Directive Dir 2000-07: Conducting Confined Research Field Trials of Plants with Novel Traits in Canada

This directive will be updated as required. For more information, contact us.

On this page

• 1. General information
  • 1.1 Introduction
  • 1.2 Scope
  • 1.3 Risk management
  • 1.4 Planning ahead for pre-market assessments
• 2. Application process for confined research field trials of PNTs
  • 2.1 Information to submit for new confined research field trials
  • 2.2 The presence of endangered species at the field site
  • 2.3 Renewal of confined research field trials
  • 2.4 Where to apply
  • 2.5 When to apply
  • 2.6 Fees
  • 2.7 Information considered confidential
    • 2.7.1 Provincial government notification
    • 2.7.2 Website summaries of authorized confined research field trials
• 3. Conditions of authorization of confined research field trials
  • 3.1 Compliance with terms and conditions of authorization
  • 3.2 Restrictions on the size and number of field sites
  • 3.3 Reproductive isolation of confined research field trials
    • 3.3.1 Minimum reproductive isolation distances and destruction zones
    • 3.3.2 Alternative reproductive isolation methods
  • 3.4 Maps and GPS coordinates
    • 3.4.1 Maps
    • 3.4.2 GPS coordinates and field site markers
  • 3.5 Chemical treatment notice
  • 3.6 Equipment check and cleaning
  • 3.7 Record-keeping
  • 3.8 Harvest, disposal, and storage of plant material
    • 3.8.1 Harvest notification
    • 3.8.2 Disposal and storage of seed and propagable plant material
    • 3.8.3 Disposal of residual plant material
  • 3.9 Post-harvest land use restrictions
  • 3.10 Local wildlife management
  • 3.11 Inspection of confined research field trials
    • 3.11.1 Inspection of research field trial sites
    • 3.11.2 Inspection of the records, disposal, and storage methods
  • 3.12 Special cases
    • 3.12.1 PNTs used for plant molecular farming
    • 3.12.2 Stacked plant products
    • 3.12.3 Outcrossing studies
    • 3.12.4 Herbicide efficacy studies
    • 3.12.5 Disease nurseries
    • 3.12.6 Restrictions lifted after unconfined environmental release authorization
• 4. Other requirements
  • 4.1 Importation of PNT
  • 4.2 Notification of the Animal Feed Program
    • 4.2.1 PNT used for livestock feeding research
    • 4.2.2 Traditional feed crop species intended for end uses other than feed production
  • 4.3 Notification of Health Canada
    • 4.3.1 Notification of the Pest Management Regulatory Agency
    • 4.3.2 Traditional food crop species intended for end uses other than food production
• Appendix I Species-specific requirements
• Appendix II Confined research field trial map
• Appendix III Non-compliance and corrective actions
• Appendix IV Definitions

1. General information

The Seeds Act provides authority to regulate the quality, testing, inspection and sale of seeds in Canada. The Seeds Regulations, Part V - Release of seeds, defines the regulatory requirements for both confined and unconfined environmental release of plants with novel traits (PNTs) in Canada.

A PNT is a plant into which a trait has been intentionally introduced, where the trait is new to the species, and has the potential to affect the specific use and safety of the plant with respect to the environment and human health. These traits can be introduced using biotechnology, mutagenesis or conventional breeding techniques and may have some potential to impact weediness, gene flow, plant pest potential, non-target organisms, or biodiversity. More information about determining whether a plant is a PNT is available in the Directive 2009-09: Plants with novel traits regulated under Part V of the Seeds Regulations: Guidelines for determining when to notify the CFIA.

The Canadian Food Inspection Agency (CFIA)'s Plant Biosafety Office (PBO) delivers programming for the intentional introduction of PNTs into the environment in Canada. PNTs that are not approved for unconfined release into the environment may only be released in confinement.

1.1 Introduction

A confined research field trial is the release of a PNT in the environment, for research purposes, under terms and conditions of confinement. These terms and conditions include reproductive isolation, site monitoring and post-harvest land use restrictions.

The program provides developers with the opportunity to:

• evaluate the performance of PNTs
• study the environmental safety of PNTs
• gather data to be considered in pre-market safety assessment(s) of PNTs
• generate data for variety registration purposes

1.2 Scope

This directive provides guidance to applicants regarding the regulatory requirements for confined research field trials. It also summarizes the information requirements and procedures used by the PBO, and where appropriate, other federal and provincial organizations. The information presented in this directive does not preclude additional regulatory requirements of the CFIA or other government organizations.

1.3 Risk management

General, species-specific, and case-specific terms and conditions of authorization are imposed on confined research field trials (see Approved confined research field trials and terms and conditions). These conditions are designed to limit environmental exposure and are developed by taking into account:

• the biology of the species
• the novel trait
• the confinement methods chosen by the proponent
• the proponent's compliance history

A confined trial may be refused or restricted in scope when the proposed release poses an unacceptable risk to the environment and/or animal health and/or human health, or there is a reasonable risk of not meeting the confinement conditions.

1.4 Planning ahead for pre-market assessments

Applicants considering commercialization are encouraged to review the information requirements for:

• unconfined environmental release (Directive 94-08 (Dir 94-08): assessment criteria for determining environmental safety of plants with novel traits)
• novel animal feeds (Guidelines for the assessment of novel feeds: plant sources)
• novel foods (Guidelines for the safety assessment of novel foods) 

Confined field trials can be used for studies that address the 5 key criteria of environmental safety assessments:

• altered weediness potential
• gene flow consequences
• altered plant pest potential
• impact on non-target organisms
• other impacts on biodiversity

Sound trial design will also help to ensure that materials harvested from the field trials will be suitable for use in studies of food and feed safety. For example, this can include studies of novel trait expression, stability, and nutrient composition of the foods and feeds derived from the PNT.

2. Application process for confined research field trials of PNTs

Complete the Confined Research Field Trial Application (CFIA/ACIA 5707).

This form can also be accessed through My CFIA. The applicant must be a permanent resident or a citizen of Canada. The application form must be completed in full to ensure timely evaluation and to minimize requests for further information. Separate application forms are required for new confined research field trials and for renewals of previously authorized confined trials.

2.1 Information to submit for new confined research field trials

The potential adverse environmental impacts associated with the confined research field testing of the PNT must be identified in the application. The CFIA's risk assessment of the proposed field trial takes into account:

• the development method
• the characteristics of the novel trait
• the altered characteristics of the PNT
• any novel gene product (toxicity and allergenicity)
• the ecosystem and geographic location of release (including species present at or near the field site)
• the trial protocol

The applicant must ensure that the confined research field trial will not negatively affect the environment, including any other trial(s) or crop(s). The PBO requires that each applicant:

• determine what plant material, if any, will be in proximity to each field site (including within the isolation distance) before the confined research field trial is planted, and
• consider contingency plans in the event of accidental release of material or inadvertent breakdown in reproductive isolation (these contingency plans must include immediate notification of regulatory authorities and commodity handlers, and provide for monitoring, tracking, recall, and destruction of accidentally released plant material from the environment and/or food or feed supply chains)

2.2 The presence of endangered species at the field site

It is important to know if there are any endangered species at or near the field site that could be affected by the confined research field trial. To obtain information on endangered species contact:

Canadian Wildlife Service
COSEWIC Secretariat (Committee on the Status of Endangered Wildlife in Canada)
351 St-Joseph Blvd, 14th floor
Gatineau, QC K1A 0H3

Telephone: 819-307-7600
Email: cosewic-cosepac@ec.gc.ca

2.3 Renewal of confined research field trials

Renewals can be granted for confined trials that are identical to those authorized in previous years (in other words, ongoing field trials of perennial PNTs, or a field trial of the same species, same construct, and in exactly the same location).

The PBO must be notified in writing of an applicant's intent to renew each year following the initial authorization of the confined field trial. Confined Research Field Trial Application (CFIA/ACIA 5707) must be submitted to the PBO for review.

The original terms and conditions of authorization will typically remain in effect, however, the CFIA may modify, add, or remove any condition of authorization upon renewal, and any changes will be communicated to other provincial and federal authorities.

2.4 Where to apply

Completed confined research field trial application forms must be submitted through the electronic platform My CFIA or by postal mail. Submissions will be processed in the order received.

Applications sent through postal mail must be sent directly to the CFIA's Pre-market Application Submissions Office (PASO):

Pre-market Application Submissions Office
Canadian Food Inspection Agency
1400 Merivale Road
Ottawa, ON K1A 0Y9

2.5 When to apply

Applications for new confined field trials should be received by the PBO a minimum of 30 days before the expected planting date, but applying earlier is advisable. Applicants are encouraged to consult with the PBO early in the application process, and to be prepared to provide any necessary information at least 90 days before the anticipated planting date, to avoid planting delays. The PBO provides provincial government counterparts with a minimum 30 day comment period. Thirty days is the absolute minimum application processing time for this reason. Depending on the complexity and volume of requests received, processing times may vary. Due to the seasonal nature of this program, the volume of applications tends to be highest in the early spring, and so applicants are advised to apply at their earliest opportunity.

For renewals, applications should be received before the anniversary date of the original application.

Applications for confined research field trials of PNTs not suitable for food or feed use (for example, plant molecular farming) require additional time for assessment of potential risks to food and feed supplies. Please consult section 3.12.1 for further detail. Note that a minimum of 60 days is required for this assessment. However, where submitted data is incomplete, additional data will be requested and a new 60 day assessment period will commence once the additional data is received. Applicants are encouraged to consult with the PBO as early as possible to avoid planting delays.

In all cases, incomplete applications may require additional processing time due to further information requests. Failure to submit all the required information may make it impossible to receive authorization on time for planting.

2.6 Fees

Consult the CFIA Fees Notice for an up-to-date schedule of fees for confined research field trials. For a new application, the applicable fee is calculated based on the number of submissions and the number of field sites in the application. Fees can be paid online via My CFIA. Payment information will not be accepted via email.

For a renewal of authorization, the applicable fee is calculated and due each year that the renewal is requested. A renewal fee per submission will apply in addition to a fee per field site.

2.7 Information considered confidential

Personal and confidential information will be protected under the provisions of the Privacy Act. Other information will be protected or provided as required under the provisions of the Access to Information Act and the Privacy Act. For additional information, contact the CFIA's Access to Information and Privacy (ATIP) services at ATIP-CFIA-AIPRP@inspection.gc.ca or through the CFIA general enquiries line at:

• Telephone: 1-800-442-2342; 613-773-2342
• TTY: 1-800-465-7735

Non-confidential information that will be shared includes the organization's name, CFIA's trial codes, crop(s), a general description of the trait(s) being field tested, and the province(s) in which the field sites are located.

2.7.1 Provincial government notification

The PBO will send non-confidential information about each confined research field trial to designated provincial government contacts in those provinces where field sites are proposed. Provincial governments have a 30 day comment period, and any comments are considered by the PBO in the final evaluation of the application.

If provincial government representatives request additional information about the application, the PBO will contact the applicant to determine what information can be shared with provincial governments.

2.7.2 Website summaries of authorized confined research field trials

Non-confidential information about confined research field trials is made available to the public upon request and on the PBO's website at Approved confined research field trials and terms and conditions. The CFIA endeavors to update this information shortly after each field season has concluded.

3. Conditions of authorization of confined research field trials

3.1 Compliance with terms and conditions of authorization

The terms and conditions of authorization include reproductive isolation, site monitoring, and post-harvest land use restrictions. General and species-specific terms and conditions are available at Approved confined research field trials and terms and conditions. When planning research field trials, please refer to the most recent versions available online. An updated version of the terms and conditions will be provided to the applicant upon authorization.

Applicants are encouraged to view the terms and conditions as minimum requirements. The PBO may alter the terms and conditions from year to year based on the most recent scientific data. The PBO may amend terms and conditions on a case-by-case basis to account for specific risks associated with a release.

It is the applicant's responsibility to ensure compliance with the terms and conditions of authorization, including the conduct of any subcontractors. The applicant must ensure that the field managers are familiar with, and have a copy of, the terms and conditions under which the release was authorized. Each case of non-compliance will be treated by the PBO on a case-by-case basis. Examples illustrating the type of corrective actions that PBO may require are available in Appendix III.

The Minister has the authority to deny an authorization to conduct confined research field trials where it is believed that an applicant may not comply with the terms and conditions. For example, in cases where an applicant has a history of breaching the terms and conditions, authorizations could be refused, or the size and number of field sites or trial entries could be restricted.

3.2 Restrictions on the size and number of field sites

The confined research field trial program is for research purposes and is not intended to support other activities such as seed multiplication for commercial purposes. To maintain the integrity of this system, there are limits on the size and number of field sites per province. Specifically, field sites are limited to no more than:

• 1 hectare per field site
• 10 field sites per submission per species per province (includes locations submitted in new applications and renewal of authorizations)
• 5 hectares cumulative per submission per province (includes locations submitted in new applications and renewal of authorizations)

For example, in 1 province an applicant may choose to grow:

• 1 submission at 5 field sites
  • the field sites are 1 hectare each or less, and the submission doesn't exceed 5 hectares total
• 1 submission at 10 field sites
  • the field sites are 0.5 hectare each or less, and the submission doesn't exceed 5 hectares total
• 10 submissions at 5 field sites
  • each field site is 1 hectare or less, planted to 0.1 hectare of each submission (this reaches the field site maximum of 1 hectare per site, but falls well under the cumulative area of less than 5 hectare per submission)

Plants of the same species grown on the field site, such as control plots and border rows, are treated as PNTs. These plants are subject to the terms and conditions of authorization, and count towards the total size of the field site.

Exemptions from the restrictions may be granted on a case-by-case basis. Along with their application, the applicant must submit a rationale for the exemption and a precise description of management practices that will mitigate the additional exposure to the environment. To reach a decision on granting an exemption, the CFIA will consider:

• rationale provided by the applicant that outlines why an exemption would be reasonable in terms of environmental risk
• rationale provided by the applicant that outlines why an exemption is necessary to meet a research objective
• whether management practices proposed by the applicant would be effective in mitigating any increased environmental exposure
• experience and compliance history of the applicant
• biology of the crop type, including any traits or variations relevant to environmental risk
• geographical factors such as the typical uses of surrounding lands
• how much of an increase in size and/or number is being requested vs. the program limits
• CFIA's practical ability to inspect the site(s)

If an exemption for field site size and/or number is granted, the PBO may request that the proponent keep seed as reference material from each submission for 7 years after all restrictions are lifted. Exemptions granted from the field site size limit may involve additional restrictions on the number of field sites that will be authorized.

3.3 Reproductive isolation of confined research field trials

To minimize potential for gene flow, it is necessary to reproductively isolate all PNTs from neighbouring related commercial crops, breeding nurseries, seed multiplication plots, other trials, and sexually compatible wild relatives. This may be done through isolation distances or alternative methods.

The PBO strongly recommends that applicants notify neighbours that have land surrounding the field site that their crops may be affected in the event of a breakdown in reproductive isolation.

3.3.1 Minimum reproductive isolation distances and destruction zones

It is the responsibility of the applicant to ensure that the conditions for the reproductive isolation are met.

The most common means to achieve reproductive isolation is through the use of spatial isolation distance between the trial plants and neighbouring sexually compatible plants. Minimum isolation distances have been established through consultation with academics, scientists, and other stakeholders, using requirements adapted from the Canadian Seed Growers Association for producing pedigreed seed crops.

Should the same or related species be found within this isolation zone the applicant must remove them immediately. If inadvertent pollination/hybridization and seed set occur, additional post-harvest land use restrictions and monitoring requirements will be imposed.

As a condition of authorization, the PBO will impose minimum distances to food or feed crops, to pasture, and to seed production. The PBO may impose greater minimum isolation distances for trials of PNT expressing traits that could have the potential for high environmental, food or feed safety issues if released.

3.3.2 Alternative reproductive isolation methods

Applicants who choose alternative methods for reproductive isolation must ensure that they will have control over the appropriate reproductive isolation distance around each field site, in the event that the alternative method fails to provide reproductive isolation. The use of an alternative reproductive isolation method must take into account neighbouring fields and any potential financial implications to their owners.

The following alternative methods may be available to reproductively isolate specific PNTs:

• harvest of plants before flowering requires close monitoring at the onset of flowering
• bags, nets or cages placed over flowering plants to prevent pollen exchange, provided that scientific rationale is provided in writing in the application to justify the effectiveness of such measures
• removal of floral parts before pollen maturity

If an applicant chooses an approved alternative method of reproductive isolation other than the minimum required isolation distance, and if that method fails to prevent potential pollination/hybridization and seed set in plants outside the field site, then current season and post-harvest monitoring and restrictions may also apply to the isolation distances.

For example, if an applicant chooses to ensure reproductive isolation of a Brassica rapa field site by netting the PNTs, and if the netting fails to prevent pollen movement, a 400 m isolation distance around the field site will be imposed. It is the applicant's responsibility to ensure that all the terms and conditions related to the isolation distance, including destruction of any B. rapa or related species, are met.

3.4 Maps and GPS coordinates

The PBO recognizes that exact field site locations may not be finalized at the time of submitting the application. Applications without exact field site locations will be accepted if:

• the application includes the general location (to the nearest town), the expected planting date, the number of field sites within each general location
• the legal land location (where applicable) or civic address is subsequently submitted (note: the PBO will not authorize a confined research field trial until information detailing the legal land location or nearest civic address of each field site has been provided)
• a map and GPS co-ordinates are submitted within 7 days of planting, in accordance with section 3.4.1

Geographic factors should be considered when selecting the exact field site location. For example, the tendency for soil erosion and the proximity to natural ecosystems and waterways should be considered to minimize the risk of dissemination of novel traits into the environment.

Any changes to confined research field trial plans made subsequent to authorization must be received by the PBO on or before May 15 (spring planting) or August 1 (fall planting) of the year of application. Examples include a change in the planned field site location or size, or additional trial entries. After this date, field site changes may not be accepted, with the exception of cancellations. Any materials planted without prior authorization (or an accepted amendment) may need to be destroyed.

3.4.1 Maps

It is the responsibility of each applicant to provide a detailed and complete map of each field site and surrounding area, as well as detailed directions to the site, within 7 days after all planting at the field site is completed. Please don't submit maps until field site planting has been completed. In the case of a renewal, when a complete map has already been submitted with the application, the applicant must inform the PBO of the exact planting date(s) of the trial(s), within 7 days after all planting is completed.

Maps of confined research field trial sites must be legible and precise so that CFIA inspectors do not encounter problems locating field sites, particularly in post-harvest years. Maps should be created electronically, with white background, crisp line drawings and block letters. The use of colours should be avoided. Maps on lined or graph paper will not be accepted. Photocopies or scans of road maps may only be used as a reference for directions to the field. It is recommended to submit the maps electronically via email to pbo@inspection.gc.ca.

On each map the following information must be clear:

• inspection number designated by PBO (for example, 24-INC1-WHT-SK001-01)
• general location of the field site (city/town/province)
• legal land location and/or civic address
• name and phone number(s) of the field contact (optional: provide email address as well)
• compass arrow or star, with North at the top of the page
• measurements from permanent surrounding landmarks must be provided for precise location of the site (a minimum of 2 landmarks or 1 landmark plus a bearing are recommended)
• GPS coordinates from all field site corners in the latitude longitude decimal degree format (see section 3.4.2 for detailed GPS coordinates requirements)
• exact dimensions of the field site in metres
• surrounding crops, particularly those that may lie within the isolation distance
• locations of any nearby past confined research field trial sites still under post-harvest obligations
• planting date of the field site(s) of the field site

A map of a confined research field trial site is presented in Appendix II.

3.4.2 GPS coordinates and field site markers

It is the responsibility of each applicant to submit the GPS coordinates of each field site to the PBO within 7 days of completing planting. Authorization may be withdrawn if GPS coordinates are not submitted in a timely manner.

GPS coordinates must be taken precisely at all corners of each field site and provided in the latitude longitude decimal degree format (for example, N45.42373, W75.69870). GPS coordinates will be used by CFIA inspectors to assist in locating the field sites for current year and post-harvest inspections.

Minimum recommended GPS unit requirements:

• accuracy: 1-5 metres
• datum set: WGS84
• latitude longitude decimal degree format
• Wide Area Augmentation System (WAAS)

Markers should be placed at all corners of the field site (see map in Appendix II) to facilitate the identification of the field site boundaries and associated isolation distance and post-harvest buffer zone. The markers (for example, flags or corner posts) should be obvious, identifiable above the maximum height of the surrounding crop and in place for the growing seasons of both the trial and the post-harvest restriction period.

3.5 Chemical treatment notice

If a chemical treatment is used on the field site that requires a time until safe entry, a sign must be posted at the point of entry to the trial indicating the treatment, the date and time of spraying as well as the time until safe entry. This condition is intended to protect the health and safety of the CFIA inspection staff.

3.6 Equipment check and cleaning

During the year of the trial and during all post-harvest years, seeding, transplanting, harvesting and site maintenance machinery and equipment used on the field site must be free from PNT materials prior to being moved to other locations. This includes a visual inspection of workers' clothing and footwear, and removing any identified plant material (for example, seed hidden in caked-on mud), prior to exiting the site. Any necessary machinery cleaning must take place on the field site. Any material collected during cleaning must be destroyed according to the terms and conditions. This is to prevent dispersal of plant material, especially propagable plant material and pollen.

As an additional best practice, workers should also be aware of scenarios where dispersal is more likely to occur, and take sensible precautions to minimize the opportunities to spread PNT materials. For example, consider visiting non-PNT sites before PNT sites, or change footwear and/or outerwear when pollen is abundant or when there is seed on the soil surface, and avoid visiting sites when fields are muddy (if possible).

3.7 Record-keeping

Records for all field sites, including current season and post-harvest site activities, must be maintained by the applicant and kept for at least 7 years after the post-harvest period has ended. All plant material used on or harvested from each field site must be accounted for. Records must be made available to the CFIA upon request.

To facilitate eventual records inspection, the PBO recommends including basic information about the field site such as:

• PBO inspection number
• crop type/species
• legal land location
• GPS coordinates
• planting date(s)
• name of field manager
• reproductive isolation method used
• isolation distance (in metres) if applicable
• area under post-harvest confinement (for example, additional 10 m or 50 m based on harvest method, or additional land use restriction due to a compliance problem)

The following activities must be documented for each field site in the current year of the trial (CY) and/or during the post-harvest monitoring years (PH):

• transportation of planting materials (CY)
  • description of the method of transportation
  • date of transportation
  • origin and destination
  • name of the responsible party who recorded the information
• disposal and/or storage of all surplus planting materials (CY)
  • total quantity of surplus planting material
  • information on the disposal and storage:
    • quantity of material disposed and/or stored
    • method of disposal/storage
    • date of disposal
    • location(s) of disposal and/or storage 
  • name of the responsible party who recorded the information
• cleaning machinery and equipment (CY and PH)
  • description of the machinery
  • date of machinery use
  • optional: result of visual checks that were done on machinery, equipment, and clothing
  • date, location, and method of machinery cleaning (if cleaning was needed)
  • disposal method of materials from the cleaning
  • any additional measures that were taken to limit dispersal of propagable materials
  • name of the responsible party who recorded the information
• materials harvested from the field site (CY)
  • total quantity of material harvested from the field site (this total should include all test material, and reference material, if applicable - no need for subtotals for each trial entry)
  • date(s) of harvest
  • description of the method of transport of the harvested material
  • description of the method of disposal and/or storage
  • date(s) of disposal, the quantity of material disposed of and/or in storage
  • location of disposal and/or storage
  • name of the responsible party who recorded the information
• disposal of residual plant matter (CY)
  • description of the method of disposal
  • date of disposal
  • name of the responsible party who recorded the information
• monitoring the field site (CY and PH), isolation distance (CY) and harvest buffer zone (PH) for the presence of related species or volunteers
  • description of the activity
  • date monitoring took place
  • growth stage of the plants in the trial (if applicable)
  • location of any volunteers or related species and their growth stage
  • date the plants were removed/destroyed
  • destruction method
  • name of the responsible party who recorded the information
• compliance and corrective actions (if applicable - CY and PH)
  • description of the issue and corrective actions taken to return to compliance
  • date on which the corrective actions were taken
  • name of the responsible party who recorded the information

3.8 Harvest, disposal and storage of plant material

No material from a confined research field trial may be used as human food or livestock feed without the prior approval of Health Canada or the CFIA Animal Feed Program, respectively.

3.8.1 Harvest notification

Completed harvest notifications must be sent to the PBO no later than 3 weeks after the field site harvest is complete. These notifications help CFIA inspectors verify that all trial materials are accounted for and have been suitably stored or destroyed. To facilitate arranging site inspections prior to snowfall, applicants are encouraged to provide the PBO with these harvest notifications as soon as all the required information has been assembled. Applicants must provide information on:

• final date of field site harvest
  • there is no need to inform PBO of a partial harvest, including any partial early trial termination
• retained materials:
  • total quantity retained and stored (by weight, if feasible) (note: there is no need to provide subtotals for each trial entry tested)
  • storage location and method
• harvested materials not retained (for example, grains, tubers):
  • total quantity harvested (by weight, if feasible) (note: there is no need to provide subtotals for each trial entry tested)
  • location, method and date of disposal
  • if disposal occurs at a location other than the field site, a detailed and complete map of the disposal site location(s) and detailed directions to the site(s)
• residual vegetative materials:
  • description of what was disposed (for example, "all chaff and stalks")
  • location, method and date of disposal

3.8.2 Disposal and storage of seed and propagable plant material

Field sites should be harvested as soon as reasonably possible to minimize seed loss. This is intended to limit the quantity of propagable plant material incorporated into the soil at the conclusion of the trial(s), thus limiting the seed bank.

Seed or other propagable plant material that is not retained must be disposed of by an approved method that renders the propagable material non-viable (for example, autoclaving, burning to ash, crushing or deep burial to a depth >1m). Accepted methods are specific to the biology of the species and are detailed in the terms and conditions of authorization for the trial. Composting is not an acceptable method for the disposal of plant material.

Harvested seed or plant material from confined research field sites (including non-modified control material) that is to be retained must be stored appropriately in clearly labelled and secure containers and kept separate from other seed and/or plant material. A secure container includes any means by which seed and any propagable plant material may be contained for transport and storage such that a spill or dissemination cannot occur. Each container must be labelled at minimum with the following information: PNT material - Do not mix.

3.8.3 Disposal of residual plant material

Applicants must destroy all residual plant material in a manner whereby the material is not easily distributed by wind or local fauna yet does not promote seed dormancy. Soil incorporation using a rototiller, double disc, or heavy plow is a common choice. Light disking and heavy harrowing is acceptable for small-seeded crops such as Brassica species. More aggressive incorporation is recommended for crop kinds with larger seeds. If the applicant decides to burn the plant material, material must be burned to ash.

For certain trials (for example, plant molecular farming), disposal and destruction of all residual plant material must be witnessed by a CFIA inspector – this will be specified in the terms and conditions of authorization for the trial. Records that track materials through planting, harvest, and disposal must be presented to the inspector at that time.

Where a confined research field trial must be terminated, the applicant is responsible for the cost(s) of appropriate disposal of the PNT. Furthermore, the applicant is also responsible for the cost(s) of all remedial actions required in the event of an accidental release of the PNT. Applicants must not undertake confined research field trials without an authorization.

3.9 Post-harvest land use restrictions

Applicants must notify the PBO in writing of any crops planted on field sites during the post-harvest period. This notification must be received every year by June 1.

PNTs may emerge as volunteers in subsequent growing season(s). Therefore, the following precautions must be taken to prevent volunteers from setting seeds or from crossing with crops of the same species or with sexually compatible related species:

• monitoring of the field site and buffer zone after harvest and in subsequent growing seasons during each year that the site is subject to post-harvest land use monitoring, at a frequency specified in the terms and conditions of authorization (see Approved confined research field trials and terms and conditions)
  • this helps to identify volunteer plants and sexually compatible related species and ensure they are destroyed before flowering
• strictly no planting of any species related to the PNT on the field site and surrounding buffer zone, during each year that the site is subject to post-harvest land use restrictions, in accordance with the species-specific terms and conditions
  • should an applicant choose to plant a field trial of the same species on an area under post-harvest land use restrictions, a request must be made to the PBO and will be considered on a case-by-case basis
• applicants are encouraged to select a cover crop that is morphologically distinguishable, throughout all growth stages, from the PNT to facilitate identification and destruction of volunteers during the post-harvest restriction period
  • for PNTs with a high occurrence of volunteers, applicants are encouraged to leave the field site and buffer zone fallow during the first year of the post-harvest restriction period

If harvested by combine (other than small plot combines), a 50 m buffer zone around the field site must be monitored during each year that the site is subject to post-harvest land use restrictions. If a combination of commercial-scale and small plot combines is used, the 50 m buffer will be imposed. For all other field sites, a 10 m buffer zone around the field site must be monitored during each year that the site is subject to post-harvest land use restrictions. A map of a field site, buffer zone, and isolation distance is presented in Appendix II.

To prevent the entry of regulated material into the food and feed chain, no field sites subject to post-harvest land use restrictions can be used as pasture for animal grazing since volunteer plants may grow on the site in subsequent growing seasons.

Additional post-harvest land use restrictions, including restrictions on cultivation of food or feed crops, may be imposed in some cases following trials of PNTs expressing traits that may have greater potential environmental, food, or feed safety issues if released.

3.10 Local wildlife management

It is the applicant's responsibility to implement mechanisms to deter local fauna from removing novel plant material from field sites. If significant wildlife activity is anticipated, implementing measures to protect the field site is recommended. This could include the use of fences, tents, scare devices or specific monitoring. When selecting the exact field site location, an evaluation of the presence of wildlife should be done to assess the need for mitigation measures. In all cases, applicants must notify the PBO immediately if significant animal activity and/or dispersal of trial materials are observed.

3.11 Inspection of confined research field trials

3.11.1 Inspection of research field trial sites

CFIA inspectors have the authority to inspect confined research field trials for compliance with the terms and conditions of authorization during both the growing season and the post-harvest period. Inspections may be conducted without prior notification to the applicant or field manager.

3.11.2 Inspection of the records, disposal, and storage methods

CFIA inspectors have the authority to inspect the records and methods of disposal and storage of plant material from the confined research field trials during or after completion of the trials to verify compliance with the terms and conditions of authorization. The field manager and/or the person in charge of the storage location and/or the person in charge of disposal must have access to the confined research field trial site records (see section 3.7). This person must be available during the inspection of records to provide the inspector with the required information and documentation. The contact person in charge of the disposal and/or storage of plant material from the confined research field trial(s) will be contacted prior to this inspection and should assist the inspector.

3.12 Special cases

3.12.1 PNTs used for plant molecular farming

Applications for confined research field trials of PNTs intended for plant molecular farming will be addressed on a case-by-case basis. In all cases, applicants should note the following:

Recommendations regarding plant molecular farming field trials

• The use of major food or feed crop species for plant molecular farming is not recommended
• The use of crop species that are pollinated by bees that contribute to commercial honey production is not recommended
• Developers are encouraged to consider fibre crops, crops with only minor food or feed use, small-acreage specialty food or feed crops, or new crops as production platforms
• The host species should be as amenable to confinement as possible (in other words, developers should consider level of outcrossing, mode of pollination, weediness, seed dormancy, seed dispersal, harvest efficiency, tendency to volunteer, and available reproductive control mechanisms in choosing a production platform)
• Genetic mechanisms such as inducible fertility, tissue-specific or post-harvest inducible expression of the compound may be useful in mitigating environmental exposures

Additional terms and conditions for plant molecular farming field trials

For traditional food or feed crop species, the minimum isolation distances are 2 times that prescribed for the species as listed in Appendix I of this page. These distances may be reduced if alternative methods of reproductive isolation are used (see section 3.3.2).

For any species, the trial must be isolated from any seed production field of the same or related species by a distance of 4 times the isolation distance listed for the species in Appendix I of this page.

Land within 50 m of the trial perimeters may not be used for food or feed production, including grazing of livestock. It is not necessary that this 50 m be left clean. For example, ornamental species, or any other plant that will not be grazed or harvested for food or feed, may be cultivated in this area. Research trials of material that will not enter the food or feed chain will also be permitted within the 50 m area.

The PBO may in some cases impose restrictions on cultivation of crops for food or feed use or on grazing of livestock during post-harvest years of sites of trials of PNTs intended for plant molecular farming. These restrictions will be imposed on a case-by-case basis. Developers are encouraged to consult with the PBO early in the application process to ensure appropriate planning for post-harvest land use.

Disposal of plant residue after harvest must be witnessed by an inspector of CFIA.

Additional information requirements for plant molecular farming trials

Health Canada and the CFIA's Animal Feed Program require 60 days to assess potential risks to food and feed supplies in cases of plant molecular farming trials are conducted in crop species traditionally used for food or feed. Where submitted data is incomplete, additional data will be requested and a new 60-day assessment period will commence when the additional data is received. Consult sections 4.2.2 and 4.3.2 for data requirements of these assessments. Applicants are encouraged to consult with the PBO as early as possible to avoid planting delays.

3.12.2 Stacked plant products

Stacked plant products are developed by conventional crossing of 2 or more PNTs that have been previously authorized in Canada. Stacks must be authorized by CFIA prior to unconfined release. However, in cases where an unconfined release authorization hasn't yet been granted, stacked products are exempted from the requirements of this directive if:

• the proposed planting falls within the confined research field trial size limits (section 3.2)
• the proposed planting is intended for scientific research or technical data gathering on the stack

If a planting is on a larger scale or is intended for purposes other than research (for example, demonstration or promotion of a product or application) the proponent must notify the PBO. The PBO will make a determination as to whether a confined research field trial application is required.

3.12.3 Outcrossing studies

If an outcrossing study is being performed, related species (modified or non-modified) can be deliberately planted on the field site and will be part of the experiment. However, PNTs must be separated from plants not included in the experiment by the recommended isolation distance. At the completion of such a study, the experimental plants must be handled in the same manner as PNTs.

3.12.4 Herbicide efficacy studies

For herbicide efficacy studies, related weeds may remain within the field site, provided they are removed and destroyed before seed set. The isolation distance must remain free from plants of the same species as the PNT and from any sexually compatible relatives of the PNT.

3.12.5 Disease nurseries

Reduced rotation cycles are sometimes required for building up disease inoculum in the soil of field sites. A partial exemption regarding the post-harvest land use restriction on crop sequences may therefore be allowed in the case of disease nurseries. For example, an applicant may decide to continue to grow a non-modified crop related to the PNT on a confined research field site that is subject to post-harvest land use restrictions. Additional terms and conditions may apply on a case specific basis.

3.12.6 Restrictions lifted after unconfined environmental release authorization

Applicants may request that the PBO lift restrictions on certain confined research field trials after a PNT has received an authorization for unconfined environmental release. The PBO will lift all restrictions provided that no other PNTs were tested at the field site. It is the applicant's responsibility to submit a written request to the PBO, including a list of sites where restrictions could be lifted, and a confirmation that only the authorized PNT was planted at these locations.

4. Other requirements

The PBO will exchange information with the Plant and Biotechnology Risk Assessment Unit and the Animal Feed Program of CFIA, the Pest Management Regulatory Agency (PMRA) and the Novel Food section of Health Canada, where required. However, it is the applicant's responsibility to ensure that all requirements of these departments are met directly.

4.1 Importation of PNT

If a PNT must be imported into Canada, the PBO will not authorize a confined research field trial until an import permit has been issued. Information on how to apply to import a PNT can be found online or can be obtained from any local CFIA office. A pest risk assessment may be required if the species has not previously been imported into Canada, or is being imported from a new origin.

4.2 Notification of the Animal Feed Program

Using the authority of the Feeds Act, the CFIA administers a national livestock feed program to verify that livestock feeds manufactured and sold in Canada or imported into Canada are safe, effective and labelled appropriately. All feeds, including novel feeds, must be authorized and/or registered by the Animal Feed Program prior to use as livestock feed.

4.2.1 PNT used for livestock feeding research

Authorization must be obtained from the Animal Feed Program prior to the use of any materials generated in confined research field trials as livestock feed. Applicants are responsible for notifying the Animal Feed Program to obtain this authorization, and must ensure that all of the requirements of the Feeds Regulations are met. Applicants should refer to Chapter 2.6 of the Regulatory Guidance: Feed Registration Procedures and Labelling Standards, entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources" for guidelines regarding the data requirements for authorization of PNTs for feed use. More information concerning the feed use of PNTs is available on the Livestock Feeds webpage.

4.2.2 Traditional feed crop species intended for end uses other than feed production

When a traditional feed crop species is developed for uses other than feed or food use, such as for plant molecular farming, "Exposure and Hazard" information must be included in the confined research field trial application. The PBO will send this information to the Animal Feed Program for a 60-day assessment period. Where submitted information is incomplete, additional information will be requested and a new 60-day assessment period will commence once the response is received.

The Exposure and Hazard documents must address all of the following points through data or scientific rationale:

Potential exposure

• Describe the plant tissues in which the novel compound(s) is (are) expressed and the extent to which these plant tissues may traditionally be present in livestock feed
• Provide expression levels of the novel compound(s) in any plant tissues from which livestock feed may be derived, or which may Be inadvertently present in livestock feed
• Describe if the novel compound(s) is (are) present in an active form in the plant and/or describe the trigger or procedure for activation
• Provide a description of the processing of the plant material highlighting areas where by-products are produced

Potential hazard

Toxicity and biological activity

• Describe the mode of action of the novel compound(s) in humans and animals
• Provide any available toxicology data for the expressed compound (note: data on the compound does not need to be from the plant-expressed source; however, if it is not, provide data to demonstrate similarity of the plant-expressed compound to products produced from traditional sources)
• Compare the amino acid sequence of the plant-expressed compound to amino acid sequences of known toxins to determine any potential homology

Allergenicity

• Compare the amino acid sequence of the plant-expressed compound to amino acid sequences of known allergens to determine any potential homology
• Based on those endogenous allergens known to be present in the host plant, parental lines, or donor organisms, provide any available data on levels of endogenous allergen(s) in the modified plant compared to that of an appropriate comparator

Information on donor organism

• Provide any available information on the history of the donor organism(s) being used in livestock feed
• Provide a critical assessment of the ability of the donor organism(s) to produce potentially toxic compounds, anti-nutritional compounds, and/or endogenous allergens

4.3 Notification of Health Canada

4.3.1 Notification of the Pest Management Regulatory Agency

Health Canada's PMRA administers the Pest Control Products Act, which provides authorities regarding the use and testing of pest control products.

Where a trial protocol involves the use of a pesticide not covered by a current registration, a research permit from the PMRA may be required. It is the applicant's responsibility to notify the PMRA when the protocol proposes the use of an unregistered product, or a registered product used for a non-registered purpose. Applicants are responsible for communicating with the PMRA regarding registration status of pesticides, research permit applications, and notification submissions. Regulatory directives and other general information, including information on how to apply for a pesticide research permit, are available at Pesticides and pest management.

4.3.2 Traditional food crop species intended for end uses other than food production

When a traditional food crop species is developed for uses other than feed or food use, such as for plant molecular farming, "Exposure and Hazard" information must be included in the confined research field trial application. The PBO will send this information to Health Canada for a 60 day assessment period. Where submitted information is incomplete, additional information will be requested and a new 60 day assessment period will commence once the response is received.

The Exposure and Hazard documents must address all of the following points through data or scientific rationale:

Potential exposure

• Describe the plant tissues in which the novel compound(s) is (are) expressed and the extent to which these plant tissues may traditionally be present in human food
• Provide expression levels of the novel compound(s) in any plant tissues from which human food may be derived, or which may be inadvertently present in human food
• Describe if the novel compound(s) is (are) present in an active form in the plant; if not, describe the trigger or procedure for activation
• Provide a description of the processing of the plant material highlighting areas where by-products are produced

Potential hazard

Toxicity and other biological activity

Show the anticipated human toxicity and/or biological activity of any human food derived from or containing material derived from the PNT if inadvertently consumed by humans, as follows:

• for protein expression products, the assessment of potential toxicity should focus on amino acid sequence similarity between the protein and known protein toxins and anti-nutrients (for example, protease inhibitors, lectins) as well as stability to heat or processing and to degradation in appropriate/representative gastric or intestinal model systems
  • acute oral toxicity studies using "gram/kg body weight" doses of the novel protein are appropriate for assessing the potential toxicity of proteins
  • results indicating no adverse effects using doses in the gram/kg body weight range together with evidence that the protein is digested to small peptides and amino acids would provide assurance that the protein is not a toxin and is digested to nutrients as are the vast majority of dietary proteins
• different types of in vivo or in vitro studies would be needed to assess the toxicity of introduced substances other than proteins that will be used for industrial purposes (for example, oils, plastics)
  • the types of studies are determined on a case-by-case basis and depend on the original source of the introduced substances and their function (such studies may include assays of metabolism, toxicokinetics, chronic toxicity/carcinogenicity, impact on reproductive function, and teratogenicity)

Allergenicity

Expression products of protein origin would require assessment for their potential to cause allergic reactions. This assessment should include consideration of whether a novel protein is one to which certain individuals may already be sensitive as well as whether a protein is likely to induce allergic reactions in some individuals.

The steps in assessing possible allergenicity of any novel proteins involve determination of:

• the allergenicity of the source of the introduced protein
• any similarity between the amino acid sequence of the protein and that of known allergens
• certain physicochemical properties, including but not limited to the protein's susceptibility to enzymatic degradation

The endpoint of the assessment is a conclusion as to the likelihood of the expressed protein being a food allergen. For more information on the assessment of potential allergenicity, please refer to Health Canada's Guidelines for the safety assessment of novel foods.

Information on donor organism

• Provide any available information on the history of use in food of the donor organism(s)
• Provide a critical assessment of the ability of the donor organism(s) to produce potentially toxic compounds, anti-nutritional compounds and/or endogenous allergens

Appendix I Species-specific requirements

Appendix II Confined research field trial map

Description for Confined research field trial map

The image is an example map of a field site, buffer zone and isolation distance as viewed from above.

At the top left of the image is a directional arrow with "N" indicating north. The top centre of the image contains a box with the following information "Inspection code: 24-INC1-WHT-SK001-01; Location: Saskatoon, SK, SW SW 31-35-5 W4; Trial Manager: Robin Johnson (306) 123-4567; Planting Date: May 15, 2024; NW: N52.36974, W106.01000; NE: N52.36974, W106.02000; SW: N52.36960, W106.01000; SE: N52.36960, W106.02000; Permanent marker: N52.36946, W106.02005."

The top right of the image contains an optional legend box with descriptors and the corresponding image. This includes a dashed line for field site boarder, a long dash dot line for permanent fence, a four-point star for GPS coordinate, a circle for corner fence post, and a flag for corner marker.

The central image consists of a center rectangle indicating the example current year field site, with a surrounding outer rectangle indicating the isolation distance. The current year field site contains the following information "Current Year Field Site 24-INC1-WHT-SK001-01." The field site square has marker flags at the corners and corresponding four-point stars with directional labels (including NW, NE, SW, and SE) indicating GPS coordinates. Along the length and height of the square, distance measurements indicate the size of the field site (54 m by 47 m). The space between the field site and the outer square is identified as the "Isolation Distance 30 m." The isolation distance contains the text "Surrounding crop: Canola" indicating the land use around the field site. Outside of the isolation distance square, in the bottom left of the image, there is a horizontal long dash dot line that meets a small circle and a vertical long dash dot line that extends downwards to the bottom of the image. This represents a permanent fence with a post at the corner. A four-point star at the fence post along with the label "Permanent marker" indicates GPS coordinates. An arrow from the fence post to the SW corner of the field site square is labelled as 34 m, 190° indicating the distance between the two.

In the bottom right corner of the isolation distance is a grey area representing a post-harvest area from a previous year field site. The central rectangle is labelled "Post-Harvest Year Field Site 23-INC1-BAR-SK001-01". The surrounding rectangle includes a double-pointed arrow, which indicates the "Buffer Zone 10 m." The upper left corner of the post-harvest field site is indicated with a flag as a corner marker. The post-harvest field site and corresponding buffer zone extends off the map and is partially included in this map as to indicate proximity to the current year field site and isolation distance. The field site and buffer zone combined are considered the "Post-Harvest Land Use Restriction Area" for proceeding post-harvest inspection years. Another arrow, labelled as 57 m, from the edge of the post-harvest year field site extends left to the fence post indicating the distance between these two points.

Appendix III Non-compliance and corrective actions

The information in this appendix is provided for illustrative purposes only. Each non-compliance will be managed on a case-by-case basis. It is the applicant's responsibility to ensure compliance with the terms and conditions of authorization, including the conduct of any subcontractors.

The responses to non-compliances are often determined by the growth stage of the plants that are found. To maintain a time buffer and minimize risk, please note that PBO considers any plants with flowers as "flowering", regardless of whether the plants reached anthesis (flower opening) or pollen shed. Similarly, PBO considers that any plants with seed have reached "seed set" regardless of whether the seeds are still immature.

Current Year

Post-harvest

Appendix IV Definitions

Applicant

The applicant must be a permanent resident or a citizen of Canada. Correspondence regarding the application will be addressed to the applicant. The applicant must accept full responsibility for compliance with all terms and conditions of authorization. Note: If a foreign entity intends to conduct field trials in Canada, arrangements must be made with a permanent resident or citizen of Canada who will act as the applicant. A signed statement is required from the foreign entity authorizing representation by the applicant.

Application

An application is the information submitted for each modified plant species. More than one submission and more than one field site may be included in a single application.

Buffer zone

The 10 m (50 m if commercial-scale equipment is used for harvest) perimeter surrounding the field site that must be monitored during the post-harvest restrictions period.

Confined research field trial

an all-encompassing term that can include the field site, isolation distance, buffer zone, and related applications, permissions, inspections, corrective actions, and record-keeping.

Construct

An engineered DNA fragment (for example, a plasmid) that includes the DNA sequences to be integrated into a target plant's genome.

Field site

Confined area where the trial plants are released into the environment. The field site is a single, unbroken geographical location. It does not include the isolation distance or buffer zone.

Gene flow

The transfer of genetic material through interbreeding between sexually compatible plants.

Growth stage

For the purposes of this program, key growth stages to note include:

• vegetative
• flower formation
• seed set (additional information about seed maturity can be useful in the case of a non-compliance)

Plant molecular farming

The use of novel plants for producing industrial or pharmaceutical compounds that may make the plants unsuitable for their traditional uses (for example, food and feed). These compounds are known as plant-made industrial products (PMIPs) or plant-derived drugs (PDDs).

Plant with novel traits (PNT)

Plant into which a trait has been intentionally introduced that is new to plants of the same species cultivated in Canada, and which has the potential to affect the specific use and safety of the plant with respect to the environment and human health.

Reproductive isolation

Refers to any methods used to limit gene flow between the trial plants and any other sexually compatible plants, and/or to limit the spread of the trial plants beyond the field site.

Secure container

Any means by which seed and any other propagable plant material may be contained for transport and storage such that a spill and/or dissemination cannot occur. The container must be labelled.

Seed

A "seed" as stated in the Seeds Act is defined as follows: Any plant part of any species belonging to the plant kingdom, represented, sold or used to grow a plant (Seeds Act).

Submission

A line derived from transformation with a DNA construct, or from a plant breeding selection. For example:

1. A plant transformed with one construct is one submission, including cases where a construct is intended to edit multiple target genes that are not genetically linked.
2. A plant transformed with two different constructs simultaneously to create a single line is two submissions.
3. A plant species transformed with one construct, where five different transformation events will be tested, is one submission, provided that the five events express the traits in a similar fashion.
4. A plant selected as part of a plant breeding program to develop a line with a novel trait is one submission.

Trait(s)

The phenotypic characteristic(s) conferred to the recipient plant by specific genetic changes.

Trial entry

An experimental trial of one submission, grown at one contiguous field site during a single growing season. For example:

1. Two different lines, each transformed with a variation of a construct conferring the same type of herbicide tolerance, planted on the same field site. This is two submissions at one field site and is counted as two trial entries.
2. Multiple lines, each transformed with the same construct, planted on the same field site. This is a single submission and is counted as one trial entry.
3. A perennial crop, such as alfalfa, tested at one site over a period of several years, will be counted as one trial entry for each year it is tested – a renewal application is required each year.

Unconfined release

A release into an environment of a plant with novel trait(s) that is not isolated either reproductively or physically from managed or natural environments, but which may be subject to other restrictions.