Animal Biotechnology

In Canada, the animal biotechnology sector, which includes research and development activities and the resultant animals and their products, is subject to the same rigorous health and safety regulations that apply to conventional animals and their derived products. These regulatory controls include the Health of Animals Act and Regulations, the Food and Drugs Act and Regulations, the Meat Inspection Act and Regulations, and the Feeds Act and Regulations, administered by the Canadian Food Inspection Agency (CFIA) and Health Canada. In addition, animals and their derived products produced through biotechnology are considered as "novel" or "new", triggering additional regulatory controls depending on the intended use of the product and/or its release into the environment.

Currently, animal biotechnology research is permitted in Canada, including research on livestock animals; however the animals must be housed in contained facilities to prevent release from the facility of the animal, its genetic material in living cells, or any material which might be associated with toxicity. To date, no animals produced using biotechnology have been approved for release into the Canadian environment, or into the food or feed chain.

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.

Health Canada considers novel foods, including animals produced through biotechnology, to be subject to the regulations in Division 28, Part B, of the Food and Drug Regulations. Therefore, developers producing animals through biotechnology must not introduce the products or by-products of these animals or their progeny into the human food supply in Canada, unless they have been subject to a pre-market safety assessment which is required for novel foods.

The CFIA also considers novel feeds, including ingredients from animals produced through biotechnology, to be subject to assessment before any derived products and by-products can be released in the feed chain.

Animals produced though biotechnology and their progeny are also considered to be "new substances" under the Canadian Environmental Protection Act 1999 and must meet the Environment Canada notification requirements under the New Substances Notification Regulations.

Information we provide for the general public includes:

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

Information we provide to the livestock sector and scientific community includes:

• Government of Canada's comments on the USFDA's document "Animal Cloning: a Draft Risk Assessment"
• Notification Guidelines for the Environmental Assessment of the Use of Animal Biotechnology in Livestock