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:

• Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA
• Directive 2000-07: Conducting Confined Research Field Trials of Plants with Novel Traits in Canada
• Fee Submission
• Crop-Specific Terms and Conditions

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:

• Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits (Dir94-08)
• Biology Documents (Companion Documents for Regulatory Directive 94-08)
• Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA
• Fee Submission
• CFIA Detection and Identification Method Criteria