Canadian Food Inspection Agency
Plant Products Directorate
Plant Biosafety Office

Directive 94-08 (Dir94-08)
Assessment Criteria for Determining Environmental
Safety of Plants With Novel Traits

This document updates Directive 94-08 (Dir94-08),
"Assessment Criteria for  Determining Environmental Safety of Plants with Novel Traits."
The original Dir94-08 was first published December 16, 1994, revised September 15, 2000, and then again on October 29, 2004.

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Table of Contents

1. Introduction

Directive 94-08, entitled "Assessment Criteria for Determining Environmental Safety of Plant with Novel Traits", has been prepared to provide guidance regarding the submission of an application for the authorization of the unconfined release of a plant with a novel trait (PNT) in Canada, as may be required under Part V of the Seed Regulations. Due to the broad range of PNTs that may be developed and submitted for approval in Canada , the information provided in these guidelines should not be considered as exhaustive and will be updated as appropriate to reflect current scientific knowledge and acquired field experience. For further clarification, applicants are strongly recommended to consult with the Canadian Food Inspection Agency's Plant Biosafety Office. For all purposes of interpreting and applying the law, applicants are invited to consult the official versions of the relevant Acts and Regulations.

The scope of this Directive covers all plants (excluding aquatic plants) containing a novel trait that has been intentionally selected, created, or introduced into a distinct, stable population of the cultivated plant species through a specific genetic change, including agricultural and horticultural crop plants and forest trees.

The purpose of this Directive is to (i) provide guidance on what constitutes a PNT, (ii) define the criteria and information relevant to an environmental safety assessment of a PNT under consideration for release and (iii) describe the steps leading to the unconfined release of a PNT. This includes identification of potential concerns, relevant information, and procedures to assess potential environmental effects associated with the unconfined release of PNTs. It should be noted that the definitions provided in Appendix 1 have been adapted from multiple sources to reflect the context of this Directive.

The Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA) is responsible for the administration of regulatory provisions regarding notification and authorization of the release of plants with novel traits (PNTs) into the Canadian environment.

By definition:
A PNT is a plant containing a trait not present in plants of the same species already existing as stable, cultivated populations in Canada, or is present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada. All PNTs are subject to an environmental safety assessment.

Substantial equivalence is used in the comparative assessment of a PNT relative to its counterpart to assess its relative and acceptable risk:

i) A PNT that is substantially equivalent, in terms of its specific use and safety for the environment, as well as for human and animal health, to plants currently cultivated in Canada, having regards to its potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, should pose no greater risk to the Canadian environment compared with its counterpart. A plant that is substantially equivalent to its counterpart and is derived from seed authorized for unconfined release  may be exempted from the notification and authorization requirements under the Seeds Regulations.

ii) A PNT that is not substantially equivalent, in terms of its specific use and safety for the environment as well as for human and animal health, to plants currently cultivated in Canada, having regards to their potential changes in weediness/invasiveness, gene flow, plant pest properties, impacts on other organisms and impact on biodiversity, may be authorized for release into the Canadian environment with appropriate environmental risk management and risk mitigation measures.

Before a PNT can be released into the environment, a determination of the associated risk to the environment, including to human health, is required.

The PBO is responsible for the authorization of release, whether it is confined or unconfined, of PNTs into the Canadian environment. The confined release, which may be considered to be a release for research purposes, involves imposing conditions such as reproductive isolation as well as restrictions on the use of harvested material and the field plot in subsequent growing seasons. Information relevant for the purpose of submitting an application for an authorization of confined research field trials is detailed in Directive 2000-07 (Dir2000-07), entitled "Directive for the Environmental Release of Plants with Novel Traits Within Confined Research Field Trials in Canada."

An unconfined release involves the release of a PNT into the environment with no restrictions, with a view towards commercialization. In general, a PNT will proceed from the research stage in a laboratory, growth chamber or greenhouse, to a confined field trial-based environmental release, and finally, to an unconfined release. Information gathered over several years regarding the agronomic/silvicultural and environmental characteristics of the PNT during its confined release stage will generally contribute to a developer's determination as to whether or not to proceed to the next stage of development, which is the unconfined environmental release. Particular PNTs, such as those intended for the production of pharmaceutical or industrial compounds, may be required to grow under conditions that provide for physical and reproductive confinement, even during its commercialization.

2. Regulatory Scope

2.1 Determination of Novelty

Prior to the introduction of a new plant into the Canadian market, it is necessary to consider whether or not it would be classified as novel under the provisions of the Feeds Act, the Food and Drugs Act, the Seeds Act, as well as under the provisions of the respective regulations of these Acts.

A new variety of a species is subject to the notification and authorization requirements of the Seeds Regulations when it possesses trait(s) novel to that species in Canada, i.e.,

i) the new trait is not present in stable, cultivated populations of the plant species in Canada, or

ii) the trait in the plant species is present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada.

Canada has a product-based regulatory system for plants with novel traits. It is the presence of a novel trait in a plant, irrespective of the method used to introduce it, which will trigger the notification and authorization requirements under the Seeds Regulations. PNTs may be developed through mutagenesis, somaclonal variation, intra-specific and inter-specific crosses, protoplast fusion, recombinant DNA technology, or other techniques.

Conventional breeding may produce a plant with a novel trait requiring notification and authorization of its release, depending on the selected trait's level of expression in comparison with similar existing traits present in stable, cultivated populations of the plant species in Canada. For example, an increase in yield in a new wheat line, similar to increases seen historically in wheat lines cultivated in Canada, may not be considered to be a PNT. However, a new sclerotinia resistant canola line exhibiting a resistance many folds higher than that currently grown in Canada would likely be considered a PNT. The introduction of a trait from wild biotypes or from germplasm originating outside of Canada, is more likely to produce a PNT than conventional breeding with germplasm already in use in the Canadian environment.

It is the responsibility of proponents (e.g., plant breeders, product developers, etc.) based both on their expertise and relevant scientific literature reviews, to determine the range of the selected trait in cultivated populations of the plant species in Canada. i.e. it is the proponent's responsibility to determine if they have produced a PNT. Thus, the PNT status of a new plant variety is determined on a case-by-case basis. The requirement for notification and authorization under the Seeds Regulations is triggered by the presence of a novel trait in a plant. Certain information detailed in this directive may be waived by the CFIA if it determines, based on valid, scientific rationale (supported by appropriate data and/or literature references) submitted by the proponent, that the information in question is not relevant to a particular PNT's environmental safety assessment, and as such, is not required for the CFIA's decision as to whether or not to authorize the environmental release of the PNT.

When a proponent contacts the PBO, CFIA, the Feed Section, CFIA, and/or the Novel Foods Section, regarding the determination of their plant's novelty status, as well as the novelty status of food and feed products derived therefrom, a meeting may be organized among all three groups to review the case to analyze the factors contributing to its status and to provide guidance to the proponent on applicable requirements.

Where a plant variety has been determined by the proponent to be a PNT, the food and feed products derived therefrom will usually be considered to be novel as well. However, in some cases, a plant variety will be determined not to be a PNT, but the food and feed products derived therefrom will be considered as novel. In other instances, a plant will be considered to be a PNT, but the food and feed products derived therefrom will not considered novel because of their history of safe use in the marketplace. In order to respond to a proponent's request for guidance on the novelty of their plant product, additional information may be required necessary in order to reach a decision.

2.2 Intra-specific Crosses

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

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

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

2.3 Inter-specific Crosses

Once a plant is authorized for unconfined release, an environmental safety assessment of the plant created from the first interspecific cross may be necessary. Subsequent to an unconfined release authorization for an interspecific cross, the proponent may not need to apply for unconfined release authorization of further lines, provided that the proponent has determined:

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

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

2.4 Intentional Trait Stacking

Proponents are asked to advise the PBO at least 60 days prior to the anticipated environmental release of plants having stacked traits and resulting from either intentional intra-specific or inter-specific crosses between PNTs already authorized for unconfined environmental release. Following notification, the PBO may issue a letter (within 60 days of notification) informing the proponent of any concerns the it may have regarding the unconfined environmental release. The PBO may request and review data to support the safe use of the modified plant in the environment. Stacking of traits with potential incompatible management requirements, possible negative synergistic effects, or where production of the plant may be extended to a new area of the country, may elicit an environmental safety assessment. Until all environmental safety concerns have been resolved, the modified plant should not be released in the environment.

2.5 Re-transformation and Re-mutation

A re-transformation/re-mutation, i.e.,

• transformation of a plant, with the identical construct(s) as a previously authorized plant of the same species
• mutation of the same gene in a plant as a previously authorized plant of the same species

which conveys the same novel trait to a plant as a transformation/mutation in a previously authorized plant may not trigger the notification and authorization requirements under the Seed Regulations, provided that:

• the method is identical to that used previously;
• the intended uses are similar;
• it is known based on characterization, that the plant does not display any additional novel traits and is substantially equivalent, in terms its specific use and safety for the environment and for human and animal health, to plants currently cultivated; and
• the novel genes are expressed at similar levels as that of the authorized line.

The PBO may ask the proponent to provide scientific evidence supporting these conclusions. For further guidance, consultation with the PBO, CFIA, the Feed Section, CFIA, and the Novel Food Section, Health Canada, is recommended.

3. Completion of an Application for Authorization of Environmental Release of PNTs

Proponents are encouraged to consult with the PBO in the early stages of development of their new plant variety in order to receive guidance regarding the determination of their plant variety's novelty status and, where appropriate, for clarification on what specific information is necessary for the PNT's environmental safety assessment. Applications that are complete and of acceptable quality and legibility will allow for timely assessments with a minimum of correspondence requesting further information.

3.1 Where to Apply

Please address your application for unconfined environmental release authorization of a PNT to:

Plant Biosafety Office
Plant Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: (613) 225-2342

3.2 When to Apply

The developer of a PNT is strongly encouraged to apply for unconfined environmental release authorization well in advance of the anticipated time of commercialization. Applications for authorization will be processed on a first-come-first-served basis. Degree of completeness of the application will also be a factor in the length of the review period required.

3.3 How to Apply and Number of Copies Requested

Applicants are asked to send a covering letter along with their application, summarizing their request for an unconfined environmental release authorization for their plant product and an explanation as to why their new variety is subject to regulatory oversight. A description of the plant species, the novel traits, and the potential geographic scope of the release should be included in this summary. Two copies of the application should be submitted to the PBO for review.

3.4 Information Considered to be Confidential

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

All requests for such information are subject to the federal Access to Information and Privacy Acts . Please consult with CFIA's ATIP service, at (613) 225-2342, for further information.

3.5 Fees

The application fee should be included with the application for the review to be initiated. Please see Appendix 2 for a schedule of fees for the review of applications and authorization for the environmental release of PNTs. Once review of an application has been initiated, the application fee will not be refunded. Please make cheques payable to the Receiver General of Canada.

3.6 Submission to Feed Section and Health Canada

The Feed Section, CFIA, is responsible for the administration of regulatory provisions with respect to the authorization of the release of novel feeds. The Novel Foods Section, Health Canada, is responsible for the administration of regulatory provisions with respect to the authorization of the release of novel foods intended for human consumption. The unconfined environmental release of a PNT in Canada intended for feed and/or food use, or that could reasonably be expected to be used as feed or food, may require:

• a determination of environmental safety by the PBO (CFIA),
• a determination of product safety as a novel livestock feed by the Feed Section (CFIA), and
• a determination of product safety as a novel food by the Novel Foods Section (Health Canada).

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

Where registration of a pest control product is mandatory, it is the applicant's responsibility to meet all the requirements of the Pest Control Products Act, an act which is administered by Health Canada's Pest Management Regulatory Agency (PMRA). PMRA is the federal agency responsible for conducting the appropriate risk and value assessments of pest control products in Canada. Applicants may wish to refer to the Registration Handbook for Pest Control Products as a detailed reference for the registration process.

3.7 Submissions to PNT Authorities

Applicants seeking authorization for the unconfined environmental release in Canada of plants that may be regulated in the United States are encouraged to seek authorization for the environmental release of their product in the United States simultaneously. Obtaining such authorizations may minimize the movement of unauthorized material across the border of a product released in one country but whose release is not authorized in the other. It is recommended that applicants advise the CFIA of any notification to foreign governments of the intended unconfined environmental release within their respective foreign borders of a PNT under review in Canada. Where appropriate, the CFIA may try to coordinate its activities and work with foreign governments to minimize the presence of unauthorized products in each country's respective environment.

4. Legal Authorities

For the regulation of PNTs in confined research field trials and unconfined release:

The Seeds Act, R.S., c. S-8
The Seeds Regulations, C.R.C., c. 1400, Part V

For the importation of plant materials, including PNTs:

The Plant Protection Act, S.C. 1990, c.22
The Plant Protection Regulations, SOR/95-212

For the collection of fees:

Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part 1 (05/13/2000)

5. Exemptions

A seed (which covers plants under the Seeds Act) is not subject to Part V of the Seeds Regulations if one of the following applies:

i) the seed was grown in Canada outside of containment before the coming into force of Part V of the Seeds Regulations (i.e., prior to December 1996),

ii) the seed is derived from seed referred to in paragraph i), or from seed in respect of which an unconfined release has been already authorized, or

iii) the seed is grown in containment in such manner that there is no release into the environment of any genetic materials from the plants derived from the seed.

6. Environmental Safety Assessment of Plants with Novel Traits

6.1 Environmental Safety Assessment Criteria

• The PBO assesses the environmental safety of PNTs based on the five criteria:
• potential of the PNT to become a weed of agriculture or be invasive of natural habitats,
• potential for gene-flow to wild relatives whose hybrid offspring may become more weedy or more invasive,
• potential for the PNT to become a plant pest,
• potential impact of the PNT or its gene products on non-target species, including humans,
• potential impact on biodiversity.

6.2 Environmental Safety Assessment

The PBO performs environmental safety assessments of PNTs based on the five criteria listed above, primarily using two sets of information. The first set is a companion biology document, which provides baseline information for the plant species of the PNT under review (Please see Section 7.2 for details).

The second set of information is submitted by the applicant as part of a complete application for the unconfined release authorization of the PNT is question and consists of appropriate data and relevant scientific information describing the environmental risk of the PNT relative to its counterpart(s) already present in the Canadian environment (Please see Section 7, entitled "Authorization for Environmental Release of a PNT"). This data should be collected through testing and analysis, and during confined research field trials conducted either in Canada (Please refer to Dir2000-07 for further details), or in foreign environments similar to that of Canada's. Based on the information provided in the biology document, field experiments can be carefully designed to generate data demonstrating the agronomic/silvicultural and environmental characteristics of the PNT relative to its counterpart.

The PBO may also use other peer-reviewed scientific literature, as appropriate, to guide their safety assessments.

6.3 Consultation with Experts

During its evaluation of an application for the authorization of the environmental release of a PNT, the PBO may consult relevant scientific experts on specific issues with regards to the environmental safety of a PNT. For example, the PBO may solicit the scientific expertise of Health Canada' PMRA with respect to the environmental safety of a PNT expressing altered pesticidal tolerance or altered pesticidal properties. Information considered as confidential business information (CBI) will not be shared without prior written authorization from the applicant. Solicited advice, given by either PMRA or other consulted scientific experts, will be considered by the PBO in the final evaluation of the PNT for unconfined environmental release.

7. Authorization of Environmental Release of a PNT

7.1 Specific Information

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

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

The specific information relevant for the purposes of conducting environmental safety assessments can be found in Appendix 3, entitled "Relevant Information Regarding the PNT" , and Appendix 4, entitled "Information on the Biology and Interactions of the PNT" . Specific information will vary with the species, characteristics of the novel trait, and the PNT's end use. All other supporting information and test data that are relevant to environmental and human health exposure and hazard identification, and which are in the applicant's possession or to which the applicant should reasonably have access to, must be included in the application. For further guidance, the applicant is encouraged to consult with the PBO.

In addition to data generated by the applicant through research and testing in laboratory, growth chamber, and/or greenhouse, as well as during confined research field trials, further information can also be submitted in an application based on available scientific literature and any other recent research. The PBO may also refer to data generated from CFIA's own research on specific key environmental areas.

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

7.2 Biology Documents of the Plant Species

The biology of certain plant species is described in a series of species-specific biology documents, which are published on the PBO web site at the following address: http://www.inspection.gc.ca/english/plaveg/bio/dir/biodoce.shtml.

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

Where a biology document is not available for a particular PNT's plant species, one should be provided to the PBO with a proponent's application for unconfined environmental release authorization. Once a biology document is submitted, it will be reviewed by the PBO as well as peer-reviewed. Comments received from the peer review will be incorporated into the biology document as appropriate. Based on comments received from the peer review, an applicant may need to submit further information and test data for the PNT's environmental safety assessment.

The format of the new biology document should follow that of the existing biology documents. The Organisation for Economic Cooperation and Development (OECD) Consensus Documents may be used as a reference tool to help applicants in the preparation of biology documents.

7.3 Quality of Data Submitted

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

A guide to the expected quality for some types of submitted analytical data can be found in the reviewer's checklist. This guide has been developed jointly with Health Canada and the United States Department of Agriculture's Animal and Plant Health Inspection Service ( USDA-APHIS), and is available at http://www.inspection.gc.ca/english/plaveg/bio/usda/usda04e.shtml.

7.4 Detection and Identification Requirements

Along with all other data, relevant to the environmental safety assessment of a PNT, the following should also be submitted to the CFIA:

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

Certain information regarding the detection and identification of a PNT, which is provided to the CFIA for the purposes of conducting an environmental safety assessment, may be protected under the provisions of the Access to Information Act. All requests for such information are not only subject to the Access to Information Act but to the Privacy Act as well.

CFIA's criteria regarding acceptable detection and identification methods can be found on the PBO web site at the following address: http://www.inspection.gc.ca/english/plaveg/bio/detecte.shtml

Consultation with the CFIA is recommended prior to the submission of an application for authorization of environmental release for guidance in the determination of appropriate test methodologies and reference materials.

7.5 Stewardship Plan Requirements

As part of the PBO's assessment of a PNT's environmental safety, in particular, of its assessment of longer term environmental effects, the PBO's decision with regards to authorizing the release of a PNT expressing either a novel herbicide tolerance or a novel insect resistance will take into consideration whether or not the applicant has provided a stewardship plan addressing the need for the responsible deployment of the novel crop into the environment.

Stewardship plans should include appropriate strategies that will allow for the environmentally safe and sustainable deployment of such novel plants (Please see Sections 7.5.1 and 7.5.2 for specific information). In addition, communication to growers and an efficient mechanism allowing growers to report problems to the applicant are all integral parts of a stewardship plan.

7.5.1 Insect Resistance Management (IRM)

The CFIA strongly recommends that an IRM plan be implemented for all plants expressing novel insect resistance (including those expressing Bacillus thuringiensis (Bt) endotoxins) grown in fields of greater than one hectare in size. IRM strategies are intended to delay the development of resistance in the insect to the active compound(s) and thereby prolong the lifespan and usefulness of the technology. The development of resistance in insects to these active novel compounds due to the non-adoption of effective IRM plans could also have significant implications on sustainable agriculture.

The IRM plans currently in place for Bt corn and Bt potatoes consist of planting refugia, areas of non-Bt crops which provide a population of insects which have not been exposed to the Bt toxin and are available to breed with potentially resistant insects which could be emerging from the cultivation of a Bt crop.

The IRM plan should take into consideration the most recent available scientific evidence on, among other factors, the following:

1. the reproductive biology and behaviour of the insect pest;
2. the mobility of the larvae;
3. the ability of adults to disperse from the natal field before and after mating;
4. an estimate of resistance allele frequency in the insect population;
5. the impact of management practices such as insecticide use in the refuge;
6. the targeted life cycle stage of the insect pest, and;
7. any history of insect resistance to the active compound(s).

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

Communication to growers, the monitoring of the effectiveness of the plan, and an efficient mechanism allowing growers to report problems to the applicant, are all integral parts of an IRM stewardship plan.

7.5.2 Herbicide Tolerance Management (HTM)

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

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

A PNT with a novel herbicide tolerance that could be introgressed to related species, resulting in hybrids that have no effective or sustainable control options, will not be authorized.

The PBO also cooperates with the PMRA on strategies for the safe and effective use of herbicides and herbicide tolerant crops in Canada. Safety issues concerning the application of herbicides on plants expressing novel herbicide tolerance(s) are assessed in collaboration with the PMRA.

7.6 Post-release Monitoring Plan

A general post-release monitoring plan to monitor for unintended or unexpected environmental effects of an authorized product should also be an integral part of a complete application and will be reviewed during the environmental safety assessment of the novel plant in question. The use of appropriate indicators to evaluate these effects should be based on the characteristics of the PNT. A stewardship plan (Please see Section 7.5) may be considered acceptable for post-release monitoring purposes.

The applicant must inform the PBO of any new information regarding the risks to the environment or to human health resulting from worker exposure to the PNT that could result from the unconfined release of the PNT (Please see Section 9 for further details).

8. Decision Process

The PBO will consider the information provided by the applicant to determine if the PNT poses risks to the environment. The PBO may authorize or refuse to authorize the release of a PNT based on its environmental safety assessment.

8.1 Regulatory Decision

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

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

8.2 Harmonization of Approvals under Other Federal Acts and Regulations

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

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

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

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

8.3 PNTs Carrying Antibiotic Resistance Markers

While the presence of antibiotic resistance marker genes in transgenic plants may not pose a significant environmental risk, developers of transgenic plants are encouraged to consider alternative selection systems. The presence of an antibiotic resistance marker, to which no significant environmental risk has been associated, will not be considered as grounds for denying authorization for the environmental release of the PNT in question.

8.4 Web Site Summaries of PNTs authorized for unconfined release

A list of all authorized PNTs and novel feeds derived therefrom, as well as their accompanying decision documents, is available on the CFIA PBO's web site at the following address: http://active.inspection.gc.ca/eng/plaveg/bio/pntvcne.asp. The PBO will update its list of authorized PNTs and post related decision documents on its web site within 15 days after authorizing a PNT.

A list of approved novel foods in Canada derived from PNTs whose environmental release has been authorized, as well as their accompanying decision documents, is available onHealth Canada's web site at the following address: http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_nf_dec.html

The decision documents explain the decision reached by the CFIA's PBO and the Feed Section and Health Canada's Novel Food Section following their safety assessments.

The PBO also submits information on the environmental release of PNTs to the Organization for Economic Cooperation and Development (OECD) publicly available Biotrack database at: http://www.oecd.org/ehs/service.htm and to the Canadian Node of the Biosafety Clearing-House under the Cartagena Protocol on Biosafety (http://www.bch.gc.ca). It is therefore important that CBI be clearly identified.

9. New information related to PNTs authorized for unconfined release

Where, at any time after providing notification of the proposed unconfined release or receiving authorization for the unconfined release of a particular PNT, the applicant becomes aware of any new information regarding the environmental safety of the PNT (e.g., enhanced weediness characteristics), including the risk to human health (e.g., exposure to allergens) that could result from the release, the applicant must immediately provide the PBO with the new information. On the basis of the new information, the PBO will re-evaluate the potential effect on, and risk to the environment, including the potential effect on, and risk to human health posed by the release. The PBO may maintain, change, or remove existing conditions respecting the release; impose additional conditions; or refuse or cancel the authorization and require the applicant to stop the release and take any appropriate action necessary to eliminate from, or minimize the risk to, the environment.

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

Plant Biosafety Office,
Plant Products Directorate,
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: (613) 225-2342
Facsimile: (613) 228-6140
http://www.inspection.gc.ca/english/plaveg/bio/pbobbve.shtml