Regulation and Labeling of GM Foods

Education Services / L’équipe des services d’éducation
12 September 2012

Genetically Modified Crops – Canadian Regulation from Field to Table

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Years of work go into the research and development of GM/GE food crops, yet the laboratory phase is only the first step on the path to successful commercialization. In Canada, all genetically modified crops are subject to strict government safety assessments before they are allowed in farmers’ fields or on our dinner tables. The Canadian Food Inspection Agency (CFIA) is responsible for regulating the crop plants that are grown or imported, and Health Canada is responsible for regulating whether they can be sold as food. It usually takes seven to ten years for a GM/GE food crop to receive full approval.

We’ll take a closer look at the CFIA and Health Canada’s regulatory processes in a minute, but first there are two important concepts to discuss: trait regulation and substantial equivalence.

Trait Regulation

Both the CFIA and Health Canada take the approach of trait regulation rather than procedure regulation, and encapsulate this philosophy using the idea of “novelty”. If something is novel, it is new. The CFIA regulates plants with novel (new) traits and Health Canada regulates novel (new) foods, no matter how those plants or foods have been created. It is the novel crop trait or novel food characteristic that has the potential for environmental or health risks, not the procedure that created the novelty. This means crops with novel traits are regulated if they result from genetic engineering, mutation breeding, or conventional crop breeding. Here are two useful definitions:

Plants with Novel Traits (PNTs): The CFIA defines a PNT as “a new variety of a species that has one or more traits that are novel to that species in Canada.” A trait is considered novel if it “is new to stable, cultivated populations of that plant species in Canada and it has the potential to have an environmental effect.”

Novel Foods: For Health Canada, novel foods are “products that do not have a history of safe use as a food; foods resulting from a process not previously used for food; foods that have been modified by genetic manipulation” (including, but not limited to, genetic engineering).

Substantial Equivalence

The concept of substantial equivalence is used by both the CFIA and Health Canada. In most cases, the characteristics of a PNT or novel food are very similar to a familiar plant or food. For example, imagine a new variety of herbicide tolerant (HT) soybeans with the same agricultural characteristics, such as length of growing season, water requirements, and insect pests, as other traditional soybean varieties. Excepting the HT trait, the new soybean variety is considered substantially equivalent to traditional varieties. Therefore, CFIA scientists use their knowledge of the environmental impact of soybean agriculture in general to focus their safety assessment on any new risks that arise from the HT trait in particular. Similarly, Health Canada applies the principle of substantial equivalence to its food safety assessment by determining if these novel soybeans are similar to traditional soybeans with respect to nutrient composition, toxins, and allergens (more about that later).

Now we’re ready to take a more detailed look at the Canadian regulation of GM and GE food crops, keeping in mind the broad regulatory scope encompassed by the concept of “novelty”.

Step One: CFIA Regulation - From the Lab to the Field

When a crop trait developer (usually a company) has completed all the laboratory research and development of a genetically engineered crop plant (PNT), they can apply to the CFIA Plant Biosafety Office for permission to conduct a confined research field trial.

Confined field trials give the trait developer an opportunity to study the growth and yield of the new crop plant in a natural environment, and to collect the data that the CFIA needs to approve a subsequent, unconfined release.

Before approving a confined field trial, the CFIA considers the molecular characteristics of the PNT, such as the new or modified genes and their predicted behaviour, as well as preliminary data on the agricultural characteristics and environmental impact. The principle of substantial equivalence is used to predict how the PNT is likely to behave in the field. The CFIA also enforces rules for approved field trials that help prevent the unintentional release of the PNT into the environment.

The scientific data collected by the trait developer during the confined field trial is used by the CFIA for a more detailed environmental safety assessment. This detailed analysis must be done before a PNT can be approved for unconfined, commercial release. The CFIA examines data for the following categories of environmental risk:

·         Can the PNT become a weed or become invasive?

·         Can the PNT spread its genes to wild plant relatives? (gene flow, discussed in more detail later)

·         Can the PNT, or its novel gene products, have an impact on other (non-target) species?

·         Can the PNT have an impact on biodiversity?

CFIA scientists use data that is provided by the trait developer, usually a company that needs government approval to commercialize its new crop plant. If the data are flawed or incomplete, the CFIA will ask the company to correct the deficiency. This method of safety assessment is used by regulatory agencies around the world. The scope of the CFIA environmental safety assessment meets or exceeds the requirements set out in the Cartagena Protocol on Biosafety. This is a legally binding global protocol that aims to ensure that genetically modified organisms (including plants) are handled and transferred safely, and that potential environmental and health risks are identified and minimized.

Step One, Continued: Environmental Issues Associated With GE Crops

It is important to realize that even if some environmental risk is identified, a GE crop can still be considered safe by a regulatory agency. Risk and safety are not opposites. Risk is an objective measurement of the probability of undesired consequences. Safety is a subjective decision about the level of acceptable risk. When risks can be managed and minimized, a GE crop can be given government approval. Let’s look at two good examples of environmental risk management strategies that are used in Canada: herbicide tolerance management and insect resistance management.

Herbicide Tolerance Management Plans

Herbicide tolerant (HT) soybeans, corn, canola and sugarbeets are widely grown in Canada. If an HT-crop breeds with a different plant or weed, it is possible that the HT gene could be spread unintentionally. Some people are concerned that this type of gene flow (movement of genes from one organism to another) could create “superweeds” that are hard to control. The risk of unintended HT gene flow is real, but the creation of “superweeds” can be minimized and managed. The term “superweed” evokes the image of a giant weed that spreads out of control, but the scientific reality is less alarming.

HT genes in GE crops can spread only to closely related plant species (similar to conventional crop breeding). Soybeans, corn and sugarbeets don’t have wild or weedy relatives in Canada, so the risk of HT gene flow from these crops is very small. Canola is different because it is closely related to weedy field mustard, and HT-canola can breed with field mustard and transfer its HT genes. However, HT-field mustard can still be controlled with different herbicides (HT genes confer resistance to one type), or with non-chemical weed control methods.

When any new HT-crops are approved in Canada, the CFIA requires that the trait developer provide farmers with a detailed herbicide tolerance management plan to minimize the chance of HT gene flow to weeds. Two important aspects of these plans are crop rotation and herbicide rotation. Different weeds are associated with different crops, so crop rotation helps with weed control by changing the soil conditions each year to prevent the dominance of one particular weed. When farmers grow an HT-crop, such as glyphosate tolerant soybeans, they can use glyphosate to control weeds without damaging their soybeans. However, use of a single herbicide can provide selective pressure for weeds to evolve HT traits. Herbicide rotation, or changing the type of herbicide used, helps reduce this selective pressure and decreases the odds of HT-weeds evolving. Note that these strategies apply to conventionally bred crops just as much as HT-crops, because herbicides are used on both.

Insect Resistance Management Plans

The soil bacterium Bacillus thuringiensis produces an insecticidal protein called Bt. Farmers have used this natural insecticide for decades to control insect pests. Bt is also used in organic farming because it is not synthetic. Crops such as corn and potatoes have recently been genetically engineered to produce insecticidal Bt proteins in their own cells. Bt-corn is widely grown in Canada, and reduces crop damage from the European corn borer (ECB) and corn rootworm (CRW). (For more information, see Table 1 in the backgrounder about GM and GE crops.) If insects are repeatedly exposed to only one kind of insecticide, whether it is sprayed on the field (conventional) or produced by the crop plants themselves (GE), they will almost certainly evolve resistance. Farmers who grow Bt-corn in Canada are required to follow an insect resistance management plan to help delay the development of insecticide-tolerant pests. The key aspect of these plans is the provision of a refuge in a field of Bt-corn. A refuge is an area of unsprayed non-Bt-corn that is planted beside the Bt-corn. This allows a population of insect pests to survive without any selective pressure to evolve insecticide resistance. They will mate with the neighbouring insects (in the Bt-corn) that may have evolved resistance and delay the development of a dominant resistant pest population.

Step Two: Health Canada Regulation - From the Field to the Table

When a company is ready to sell any GE food crop in Canada, it submits a pre-market notification to Health Canada and the detailed safety assessment is started. Analogous to the environmental safety assessment done by CFIA scientists, Health Canada scientists review the health safety data provided by the trait developer before approving a novel food for consumption. The following data categories are examined:

·         Technical details about the laboratory procedure used to create the GE food, including what new genes are expressed and how they were introduced into the plants.

·         Detailed analysis of the nutrient composition of the GE food (fatty acids, amino acids, carbohydrates, vitamins, minerals), and how it compares to the non-GE food.

·         Evidence that the GE food does not contain toxins resulting from the genetic engineering.

·         Evidence that the GE food does not contain allergens (proteins that cause allergic reactions) resulting from the genetic engineering.

·         Detailed comparison of the composition of the GE food and the related non-GE food to ensure that there are no changes in the levels of any undesirable substances, and that the GE food is safe to eat.

As mentioned earlier, the principle of substantial equivalence is used extensively during the health safety assessment. The GE food is compared to the related non-GE food to ensure that there are no unintentional changes in the nutrient composition, level of toxins or presence of allergens. Any food, whether it is GE or not, can pose a risk to some people. Many foods contain naturally occurring toxins or anti-nutrients at low levels, and some people are allergic or intolerant to certain food components, such as soy protein or wheat gluten. It is impossible to guarantee the absolute safety of any food.

Ensuring substantial equivalence means that approved GE foods are just as safe as their non-GE counterparts. In fact, PNTs and GE foods have been assessed more than any other crop plants and foods ever consumed.

Health Canada’s safety assessment follows the international standards outlined by the Codex Alimentarius Commission, which is part of the World Health Organization and the Food and Agriculture Organization of the United Nations. The Codex Alimentarius defines food safety and quality standards that are followed by 184 countries around the world.

Labelling Standards for GE Foods in Canada

You’re probably familiar with the nutrition labels that appear on packaged foods sold in Canada. These are mandatory labels to help consumers decide what foods to buy. Foods must also be labelled if they contain allergens like peanuts, soy or milk, or if the nutritional composition of a food has been changed. In general, food labelling is mandatory if there is a potential health or safety concern.

Since all GE foods sold in Canada have passed Health Canada’s detailed safety assessment, they are not considered to pose any health risks, so there are no requirements for mandatory labeling. However, food companies can voluntarily label their products to indicate if they contain, or do not contain, GE ingredients. Since these labels are voluntary, consumers who choose to avoid GE foods must look for labels that specify the absence of GE ingredients. Often, the “non-GE” labels appear on certified organic food, since genetic engineering is not allowed in organic agriculture (but remember that all crop breeding results in genetic modification). Corn and soybean ingredients are very commonly used in processed foods, and most corn and soybeans grown in Canada are genetically engineered. Therefore, if a processed food containing soy or corn ingredients is not labelled “non-GE” (or “non-GM” since the terms are often used interchangeably), then it most likely is.

Canada has defined rules for these voluntary labels. Some examples of these rules are: a single-ingredient food can be labeled as non-GE if less than 5% of the food source is not genetically engineered; foods can’t be labeled as non-GE if no GE varieties of that food actually exist; claims can’t be made unless they can be verified.

Voluntary labeling for GE foods is the standard in the United States as well, but that may soon change. Voters in California will decide in their 2012 fall election whether to adopt mandatory GE food labeling (they use the term GM). Those who want mandatory labels believe that people have a right to know how their food is produced. Those opposed argue that simply labeling foods, without public education about the science-based safety assessments of GE foods, would be confusing and misleading. The decision in California may trigger labelling changes across North America, for better or worse.

For More Information:

CFIA home page for PNTs (lots of detailed information in the links):

Health Canada’s home page for genetically modified foods (and links):

For a list of PNTs approved by CFIA, and the decision documents:

For a list of novel foods approved by Health Canada, and the decision documents:

Additional References:

The Cartagena Biosafety Protocol:

The Codex Alimentarius Commission:

Gene Flow, specifically related to GE crops:

Insect Resistance Management for Corn:

Canadian Voluntary Labeling Standard for GE Foods:

Homepage of the campaign for mandatory GM food labelling in California:

Links to articles about scientific opposition to mandatory labelling:

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