Regulations on Biotechnology and Agriculture

To Whom Does This Apply?

Summary

While the Canadian Food Inspection Agency is the lead agency responsible for the regulation of agricultural products, it is not the only agency with this responsibility. Health Canada reviews novel products for food safety and sets data requirements for the assessment of the safety of all foods.

Health Canada also identifies hazards and specifies the standards that food inspectors observe. Its Pest Management Regulatory Agency (PMRA), assumed responsibility for registration and regulation of all pest control products in April 1995. It evaluates any product having pesticidal properties. Environment Canada works with regulatory agencies to help develop standards required for products that may affect the environment.

A wide range of products are regulated under the authority of the Canadian Food Inspection Agency (CFIA).

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 which are developed;
• 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

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.

Alberta Contact(s):
Regional Director, Alberta North
Canadian Food Inspection Agency
Room 205
7000 - 113 Street
Edmonton, Alberta  T6H 5T6
Telephone: 780-495-3333
Fax: 780-495-3359
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

British Columbia Contact(s):
Regional Director
Canadian Food Inspection Agency
Suite 400
4321 Still Creek Drive
Burnaby, British Columbia  V5C 6S7
Telephone: 604-666-6513
Fax: 604-666-1261
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Manitoba Contact(s):
Canadian Food Inspection Agency
Room 613
269 Main Street
Winnipeg, Manitoba  R3C 1B2
Telephone: 204-983-2200
Fax: 204-984-6008
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

New Brunswick Contact(s):
Regional Director, New Brunswick
Canadian Food Inspection Agency
850 Lincoln Road
P.O. Box 2222
Fredericton, New Brunswick  E3B 5G4
Telephone: 506-452-4964
Fax: 506-452-3923
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Newfoundland & Labrador Contact(s):
Regional Director, Newfoundland
Canadian Food Inspection Agency
10 Barter's Hill Road
St. John's, Newfoundland & Labrador  A1C 5X1
Telephone: 709-772-4424
Fax: 709-772-2282
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Northwest Territories Contact(s):
Regional Director, Alberta North
Canadian Food Inspection Agency
Room 205
7000 - 113 Street
Edmonton, Alberta  T6H 5T6
Telephone: 780-495-3333
Fax: 780-495-3359
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Nova Scotia Contact(s):
Regional Director, Nova Scotia
Canadian Food Inspection Agency
1992 Agency Drive
P.O. Box 1060
Dartmouth, Nova Scotia  B2Y 3Z7
Telephone: 902-426-2110
Fax: 902-426-4844
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Nunavut Contact(s):
Regional Director, Alberta North
Canadian Food Inspection Agency
Room 205
7000 - 113 Street
Edmonton, Alberta  T6H 5T6
Telephone: 780-495-3333
Fax: 780-495-3359
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Ontario Contact(s):
Regional Director, North East Ontario
Canadian Food Inspection Agency
Room 208, Unit 6
345 College Street East
Belleville, Ontario  K8N 5S7
Telephone: (613) 969-3750
Fax: (613) 969-3721
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Prince Edward Island Contact(s):
Regional Director
Canadian Food Inspection Agency
690 University Avenue
Charlottetown, Prince Edward Island  C1E 1E3
Telephone: 902-566-7290
Fax: 902-566-7334
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Quebec Contact(s):
Regional Director, Montreal East
Canadian Food Inspection Agency
Room 600
7101 Jean-Talon Street East
Anjou, Quebec  H1M 3N7
Telephone: 514-493-8859
Fax: 514-493-9965
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Saskatchewan Contact(s):
Regional Director, Saskatchewan
Canadian Food Inspection Agency
Room 300
3085 Albert Street
Regina, Saskatchewan  S4P 4E3
Telephone: 306-780-5180
Fax: 306-780-5177
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml

Yukon Contact(s):
Regional Director
Canadian Food Inspection Agency
Suite 400
4321 Still Creek Drive
Burnaby, British Columbia  V5C 6S7
Telephone: 604-666-6513
Fax: 604-666-1261
Toll-free (information): 1-800-442-2342
Web site: http://www.inspection.gc.ca/english/toce.shtml