Question Period Note: Genetically modified foods - new plant breeding guidance

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• In response to stakeholder requests for greater clarity and predictability around which products of plant breeding are considered novel foods, Health Canada published new guidance on May 16, 2022. The new guidance will continue to use a product-based approach to novelty. This means that some genetically modified (GM) foods, including those from gene editing, will not be considered novel and will not require a pre-market assessment. This is not a change in approach to the regulation of these products, but rather provides clarity as to what is considered novel. This guidance is based on the evidence in the scientific literature and engagement with experts in plant breeding and gene editing. For products of plant breeding that will still be considered novel, Health Canada has established a clear and stringent process for evaluating the safety of novel foods derived through genetic modification (GM). However, concerns have been raised by some organizations about the safety of gene editing and they have called for mandatory pre-market oversight and transparency around all products of this technology. Health Canada has taken steps to increase the transparency of products of gene editing and novel foods in general.
• Our Government is committed to ensuring the safety and quality of Canada’s food supply using science and evidence based decision-making.
• Health Canada will continue to assess any food derived from plant breeding that meets the definition of a novel food to ensure that the product is safe for use as a food. Novel Foods are not permitted to be sold until Health Canada has determined that the food is as safe and nutritious as its conventional counterpart.

IF PRESSED ON SAFETY …
• Health Canada has published a Scientific Opinion on the regulation of gene-edited plant products within the context of Division 28 of the Food and Drug Regulations (Novel Foods). This document outlines Health Canada’s review and findings regarding the use of these technologies in plant breeding.
• Health Canada concluded that gene editing technologies do not present any unique or specifically identifiable food safety concerns as compared to other technologies of plant development. Therefore, gene-edited plant products should be regulated like all other products of plant breeding within the Novel Food Regulations.
• The Department is confident that gene-edited plants are just as safe as their conventionally bred counterparts.

IF PRESSED ON TRANSPARENCY …
• Health Canada does not have the authority to require notification of products that are not novel. As such, Health Canada has launched a voluntary transparency initiative for non-novel gene-edited plant products. With this initiative, Health Canada maintains a list of non-novel products of plant breeding (including gene-edited plants) for food use that can be accessed on the Department’s website.
• Industry members have publically committed to participating in this initiative and it will provide Canadians with increased transparency around these products.
• Further, in 2020 Health Canada took steps to increase the transparency around food and food ingredients that are not novel, through the publication of the list of such ingredients. This list does not contain products of plant breeding.

Regulation and Safety Assessment of Genetically Modified Foods

Novel GM foods are regulated under Part B, Division 28 of the Food and Drugs Regulations (Novel Foods). Manufacturers of novel foods, including novel GM foods are required to file a pre-market notification with Health Canada prior to being sold in Canada. This pre-market notification permits Health Canada to conduct a thorough food safety assessment according to the Guidelines for the Safety Assessment of Novel Foods. These guidelines are based on scientific principles developed through expert international consultation with agencies such as the World Health Organization, Food and Agriculture Organization of the United Nations and the Organisation for Economic Co-operation and Development.

The safety assessment involves determining: (1) how the food was developed; (2) how its composition and nutritional quality compares to non-modified counterpart foods; and (3) what potential the food has for being toxic or causing allergic reactions. This assessment also takes into account the safety of the food for vulnerable sub-groups (e.g., children, the elderly and the immuno-compromised), as well as its safety for the general population.

Since 1993, Health Canada has approved over 160 novel GM crops. The majority of these are canola, soybean, corn and cotton. Health Canada and the Canadian Food Inspection Agency (CFIA) authorized the sale of AquAdvantage Salmon as a food and livestock feed in Canada in 2016 – this was the first approval of a GM fish or animal in Canada.

Development of New Guidance for the Novel Food Regulations focused on Plant Breeding

Industry stakeholders (i.e., plant developers) have expressed the need for the Novel Food Regulations to be clearer, more predictable, and more transparent regarding products of plant breeding, including those developed using new tools of modification such as gene editing technologies.

In the 2019 Agri-food and Aquaculture Regulatory Review Roadmap, Health Canada and the CFIA committed, with support from Agriculture and Agri-Food Canada (AAFC), “to provide better clarity around novelty determination and the oversight of environmental release and stewardship of novel products”.

The guidance is informed by an internal scientific review on the use of gene editing in plant breeding. The Department also engaged in outreach activities with diverse external and internal experts, including a scientific expert panel, to validate the information used in the internal review. These activities concluded that gene-edited plants are just as safe as their conventionally bred counterparts. Health Canada will publish a scientific opinion outlining these findings.

The Guidance on the Novelty Interpretation of Products of Plant Breeding describes the specific criteria by which a food derived from a product of plant breeding, including those that are gene-edited, would (or would not) meet the definition of a ‘novel food’ as defined under the Novel Food Regulations. This guidance describes each of these criteria in detail such that a developer will be able to confirm whether or not their product is novel (i.e., require pre-market notification). Accompanying this new guidance is a Transparency Initiative (TI) process, which aims to increase transparency and raise public awareness of products derived from gene-edited plants that do not meet the definition of novel foods, but are present in the Canadian food supply. Through the TI process, developers will voluntarily submit information about their products to Health Canada for publication on the Department’s website.

The Guidance on the Pre-Market Assessment of Foods Derived from Retransformants describes a tiered pre-market assessment process for products of plant breeding that are still ‘novel foods’, but closely resemble products that have previously been assessed by Health Canada. The guidance describes in detail what information is required for the pre-market assessment of these products (defined as ‘retransformants’) as well as an expedited service standard for these assessments.

Health Canada and CFIA Responsibilities

The CFIA conducts livestock feed safety assessments for all novel GM products used as livestock feed. The CFIA is also responsible for conducting environmental safety assessments of novel GM crops (Environment and Climate Change Canada conducts the environmental assessment of GM microorganisms and animals) that are to be released into the Canadian environment. Health Canada and the CFIA have a joint approval policy, which requires coordination of timing of authorizations in order to ensure lawful entry of authorized products into the food or livestock feed chains.

The CFIA is also responsible for dealing with issues of non-compliance with the Food and Drugs Act. When requested by the CFIA, Health Canada would provide support if there is an occurrence of GM food non-compliance. This was the case with the non-compliant GM wheat that occurred in 2017.

• Health Canada’s new guidance is based on a scientific review of gene-edited plants for use as a food, multiple engagements with diverse external and internal experts in plant breeding, and decades of experience regulating plant breeding products, over which time there have been no safety issues identified.
• This scientific review concluded that the use of gene editing technologies does not present any unique safety concerns compared to other more conventional methods of plant breeding. This conclusion is similar to that drawn by other international regulators.
• Health Canada’s new guidance provides very clear conditions under which a product of plant breeding is considered novel, but does not change who is responsible for making this determination. In fact, this clarity will ensure that developers know when a product requires pre-market assessment.
• Health Canada is committed to increasing transparency and has introduced a transparency initiative for non-novel gene-edited plant products. This initiative will provide Canadians with transparency about non-novel gene-edited crops that may be marketed for food use in Canada. Health Canada maintains a list of non-novel products of plant breeding (including gene-edited plants) for food use that can be accessed on the Department’s website.