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Canada: Crops / Food

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Lightly Regulated

Agricultural products with novel traits and foreign DNA, derived from genetically modified crops and food, are regulated regardless of the process used to genetically engineer the plant. Crops developed via gene editing are not subjected to additional regulations.

Canada adopted guidelines in May 2023 on crops developed through gene-editing and other New Breeding Techniques (NBTs), regulating them in the same limited way as conventional crops. No labeling is required for almost all crops grown using NBTs. According to the government:

”Plant breeding innovations allow new plant varieties to be developed more effectively and efficiently than through conventional breeding. This can benefit farmers and consumers by providing them with access to plants and seeds that are both safe for humans, animals, and the environment. These varieties can also be more resistant to extreme temperature, precipitation, and insects, helping us adapt to climate change, feed a growing population and keep food costs down for consumers.”

Three products developed using NBTs have been commercialized under the new regulations.

Genetically modified crops (GMOs) will continue to require a pre-market safety evaluation based on restrictive regulations adopted in 2006 that apply to agricultural products with novel traits and foreign DNA (GMOs). Any plants, food or feed that contain novel traits require environmental and safety assessments to be approved, limiting Canada to just a few approved GMO crops.

In part to protect organic crop certification, the Canadian Food Inspection Agency announced the creation of THE industry-managed Seeds Canada Canadian Variety Transparency Database to make it clear which seeds are and are not organic. While that database is voluntary, it will be overseen by a Steering Committee on Plant Breeding Innovations Transparency, and will engage in ongoing discussions with farmers and the public. 

The 2023 revisions concluded a multi-year evaluation. Health Canada classifies five categories of food that no longer must be individually assessed as novel foods, and so will not require pre-market safety assessments, stating that “their safety is already consistently well characterized’’:

  • Foods derived from plants with genetic modifications that do not alter an endogenous protein in a way that introduces or increases similarity with a known allergen or toxin relevant to human health;
  • Foods derived from plants with genetic modifications that do not increase levels of a known endogenous allergen, a known endogenous toxin or a known endogenous anti-nutrient beyond the documented ranges observed for these analytes in the plant species;
  • Foods derived from plants with genetic modifications that do not have an impact on key nutritional composition and/or metabolism;
  • Foods derived from plants with genetic modifications that do not intentionally change the food use of the plant; and
  • Foods derived from plants with genetic modifications that do not result in the presence of foreign DNA in the final plant product.

The Council of Canadian Academies (CCA) is reevaluating the potential use of gene editing to control pests such as mosquitoes and rodents. At the request of Health Canada’s Pest Management Regulatory Agency, CCA formed an expert panel in 2022 to examine the scientific, bioethical, and regulatory challenges associated with the use of gene-edited organisms and technologies, including gene drives for pest control. 

Currently Canada pest control products are regulated under the Pest Control Products Act and requirements for approval are well established. The Canadian government has seen the potential to use gene-edited organisms (e.g. mosquito vectors, agricultural pests) in pest control applications. The chair of the CCA is leading a multidisciplinary group with expertise in molecular biology and genetics, ecology and disease vectors, bioethics, agriculture, science and risk communication, and regulation and governance to answer the following question: “What are the scientific, bioethical, and regulatory challenges regarding the use of gene-edited organisms and technologies (e.g., CRISPR) for pest control?” 

Products/Research (partial list as many products are in development)

  • Commercialized Improved alfalfa, 2017: US company Calyxt developed alfalfa with enhanced forage quality for livestock. In 2019 field trials were conducted, and the product is expected to hit the market in 2023. 
  • Commercialized Mustard greens with decreased bitterness, 2022: US company Pairwise developed a knock-out mustard green using CRISPR-Cas12a, which results in stable reduction in pungency.
  • Commercialized Non-browning apple, 2015: Arctic Apple developed by Okanagan Specialty Fruits using RNA interference, a New Breeding Technique (NBT). Arctic Golden, Granny Smith and Fuji apples are approved and Galas are in development. 
  • Commercialized Non-browning potato, 2016: US company Simplot developed a non-browning potato using the New Breeding Technique RNA interference that was approved for sale in Canada in 2016.
  • Approved Easily digestible corn, 2020: Pioneer Hi-Bred Canada Company produced their ‘Next Generation Waxy corn’ using CRISPR to increase amylopectin levels. This will increase the digestibility and allow the starch to be absorbed more quickly. 
  • Approved Herbicide-tolerant canola, 2016: Cibus, a US company, used a gene editing technique called oligonucleotide-directed mutagenesis (ODM) to develop an herbicide-resistant canola that was approved in 2013. Field tests were conducted in 2015.
  • Research Salt-resistant rice, 2020: Agrisea, an ocean agriculture startup, developed rice that can be grown in the ocean.

Regulatory Timeline

2022: Health Canada determines that crops developed via gene editing will not be subject to regulation requirements imposed on GMOs and will not be labeled. 

2022: USDA Secure rule is implemented

2018: Canada and 12 other nations, including Argentina, Australia, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”

2011: The Food and Drug Regulations amended.

2005: Adoption of GMO regulations

2004: The Voluntary Labeling and Advertising of Foods that Are and Are not Products of Genetic Engineering adopted.

1985: Canada passes Food and Drugs Act, Feeds Act and Seeds Act, which together form the regulations for food, feed, and plants.

NGO Reaction

Canada Organic Trade Association (COTA) says Canada’s relaxed seed guidelines are a “step backwards”.  “These seeds have never been introduced into nature,” said executive director Tia Loftsgard, demanding further studies.

CBAN, consisting of 15 groups — Canadian Organic Growers, Council of Canadians, National Farmers Union, as well as several provincial organic or ecology groups and organizations opposing GMOs — stated it is ‘’shocked that the minister of health has committed to corporate self-regulation of these gene-edited foods’’.  

The National Farme’s Union (NFU) of Canadian family farmers launched a campaign in May 2023 to encourage the government to rollback the new regulations. It opposes the reforms, it says, because “private companies decide if their own products are safe for the environment — and put them on the market without revealing they are gene-edited.” The NFU petition says: “Farmers will be the ones to pay the cost of unknowingly planting gene edited seed that is not accepted in a sensitive market. Canada’s reputation as an exporting country will be damaged if customers cannot trust that we are providing full disclosure on the products we sell.”

In 2022 Martin Caron, president of the Union of Agricultural Producers (UPA) called on the government to require labeling. Knowing which seeds are modified is “essential information if we are to continue to meet the demands of consumers who do not wish to consume these products,” he said.

In 2020 CBAN released a report: Genome Editing in Food and Farming: Risks and Unexpected Consequences, in which the organization states that gene-editing leads to off-target effects. The report furthermore states that these effects are not well documented and there are no protocols for detecting them.

NGO’s, led by the ETC Group (an international organization based in Canada), consider synthetic biology and gene editing to be “extreme genetic engineering” and have extensively campaigned against biotechnology in Canada and elsewhere.

Additional resources

Last updated: 04/08/2023

 

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

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Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Ecuador101010
Norway666
Africa555
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
Switzerland555
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.