Safety Assessment Process for Novel Foods and Agricultural Products of Biotechnology

Safety assessment process for novel foods and agricultural products of biotechnology

The safety assessment process for novel foods and agricultural products of biotechnology is a rigorous one. In assessing the safety of new biotechnology products the phases of assessment include: proven research and development of the new product, evaluation (including field trials and case-by-case assessments prior to commercialization), and finally, the new product must meet registration and marketing standards.

Research and Development

Novel crops, including those developed using genetic engineering, are produced in laboratories, and studied in growth chambers or greenhouses under conditions of environmental isolation.

In Canada, scientists working with genetically modified organisms adhere to guidelines established by the Medical Research Council, as well as the codes of practice established by their own institution.

Evaluation

The Canadian Food Inspection Agency (CFIA) regulates the confined field trial evaluation of all novel crops. Conditions prescribed by the CFIA are designed to minimize the possibility of any environmental impact. These criteria include: measures to prevent the transfer of pollen to other plants, inspection by CFIA staff, post-harvest land use restrictions, as well as follow-up monitoring.

The agronomic and environmental characteristics of these plants are evaluated over many years of confined field trials prior to the selection of commercially viable lines.

Assessment

All novel crops and their products are subjected to a rigorous environmental, livestock feed and food safety assessment before they move into the marketplace. Scientists from the CFIA and Health Canada are responsible for a critical review of the data collected from laboratory and field experiments conducted by the proponent.

Decision documents describing the assessment and its results are published by the CFIA and Health Canada and are available to the public.

Registration and Marketing

When required by the Seeds Act, Canada's variety registration system is designed to ensure that only varieties that are safe and have proven merit are sold.

Like their traditional counterparts, novel varieties are subject to the standard requirements for variety registration and regulatory oversight.

Roles and Responsibilities

Both Health Canada and the CFIA share responsibility for the safety assessments and final approval of new products of biotechnology. Under the Food and Drugs Act, Health Canada conducts a thorough assessment for human health of each new product before it can be sold in Canada. The Canadian Food Inspection Agency also has responsibility for the regulation of products derive from biotechnology including plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics.