. In such a case, the CFIA and/or Health Canada evaluate the risk associated with the non-compliance. The CFIA would then determine which risk management options and compliance actions are required.

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