Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA

Updated May 3, 2023

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1. Introduction

1.1 Legal authority

"Seed" is defined in the Seeds Act as "any part of any species belonging to the plant kingdom, represented, sold, or used to grow a plant." Part V of the Seeds Regulations, "Release of Seed", sets out the regulatory requirements for both the confined and unconfined environmental release of seed. Seed that is not substantially equivalent to seed of that species that is already present in Canada, in terms of its specific use and safety for the environment and human health, is subject to Part V. Seed that is subject to Part V must be authorized before release into the environment.

This guidance document does not change the Seeds Regulations. Rather, this guidance explains how Part V of the Seed Regulations is applied.

1.2 Privacy

Any information provided to the Canadian Food Inspection Agency (CFIA) is subject to the Access to Information Act and the Privacy Act and will be protected in accordance with these acts. Information submitted to the CFIA may be made available to the public in accordance with these acts.

1.3 Purpose

Part V of the Seeds Regulations provides a mechanism to verify that the release of new plants does not have a significant negative impact on the Canadian environment, including human health through environmental exposure. This guidance provides information to assist proponents in determining whether a plant is considered to be a plant with novel traits (PNT) that is subject to Part V.

This guidance is supported by the rationale provided in the Rationale for updated guidance determining whether a plant is subject to Part V of the Seeds Regulations. Please refer to the glossary of terms in appendix 1 to familiarize yourself with the terms used in this guidance.

1.4 Scope

While the Seeds Regulations Part V encompasses all plants, including agricultural crops, trees, and plants released for non-agricultural uses, this guidance is focused on the environmental release of crop plants commonly used in agricultural systems (for example, field crops and horticultural crops). For plants with other intended uses (for example, forest trees, aquatic plants, new crop species and the release of plants into natural environments), proponents should contact the Plant Biosafety Office (PBO) at PBO@inspection.gc.ca for additional guidance.

Plants with novel traits require an authorization prior to release into the environment. The process for receiving an authorization is outside of the scope of this guidance. For information about the submission, assessment, and decision process for PNTs, refer to:

This guidance does not address the determination of whether or not a plant is a novel livestock feed or a novel food. Information on determining whether a plant is considered a novel feed or a novel food is available in the following documents:

2. Plants with novel traits

Plants with novel traits (PNTs) are plants into which 1 or more traits have been intentionally introduced, regardless of method, where:

  • the trait is new to cultivated populations of the species in Canada, and
  • the plant has a potential to have a significant negative environmental effect

If a plant meets only 1 of these criteria, it will not trigger regulation as a PNT under Part V of the Seeds Regulations. This guidance provides information on how to determine whether a plant meets this definition.

Part V of the Seeds Regulations, "Release of Seed", sets out the regulatory requirements for the environmental release of seed in Canada. Part V does not make distinctions between the various technologies that may be used in the development of a plant. This is a logical and product-based approach that places emphasis on the traits of the plant (that is, its observable or measureable characteristics), and its interactions with the environment when determining whether a plant is subject to Part V.

The CFIA continues to take a product-based approach to the oversight of PNTs intended for environmental release. To determine whether a PNT poses a risk to the environment and/or human health, the CFIA considers 5 environmental safety criteria:

  • weediness potential
  • impacts of gene flow to related plants
  • plant pest potential
  • impacts on non-target organisms
  • impacts on biodiversity

For a description of how these criteria are applied, see Appendix 2 – Environmental safety criteria.

3. Proponent responsibilities for determining if a plant is a PNT

It is the continued responsibility of the proponent to consider how an introduced trait or traits could impact the 5 environmental safety criteria and ultimately to determine whether their plant is a PNT. For all PNTs, it is the proponent's responsibility to notify the PBO and receive an authorization for release. Proponents must also notify the PBO if new information becomes available that would change their original determination of whether that plant is a PNT.

If there is reason to question a proponents' determination, the PBO may require a proponent to provide scientific justification for this determination, and ultimately satisfy the CFIA that their plant is not subject to regulation under Part V of the Seeds Regulations. The proponent may submit an appeal to the CFIA Complaints and Appeals Office if they believe that an incorrect conclusion has been reached.

4. Determining whether a plant is a PNT

4.1 Environmental safety of plants developed using conventional and gene editing breeding techniques

Based on breeding outcomes reviewed since the environmental release programs were launched in the late 1980s, and based on a history of safe use of plant breeding domestically and internationally, the CFIA foresees that almost all plants derived through conventional breeding will result in plants that are substantially equivalent to other plants of that species in Canada, with respect to their safety for the environment and human health. An exception is conventionally-bred plants with a newly developed or introduced commercially-viable herbicide tolerance trait (see section 4.2.2).

Based on this context, the CFIA does not foresee an outcome of conventional breeding where an authorization for environmental release would be required, other than in the case of herbicide tolerant plants.

It is the scientific opinion of the CFIA that gene editing technologies do not present any unique or specifically identifiable environmental or human health safety concerns as compared to other technologies of plant development. For this reason, gene-edited plants are regulated using a product-based approach, like any other product of plant breeding. Namely, it is the traits that a plant exhibits and whether these traits would have a significant negative impact on environmental safety that are used to determine whether a plant would be subject to Part V of the Seeds Regulations.

4.2 When to notify the CFIA prior to environmental release

The context described above outlines the CFIA's experiences and expectations using a product-based approach, including a proponent's ongoing responsibility to request and receive an authorization from the CFIA prior to environmental release of any PNT, or if new information about novelty and/or safety becomes available. Prior to any release into the environment (for example, field trials, seed production, commercial cultivation), the following guidelines apply:

4.2.1 New crop species and new uses are outside the scope of this guidance

As the scope of this guidance is focused on crops commonly cultivated in Canada, proponents are advised to contact the CFIA for additional guidance about other scenarios and uses if they intend to:

  • release or domesticate a new crop species
  • release plants into natural environments, or
  • develop traits in species that may have unique management considerations (for example, forest trees or aquatic plants)

4.2.2 Plants with a new commercially-viable herbicide tolerance trait (but no inclusion of foreign DNA) always require authorization

These plants always require an authorization from the CFIA. The CFIA offers a streamlined process for herbicide tolerant plants that do not contain foreign DNA. Proponents must submit the following to the CFIA:

  • summary information about the trait, including intended use
  • a description of how the trait functions at a biochemical level (for example, the mutation, gene and/or protein impacted and interactions with the herbicide), and
  • the herbicide tolerance management plan

The CFIA will review the herbicide tolerance management plan within 60 days to verify that it is suitable to address any negative impacts on the environment. If the plant is authorized for release, the authorization would include conditions that the herbicide tolerance management plan is implemented. The CFIA will also post a summary rationale of the decision.

4.2.3 Plants containing foreign DNA always require authorization

Regardless of the technique used to develop a plant, all plants that contain foreign DNA require an authorization from the CFIA prior to release. For gene-edited plants, the DNA that encodes gene editing machinery (for example, Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-associated (Cas) protein(s) and associated guide ribonucleic acids (gRNAs)) is considered foreign DNA if not removed through rounds of breeding and selection. If a gene-edited plant intended for environmental release still contains the DNA encoding this machinery within its genome, that plant requires an authorization.

4.3 Release of plants that are not PNTs

If a plant is not a PNT, then the plant is not subject to Part V of the Seed Regulations and therefore there is no requirement to notify the CFIA and receive an authorization prior to environmental release. The plant can be released in Canada, subject to any other applicable requirements (for example, authorizations for food and feed use, or variety registration).

Even when a plant is not a PNT, the Government of Canada expects that proponents will fully participate in available mechanisms that support transparency. Regardless of breeding method, transparency around the technologies used to develop a plant line enables producers and consumers to benefit from the technologies and production systems that best meet their needs. These mechanisms can include:

4.4 Assistance in making a novelty determination

While proponents are responsible for determining if a plant is a PNT, they may request a novelty determination from the CFIA at any stage of planning or development. The CFIA is available to provide advice on a case-by-case basis. Furthermore, the CFIA recommends that proponents contact the PBO in cases where there is limited historical knowledge and experience regarding the environmental safety of an intended new use and/or new crop species, or if there is a reasonable expectation that a new plant would negatively impact the environment.

The CFIA will review information provided by the proponent and respond with written advice regarding novelty determination. To uphold transparency and consistency, and for the benefit of all parties who may develop similar plants in the future, the PBO will also work with proponents to publish summaries of CFIA's novelty determination advice in a manner that protects privacy. For more information, contact the PBO at PBO@inspection.gc.ca.

4.5 Summary

In summary, the CFIA considers a plant to always be a PNT if it expresses a commercially-viable herbicide tolerance trait, and/or if it includes foreign DNA. Outside of these categories, the CFIA does not foresee significant negative impacts on the 5 environmental safety criteria for crop plants that are already grown in Canada, and does not expect to receive requests to authorize such plants. However, it remains the proponent's responsibility to notify the CFIA if the plant could have significant negative environmental impacts and be considered a PNT. Proponents are also expected to fully participate in mechanisms that provide transparency about non-novel products. The CFIA is available to provide advice to proponents regarding novelty determination.

The CFIA is committed to continuously improving guidance to reflect emerging trends and technologies. Up-to-date guidance and program design enables CFIA to uphold our mandate of minimizing and managing risks to Canada's plant resource base, in support of the current and future prosperity of the Canadian agricultural sector. This guidance will be updated as needed in the future to adapt to new information, to meet the needs of regulated parties for clear guidance, to account for familiarity with products in the marketplace, and to align with the programs delivered by other Canadian regulators.

Appendix 1 – Glossary of terms

Commercially-viable herbicide tolerance trait
Trait(s), new to the species, that convey herbicide tolerance to a degree that would be useful in agriculture for control of weeds without impairing the crop. This does not include cases where no new trait has been developed in the plant (for example, if a herbicide is added to the label for a crop that was already inherently tolerant to the herbicide). This also does not include cases where a herbicide tolerance trait has been introduced as a selectable marker but isn't expressed to a degree that it would offer protective value against a herbicide in an agricultural setting.
Conventional breeding
Breeding methods including the crossing and selection of plants, marker-assisted breeding, cell and embryo fusions, and chemical or radiation-based mutagenesis (see appendix 3 for a list of conventional methods of plant breeding).
Cultivated
The PBO interprets "cultivated" to mean "deliberately grown or planted by an individual." This means that seed multiplication plots and breeding lines are considered "cultivated."
Foreign DNA
DNA that is originally sourced from genetic sources outside the plant species and cannot be introduced into that plant species using conventional breeding methods.
Gene editing
Gene editing technologies refer to biotechnology tools that can be used to generate specific modifications to the genome of living organisms by adding, removing, or altering genetic sequences at precise locations.
Human health
In the context of this guidance, risk to human health is included in the overall consideration of environmental safety. This is not related to consumption as food, but rather to the risk to human health that could result from the release of seed, including via environmental exposures as may be experienced by field workers, or by those with environmental sensitivities.
New crop species

A species that has not been previously grown as a crop in Canada. Examples include:

  • the cultivation of a species previously found only in natural habitats
  • the cultivation of a domesticated plant species that has not been previously cultivated as a crop in Canada
New trait
As specified in section 108 of the Seeds Regulations, a trait is considered new to cultivated populations of seed if it was introduced into Canada after December 1996, when Part V of the Seeds Regulations came into force. If a trait is bred into a plant from germplasm (of the same species) cultivated in Canada prior to December 1996, or previously authorized by the PBO for use in a plant of the same species, then the trait is not new: the plant is not a PNT and is not subject to regulation under Part V of the Seeds Regulations.
Plant with novel trait(s)
Plants with novel traits (PNTs) are plants into which 1 or more traits have been intentionally introduced, regardless of method, where the trait is new to cultivated populations of the species in Canada and the plant has a potential to have a significant environmental effect.
Proponent
Any person proposing to release seed (for example the developer, breeder, or owner of a plant).
Significant negative impact
For the purpose of this guidance, a significant negative impact on 1 or more of the 5 environmental safety criteria would be an impact where a mitigating action is required, including, for example, through the preservation of agricultural tools that support environmental health. Mitigating actions include the use of stewardship practices such as a herbicide tolerance management plan, following conditions to limit environmental exposure, or withdrawal of the plant from a particular region. See Appendix 2 - Environmental safety criteria, for more information on how the CFIA considers whether a plant may have the capacity to have a significant negative impact on the environment.
Substantial equivalence
Plants are considered to be substantially equivalent to their counterpart(s) where there is no meaningful difference in the specific use and safety of the plant compared to plants of that species that have previously been grown in Canada. In considering whether a plant is substantially equivalent to its counterparts, consideration must be given to the plant's capacity to impact the 5 environmental safety criteria: weediness potential, impacts of gene flow to related plants, plant pest potential, impacts on non-target organisms, and impacts on biodiversity.
Trait(s)
The observable or measurable characteristic(s) conferred to the recipient plant by specific genetic changes.

Appendix 2 – Environmental safety criteria

This appendix provides additional details on how the environmental safety criteria are applied. These details are provided to explain how the CFIA considers whether a plant may have the capacity to have a significant negative impact on the environment. As outlined in section 3 – Proponent responsibility for determining if a plant is a PNT, it is the proponent's responsibility to consider the environmental safety criteria that are set out in Part V and explained below. If the proponent determines that the plant is a PNT based on their evaluation of these criteria, it is their regulatory obligation to notify the CFIA.

When the CFIA assesses the capacity of a plant to negatively impact the environment, the CFIA compares the plant to its counterpart(s) already present in the Canadian environment. As outlined in Part V of the Seeds Regulations, this environmental safety assessment is based on the following 5 criteria, with examples of considerations for each:

  1. Potential for the plant to become a weed of agriculture or be invasive of natural habitats
    • the likelihood and persistence of herbicide-tolerant volunteers
    • the likelihood that continued application of the same herbicide in subsequent rotations may increase selection pressure for herbicide-tolerant weeds
    • the capacity of the trait to enhance weedy characteristics in the plant (for example, increase seed production, change in germination rate, change in seed dormancy, etc.)
  2. Potential consequences of gene flow to sexually compatible related species, where gene flow may alter how the hybrid offspring interacts with the environment
    • the likelihood that hybrid offspring are viable and can become established
    • the likelihood that the hybrid offspring may have negative impacts on any of the other environmental safety criteria (that is, be more weedy or more invasive, alter plant pest potential, have impacts on non-target organisms, have impacts on biodiversity)
  3. Plant pest potential
    • the capacity of the trait to affect other pathways in the plant, including those involved in plant defence against pests
    • the capacity of the trait to result in the creation or enhancement of a reservoir for a plant pest
  4. Potential impact of the plant or its gene products on non-target species, including humans
    • the capacity for the gene product (for example RNA, protein) that confers the trait of interest to act as a toxin or allergen, and adversely impact non-target species, including humans as workers or bystanders
  5. Potential impact of the plant on biodiversity
    • the risk of environmental impacts related to trait, which could include:
      • a reduction in local plant biodiversity that adversely impacts other species in the food web
      • persistence or spread of the plant outside its current cultivation areas that adversely impacts biodiversity in a natural, unmanaged environment
      • field-evolved pest/weed resistance to the trait, that would have downstream pest/weed management consequences and related biodiversity impacts
      • consequences of the release of the biomolecules into the environment (air, soil, water) during cultivation

These 5 criteria serve as a framework that allows safety assessors to consider the potential for significant negative impacts posed by a plant to the Canadian environment. This is accomplished through consideration of:

  • characteristics of the plant, including ability to outcross to related species
  • characteristics of the trait(s)
    • phenotypic characteristic(s) conferred to the plant by specific genetic changes
  • receiving environment
    • the geographic distribution or cultivation area of the plant and related species in Canada
  • interactions among the 3 considerations above

The characteristics of the plant will dictate the applicability of the 5 environmental safety criteria. For example, the potential for and consequences of gene flow will only apply to plants with sexually compatible relatives in Canada. Thus, the consequences of gene flow need not be considered for species such as corn and soybean, which do not have relatives in Canada.

Appendix 3 – List of conventional methods of plant breeding

This is a non-exhaustive list of methods which were, at the minimum, researched as potential tools for plant breeding. The majority of these methods have been adopted by proponents and are used in current breeding programs. Detailed descriptions and examples of the listed techniques can be found in van de Wiel et al., 2010. Traditional plant breeding methods. Wageningen UR Plant Breeding, Wageningen. Report 338.

Techniques for overcoming reproductive barriers

  • Bridge cross
  • Pollination through use of sub- or supra-optimal stigma age, or suboptimal conditions
  • Chemical-facilitated pollination
  • Pollination using pollen mixture treatments
  • Pollination through treatment and/or manipulation of the style
  • In vitro pollination
  • In vitro culture of excised ovaries
  • In vitro culture of excised ovules
  • In vitro culture of excised embryos (embryo rescue)
  • In vitro fertilization

Techniques for chromosome and genome manipulation

  • Haploidization
  • Genome doubling, polyploidization
  • Production of alien addition or substitution lines
  • Chromosome translocation breeding
  • Manipulation of chromosome pairing in meiosis
  • Mutagenesis (via chemical mutagens or ionizing radiation)
  • Cell fusion (that is, somatic hybridization)
  • Partial genome transfer

Other plant breeding techniques

  • Interspecific grafting
  • Hybrid variety production
  • In vitro tissue culture
  • Sex expression in monoecious or dioecious species
  • Apomixis
  • Marker-assisted breeding (MAB)
  • Targeting Induced Local Lesions IN Genomes (TILLING)
  • Cell sorting
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