Canada regulates products derived from biotechnology processes as part of its existing regulatory framework for “novel products.” The focus is on the traits expressed in the products and not on the method used to introduce those traits. The Canadian Food Inspection Agency (CFIA) is responsible for regulating genetically modified (GM) plants and approving GM feed for animals. Health Canada is mandated to assess the safety of foods for human consumption, including genetically modified organisms (GMOs) in foodstuff, and for authorizing them to be sold in Canada. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern.
Canada is the third largest producer of genetically modified organisms (GMOs) in the world. It is one of the largest producers of GM canola oil and other GM crops include maize, soybean, and beet.
In 1993, the Canadian government established the Federal Regulatory Framework for Biotechnology. This framework resulted from an agreement between “federal regulatory departments on principles for an efficient, effective approach for regulating biotechnology.” The Framework established that, rather than creating new regulations, novel products produced through biotechnology will be regulated under existing regulations that cover traditional products. The motive behind the Framework was to avoid the creation of a separate agency and separate legal framework for the regulation of biotechnology and to avoid duplication among regulatory agencies.
In Canada, GMOs used either as food or animal feed must be approved before entering the market. The approval process is based on numerous regulations that are enforced by Health Canada for foods, the Canadian Food Inspection Agency (CFIA) for seeds and livestock feed, and Environment Canada “for new substances intended for environmental release.” Approvals for GMOs are required for both locally produced and imported products. As of 2012, over eighty-one genetically modified foods had been approved by CFIA.
Canada’s regulatory approach is essentially to review products rather than processes. In other words, the focus is on the traits expressed in the products and not on the method used to introduce those traits. This approach applies to both traditional breeding methods and genetic engineering. As noted by Professor Eric Montpetit:
…the principle behind this so called product-based approach entails channelling all products, whether they are genetically modified or not, through a single risk management system. Since existing acts and regulations already provide for effective risk management systems, the product-based approach does not require any major legislative change.
Unlike other countries, “Canada relies on the concept of novelty to trigger regulatory oversight, thereby enabling the regulation of a wider array of novel seeds or foods.”
II. Public and Scholarly Opinion
A. Public Opinion
Public opinion polls have consistently shown that a large majority of Canadians are concerned about GMOs. According to a 1999 Environics poll, 80 percent of Canadians want GM foods to be labeled. However, some assert that the polls are misleading since most consumers do not have a well-developed view of the products. Moreover, as press attention on GMOs has declined so has public opposition to them. According to a 2007 report, “[c]ompared to 29 OECD countries, Canadians see the least amount of media reporting on GMOs.” In a more recent poll, it was shown that “76 per cent of respondents said the federal government has not provided them enough information to make an informed decision on GM foods. Another nine per cent said they’d never even heard of GM foods.”
A recent controversy over GM foods related to the development of a genetically modified apple that resists browning by a British Columbia company. The apple has been submitted to the CFIA for approval.
B. Scholarly Opinion
According to one commentator “the official view in government is that transgenic organisms are not really all that different form non-GM food and crops.” This view is seen as being based on a “purely scientific assessment, backed by international expert consultations” and it is argued that it “should set the context for any policies dealing with GMOs.”
In 2001, the Royal Society of Canada (RSC), a senior national body of pre-eminent scholars, scientists, and artists published a report that contained “substantive critiques of Canadian regulatory processes and scientific capacity and concluded with 53 recommendations to address issues in four areas: fundamental policies and principles; specific regulations and guidelines; the regulatory process itself; and scientific capacity for the regulation of food biotechnology.”
In 1999, a Biotechnology Advisory Committee (CBAC), an expert panel advising the Government of Canada, was set up to assess the regulation of GM foods between 1999 and 2003.
Some of the criticisms noted by scholars in respect to Canada’s regulatory framework include: “the perception of undue industry influence and the appearance of potential conflicts of interest” of the CFIA; lack of transparency regarding the scientific assessment procedure and the approval and evaluation process; lack of independent “peer reviews and scientific risk assessments;” heavy reliance on data and information provided by the biotech companies themselves “in making its scientific assessment;” and concerns about the application of the substantial equivalence standard by CFIA and Health Canada “for evaluating new products derived from biotechnology.”
III. Structure of Pertinent Legislation
Health Canada and the CFIA are both mandated to evaluate the safety and nutritional value of genetically modified foods released in Canada.
Genetically modified (GM) or genetically engineered (GE) foods are primarily regulated by the Food and Drugs Act and its subordinate regulations. Health Canada is responsible, under the above legal framework:
for provisions related to public health, food safety and nutrition. Through science-based regulation, guidelines and public health policy, as well as health risk assessments concerning chemical, physical and microbiological contaminants, toxicants and allergens in the food supply, Health Canada works to protect the health and safety of Canadians. Health Canada also conducts pre-market evaluations to assess the safety and nutritional adequacy of novel foods proposed for sale in Canada, including foods derived from biotechnology.
Under Canada’s regulations, GE and GM foods are classified as one class of “novel foods.” Health Canada “regulates the sale of novel foods in Canada through a pre-market notification requirement which is specified under Division 28 of Part B of the Food and Drugs Regulations.”
The CFIA “is responsible for regulating the environmental release of a plant with a novel trait (PNTs).” This mandate is authorized through the following laws and regulations: the Plant Protection Act, Plant Protection Regulations, the Seeds Act and Seed Regulations (Part V).
IV. Restrictions on Research, Production, and Marketing
The development and planting of PNTs for research purposes is overseen by the CFIA’s Plant Biosafety Office (PBO). The PBO evaluates applications for confined research field trials and sets out the rules and conditions for how they are to be conducted. These confined research field trials of PNTs are assessed by government scientists to ensure that the trials do not endanger the environment. Stringent conditions are placed prior to conducting a confined research trial and developers are required to provide the government evaluators with “information about the plants (such as where they are being grown and the procedures being used) and must also work with the CFIA both during the field trial and after harvest.”
Before a GMO can be released into the environment more generally or sold for human consumption it must go through an authorization process as outlined below. The CFIA is mandated to assess GM plants and authorize their release into the environment. Health Canada, on the other hand, authorizes the sale of GM foods for human consumption.
V. Restrictions on Releasing Organisms into the Environment
As noted above, the CFIA is responsible for regulating GM plants and approving GM feed for animals. Therefore, the CFIA is largely responsible for the regulation of the environmental release of PNTs. This oversight is conducted under the authority of the Plant Protection Act, Plant Protection Regulations, the Seeds Act, and Seed Regulations (Part V).
The CFIA’s responsibilities are performed through “an assessment of the GM plants’ impact on the environment and biodiversity, including assessing the possibility for gene flow and impact on non-target organisms, as well as ensuring the safety of livestock feed.”
The first step in the approval process requires the applicant to provide scientific data which includes information on the “nature of the novel trait, its stability in the plant, all test data pertinent to environmental and human risk assessment; and protocols that address preventing the establishment and spread into the environment of the genetic material, as well as monitoring and contingency plans to minimize any adverse effect of an accidental movement outside the confined release site.”
As stated by Thomas Moran, Nola M Ries and David Castle, in assessing a plant with a novel trait,
the regulations require consideration of “all relevant matters, including […] the potential impact on and risk to the environment, including the potential impact on and risk to human health, posed by the proposed release” of a seed, including a seed with novel traits. The environmental and human health risks associated with release (ranging from minimal to unacceptable risk) must be assessed, which requires evaluation of scientific data and specialized knowledge. The regulations give authority to reject, approve and impose conditions on the release of seeds.
The CFIA applies the principle of substantial equivalence when comparing the characteristics in the novel food with its “conventional counterpart” in respect to its “molecular, compositional, toxicological and nutritional makeup” In other words, a product will be approved if it is substantially equivalent to its conventional counterpart. This has caused significant controversy since some critics believe the standard is a “decision-threshold standard in the decision-making process, rather than as a safety standard.”
Canada does not have a biosafety framework to track GMOs released into the environment or the food production system.
VI. Restrictions on GMOs in Foodstuffs
A. Safety Assessment
Health Canada has the mandate to assess the safety of foods for human consumption, including GMOs in foodstuff, and for authorizing them to be sold in Canada. It does so in accordance with the Food and Drugs Act and its regulations. Health Canada’s process for assessing the safety of GM foods follows a “similar pattern” to the CFIA’s assessment process explained above. According to Division 28 of Part B of the Food and Drugs Regulations (Novel Foods), manufacturers and importers “who wish to sell or advertise a GM food in Canada, must submit data to Health Canada for a pre-market safety assessment.” This safety assessment “provides assurance that the food is safe when prepared or consumed according to its intended use.”
The safety reviews are based on the concepts of “familiarity” and “substantial equivalence.” Familiarity is defined as “our knowledge of the characteristics of a plant species and experience with the use of that species in Canada.” Substantial equivalence is defined as “the equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.”
According to Health Canada, it is a “seven to ten year process to research, develop, test and assess the safety of a new GM food” before it can be approved.
Since the government relies on scientific data provided by corporations there does not appear to be requirements for independent testing to be conducted. There is also no long-term testing or monitoring of approved products. The assessment and testing process is described by Health Canada as follows:
1. Pre-submission consultation
Health Canada encourages proponents to consult with the Novel Foods Section of the Food Directorate in advance of notifying a GM food to Health Canada for safety assessment. This provides the opportunity for regulatory process requirements to be clarified and for any specific safety issues to be raised.
2. Pre-market notification
When the product’s proponent believes it has sufficient information about the safety of a GM food to address Health Canada’s criteria, a submission is made to the Novel Foods Section. This office coordinates a full safety assessment of the product, which involves a rigorous scientific evaluation by Health Canada scientific evaluators. These criteria are described in Health Canada's Guidelines for the Safety Assessment of Novel Foods.
3. Scientific Assessment
Scientific evaluators, with individual expertise in molecular biology, toxicology, chemistry, nutritional sciences and microbiology, assess the following:
· development of the modified organism, including the molecular biological data that characterizes the genetic change;
· composition of and nutritional information about the GM food compared to a non-modified counterpart food;
· the potential for production of new toxins in the food;
· the potential for causing allergic reactions;
· microbiological and chemical safety of the food;
· the potential for any unintended or secondary effects;
· key nutrients and toxicants; and,
· major constituents (for example, fats, proteins, carbohydrates) and minor constituents (for example, minerals and vitamins).
4. Requests for additional information
If Health Canada evaluators find that any of the information provided about a GM food is insufficient, further documentation is requested from the proponent of the submission. Health Canada does not give any further consideration to the submission until all requested material is provided and deemed to be scientifically valid.
5. Summary report of findings
Once evaluators have completed their assessments, they summarize their findings and recommendations in a report.
6. Preparation of food rulings proposal
Once the evaluation of the product is completed, a Health Canada Food Rulings Proposal is prepared. This proposal is reviewed by senior staff (Directors and Director General) in the Food Directorate to ensure that all issues have been addressed. Once this has been done, a decision is made whether or not to approve the product.
7. Letter of no objection
If a product has successfully completed the evaluation process, and the other regulatory approvals such as environmental and feed safety are in place, a “Letter of No Objection” is sent to the product proponent. This letter indicates that the product can be sold in Canada for the intended uses, as listed in the submission, and whether there are any restrictions or requirements associated with the Health Canada decision.
8. Decision document on Health Canada Web site
A decision document, describing the novel food and summarizing the safety information used to determine its safety as a food, is posted on the Novel Foods and Ingredients page of Health Canada’s Web site.
Health Canada and the CFIA have a joint mandate for federal food labeling policies under the Food and Drugs Act. Health Canada is “responsible for setting food labelling policies with respect to health and safety matters (i.e., nutritional content, special dietary needs, etc.). This applies to all foods, including foods that have been derived through genetic engineering.” The CFIA, on the other hand, “is responsible for the development of non-health and safety food labelling regulations and policies and enforcement of all food labelling legislation. The CFIA sets standards for Canadian food labels so that they will be truthful and not misleading.”
Advertising or labeling of products containing GMOs or derived through GE processes is largely voluntary in Canada. There have been three major public consultation processes since 1993 in Canada on the labeling of novel foods derived from genetic engineering. Based on these consultations, a set of guidelines for food importers and manufacturers was developed. The guidelines reflect a general consensus to
- require mandatory labelling if there is a health or safety concern, i.e., from allergens or a significant nutrient or compositional change (these decisions will be made by Health Canada), in order to inform consumers of the allergen or change;
- ensure labeling is understandable, truthful, and not misleading;
- permit voluntary positive labeling on the condition that the claim is not misleading or deceptive and the claim itself is factual; and
- permit voluntary negative labeling on the condition that the claim is not misleading or deceptive and the claim itself is factual.
Therefore, in Canada labeling is required “if there is a health or safety issue with the food which might be mitigated through labeling” (e.g., if the “nutritional value or composition has been changed or if an allergen is present”). This rule applies to all novel foods, whether GM or not. In respect to the labeling of the majority of GMOs, there is only “a national standard for the voluntary labelling of foods derived through biotechnology.”
VII. Liability Regime
According to health law experts Thomas Moran, Nola M Ries, and David Castle “Canadian jurisdictions have not enacted statutory compensation regimes for harms associated with GM crops, so liability flowing from GM activities must be assessed through the common law of torts.”
VIII. Judicial Decisions / Prominent Cases
One of the most well-known recent cases involving GMOs is Monsanto Canada Inc. v. Schmeiser, which largely involved property or patent rights in respect to GMOs. This case was a “patent infringement claim brought by [the agricultural biotech company] Monsanto against an arable farmer whose rapeseed crop had acquired its patented RT73 gene, either by wind drift and crosspollination or by any of a number of other unproved means.”
Prepared by Tariq Ahmad
Foreign Law Specialist
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Last Updated: 05/29/2014