How was this regulation created?
The Federal Regulatory Framework for Biotechnology was established in 1993 by the Canadian Government. One of the principles of the Framework is that, rather than creating new regulations, novel products produced through biotechnology will be regulated under existing regulations that cover techniques already in use prior to 1993 (also called ‘traditional’).
Canada’s regulatory approach essentially reviews products rather than processes – the focus is on the traits expressed in the products and not on the method used to introduce those traits. Approvals for genetically modified organisms (GMOs) are required for both locally produced and imported products and those used either as food or animal feed must be approved before entering the market.
Why does this regulation exist?
Governments regulate products for a variety of reasons, including to protect human, animal and environmental health, maintain international quality and safety standards that facilitate trade, and protect consumers against fraud. In the case of Canada, this regulation also helps to maintain a level playing field with novel products produced by techniques prior to 1993.
Who is responsible for regulating and which products?
There are three federal agencies responsible for regulation:
- Health Canada, which is responsible for safety assessment of Genetically Engineered (GE) and Genetically Modified (GM) foods for human consumption.
- Canadian Food Inspection Agency (CFIA), which is responsible for environmental risk assessment of GM plants for growing, safety assessment of GM foods for animal feed, and safety of GM field trials.
- Environment and Climate Change Canada, which is responsible for environmental risk assessment for GM animals, including fish, in collaboration with Health Canada.
Genetically Engineered and Genetically Modified Food
GE and GM foods are classified as one class of “novel foods” and manufacturers and importers who wish to sell or advertise a GM food in Canada, must submit data to Health Canada for a pre-market safety assessment. Health Canada’s authority to regulate derived from the Food and Drugs Act and their safety reviews are based on the concepts of “familiarity” and “substantial equivalence”.
- Familiarity is defined as “our knowledge of the characteristics of a plant species and experience with the use of that species in Canada.”
- Substantial equivalence is defined as “the equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.”
Labeling of Genetically Engineered or Genetically Modified Food
Advertising or labeling of products containing GMOs or derived through GE processes is largely voluntary in Canada.
Under the Food and Drugs Act, labelling of all foods, including novel foods, is required only in cases where the foods have significant nutritional or compositional changes and where Health Canada has determined that there is a health and safety concern that can be mitigated through labelling. It is not required to indicate that the food is a product of genetic engineering.
Voluntary labelling of foods containing or not containing GE or GM products is permitted under current federal policy, provided the label is truthful and not misleading. This approach is consistent with labelling for method of production claims on foods in Canada (e.g., “raised without antibiotics”, “natural”), which are voluntary and market-driven; this approach is supported by international standards.
To provide specific guidance on voluntary labelling to Canadian manufacturers, and to address consumer demand for the labelling of GM foods in Canada, the federal government developed the Voluntary Labelling and Advertising of Foods that are and are not Products of Genetic Engineering standard by working with the Canadian General Standards Board and in consultation with food associations, consumer groups, food companies, producers, environmental groups, and others. The voluntary labelling standard was adopted by the Standards Council of Canada in April 2004 and its technical content was re-affirmed in April 2016.
Genetically Engineered and Genetically Modified Seed and Livestock Feed
The CFIA is responsible for regulating the environmental release of a plant with a novel trait (PNTs) and is authorized through the Plant Protection Act, Plant Protection Regulations, and the Seeds Act and Seed Regulations.
CFIA performs an assessment of the GM plant’s impact on the environment and biodiversity, including assessing the possibility for gene flow and impact on non-target organisms, as well as ensuring the safety of livestock feed.
CFIA then applies the principle of substantial equivalence when comparing the characteristics in the novel food with its conventional counterpart in respect to its molecular, compositional, toxicological and nutritional makeup. In other words, a product will be approved if it is substantially equivalent to its conventional counterpart.
The development and planting of PNTs for research purposes is overseen by the CFIA’s Plant Biosafety Office (PBO). The PBO evaluates applications for confined research field trials and sets out the rules and conditions for how they are to be conducted.it. In some cases, but not all, this can help physicians determine the most appropriate treatment for each patient and help better manage a particular disease and manage health issues.
Other Genetically Engineered and Genetically Modified products
The Canadian Environmental Protection Act (CEPA) is used as a “catch-all” to regulate GM products that fall outside the responsibilities of other agencies.
CEPA covers the environmental assessment of genetically modified animals and Environment Canada manages these assessments.
More Information and Resources:
CFIA, Directive Dir2000-07: Conducting Confined Research Field Trials of Plant with Novel Traits in Canada
Regulating agricultural biotechnology in Canada
CFIA, Tool – Guidance Document Repository
An Overview of Genetically Modified Organisms, Genome BC
Labelling of genetically engineered foods in Canada
Voluntary labelling and advertising of foods that are and are not products of genetic engineering