Summary of the guidance for determining whether a plant is subject to Part V of the Seeds Regulations

On this page

• Scope
• Gene editing tools highlight a need for clear guidance
• Regulatory and scientific basis for updated guidance
• Determining which plants are exempt from Part V of the Seeds Regulations
• Clarifying which plants are subject to Part V of the Seeds Regulations
• Conclusion
• Related content

Scope

The Government of Canada is committed to providing a clear and predictable regulatory framework for products of agricultural biotechnology. As part of that commitment, the proposed guidance for determining whether a plant is subject to Part V of the Seeds Regulations clarifies which plants are subject to Part V, and which plants are exempt. Proposals to improve the assessment process for plants that are subject to Part V will be addressed in a future phase of this work.

Gene editing tools highlight a need for clear guidance

Gene editing technology is a new tool that allows plant developers^{Footnote 1} to make targeted changes to a plant's DNA. This editing tool can help speed up breeding programs. Using gene editing tools allows plant developers to:

• combine useful traits
• enhance existing qualities of the plant
• shorten the breeding cycle
• introduce a range of new traits into plants

Gene editing can be used to develop useful new plant lines. However, plant developers have expressed that the rules are complex and it's difficult to know if an authorization to release seed is required or not, since some gene edited plants can resemble their conventionally bred counterparts.

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

Regulatory and scientific basis for updated guidance

Part V of the Seeds Regulations describes regulatory requirements for the release of seed into the Canadian environment, and how to apply for permission to release seed.

Over the past 25 years, the CFIA has assessed over 120 plant products for release into the environment. This has included plants developed using conventional breeding methods such as mutagenesis, as well as plants developed by inserting foreign DNA (genetically modified plants). All were found to be safe for release into the Canadian environment.

Gene editing technologies can also be used to develop new plant lines. Gene editing is a flexible set of tools, and can be used to produce plants that include foreign DNA, as well as plants that resemble conventional plant lines. The outcomes that are possible with gene editing fall within the range of outcomes that are already familiar to CFIA regulators.

Based on a long history of safety assessments, and with a new technology raising new questions for developers, the CFIA recognized the need for an update to our guidance. In preparation for developing new guidance, the CFIA:

• reviewed literature on gene editing technologies
• organized webinars with plant breeding experts
• participated in expert panels with industry and public research representatives
• engaged with international regulatory counterparts

These activities informed the CFIA of the most current scientific knowledge about gene editing technologies, and of how plant developers are using these technologies in plant breeding.

Determining which plants are exempt from Part V of the Seeds Regulations

Canada's outcome-based approach to regulation focuses on the characteristics of the plant product. This approach considers whether a new characteristic has been introduced and, if so, whether the new characteristic could affect the safety of the plant.

When plants with new traits could have a negative impact on the environment, they are subject to Part V. The CFIA must evaluate these plants and authorize their release before they can be grown in Canada.

Most plants developed using conventional breeding are exempt from Part V, since breeding generally doesn't result in new characteristics that would affect safety. Similarly, when a product of gene editing resembles its conventional counterparts, it would also be exempt from Part V. This is a consistent approach that applies regulatory oversight only where it is scientifically justified.

Regardless of the methods used in development, the underlying genetic change, or number of edits, the plant is exempt from Part V as long as the plant:

• is not a new crop kind
• does not include DNA from another species (foreign DNA)
• does not have the capacity to negatively impact the environment

If the CFIA concludes that the plant won't have a negative impact on the environment, the CFIA will authorize the release without conditions. Any similar plants developed in the future would be exempt. Since the interaction of the plant with the environment has already been assessed, evaluating similar plants is highly unlikely to reach a different conclusion. This approach allows the CFIA to focus on plants and traits that are new to the Canadian environment. Note that other regulatory requirements will continue to apply – this exemption is for the sole purpose of release into the environment.

Clarifying which plants are subject to Part V of the Seeds Regulations

There are 3 reasons for a plant to be subject to Part V:

1. plants that are new crop species to Canada
2. plants where DNA from another species was introduced
3. plants that have the capacity to negatively impact the environment, as defined by 4 specific outcomes:
   • a plant that is more difficult to control
   • a toxin, allergen, or other compound that would negatively affect plants, animals, or microbes
   • improved survival of plants in natural environments to a degree that ecosystems would be disrupted
   • increased ability to support the activity of a plant pest

Conclusion

The CFIA sought feedback from all stakeholders who have an interest in this guidance. The CFIA is analyzing input received through general comments and an online questionnaire. This feedback will help the CFIA determine if the guidance is achieving the stated goals of decreasing regulatory burden, providing clarity for developers, and maintaining Canada's standards for safety, while allowing Canadians to benefit from improved crops.

Related content

• Draft guidance for determining whether a plant is subject to Part V of the Seeds Regulations