Response to concerns about the new guidance on Novel Food Regulations, products of plant breeding

Health Canada implemented a new guidance on the Novel Food Regulations, focused on products of plant breeding. Canadians have expressed a number of concerns regarding the regulation of these products, including those developed using gene editing technologies and other methods of genetic modification. Here are the department's responses to these concerns.

Concern #1

Health Canada is no longer regulating or conducting safety assessments for foods produced from genetically modified (GM) plants unless they contain foreign DNA.

Health Canada's response #1

Health Canada will continue to regulate and conduct safety assessments for all novel foods prior to their use in the Canadian food supply.

The Novel Food Regulations are product-based. The regulatory status of a product is based on the characteristics of that product. It's not based on the process by which the product is developed. This regulatory approach is scientifically supported, as it's the characteristics of a product, like whether it contains an allergen or a toxin, that determine if it's safe to eat.

The new guidance doesn't change this approach. The guidance identifies 5 categories of characteristics that a plant may have that would require a safety assessment before its use in the Canadian food supply. The presence of foreign DNA is only 1 of these categories. Under the new guidance, the department considers any foods produced from plants having any of the identified characteristics as "novel foods," regardless of whether a plant has been developed using:

• conventional breeding
• gene editing
• other methods of genetic modification

Concern #2

Health Canada is allowing industry developers to decide for themselves if foods produced from GM plants are regulated under the Novel Food Regulations.

Health Canada's response #2

All food producers are responsible for ensuring they comply with the provisions of the Food and Drugs Act and its regulations. This responsibility includes determining if their products meet the definition of a "novel food" and submitting a notification for pre-market assessment to Health Canada prior to sale in Canada. Health Canada's new guidance doesn't change this responsibility.

Health Canada will continue to encourage developers to request a novelty determination in cases where they're unsure of the regulatory status of their products.

Concern #3

There's a lack of transparency about the presence of foods produced from GM plants in the Canadian food supply.

Health Canada's response #3

Health Canada recognizes that transparency regarding foods produced from GM organisms is important to people in Canada. The department publishes technical and plain language summaries for every novel food safety assessment, including for those produced from GM organisms (GMOs). Health Canada will continue to publish these summaries for all novel foods.

The department acknowledges that certain products of plant breeding don't meet the definition of a "novel food." This can include foods produced from specific GM plants, depending on the characteristics expressed by those plants.

Health Canada doesn't have the regulatory authority to require notification of products that are not novel. However, the department has sought ways to increase transparency around non-novel products. Currently, Health Canada maintains a list of products for which the producer has sought confirmation regarding the novelty status.

Given the high degree of interest in products of gene editing, Health Canada has also introduced a new transparency initiative. This initiative will help people in Canada access information about non-novel, gene-edited products of plant breeding. Health Canada will maintain and publish a list of every non-novel product of plant breeding submitted to the department. While this initiative is voluntary, it increases transparency regarding these non-novel products where previously none existed.

Furthermore, the Minister of Health has received letters from industry developers indicating their commitment to participate fully in this process. These letters are available on the openness and transparency page.

Concern #4

In developing the new guidance, Health Canada hasn't considered the current scientific literature regarding the safety of gene editing technologies and their use to develop new products of plant breeding.

Health Canada's response #4

Health Canada considered all of the available scientific literature regarding the use of gene editing technologies in plant breeding, as well as expert opinions, including those from:

• industry
• academia
• government

There's a consensus that the use of gene editing technologies doesn't present any unique safety concerns compared to other more conventional methods of plant breeding. As such, Health Canada should regulate gene-edited products of plant breeding in the same manner as all other products of plant breeding as described in the new guidance.

Health Canada has also published a scientific opinion on the regulation of gene-edited plant products within the context of the Novel Food Regulations. The scientific opinion acknowledges that unintended genetic changes can occur in plants when using gene editing technologies. However, both the scientific literature and opinions from experts in the field of plant breeding confirm that these changes aren't unique to gene editing and can occur through all methods of plant breeding. Furthermore, these changes can be removed from a plant through standard plant breeding practices. One of the main conclusions of this opinion is that gene-edited plants are just as safe as their conventionally bred counterparts.

Concern #5

Health Canada developed the new guidance in a manner that wasn't transparent and Canadians weren't properly consulted.

Health Canada's response #5

Given the high degree of interest in genetically modified foods, Health Canada undertook the development of its new guidance in an open and transparent manner. Since the department announced its intent to develop the new guidance, summaries of all meetings with stakeholders have been available through the openness and transparency page for this project. This includes all documents shared and all correspondence with stakeholders on this topic. Health Canada accepted all invitations from stakeholders to present and discuss the development of the new guidance. Health Canada also reached out to groups with special interest in GMOs to discuss the new guidance.

Health Canada undertook a 60-day public consultation on the proposed new guidance from March to May 2021. The department received and reviewed over 4,600 comments. This included reviewing any new scientific information submitted. Evidence-based comments are reflected in the new guidance.

Health Canada also accepted feedback submitted after the close of the consultation period and provided additional time when requested to ensure that all stakeholders had the opportunity to provide comments. We published a summary of the comments received in a "What we heard" report.