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What we heard: Guidance for determining whether a plant is subject to Part V of the Seeds Regulations

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Introduction

The Canadian Food Inspection Agency (CFIA) is committed to providing a clear regulatory framework for products of agricultural biotechnology, while maintaining a science-based approach that upholds Canada's high standards for safety. CFIA regulates novel seed under the authorities in Part V of the Seeds Regulations, and provides plain-language guidance that explains how the regulations are applied. CFIA is updating its guidance to help plant developers understand whether their plant lines are novel. Updated guidance will help the CFIA regulatory programs for agricultural biotechnology keep pace with new technologies like gene editing.

As part of the CFIA's commitment to science-based regulation and transparency about the regulatory process, the CFIA sought feedback on draft guidance. This report summarizes the feedback that the CFIA received from stakeholders during the consultation.

About the consultation

The CFIA sought feedback on the draft guidance from May 19, 2021 to September 16, 2021 (120 days). Consultation materials included a consultation survey, summary, and the draft guidance. Feedback from this consultation helped the CFIA determine that the draft guidance required further revisions to provide stakeholders with the clarity and predictability they need.

Who we heard from

The CFIA received 316 completed surveys, 143 emails, and 49 formal letters from:

What we heard

Feedback highlights

Respondents provided a range of perspectives on the draft guidance. Overall, respondents expressed views that can be summarized under 4 key themes:

Figure 1 - Diagram of key feedback themes and the related common comments or concerns. Description follows.
Description for Figure 1 - Diagram of key feedback themes and the related common comments or concerns

Feedback received by the Canadian Food Inspection Agency included 316 survey submissions, 143 emails, and 49 formal letters summarized into 4 key themes.

  • regulatory process
    • how the regulatory process functions
    • are gene-edited plants safe
    • improve transparency of decisions and processes
  • align with other regulatory systems
    • ensure Canadians have access to innovative products
    • ensure import and export consistency
  • clear guidance
    • use clear language and definitions
  • impact on Canadian farmers
    • gene flow and presence of gene-edited plants
    • uncertainty and difficulties with organic certification

1. Regulatory process

How the regulatory process functions

Respondents communicated varying opinions on the CFIA's overall regulatory approach, application process, assessment process, and the authorization of plants under Part V. Some of these comments were outside of the scope of an update to guidance, and would require regulatory changes to implement. In summary, some respondents indicated that the CFIA should require a mandatory assessment of all products of gene editing. Others highlighted that many of the responsibilities relating to the use of biotechnology can be well-managed by the agricultural sector. Specifically, respondents expressed comments on:

Safety of gene editing and edited plantsFootnote 1

Several respondents expressed concerns over the release of gene-edited seeds and the potential negative impact on human and environmental health. Others commented that the guidance sufficiently recognizes the safety of gene editing. These comments included:

2. Align with other regulatory systems

Generally, respondents who made comments about international alignment indicated that alignment with other systems is desirable. However, views on the preferred approach varied. Comments included:

3. Clear guidance

Respondents indicated a need for clear guidance definitions and terminology.

Clear language and definitions

Many respondents said that the draft guidance lacked clarity in several definitions, processes, and information requirements. Respondents indicated that:

4. Impact on Canadian farmers

Gene editing technology was widely recognized as being a significant shift for agriculture. Some respondents expressed that this technology will bring opportunity for farmers and support sustainable agriculture and benefits for consumers. Other respondents expressed the desire for the CFIA to ensure Canadian plant populations remain free of gene-edited seed to support a wide variety of production methods for Canadian farmers, including organic production and market access where edited plant products would not be accepted.

Unintentional release into seed populations and natural areasFootnote 2

Respondents highlighted that edited plants could lead to unintentional release and impact farmers through:

Impacts on farmers

Many respondents commented on the challenges of maintaining the integrity of organic production. They identified that gene-edited seeds could complicate this situation through:

Several respondents commented that the draft guidance did not address issues concerning competitiveness and access to innovative products, such as:

Other feedback

Feedback on topics that fall outside the scope of Part V of the Seeds Regulations was forwarded to the responsible office at the CFIA and other government departments including Health Canada, Environment and Climate Change Canada, and Agriculture and Agri-Food Canada. Examples included comments about:

Next steps

The CFIA thanks everyone who participated in the consultation process. The CFIA has used input from this consultation to develop guidance that clearly communicates regulatory requirements and decisions, while supporting Canadian innovation and access to new technologies.

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