Question Period Note: GENE EDITING: UPDATED GUIDANCE

Q1 – What is the Government of Canada doing to support modern plant breeding innovation and keep pace with technology in plant breeding? Q2 – Why was a guidance update needed? Q3– How is the Government working with industry on plant breeding innovation? Q4 – Was the Government’s consultation on plant breeding innovation too narrow, or compromised by outside influence? Q5 – How does the Government ensure the integrity of the organic sector? Q6–How do plant breeders know if a pre-market safety assessment is needed? Q7 – How does Canada’s updated gene editing guidance compare with other countries?

R.1 - The Government supports modern plant breeding innovations. These technologies will play a role in mitigating climate change challenges and enable Canada to provide leadership in addressing global food security.

In May 2022, Health Canada published an updated guidance for novel food. The Canadian Food Inspection Agency released updated guidance for novel seeds the following year, in May 2023.

The Canadian Food Inspection Agency finalized a guidance update for livestock feeds in May 2024.

The Government carefully considers scientific information about the use of gene editing technologies in agriculture. Evidence-based decisions are essential for supporting plant innovation and maintaining the trust of Canadians, particularly when it comes to matters of health and the environment. R.2 - Improved regulatory clarity was a commitment in the 2019 Agri-food regulatory roadmap in support of Canada’s agriculture sector. Agriculture represents 7% of Canada’s GDP.

A clear and science-based approach will drive competitiveness and market leadership, while upholding Canada’s high standards and allowing Canadians to benefit from the advances offered by new technologies. R.3 - During consultations on the updated guidance for novel seeds, the organic sector highlighted the importance of comprehensive transparency for edited seed.

A Government-Industry Steering Committee was put in place composed of seed, grain, and organic industry stakeholders. It oversees the implementation of transparency recommendations for edited seed varieties, including an industry-led seed variety database.

The Government is collaborating with industry and other government organizations to support innovation and transparency, while continuing to protect food and feed safety and the environment. R.4 - The consultation process for plant breeding innovation has been comprehensive, robust, and science-based.

The Government is confident that the updated guidance will help Canada’s agriculture and agri-food sector to sustainably contribute to growth and global food security without compromising important principles of health, food safety, and environmental protection for Canadians.  

The Government of Canada authors its own guidance and policies and routinely consults with all stakeholders as part of the process. The updated guidance for novel seeds and livestock feeds are the result of a deliberate, multi-phased consultative process. They included engagement with a wide range of stakeholders, such as regulated parties, scientific experts, interested stakeholders, and the general Canadian public. R.5 - The Government works with various agricultural stakeholders, including certification bodies accredited by the Canadian Food Inspection Agency to certify organic products.

The Safe Food for Canadians Regulations sets out the oversight and requirements relating to the certification of organic products.

In addition, during consultations on the updated guidance, the organic sector highlighted the importance of comprehensive transparency for edited seed.

A Government-Industry Steering Committee composed of seed, grain, and organic industry stakeholders was established to implement enhanced transparency measures for edited seed varieties. For example, an industry-led database is an additional tool for the organic industry to verify that the seeds they purchase meet the requirements specified in the Canadian Organic Standard. R.6 - The Government of Canada has standards and regulatory requirements for safety and quality for all seeds, feeds and foods, whether developed using conventional methods or through biotechnology.

The regulations have not changed, and Canada is upholding its high standards for safety and quality. The updated guidance clarifies the requirements and helps developers know when to apply for an assessment of a novel product. R.7 - To enable innovation and market competitiveness, it is important to consider international alignment. Canada’s science-based approach and standards for safety and quality also need to be upheld.

The Government continuously monitors other countries’ regulatory and guidance updates relating to plant products of genome editing.

There is a growing global consensus that products of gene editing should not be regulated in the same manner as genetically modified organisms. Canada’s regulatory programs are in line with this approach.

The Government continues to engage with international regulatory counterparts in both the organic and non-organic sectors and with domestic stakeholders.

Gene editing:

Gene-editing is a new technology that allows for precise changes to the DNA sequence. It 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 for novel plants based on the characteristics of the final product. To develop updated guidance, the Canadian Food Inspection Agency (CFIA) and Health Canada considered a number of factors, including the following:

scientific weight of evidence about the safety of gene editing technologies relative to other breeding methods;

breeding approaches and best practices in the seed production system;

the government’s 25 years of experience in assessing products of biotechnology and familiarity with conventional breeding outcomes; and,

the approaches being taken by regulatory authorities around the world.

Current status:

Three separate regulatory programs are in place to assess the safety of novel products of biotechnology:

Food: Health Canada is responsible for the assessment of novel foods, and published updated regulatory guidance in May of 2022

Seed: The CFIA is responsible for the assessment of novel seeds (plants with novel traits) for environmental release and published updated regulatory guidance in May of 2023.

Feed: The CFIA is also responsible for the assessment of novel livestock feeds. A consultation on a draft guidance update for livestock feeds ran from September 28 – November 27, 2023. Stakeholder input was analyzed and the final document and a What We Heard Report were published in May 2024.

International Alignment:

Canada recognizes that many gene-edited products will be the same as products of conventional breeding. This aligns with approaches taken by many of our major trading partners, who also recognize that gene-edited products should not be regulated in the same manner as genetically modified organisms.

Canada’s scientific conclusions about the overall safety of gene-editing technologies are in alignment with findings of other regulators, including in the European Union, England, the United States, Japan, Argentina, and Australia.

Transparency Initiatives:

During the consultations on novel seed, organic-sector stakeholders spoke to the potential for decreased transparency related to seeds that have been gene-edited. Specifically, the sector raised concerns that organic producers may inadvertently purchase and plant gene-edited seed varieties, which would lead to loss of their organic certification.

In January 2023, Agriculture and Agri-food Canada launched an Industry-Government Technical Committee on Plant Breeding Innovation Transparency in an effort to address those transparency concerns. The committee, which consisted of stakeholders representing the seeds, organic and conventional sectors, developed a report that included a number of recommendations to increase transparency surrounding gene-edited varieties. One of the recommendations was the establishment of a Government-Industry Steering Committee to provide guidance on development and implementation of various transparency initiatives.

The Government accepted the report of the Technical Committee on May 3, 2023 and the Government-Industry Steering Committee subsequently began work on the development of various transparency measures. The Steering Committee held its first meeting on June 30, 2023 and has continued to meet regularly to advance these initiatives.

The Canadian Food Inspection Agency’s proposal for novel feeds:

The CFIA is responsible for assessing all feeds including novel feeds and held a public consultation from September 28 to November 27, 2023, on proposed guidance. It published the final guidance document and a What We Heard Report on its website in May 2024.

Tiger Team:

The Government’s 2018 Fall Economic Statement and 2019 Agri-food and Aquaculture Regulatory Roadmap commitments recognized a need for improved predictability, clarity and transparency with respect to the regulation of products developed through plant breeding innovation. 

The work on plant breeding innovation was advanced through several government-industry working groups set up under the Agriculture Agri-Food Canada-led Grains Roundtable, and included a focused industry-government Tiger Team created in August 2019.

The work of the Tiger Team was wound down in 2020, having accomplished its focused, short-term mandate to put forward options and help identify outstanding scientific questions and technical/implementation details for ongoing consideration by regulators in determining how to move forward on commitments to increase predictability, clarity, and transparency in the regulation of plant breeding innovation.

The Government is committed to providing Canadians with access to safe, nutritious foods and credible information about products in the market.

Modernizing guidance for industry on food, seed and feed helps clarify how new technologies, such as gene editing, can safely be used and support innovation and competitiveness in the agri-food sector.

The Government continues to work closely with a broad range of stakeholders, including a public consultation in 2023, to enhance transparency measures.