Canadian Food Inspection Agency
Science Branch
Office of Biotechnology

General Questions and Answers on Agricultural Acts and Regulations

Health of Animals Act

Feeds Act

Fertilizers Act

Food Acts

Genetically Modified Micro-organisms

Plant Protection Act

Seeds Act

What is the Canadian Food Inspection Agency's approach when regulating products of biotechnology?

The Canadian Food Inspection Agency follows several basic principles similar to those adopted by other governments and international organizations. They are:

Build on current legislation where possible. The Acts administered by the Canadian Food Inspection Agency provide it with the legal authority to regulate agricultural products, including those derived through biotechnology. Regulatory amendments (regulations) and guidelines developed for these Acts apply to the planned release of experimental material into the environment for research purposes. Thus they will clarify the regulatory requirements for agricultural biotechnology products.

 

Regulate based on characteristics of the product. When reviewing researchers requests to conduct field trials, government regulators focus primarily on the product's use and traits, rather than the methods used to produce it;allowing regulation to be carried out under existing legislation. An animal feed is still an animal feed regardless of the process by which it was devised. What is important is that such products are found too be safe, effective and not harmful to the environment.

Whether the product is a genetically engineered tomato or a vaccine that protects livestock from disease the scientific evaluation process considers its potential risks. It takes into account the product's total properties, safety, and effect on the environment. Canada's approach matches that of the Organization for Economic Co-operation and Development ( OECD) and the United States.

Regulate on a case-by-case basis.  In order to determine the data and studies needed to demonstrate product safety, products are evaluated individually. As new types of products become more familiar, it may become possible to reduce regulatory requirements or provide an exemption from regulation in some cases.

Health of Animals Act

What type of products are regulated by the Health of Animals Act?

The Health of Animals Act regulates those products used for the diagnosis, treatment or prevention of infectious diseases in animals, and applies to transgenic animals that are resistant to certain diseases. The objectives of this Act are to minimize the risk of introducing foreign animal disease, to prevent the spread of disease-producing micro-organisms in Canadian livestock as a result of contaminated products, and to reduce the risk of exposing people to animal diseases that may be transmitted to humans.

Before they are registered for commercial sale, all biological products used for veterinary purposes (such as vaccines) must be shown to be safe, potent, pure and effective. To prove the safety of a product, the manufacturer must demonstrate that it will not endanger the environment, or animal and human health.

Veterinary biological products are broadly classified into two groups according to their characteristics and the safety concerns attached to them: Class I includes products prepared from inactivated organisms such as viruses and bacteria or their derivatives or toxoids that have been manufactured using genetic engineering techniques. Also in this group are monoclonal antibodies used to diagnose and treat diseases. Live products in this class come from organisms in which a single gene has been altered. These are very similar to modified vaccines already in commercial use. In summary, the inactive and live Class I substances pose little environmental risk or new safety concerns.

Class II includes products containing live micro-organisms that have been modified by introducing DNA with genetic material from different organisms or different strains. Substances in this group may also use a live delivery agent such as a virus to carry genetic material, infect the host animal and, in this way, immunize it. Government, industry and university researchers are now testing vaccines genetically engineered to prevent infectious diseases that afflict cows and other domestic animals. At the same time, many laboratories are working on diagnostic kits to detect various infectious diseases. Live products of Class II require special attention and data to prove that they will not harm human and animal health, and pose minimal threat to the environment.

Are import permits required for veterinary biologics?

Import permits are required for all veterinary biologics, animal tissues, genetically engineered animals, infectious organisms and related materials.

Feeds Act

What type of products are regulated under the Feeds Act?

The Feeds Act governs all feeds fed to livestock, including those produced through biotechnology. There are eight broad categories of regulated feeds: complete feeds, supplements and macro premixes, micro premixes, converter feeds, specialty feeds, and single-ingredient feeds. For the most part, products of biotechnology are regulated under the specialty feeds categories, which include products such as forage additives, enzyme, yeast, and microbial products, and all non-viable and viable products. Examples of single ingredient feeds include new plant varieties used as livestock feed.

Fertilizers Act

What type of products are regulated by the Fertilizers Act?

Under the Fertilizers Act, two types of products are regulated - fertilizers and supplements. Microbial products regulated by the Fertilizers Act are classified as supplements and include naturally occurring and genetically modified organisms that:

• produce and/or provide nutrients to the plant (e.g., nitrogen-fixing bacterial seed inoculants);
• improve the availability of plant nutrients in the soil (e.g., nitrification inhibitors, phosphate solubilizing bacteria and fungi);
• promote plant growth (e.g., plant growth regulators, growth-promoting rhizobacteria); and,
• improve the physical condition of the soil (e.g., eukaryotic microalgal conditioners, microbial biomass).

What is required to register a supplement in Canada?

In order to register a supplement product, the manufacturer must demonstrate the safety and effectiveness of the product. In cases where efficacy data from trials conducted in Canada do not exist, they must be collected in field tests on Canadian soil. A provision in the Fertilizers Regulations permits a product to be exempted from registration so that field tests for research purposes may be carried out. Guidelines also exist for registration of microbial supplements (same as for field testing - T-4-118 and T-4-119).

What is required to field test a supplement?

To obtain a research exemption, a company must apply to and obtain written permission from the Minister. Guidelines describe the requirements for both naturally occurring and genetically engineered micro-organisms.

Food Acts

Which Acts are administered by the Food Inspection Directorate?

The Canada Agricultural Products Act (CAP Act) and the Meat Inspection Act.

What activities are included in the inspection and regulation of agri-food products?

Food inspection programs protect the market competitiveness of agri-food products by monitoring the compliance of products imported, exported or processed in federally registered establishments. Products are monitored for safety, wholesomeness and accurate representation.

Monitoring programs, based on principles of risk assessment, are carried out via the registration and inspection of establishments, licensing of dealers and operators, inspection of processes, testing for biological and chemical contaminants, and inspection of products for conformity with safety, compositional quality, packaging and labelling standards.

What food products are inspected?

Regulated agri-food products include: meat and meat products, processed egg products, shell eggs, fresh fruit and vegetables, dairy products, processed fruits and vegetables and honey and maple products.

Genetically Modified Micro-organisms

Who regulates genetically modified micro-organisms?

It depends on the organism, its properties, and intended use. For example, microbes with pesticidal properties are registered by the Pest Management Regulatory Agency of Health Canada whereas microbials used to increase crop yields or improve the physical condition of the soil are regulated by the Fertilizer Section of the Canadian Food Inspection Agency.  Guidelines for the field testing of naturally occurring biofertilizers are available from the Fertilizer Section.

Plant Protection Act

What products are regulated by the Plant Protection Act?

The Plant Protection Act is used to protect Canadian plant life and the agricultural and forestry sectors from potential plant pests. It regulates plant products and organisms imported or developed in Canada that are potential plant pests, including genetically engineered plants or organisms. The Act defines a pest as any insect, plant or animal organism, virus, bacterium or disease-inciting agent that causes, or is likely to cause, injury or damage to any plant or plant part.

The Canadian Food Inspection Agency requires that importers of plant products genetically engineered or otherwise (that could carry pests) apply for a permit specifying conditions under which these products may enter or be released in Canada. The government may ask importers to conduct certain tests before the products are allowed into the country, or the products may be allowed entry but be kept in quarantine for testing and examination. To help evaluate possible risks connected with products of biotechnology, the Canadian Food Inspection Agency is using a database listing the most significant plant pests of concern.

Do I need a permit to import plants or other live organisms?

Yes. The Import Permit Office of the Canadian Food Inspection Agency issues permits for the importation into Canada of plants and plant parts including seeds from all countries. To obtain an importation permit, request application form AGR-1274, and the Notice to Importer N.L34B. The Notice to Importer lists all materials subject to prohibition or specific restrictions and is available from the permit office at Plant Protection Division.

Seeds Act

What types of products are regulated under the Seeds Act?

The Seeds Act regulates the inspection, testing, quality and sale of seeds in Canada. Seeds developed through biotechnology must meet the same requirements as those developed through traditional methods. The regulated products include new crop varieties produced by biotechnology with genes novel to the crop species. Work is now focused on lines that have novel pest resistance, pesticide resistance, altered nutritional value or stress tolerance.  Since 1988, confined field trials have been carried out using the seed of several plants with novel traits in Canada, including alfalfa, barley, broccoli, canola, cherry, corn, flax, grapevine, mustard, pea, potato, soybean, strawberry, sugar beet, sweet pepper, tobacco, tomato, and wheat.

Are guidelines outlining data requirements for confined and unconfined testing available?

Applications for field testing genetically engineered plants are evaluated on a case-by-case basis by the Plant Biosafety Office of the Canadian Food Inspection Agency. A detailed description of the data requirements can be obtained by contacting the Plant Biosafety Office.