Plants > Biotechnology / PNTs > Confined Release 

Directive Dir2000-07:
CONDUCTING CONFINED RESEARCH FIELD TRIALS OF
PLANTS WITH NOVEL TRAITS IN CANADA

This is an updated Directive 2000-07 which includes new changes and all previous amendments.

TABLE OF CONTENTS

1 GENERAL INFORMATION

1.1 INTRODUCTION

The Canadian Food Inspection Agency' s (CFIA) Plant Biosafety Office (PBO) is responsible for regulating the intentional introduction into the environment in Canada of plants with novel traits (PNTs).

By definition:

• PNTs are plants containing traits not present in plants of the same species already existing as stable populations cultivated in Canada, or are expressed outside the normal statistical range of similar existing traits in the plant species.

• PNTs that are subject to an environmental safety assessment are those plants that are potentially not substantially equivalent to their counterpart plants with regards to potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity.

• Consistent with the Canadian approach, the CFIA recognizes that it is the presence of a novel trait in a plant that potentially poses environmental risk, and hence is subject to regulatory oversight, as opposed to how the traits are specifically introduced, e.g., introduction of novel traits by traditional breeding, mutagenesis, recombinant DNA techniques, etc.

A confined research field trial is the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any impact the PNT may have on the environment. These terms and conditions include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions. In Canada, confined field trials for research on plants with novel traits (PNTs) provide developers with the opportunity to evaluate the performance of PNTs, study the environmental safety of these modified plants, address the criteria and information requirements considered in the environmental safety assessment of PNTs for unconfined releases and generate data for variety registration purposes.

1.2 SCOPE

The purpose of this Directive is to provide clear and concise instructions to help applicants meet the regulatory requirements of the Canadian Food Inspection Agency (CFIA) for authorization of, or renewal of previously authorized, confined field trials of PNTs for research purposes. It considers only field trials of imported or domestically developed PNTs released into the environment under terms and conditions of confinement. This Directive summarizes the information requirements and procedures used by the Plant Biosafety Office (PBO) of the Plant Products Directorate, CFIA, and where appropriate, other federal and provincial agencies that reserve the right to comment on the conduct of the trials. The information presented in this Directive does not preclude additional regulatory requirements from other sections of the CFIA or other government agencies (see Section 4). If in doubt, please call the PBO at (613) 225-2342 to verify if these guidelines apply to your material.

Please Note: Additional requirements for Plant Molecular Farming Confined Research Field Trials can be found at http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007ie.shtml "Interim Amendment to DIR2000-07 for Confined Research Field Trials of PNTs for Plant Molecular Farming"

1.3 REGULATORY TRIGGER

1.3.1 INTERPRETATION OF NOVELTY

A new variety of a species is subject to regulatory oversight when it possesses characteristic(s) or trait(s) novel to that species in Canada, i.e., the trait(s) itself/themselves, its/their presence in that plant species or its/their use are considered unfamiliar when compared with those of other plants of the same species that are grown in the Canadian environment and already regarded as safe, regardless of how the trait(s) was/were introduced. As a result, plants developed through mutagenesis, somaclonal variation, wide cross, protoplast fusion or other techniques, as well as the plants developed through recombinant DNA technology may be considered PNTs.

For example, a new wheat line with a different resistance to lodging developed from an intra-specific cross of seeds already grown in Canada or a new canola line with a higher known disease resistance developed from an intra-specific cross of seeds already grown in Canada would not be considered PNTs. Beyond the more straightforward examples, there are cases that may or may not trigger regulation, depending on the expressed trait. Conventional breeding may result in a PNT if the selected trait falls well outside the agronomic, nutritional and compositional range for that species in Canada. In general, conventional breeding with approved germplasm in cultivation in Canada will not usually result in a PNT. Enhancing a trait in a cultivated species by introgressing genes from wild biotypes, using germplasm from outside of Canada, or mutagenesis techniques, may result in a PNT.

The components of novelty are different for plants with novel traits, novel feeds, and novel foods, because the risks associated with each are somewhat different. Environmental release of PNTs requires authorization from the CFIA' s PBO, while novel feeds and novel foods are regulated by the CFIA' s Feed Section (FS) and Health Canada, respectively.

The applicant has the responsibility for determining the novelty of the product in question. To ensure compliance with all directives and guidelines, consultation with the PBO of FS of the CFIA, or with the Office of Food Biotechnology of Health Canada is encouraged.

1.3.2 INTRASPECIES CROSSES INVOLVING PNTs

After a plant has received regulatory authorization for unconfined environmental release, all sister lines derived from the original transformation are also authorized provided:

• no inter-specific crosses are performed,
• the intended use is similar,
• it is known following thorough characterization that these plants do not display any additional novel traits and are substantially equivalent to the plant currently used in cultivation,

1.3.3 INTERSPECIES CROSSES INVOLVING PNTs

An environmental safety assessment of the plant created from the first interspecific cross will be required. Subsequent to an unconfined authorization by the PBO for that interspecific cross, a company may not be required to apply to the PBO for authorization of further lines, provided that the developer has generated data to support the determination that the plant is not a PNT, and provided there is no new transformation event. The company must always ensure that the novel gene(s) are expressed at the same level as that of the authorized plant. The data used to determine non-PNT of plants created through subsequent crosses must be retained by the applicant and presented on request.

1.3.4 RE-TRANSFORMATION AND RE-MUTATION OF APPROVED PNTs

Once a PNT has received unconfined environmental release approval, similar future plant lines developed by means other than conventional breeding (e.g. re-transformation of the same species with the same construct, mutation of the same gene in the same plant species) may not require a submission to the PBO, provided that the developer has generated data to support the determination that the plant is not a PNT. The PBO recommends consultation with regulatory authorities for further guidance. The PBO reserves the right to request access to this data at any time, or require the submission of an unconfined environmental release application.

1.4 LEGAL AUTHORITY FOR THE REGULATION OF PNTs IN CONFINED RESEARCH FIELD TRIALS

The Seeds Act, administered by the Plant Products Directorate, CFIA, provides authority to regulate the quality, testing, inspection and sale of seeds in Canada. The Seeds Regulations, Part V - Release of Seed defines the regulatory requirements for both confined and unconfined environmental release of PNTs in Canada.

For your information, the importation of any PNT for any purpose requires an import permit that must be obtained from the Director, Plant Health Division. PNTs exempt from this requirement are those that have been previously authorized by the CFIA for unconfined release into the environment. Import permits are issued under the authority of the Plant Protection Act, administered by the Plant Health Division, CFIA, for the purposes of protecting Canadian agriculture and forestry from pests injurious to plants.

1.5 ENVIRONMENTAL SAFETY ASSESSMENTS OF PNTs FOR CONFINED RELEASES

Research field trials of PNTs which are not approved for livestock feed, human consumption and unconfined release into the environment must be released under confinement in order to minimize any risks the PNT may pose on the environment, livestock and human health.

The confined research field trial application addresses the information requirements and must be submitted by the applicant to the PBO for review. The potential adverse environmental impacts associated with the confined field testing of the PNT are identified in the application. The potential hazards can be identified based on the information submitted regarding the novel gene product (toxicity and allergenicity), the transformation method, the characteristic of the novel trait, the altered plant characteristics of the PNT, the habitat where it is released, the indigenous species present at the trial site and the trial protocol. The information requirements for the confined research field trials are described on the confined research field trial application form presented in Appendix 1.

General and species-specific terms and conditions of authorization are imposed by the PBO on confined research field trials in order to keep the plant material confined (see section 3.1). The PBO may increase or add terms and conditions on a case by case basis depending on the PNT used in the trial and the risks associated with its release under confined conditions. The PBO may also refuse to authorize the release of a PNT into confined field trial conditions, where the proposed confined release poses an unacceptable risk to the environment and/or animal and/or human health. In addition to the terms and conditions of authorization, each confined research field trial submission is subject to restrictions in the size and number of sites per province and to a maximum cumulative hectarage per province (see section 3.3). Restrictions on the size and number are required to mitigate the impacts the PNT material may have on the environment.

1.6 GENERATION OF DATA FOR ENVIRONMENTAL SAFETY ASSESSMENTS OF PNTs FOR UNCONFINED RELEASES

Applicants considering future commercialization of a PNT for eventual release into the environment without confinement are encouraged to include experiments designed to meet the information requirements of Directive Dir94-08 "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits" . Specifically, such experiments could contribute to generating data which can be used to address the five key criteria of environmental safety assessments: altered weediness potential, potential for out-crossing, altered plant pest potential, impact on non-target organisms, and other impacts on biodiversity. Applicants for confined research field trials should keep in mind that the generation of data for a determination of environmental safety under Dir94-08 must be produced using statistically valid experimental designs and protocols (i.e. equivalent to the standards required for inclusion in peer-reviewed research publications). In making an application for the unconfined release of a PNT, proponents will be required to submit details of field trial protocols, including experimental designs and sampling procedures. Trials must be conducted in a manner consistent with the proposed farming practices the PNT.

1.7 DEFINITIONS

1.7.1 Applicant: The applicant must be a permanent resident of Canada or must designate a Canadian agent who is a permanent resident of Canada. The applicant does not have to be the breeder or owner of the PNT, however, if the applicant is not the breeder/owner, a signed statement is required from the breeder/owner authorizing representation by the applicant or the designated Canadian Agent. All correspondence with respect to the application, including authorization of trials, will be addressed to the applicant, or when appropriate, the Canadian Agent. The applicant/Canadian Agent must accept full responsibility for compliance with all terms and conditions of authorization.

1.7.2 Application: An application is the data package submitted for each modified plant species intended for a confined release and which meets the information requirements of this Directive. More than one submission (see definition 1.7.12) may be included in a single application.

1.7.3 Confined research field trials: A confined research field trial is the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any impact the PNT may have on the environment. These terms and conditions include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions.

1.7.4 Construct: An engineered DNA fragment (e.g. plasmid) which contains, but is not limited to, the DNA sequences to be integrated into a target plant's genome.

1.7.5 Familiarity: Knowledge of the characteristics of a plant species and experience with the use of that plant species in Canada.

1.7.6 Field trial: A field trial is an experimental trial of one submission (see definition 1.7.12), grown at one trial site location (see definition 1.7.16) for the purpose of conducting research.

For example:

a) Two different lines of a plant species, such as canola (Brassica napus), one showing tolerance to the herbicide sulfonylurea, resulting from the insertion of the gene coding for an altered acetolactate (ALS) enzyme, and the other showing tolerance to certain insects by the insertion of the d-endotoxin gene from Bacillus thuringiensis, both to be grown in the same field trial site location in one year will be considered as two field trials.

b) Two different lines of tobacco, both showing tolerance to the herbicide sulfonylurea, resulting from the insertion of two different genetic constructs, both to be tested in a confined research field trial site location in one year will be considered as two field trials. A separate assessment will be carried out on each of the two different genetic constructs.

c) Flax modified to be resistant to a specific herbicide as a result of one specific gene insertion, to be tested for agronomic performance in confined research field trials at six locations will be considered as six field trials.

d) The same modified soybean to be tested at the same six general locations over two growing seasons will constitute 12 field trials

e) Perennial crop such as alfalfa, tested at one site over a period of several years, will be counted as one trial for each year it is tested.

1.7.7 Gene flow: The transfer of genetic material through interbreeding between sexually compatible plants.

1.7.8 Plant Molecular Farming: The use of plants in agriculture for the production of pharmaceutical or industrial compounds and not intended for general use as food and/or feed.

1.7.9 Plant with novel traits (PNT): A plant variety possessing a characteristic that is intentionally selected or created through a specific genetic change and is either not previously associated with a distinct and stable population of the plant species in Canada or expressed outside the normal range of a similar existing characteristic in the plant species.

1.7.10 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.

1.7.11 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).

1.7.12 Submission: A submission refers to each plant species/genetic modification combination. For example, two lines of the same plant species transformed with different constructs constitute two submissions. Two lines of the same plant species transformed with the same construct will constitute one submission, provided the two lines express the traits encoded by the construct in a similar fashion.

1.7.13 Substantial equivalence: The equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.

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

1.7.15 Transgenic plant: A plant in which one or more genes, genetic constructs, or traits have been introduced using recombinant DNA techniques, which could be considered to include the insertion of genetic material from the same or different species.

1.7.16 Trial site location: A field trial or trials of a submission or submissions of a single species at a single location. Single location is defined as a single, unbroken geographical location.

1.7.17 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 may be subject to other restrictions.

2 APPLICATIONS FOR CONFINED RESEARCH FIELD TRIALS OF PNTs

2.1 REQUIREMENTS FOR CONFINED FIELD TRIAL APPLICATIONS

Applications for new, and renewals of previously authorized confined research field trials of PNTs are required and must be submitted to the PBO for review (must be provided in one of Canada' s two official languages; French or English). The applicant engaged in a confined research field trial must be a permanent resident of Canada or must designate a Canadian agent who is a permanent resident of Canada. The applicant/Canadian Agent must accept full responsibility for compliance with all terms and conditions of authorizations. The applicant/Canadian Agent is responsible for the cost(s) of disposal of the PNT, in those cases when the confined release of this PNT is stopped. The applicant/Canadian Agent is also responsible for the cost(s) of all remedial actions required in the event of an accidental release of the PNT. Applicants or Canadian Agents should not undertake confined research field trials unless they have been authorized by the PBO.

The onus is on the applicant/Canadian Agent to ensure that the confined research field trial will not negatively affect any other trial or non-PNT crop(s). The PBO requires that each applicant/Canadian Agent (i) determine what plant material, if any, will be in proximity to each trial (including within the isolation distance) before the confined research field trial is planted, and (ii) consider contingency plans in the event of accidental release of material or inadvertent breakdown of reproductive isolation.

The information requirements for new confined research field trial applications are outlined on the application form provided in Appendix 1 of this directive. Applications must be completed in full to ensure timely evaluation and to minimize requests for further information. The PBO must be notified in writing of renewals of previously authorized confined research field trials each year following the field trial' s initial approval (see Section 2.2).

If the PNT intended for use in the trial is to be imported into Canada the PBO will not authorize a confined research field trial until an import permit has been issued by the Plant Health Division. An "Application for Permit to Import" can be downloaded as a PDF file at: http://www.inspection.gc.ca/english/plaveg/bio/importe.shtml or can be obtained from any local CFIA office.

The PBO will distribute copies of received field trial applications to the Feed Section, CFIA, if the applicant intends on feeding the material from the confined research field trial to livestock for research purposes. In these case(s) a review will be completed by the Feed Section, CFIA. It is the applicant' s responsibility to notify the Pest Management Regulatory Agency (PMRA), Health Canada, when the confined research field trial proposes the use of an unregistered product, or a registered product used for a non-registered purpose. While the PBO will exchange information with PMRA and the Feed Section, where required, it is the applicant' s responsibility to ensure that all requirements of these offices are met directly (see Section 4). Additionally, the PBO will send non-confidential information about each trial to designated provincial government contacts in those provinces where proposed trials are to be conducted. Secondary agencies and provincial governments have a 30 day turnaround time and any comments from them are considered by the PBO in the final evaluation of the application.

2.2 RENEWALS OF PREVIOUSLY AUTHORIZED CONFINED RESEARCH FIELD TRIALS

The PBO must be notified, in writing, of renewals of previously authorized confined research field trials each year following the field trials initial approval. It is the applicant' s responsibility to ensure that all requirements of PMRA and the Feed Section are met directly for the renewal of application (see Section 4). The PBO will notify the designated provincial government contacts about the renewal of application. Secondary agencies and provincial governments have a 30 day turnaround time and any comments from them are considered by the PBO in the final evaluation of the application.

Gene constructs, genetic modifications, plant material, and the trial sites (including size and location) must be identical, and the trial purposes, and experimental protocols must be similar to those reviewed and authorized in previous years.

The terms and conditions of authorization required in previous years still apply, however, the CFIA reserves the right to modify, add, or remove any condition of authorization upon renewal and any changes will be communicated to provincial and other federal authorities.

Applications for renewals of previously authorized confined research field trials should be forwarded to the PBO prior to the deadlines, March 15 for spring planting or June 15 for fall planting. For perennial crops or trees, the years following the field trial' s initial approval shall be considered to be renewals and applications should be submitted to the PBO prior to the deadlines.

2.3 WHERE TO APPLY

Applications for new, and renewal of previously authorized, confined research field trials of PNTs should be mailed to:

National Manager, Environmental Release Assessment
Plant Biosafety Office
Plant Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

In the case of confined research field trials involving imported PNT' s, a " Permit to Import" must be obtained. Applications for "Permit to Import" must be sent to:

The Permit Office
Plant Health Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

In the case of confined trials involving unregistered pesticides, or unregistered use of registered pesticides, see Section 4 regarding the requirements of the PMRA.

2.4 WHEN TO APPLY

Applications for field trials must be received by the PBO on or before March 15th for spring-planted trials or June 15th for fall-planted trials. Applications are processed on a first-come, first-served basis. Failure to meet the application deadline may make it impossible to provide authorization in time for planting. See also Section 4 regarding the requirements of PMRA if applicable.

2.5 FEES

Please see Appendix 2 for a schedule of fees for the review and authorization of confined research field trials of PNTs. For a new application, the fee applicable shall be calculated based on the number of submissions included in the application and the number of trial site locations that exist. For a renewal of authorization, the fee applicable shall be calculated and due each year that the trial is to continue to exist on the basis of the renewal of the application, and the number of trial site locations. A renewal fee of $100.00 will be imposed only when the trial meets the renewal criteria outlined in section 2.2.

The submission fee must be included with the application. The review and processing of an application will only commence once the PBO receives the payments. Once review of an application has been initiated, the submission fee will not be refunded. Fees for trial site locations are due prior to May 15^th in the case of spring planting and August 1^st for fall planting. These fees will not be refunded after the respective due date or after an authorization letter has been issued.

2.6 INFORMATION CONSIDERED CONFIDENTIAL

Please indicate on the application any specific information that is considered to be confidential business information (CBI ). Please do not apply a confidential stamp to all pages of the application. Although information is held as confidential, the retention of this information as CBI is subject to the federal Access to Information Act and Privacy Act (ATIP). Please contact the CFIA' s ATIP Services at (613) 225-2342 for additional information.

2.7 WEBSITE SUMMARIES OF AUTHORIZED CONFINED RESEARCH FIELD TRIALS

General and non-confidential information about confined research field trials authorized by the PBO for each growing season is made available to the public upon request from the CFIA or from the PBO' s web site at: http://www.inspection.gc.ca/english/plaveg/bio/confine.shtml#sum. The PBO web site contains tables summarizing the total number of field trials authorized and information on the trials including the organization conducting the research field trial(s), the crop species, a general description of the novel trait(s) and the province(s) in which the trials are being conducted. For example:

The PBO also submits non-confidential information on authorized confined research field trials to the Organization of Economic Cooperation and Development' s BioTrack database.

3 CONDITIONS OF AUTHORIZATION OF CONFINED FIELD TRIALS

3.1 GENERAL AND SPECIES-SPECIFIC TERMS AND CONDITIONS FOR CONFINED RESEARCH FIELD TRIALS

The terms and conditions include, but are not limited to, reproductive isolation, site monitoring, and post-harvest land use restrictions. See Appendix 3 for general terms and conditions that will be imposed on all trials. To view the species-specific terms and conditions from 2003 to the present please refer to the PBO website (will require a web address). When planning trials please refer to the most recent information. The PBO may alter the terms and conditions from year to year based on the most recent scientific data. Applicants are encouraged to view these terms and conditions as minimum requirements. The PBO may increase or add terms and conditions on a case by case basis depending on the PNT used in the trial and the risk associated with its release under confined conditions.

It is the applicant' s (or Canadian Agent' s, as appropriate) sole 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.

The PBO strongly recommends that applicants notify neighbours that have land surrounding the trial site and may be affected by a breakdown of reproductive isolation.

3.2 THE PRESENCE OF ENDANGERED SPECIES AT THE TRIAL SITE LOCATION

It is important to know if there are any endangered species at or near the trial site location which could potentially 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 Boulevard
Hull, Quebec
K1A 0H3

3.3 RESTRICTIONS ON THE SIZE AND NUMBER OF CONFINED RESEARCH FIELD TRIAL SITE LOCATIONS

In Canada, confined research field trials of PNTs provide researchers with the opportunity to evaluate the PNTs under conditions which minimize their impact on the environment. The confined research field trial system is only for research purposes and is not intended to support other activities such as seed multiplication for commercial purposes. In order to maintain the integrity of this system, each confined research field trial submission is subject to restrictions in the size and number of sites per province and to a maximum cumulative hectarage per province as follows. Confined research field trial site locations are limited to no more than:

1. 1 hectare per trial location site.

2. 10 trial site locations per submission per province (includes locations submitted in new applications and renewal of authorizations).

3. 5 hectares cumulative per submission per province (includes locations submitted in new applications and renewal of authorizations).

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

a) one line (submission) of a plant species at 5 trial site locations. The trial site locations are 1 hectare each or less.

b) one line of a plant species at 10 trial site locations. The trial site locations are 0.5 hectare each or less.

The above restrictions still apply in situations where the confined research field trial is part of variety registration and/or performance trials. Minor exemptions from the restrictions may be granted under extenuating circumstances, but only for research purposes. The applicant must submit a detailed project proposal, including a rationale for the exemption, along with their application to the PBO, by March 15th (spring planting) or June 15th (fall planting) of the year of planting.

3.4 REPRODUCTIVE ISOLATION OF CONFINED RESEARCH FIELD TRIALS

In order to minimize potential 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.

3.4.1 ISOLATION DISTANCES (SPATIAL SEPARATION) AND DESTRUCTION ZONES

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

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

3.4.2 ALTERNATIVE METHODS FOR REPRODUCTIVE ISOLATION

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

1. 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.

2. Harvest of plants before flowering (requires close monitoring at the onset of flowering).

3. Removal of floral parts before pollen maturity.

4. Guard rows/Pollen traps must be seeded no greater then 10 metres and no less then 3 metres from the trial. In the case of field trials of modified Medicago sativa, Brassica napus or B. carinata the use of a 10 metre deep perimeter of non-modified plants of the same species is acceptable to act as guard rows and pollen traps (bee traps). For B. rapa a 100 metre deep perimeter of non-modified plants of the same species is acceptable to act as guard rows and pollen traps (bee traps). In all cases, the guard row plants must flower concurrently with the PNTs and no large gaps can be created for machinery use. The maximum gap size permitted is 50 cm. If machinery use is required a maze entrance to the trial may be acceptable. The applicant must provide a maze proposal with scientific justification for the design. The density of flowering plants in the guard rows must be similar to the density of flowering plants within the trial plot.

Should guard rows fail to flower concurrently with the test material, or should they be interrupted by large gaps (>50cm), a destruction zone corresponding to the minimum isolation distance will most likely be enforced, and this perimeter must be kept free of sexually compatible plants. The guard rows should be seeded with different varieties (with early and late season flowering period) to ensure concurrent flowering of the guard rows with the PNTs in the trial. The guard row area is considered to be part of the trial site and will be subject to the same terms and conditions and to post-harvest land use restrictions. Progeny from the non-modified guard rows (which may result from fertilization with modified pollen) must be handled in the same manner as PNTs and may not be used as human food or livestock feed unless prior approval is granted by Health Canada or the Feed Section of CFIA, respectively.

If an applicant (or Canadian Agent, as appropriate) 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 trial, then current season and post-harvest monitoring and restrictions will also apply to the minimum isolation distances. For example, if an applicant/Canadian Agent chooses to ensure reproductive isolation of a B. rapa trial by netting the PNTs, and if the netting fails to prevent pollen movement, a 400 m isolation distance around the B. rapa trial will be imposed. It is the applicant' s (or Canadian Agent' 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.

3.5 MAPS AND GPS COORDINATES

Maps and GPS coordinates for all confined research field trials are a prerequisite of authorization and must be supplied to the PBO, i.e. maps and GPS coordinates must not be submitted to CFIA inspector or area staff. The PBO recognizes that exact trial locations may not be finalized by the March 15th application deadline (spring planting) or the June 15th application deadline (fall planting). Applications without exact trial locations will be accepted if:

1. The application is received by March 15th (spring planting) or June 15th (fall planting) and includes the general location (to the nearest town), the expected planting date and the number of trial site locations within each general location.

   and

2. The legal land location is subsequently submitted no later than May 15th (spring planting) or August 1st (fall planting).

The PBO will not authorize a confined research field trial until information detailing the legal land location of each trial site location has been given.

Any changes to confined research field trial site locations made subsequent to authorization must be received by the PBO on or before May 15th (spring planting) or August 1st (fall planting) of the year of application. After this date trial site changes will not be accepted with the exception of cancellations. If a trial site change is made after May 15th (spring planting) or August 1st (fall planting), authorization of the trial will be revoked and the trial will have to be destroyed.

3.5.1 MAPS

It is the responsibility of each applicant to provide an exact map of each confined research field trial site location, no later than 7 days after planting. When a complete map has already been submitted with the application, the applicant must forward to the PBO the exact planting date of the trial within 7 days after planting.

Maps of confined research field trials must be legible and precise. CFIA inspectors have previously encountered problems locating trials sites, particularly in post-harvest years. Maps should be on a blank page with crisp line drawings and block letters. Maps on lined or graph paper will not be accepted. Photocopies of road maps may only be used as a reference for directions to the field. A site specific map must be included with the road map.

3.5.2 GPS

It is the responsibility of each applicant to submit the GPS (Global Positioning System) coordinates of each confined research field trial site location to the PBO within 7 days after planting. GPS coordinates must be taken precisely at all corners of each trial site and provided in the latitude longitude decimal degree format (degree only format) e.g. Lat 37.39941, Long 122.01816. Most of the economically priced units have the option to provide readings in this format. GPS coordinates will be used by CFIA inspectors to assist in locating the trial sites for current year and post-harvest inspections. The PBO reserves the right to cancel the authorization of any confined field trial for which GPS coordinates have not been received within seven days after planting of the trial.

Minimum Recommended GPS Unit Requirements

• Accuracy of 10-15 meters

• Datum set WGS84

• Latitude longitude decimal degree format (degree only format)

  e.g. Lat = 37.39941, Long = -122.01816

• All new units purchased should have Wide Area Augmentation System (WAAS) as a minimum requirement.

• Land based correction data to improve accuracy.

3.6 CHEMICAL TREATMENT NOTICE

If a chemical treatment is used on the trial site location that requires a time until safe entry a sign should be posted at the access to the trial indicating 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.

3.7 EQUIPMENT CLEANING

Seeding, transplanting, harvesting, and site maintenance machinery and equipment must be cleaned at the trial site prior to being moved to other locations. This is to prevent dispersal of plant material, especially propagable plant material. Any material collected during cleaning must be destroyed according to the terms and conditions.

3.8 RECORDS AND REPORTING OF CONFINED RESEARCH FIELD TRIALS

Records of all confined research field trials, including current season and post-harvest site monitoring, activities related to trial site compliance (including subcontracts), cleaning of machinery, transportation, disposition and storage of all surplus and harvested seed and plant material must be maintained by the applicant and must be made available to the CFIA upon request. A report summarizing the completed trials and experimental data, including any amendments to the original protocol, must also be made available to the CFIA upon request. Please note that a copy of these trial site records must be kept by the field manager at the trial site in order to facilitate the inspection of the records and disposal and storage methods by CFIA inspectors.

Applicants must keep a separate log book for each trial, during the current and post-harvest years of the trial:

To facilitate the records inspection, the PBO recommends that you include in the records general information about the trial such as:

• PBO trial 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 land use restriction (e.g. additional 10m or 50m based on harvest method, or additional land use restriction due to a compliance problem)

The following information and activities are required in the trial log books;

a) the transportation of seed to be planted, harvested seed and/or plant material to and from the trial site. These records should include a description of the method of transportation, date of transportation, a description of where the material is being transported to and from and the signature of the responsible party who recorded the information.

b) the disposition and/or storage of all surplus seed from planting at the trial site. These records should include the quantity of surplus seed, quantity of material disposed of and/or in storage, a description of the method of disposition and/or storage, date of disposition, a description of the location where the material is being disposed of and/or stored and the signature of the responsible party who recorded the information.

c) the cleanliness of the machinery involved in seeding or transplanting, site maintenance, harvesting, and trial destruction equipment. These records should include a description of how the machinery was cleaned, date of machinery use and date of cleaning, a description of the site where the machinery was cleaned and the signature of the responsible party who recorded the information.

d) the monitoring of the trial site, isolation distance and guard rows, if applicable, for the presence of prohibited related species or the same species. These records should include a description of each site monitoring activity indicating the presence of related species and their growth stage as well as the growth stage of the plants in the trial and guard rows, if applicable, the date the trial was monitored, the date the prohibited species were removed/destroyed, the destruction method of the prohibited species that were found and the signature of the responsible party who recorded the information.

e) the recording of compliance problems and corrective actions related to the trial, if applicable. These records should include a description of the nature of the compliance problem and corrective actions necessary to rectify the problem, the date on which the corrective actions were taken and the signature of the responsible party who recorded the information.

f) the disposition and/or storage of all seed and/or plant material harvested from the trial site (including the material from the guard rows if applicable). These records should include the quantity of material harvested, the date(s) of harvesting, a description of the method of disposition and/or storage, date of disposition, the quantity of material disposed of and/or in storage, a description of the location of where the material is being disposed of and/or stored and the signature of the responsible party who recorded the information.

g) the disposition of non-harvested residual plant matter resulting from the trial. These records should include a description of the method of disposition, the date of disposition and the signature of the responsible party who recorded the information.

3.9 DISPOSITION AND STORAGE OF PLANT MATERIAL FROM CONFINED RESEARCH FIELD TRIALS

Applicants must receive authorization by the PBO to retain seed and/or propagable plant material. Seed or other propagable plant material which is not authorized by the PBO to be retained, or which is not approved for use in the food or feed supply, must be disposed of by an approved method that will render the seed or propagable plant material non-viable (eg. autoclaving, burning or deep burial to a depth >1m). Composting is not an acceptable method for the disposal of plant material. Other plant material harvested that is not to be retained must be destroyed in the manner described above. Disposal of all remaining non-harvested plant material must be in accordance with the stipulated terms and conditions of authorization for that plant species.

Applicants are encouraged to 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. In order to complete the soil incorporation process the applicant is encouraged to use a rototiller, double disc or heavy plow. Light discing and heavy harrowing is acceptable for small seeded crops such as Brassica spp. More aggressive incorporation is recommended for larger seeded crop kinds. If the applicant decides to burn the plant material, incineration must be complete.

Confined field trial 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, thus limiting the seed bank.

Harvested seed and/or plant material from confined research field trials (including guard rows) that is to be retained must be stored appropriately in clearly labeled 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 and/or dissemination can not occur. No seed and plant material from the confined field trials may enter the human or livestock feed chain unless approved by Health Canada and the Feed Section, CFIA, respectively.

Applicants must provide the PBO in writing and within 15 working days after harvest (the final harvest at each trial site location, unless another reporting method has been approved by the PBO) with information on the quantity of seed and/or plant material harvested at the trial site, the date of harvest, the quantity of seed and/or plant material disposed of and date of disposal, and the quantity of seed and/or plant material retained and stored.

3.10 POST-HARVEST LAND USE

Following harvest, PNTs may arise at the field trial site in subsequent growing season(s) as volunteers. Therefore, the following precautions must be taken, to prevent volunteers crossing with crops of the same species or with sexually compatible related species:

1. monitoring of the trial site (including guard row area, if applicable) after harvest and in subsequent growing seasons each year the site is subject to post-harvest restrictions, in order to identify and ensure the destruction of volunteer plants and sexually compatible related species.
2. strictly no planting of any species related to the PNT on the trial site (including guard row area, if applicable) and surrounding 10m, each year the site is subject to post-harvest restrictions, in accordance with the species-specific terms and conditions.
3. monitoring the isolation distance zone (each year the site is subject to post-harvest restrictions), in addition to the trial site, for volunteers and for sexually compatible related species may be required in cases when reproductive isolation has failed.
4. If harvested by combine (other than small plot combines), an additional 50-metre buffer zone around the site must be monitored each year the site is subject to post-harvest restrictions. If a combination of large and small plot combines are used the 50 metre buffer will be imposed.  For all other trials, a 10B metre buffer zone around all sites must be monitored each year the site is subject to post-harvest restrictions.

All trial sites subject to post-harvest land use restrictions cannot be used as pasture for animal grazing since volunteer plants may grow on the site in subsequent growing seasons.

It is the applicant' s (or Canadian agent' s, as appropriate) responsibility to communicate with field managers precisely which material has, or has not, been authorized for unconfined release and therefore no longer subject to post-harvest land use restrictions.

3.11 INSPECTION OF CONFINED RESEARCH FIELD TRIALS

3.11.1 INSPECTION OF THE TRIAL SITES

CFIA regional inspectors have the authority to inspect trial sites during both the growing season and the period of post-harvest land use restriction for compliance with the terms and conditions under which the trials were authorized. Inspection activities regarding current year and post-harvest trial sites are completed on a random basis without prior notification to the applicant or field manager.

3.11.2 INSPECTION OF THE RECORDS AND DISPOSAL AND STORAGE METHODS

CFIA regional 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. The field manager must keep a copy of the confined research field trial site records (see Section 3.8) and must be present 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 the inspection of disposal and storage methods and should assist the inspector during the inspection.

3.12 SPECIAL CASES

3.12.1 OUTCROSSING STUDIES

If an outcrossing study is being performed, related species (modified or non-modified) can be deliberately planted on the trial 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.

3.12.2 HERBICIDE EFFICACY STUDIES

For herbicide efficacy studies, related weeds may remain within the trial 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.

3.12.3 REPLANTING TRIAL SITES WITH PNTs

If applicants wish to use the same trial site location in consecutive years, a partial exemption regarding required post-harvest land use restrictions such as crop rotations may be allowed for plants containing the same gene(s) in the same genetic background, tested on the same exact sites as the original trials. All resulting plant material will be destroyed after harvest, unless the PBO has authorized the retention of this material. The post-harvest land use restrictions must be observed following the last PNT trial. These trials are considered a renewal.

3.12.4 DISEASE NURSERIES

Reduced rotation cycles are sometimes required for building up disease inoculum in the soil of trial 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 field trial site that is subject to post-harvest land use restrictions. This exemption will only be authorized under the following conditions:

1) The applicant must provide in the original confined field trial application a list of crop species that will be grown at the site in the disease nursery each year the site is subject to post-harvest land use restrictions. Please note that if this information has not been submitted with the application, the exemption in crop sequences will not be authorized.

2) It is the applicant' s responsibilities to make sure that during the post-harvest land use restriction period, all species sexually compatible with the PNT (including the related crop grown at the site) are destroyed prior to flowering.

3) All resulting plant material from the related crop being grown at the site during post-harvest will be destroyed after harvest by burning, autoclaving, or burial to a minimum depth of one metre.

An applicant may also choose to renew his confined research field trials in subsequent growing seasons. Applications for renewal of previously authorized confined field trials of PNTs are required by the PBO. The post-harvest land use restrictions will be observed after the last PNT planting.

3.12.5 INSECT RESISTANCE MANAGEMENT FOR PNTs EXPRESSING BT ENDOTOXINS

Insect resistant management plans for all plants expressing Bacillus thuringiensis endotoxins must be implemented for any trial for which exemptions to the trial size have been granted (see section 3.3).

4 OTHER REQUIREMENTS

1) Using the authority of the federal Feeds Act, the Canadian Food Inspection Agency administers a national livestock feed program to verify that livestock feeds manufactured and sold in Canada or imported into Canada are safe, effective and are labeled appropriately. All feeds, including novel feeds, must be authorized and/or registered by the Feed Section prior to use as livestock feed.

Authorization must be obtained from the Feed Section prior to the use of any materials generated in confined field trials as livestock feed. Applicants or their Canadian agents are responsible for notifying the Feed Section to obtain authorization for the use of any materials generated in the trial as a livestock feed. It is the applicants' responsibility to ensure that all of the requirements of the Feeds Regulations are met. Applicants or their Canadian agents should refer to the CFIA' s Directive Dir95-03 "Guidelines for the Assessment of Livestock Feed From Plants with Novel Traits" for guidelines regarding the data requirements for authorization of PNTs for feed use.

For more information concerning the feed use of PNTs, refer to the Feed Section of the CFIA web page at: http://www.inspection.gc.ca/english/anima/feebet/feebete.shtml

2) The Pest Management Regulatory Agency (PMRA), Health Canada, administers the Pest Control Products Act which provides authority to the PMRA for regulating the use and testing of pest control products.

Applicants or their Canadian agents are responsible for communicating with the PMRA regarding registration status of pesticides, research permit applications, and notification submissions. It is the applicant' s responsibility to ensure that all the requirements of the PMRA are met. Applicants or their Canadian agents should refer to the PMRA' s Regulatory Directive Dir98-05 "Chemical Pesticide Research Permit Guidelines" for guidelines regarding permit applications and notification submissions.

Where a trial involves the use of a pesticide not covered by a current registration, a research permit from the PMRA may be required. Requirements for permits depend on the size of the field trial, the type of personnel conducting the trial and the premises where it is conducted. For small scale trials, there may be exemptions to the requirement for Permits, but a Notification of Pesticides Research in lieu of an application for Permits of Pesticides Research may be required. The PMRA requires that Applications for Permits of Pesticides Research be submitted 30 to 180 days before treatment, depending on the nature of the pesticide and trial site. Notifications must be submitted to the PMRA at least 30 days before the pesticide treatment.

Information on obtaining research permits or on the registration status of pesticides can be obtained from the PMRA' s Pest Management Information Service by phone at 1-800-267-6315 (outside Canada: 1-613-736-3799; long distance charges apply), by e-mail at pmra_infoserv@hc-sc.gc.ca, or by fax at 613-736-3798. Regulatory directives and other general information are available on the Internet at: http://www.hc-sc.gc.ca/pmra-arla.

Applications and Notifications regarding pesticides research should be addressed to the Submission Management and Information Division, PMRA, Health Canada (A.L. 6605E1), 2250 Riverside Drive, Ottawa, Ontario K1A 0K9.