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Directive 94-08 (Dir 94-08) Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits

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This document updates Directive 94-08 (Dir94-08), "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.

The original Dir94-08 was first published December 16, 1994, revised September 15, 2000; October 29, 2004; July 4, 2012; December 23, 2016, and December 19, 2017.

Table of Contents

1. Purpose

All plants with novel traits (PNTs) must be authorized prior to their release into the Canadian environment as per the Seeds Act and Seeds Regulations . In order to obtain an authorization for unconfined release, proponents must demonstrate that their product is as safe for the Canadian environment as its counterpart(s).

This document provides proponents with guidance on: (i) on what constitutes a PNT, (ii) the criteria and information relevant to an environmental safety assessment of a PNT, and (iii) the process to follow when seeking authorization for the unconfined release of a PNT.

The information contained in this directive should not be considered exhaustive. For further clarification, proponents are advised to consult with the Canadian Food Inspection Agency's Plant Biosafety Office (PBO). For all purposes of interpreting and applying the law, proponents are invited to consult the official versions of the relevant acts and regulations.

Products intended for livestock feed and/or human food use require additional assessments under the Feeds Act by the Animal Feed Division at the CFIA, and Food and Drugs Act by the Food Directorate at Health Canada.

2. Regulatory Scope

All plants containing a novel trait, including: agricultural crops, horticultural plants, and forest trees, unless otherwise exempted under section 108 of the Seeds Regulations.

2.1 Determination of Novelty

It is the responsibility of proponents (e.g., plant breeders, product developers, etc.), based on their expertise, on familiarity with their product, and on relevant scientific literature, to determine whether their product fits the definition of a PNT. Thus, the PNT status of a plant is determined on a case-by-case basis.

A PNT is a plant where:

  1. the new trait is not present in stable, cultivated populations of the plant species in Canada, or the trait is present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada, and
  2. where the new trait has the potential to negatively affect environmental safety.

The PNT status is determined by the presence of a novel trait in a plant, irrespective of the method used to introduce it. For further information on how to determine if a product is a PNT, please refer to Directive 2009-09. If a proponent requires additional guidance regarding a novelty determination, they should contact the CFIA at: cfia.pbo.acia@canada.ca.

It is necessary to consider whether or not food or feed derived from a PNT would be classified as novel under the Feeds Act, and Food and Drugs Act, or their applicable regulations, prior to introduction into the Canadian market.

3. Environmental Safety Assessment

3.1 Environmental Safety Assessment Outline

To assess the potential risks a PNT may pose to the environment, a comparative assessment of the PNT relative to its counterpart(s) is used. Furthermore, the characteristics of the species are defined in a companion biology document (see Section 3.2 for details). The environmental safety assessment of a PNT is then based on five criteria:

  • potential of the PNT to become a weed of agriculture or be invasive of natural habitats,
  • potential for gene flow to sexually compatible plants whose hybrid offspring may become more weedy or more invasive,
  • potential of the PNT to become a plant pest,
  • potential impact of the PNT or its gene products on non-target species, including humans,
  • potential impact on biodiversity.

A proponent must submit a comprehensive package of information that consists of appropriate data and relevant scientific information to describe the environmental risk the PNT may pose relative to its counterpart(s) already present in the Canadian environment. This data may be collected through testing and analysis, and may include confined research field trials conducted either in Canada (refer to Dir 2000-07) for further details on conducting confined trials) or in foreign environments similar to Canada. Based on the information provided in the biology document, field experiments can be carefully designed to generate data demonstrating the agronomic/silvicultural and environmental characteristics of the PNT relative to its counterpart. A proponent may also include scientific rationales and bridge data to previous risk assessments to support their application.

Additional peer-reviewed scientific literature may also be used by the CFIA, as appropriate, to guide their safety assessments.

3.2 Biology Documents for Plant Species

The biology of certain plant species is described in a series of species-specific biology documents published on the CFIA web site.

These documents describe the characteristics of the plant species in question, such as habitat, fertility, dispersal, and endogenous toxins, and include information about the plant species' major interactions with other life forms in its production range in Canada (e.g., predators, grazers, parasites, pathogens, competitors, symbionts and beneficial organisms, including humans, where appropriate). This information helps identify potential risks associated with a PNT relative to its counterpart(s) of the same species already present in the Canadian environment. These documents act as references for comparative data.

Where a biology document for a particular PNT's plant species is not available, proponents should notify the PBO at least one year prior to the anticipated submission of an application for unconfined environmental release. This document will be drafted using subject matter experts, published peer-reviewed literature, and consensus documents developed by the Organisation for Economic Cooperation and Development (OECD). Please note that the review of an application for a PNT will not be initiated until a finalized biology document is available. Therefore, it is in a proponent's best interest to notify the PBO as early as possible if a required biology document is not available in order to avoid any delays in the assessment of their application.

3.3 Consultation with Experts

During the CFIA's evaluation of an unconfined environmental release application, the CFIA may consult relevant scientific experts on specific issues with regards to the environmental safety of a PNT. Advice provided by experts will be considered by the CFIA in the final evaluation of the PNT. Information considered as confidential business information (CBI) will not be shared without prior written authorization from the proponent.

4. Application for Environmental Release

Proponents are encouraged to consult with the PBO in the early stages of development for clarification on what specific information is necessary for the environmental safety assessment of the PNT. Please consult our Pre-submission consultation procedures.

4.1 Environmental Safety Application Requirements

To enable the PBO to assess the environmental safety of a PNT, the proponent must address the following issues:

  • the identity and origin of the PNT;
  • the properties of any novel gene and gene products;
  • the phenotypic expression of the PNT compared to a similar counterpart; and,
  • anticipated or known relative effects on the environment resulting from the release.

The specific information relevant for the purposes of conducting environmental safety assessments can be found in Appendix 3, entitled "Relevant Information Regarding the PNT", and Appendix 4, entitled "Information on the Biology and Interactions of the PNT".

Specific information requirements for a PNT will vary based on species, characteristics of the novel trait, the PNT's end use, and its similarity to previously authorized PNTs Criteria of what qualifies as a similar PNT can be found in Appendix 5.

All other supporting information and test data that are relevant to environmental and human health exposure and hazard identification, and which are in the proponent's possession or to which the proponent should reasonably have access, must be included in the application. For further guidance, the proponent is encouraged to consult with the PBO.

The PBO may waive the requirement for certain information if it determines, based on written scientific rationale submitted by the proponent, that the information is not relevant to the particular environmental safety assessment, and as such, is not required for the PBO's decision as to whether or not to authorize the environmental release of the PNT.

4.2 Quality of Data Submitted

The quality of information in the data package should be equivalent to that provided for peer reviewed publications. Proponents should clearly describe the test procedures followed in developing the test data, including test methods, reference products, quality control, quality assurances procedures, appropriate statistical analysis, together with bibliographic references, including numbered patents, where these are appropriate. The generation of field trial data should be produced using statistically valid experimental designs and protocols. Field trials should be conducted in a manner consistent with the proposed farming practices of the PNT. The proponent may be asked to submit details of field trial protocols, including experimental designs and sampling procedures.

A guide to the expected quality for some types of submitted analytical data can be found in the reviewer's checklist. This guide has been developed jointly with Health Canada and the United States Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS).

4.3 Confidential Information

Information submitted to the PBO for the purposes of obtaining an authorization for the environmental release of a PNT may be protected under the federal Access to Information Act, Section  20.

All requests for such information are subject to the federal Access to Information and Privacy Acts. Please consult with CFIA's Access to Information and Privacy Service for further information.

4.4 Environmental Safety Application Process

4.4.1 When to Apply

Applications for authorization will be processed on a first-come-first-served basis. Degree of completeness of the application will also be a factor in the length of the review period required.

4.4.2 How to Apply

Proponents must submit a cover letter, an electronic data package, and the application fee to:

Pre-market Application Submissions Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
Canada
Phone: 1-855-212-7695
Email: cfia.paso-bpdpm.acia@canada.ca

Proponents may also send a paper copy, however it is not required.

The cover letter must summarize the proponents' request for an unconfined environmental release authorization for their plant product and include a description of the plant species, the novel trait(s), and the potential geographic scope of the release. To initiate the environmental safety assessment, the CFIA must have received an application fee. Please see Appendix 2 for a schedule of fees for the review of applications and authorization for the environmental release of PNTs. Once review of an application has been initiated, the application fee will not be refunded. Please make cheques payable to the Receiver General of Canada.

4.4.3 Applications to Animal Feed Division and Health Canada

Products intended for livestock feed and/or human food use require additional assessments under the Feeds Act by the Animal Feed Division at the CFIA, and Food and Drugs Act by the Food Directorate at Health Canada.

Where registration of a pest control product is mandatory the product must meet all the requirements of the Pest Control Products Act, an act which is administered by Health Canada's Pest Management Regulatory Agency (PMRA).

Please note that it is the responsibility of the proponent to contact these offices.

4.4.4 Additional Application Considerations

In order to minimize complications, proponents are encouraged to seek authorization for the environmental release of their product in other international markets simultaneously. Obtaining such authorizations would minimize issues with the movement material across borders where release in one country is unauthorized but not authorized in the other. Proponents should advise the CFIA of other jurisdictions to which they have provided applications to. Where appropriate, the CFIA may try to coordinate its activities and work with foreign governments to minimize the presence of unauthorized products in each country's respective environment.

4.5 Stewardship Plan

For products intended for commercial release in Canada, the CFIA will take into consideration whether or not the proponent has addressed a PNT's potential long term environmental effects by submitting a stewardship plan that is appropriate for that product. For example, in the case of a PNT event that will be stacked with other events prior to release for cultivation, a stewardship plan for the stacked events may be most appropriate. Stewardship plans address the need for the responsible deployment of the PNT into the environment for:

  • insect-resistant crops,
  • herbicide tolerant crops,
  • disease-resistant crops.

Stewardship plans should include appropriate strategies that will allow for the environmentally safe and sustainable deployment of such PNTs. Stewardship plans must take into consideration the most recent available scientific evidence, communication with growers, an efficient mechanism allowing growers to report problems to the developer, and monitoring of the plan.

4.5.1 Insect Resistance Management (IRM)

The development of an IRM plan is the proponent's responsibility and should contain elements that address:

  1. the reproductive biology and behaviour of the insect pest;
  2. the mobility of the larvae;
  3. the ability of adults to disperse from the natal field before and after mating;
  4. an estimate of resistance allele frequency in the insect population;
  5. the impact of management practices such as insecticide use in the refuge;
  6. the targeted life cycle stage of the insect pest;
  7. any history of insect resistance to the active compound(s);
  8. providing education to seed licensees, retailers and growers;
  9. communication to growers including an efficient mechanism allowing growers to report problems to the entity legally responsible for plan implementation (most often, the proponent or licensee);
  10. responding with mitigation/remediation procedures in case of the development of insect resistance; and
  11. monitoring the effectiveness of the IRM plan.

The IRM plan submitted in an application for unconfined environmental release authorization is specific to the target insect species and is based on field or laboratory research and computer models.

A significant component of IRM plans currently in place includes the planting of refugia. These are areas of non-resistant plants of the same crop kind planted within or adjacent to the resistant crop. Refugia provide a population of insects that have not been exposed to the toxin and are thereby available to breed with potentially resistant insects that could be emerging from the cultivated resistant crop.

4.5.1.1 Exemption from Planting Refuge Requirement: Planting for Seed Production

Authorized insect resistant products that are to be planted for breeding or seed production purposes are exempt from refuge planting conditions of their authorization for unconfined environmental release. All other conditions still apply.

4.5.2 Herbicide Tolerance Management (HTM)

The development of an HTM plan is the proponent's responsibility and should contain elements that address:

  1. the control of volunteers, more specifically, any changes in usual agronomic practices that may arise from the novel herbicide tolerance and which could result in reduced sustainability or have significant impacts on soil conservation;
  2. the selection of herbicide tolerance in weeds resulting from the potential continued application of the same herbicide in subsequent rotations;
  3. the introgression of novel trait into related species;
  4. the management of the herbicide tolerant crop during the growing season, particularly where multiple herbicide tolerances, due to cross pollination, could arise in subsequent growing seasons;
  5. providing education to growers to ensure understanding of the HTM plan,
  6. communication to growers as well as an efficient mechanism allowing growers to report problems to the entity legally responsible for plan implementation (most often, the proponent or licensee); and
  7. monitoring the effectiveness of the HTM plan.

Safety issues concerning the application of herbicides on plants expressing novel herbicide tolerance(s) are assessed by the PMRA.

4.5.3 Disease Resistance Management (DRM)

The development of a DRM plan is the proponent's responsibility and should contain elements that address:

  1. the biology of the pathogen (reproduction, behaviour, mobility, life stages, host(s) in Canada, etc.),
  2. the range and severity of the pathogen in Canada,
  3. the pathogen's likelihood of evolving resistance, which may include information on mode of action of the disease resistance (DR) trait, inheritance of resistance to the DR trait in the pathogen, DR allele frequency in pathogen populations, potential for cross resistance with other control tactics, and history of resistance evolution to other control tactics,
  4. any changes in usual agronomic management practices (i.e., in the use of insecticides, fungicides, crop rotation, etc.),
  5. providing education to growers to ensure understanding of the DRM plan,
  6. communication to growers including an efficient mechanism allowing growers to report problems to the entity legally responsible for plan implementation (most often, the proponent or licensee); and
  7. monitoring the effectiveness of the DRM plan.

4.6 Post-release Monitoring Plan

A general post-release monitoring plan to monitor for unintended or unexpected environmental effects of an authorized PNT should be part of a complete application. This monitoring plan will be reviewed during the environmental safety assessment of the PNT. To identify these potential environmental effects, indicators selected should be based on the characteristics of the PNT. A stewardship plan (Please see section 4.5) may be considered acceptable for post-release monitoring purposes.

4.7 Detection and Identification Requirements

In certain situations where it is required to verify compliance with the conditions of authorization, the CFIA may request the following information be submitted:

  • appropriate test methodologies for the detection and identification of the PNT;
  • written agreement to provide the CFIA with reference material suitable to support these methods.

If the CFIA identifies that a method of detection and identification is required as part of the PNT submission, the CFIA will provide guidance on the information to be provided.

Certain information regarding the detection and identification of a PNT may be protected under the provisions of the Access to Information Act. All requests for such information are not only subject to the Access to Information Act but to the Privacy Act as well.

5. Special Cases

In specific cases, the CFIA may have previously assessed information pertinent to a regulated PNT. In the instances listed below, the CFIA has developed policies that consider the previously assessed information in the determination of regulatory requirements for these products.

5.1 Intra-Specific Crosses

Once a PNT is authorized for unconfined release, all its progeny and sister lines which have been derived from the original transformation, and their respective progenies, are also authorized for unconfined release provided that the proponent has determined that:

  • no inter-specific crosses are performed;
  • the intended uses are similar;
  • based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to plants currently being cultivated; and
  • the novel genes are expressed at a level similar to that of the authorized line.

The CFIA may ask the proponent to provide scientific evidence supporting these conclusions.

5.2 Inter-Specific Crosses

Once a PNT is authorized for unconfined release, an environmental safety assessment of the plant created from the first inter-specific is necessary unless the proponent has determined:

  • there is no new transformation event;
  • the intended uses are similar;
  • based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to plants currently being cultivated; and
  • the novel genes are expressed at a level similar to that of the authorized line.

The CFIA may ask the proponent to provide scientific evidence supporting these conclusions.

5.3 Intentional Stacking of Traits

A "stack" means:

  • a single product that was created through a combination of multiple previously approved PNTs.

Proponents are asked to notify the PBO at least 60 days prior to the anticipated environmental release of plants having stacked traits and resulting from either intentional intra-specific or inter-specific crosses between PNTs already authorized for unconfined environmental release.

Following notification, the PBO may issue a letter (within 60 days of notification) informing the proponent of any concerns it may have regarding the unconfined environmental release. The PBO may request and review data to support the safe use of the modified plant in the environment.

Stacking of traits with potential incompatible management requirements, possible negative synergistic effects, or where production of the plant may be extended to a new area of the country, may elicit an environmental safety assessment. Until all environmental safety concerns have been resolved, the modified plant should not be released in the environment.

5.3.1 Stacked Products Intended for Research

The PBO does not require notification of unconfined release of stacked plant products into the Canadian environment if:

  • the proposed planting is less than regular confined research field trial size restrictions as specified in Directive Dir2000-07, and
  • the proposed planting is intended for scientific research or technical data gathering on the stack.

5.3.2 Intermediate Stacked Products

As described above, multiple previously approved PNTs may be combined into a single stacked product. An "intermediate stacked product" consists of only a subset of the PNTs used to generate an authorized stacked product.

Unless explicitly specified otherwise in the authorization of a stacked product, the authorization allows the unconfined release of its intermediate stacked products, provided that:

  • the intended use of the intermediate stacked product is limited to research or seed multiplication;
  • it is known through characterization that the intermediate stacked product does not express any additional novel traits, and the novel genes are expressed at levels similar to those of the parental lines; and
  • conditions imposed on the original authorized stacked product that are appropriate for the intermediate stacked product are implemented.

Proponents of stacked plant products must ensure that they remain in compliance with all other applicable acts and regulations, including policies on stacked products for feed and food as set out by the Animal Feed Division, CFIA and Health Canada.

5.4 Retransformation (RT) and Remutation (RM)

A "retransformation" means:

  • a transformation of a plant with the identical construct(s) as a previously authorized plant of the same species.

A "remutation" means:

  • the same mutation in a plant as in a previously authorized plant of the same species.

In either case, the RT or RM must impart the same novel trait(s) to a plant as a transformation or mutation in a previously authorized PNT of the same species.

A product of RT or RM, when compared with the originally authorized PNT, must meet the following criteria:

  • the novel trait(s) is/are expressed within a similar range to that of the authorized PNT;
  • it is known, based on characterization, that the plant does not display any additional novel traits and is substantially equivalent, in terms of its specific use and safety for the environment and for human and animal health, to the originally-authorized PNT; and
  • novel food and livestock feed requirements are met as appropriate.

Data or information used to support the characterization of the RT or RM are to be made available to the PBO of the CFIA upon request.

Products of remutation that meet the criteria above are included in the authorization of the original PNT, and are subject to the same conditions as the originally authorized PNT.

Products of retransformation that meet the criteria above require notification to the PBO of the CFIA. The notification must include a unique identifier for the RT product.

For further guidance, consultation with the PBO of the CFIA is recommended.

Decisions made by the PBO do not preclude additional regulatory requirements from other acts and regulations that may apply and are administered either by other groups of the CFIA or by other government departments or agencies. For a product of RTRM that is considered to be a novel food or novel feed, please see Section 6.2: "Harmonization of Approvals under Other Federal Acts and Regulations".

6. Decision Process

6.1 Regulatory Decision

The PBO will consider the information provided by the proponent to determine if the PNT poses risks to the environment.

Where the proposed release of a PNT poses a minimal apparent risk to the environment, the PBO may authorize the unconfined release of the PNT, and may, where necessary, impose conditions for the management of the apparent risk. Conditions will be imposed on an indeterminate basis.

Where the proposed release of a PNT has been assessed to pose unacceptable risk to the environment, the PBO may refuse to authorize the unconfined environmental release of the PNT, and will provide reasons for the refusal.

6.2 Harmonization of Approvals under other Federal Acts and Regulations

A PNT that could reasonably be expected to be used as feed and food will not be authorized for unconfined environmental release by the PBO, among other requirements, until:

  • the Animal Feed Division of the CFIA is ready to authorize the novel feed for livestock feed use under the authority of the Feeds Act and Regulations, and
  • the Novel Foods Section, Health Canada, is ready to provide notification of no objection for human food use under the authority of the Novel Food Regulations.

Where products are intended for exclusive use as either food, feed or molecular farming (use of plants to produce industrial or therapeutic products), consultations among regulatory authorities will be required to assess any potential risks associated with the release of the product in an unintended commodity stream. For these products, an identity preservation system or alternative will be essential to minimize the likelihood of such an event.

Please note that once the safety assessments have been completed, the proponent is notified in writing by the CFIA and Health Canada (separate letters) of their respective decisions regarding the application.

6.3 Online Summaries of Authorized PNTs

A list of all authorized PNTs and novel feeds derived therefrom is available on the CFIA PBO's web site. The PBO will update its list of authorized PNTs within 15 business days of authorizing a PNT.

In addition, accompanying decision documents for all authorized PNTs and novel feeds derived therefrom are available on the CFIA web site. The decision documents explain the decision reached by the CFIA's PBO and the Animal Feed Division following their safety assessments.

A list of approved novel foods in Canada derived from PNTs whose environmental release has been authorized, as well as their accompanying decision documents, is available on Health Canada's web site.

The PBO also submits information on the environmental release of PNTs to the Biosafety Clearing-House under the Cartagena Protocol on Biosafety.

7. New Information Related to Authorized PNTs

If at any time the proponent becomes aware of any new information regarding the environmental safety of the PNT or its risk to human health, the proponent must immediately provide the PBO with the new information. On the basis of the new information, the PBO will re-evaluate the potential effect on, and risk to the environment, including the potential effect on, and risk to human health posed by the release. The PBO may maintain, change, or remove existing conditions respecting the release; impose additional conditions; or cancel the authorization and require the proponent to stop the release and take any appropriate action necessary to eliminate or minimize the risk.

This document is published by the Plant Biosafety Office. For further information, please contact:

Plant Biosafety Office,
Plant Health and Biosafety Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Email: cfia.pbo.acia@canada.ca

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