Regulating agricultural biotechnology in Canada

Where are products of biotechnology used in agriculture?

The agriculture and agri-food sector uses biotechnology in a variety of ways to produce agricultural inputs and food products. Agricultural inputs (products) of biotechnology include:

• veterinary drugs and biologics (drugs used for the treatment or diagnosis of infectious diseases of animals);
• plants with novel traits (crops and horticultural plants);
• biopesticides (for insect, disease and pest control);
• novel fertilizer supplements or "biofertilizers"(to improve plant growth);
• livestock feed and feed additives; and
• novel foods.

Why do these products need to be regulated?

Products are regulated by government in order to protect human, animal and environmental health and to protect consumers against fraud. Regulations also serve to maintain international quality and safety standards that facilitate trade.

Before any of these products are registered, licensed or used commercially, regulators must determine:

• the potential effect of the product on human and/or animal health;
• the potential environmental impact of the product; and
• the merit or efficacy of the product (on some agricultural products)

Who is responsible for regulating these products?

In 1993, the federal government announced a framework for the regulation of biotechnology products in Canada. One of the principles of the framework was that existing legislation and regulatory bodies would be used to regulate biotechnology products, and that they would build on existing laws and expertise, rather than developing entirely new laws and agencies. This means that agricultural products of biotechnology are regulated under the same broad legislation and structures, with the addition of some new regulations and administrative procedures, as agricultural products produced in more traditional ways.

Several agencies are involved in the regulation of agricultural products. The main regulators are The Canadian Food Inspection Agency, Health Canada and Environment Canada.

The Canadian Food Inspection Agency is the lead agency responsible for regulating these products under, among others, the Health of Animals Act, the Plant Protection Act, the Seeds Act, the Fertilizers Act, and the Feeds Act. The Agency is responsible for regulating both the performance (or efficacy) and the environmental safety of the product in question. Regulations passed in 1996 clearly describe how the CFIA will conduct environmental assessments of agricultural products of biotechnology. CFIA is also responsible for inspection and monitoring so that registered products continue to meet quality and safety standards after their approval. This inspection and monitoring includes imported products that are products of biotechnology.

Health Canada, under the Food and Drugs Act has primary responsibility for human health related issues. Health Canada is responsible for setting standards for safety of the food supply, including food products of biotechnology (novel foods). Their Guidelines for the Safety Assessment of Novel Foods outline the criteria they consider in making an assessment of the safety to human health from genetically modified microorganisms and plants.

With regard to the important issue of labelling, responsibility is shared. The CFIA is responsible for non-safety related product labelling, i.e. voluntary labelling and consumer fraud issues, while Health Canada is responsible for required labelling related to health and safety issues, i.e. allergenicity, changes in nutritional composition etc.

Regulatory Directives for Evaluating Products

Product evaluators at the Canadian Food Inspection Agency have developed regulatory directives that are consistent with those used by international authorities. Some of the principles that are followed in Canada are:

1. To build on current legislation where possible, rather than creating new legislation to govern new products which are developed.
2. To regulate products based on the expression of a novel trait, rather than the method that was used in its development.
3. To conduct evaluations for each product on the basis of its unique characteristics and to establish appropriate safety levels based on the best scientific information. Safety is defined, not as the complete absence of risk, but rather as the level of "acceptable risk". If the risk is not acceptable, the application will be refused.

Scientific information is increasing continually and regulators must build their regulatory approach on this changing information base. This results in more efficient assessment as similar products are developed over time, and could also mean expanded uses and additional applications for a product as new information becomes available.

Methods of Control

There is a vast array of agricultural products being developed or imported into Canada. Depending on the type of product, where it comes from and the intended use, different control measures are used. All potentially hazardous imported commodities are controlled to reduce the possibility of the introduction of agricultural pests and diseases. Examples of such controls include the use of permits, testing, quarantine or inspection. Products which may pose a hazard to the environment are subjected to an environmental safety assessment. All new products, whether produced by traditional means or derived through genetic engineering would be included in this category.

Government evaluators, in collaboration with experts and the public, have developed guidelines for each class of domestically-produced product, which assist in the development of new products still in the research stage. These regulatory directives facilitate the presentation of adequate and appropriate information by the product developer, so that potential hazards can be identified early in the process. Government regulators use this information to determine whether new products meet acceptable safety standards.

Based on the product definition, specified protocols are applied which govern the conditions of release into the environment. Frequently, field testing is performed on a confined basis. In certain cases, such as for contract growing, certain confinement conditions may be either imposed or relaxed depending on the characteristics of a novel product. Scientific information is gathered during the development phase, and provided to evaluators as required. Information is produced during research trials conducted under laboratory conditions and field testing of new plants, or, in the case of veterinary biologics and livestock feeds, animal testing.

Depending on the product, prior to commercial production, approval, registration or licensing might be required. This is done in the case of biofertilizers, certain plant species, livestock feeds and veterinary biologics. Once the product has been approved, quality assurance monitoring of the products, as in the case of veterinary biologics, or food safety inspection, will be performed. All of these regulatory control measures are taken to assess the quality, safety and efficacy of the product. Labelling is an important means to inform the consumer about product facts. Discussions are underway concerning the various ways to communicate information on products that are derived through genetic engineering.

Who decides whether or not we need these products?

The Canadian Food Inspection Agency and Health Canada regulate for safety and efficacy of these products, but are not responsible for evaluating need. The issue of whether or not these products are "necessary" is left to the market place to determine.