Gene edited products with novel traits, including gene edited animals, are regulated regardless of the process used to genetically engineer the animal.
There is no regulatory distinction between gene edited animals and those modified using transgenics. Canada regulates any products that contain novel traits regardless of the process that was used to develop the product, including traditional breeding, gene editing or any other process.
The regulatory framework for animal biotechnology in Canada is designed to protect human and animal health and safety, and environmental safety. Provided that assessments do not indicate any unique concerns or risks, an animal or animal product genetically engineered by any process, once approved, are treated no differently than the respective conventional animal or animal product under Canada’s regulatory process.
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 both imported animals and those developed in Canada. Any food that contains novel traits require environmental and safety assessments to be approved.
The Canadian Food Inspection Agency (CFIA) and Health Canada regulate gene edited food, including animals, through the Food and Drugs Act and Regulations. 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.
The Canadian Food Inspection Agency (CFIA) and Health Canada regulate gene edited food, including animals through the Food and Drugs Act and Regulations. 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 GE food is approved.
- 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.
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