Canada takes a unique stance on gene editing by regulating any products that contain novel traits, including gene edited crops, regardless of the process (e.g. conventional breeding, mutagenesis, transgenesis or gene editing) used to develop the product. The Canadian Food Inspection Agency (CFIA) evaluates products on a case-by-case basis to decide whether they contain novel traits. Any plants, food or feed that contain novel traits require environmental and safety assessments to be approved. Although Canada appears to be headed towards regulating gene-edited crops lightly, there remains uncertainty as to what types and how many products of gene editing will trigger oversight and what that level of oversight might be. Most crop varieties designated as mutagenic (which are regulated as conventional) are not considered to have novel traits and therefore are not subject to pre-market assessment as novel foods. Most gene-edited crops are viewed as products of a (more precise) version of mutagenesis. That acknowledged, there is uncertainty if regulators will view them as such, as no formal framework or decisions have yet been issued. If it is determined that pre-market assessment is necessary, the current submission requirements would be high and often prohibitive.
In 2018, Canada and 12 other nations, including Argentina, Australia, Brazil and the US, issued a joint statement to the World Trade Organization supporting relaxed regulations for gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between crops developed through gene editing and crops developed through conventional breeding.
Synthetic biology, including gene editing of agricultural products, has become a contentious issue, with researchers and government agencies pushing for Canada to invest more in synthetic biology to stay competitive within the international biotechnology space. NGOs such as ETC Group fiercely oppose deregulation, as they consider gene editing to be a new form of potentially dangerous genetic engineering that needs to be regulated as strictly as older genetic modification techniques such as GMOs.
The Canadian Food Inspection Agency (CFIA) and Health Canada regulate gene edited crops and food, including both imported products and those developed in Canada. Canada regulates any feed, food and plants that contain novel traits through three different regulations:
- Feeds Act and Regulations (livestock feed assessment required before authorization)
- Food and Drugs Act and Regulations (novel food assessment required before authorization)
- Seeds Act and Regulations (requires environmental safety assessment before release)
Canada implemented a national voluntary labelling standard for genetically engineered foods, the Voluntary Labelling and Advertising of Foods that Are and Are not Products of Genetic Engineering. Genetically engineered foods are therefore not required to be labelled, but manufacturers may choose to label them.
Products/Research
- Non-browning apple: Arctic Apple developed by Okanagan Specialty Fruits using RNA interference, a more traditional New Breeding Technique (NBT) known as agrobacterium-mediated transformation. Arctic Golden, Granny Smith and Fuji apples are approved and Galas are in development. None has been brought to market yet in Canada although they are sold in the US.
- Herbicide-tolerant canola: Cibus, a US company, used a gene editing technique called oligonucleotide-directed mutagenesis (ODM) to develop an herbicide-resistant canola that was approved by CFIA in 2013. Field tests conducted in 2015.
- Non-browning potato: The US company Simplot developed a non-browning potato using RNA interference that was approved for sale in Canada in 2016.
- Alfalfa research: Researchers from Agriculture and Agri-Food Canada used CRISPR to study gene editing in alfalfa. This research may be used to produce gene edited alfalfa in the future.
Regulatory Timeline
2018: Canada and 12 other nations, including Argentina, Australia, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”
2011: The Food and Drug Regulations amended.
2004: The Voluntary Labelling and Advertising of Foods that Are and Are not Products of Genetic Engineering adopted.
1985: Canada passes Food and Drugs Act, Feeds Act and Seeds Act, which together form the regulations for food, feed, and plants.
NGO Reaction
NGO’s, led by the ETC Group (an international organization based in Canada), consider synthetic biology and gene editing to be “extreme genetic engineering” and have extensively campaigned against biotechnology in Canada and elsewhere.
Additional Resources
- Genes and Science’s FAQ on gene editing
- Library of Congress summary of Canada gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- Regulation of Plants with Novel Traits: Canadian Perspectives on the “Novelty” Trigger
- Health Canada: Approved Novel Foods
- Targeted Regulatory Review: Agri-Food and Aquaclture Roadmap
- Canadian Pre-Market Regulatory Process for Plant with Novel Traits and Novel Foods and Feeds Derived from Plant Sources
- Regulatory Decisions Issued Under the Seeds Act and Regulations and/or Feeds Act and Regulations
- USDA Agricultural Biotechnology Annual 2020: Canada
