Animal pathogen importation and transfers

Delays for animal pathogen import permits

Processing times for animal pathogen import permits are estimated at 17 weeks. Complex requests or requests with missing information may take longer. To avoid delay or interruption in your operations, submit your documentation early.

The importation and transfer of animal pathogens or part thereof (for example, toxins), as well as live animals, animal products or by-products containing a pathogen or part thereof, are regulated under the authority of the Health of Animals Act (HAA) and Health of Animals Regulations (HAR).

The Canadian Food Inspection Agency (CFIA) evaluates the risk(s) associated with the imported product(s) and the proposed activities and verifies that the destination facility meets the physical containment and operational practice requirements of applicable Canadian containment standards. Regulatory authorizations and conditions are put into place to prevent the introduction and the spread of disease in Canada.

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When to apply

You must apply to the Office of Biohazard Containment and Safety (OBCS) for permission before importing or transferring any of the following:

  • any terrestrial or aquatic animal pathogen or part thereof in an animal product or animal by-product (such as tissue, blood, fetal bovine serum, etc.)
  • any terrestrial or aquatic animal pathogens or part thereof in a live animal
  • all non-indigenous terrestrial animal pathogens or part thereof (that is, foreign animal disease (FAD) and emerging animal disease (EAD) agents)
  • all non-human primate (NHP) products and NHP by-products (such as feces, serum, cell lines, etc.)
  • all aquatic animal pathogens
  • all bee pathogens
  • specified risk materials (SRM) and other products that can carry prions

What importers need to know

Every importation or transfer request application is assessed for the risk of introduction or spread of animal diseases in Canada. Assessment includes both a risk group (RG) classification and a Containment Level (CL) assessment which considers the intended type of activities to be performed with the materials (for example, in vitro vs in vivo; diagnostic vs research).

We assess not only the animal pathogen being imported but also the type of animal product or by-product that the pathogen is in (for example, animal tissues, serum, feces, etc.) and the animal health disease status of the exporting country to determine if there is the risk of an animal disease. An example is bovine serum from a country with unknown health status for Foot and Mouth Disease.

In some cases, a formal risk assessment may be required to determine the risks associated with the product. Completion times for formal risk assessment requests vary and may incur additional costs. Providing the OBCS with as much information as possible about the pathogen or product being requested will help with the turn-around time of the assessment.

Factors taken into consideration when assessing the disease risks associated with a particular import may include:

  • identification of hazard and risk analysis
  • country of origin of the commodity (evaluation of animal health status and veterinary infrastructure)
  • species from which the animal product or by-product is derived
  • processing of the commodity (for example, how samples are gathered, inactivation or treatments)
  • end use in Canada
  • the disease status and existing national disease controls in Canada

All terrestrial and aquatic animal pathogens or part thereof must have a valid import permit before arriving in Canada. It is impossible to issue a permit once that package has arrived at the border and the package will need to be returned or destroyed.

Terrestrial animal pathogens

The CFIA's OBCS and the Public Health Agency of Canada's (PHAC) Centre for Biosecurity (CB) share responsibility for the importation and transfer of indigenous terrestrial animal pathogens (for example, Listeria, Salmonella, E. coli). The CFIA and the PHAC share authorities of terrestrial animal pathogens as follows:

  • the CFIA is the regulatory authority for non-indigenous terrestrial animal pathogens (that is, FAD and EAD agents) [HAR 51a and 51b]
  • the PHAC is the regulatory authority for indigenous terrestrial animal pathogens in pure culture or in a non-animal matrix (for example, human or water sample) [HAR 51a]
  • the CFIA is the regulatory authority for indigenous terrestrial animal pathogens when present in or with an animal product, animal by-product or live animal [HAR 51b]

Foreign animal disease (FAD) or emerging animal disease (EAD) agents

A permit is required for importing a FAD or EAD agent as per section 51 of the HAR. If the animal pathogen you wish to import is on the CFIA's list of FAD or EAD agents, you must submit an FAD or EAD Request Form with your import permit application.

Non-federal government facilities (private, provincial or academic facilities) may request to import Category II and III FAD and EAD agents. Category I FAD and EAD agents remain prohibited to non-federal government facilities but may be considered for approval depending on several factors, including if and how the pathogen has been modified to decrease the risk (that is, attenuated).

Find the list of Category I, II and III FAD and EAD agents as well as information on the criteria for evaluating requests in our Policy on the Importation of Terrestrial Foreign or Emerging Animal Disease Agents into Canada by External Facilities.

Note: classification as a FAD or EAD is determined by us and the list is updated as needed (for example, new disease emerges; status of disease in Canada).

Note: the term the CFIA Designated Terrestrial Animal Pathogen (CD-TAP) is being introduced to capture non-indigenous animal pathogens and FAD or EAD agents under our authority.

FAD or EAD Request Form is available from the National Centre for Permissions (NCP) (formerly known as the Centre of Administration for Permissions) (permission@inspection.gc.ca) until made available online.

Aquatic animal pathogens

A permit is required for importing aquatic animal pathogens as per section 51 of the HAR. The CFIA assesses the risk and determines the conditions for import of any aquatic animal pathogen that causes disease in an aquatic animal.

The risk is assessed based on several factors, including but not limited to; the severity of the disease, how easily the disease is transmitted to aquatic animals, if the disease is present or not in nearby waters of the importing facility and the type of activities to be performed with the pathogens. From the assessment, we determine the aquatic containment level that is required.

Animal product, animal by-product or live animal containing an animal pathogen

A permit is required for importing an animal pathogen in an animal product, animal by-product or live animal as per section 51b of the HAR. Consult the Automated Import Reference System (AIRS) for importation requirements and restrictions related to the animal (species, product type) and country of origin before submitting a request to import.

Depending on the disease status of the country of origin, a zoosanitary export certificate may be required. Please note that a zoosanitary export certificate will only be accepted from a country where the veterinary infrastructure is accepted by the CFIA.

Note: all non-human primate (NHP) products and NHP by-products will require an import permit and must be handled in a CL2 facility or higher.

In your application, provide the following information whenever possible:

  • specify all animal-origin product(s) including animal-origin products in such things as cell culture medium
  • for each animal-origin product, specify:
    • the country of origin of the animal(s) that the materials were collected from
    • if the animal-origin product was from domestic or wild animals
    • if it has undergone any pathogen-destroying treatments (for example, heat, irradiation etc.) provide details of the treatment(s)
    • if the product or any of its components have undergone any activities in another country (for example, sub-cultured in the U.S. but originated in France)

Non-human primate (NHP) products and NHP by-products

A permit is required for importing an animal pathogen in an animal product, animal by-product or live animal as per section 51 of the HAR.

Tissue, blood, body fluids and primary cell cultures from NHPs pose greater risks since they often contain pathogenic agents readily transmissible to other animals and humans. Therefore, the CFIA has assigned handling and storage of these products to a minimum of CL2.

Manipulation of NHP products (including Cynomolgus and Rhesus monkeys) may require CL2 with CL3 operational requirements (CL2+CL3 OPS) to protect the user against higher risk diseases, such as Herpes B virus (Cercopithecine Herpes Virus 1) and minimize the potential spread of disease in Canada. This is determined by us on a case-by-case basis.

Toxins

A permit is required for importing all animal (terrestrial or aquatic) pathogens or part thereof (for example, toxins) as per section 51 of the HAR.

Therefore, toxins produced by microorganisms which affect animals (that is, animal pathogen) are regulated under the HAR. Examples of HAR regulated toxins include:

  • Botulinum neurotoxin
  • Shigatoxin
  • Pasteurella multocida toxin
  • Toxic Shock Syndrome
  • Alpha toxin
  • Ochratoxin A
  • Heat-Labile (LT) and Heat-Stable (ST) Enterotoxins
  • Tetanus toxin
  • Aflatoxin B1

Facilities need to ensure that they obtain a permit from the CFIA for a toxin affecting terrestrial animals if it is present in an animal, animal product or animal by-product. Purified toxins affecting terrestrial animals are otherwise regulated under the HAR by an import permit issued by the PHAC as part of a Pathogen and Toxin Licence.

A permit from the CFIA is required for toxins that affect aquatic animals.

Cell lines

A permit is required for importing all animal (terrestrial or aquatic) pathogens or part thereof as per section 51 of the HAR.

Therefore cell lines that contain an animal pathogen or part of one, that retains pathogenicity must have a permit from the CFIA and/or the PHAC in relation to their respective authorities (see When to apply).

Three aspects of cell lines are considered when determining if a permit is required under the HAR and whether it must be issued by the CFIA and/or the PHAC.

  • Pathogenic elements:
    • passage history notwithstanding, if the cell line being imported into Canada contains a viable pathogen, you will require a permit from the CFIA and/or the PHAC
  • Species the cell line was derived from:
    • if a cell line was derived from an animal and contains an animal pathogen or part of one, you will require a permit from the CFIA
    • if the cell line is derived from human cells or another non-animal species, a permit to import under the HAR is still required if it carries a viable animal pathogen or part of one
      In these cases, the CFIA will issue the permit when the pathogen affects aquatic animals or is an FAD or EAD. For non-animal cell lines containing an indigenous terrestrial animal pathogen a Pathogen and Toxin Licence issued by the PHAC under the HAR is required.
  • Storage or shipping matrix:
    • regardless of if an animal pathogen affects aquatic or terrestrial animals or is considered indigenous or an FAD or EAD, if your cell line contains an animal pathogen and an animal product or animal by-product (fetal sera, etc.), you will require a permit from the CFIA
    • a large majority of cell lines are maintained and stored in media that contains an animal product or by-product (for example, fetal bovine serum)
      Importers need to ensure that they obtain a permit from the CFIA prior to importing any cell lines that contain an animal pathogen along with an animal product or animal by-product.

In your application, provide the following information whenever possible:

  • specify all animal-origin products (for example, mouse cell line) including ingredients in the culture media (for example, fetal bovine serum)
  • for each animal-origin component, specify
    • the country of origin of the animal(s) from which the materials were collected
    • if it has undergone any pathogen-destroying treatments (for example, heat, irradiation etc.)
    • provide details of treatment(s)
    • if the cell line or any of its components have undergone any activities in another country (for example, sub-cultured in the U.S. but originated in France)

Pathogens and products classified as Risk Group 1

Classification conducted by another organization cannot be used to determine if an import permit is required.

Classification of microorganisms vary from one country to another depending on various elements. For example:

  • host of interest
  • climate to survive
  • presence of vector transmitting the pathogens
  • population of host animals, etc

Most organizations worldwide classify organisms according to their risk to human health. Since the CFIA's mandate and the HAA/HAR are focused on the health and safety of terrestrial and aquatic animals, our classification may differ from others.

If you are unsure if an import permit is required or which containment level is required, please contact the CFIA's NCP (permission@inspection.gc.ca).

Inactivated pathogens and products

Depending on the material to be imported or transferred and the inactivation method(s) used, a permit may be required.

Before importing, an application needs to be submitted to the CFIA for assessment. The application should include specific details about material to be imported, for example, animal species, type of product or by-product, country of origin, known and potential pathogens present in the material. Documentation detailing the protocol(s) used for inactivation and/or validation of inactivity must also be provided.

If it is determined that the material is no longer infectious ("non-pathogenic") then a permit will not be required and a courtesy ("non-pathogenic") letter may be issued.

Canadian distributors

Canadian distributors facilitate the importation process by obtaining the CFIA distribution permits which allows them to import biological material for resale within Canada.

Distribution permits may only be issued for RG2 pathogens and for in vitro only activities.

Before completing an order, the Canadian distributor must ensure that the recipient facility meets the Canadian Biosafety Standard (CBS) by requesting a valid Compliance Letter issued by the CFIA.

Recipient facilities must follow the permit conditions outlined on the distributor permit including no in vivo activities or further transfer of material without prior approval from us.

Transferring an imported pathogen or product within Canada

A transfer permit is required from the CFIA before transferring the CFIA authorized imported pathogens or products, including anything derived from it, to a location other than that specified on the import permit. This includes transferring material to another individual not named on the original permit.

The receiving facility must also have valid compliance or certification at the appropriate containment level and type before the transfer permit being issued.

The transfer permit issued by us will specify the conditions the material is to be maintained in and the work that is able to be carried out.

Overlapping regulatory requirements

Pathogens, infectious material and other biological materials may fall under more than 1 regulatory authority or regulatory program.

Human, terrestrial animal, aquatic animal and plant pathogens

The majority of pathogens and toxins affect more than 1 category of host (that is human, terrestrial animals, aquatic animals and plants). As a result, materials fall under multiple regulatory authorities (Human Pathogens and Toxins Act [HPTA], HAR and Plant Protection Act [PPA]) and will require more than 1 import authorization depending on the organism and proposed work.

Biological materials

There are separate importation requirements for infectious and biological materials such as animals, animal products and animal by-products (APABP) that are additional to the requirements for pathogens and toxins.

Veterinary biologics

Veterinary biologics include veterinary vaccines, diagnostic tests for the diagnosis of animal infectious diseases and antibody products used to treat or prevent animal infectious disease.

Importation of an animal product which contains a veterinary biologic may require a permit from the Canadian Centre for Veterinary Biologics (CCVB), in addition to an animal pathogen import permit.

Where dual authorities exist, importers need to ensure that valid importation documentation is obtained under the correct authorities and issued by the correct agency (that is the PHAC and/or the CFIA) prior to importation.

How to submit an application or question

Login to your My CFIA account to submit import permit applications, transfer permit request forms, FAD or EAD request forms and CL2 inspection checklists.

Please note that import permit applications must be submitted via your My CFIA account. However, request forms and checklists can alternatively be sent to the NCP by email (permission@inspection.gc.ca).

General enquiries can also be directed to the NCP (permission@inspection.gc.ca).

Importation and transfer request documents

When submitting a permit application, list all the rooms that you think the product(s) may be used in. As long as the rooms are listed on the permit and they are compliant, the imported product(s) can be transferred back and forth between the rooms without having to request transfer permit(s).

Demonstrating compliance

Before a permit is issued, the specific room(s) where the animal pathogen or product will be handled must demonstrate valid compliance or certification with the appropriate containment level and type.

Visit Biocontainment compliance and certification for submission requirements and to obtain compliance verification documentation from the CFIA.

Note: in the majority of terrestrial animal pathogen cases, compliance or certification from the CFIA is required even if the containment zone has a PHAC Pathogen and Toxin Licence.

A Pathogen and Toxin Licence issued under the HPTA and the HAA/HAR does not give authority to import or transfer materials under the CFIA's regulatory authority.

When you apply for a permit from the CFIA, the OBCS completes an assessment of each request and specifies which pathogen(s) or infectious material, containment zone and activities have been approved. The CFIA will often also apply additional specific conditions of import and handling to mitigate risks associated with the imported material. Additionally, in the event of a reported outbreak in an exporting country, detailed permits allow the CFIA to cancel or suspend only permits of concern without impacting all activities/importation of a facility.

Harmonization is actively sought with our co-regulators at the PHAC where possible; however, the responsibility for the assessment of these imports and the risks they may pose to Canada's animal resource base rests with the CFIA.

For these reasons, currently we do not automatically accept a Pathogen and Toxin Licence issued by the PHAC in place of a valid CFIA permit and Compliance Letter.

Helpful hints for applying

It is not always possible to avoid delays in processing applications (for example, high influx of applications, consult and approval required from other CFIA programs, risk assessment needed) but there are a few things that you can do to reduce delays:

  • contact your institutional Biological Safety Officer (BSO) in advance
    • advise them of the material(s) you wish to receive
    • complete documentation together, as applicable
    • obtain institutional My CFIA account information, as applicable
  • ensure that you complete Form CFIA/ACIA 5858 (not Form 5859) for all OBCS import permit applications (see When to apply)
  • ensure facility compliance/certification status is valid
    • level 2 checklists can be processed at the same time as your permit application; however, the recertification process requires more time and there would be delays in the issuance of your permit(s) if your certification has expired
  • provide complete information and details
    • be specific in the description (product or catalogue number)
    • provide product information sheet, if available
    • when requesting specialized products or recombinant organisms, provide information on the producer / author and provide references (links)
    • provide as much additional information as possible to assist the technical specialist in conducting the review and approval of your request
  • if the animal pathogen you want to import includes an animal, animal product or animal by-product (for example, fetal bovine serum), whenever possible, select a country recognized by the CFIA as being free of disease(s) of concern and/or the country can provide a zoosanitary export certificate of health signed by the country's competent authority
  • review your documents before submitting them
    • be sure that all sections are complete
    • be sure all forms and documents are signed and dated by the applicant, BSO and other responsible individuals, as appropriate
  • plan ahead
    • combine permit applications when possible
    • if importing RG2 products, consider "various exporters" from a country rather than a single exporter
    • list what you intend to order as well as anticipate what you may need
      • think genus instead of species specific to provide greater flexibility when importing

How long will it take to process my application

All applications for animal pathogens are considered complex because they require a technical specialist's assessment of the following:

  • pathogen(s) or part thereof present
  • type of work being conducted
  • type of product
  • health status of an animal from which the product is derived (if applicable)
  • country of origin's disease status and veterinary infrastructure (if applicable)
  • compliance status of the importing facility
  • product and work specific conditions required to mitigate risks

Find more information on managing your application, standard processing times and payment options through the NCP.

Conditions and validity period of import and transfer permits

Import and transfer permits lay out the conditions that must be followed to safely possess and handle imported material to reduce the risk to Canada. Import permits have standard conditions common to all similar commodities as well as product or activity specific conditions.

Examples of standard conditions:

  • compliance with containment standard(s)
  • the imported material may only be used in room(s) specified on permit
  • no movement of imported material without written authorization
  • record retention
  • disposal (decontamination) of imported material and any derivatives thereof
  • approved activities (for example, in vitro only, in vivo, no culturing, etc.)
  • incident notification

An imported pathogen or product must only be used for the purposes identified on the original import permit. For example, if the original permit was issued for in vitro use only, then an amendment to the permit conditions must be made to include approval to conduct in vivo activities.

It is the responsibility of the importer to understand and abide by all conditions indicated on the permit. Failure to meet a condition may result in the suspension or cancellation of a permit and removal of the item(s) from the facility or disposal of the item(s) in a manner approved by the CFIA. If further clarification on a condition is required, please submit your question to the NCP (permission@inspection.gc.ca) before importing.

Conditions do not expire at the end of the permit validity period. As long as a facility continues to possess imported materials, including any 'thing' derived from them (for example, subcultures, experimentally infected animals and animal products and by-products obtained from them), all of the permit conditions must continue to be met.

Fees

Animal pathogen import permits are subject to a feeFootnote 1.

  • Single entry permit: a single entry import permit is a one-time use only and is valid for 3 months
  • Multiple entry permit: a multiple entry import permit allows multiple shipments of the imported material and is valid for up to 1 year
  • Amendment: amend an existing valid import permit

Currently there are no fees for transfer permits or for facilities to obtain compliance or certification.

Disease agent information

Terrestrial animal

Fact sheets for reportable, immediately notifiable and annually notifiable diseases were prepared by the CFIA and focus on the characteristics of disease in terrestrial animals.

The PHAC has prepared Pathogen Safety Data Sheets (PSDS) for zoonotic and human pathogens.

The risk groups of most terrestrial animal pathogens are posted on the ePATHogen - Risk Group Database. The column "CFIA" identifies agents under our authority.

Note: if you are importing a terrestrial animal pathogen in an animal, animal product or by-product, it is also under our authority if identified as a RG2 or higher in the "Classification Animal" column, regardless of the classification under the "CFIA" column.

Aquatic animal

Fact sheets for reportable, immediately notifiable and annually notifiable diseases were prepared by the CFIA and focus on the characteristics of disease in aquatic animals.

Related links

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