Share your thoughts: Guidance for determining whether a plant is subject to Part V of the Seeds Regulations

The Canadian Food Inspection Agency (CFIA) is dedicated to protecting Canada's plant resources, which in turn enhance the health and well-being of Canada's people, our environment, and our economy.

Part V of the Seeds Regulations describes the regulatory requirements for the release of plants that may impact the Canadian environment. This includes new crop kinds, as well as plants with novel traits.

The CFIA is seeking feedback on proposed guidance for Part V – Release of Seed under the Seeds Regulations, with the objective of clarifying which plants are subject to Part V and which plants are exempt. This will allow stakeholders to better understand the requirements that are relevant to them in the context of new and emerging technologies such as gene editing.

The proposed updated guidance aims to clarify the requirements of Part V of the Seeds Regulations and make it easier to understand:

• how the release of seed is regulated in Canada
• how the Seeds Regulations maintain Canada's high safety standards
• when to inform the CFIA about a new plant line
• when scientific pre-market safety assessments are required
• comparisons to international approaches to the extent possible
• how new technologies can be used

This consultation addresses the environmental release of seed. Health Canada is holding a related public engagement activity until May 24, 2021, regarding proposed new guidance for Novel Food Regulations focused on plant breeding.

Input gathered from CFIA's consultation will help determine if the updated guidance provides stakeholders with the clarity they need to understand Part V of the Seeds Regulations, to innovate and better use new technologies, while maintaining high safety standards.

This consultation will be open for a 120-day period from May 19, 2021 to September 16, 2021.

How to participate

1. Read the Summary of guidance for determining whether a plant is subject to Part V of the Seeds Regulations
2. Read the full draft guidance for determining whether a plant is subject to Part V of the Seeds Regulations
3. Complete the online questionnaire

Who is the focus of this consultation

We want to hear from all interested parties, specifically those impacted by this guidance, including:

• plant developers, companies, industry associations, academia, government and not-for-profit organizations in the Canadian agriculture biotechnology sector
• anyone who has an interest in this topic

Key themes to be covered

• how to determine which plants are exempt from Part V of the Seeds Regulations
• clarifying which plants are subject to Part V of the Seeds Regulations:
  • new crop species
  • plants that have foreign DNA
  • outcomes that could negatively impact the environment

Related information

• Gene editing techniques
• Directive 94-08 (Dir 94-08) Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits

Contact us

If you have any questions about this consultation, please send an email to the Plant Biosafety Office.