Health Canada is responsible for ensuring that all foods, including those derived from biotechnology, are safe prior to their entering into the Canadian food system. The Novel Foods Regulation (under the Food and Drugs Act) requires that notification be made to the Health Products and Food Branch (HPFB) by the company who wants to sell the product prior to the marketing or advertising of a novel food. Pre-market notification permits Health Canada to conduct a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is safe and nutritious before it is allowed in the Canadian marketplace.
Novel foods are defined in the Novel Foods Regulation 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 manipulation. 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).
In 1993, a Canadian Federal Regulatory Framework for the regulation of biotechnology products was announced by the Government. The framework is intended to ensure that the benefits of biotechnology products and processes are realized in a way that protects health, safety, and the environment. One of the key principles adopted by the regulatory departments includes the use of existing laws and regulatory departments to avoid duplication. Regulatory authority for food products derived from biotechnology falls under several federal departments and agencies including the following:
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.
The Canadian Food Inspection Agency (CFIA) shares responsibility for the regulation of products derived from biotechnology including plants, animal feeds, 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.
Health Canada published the Novel Foods Regulation in the Canada Gazette, Part II, on October 27, 1999. This regulation provides for pre-market notification and review for all novel foods including foods derived from biotechnology. To date, Health Canada has reviewed over 81 novel food submissions. The information requirements for the pre-market safety assessment of novel foods are contained in guidelines which have been in place since 1994. Health Canada has revised these guidelines to reflect the advancement of methods and knowledge regarding product review. These updated guidelines were published in 2006.
Health Canada is also responsible for the environmental assessment of products regulated under the Food and Drugs Act, including novel foods. This activity is required by the New Substance Notification Regulations of the Canadian Environmental Protection Act. Health Canada is currently working with Environment Canada to develop new regulations to assess the impact on the environment and on human health of these products. More information regarding the Environmental Impact Initiative is on Health Canada web site.
Health Canada has established a clear and stringent process for evaluating the safety of foods derived through genetic modification. The specific criteria for the safety assessment of such foods are outlined in the Health Canada publication "Guidelines for the Safety Assessment of Novel Foods." Health Canada conducts a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is as safe and nutritious as foods already on the Canadian marketplace.
After twelve years of reviewing the safety of novel foods, Health Canada is not aware of any published scientific evidence demonstrating that novel foods are any less safe than traditional foods. The regulatory framework put in place by the federal government ensures that new and modified foods can be safely introduced into the Canadian diet. Safety assessment approaches are well established to address the potential risks associated with foods.
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, the Codex Alimentarius Commission and the Organisation for Economic Co-operation and Development (OECD).
The safety assessment of foods developed using genetic modification includes the following considerations:
The concept of substantial equivalence is used as a guide in the safety assessment of genetically modified foods by comparing the novel food to its unmodified counterpart which has a history of safe use. This approach allows regulatory agencies to include in their consideration, the substantial history of information related to foods which have long been safely consumed in the human diet to aid in the identification of potential safety and nutritional issues.
The approach to the safety assessment of biotechnology-derived foods is currently applied by regulatory agencies around the world in countries such as the European Union member states, Australia, New Zealand, Japan, and the United States. Health Canada's approach is consistent with guidance documents adopted by the Codex Alimentarius Commission.
The federal government recognizes that it must ensure that it will have the necessary scientific and regulatory capacity to adequately regulate products of biotechnology as the science continues to advance and new products are proposed for commercialization. Health Canada keeps pace by using the best technology available 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 World Health Organization (WHO), the Food and Agriculture Organization (FAO), the Codex Alimentarius Commission and the Organisation for Economic Co-operation and Development (OECD).
In addition, the recommendations from reports released by the Royal Society of Canada's Expert Panel and by the Canadian Biotechnology Advisory Committee (CBAC) are helping us to make sure we keep pace with scientific developments.
In 1999, at the request of the government, 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 ensure the safety of new food products being developed through biotechnology into the 21st century. The Royal Society Expert Panel submitted its report to the Government in February 2001. The government response was published in the form of an action plan in November 2001. The action plan recognizes the need to continually enhance our regulatory processes and protocols, and the scientific knowledge that supports them. The government has published several progress reports on the implementation of the action plan.
The mandate of CBAC, which was created by the federal government in 1999, is to provide expert advice to the federal government on ethical, social, regulatory, economic, scientific, environmental and health aspects of biotechnology. In addition to its general activities, CBAC focuses on a number of special projects, one of which relates to the regulation of foods derived from biotechnology: the science base underpinning assessments; governance, organization and efficacy; and, social, ethical and legal dimensions. In 2002, CBAC released its report entitled Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada. It is a comprehensive and balanced report which identifies opportunities for improvement of the government regulatory approach for products derived through biotechnology. Health Canada led the interdepartmental review of CBAC's recommendations, many of which have been implemented.
In 1999, the Codex Alimentarius Commission created the Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology to elaborate general principles for risk analysis of foods derived from biotechnology and specific guidance on the safety assessment of such foods. The Task Force was given a mandate of four years to complete its task.
Health Canada participated actively in the work of the Task Force, which led to the following documents being adopted by the Codex Alimentarius Commission in July 2003:
Given the success of the former Task Force, the Commission agreed to establish a new Ad Hoc Task Force with the understanding that its final report should be submitted in 2009. As for the first Task Force, Health Canada actively participates in the work of the new Task Force.
Health Canada also participates in the work of the OECD Task Force for the Safety of Novel Foods and Feeds. The program of work of the OECD Task Force is intended to promote international harmonisation in the safety assessment and regulation of novel foods and feeds, including the products of modern biotechnology.
The OECD Task Force focuses its work on the development of consensus documents containing key nutritional and compositional information, such as nutrients, anti-nutrients and toxicants associated with specific crop species and other information on the particular use of these species as food or animal feed, for use during safety assessments of novel food and feed products. In the area of food and feed safety, more than 10 species specific consensus documents have been developed, including for corn, soybean, wheat, rice, canola and sugar beet.
Genetic modification does not introduce unique risks. Since the risks for these novel foods are the same as for conventional foods, the issues of interaction are the same as for conventional foods (e.g., consuming oranges and meat together enhances absorption of iron).
As is the case with any food or health product, it is Health Canada's mandate to monitor potential long-term health trends associated with exposure to a breadth of product areas - including but not limited to - biotechnology products.
Many of the issues raised by foods resulting from the application of biotechnology are equally applicable to foods produced by conventional means. Potential food safety issues are those associated with toxic or allergenic compounds which are present already in the food supply. Given that the application of genetic modification does not introduce unique risks, the potential for long term effects of these foods are no different than that for conventional foods which have been safely part of the Canadian diet for a long time.
Therefore, there is no current evidence to indicate that long term studies are needed to ensure the safety of foods produced using this technology. Health Canada has established a comprehensive safety assessment approach that addresses those potential risks in foods derived from biotechnology.
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 address long term health effects. In such cases long term studies may be a valid approach to include in the assessment of the overall safety of such products. At this time no products representing such true novelty to the food supply have been proposed for commercialization.
As noted above, should products which represent true novelty to the food supply be proposed for commercialization, long-term studies may be an appropriate part of their safety assessment.
Cost recovery is not practised in the area of the regulation of novel foods by Health Canada.
To date, over 81 genetically modified foods have been approved for sale in Canada.
No applications have been turned down. Health Canada has issued strict guidelines outlining requirements for data and protocol which are well known by industry. Therefore products are usually not submitted it they don't meet the criteria. In some instances, those products submitted that do not meet Health Canada's strict criteria are withdrawn voluntarily by the petitioner before a decision is taken.
Health Canada's requirements are extremely rigorous. Companies spend millions of dollars testing their products according to these requirements, which include detailed documentation of testing. Thorough analysis is conducted of the data and of the protocol used to ensure the validity of results. If the evaluator determines that the data is not sufficient, additional information and additional testing may be required. Evaluators may also supplement the information provided by the petitioner with any published data in Canada or internationally that is relevant to the product in question.
Paper reviews are a standard scientific method of evaluation used by regulators around the world, to evaluate the health and safety of a variety of products including food and drugs. Methods used by Health Canada are based on international expert consultations endorsed by the World Health Organization (WHO), Food and Agriculture Organization (FAO), and the Organisation for Economic Co-operation and Development (OECD).
Health Canada and the Canadian Food Inspection Agency (CFIA) share the responsibility for food labelling policies under the Food and Drugs Act. Health Canada is responsible for developing policy and setting standards related to the health and safety aspects of labelling under the Food and Drugs Act and Regulations, whereas the CFIA applies these policies and enforces the regulations. The CFIA also has the mandate to develop 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.
With respect to genetically modified foods, as with all foods, Health Canada's role is to identify the information required on the label of that food to ensure its safe use. Special labelling is required if changes occurred in the food that the consumer needs to be informed of for health and safety reasons, such as major compositional or nutritional changes. Health Canada would determine what type of information is needed on the label to inform Canadians about these changes in the food.
In principle, food products derived from genetic modification that are demonstrated to be safe and nutritious, are treated the same as non-genetically modified foods with regard to labelling requirements. In cases where a product has been intentionally modified, special labelling is required to inform consumers of the change to the product. For example, oil derived from high oleic soybean lines must be listed in food ingredient lists by the common name "high oleic soybean oil", to distinguish it from regular soybean oil.
The current federal position on labelling foods derived from genetic modification was developed based upon the outcomes of three public consultations which started in 1993. These consultations include the workshop on Regulation Agricultural Products of Biotechnology, November 1993, and the Technical Workshop on the Labelling of Novel Foods Derived Through Genetic Engineering, November 1994. The public consultation process considered the views of a wide range of stakeholders including industry and industry associations, consumer groups and the federal and provincial governments. At the Technical Workshop held in 1994, nutritionists, academics, consumer and environmental groups, producers and government representatives recommended that unless there was a potential health and/or safety concern or significant nutritional or compositional changes, the fact that the process of genetic engineering was utilized need not be identified on the label.
In Canada it is not mandatory to identify the method of production, including genetic modification, that was used to develop a food product. Nevertheless, voluntary method of production labelling is permitted, provided it is truthful and not misleading.
To facilitate the use of such voluntary labelling, the Canadian government supported the development of a national standard for the voluntary labelling of foods derived through biotechnology. This standard was developed by the Canadian Council of Grocery Distributors, under the guidance of the Canadian General Standards Board. This initiative was launched in November 1999 with participation from consumer groups, food companies, producers, environmental groups, general interest groups and government.
The draft standard developed through this initiative includes:
The voluntary labelling standard is not intended to address health and safety concerns as these are already addressed by the Food and Drugs Act and Regulations. Health Canada's involvement in the development of the standard was to provide technical information and guidance regarding the Department's role in the regulation of genetically modified foods in Canada and to minimize potential inconsistency between the standard and the Food and Drugs Act.
The standard was published as a National Standard of Canada in April 2004.
The federal policy on labelling foods derived from biotechnology remains under discussion with Canadians and international standards organizations such as Codex Alimentarius.
As with all foods, including foods derived through genetic modification, Health Canada requires special labelling to address health and safety issues which might be mitigated through labelling such as identifying the presence of an allergen. Labelling is also required to identify compositional or nutritional changes. In these situations, labelling is required to alert consumers or susceptible groups in the population at large. For example, oil derived from high oleic soybean lines must be listed in food ingredient lists by the common name "high oleic soybean oil", to distinguish it from regular soybean oil.
At the request of the Minister of Health, along with the Minister of Agriculture and Agri-Food, Industry and International Trade, the Standing Committee on Health initiated a study on the best options for meeting consumer information needs with respect to genetically modified foods in January 2002. The study resumed in March 2003 with participation from Health Canada. In May 2003, the Committee agreed not to pursue the subject further after hearing an update from the chair of the Canadian General Standards Board Committee on the development of a voluntary standard for the labelling of genetically modified foods. This voluntary standard was adopted as a National Standard of Canada in April 2004.
The House of Commons Standing Committee on Agriculture and Agri-Food also completed a study on the labelling of GM foods. The Committee held four public hearings between January and April 2002, and heard close to twenty groups representing the various components of the agriculture and agri-food industry. Its study entitled "Labelling of genetically modified foods and its impact on farmers" was completed in June 2002. The government response to this report was tabled in the House of Commons on October 31, 2002.
In August 2002, as part of its mandate, the Canadian Biotechnology Advisory Committee (CBAC) released the report entitled "Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada", which included recommendations concerning labelling. In its report, CBAC recommended the development of a voluntary standard for the labelling of genetically modified foods for reasons other than health and safety. It also recommended that the standard be widely publicized and reviewed five years after its implementation for adequacy and effectiveness, at which time other options may be considered. In addition, CBAC also recognized that the government must continue to cooperate with other countries to develop a harmonized approach to labelling.
Genetic modification is any change to the heritable traits of an organism achieved by intentional manipulation.
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, recombinant nucleic acid techniques which involve the introduction of a gene or genes from one species to another unrelated species (this is commonly called genetic engineering). Another modification technique is artificial mutagenesis, which involves treating cells of an organism with external agents (e.g. UV light, certain chemicals) in order to produce changes in its genetic material.
Farmers have traditionally used breeding methods to transfer desirable traits from one variety to another. The techniques of genetic modification permit scientists to transfer the genetic material responsible for these traits from one species to another in a faster and more precise fashion.
For many years farmers have used traditional breeding methods to improve crops by transferring genes that code for desirable traits such as disease and insect resistance from one variety to another. Traditional breeding techniques involve mixing thousands of genes, which in addition to providing the beneficial trait, also result in the loss of other traits of that crop considered to be valuable. Significant time and effort is required to restore the other valued traits of that crop while maintaining the desired trait using traditional breeding techniques.
Genetic modification permits food developers to add or enhance useful traits more specifically or remove undesirable traits. The technology permits food developers to add a desired trait in a more precise manner than traditional breeding without the loss of other beneficial characteristics since unwanted genes are not transferred.
The techniques of modern biotechnology do not introduce risks which are different from those already associated with the food supply. Many of the issues raised by foods resulting from genetic modification are equally applicable to foods produced by conventional means. Potential hazards remain those associated with toxic or allergenic compounds which are inherently present already in the food supply. However, unlike traditional breeding, techniques such as recombinant DNA technology permit the transfer of genetic material form unrelated species and this is precisely why a safety assessment is considered to be necessary. Similarly, a gene may be transferred from an organism expressing a protein that has no history of use as a food. Safety assessment provides assurances that toxic and or allergenic compounds are not transferred along with the desired trait when new DNA is introduced into an organism.
Benefits resulting from such changes may include longer lasting and better tasting fruits and vegetables, crops which require less use of pesticides, improved nutrient content in certain foods, etc. In general, food production could be more efficient or more inexpensive and may contribute to enhancing the global food supply.
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 product was never commercially developed and soybeans containing a Brazil nut protein were not available on the market.
The findings of a researcher in the United Kingdom (Dr. Arpad Pusztai), concerning the safety of genetically modified potatoes were described in an article published in the Globe and Mail on February 20, 1999. Since that time, several groups, including the British Royal Society, have reviewed the results of those studies and concluded that the evidence does not support claims that genetically modified potatoes used in those studies had adverse health effects on rats. The Health Products and Food Branch of Health Canada has not conducted a safety assessment on these potatoes. Similarly, the potato used in this study has not been assessed by any international regulatory agency for safety. These potatoes were not available on the market.
The Bt, or Bacillus thuringiensis family of insecticidal proteins are naturally occurring proteins which are included as the active insecticidal agent in certain commercial pest control products. These have been used safely for more than 30 years to control insect pests by home gardeners, organic growers and other farmers and are known to specifically effect certain insect pests .
The Bt proteins introduced into plants are toxic to certain species of insects yet are harmless to humans and are digested like other proteins in the human digestive system. Health Canada has thoroughly reviewed potatoes, corn, cotton and tomatoes that have been genetically modified to contain these proteins and have found them to be as nutritionally safe as their unmodified counterparts. The Department is not aware of any reports which link adverse reactions of any consumers to consumption of plants containing the Bt proteins.
Antibiotic resistant genes are used as markers for identification purposes in the development of novel food products. The safety assessment of novel foods considers the consequence of the transfer and expression of the antibiotic-resistance marker gene in recipient cells and the clinical and veterinary importance of the antibiotic in question.
It is very important to note that there is no evidence to support the transfer of antibiotic resistant genes from a genetically engineered food product to microorganisms in the gastrointestinal (GI) tract. A series of highly improbable and complex events must occur in the human GI tract for such an event to occur. The hostile nature of the GI tract provides a highly unfavourable environment for the survival of DNA coding for antibiotic resistant genes if released from the cells of the modified food. Free DNA for uptake by microorganisms is continuously degraded in the GI tract. Further, a series of steps are required for the DNA to be transferred and expressed in a recipient microorganism. There are no known reports of bacterial transformation in the GI tract and no mechanism for transfer of genes from plant/animals to microorganisms is known or have any cases been reported.
No. Health Canada has not reviewed any plants that have been genetically modified with genes from an animal source.
The government recognizes that ethical considerations are important issues related to consumer choice. Potential ethically sensitive modifications such as the inclusion of animal or fish genes into crops will need to be collectively examined and agreed upon. For some people, the use of genetically modified products to any extent is an ethical issue. To that end, the federal government announced the creation of the Canadian Biotechnology Advisory Committee (CBAC) as part of its renewed biotechnology strategy in 1999.
CBAC is an expert, arm's length committee formed for the purposes of advising the Ministers on issues related to biotechnology such as ethics but also including the scientific, social, economic, regulatory, environmental and health aspects. CBAC is working to raise the public's awareness of the regulatory process and provides an ongoing forum for the public to voice their views. The Advisory Committee under the Canadian Biotechnology Strategy is expected to consider ethical issues in a broader scope than product by product approvals covered under the Novel Foods Regulations. In addition, CBAC's report entitled " Improving the Regulation of Genetically Modified Foods and Other Novel Foods In Canada", released in 2002, included recommendations on how to address ethical issues in the regulatory framework for novel foods. Health Canada led the interdepartmental review of CBAC's recommendations, many of which are already being implemented.
In 1989-90 there were 37 deaths and about 1500 cases of the disease eosinophilia-myalgia syndrome (EMS). The only common link among those affected was the consumption of the food supplement L-tryptophan. The contaminated lots of tryptophan had been produced by a company in Japan using a genetically modified bacteria that was designed to overproduce tryptophan. In addition to changing the production organism there were also changes made in the recovery and purification steps; specifically those steps involved in removing impurities. The toxic metabolite was also produced by natural or non-genetically modified strains of bacteria. It was most likely the change in the purification step that allowed the toxic metabolite to contaminate the tryptophan. There was no indication that the illnesses were caused by the application of genetic modification to the bacterial culture.
StarLink™ corn is an insect-tolerant corn developed through the application of biotechnology. While StarLink™ corn has been approved for use as animal feed (but not for human food use) in the United States, this corn line has never been approved for use as human food, animal feed or environmental release in Canada.
Information regarding enforcement activities on imports of products containing U.S. corn is available on the Canadian Food Inspection Agency website.