Plants > Plant Protection Policy Directives > Horticulture 

Subject

This directive contains the phytosanitary import requirements for importing into Canada plants with novel traits (PNTs), including transgenic plants, and products derived from them, such as fruit, tubers and grain.

The current revision reflects the additional information required to assess an application for a Permit to Import. It also includes a new provision which allows an importer to obtain a permit for multiple destinations in one province when importing from the continental United States (US).

Table of Contents

Review
Endorsement
Amendment Record
Distribution
Introduction
Scope
Definitions, Abbreviations and Acronyms

1.0 General Requirements
1.1 Legislative Authority
1.2 Fees
1.3 Regulated Commodities
1.4 Commodities Exempt
1.5 Regulated Areas

2.0 Specific Requirements
2.1 Import Requirements
2.2 Inspection Procedures
2.3 Non-Compliance
2.4 Other

Review

This directive will be reviewed every 2 years unless otherwise needed. The next review date for this directive is June 27, 2008. The contact for this directive is Joanne Rousson. For further information or clarification, please contact the Export/Import Section.

Endorsement

Approved by:

Amendment Record

Amendments of this directive will be dated and distributed as outlined in the distribution below.

Distribution

1. Directive mail list (Regions, PHRA, USDA)
2. Provincial Government, Industry (via Regions)
3. National Industry Organizations (determined by Author)
4. Internet

Introduction

Since 1988, Agriculture and Agri-Food Canada (AAFC), now the Canadian Food Inspection Agency (CFIA) has overseen the importation and field release of plants derived through techniques often referred to as biotechnology, and through traditional plant breeding methods such as wide cross hybridization and mutagenesis. These techniques are capable of introducing novel or unfamiliar traits into a species, which are not substantially equivalent to traits already present in that species in Canada. These techniques enable the plant breeder to have access to a wide source of beneficial traits.

Although these plants may differ from presently cultivated plant species by only a few traits, all PNTs (and/or products derived from them) are subject to the CFIA regulatory review under the Plant Protection Act and Regulations, regardless of the process used to produce them. Pest risk assessments (PRAs) are conducted in order to evaluate the potential capability of PNTs to pose a pest risk to the agricultural and forestry environment. Potential pest risk is assessed on the basis of the novel traits coded by the novel genes.

For example, novel traits could potentially impart weedy characteristics, or, if the inserted genes are derived from plant pathogens, they may recombine with genes from other pathogens, forming new strains with unknown pathogenicity.

Prior to issuing this directive, all PNTs (and/or products derived from them) have required a Permit to Import, issued by the Plant Health Division, to enter Canada, regardless of regulatory decisions by other authorities outside the plant protection program. These permits included specific conditions to limit the movement or use of PNTs upon entry into Canada, in the absence of field trial experience and greater familiarity with the novel traits.

In 1995, AAFC for the first time approved several PNTs for unconfined release. These approvals were based on satisfactory environmental assessments (EAs) that involved the evaluation of several years of field testing information and the determination through PRA that these PNTs do not pose a plant pest risk. Once approved for unconfined release, these plants are no longer considered novel.

Many more applications for unconfined release are anticipated over the next few years. In addition, some products of PNTs will be imported into Canada directly as food or feed items. These are also subject to PRAs.

The policy conveyed in this directive is to discontinue the previous blanket requirement for a Permit to Import for all PNTs. There is now no requirement for a Permit to Import, issued under the Plant Protection Act and Regulations for PNTs (and/or products derived from them) that have been determined by a PRA not to pose a plant pest risk.

Scope

This directive is intended for use by those wishing to import plants with novel traits (PNTs), including transgenic plants, and products derived from them, such as fruit, tubers and grain into Canada. This directive is also intended for the use of the CFIA inspection staff and the Canada Border Services Agency.

This directive supersedes D-96-13 (Original) dated May 1, 1996.

Definitions, Abbreviations and Acronyms

1.0 General Requirements

1.1 Legislative Authority

The Plant Protection Act, S.C. 1990,c. 22
The Plant Protection Regulations, SOR/95-212
Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part 1 (05/13/2000)

1.2 Fees

The CFIA is charging fees in accordance with the Canadian Food Inspection Agency Fees Notice. For information regarding fees associated with imported product, please contact the Import Service Centres (ISC) at the following phone numbers: Eastern ISC 1-877-493-0468; Central ISC 1-800-835-4486; Western ISC 1-888-732-6222. Anyone requiring other information regarding fees may contact any local CFIA office or Canadian Food Inspection Agency Fees Notice website.

1.3 Regulated Commodities

Plants with novel traits, including transgenic plants, and products derived from them, regardless of the process used to produce them.

1.4 Commodities Exempt

PNTs that have been determined, following a PRA, not to pose a plant pest risk by the Plant Health Division. These can include PNTs that have been authorized for unconfined, release under the Seeds Act and Regulations, following an environmental assessment (EA).

PNTs or products of PNTs that are incapable of sexual or asexual propagation, i.e., have been processed in some way to render them non viable, such as by grinding or freezing.

Plants further developed from PNTs in exemption 1. above, and plants considered substantially equivalent to PNTs in exemption 1. above, are also exempted provided that the intended use is similar, the plants do not display any additional novel traits, do not contain novel genetic elements and have not been subject to interspecific breeding.

1.5 Regulated Areas

PNTs originating from all countries.

2.0 Specific Requirements

2.1 Import Requirements

2.1.1 General

A Permit to Import, issued by the Plant Health Division, is required to import PNTs including transgenic plants, and any products derived from PNTs. Permits are issued under Section 43 of the Plant Protection Regulations, that provides for the importation of plant material for scientific research, educational, processing, industrial or exhibition purposes. This requirement is in addition to other plant protection import requirements that apply to specific commodities.Importers must complete an "Application for Permit to Import" form, which can be obtained from any local office of the CFIA.

The exceptions to this import requirement are the exempted commodities in Section 1.4. Importers do not require a Permit to Import for these unless otherwise specified under a policy governing a specific policy.

If the importer is uncertain as to whether their material is exempt from import permit requirements, he or she should submit an "Application for Permit". This will be reviewed to determine if the PNT requires a Permit to Import and the importer will be advised accordingly.

In completing an "Application for Permit to Import" form, it is essential that the description of the material is complete. As a minimum, information supplied in the "Description" section of the "Application for Permit to Import" form must include:

• the scientific name (genus and species), synonyms and common names;
• the type of material (e.g. seeds, plants, tubers, etc.). Note: a separate application must be submitted for each different type of material;
• clear identification of the novel traits and DNA inserts or modifications;
• construct/plasmid code. A map of the construct describing genes and their source must be provided for first submission;
• the quantity of material to be imported;
• the intended end use (e.g. research in a contained facility, confined field release, for processing, etc.);

To expedite the processing of an application, please provide the following information whenever appropriate:

• previous permit number if the application is for a renewal of a Permit to Import;
• the unique identifier that clearly identifies the material to be imported. This designation is associated with the specific PNT and corresponds to a single, or finite number of modification(s) also referred to as a transformation event(s), in a specific plant species.

All information provided in conjunction with permit applications will be held in confidence by the CFIA. In addition, any documents associated with material that requires a Permit to Import should clearly indicate that it is a PNT, or where appropriate, that it is transgenic.

2.1.2 Permit to import issued for multiple destinations within one province

Only one Permit to Import is required for plants and related things provided they originate from one source in the continental US and are destined to a minimum of five locations in one province in Canada. It is the applicant's responsibility to provide a complete list of destinations to which the material may be sent. This list will be attached to the Permit to Import. The Permit Office must be notified immediately of any changes to the list of destinations.

Shipments originating from areas other than the continental US require one Permit to Import for each destination.

2.2 Inspection Procedures

All material passing through Customs Canada is subject to inspection or audit according to the commodity specific instructions in the Import Inspection Manual.

2.3 Non-Compliance

Shipments of regulated articles not meeting Canadian import requirements, as specified in this directive or as part of the permit conditions, may either be confiscated and destroyed or ordered removed from Canada at the importer's expense.

Records of importation must be maintained by the importer and may be reviewed by CFIA on a regular basis.

2.4 Other Requirements

PNTs that are intended for import and release into the environment (e.g., for field testing under confined conditions), may also be subject to other regulations under such CFIA Acts as the Feeds Act, Fertilizer Act, Seeds Act, and Health of Animals Act. In addition there may be import requirements under Health Canada legislation (Food and Drug Act or Pest Control Products Act) or provincial jurisdiction.

Any importer wishing more information may contact local offices of the CFIA.