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D-12-02: Import Requirements for Potentially Injurious Organisms (Other than Plants) to Prevent the Importation of Plant Pests in Canada

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Subject

This directive contains the plant protection import requirements for potentially injurious organisms (other than plants) from all origins whether present or not in Canada, and which may be directly or indirectly injurious or potentially injurious to plants. This includes, but is not limited to:

Note: Toxic compounds derived from invertebrates or micro-organisms, in their pure state, are not regulated under the Plant Protection Act.

Table of Contents

Review

This directive will be updated as required. For further information or clarification, please contact the Canadian Food Inspection Agency (CFIA).

Endorsement

Approved by:

space
Chief Plant Health Officer

Amendment Record

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

Distribution List

  1. Directive mail list
  2. Provincial governments, other Federal departments, non-governmental organizations (as determined by Author)
  3. Industry Organizations (as determined by Author)
  4. Internet

Introduction

Potentially injurious organisms such as invertebrates (e.g. insects, mites, earthworms, snails, slugs) and micro-organisms (e.g. bacteria, fungi, viruses, phytoplasmas) are imported into Canada for a variety of purposes, including scientific research, biological control, exhibition or educational purposes, sale in pet stores (as pets or pet food), use as live bait, and industrial applications. These potentially injurious organisms are regulated under the Plant Protection Act and Plant Protection Regulations because they are or may be plant pests, may be contaminated with plant pests, or are shipped with host material that is or may be a plant pest or contaminated with a plant pest.

Plant pests can cause serious damage to Canada's natural environment as well as to its agriculture and forestry sectors and, consequently, shipments of potentially injurious organisms are subject to import requirements to mitigate this phytosanitary risk. Some organisms, such as plant pathogenic micro-organisms, pose direct risks to the health of Canada's plant resources. Other organisms, such as earthworms or pollinators, may indirectly affect plant health by acting as a pathway for the introduction of plant pests and diseases or by competitively displacing indigenous organisms.

A Pest Risk Analysis process is applied to potentially injurious organisms proposed for importation to determine the level of risk each presents and determine appropriate phytosanitary measures.

Scope

This directive is for the use of importers of potentially injurious organisms (other than plants) as well as Canadian Food Inspection Agency (CFIA) inspectors, National Import Service Centre, the Canada Border Services Agency, exporters, and National Plant Protection Organizations.

Note: For information on the CFIA's domestic requirements regarding potentially injurious organisms, please consult plant protection policy directive D-12-03: Domestic Requirements for Potentially Injurious Organisms (Other than Plants) to Prevent the Spread of Plant Pests Within Canada. D-12-03 provides a framework and process for allowing Activities to be conducted on certain potentially injurious organisms sourced from the environment or from other persons in Canada.

References

This directive supersedes the following documents:

Definitions, Abbreviations and Acronyms

Definitions for terms used in the present document can be found in the Plant Health Glossary of Terms.

1.0 General Requirements

1.1 Legislative Authority

Plant Protection Act, S.C. 1990, c. 22
Plant Protection Regulations, SOR/95-212
Agriculture and Agri-Food Administrative Monetary Penalties Act, S.C. 1995, c. 40
Agriculture and Agri-Food Administrative Monetary Penalties Regulations, SOR/2000-187
Canadian Food Inspection Agency Act, S.C. 1997, c. 6
Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part I (as amended from time to time)

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 products, please contact the National Import Service Centre. Anyone requiring other information regarding fees may contact any local CFIA office or visit the Fees Notice website.

1.3 Regulated Potentially Injurious Organisms

Potentially injurious organisms, other than plants, which are on the list of Pests Regulated by Canada, as well as potentially injurious organisms, other than plants, which may otherwise:

Information on the import requirements for a living organism is also available from the CFIA's Automated Import Reference System (AIRS) or by contacting the CFIA's National Centre of Permissions. It is the importer's responsibility to ensure that their imported commodities comply with all applicable federal and provincial import requirements.

1.4 Exempt Potentially Injurious Organisms

Note: Appendix 1 is subject to change at any time. Please consult the latest version of Appendix 1

1.5 Regulated Areas

All countries.

2.0 Import Requirements

Phytosanitary import requirements for potentially injurious organisms are based on the risk they present to Canada, in consideration of factors such as:

A list of organisms with pre-determined plant health requirements, for specified intended uses and countries of origin, is available in Appendix 1. Appendix 1 only applies to organisms that are not genetically modified.

2.1 Specific Requirements

Importers must submit an Application for Permit to Import Plants and Other Things Under the Plant Protection Act (CFIA/ACIA 5256) to the CFIA's National Centre of Permissions prior to importing an organism in any one of the following circumstances:

These applications are reviewed on a case-by-case basis in consideration of pest risks, to determine whether a proposed import is permissible, whether a plant protection Permit to Import is required and whether additional phytosanitary import requirements are needed.

Appendix 2 of this directive provides further details and guidance on the information which must be included in an application form for a Permit to Import for potentially injurious organisms. For further assistance, please contact the National Centre of Permissions by phone at 1-855-212-7695 or by e-mail PermitOffice@inspection.gc.ca.

Note: The submission of an application does not automatically guarantee that a Permit to Import will be issued. The decision whether or not to issue a Permit to Import is made once all of the required information and supporting documentation has been received and reviewed.

2.2 Containment Standards for Facilities Handling Plant Pests

Some potentially injurious organisms may only be imported into Canada under containment and cannot be released into the environment. These organisms can only be imported for specific end uses: for scientific research, exhibition/display, education or industrial/processing purposes.

Prior to a Permit to Import being issued, a person wishing to import such an organism must meet the requirements of the appropriate containment level, as determined by the CFIA, under the Containment Standards for Facilities Handling Plant Pests or its Addendum for Containment Zones where Low-Risk Exotic Invertebrates are Displayed.

Where required, the CFIA will contact the importer regarding the containment level applicable to the organism. The importer will be responsible to demonstrate that their facility is built and operates in accordance with the required containment level. The CFIA will guide the importer through the facility compliance process to ensure the facility meets all the requirements necessary to prevent escape of the organisms.

For information regarding the physical or operational requirements described in the Containment Standards for Facilities Handling Plant Pests, please contact the Office of Biohazard Containment and Safety either by e-mail cfia.biocontainment-bioconfinement.acia@canada.ca or by telephone (613-773-6520).

2.3 Shipping and Handling of Potentially Injurious Organisms

Further guidance on packaging living invertebrates for shipping purposes is available from NAPPO's Regional Standard for Phytosanitary Measures 39, Packaging for the international shipment of live invertebrates used as biological control agents.

2.4 Associated Material Imported with Potentially Injurious Organisms

Packaging and packing material as well as bedding material, growing media or carrier material and food sources (e.g. prey or host of the living organism) which are shipped with potentially injurious organisms may be subject to additional import requirements. Specific import requirements for associated material are available in the CFIA's AIRS or Plant Protection Policy Directives.

2.5 Additional Import Requirements for Specific Groups of Organisms or End-Uses

2.5.1 Biological Control Agents Not Yet Approved for Release

BCAs are potentially injurious organisms used to control other organisms considered to be pests. BCAs may be insects, mites, fungi, bacteria, viruses or nematodes and have the potential to be themselves a direct or indirect plant pest or to transport or be shipped with pests which could have a direct or indirect deleterious effect on plants or plant products in Canada.

All non-indigenous BCAs require approval from the CFIA before their first release into the Canadian environment (see Appendix 1 for a list of approved BCAs). Please see Section 3.0 of this directive for information on the process for seeking approval from the CFIA for the release of a non-indigenous BCA.

BCAs which are being evaluated for potential release, but which have not yet been approved for release in Canada, may be imported with a Permit to Import by a facility which complies with the required containment level under the Containment Standards for Facilities Handling Plant Pests.

2.5.2. Non-Apis Pollinating Insects Not Yet Approved for Release

Pollinators, such as Bombus species (bumblebees), are critical to both the Canadian agriculture sector and plant life in general. However, such organisms can carry pathogens and parasites which could, upon importation into Canada, infect native pollinating species and negatively affect pollination of crops and other plants. Through competition, imported pollinators can also displace native pollinator populations, resulting in decreased yields of cultivated crops as well as negative impacts on the environment.

All non-indigenous species of non-Apis pollinating insects require prior approval from the CFIA before their first release into the Canadian environment (see Appendix 1 for a list of approved non-Apis pollinating insects). More information on the process for seeking approval from the CFIA for the first release of a non-Apis pollinator species is available in Section 3.0.

Non-Apis pollinating insects which are being evaluated for potential release, but which have not yet been approved for release in Canada, may be imported with a Permit to Import by a facility which complies with the required containment level under the Containment Standards for Facilities Handling Plant Pests.

2.5.3 Earthworms

In addition to their inherent potential to be pests themselves, earthworms pose a risk of introducing plant pests into Canada due to their potential to be contaminated with soil, which is a major pathway for the introduction of numerous organisms injurious to plants and the introduction of soil-inhabiting pests into Canada. Only certain earthworm species known to occur in Canada and which are produced or collected from specific origins may be imported into Canada (see Appendix 1 for the list of approved species).

2.5.3.1 Earthworms from the Continental United States

Earthworms from the Continental U.S. are regulated for the possibility that they may be infested with one or more of the following soil-borne pathogens: Ditylenchus destructor, Meloidogyne chitwoodi, Globodera pallida, G. rostochiensis and Phytophthora ramorum.

For shipments originating from a U.S. state from which at least one of these pathogens is present, the worms must undergo a cleansing period of at least 15 days before shipment to Canada. The cleansing period may be carried out by maintaining the worms in a soil-free and pathogen-free substrate, such as shredded paper or pasteurized vegetables.

Shipment to Canada must take place in clean new containers filled with fresh artificial bedding. Material used for shipping must not be the same material that was used for the cleansing period.

2.5.3.2. Earthworms from Origins Other than the Continental United States

To ensure that shipments are free of soil, worms must undergo a cleansing period of at least 15 days before shipment to Canada. The cleansing period may be carried out by maintaining the worms in a soil-free and pathogen free substrate, such as shredded paper or pasteurized vegetables.

Shipment to Canada must take place in clean new containers filled with fresh artificial bedding. Material used for shipping must not be the same material that was used for the cleansing period.

Shipments must be certified by the government agency in the exporting country responsible for certifying shipments of earthworms. Such certification may take the form of a Phytosanitary Certificate, Animal Health Certificate or Zoosanitary Certificate. The certificate must state the following declarations:

3.0 Approval Process for the First Environmental Release

A person that is seeking to release into the environment a non-indigenous BCA or non-Apis pollinating insect which has not been approved for release by the CFIA (i.e., species not listed in Appendix 1 of this directive) must submit a petition requesting approval for such release.

Petitioners must provide a cover letter as well as a data package supporting the safety of the organism to the following address:

Chief Plant Health Officer
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9

Data packages on the proposed introduction and environmental release must include information on the organism's:

Guidance on preparing the required information package is available from one of the following three NAPPO Regional Standards for Phytosanitary Measures:

Regional Standards for Phytosanitary Measures 7. Guidelines for Petition for First Release of Non-Indigenous Phytophagous Biological Control Agents, 2008, Ottawa, NAPPO

Regional Standards for Phytosanitary Measures 12. Guidelines for Petition for First Release of Non-Indigenous Entomophagous Biological Control Agents, 2008, Ottawa, NAPPO

Regional Standards for Phytosanitary Measures 29. Guidelines for the Petition for Import and Release of Non-Apis Pollinating Insects into NAPPO Countries, 2008, Ottawa, NAPPO

Please note that NAPPO standards are only available in English and in Spanish.

Further information on the regulatory process for arthropod BCAs is available from Agriculture and Agri-Food Canada's Guide for the first-time importation and release of arthropod biological control agents in Canada.

Where a petition is approved, the Permit to Import will set out conditions to be complied with, for example the requirement to deposit voucher specimens into a national collection.

Note: The release of a non-indigenous BCA included in a formulated pesticide product is excluded from this petition process. Please contact the Pest Management Regulatory Agency (PMRA) for further information on the regulatory approval process for these products.

4.0 Non-compliance

The importer is responsible for any and all costs related to inspection and any costs associated with non-compliant shipments, including removal, return to origin, rerouting, treatment, disposal or any other measure deemed necessary by the CFIA. In addition, an importer could be subject to monetary penalties. The detection of quarantine pests during inspection in Canada or any other non-compliance may result in the suspension of the importation of commodities from that country until remedial action is taken at origin.

5.0 Other Requirements

Importers must also ensure their shipments meet any other applicable import requirements under:

In addition, invertebrates or micro-organisms that are intended for release into the environment (for ex., for field testing as part of a scientific research project), may be subject to other release regulations under such acts as the Feeds Act, Fertilizer Act, Seeds Act, Health of Animals Act, Pest Control Products Act, Canadian Environmental Protection Act or any applicable provincial legislation.

6.0 Appendices

Appendix 1: Plant health requirements for the import into Canada of certain potentially injurious organisms

Appendix 1 is available on the following CFIA Web site.

Appendix 2: Information required in a plant protection Permit to Import application for potentially injurious organisms (other than plants)

This appendix provides guidance to importers completing an application form for a Permit to Import potentially injurious organisms regulated under this directive. This guidance is intended to complement the guidance provided to all importers in CFIA's Plant Protection Policy Directive D-97-04: Application, procedures, issuance and use of a Permit to Import under the Plant Protection Act.

Please Note:

An application where mandatory information has not been provided will not be processed until a revised and complete application has been submitted. Furthermore, an unsigned application will not be processed until a signed original (when submitting by mail) or copy (when submitting by fax or email) is received by the CFIA's National Centre of Permissions.

A permit will not be issued until payment is received.

1.0 Importer Section

A. Educational Institution

If the organism is being imported by an educational institution, the name of the importer must be that of the institution. The applicant (person signing the form) must be either the department head or a faculty member responsible for work involving the organisms. Emeritus personnel can not be applicants.

B. Government

If the organism is being imported by a federal or provincial government department or municipality, the name of the importer must be that of the federal/provincial government department or municipality. The applicant (person signing the form) must be the employee responsible for the work involving the organism.

C. Private Company

If the organism is being imported by a private company, the name of the importer must be that of the company. The applicant (person signing the form) must be the employee who is responsible for the work involving the organism.

2.0 Exporter Section

With the exception of applications for a Permit to Import for mushroom spawn, all fields in this section are mandatory for applications for a Permit to Import for potentially injurious organisms.

Travelling and Collecting;

If an applicant intends to travel and collect potentially injurious organisms to bring back to Canada, only the Exporter Name and Country fields are required to be completed. In the Name of Exporter field, please include the following:

Travelling and collecting – (name of applicant/importer)

3.0 Origin of Items Section

The origin of a living organism is the country in which it was collected or reared/cultured. Consequently, in some cases, the exporting country will differ from the country of origin. For example, a Canadian importer could apply for a Permit to Import for the importation of an organism, which was originally isolated or collected in Argentina, but is being shipped from a supplier located in the U.S. In this case, the exporting country would be listed as the U.S. but the origin of the living organism would be listed as Argentina where the organism was originally collected, regardless if the organism has subsequently been reared/subcultured in the U.S.

4.0 List of Canadian Destinations Section

The destination must be the facility where the organisms will be stored and handled. Should the facility address be the same as the importer's, an applicant can select the option Same as Importer in the drop down menu. If the facility address is different than the importer's address, an applicant should select Other and provide the full address of the facility where the organism(s) will be stored and handled.

5.0 End Use Section

A brief description must be provided when selecting either scientific research, educational purpose or other as an end use:

Scientific Research: A short description of the nature of the research to be conducted is required (e.g., DNA/RNA extractions for genetic studies, culturing/rearing of the organism for further characterization, studies on host plants, behavioural studies, etc.). Include the location where experiments will be carried out (e.g. laboratory only, laboratory and growth cabinets, greenhouse only, etc.).

If the organism has been genetically modified, detailed information must also be provided, such as the name of the transgene or the nature of the altered traits of the transgenic organism (e.g. altered virulence/pathogenicity).

Educational Purpose: A short description of the exhibition/educational use, including a description of the physical location where the organism will be kept and displayed is required.

Other: A short description of the end-use (e.g., resale, personal) is required.

Further information on scientific research or educational purpose/exhibition as end-uses is available from the Plant Protection Policy Directive D-97-04: Application, procedures, issuance and use of a Permit to Import under the Plant Protection Act.

6.0 Description Section

6.1 Mushroom spawn:

When Mushroom Spawn is selected as a description of the commodity to be imported, the block of fields related to the producer now become mandatory to complete.

A table will be generated within the form to allow the applicant to list all of the species of mushroom spawn they intend to import (you may need to scroll down the page to locate this table):

Type Field:

For each species of mushroom spawn, an applicant must indicate whether the mushroom spawn will be imported as a pure culture or with growing media (a drop down menu is available to help with the selection).

Scientific Name Field:

For each species of mushroom spawn, an applicant must indicate the correct scientific name, including genus and species.

Details Field:

When mushroom spawn will be imported with growing media, an applicant must specify the growing media (e.g. coffee grinds, saw dust, etc.), indicating all components if the growing media is a mixture. If the growing media includes plant material (e.g. wood chips), the scientific name of the plant species must be provided.

Quantity Field:

An applicant must indicate the quantity of mushroom spawn included in each shipment. Units may be in weight (e.g. grams), or number of containers (e.g. number of Petri dishes, vials).

6.2 Living Invertebrates and Micro-organisms

For all other potentially injurious organisms regulated under this directive, an applicant must select Living invertebrates and Micro-organisms in the Description Section.

Two tables will be generated within the form (you may need to scroll down the page to locate both tables). These tables will allow an applicant to:

  1. Identify whether their facility currently complies with the Containment Standard for Facilities Handling Plant Pests, and,
  2. List all of the potentially injurious organisms they intend to import.

1) Facility/building Information

This section should be completed when applying to import an organism which is approved for import to an approved facility (as listed in sections 1 and 2 of Appendix 1 of this directive), which is not listed in Appendix 1, or which has been genetically modified.

Facility Civic Address Field:

The facility address should be the same as the Canadian destination previously identified. Please select either Same as importer or Same as Canadian destination from the drop down menu.

Name of the Building Field:

Where applicable, the applicant must provide the name of the building where the certified facility is located.

Room number(s) Field:

The applicant must provide the specific room number(s) within the facility where the potentially injurious organisms will be stored and handled.

Containment level Field:

The applicant must provide the containment level at which the specific room(s) where the potentially injurious organisms will be stored and/or handled have been certified as meeting. Where not certified, the Not certified yet option should be selected.

Certification Number Field:

Where the facility is certified under the Containment Standard for Facilities Handling Plant Pests, the Laboratory Compliance # or Certification laboratory ID # must be provided.

Expiry Date Field:

An applicant must provide the date when facility compliance or certification will expire.

2) Table Listing All Potentially Injurious Organisms Intended for Import

A separate row must be completed for each species of living organism the importer wishes to import, with the exception of the species listed in Sections 1 – Tropical Butterflies (Lepidoptera) and Section 2 - Other Invertebrates for Display of Appendix 1.

Sections 1 and 2 of Appendix 1 contain a list of organisms which all require the same containment level. Where desired, the applicant may simply refer to Section 1 of Appendix 1 or Section 2 of Appendix 1 in the Scientific Name field of the table with a view of being issued a Permit to Import for any of the organisms listed in those particular sections.

Type Field:

The applicant must indicate the organism type (e.g. bacteria, virus, phytoplasma, earthworm, snail, etc.) - a drop down menu is available to help with the selection. If the organism type is not available in the drop down menu, it can be typed directly into the field.

Scientific Name Field:

The applicant must indicate the living organism's scientific name as listed in Appendix 1. For organisms not listed in Appendix 1, both the genus and species must be provided. For micro-organisms, the applicant should also provide the variety, subspecies, special form, pathovar, etc. (where applicable).

Details Field:

The applicant must indicate any substrate, food source, or other material that will be shipped with the organism. Where a food source/substrate is either a living organism or a plant part, the applicant must also indicate the genus and species or the common name of the food source/substrate.

For microorganisms, please indicate if the microorganism will be imported as a pure culture or as part of an environmental sample. When available, include information identifying strain, isolate, pathovar, etc. (e.g. American Type Culture Collection number or Centraalbureau voor Schimmelcultures number).

Quantity Field:

The applicant must indicate the quantity of each organism to be included in the shipment(s). Units may be in weight (e.g. grams), number of containers (e.g. number of Petri dishes, vials) or simply the total number of organisms contained in each shipment.

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