Regulations on Biotechnology and Agriculture

Act: Feeds Act, R.S. 1985, c. F-9; Fertilizers Act, R.S. 1985, c. F-10; Seeds Act, R.S. 1985, c. S-8; Plant Protection Act, S.C. 1990, c. 22; Health of Animals Act, S.C. 1990, c. 21.

To Whom Does This Apply?

All producers and manufacturers of food products. 

Summary

The Canadian Food Inspection Agency (CFIA) shares responsibility with Health Canada for regulating products derived from biotechnology. The Agency is responsible for assessing the safety of plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics.

Health Canada is responsible for assessing the human health safety of products derived through biotechnology including foods, drugs, cosmetics, medical devices and pest control products.

CFIA is responsible for the development of non-health and safety food labelling regulations and policies.

Examples of products regulated by the CFIA:

• agri-food products
• veterinary vaccines and biologics
• plants and animals
• fertilizers
• livestock feeds, and
• seeds.

The regulatory authorities for these products are contained in Acts and Regulations. Whether the product has been produced by conventional methods or by advanced biotechnology, the general information requirements are the same. The Agency strives to ensure that these regulatory requirements are consistent with those of recognized international scientific groups and with other national governments.

Guidelines for Evaluating Products

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

 

• to build on current legislation where possible, rather than creating new legislation to govern new products;
• to focus on product characteristics, rather than the method of production. At the present time, all products developed through genetic engineering (recombinant products) are assessed for unintended effects that may result from the introduction of foreign genes or DNA sequences;
• 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.

Specific Product Groups

The existing legislation and the products that are regulated under it are outlined in the table below. This table gives examples of products derived from biotechnology for each of the main product groups. Some of the key control procedures that apply are also listed.

1. Plants with novel traits are one of the more active areas of research using both traditional and genetic engineering (recombinant) methods. Crop and horticultural plants are included in this group and are regulated under the Seeds Act and the Plant Protection Act. Risk assessments are conducted on plants with novel traits and consider plant biology, the new characteristics, the potential environmental impact and how the plant might affect human or animal safety. In evaluating the application, regulators may request data generated from controlled field trials.
    
2. Biofertilizers include rhizobia, other types of free-living nitrogen-fixing bacteria and some fungi. Recombinant products are not yet commercialized in Canada, and the research focus is on genetically improved rhizobia. The Fertilizers Act requires that products must be registered and specifies standards and labelling requirements.
    
3. Feeds are defined as any substance or mixture of substances, manufactured, sold, or represented for use for consumption by livestock, for providing the nutritional requirements of livestock, or for the purpose of preventing or correcting nutritional disorders of livestock. Novel feeds include microbial products (both viable and non-viable), plants with novel traits and fermentation products such as enzymes, biomass proteins, amino acids, vitamins and flavouring ingredients.
    
4. Veterinary biologics include animal vaccines, toxins, antisera and diagnostic kits. Currently there are two classes of recombinant products: those inactivated products prepared from genetically engineered organisms; and those products containing live recombinant organisms. The Health of Animals Act requires extensive testing, limited field trials with target species, and ongoing quality assurance monitoring of the manufacturer. Licensing is also required. Some categories of veterinary biologics are regulated by Health Canada under the Food and Drugs Act, because these are prescribed substances, such as hormones like rbST.
    
5. Food inspection is a broad area which covers meat, dairy products, eggs and egg products, fruits, vegetables, honey and maple products. The Canadian Food Inspection Agency provides inspection programs that enforce safety standards, review labelling, and monitor the product quality and marketing. Genetically engineered foods require a full risk assessment and Health Canada establishes safety standards and specifies labelling requirements for safety under the Food and Drugs Act.

Table - Agricultural Products, Legislation and Regulatory Controls, With Particular Emphasis on Products Derived From Biotechnology

Product	Act	Biotech Products	Contacts
Livestock feeds, additives	Feeds Act	novel feeds	Canadian Food Inspection Agency Feeds section, Plant Products Division Tel: 613- 225-2342
Fertilizers, supplements	Fertilizers Act	biofertilizers	Canadian Food Inspection Agency Fertilizer Section, Plant Products Division Tel: 613- 225-2342
Plants	Seeds Act Plant Protection Act	plants with novel traits plants with novel traits and genetically engineered micro-organisms	Canadian Food Inspection Agency Plant Biotech Office, Plant Products Division Tel: 613- 225-2342
Animals, veterinary biologics	Health of Animals Act	vaccines produced by or containing genetically engineered organisms	Canadian Food Inspection Agency Veterinary Biologics & Biotechnology Section Animal Health Division Tel: 613- 225-2342

 

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Manitoba Contact(s):
Canadian Food Inspection Agency
Room 613
269 Main Street
Winnipeg, Manitoba  R3C 1B2
Telephone: 204-983-2200
Fax: 204-984-6008
Web site: http://www.inspection.gc.ca/english/toce.shtml
 

 

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National Contact(s):
Canadian Food Inspection Agency
1400 Merivale Road
Ottawa, Ontario  K1A 0Y9
Telephone: 613-225-2342
Fax: 613-228-6601
Toll-free (information): 1-800-442-2342
TTY Toll-free (hearing impaired): 1-800-465-7735
Web site: http://www.inspection.gc.ca/english/toce.shtml
Hours of operation: Monday to Friday, 8:00 a.m. to 8:00 p.m. (Eastern Time).