Animal Pathogen Importation - Frequently Asked Questions

Q1 What forms must be completed to apply for an animal pathogen import permit?

In order to receive an animal pathogen import permit, applicants need to fill out:

  1. Application for Permit to Import (CFIA/ACIA 5083);
  2. Facility Certification for the Importation of Animal Pathogens (CFIA/ACIA 5083);
  3. If your lab has not completed an inspection checklist for the facility within the last 2 years, you may be required to complete a 3rd form called Containment level 2 Inspection Checklist.

Q2 Is it possible to request more than one product per application?

The permit to import can be issued for more than one product. To do this, please list all the microorganisms or products you wish to import in the description section of the Application for Permit to Import (CFIA/ACIA 5083). If more space is required, you can attach a list to the application.

Q3 What is the cost of an import permit for animal pathogens?

The fee varies depending on the type of permit you wish to obtain. A single entry permit (valid for 3 months) costs $35, a multiple entry permit (valid for 1 year) costs $60. The fee to amend a permit is $20.

Q4 When renewing an import permit, what forms are necessary?

To renew an import permit, you need to send us the Application for Permit to Import (CFIA/ACIA 5083) and the Statement of Renewal. If your previous checklist has expired, you will also need to complete an inspection checklist.

Q5 Who is the Applicant?

The applicant is the end user of the imported material (i.e. the person working directly with the imported material or the individual who has responsibility for the imported material, such as the laboratory director). The applicant accepts the legal responsibility for the imported material.

Q6 What method of payment is available to pay for the import permit?

Three choices are available to pay for the import permit:

  1. Credit card;
  2. Cheque made out to 'Receiver General for Canada' and sent to:
    Canadian Food Inspection Agency
    Office of Biohazard Containment and Safety
    Animal Pathogen Importation Program
    1400 Merivale Road
    Ottawa, ON
    K1A 0Y9
  3. Client account number obtained from the CFIA Financial Office in Moncton.

Q7 How can I obtain a client account number for payment for permits?

Please contact CFIA National Accounts Receivable Service Centre at 1-888-677-2342.

Q8 On the Facility Certification form, what does 'frequency' mean?

Frequency means the number of times you plan to import the material within one year.

Q9 Why do I need to apply for two permits (both PHAC and CFIA)?

Some microorganisms, called zoonotic agents, are considered pathogenic for both humans and animals. Zoonotic agents are regulated under two different Acts (Health of Animals Act and Human Pathogens Importation Regulations). Therefore, two separate permits are required.

When you receive a CFIA animal pathogen import permit for these agents, you will find a condition explaining that you will need a Human pathogen import permit to import this product into Canada. If this condition appears on your permit, please contact the Public Health Agency of Canada's Pathogen Regulation Directorate to apply for a permit.

Q10 Our Facility is not a Veterinary facility and/or I don't handle animals. Why do I have to meet the requirements of Containment Standards for Veterinary Facilities and fill out an inspection checklist?

The Containment Standards for Veterinary Facilities outlines the minimum design, physical and operational requirements for Canadian laboratories and animal facilities that import and work with animal or zoonotic pathogens. The requirements described in this document need to be met by all Canadian laboratories working with pathogens infectious to animals and not only by veterinary facilities.

Import permits can only be issued to facilities that meet the Containment Standards for Veterinary Facilities requirements. Therefore, in order to verify whether your facility meets those requirements, you need to fill out and send us a Containment level 2 Inspection Checklist. Inspection checklists sent to us are kept on file and are valid for two years.

Q11 Who can inspect our lab?

The inspection checklist is a self certification form for all level 2 laboratories. Your Institutional Safety Officer must complete and sign the form.

Q12 We don't have a designated institutional safety officer, who can sign the forms?

Anyone that is responsible for the work done in the lab. The Biosafety Officer's (BSO) duties may include, but are not limited to:

  • Developing and coordinating a biological safety program for the facility;
  • Assessing risk pertaining to the use of infectious agents and biological materials;
  • Ensuring facilities compliance with regulatory requirements and best practices, including the CFIA Containment Standards for Veterinary Facilities;
  • Inspecting laboratory facilities for suitability of biological work;
  • Developing and implementing emergency procedures for biohazardous incidents (spills, equipment failure, animal escape, etc.);
  • Being the first point of contact in case of biosafety emergencies (accidental spills, personnel contamination);
  • Planning, developing and training personnel on biosafety practices and procedures;
  • Informing staff regarding biosafety issues;
  • Providing technical advice regarding safe handling, storage and disposal of infectious agents and biological materials.

Q13 The inspection checklist has a new in vivo section, do I have to complete it?

Our office previously requested separate checklists for facilities doing in vivo work. For your convenience, all of the checklists have now been combined into one. If your facility does not work with animals, please answer no to question 1 in section II and then continue to Section III.

Q14 Why do I need a Material Safety Data Sheet (MSDS) ?

The Facility Certification for the Importation of Animal Pathogens form asks you if you have a Material Safety Data Sheet (MSDS) for the pathogen you wish to import. The CFIA's Office of Biohazard Containment and Safety considers the availability of Material Safety Data Sheets to be one component of training and an important tool for providing information about potential biohazards.

The Public Health Agency of Canada's Pathogen Regulation Directorate produces Material Safety Data Sheets (MSDS) for many pathogens. In the case where the MSDS for a pathogen is not publicly available, the importer should prepare their own MSDS using available scientific information on safety procedures that take into account virulence, transmission, and decontamination.

If you prepare your own MSDS, it would be appreciated if you could send us a copy for our own records. Please do not send us the Public Health Agency of Canada MSDS's.

Q15 Do you have an animal pathogen risk group list?

A list for level 4 animal pathogens risk group is now available: Animal Pathogen - Level 4 Risk Group.

The lists for level 1 to 3 animal pathogens are under revision. Do not hesitate to contact us if you require information about classification of specific microorganisms.

Q16 Are we allowed to transfer an animal pathogen/product acquired with an import permit to another laboratory or facility?

As stated on the permit, imported animal pathogen/product can only be transferred to another laboratory or facility with the approval of the Office of Biohazard Containment & Safety, CFIA. To receive a transfer letter, which permits the relocation of the imported animal pathogen/product to another laboratory or facility, you will need to provide to the Office of BSC the following information:

  • Permit number under which the product was imported
  • Product description
  • Name and address of product holder
  • Name and address of product receiver and room # where the product will be manipulated
  • Containment level 2 inspection checklist for the room where the product will be manipulated
  • Objective of work

Q17 When can I expect to receive my permit or letter?

The turn-around time depends on the number of permits received by our office and the information provided, but you can expect to receive your permit within 5 to 10 working days once the application is complete. Please note that your permit or letter will be sent to you by email or fax, the original copy is kept on file at OBCS, CFIA.

Q18 Can I put more than one product on an application?

Yes, we will evaluate each product listed and decide if these require a permit. If it's not considered to be an animal pathogen, we will issue a courtesy letter (non-pathogenicity letter).

Q19 Can I have a permit for more than two exporters?

Yes, if they come from the same Country. If not, then two different applications must be submitted.

Q20 Do I need to send the original application and/or copy by mail or fax?

Contrarily to PHAC, we do not need the original. Only send mail copies if you are unable to send us an email or a fax.

Q21 What are compliance letters? How do I get one for my laboratory?

Compliance letters are prepared by our office in response to an Inspection Checklist received for evaluation. The letter attests that the facility (specific room numbers) is following the physical and operational requirements for containment level 2 facilities working in vitro as described in the Containment Standards for Veterinary Facilities.

If you are requesting material from a Canadian distributor, you may be required to provide a copy of this letter to acquire microorganisms or other biological material.

Q22 My supplier of microbiological products has asked me to complete an inspection checklist (or to send him a copy of my compliance letter), why?

Within Canada, there are various companies whose activities include importation and resale of animal pathogens and other biological material. These "distributors" have acquired all the CFIA import permits needed to import containment level 2 animal pathogens and other level 2 biological material. As such, they have several responsibilities including ensuring their clients are compliant with the Containment Standards for Veterinary Facilities by asking for a compliance letter.

A Canadian distributor cannot sell a classified containment level 2 product, originally imported using a CFIA Animal Pathogen Import Permit, without having a valid compliance letter for the related facility.

If you do not have a compliance letter for the room(s) where the requested products will be handled, you need to complete an Inspection Checklist and forward it to our office for review. We will generate a Compliance Letter in response to your application.

Q23 I want to order an organism classified as level 1 in the United States, do I need an import permit?

Classification of microorganisms varies from one country to another depending on various elements (e.g. disease country status). When it comes to risk group classification, the OBCS classification might be different from other institutions or Agencies since our focus is on animal health & safety (most worldwide organizations classify according to the risk to human health).

If you are unsure about the containment level required for an organism or to know if an import permit is required, please contact us.

Q24 Monkey products, why do these usually require an import permit?

Tissue, blood, and body fluids from nonhuman primates (NHP) pose numerous problems as they often contain pathogenic agents readily transmissible to humans (viruses, bacteria, nematodes and ectoparasites).

As such, we have assigned handling and storage of these products to a minimum of containment level 2. Manipulation of macaque products (includes Cynomolgus and Rhesus monkeys) require additional operational practices to protect the user against more important disease, some described below:

Monkey B virus (Herpes simiae, Cercopithecine Herpes Virus 1) - frequently infects Old World primates of the genus Macaca and may cause an acute and potentially fatal meningoencephalitis in humans. Transmission to man occurs after direct or indirect contact / exposure to infected saliva, tissues, tissue fluid or monkey cell cultures to broken skin, eyes, or mucous membranes. Exposure to in vitro monkey tissues (primary rhesus monkey kidney cells) has been associated with laboratory acquired infection of Monkey B virus.

Simian Foamy Virus (SFV) - found to widely infect a number of non-human primate (NHP) species (monkeys, chimpanzees, baboons and macaques). This virus is probably transmitted through exposure to infected blood, saliva and other body fluids. No humans tested positive for SFV infection have become ill, but precautions are necessary, since like other retroviruses, this virus has a long latency period and therefore the long-term health effects are unknown.

Q25 Can you please explain what the Containment level 2 laboratory with operational level 3 practices condition listed on my permit means?

This condition has been added to your permit because the agent you wish to use is easily transmissible and contractible by humans, or the product may contain higher risk pathogens and therefore these requirements are added in order to protect the workers.

These requirements include:

  • second layer of protective clothing (gowns, gloves, shoe covers or dedicated shoes, eye protection and respiratory protection [if applicable, depending on the risk]).
  • All activities with infectious material are to be conducted in a certified biological safety cabinet (BSC). If not possible, other physical containment devices with personal protection & equipment must be used.
  • centrifugation of infectious material using sealed safety cups or rotors, which are loaded and unloaded in the BSC.
  • showering is required upon exiting the laboratory zone if there is a known or suspected aerosol exposure.
  • containment check to ensure the inward directional airflow is acceptable prior to entering the area.