Animal Biotechnology - Roles and Responsibilities of the Government of Canada

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The government strives to protect the health and safety of humans, animals and the environment through on-going safety assessments. The government also carries out safety assessments for novel food products before they can be produced and marketed in Canada. This includes assessing products derived through biotechnology.

What does "products derived through modern biotechnology" mean?

Biotechnology is a collection of scientific techniques that are used to create or modify plants, animals and organisms. For thousands of years, people have been using selective breeding to change the characteristics of plants and animals. Some examples for plants include increasing plant yields, and increasing plant resistance to insects and disease. Animal examples include using selective breeding to develop stronger livestock, and creating new breeds of cats and dogs.

Modern techniques now enable scientists to move genes (and therefore desirable traits) to change plants, animals, and other organisms. When used in animals, the process is referred to as "animals and animal products derived through biotechnology". No biotechnology-derived animals have been approved for release into the Canadian environment or for food. To date, the Government of Canada has not evaluated any requests for food use approval or environmental release of fish derived from biotechnology.

The term "animal biotechnology" is an extension of the definition of biotechnology. This term may include, but is not limited to, the following categories of animals:

  1. Genetically engineered or modified animals in which genetic material has been added, deleted, silenced or altered to influence expression of genes and traits.
  2. Clones of animals derived by nuclear transfer from embryonic and somatic cells.
  3. Chimeric animals that have received transplanted cells from another animal.
  4. Interspecies hybrids produced by any methods employing biotechnology.
  5. Animals derived by in vitro cultivation such as maturation or manipulation of embryos.

In Canada, who is responsible for assessing animals derived through modern biotechnology?

Environment Canada is the first point of contact for the producers of biotechnology-derived animals. If someone wants to manufacture, import, or sell such an animal in Canada, they must contact Environment Canada so that the animal undergoes a full safety assessment for potential impacts to the environment. Environment Canada administers these assessments under the Canadian Environmental Protection Act, 1999 (CEPA, 1999), and the New Substances Notification Regulations (Organisms).

Health Canada co-administers CEPA, 1999 in regard to human health aspects. Thus, Environment Canada evaluates the environmental aspects of the notification, and Health Canada evaluates the human health aspects, including the safety of the people working with the animals.

Health Canada is responsible for conducting food safety assessments for novel foods, including those derived through biotechnology. Animal products developed using biotechnology are classified under the Novel Food Regulations section of the Food and Drugs Act and Regulations. Health Canada has the authority to regulate in this area and is preparing guidelines for assessing novel foods that are of animal and fish origin.

The Department of Fisheries and Oceans (DFO) is also involved in the process because of its role in protecting fish health and habitat, and the environment. Any request to develop fish using modern biotechnology for commercial purposes would be subject to the New Substances Notification Regulations under CEPA, 1999. DFO and Environment Canada will work together to have any such products assessed for notification and compliance with those regulations.

What is the role of the Canadian Food Inspection Agency (CFIA)?

The CFIA has expertise in animal health and has jurisdiction in this area under the Health of Animals Act. Environment Canada consults the CFIA on animal health matters during the process of assessing the animals. In addition, the CFIA is responsible for assuring that diseases do not spread between animals.

When someone wants to apply to manufacture, import, or sell to Canada any animal derived through biotechnology, they are required to submit technical documentation related to the animal's health to support their application. The CFIA analyzes the documentation and helps to evaluate the submissions. (If the biotechnology-derived animal is a fish, the Department of Fisheries and Oceans Canada will participate in the assessment and will provide advice.

What about the products obtained from animals derived through modern biotechnology? Who is responsible for assessing them?

If an animal-derived product (such as an animal feed, veterinary biologic, food, or pharmaceutical) is being assessed, different government departments will take part in the assessment. The end use of the product determines which department or agency is responsible. For example:

  • If the end use is for animal feed, the CFIA's Feed Section would be consulted for the assessment.
  • If the end product is a veterinary biologic, the CFIA's Veterinary Biologics Section would assist.
  • If the end product is for food or pharmaceutical use, Health Canada would participate in the assessment.
    • Should fish and fish products of modern biotechnology be approved by Health Canada for use as food, those products will still have to meet the requirements of the CFIA's Fish Inspection Program.
  • If the end product is for industrial use (like bio-silk for bullet-proof vest) and is not on the Domestic Substances List, Environment Canada and/or Health Canada will evaluate the product.

The CFIA, Environment Canada, and Health Canada work together to assure that both the safety of the animal and of the final product will be assessed.

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