Canadian Food Inspection Agency
Science Branch
Office of Biotechnology

Livestock and Animal Products Derived Through Modern Biotechnology: Roles and Responsibilities of the Government of Canada

Canada is proud of its reputation for having a safe food supply. To maintain that reputation, 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”. To date, no biotechnology-derived animals have been approved for release into the Canadian environment or for food.

Why is animal biotechnology used?

In the last century, science—especially the study of microbiology—has moved biotechnology into new areas. Modern biotechnology techniques can be used to change the products of animals that farmers raise for food and non-food uses. These techniques can be used in conjunction with animal husbandry and production practices.

The Royal Society of Canada report on the future of food biotechnology, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, refers to some other ways of using biotechnology in animals, including making animals more resistant to diseases and viruses, and modifying animals to produce leaner meat.

The report also mentions non-food uses, such as producing spider silk from goats. Spider silk is a very strong material that can be used in a variety of industrial products, such as surgical sutures and bulletproof vests. Modern biotechnology has been used to produce proteins in goat milk that can be used to make the spider silk on a commercial scale.

Animal biotechnology has also been used to provide new ways to produce medicines, such as insulin and human growth hormone.

Are these products regulated?

The Government of Canada regulates biotechnology-derived animals and products that come from those animals. In Canada, animal products of biotechnology are subject to the same rigorous safety assessments as other products derived through biotechnology.

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

Several government agencies are involved in the process.

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.

Health Canada, through its Healthy Environments and Consumer Safety Branch, 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.

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. For more information, refer to the CFIA fact sheet, “Fish Products Derived Through Modern Biotechnology: Roles and Responsibilities of the Government of Canada”).

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.
• 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.