Canada takes a unique stance on gene editing by regulating any products that contain novel traits, including gene edited animals, regardless of the process (e.g. conventional breeding, mutagenesis, transgenesis or gene editing) used to develop the product. Any animals that contain novel traits require environmental and safety assessments to be approved. Most mutagenic products currently being developed are not considered organisms with novel traits, and it is likely that this will also be the case for most gene edited organisms, which will therefore be regulated as conventional. 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 animals developed through gene editing and animals developed through conventional breeding.
Environment and Climate Change Canada (ECCC) governs genetic technology in animals for research and release using the Canadian Environmental Protection Act of 1999 and the New Substances Notification Regulations (Organisms). The ECCC requires environmental and human risk assessments during the development of animals using biotechnology.
The Canadian Food Inspection Agency (CFIA) and Health Canada regulate gene edited food, including animals, through the Food and Drugs Act and Regulations. Any food that contains novel traits require environmental and safety assessments to be approved. Safety assessment criteria for novel foods derived from animals are under development. Health Canada also uses the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals to review and regulate gene edited animals developed for food, which requires extensive safety assessments to be completed before any genetically engineered (GE) food is approved.
There is as yet no commercial production of a gene edited or GE animal in Canada. However, AquaBounty’s GMO salmon that grows twice as fast as conventional salmon was approved as food and animal feed in 2016. Clones, derived from DNA transfer from embryonic and somatic (mature) cells, their offspring and the products derived from clones and their offspring would be subject to the same requirements and regulations as those applicable to GE animals and animal products. Health Canada has maintained an interim policy on this issue since 2003, and currently includes these food products under the novel foods definition.
Synthetic biology, including gene editing of animals, 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.
- AquaBounty’s AquaAdvantage Salmon: GMO salmon modified to grow to maturity in half the time, approved for sale in in 2016.
- Less stressed pigs: Researchers at the University of Guelph studied stress response genes in mice to begin to develop pigs with lower stress levels that can result in higher meat quality and better immunity.
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 derived from precision biotechnology and similar end products, obtained through other production methods.”
2011: Food and Drug Regulations amended.
1999: Canada releases the Canadian Environmental Protection Act to regulate animals developed using biotechnology.
NGO’s, led by the ETC Group (an international organization based in Canada), consider synthetic biology and gene editing to be “extreme genetic engineering.” They have extensively campaigned against biotechnology in Canada and elsewhere, demanding that they should be strictly regulated as older genetic modification techniques such as GMOs.
- Genetic Literacy Project’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
- USDA 2018 Agricultural Biotechnology Annual: Canada