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

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Table of Contents

1 Introduction

1.1 Purpose

This directiveFootnote 1 is intended to assist breeders, developers and importers of new plant lines ("proponents") in determining if their plant is regulated under Part V of the Seeds Regulations prior to its environmental release (i.e., whether a developer must notify the Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA) of his or her intent to release a plant into the environment).

1.2 Legal authority for the regulation of environmental releases of plants with novel traits

The Seeds Act, administered by the Plant Health and Biosecurity Directorate, CFIA, provides authority to regulate the quality, testing, inspection and sale of seed in Canada. "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 not substantially equivalent to seed already existing in Canada, such as plants with novel traits (PNTs).

1.2.1 Regulatory Exemptions

Part V of the Seeds Regulations states that the following seed is exempt from regulation:

  1. seed grown in Canada outside of containment before the coming into force of this Part (1996) in such a manner that the seed constitutes a distinct, stable population in the Canadian environment; or
  2. seed grown in containment in such a manner that there is no release into the environment of any genetic material from the plants derived from the seed; or
  3. seed that is derived from seed referred to in paragraph (a), or from seed in respect of which an unconfined release has been authorized by the CFIA and that is substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to seed of the same species, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.

1.3 Scope

This directive applies primarily to plants that were derived through conventional plant breeding techniques. Plants derived through recombinant DNA (rDNA) technology may be subject to requirements in addition to those outlined in this directive, for example, requirements related to posting notification of Canadian regulatory decisions on the Biosafety Clearinghouse.

Developers of rDNA plants are advised to contact the PBO prior to the environmental release of their plant in Canada.

This directive 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 from the following documents:

This directive does not specifically address the importation of PNTs. However, if a PNT has not been authorized in Canada for unconfined environmental release, its import may be subject to requirements under the Plant Protection Act. More information is available in D-96-13: Import Requirements for Plants with Novel Traits, including Transgenic Plants and their Viable Plant Parts.

2 Determining if a plant is a PNT and regulated under part V of the Seeds Regulations

2.1 Overview

Based on the interpretation of the exemption criteria given in Part V of the Seeds Regulations, the Plant Biosafety Office (PBO) defines plants with novel traits (PNTs) as plants into which one or more traits have been intentionally introduced, regardless of method, where:

If a plant meets only one of these criteria, it will not trigger regulation as a PNT under Part V of the Seeds Regulations. More detail on each criterion is provided in Section 2.3 of this document.

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.

If the trait is considered new, a developer must then determine if the plant has the potential to have a significant negative environmental effect. When assessing this potential, a proponent should obtain or produce data that compare the plant to an appropriate Canadian comparator line (or lines), in terms of:

If a developer finds that a new plant is different from an appropriate Canadian comparator line (or lines), based on any one of these five environmental risk criteria, then they must contact the PBO, because the plant may be a PNT and may be regulated under Part V of the Seeds Regulations.

If a developer is confident that a new plant is not significantly different from an appropriate Canadian comparator line (or lines), based on all five criteria, then they are not obligated to contact the PBO.

2.2 Responsibility for determining if a plant is a PNT

It is the responsibility of the proponent wishing to release a plant into the environment to consider whether or not their new plant is a PNT and to self-identify to the PBO when he or she has produced a product requiring authorization prior to release. The proponent may be a Canadian developer, owner or importer of a new plant line, variety or selection.

At any time, the PBO reserves the right to require a proponent to provide scientific justification for his or her determination, and ultimately satisfy the PBO that their plant does not trigger regulation under Part V of the Seeds Regulations.

In order to assist proponents in considering whether or not their new plant will trigger regulation and should be notified to the PBO, a template has been created that may be used for this purpose (Appendix 1). This template is provided as a guide, and its use is not mandatory.

A proponent is welcome to contact the PBO should he or she wish to confirm an interpretation that a plant is, or is not, regulated. When seeking confirmation from the PBO, the proponent should provide their rationale in writing, with references to supporting evidence wherever possible.

The PBO will respond with a letter providing an opinion based on the information provided and currently available knowledge.

Proponents may also wish to seek advice from independent experts.

Please note that any information provided to the PBO is subject to the Access to Information and Privacy Acts and will be protected in accordance with these Acts. Information submitted to the PBO may be made available to the public in accordance with these Acts.

2.3 Considerations when determining if a plant is a PNT

As mentioned in Section 2.1, there are two criteria in determining if a plant is regulated: its "newness," and its potential to have negative environmental impact.

2.3.1 Determination of a trait's "Newness"

Seed grown in distinct stable populations cultivated in the Canadian environment prior to December 1996 is exempt from regulation under Part V of the Seeds RegulationsFootnote 3.

Thus, if a new plant line or variety possesses a trait that has been observed in a population of the same species that was cultivated in Canada (grown by an individual as a crop, or grown in seed multiplication plots or in breeding trials), it would not be considered "new." If the frequency of such a trait in a population were to be increased through selective breeding, it would still not be considered "new" to the plant species in question. For example, the re-introduction of a trait through breeding with historical germplasm or heritage varieties is not considered "new."

However, if a quantitative trait were to be significantly changed until it is measured at levels far outside the range observed in cultivated populations of that species in Canada, it may be considered "new." It would be very difficult for the PBO to provide an explicit rule that would apply to all quantitative traits. For example, a twenty per cent increase in yield may not pose an environmental impact, whereas a twenty per cent increase in herbicide tolerance could raise such a trait to a level where stewardship plans are necessary. Given the wide variety of quantitative traits that would fall under this rule, it would not support the overarching objective of Part V of the Seeds Regulations-protecting the Canadian environment. Thus, plant breeders working with significant changes in quantitative traits are advised to apply section 2.3.2 of this document when determining if the PBO should be contacted regarding a new plant line, variety or selection with a significant change in a quantitative trait.

Possible sources of new traits include:

2.3.2 Determination of regulatory status of a plant with a "New" trait

In addition to being new to cultivated populations of the species in Canada a regulated plant, according to Part V of the Seeds Regulations, has a potential to significantly, and negatively, affect environmental safety. Proponents should consider the following criteria in determining if their plant is subject to Part V of the Seeds Regulations:

The CFIA also publishes biology documents, which provide background information on specific species, including biology, centres of origin, related species, potential for gene introgression from the plant into relatives, and details on the organisms with which it interacts. This information can serve as a guide when determining when a plant is regulated. A current list of biology documents that are available for public use can be found at: /English/plaveg/bio/dir/biodoce.shtml.

A number of examples of determinations of regulatory status for specific products can be found in the Appendices.

The PBO acknowledges that products of conventional plant breeding are, in the vast majority of cases, not likely to pose a risk to the environment. However, certain breeding objectives are likely to trigger regulation under Part V of the Seeds Regulations. Any plant breeders working to develop the following breeding objectives should notify and consult with the Plant Biosafety Office early on in their program:

  1. Any introduction of a new trait in the course of plant breeding that significantly and negatively alters the sustainable management of the crop. For example:
    1. Herbicide resistance/tolerance (where stewardship and/or volunteer management is important to delay the development of resistant/tolerant weeds)
    2. Insect resistance (where stewardship is important to delay the development of resistant insect populations)

    These types of traits would require co-operation between growers and extension personnel, in both private and public sectors, to promote sustainable agriculture.

  2. Any change to the plant that results in an accumulation of biologically active molecules (i.e. molecules that have an effect on living systems) that are intended for pesticidal, pharmacological or industrial uses.
  3. Any introduction of a new trait that may result in an increase in overall plant fitness and/or competitiveness in a crop for which Canada is a centre of diversity (e.g., sunflower (Helianthus annuus L.), Jerusalem artichoke (Helianthus tuberosus L.), Saskatoon berry (Amelanchier alnifolia (Nutt.) Nutt.), wild rye (Elymus canadensis L.), etc.)

Other traits that are not listed here may pose a negative environmental risk. When a developer is in doubt as to whether the trait of interest poses a risk of a negative impact on the environment, they should contact the CFIA for additional guidance.

3 Notification and information requirements for the environmental release of a PNT

Once a plant has been determined to be a PNT and subject to Part V of the Seeds Regulations, the proponent must obtain explicit authorization from the PBO prior to releasing the plant into the Canadian environment. There are currently two types of authorization for the release of a PNT: a confined environmental release, generally sought for research purposes; and an unconfined environmental release, generally sought prior to commercialization.

3.1 Confined environmental release for research purposes

A proponent may seek a confined environmental release (i.e., a confined research field trial) of a PNT. Confined research field trials are subject to strict terms and conditions, and are conducted to generate data required for regulatory purposes (e.g. to support an application for unconfined environmental release authorization, or for other research or analytical needs). Commercial use of material grown in field trials is prohibited. Please see Directive 2000-07, Conducting Confined Research Field Trials of Plants with Novel Traits in Canada, or contact the PBO directly for information on how to apply for and conduct a confined research field trial.

3.2 Unconfined environmental release

If a proponent seeks an unconfined environmental release of a PNT, an application must be submitted to the PBO. PNTs that are authorized for unconfined release may be grown for commercial purposes, and are generally not subject to terms and conditions of release, although stewardship plans or other conditions may apply. An environmental safety assessment will be conducted prior to making a decision on the authorization of an unconfined release.

Directive 94-08, Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits, outlines the environmental safety requirements that must be addressed in an application for unconfined environmental release of a PNT. The proponent has flexibility in the means by which these elements are addressed. For example, information elements may be addressed using experimental data, sound scientific rationale, and/or peer-reviewed literature, where appropriate (Please see Sections 3.2.1, 3.2.2, and 3.2.3 for further information). Applicants are welcome to consult with regulators when determining the specific data or information required to demonstrate the safety of their plant.

3.2.1 Data from field or laboratory experiments

Data from field or laboratory experiments provided as part of an application can be unpublished material, but must be of a standard that would be acceptable for publication in a peer-reviewed scientific journal. Statistically sound agronomic and other appropriate data needed to characterize the plant can be collected through laboratory analysis or confined research field trials. Field research should be conducted in Canada, but research conducted under comparable environmental conditions in other countries can be used, provided a valid scientific rationale is provided to explain how data collected in another country are relevant for the purposes of assessing a plant's impacts on the Canadian environment.

Please note that, in cases where data lead a proponent to believe that their plant is not a PNT, the data should still be kept on file as a matter of due diligence.

3.2.2 Scientific rationale

The proponent may address some information requirements by providing valid written scientific rationale in lieu of trial data. For example, an applicant may be able to address the potential for a particular novel trait to impact pollen production of a self-pollinating plant (if this is a concern) by discussing evidence that resulting yields were unaffected, rather than providing actual pollen production data.

Indirect data can be used to address information requirements, provided that a connection is drawn between the indirect data and its applicability in demonstrating the plant's environmental safety. This connection may be in the form of "bridging data", for example, data proving the equivalency of a protein produced by the plant and a bacterially-produced protein for which toxicological information is available. Likewise, if it is well characterized that the novel gene product is not expressed in pollen, it could be concluded that pollen is not a route of exposure for this protein and, therefore, that the protein can be expected to have minimal impacts on non-target, pollen-feeding insects.

Given the wide spectrum of plants for which authorization for release may be sought, some information requirements listed in Directive 94-08 may not be applicable in all cases. In such cases, a valid scientific rationale must be provided, describing why the information is not applicable to the safety assessment of the plant in question. For example, where a novel herbicide tolerance could be introgressed into a cultivated population of seed from a wild population of a related species. If the wild population and the cultivated species have a similar spectrum of organisms associated with them, and no toxic effects of the trait have been reported in the wild population, an applicant could make the case that specific data on impacts on non-target organisms is not required for the new trait in the cultivated species.

3.2.3 Peer-reviewed literature

Some information requirements can be met using peer-reviewed scientific literature in lieu of empirical data, or to bridge gaps in empirical data, provided the applicant includes a sound scientific discussion citing relevant scientific literature.

For example, several PNTs have a modified gene for acetolactate synthase (ALS, also known as acetohydroxyacid synthase (AHAS)). The ALS gene has one of several specific mutations that confer herbicide tolerance to a group of herbicides. ALS genes with these specific mutations are found in a wide variety of plants, bacteria, and fungi. An applicant could conduct a literature search on ALS proteins with the specific mutation of interest and establish the history of safe use or cultivation of that particular mutation. The applicant could also establish the safety of the method used to introduce and select for the novel trait using previously published studies. They could then include this rationale and accompanying literature references in their application to show that extensive mammalian testing for toxicity and allergenicity of the protein was not needed as part of the unconfined environmental release safety assessment.

4 Recourse mechanism

When the PBO provides a decision to a proponent on whether or not a plant is a PNT and regulated under Part V of the Seeds Regulations, the proponent may feel that the incorrect conclusion has been made. In such cases, the proponent may take the following steps to change the situation:

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