Applying for environmental release of plants with novel traits in Canada

Determining novelty

Plants with novel traits (PNTs) require authorization before they can be released into the environment. The following documents provide guidance on determining if a plant is a PNT:

• Directive 2009-09: Plants with Novel Traits Regulated under Part V of the Seeds Regulations: Guidelines for Determining when to Notify the CFIA
  • Rationale for updated guidance determining whether a plant is subject to Part V of the Seeds Regulations

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 2000-07: Conducting Confined Research Field Trials of Plants with Novel Traits in Canada
  • Crop-Specific Terms and Conditions

Applicants wishing to submit an application to conduct field trials of PNTs intended for plant molecular farming (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 commercialization.

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

• Directive 94-08 (Dir 94-08) Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits
  • Biology Documents (Companion Documents for Dir94-08)
• Guidance for Submitting Whole Genome Sequencing Data to Support the Pre-market Assessment of Novel Foods, Novel Feeds, and Plants with Novel Traits
• Pre-submission consultation process

Additional information

• Canadian pre-market regulatory process
• Importing plants with novel traits to Canada
• Managing cases of non-compliance of unauthorized plant products derived through biotechnology