Frequently Asked Questions - Biotechnology and Genetically Modified Foods

Part 2: Safety Assessment of Genetically Modified Foods

• How does Health Canada ensure the safety of genetically modified food?
• Is there any scientific evidence to suggest that genetically modified foods are less safe that those foods produced using conventional techniques?
• What is the basis of Health Canada's safety assessment process?
• What does the assessment look at?
• What is the advantage of this approach?
• Is this approach unique to Canada?
• How is Health Canada keeping up with the pace of change?
• How does Health Canada participate in international activities in this area?
• Do we know anything about the interactions between different genetically modified foods? For example, what are the risks to me from a salad made with corn and tomato products that were genetically altered?
• How is the potential for long term effects of genetically modified foods on humans considered in the safety assessment process?
• Is the government planning any long-term studies on the impact of genetic engineering on the health of Canadians?
• Under the guise of cost recovery, industry is actually paying to get their products approved. How can the government claim to be objective in its decisions?
• How many foods has the Department approved?
• Why does Health Canada not do its own testing of GM foods?

How does Health Canada ensure the safety of genetically modified food?

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.

Is there any scientific evidence to suggest that genetically modified foods are less safe that those foods produced using conventional techniques?

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.

What is the basis of Health Canada's safety assessment process?

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).

What does the assessment look at?

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 compared to non-modified counterparts;
• potential for introducing new toxins; and
• potential for causing allergic reactions.

What is the advantage of this approach?

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.

Is this approach unique to Canada?

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.

How is Health Canada keeping up with the pace of change?

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 21^st 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.

How does Health Canada participate in international activities in this area?

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:

• Principles for the Risk Analysis of Foods Derived from Modern Biotechnology;
  
  
• Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants;
  
  
• Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Genetically Modified Microorganisms.

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.

Do we know anything about the interactions between different genetically modified foods? For example, what are the risks to me from a salad made with corn and tomato products that were genetically altered?

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).

How is the potential for long term effects of genetically modified foods on humans considered in the safety assessment process?

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.

Is the government planning any long-term studies on the impact of genetic engineering on the health of Canadians?

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.

Under the guise of cost recovery, industry is actually paying to get their products approved. How can the government claim to be objective in its decisions?

Cost recovery is not practised in the area of the regulation of novel foods by Health Canada.

How many foods has the Department approved?

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.

Why does Health Canada not do its own testing of GM foods?

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).