Question Period Note: Gene editing: updated guidance for novel seed

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With the advent of gene editing technology, plant developers have asked the Canadian Food Inspection Agency (CFIA) for improved clarity on which plants are subject to Part V of the Seeds Regulations. CFIA is responding by updating guidance to clarify which plants--whether developed traditionally or through new plant breeding innovations such as gene editing--require approval from the CFIA before being released into the environment.

1. The Government of Canada prioritizes the health of Canadians and the environment. We provide the best access to safe and nutritious foods to Canadians and credible information about products in the market.
2. Canada’s science-based approach provides choice to farmers and allows Canadian agriculture to supply the range of products demanded by Canadian consumers and international markets.
3. Our Government is updating guidance to keep pace with technology and improve transparency. We will continue to support agriculture by enabling innovation while maintaining our high standards for the environment and our food supply.

IF PRESSED ON THE GUIDANCE
1. The Government considers that clear, evidence-based decision-making is essential for supporting innovation.
2. Our experts are carefully considering scientific information about the use of gene editing technologies in agriculture.
3. Updated guidance will make regulatory decisions clearer while allowing Canadians to benefit from the advances offered by new technologies.

IF PRESSED ON TRANSPARENCY AND PAUSING GUIDANCE UPDATE
1. This Government supports consumer and producer choice in selecting the agricultural practices, products and technologies that offer the most benefits.
2. Agriculture and Agri-Food Canada (AAFC) and the Canadian Food Inspection Agency (CFIA) are working with stakeholders to ensure the continued competitiveness of both the organic and non-organic sectors.
3. It is important to support agriculture with clear guidance and farmers with the information they need when buying seed. So discussions are focused on how to provide transparent information about new seed varieties.
4. While these discussions are ongoing, the Agency has temporarily paused its guidance update.

IF PRESSED ON ALLEGATIONS OF IMPROPER COLLABORATION BETWEEN THE CFIA AND CROPLIFE CANADA / AUTHOR OF UPDATED GUIDELINES
1. The Canadian Food Inspection Agency is an independent, scientific and evidence-based federal regulatory agency and is committed to ethical transparency and accountability in this trusted role.
2. The Agency always authors its own guidance and policies. The CFIA routinely consults all stakeholders in its mission to safeguard food, animals and plants, and considers expert knowledge and feedback from multiple sources, including diverse stakeholders, NGOs, and industry.
3. Under the Seeds Regulations, plant breeders have always been responsible for notifying the CFIA of all novel plants. This is not changing.
4. The Agency is simply making its guidance clearer so that plant breeders understand when they must notify the CFIA and seek a safety assessment of their novel plant under Part V of the Seeds Regulations.
5. Consultations with industry are a key part of the process to ensure that the guidance is clearly understood.
6. Since biotechnology is such a specialized area of scientific study, it is not uncommon for experts to have experience working for government and for industry at different points in their career.
7. Public servants must comply with values and ethics codes and with post-employment measures to avoid conflicts of interest.

IF PRESSED ON SELF-ASSESSMENT
1. The Government of Canada has standards and regulatory requirements in place for safety and quality for all seeds, feeds and foods, whether developed using conventional methods or biotechnology.
2. As always, product developers are expected to be aware of their regulatory obligations and comply with them.
3. Updated guidance will help developers know when to apply for an assessment of a novel product. The Canadian Food Inspection Agency and Health Canada will continue to conduct these assessments.
4. Clear guidance will support the agri-food sector in having access to the latest technologies while upholding Canada’s standards for safety and quality.

IF PRESSED ON ORGANIC CERTIFICATION AND LABELLING
1. The Government of Canada is working with various stakeholders impacted by the proposed updated guidance.

Issue:
With the advent of gene editing technology, plant developers have asked the Canadian Food Inspection Agency (CFIA) for improved clarity on which plants are subject to Part V of the Seeds Regulations.

CFIA is responding by updating guidance to clarify which plants – whether developed traditionally or through new plant breeding innovations such as gene editing – require approval from the CFIA before being released into the environment

Gene editing:
Editing is a new technology that allows for precise changes to the DNA sequence. Gene editing can help plant breeders combine useful traits more easily without introducing anything new into the plant. Alternatively, gene editing can also be used to introduce more complex genetic changes.

Product-focused regulatory guidance:
Canada applies regulatory oversight based on the characteristics of the final product. To develop updated guidance, the CFIA is considering a number of factors, including:
o scientific weight of evidence about the safety of gene editing technologies relative to other breeding methods
o breeding approaches and best practices in the seed production system
o the CFIA’s 25 years of experience in assessing products of biotechnology and familiarity with conventional breeding outcomes and
o the approaches being taken by regulatory authorities around the world

Current status:
Feedback on the CFIA’s consultation on this topic (May to September 2021) was polarized, with stakeholders raising a range of views about CFIA’s proposed update. As a result, the CFIA has further revised the proposed guidance and resumed discussions with key stakeholder groups (April 2022 through July 2022) to finalize a proposal. Updated guidance is anticipated by October of 2022.

Health Canada’s proposal for novel foods:
Health Canada is responsible for the assessment of novel foods, and has undertaken a similar consultation to update guidance. Health Canada’s updated guidance was published May 18, 2022.

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