Information
February 2001
Frequently asked questions on genetically modified foods
Q1. What is biotechnology?
Biotechnology is an umbrella term that covers a broad spectrum of tools and techniques, ranging from fermentation (bread, wine, cheese) to plant and animal breeding, cell and tissue culture, antibiotic production and genetic engineering. The traits of every organism are encoded in its genetic material (DNA or RNA) which is organised into individual units called genes. Genetic modification is achieved by changing the code or organization of the genetic material of an organism. This includes, but is not limited to, moving a gene or genes from one organism to another (this is commonly called genetic engineering).
Q2. What is a Novel Food?
Novel foods are defined as products that have never been used as a food; foods which result from a process that has not previously been used for food; or, foods that have been modified by genetic modification. This last category of foods have been described as genetically modified foods (often referred to as GM foods, genetically engineered foods or biotechnology-derived foods).
Q3. How many genetically modified food products are permitted in Canada?
Forty-eight novel foods have been approved by Health Canada, most of which are derived from genetically modified crop plants. Crops so far approved include:
- corn, including types resistant to corn borers and herbicides;
- canola, including varieties resistant to herbicides;
- potato including varieties resistant to Colorado potato beetles;
- tomato including varieties that ripen slowly;
- squash;
- soybean;
- sugarbeet;
- flax; and
- cottonseed oil.
A list of approved novel food products can be found on the Health Canada website along with further information on each evaluation.
Q4. Can you give an example of a food derived from biotechnology that was not given regulatory approval by the government?
Most companies will not submit an application or will withdraw a submission when they see that it will not meet the strict criteria outlined by Health Canada. For example, several years ago, research was conducted in order to improve the quality of soybean meal as an animal feed. This involved the transfer of genetic material coding for a storage protein from a Brazil nut to soybean.
Since the Brazil nut is known to cause allergic reaction in a small number of sensitive individuals, laboratory tests using sera from Brazil nut-sensitive individuals were conducted in order to determine whether an allergenic protein had been transferred to the soybean.
The results of the laboratory tests showed that the gene obtained from the Brazil nut likely encoded the major Brazil nut allergen and research on this product was discontinued. The company did not officially apply for approval of this product, the product was never commercially developed and soybeans containing a Brazil nut protein were never available on the market.
Q5. Which government departments are responsible for assessing the safety of foods derived from biotechnology?
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. In the case of novel foods, each safety assessment considers the process used to develop the novel food, its characteristics compared to those of its traditional counterpart, its nutritional quality, the potential presence of any toxicants or anti-nutrients, and the potential allergenicity of any proteins introduced into the food.
The Canadian Food Inspection Agency (CFIA) shares responsibility for the regulation of products derived from biotechnology including plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics. For genetically modified crop plants, the CFIA assesses the potential risk of adverse environmental effects; authorizes and oversees import permits, confined trials, unconfined release and variety registration.
Q6. Is there any scientific evidence to suggest that genetically modified foods are less safe than those foods produced using conventional techniques?
Health Canada has been reviewing the safety of foods derived from genetic modification for the last seven years, and is not aware of any scientific evidence which demonstrates that genetically modified foods are less safe than traditional foods. Each of the 48 foods currently allowed for sale in Canada have undergone a rigorous safety assessment. Health Canada has concluded that these products do not pose a health or safety concern. Similarly, there have been no products that we have reviewed that have the potential to introduce unique or new allergens or toxicants into the food supply.
Q7. What is the government doing to address the long-term impacts of genetically modified foods?
The foods that have been approved to date represent examples of relatively simple genetic engineering, involving the transfer of one or two genes which introduce a limited number of new traits, including resistance to an insect or a plant virus. A scientific comparison of their traits with those of conventional foods indicates that they are no less safe than conventional foods which have been safely part of the Canadian diet for a long time. The comparative approach permits linking the composition of the new food to existing products with a history of safe use, permitting prediction of the impact of the new food in the diet. Differences identified in the comparison are the focus of further detailed assessment.
However, as the science advances, should developments in the technology result in modifications that provide significantly different nutrient combinations or other novel food characteristics not previously encountered in the food supply, such foods may require additional considerations to permit comprehensive assessment. The guidelines for the safety assessment of novel foods provide this flexibility of approach. If Health Canada and CFIA scientists' assessments indicate that longer terms studies are required, the food will not be approved and the organization applying for approval will be required to undertake the longer term studies and submit further detail before their application is considered further. At this time no products representing such true novelty to the food supply have been proposed for commercialization.
Q8. What is Health Canada's safety assessment approach?
The safety assessment of foods developed using genetic modification includes the following considerations:
- how the food crop was developed, including the molecular biological data which characterizes the genetic change;
- composition of the novel food compared to non-modified counterpart foods;
- nutritional information for the novel food compared to non-modified counterparts;
- potential for new toxins;
- and potential for causing allergic reaction.
In assessing the safety of GM foods, we undertake a detailed scientific assessment. We examine how the food was developed, including a full description of the genes involved in the modification and their integration into the modified product; we assess the composition of the product and its nutritional quality; and we assess the potential for the production of toxic or allergenic products. Only when we are completely satisfied do we approve the product.
Additional research or testing can be required if Health Canada scientists are not satisfied at any stage in the safety assessment process. Only if all of Health Canada's stringent criteria are met is a novel food allowed access to the Canadian market.
The safety assessment process is based upon principles developed through international expert consultations carried out by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations, and the Organization for Economic Co-operation and Development (OECD).
Q9. Health Canada and the CFIA rely on information provided by the industry to determine the safety of biotechnology products. Does this provide for sufficient independence in the review process?
The Government of Canada has a rigorous food safety assessment process that is strictly adhered to in all instances in order to protect the safety and nutritional value of Canada's food supply, and to protect the health and safety of Canadians and the environment.
There are strict guidelines about the types of information that must be provided to Health Canada and how this information must be generated. When organizations approach the Department they are provided with these guidelines.
The data submitted for assessment is evaluated by a team of scientific experts in the areas of nutrition, molecular biology, chemistry, environmental science and toxicology who evaluate the product for its safety. This review is based on a scientific assessment of the results as well as the protocols and methodologies used to derive the information. In addition to this detailed assessment, evaluators may also refer to any published data in Canada or internationally that is relevant to the assessment.
If any part of the information provided is insufficient, evaluators will require the applicant to supply further studies or information. With this scrupulous examination of all data, it is virtually impossible for information to be hidden or misrepresented. Products are not approved until all evaluators are satisfied that the application addresses all regulatory requirements and the science has been properly carried out.
Q10. What is the government doing to address the issue of labelling of foods derived from biotechnology?
Health Canada and the Canadian Food Inspection Agency (CFIA) share the responsibility for food labelling policies under the Food and Drugs Act. Health Canada's responsibilities for food labelling falls within the Department's mandate for health and safety issues. Mandatory labelling is required to indicate when safety concerns such as allergenicity and compositional or nutritional changes are identified for all foods including genetically modified foods. In this situation, labelling will be required to alert consumers or susceptible groups in the population. Voluntary labelling of foods derived from biotechnology is permitted under current legislation as an option for food companies to meet marketplace demands.
In addition to safety concerns, the CFIA has been leading the federal program in the development of general food labelling policies and regulations not related to health and safety. In particular, the CFIA is responsible for protecting consumers from misrepresentation and fraud with respect to food labelling, packaging and advertising, and for prescribing basic food labelling and advertising requirements.
Health Canada and the CFIA recognizes that labelling foods derived from biotechnology has become an important issue for consumers. In response to increasing public demands for information on foods derived from biotechnology including mandatory labelling, the federal government has implemented a number of initiatives that are considering how to address public demands.
For example, on September 17, 1999, Minister of Agriculture and Agri-Food, Lyle Vanclief announced support for a project of the Canadian Council of Grocery Distributors (CCGD) and the Canadian General Standards Board (CGSB) to develop a Canadian standard for the labelling of foods derived from biotechnology with participation from over 100 organizations including consumer groups, food companies, producers, environmental groups, general interest groups and government. The standard is expected to be ready in the Spring 2001.
Q11. What are Health Canada and the Canadian Food Inspection Agency doing to ensure that its evaluation processes keep pace with the evolving science of biotechnology and that it employs the most stringent practices available?
As the science of biotechnology continues to evolve, the federal regulatory system keeps pace by using the best technology available at the moment and by continually reviewing the effectiveness of its approach. The approach that is used to assess the safety of biotechnology-derived foods in Canada reflects more than a decade of work by international experts working through such fora as the WHO, FAO, and OECD.
The Royal Society of Canada established an independent expert panel to examine future scientific development in food biotechnology. The independent expert panel's mandate was also to advise Health Canada, the Canadian Food Inspection Agency, and Environment Canada on the science capacity that the federal government will require to continue to ensure the safety of new food products being developed through biotechnology into the 21st century. A final report was released February 5, 2001 and federal scientists are studying its findings in detail.
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