Download the PDF – Approval and Regulation of New Genetically Modified/Genetically Engineered Plant Varieties in Canada

Approval and Regulation of New Genetically Modified/Genetically Engineered Plant Varieties in Canada

To deal with the products of genetic engineering, or genetically modified organisms (GMOs), the Canadian government created a new term and category called novel foods or plants with novel traits which includes genetic engineering among other technologies. The CFIA states, "This term covers products that have not been previously available for sale in Canada, have been substantially modified, or are produced by a new process."

GMOs are considered “novel foods” and “plants with novel traits” or PNTs.

Before a new GMO can be grown and sold as a crop in Canada it first must be
1. approved for food safety by Health Canada, and
2. approved for feed safety and unconfined environmental release by the Canadian Food Inspection Agency (CFIA).
Commercial seed varieties (whether GMO or not) must be registered.
1. For most crop kinds, the variety undergoes independent field trials to demonstrate that it meets merit criteria. A Recommending Committee of experts on that crop reviews the results and may recommend registration if the variety meets or exceeds the performance standard for the crop. The CFIA then registers the variety based on this recommendation.
2. Vegetable seed or commercial corn seed do not require variety registration.
The federal government is planning to change the seed regulations to eliminate the field trial and recommending committee process for soybeans and all forages.
Companies that sell GMOs normally patent the relevant genes, or obtain licenses to use patented genes from the patent owner. Companies that sell new non-GMO crop varieties usually seek and obtain plant breeders rights (PBR). Obtaining gene patents and PBRs are separate processes outside of the GMO regulatory process, but once these rights are given they affect the dynamics of the seed system.

Canada’s Regulatory Approach

1) Reviews the product, not the process: Plants in Canada are regulated on the basis of the traits expressed and not on the basis of the method used to introduce the traits.

2) Safety reviews are based on concepts called "familiarity" and "substantial equivalence."

o Familiarity is defined as “our knowledge of the characteristics of a plant species and experience with the use of that species in Canada.”

o 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.”

3) Testing: no long term testing or monitoring is required, and there is no independent testing; instead the government relies on data provided by corporations.

Patenting Genes

Canada does not permit patenting of higher organisms; however, it does permit genes to be patented. The 2004 Supreme Court of Canada decision in Schmeiser v. Monsanto determined that if a gene-patented plant occurs in a farmer’s field without the patent-holder’s permission, regardless of how it got there and regardless of whether the farmer made use of the trait conferred by the gene, the farmer is guilty of patent infringement. To avoid legal action by patent holders, therefore, many farmers purchase gene-patented seed, pay royalties and agree to the company’s terms and conditions outlined in Technology Use Agreements or other contracts that prohibit saving seed for planting. As a result, farmers must purchase new seed every year.

Plant Breeders Rights

The Canadian Plant Breeders Rights (PBR) Act conforms with the International Union for the Protection of New Varieties of Plants (UPOV) 1978 standard. It grants property rights to the owners of new plant varieties, giving them18 years of exclusive rights to collect royalties on seed when it is sold. Under UPOV ’78, a seed owner cannot hold both patent rights and plant breeders’ rights on the same variety.

The federal government is expected to attempt to amend the PBR Act and related laws and regulations to conform with the UPOV 1991 standard. This newer regime confers greater rights on the PBR owner for a longer term, and makes it more expensive and difficult — in practice, impossible – for farmers to save and replant seed. It also permits simultaneous patent and PBR rights on the same variety. UPOV ’91 allows PBR owners to collect royalties at any point, including on the sale of the harvested crops grown from their seed varieties. Royalty collection rights are granted for at least 20 years under UPOV ’91.

Variety Registration

Vegetable seeds used by home gardeners and market gardens are not covered by the variety registration system.

Before 2009, all new varieties of commercial crops except for corn were registered using the Part I process (described below). Corn has been exempt from variety registration because most growers have adopted hybrid seed. In 2009, the variety registration system for commercial crops changed, and the three tiers (Part I, Part II and Part III) were introduced. Crop kinds can now be moved from Part I to Part II or Part III by amending the Seeds Act regulations. In 2009, potatoes were moved to Part III.

Part I – The new variety must undergo two or three years of field trials, depending on the crop kind, conducted by an independent third party (usually Ag Canada or a university). Data from the field trials is submitted to the Recommending Committee, a group of experts on that crop. The Recommending Committee reviews the data and evaluates the variety on specific criteria such as agronomic performance, disease resistance and quality. Since 2009, merit can be determined on the basis of performance on as little as one criterion. If the variety meets or exceeds the performance of a reference variety, it is considered to have merit, is eligible for registration and the Recommending Committee may recommend that it be registered. If the variety is recommended, the seed developer may submit its registration information, and the CFIA can register the variety.

Part II – requires field-testing and submission of data to the Recommending Committee. There is no merit requirement and the data may not be published, as it is considered confidential business information. Varieties with inferior performance can be registered under Part II. Safflower is the only crop kind in Part II.

Part III –There is no requirement for merit or field testing. A seed breeder or seed breeding company can apply to have a new variety registered simply by submitting basic information about the variety to the CFIA. The CFIA has the authority to deny registration only if it considers the new variety a threat health or safety. Potatoes and sunflowers (non-ornamental) are in Part III. The proposed amendment to the regulation would place all forages and soybeans into Part III as well.

Canadian Food Inspection Agency (CFIA)’s Role

Assesses environmental impact and livestock feed safety
Responsible for Seeds Act, Plant Protection Act, Feeds Act, Fertilizers Act, Health of Animals Act and Regulations, Food & Drugs Act and Novel Foods Regulations

The CFIA is the lead agency responsible for regulating genetically engineered plants or "plants with novel traits" for environmental safety under the Seeds Act. It grants approval for field trials of GMO crops during their development and for commercial growing (unconfined release). The CFIA also approves crops for use as animal feed under the Feeds Act and Regulations. The CFIA enforces food safety standards through inspection and monitoring activities and also provides consumer information which generally supports the current policy bias toward allowing corporations to self-regulate their operations. There seems little recognition of the inherent conflict of interest that is evident in allowing a self-interested corporation to self-regulate.

Health Canada’s Role

Assesses food safety for human consumption
Responsible for Food and Drug Act and Novel Foods Regulations

Health Canada is responsible for assessing the human health safety of genetically engineered foods as well as the safety of veterinary drugs, pharmaceuticals, pesticides and cosmetics.

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

For Novel Foods from GMOs it examines the following: characterization of derived line; genetic modification considerations; history of organism; dietary exposure; nutritional considerations; toxicology considerations; allergenicity considerations; and chemical considerations.

Environment Canada’s Role

Responsible for the Canadian Environmental Protection Act

Environment Canada plays a small role, and only regulates products that fall outside the responsibilities of other departments (genetically modified animals, for example)

What are GMOs?

Genetically modified organisms contain genes altered by using molecular processes to manipulate genes and genomes, a process called genetic engineering (GE). One of the most common GE technologies used to make GM crops is recombinant DNA, which takes DNA from several sources, often different species, to create novel DNA sequences with desired characteristics that do not occur naturally in the host organism. The `recombined DNA` with its desired trait activated is then inserted into the host, and the genetically modified organism is created.

The result is that completely new (exotic) genes can be created, and that new genetic material can be transferred between entirely unrelated species. For example, genes from a soil bacterium (Bt) known to have insecticidal properties have been put into the DNA of corn, which turns every cell in the plant into a factory for making its own insecticide. The technology enables science to cross the species barrier – a natural barrier to genetic exchange between unrelated species. This has never happened before – has never been done before – and cannot be achieved through traditional plant breeding techniques, including hybridization. Essentially, therefore, genetic engineering can introduce into food crops genes that have never before been part either of the human diet or of the ecological system where the crop is grown.

References:

NFU Backgrounder on changes to the Variety Registration System. http://www.nfu.ca/story/government-ignores-concerns-variety-registration-change-and-plows-ahead-anyway

Regulating Genetic Engineering… for Profit. Lucy Sharrat. Polaris Institute, 2002. http://cban.ca/content/download/173/1078/file/Guide%20to%20Regulation%20of%20GE.pdf

Guidelines for the Safety Assessment of Novel Foods. Health Canada, Accessed May 10, 2013 http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/nf-an/guidelines-lignesdirectrices-eng.php

Frequently Asked Questions – Biotechnology and Genetically Modified Foods. Health Canada. Accessed May 10, 2013. http://www.hc-sc.gc.ca/fn-an/gmf-agm/fs-if/faq_1-eng.php#p2

Genetically Modified Organisms. Environment Canada. Accessed May 10, 2013. http://www.ec.gc.ca/inre-nwri/default.asp?lang=En&xml=E8A9C49D-9F73-4EC2-90BB-F4C3FDF49A3F

Acts and Regulations under CFIA administration – http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/eng/1299846777345/1299847442232

Acts and Regulations under Health Canada administration – http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-lois-eng.php

Acts and Regulations under Environment Canada administration –http://www.ec.gc.ca/default.asp?lang=En&n=48d356c1-1