Yes. Avian influenza A(H5N1) virus is both a human and animal pathogen (i.e., zoonotic). It is a regulated pathogen under the Health of Animals Act and Regulations and under the Human Pathogens and Toxins Act and Regulations.

2. What is the risk group classification of avian influenza A(H5N1)?

Avian influenza A(H5N1) virus is classified as a risk group 3 animal pathogen regulated under the Health of Animals Act or Regulations by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety due to its status as a foreign animal disease agent and identification as a Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen. Avian influenza A(H5N1) is a federally reportable disease under the Health of Animals Act and the Reportable Diseases Regulations.

Avian influenza A(H5N1) virus is classified as a risk group 3 human pathogen regulated under the Human Pathogens and Toxins Act or Regulations by the Public Health Agency of Canada-Centre for Biosecurity. Highly Pathogenic Avian Influenza is also categorized as a security sensitive biological agent due to its biosecurity risk and dual-use potential. Security sensitive biological agents are a subset of human pathogens and toxins that have been determined to pose an increased biosecurity risk due to their potential for use as a biological weapon.

Genetically engineered strains or attenuated strains of the avian influenza A(H5N1) virus may be classified differently by the Public Health Agency of Canada and/or the Canadian Food Inspection Agency. For further information on risk group classification and containment requirements, consult the Public Health Agency of Canada’s ePATHogen – Risk Group Database or contact the Public Health Agency of Canada and/or the Canadian Food Inspection Agency.

The current circulating strain of avian influenza A(H5N1), clade 2.3.4.4b, is considered a Highly Pathogenic Avian Influenza virus strain as is the case for other H5 and H7 subtype strains. For further information on classification of specific subtypes or strains of Highly Pathogenic Avian Influenza virus, consult ePATHogen – Risk Group Database or contact the Public Health Agency of Canada and/or the Canadian Food Inspection Agency.

For additional information on Influenza A viruses, refer to the Biosafety Directive for New and Emerging Influenza A Viruses , the Public Health Agency of Canada’s Pathogen Safety Data Sheet , and the Canadian Food Inspection Agency’s website on Avian influenza (bird flu) .

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3. Is a Human Pathogens and Toxins Act Security Clearance required to work with avian influenza A(H5N1)?

Yes . The current strain of A vian influenza A(H5N1) is considered a Highly Pathogenic Avian Influenza virus strain and therefore a security sensitive biological agent under the Human Pathogens and Toxins Act . Personnel entering an area where controlled activities, such as cultivating the virus, are taking place require a Human Pathogens and Toxins Act Security Clearance or need to be under 1:1 supervision of a person who holds a valid Human Pathogens and Toxins Act Security Clearance. Human Pathogens and Toxins Act security clearances are issued by the Public Health Agency of Canada (not the Canadian Food Inspection Agency).

To apply, applicants must first create a Biosecurity Portal account online and receive an endorsement from the licence holder or licence holder representative of the facility applying for a risk group 3 security sensitive biological agent Pathogen and Toxin Licence.

4. What type of facility is needed to conduct research activities with avian influenza A(H5N1)?

In vitro and in vivo research work, and animal and/or human vaccine development activities involving avian influenza A(H5N1) virus need to occur in a Canadian Food Inspection Agency-approved and the Public Health Agency of Canada-licensed containment level 3 facility, unless activities or samples are otherwise excluded or exempt from the legislation.

A containment level 3 laboratory work area is required for in vitro activities
A containment level 3 small animal zone is required for in vivo work with small animals
A containment level 3 large animal zone is required for in vivo work with large animals

The facility must adhere to the corresponding containment level 3 (laboratory work area, large scale production area or small animal zone) and containment level 3-Ag ( large animal zone ) physical containment, operational practices, and performance and verification testing requirements of the Canadian Biosafety Standard, 3rd Edition .

As Highly Pathogenic Avian Influenza A(H5N1) virus is classified as a security sensitive biological agent, facilities also need to adhere to unique requirements for areas where activities with security sensitive biological agents are conducted, as identified in the Canadian Biosafety Standard, 3rd Edition. Moreover, facilities must respect specified sections of the Human Pathogens and Toxins Act and Regulations for “prescribed human pathogens”.

As avian influenza A(H5N1) virus is classified as a Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen, facilities also need to adhere to additional, more stringent requirements to prevent its release into the environment with potential subsequent spread of the disease. These requirements are indicated in the Canadian Biosafety Standard, 3rd Edition for non-indigenous terrestrial animal pathogens.

Facilities conducting research with avian influenza A(H5N1) may also need to develop a Plan for Administrative Oversight.

Refer to the Scientific Research Policy for Human Pathogens and Toxins - Canada.ca for guidance on the definition of scientific research as it pertains to controlled activities under the Human Pathogens and Toxins Act .

Refer to the Biosafety Directive for New and Emerging Influenza A Viruses for additional information on containment requirements for various activities with avian influenza A(H5N1) virus.

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5. Would my containment level 3 facility be regulated by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety?

Yes. Facilities must contact the Canadian Food Inspection Agency ’s Office of Biohazard Containment & Safety prior to conducting regulated activities involving a Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen and requiring containment level 3. As such, any containment level 3 facilities, whether new or existing, must contact the Canadian Food Inspection Agency -Office of Biohazard Containment and Safety Biocontainment and Certification Program ( biocon@inspection.gc.ca ) before initiating any new work with avian influenza A(H5N1) virus. This is the case even if the facility holds a valid Containment Level 3 Facility Certification Letter from the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety for work with other Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogens and holds a valid risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada- Centre for Biosecurity for work with avian influenza A(H5N1) virus or other Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogens. Moreover, the containment level 3 facility must contact the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Biocontainment and Certification Program if they are currently certified to work with avian influenza A(H5N1) virus or other Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogens but intend to make a change to their program intent.

The Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Biocontainment and Certification Program evaluates containment level 3 facilities through a certification program that verifies physical containment, operational practices, and performance verification and testing requirements, as described in the Canadian Biosafety Standard, 3rd Edition . Following the completion of the evaluation, a Containment Level 3 Facility Certification Letter is issued.

It must be noted that Containment Level 3 Facility Certification Letters are issued to specific containment zone room number(s) and are not facility wide. The facility must maintain its certification status if it is in possession of Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen s and Canadian Food Inspection Agency -regulated materials.

An overview of the Canadian Food Inspection Agency -Office of Biohazard Containment and Safety containment level 3 certification and recertification process can be found in Annex C of this document.

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6. Would my containment level 3 facility be regulated by the Public Health Agency of Canada?

Yes. The Public Health Agency of Canada regulates facilities where work with avian influenza A(H5N1) is conducted under the Human Pathogens and Toxins Act or Regulations. Any controlled activity with avian influenza A(H5N1) live virus requires a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada-Centre for Biosecurity.

7. What authorization is required from the Canadian Food Inspection Agency to conduct regulated activities with domestically acquired avian influenza A(H5N1)?

Facilities performing human surveillance studies, clinical work, or diagnostic activities using primary human specimens collected in Canada are not regulated under the Health of Animals Act or Regulations and do not require an authorization from Canadian Food Inspection Agency. As such, hospital laboratories, public health laboratories and any other laboratories strictly doing human diagnostic testing for avian influenza A(H5N1) would not be regulated. However, a Quarantine Order under section 91.4 of the Health of Animals Regulations may be issued should work with avian influenza A(H5N1) go beyond human surveillance and diagnostic activities (e.g., research activities with live virus, human vaccine development work, propagative in vitro activities, in vivo activities).

Facilities performing animal surveillance studies, clinical work, or diagnostic activities using animal samples acquired domestically where there is no suspicion of disease caused by avian influenza A(H5N1) in the tested animal or animal sample are not regulated under the Health of Animals Act or Regulations and do not require an authorization from the Canadian Food Inspection Agency. However, upon reporting to the Canadian Food Inspection Agency of avian influenza A(H5N1) following its suspicion, detection, or diagnosis in an animal, an animal specimen or sample (e.g. tissue, serum, blood), or an animal product or by-product (e.g. milk), a Quarantine Order under section 91.4 of the Health of Animals Regulations may be issued by the Canadian Food Inspection Agency if the facility intends to keep the domestically acquired virus.

The Quarantine Order will specify conditions to be respected, including the type of activities permitted and the biosafety and containment level requirements to be followed. For regulated activities with avian influenza A(H5N1) to continue, these facilities must hold a valid Canadian Food Inspection Agency-issued Containment Level 3 Facility Certification Letter or Containment Level 2 Facility Compliance Letter, depending on the planned activities. A Containment Level 3 Facility Certification Letter or Containment Level 2 Facility Compliance Letter can be obtained proactively, ahead of any work where suspicion, detection, or diagnosis of avian influenza A(H5N1) in an animal or animal sample could occur. However, a Quarantine Order cannot be obtained in advance as it can only be issued once there is suspicion, detection, or diagnosis of avian influenza A(H5N1) in an animal or animal sample.

The Quarantine Order will specify that the material subject to the order, or any of its derivatives, cannot be moved, transferred, or transported without prior authorization from the Canadian Food Inspection Agency. This type of authorization must be obtained from the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety before any movement, transfer, or transport occurs.

An overview of the steps to follow to proactively obtain a Containment Level 3 Facility Certification Letter or a Canadian Food Inspection Agency-issued Containment Level 2 Facility Compliance Letter can be found in Annex C and D of this document.

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8. Is inactivated avian influenza A(H5N1) regulated by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety and/or the Public Health Agency of Canada?

Primary specimens, products, and cultures of avian influenza A(H5N1) virus that have been completely inactivated (i.e. rendered non-pathogenic) using a validated and routinely verified inactivation method are not regulated by the Public Health Agency of Canada or the Canadian Food Inspection Agency - Office of Biohazard Containment and Safety . Any subsequent activities (e.g. laboratory procedures, transfer, disposal) with the inactivated material are also not regulated.

The inactivation must be performed at the containment level required for the pathogen or type of specimen (e.g. containment level 3 for cultures of avian influenza A(H5N1) virus).

Inactivation methods can include heat, chemicals, and irradiation. The ability of a nucleic acid extraction method to inactivate a pathogen must also be validated and verified in house.

Refer to the Biosafety Directive for New and Emerging Influenza A Viruses for additional information on inactivated material.

9. Are there any exclusions or exemptions from the Human Pathogens and Toxins Act or Regulations to work with avian influenza A(H5N1)?

Primary specimens or environmental samples found in the environment in which they naturally occur (e.g., respiratory samples, nasopharyngeal or nasal swab, or a nasal wash or aspirate) are excluded from the Human Pathogens and Toxins Act .

Those seeking to cultivate avian influenza A(H5N1), including those seeking to conduct research, would no longer be excluded nor exempt from the Human Pathogens and Toxins Act or Regulations and would require authorization by the Public Health Agency of Canada.

Incidents involving inadvertent release, inadvertent production, or inadvertent possession of a human pathogen or toxin require a notification to the Public Health Agency of Canada by completing a report in the Biosecurity Portal.

For more information, please consult these statements of administrative intent:

B. Importation or Transfer

10. What is required from the Public Health Agency of Canada and the Canadian Food Inspection Agency to import or transfer imported avian influenza A(H5N1)?

Facilities wanting to import or transfer imported avian influenza A(H5N1) require both a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada-Centre for Biosecurity and an Animal Pathogen Import Permit or Animal Pathogen Transfer Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety.

An Animal Pathogen Import Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Animal Pathogen Import Program is required when importing pure cultures or isolates of the virus, biological material (e.g., quality control samples, proficiency panels, vaccine candidates) containing the virus, or any samples (e.g., human, animal, environmental) that may, but are unlikely to, contain avian influenza A(H5N1), or that are suspected or confirmed to contain avian influenza A(H5N1) virus.

The Animal Pathogen Import Permit issued by the Canadian Food Inspection Agency - Office of Biohazard Containment and Safety will specify the conditions under which the material is to be maintained. The permit will also specify the work that the facility will be able to carry out.

The importing facility must also have a valid Facility Compliance Letter or Facility Certification Letter at the appropriate containment level and type issued by the Canadian Food Inspection Agency - Office of Biohazard Containment and Safety before the Animal Pathogen Import Permit can be issued . While also necessary, a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada- Centre for Biosecurity is not sufficient as a standalone document to authorize the import of avian influenza A(H5N1) virus in Canada.

An Animal Pathogen Transfer Permit is required for the transfer of imported material or its derivatives.

As per the Canadian Food Inspection Agency ’s Policy on the Importation of Terrestrial Foreign or Emerging Animal Disease Agents into Canada , facilities can submit a request to import avian influenza A(H5N1) virus into Canada for the purpose of research, vaccine development, or to perform other work in the interest of public health.

An overview of the steps to follow to obtain an Animal Pathogen Import Permit, a Canadian Food Inspection Agency -issued Containment Level 3 Facility Certification Letter and a Canadian Food Inspection Agency -issued Containment Level 2 Facility Compliance Letter can be found in Annex A, C and D of this document.

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11. Can my facility submit a request to the Canadian Food Inspection Agency to transfer previously imported avian influenza A(H5N1) to another facility within Canada?

Yes. A request to transfer avian influenza A(H5N1) that was previously acquired under an Animal Pathogen Import Permit can be submitted to the Canadian Food Inspection Agency. As avian influenza A(H5N1) virus is identified as a Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen, an Animal Pathogen Transfer Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Animal Pathogen Import Program is required in order for a facility to transfer the virus , including anything derived from it, to a facility other than the one specified on the original Animal Pathogen Import Permit . The receiving facility must also have a valid Facility Compliance Letter or Facility Certification Letter at the appropriate containment level and type issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety before the Animal Pathogen Transfer Permit can be issued. While also necessary, a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada- Centre for Biosecurity is not sufficient as a stand-alone document to authorize the domestic transfer of imported avian influenza A(H5N1) virus.

The Animal Pathogen Transfer Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety will specify the conditions under which the material is to be maintained. The permit will also specify the work that the facility will be able to carry out.

An overview of the steps to follow to obtain an l Animal Pathogen Transfer Permit, a Canadian Food Inspection Agency -issued Containment Level 3 Facility Certification and a Canadian Food Inspection Agency -issued Containment Level 2 Facility Compliance Letter can be found in Annex B, C and D of this document.

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12. Can avian influenza A(H5N1) strains be transferred to provincial labs?

The existing avian influenza A(H5N1) strain that is circulating in the United States is designated as a Select Agent by the United States-Centers for Disease Control and Prevention. The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Regulatory Science and Compliance and the Animal and Plant Health Inspection Service/Division of Agricultural Select Agents and Toxins. The Federal Select Agent Program oversees the possession, use and transfer of select agents and toxins, which pose a threat to public, animal or plant health.

As such, should the National Microbiology Laboratory receive the strain, they will be held to the restrictions of their signed material transfer agreement, which would restrict any further transfer to authorized Select Agent approved facilities. Any imported avian influenza A(H5N1) would also require permission from the Canadian Food Inspection Agency before transferring/receiving the pathogen as a condition of the Canadian Food Inspection Agency’s Animal Pathogen Import Permit.

13. Does my facility need a permit from the Canadian Food Inspection Agency to import or transfer inactivated avian influenza A(H5N1)?

The need for a permit issued by the Canadian Food Inspection Agency will depend on the material to be imported or transferred and the inactivation method(s) used.

Before importing or transferring inactivated avian influenza A(H5N1) virus, an application must be submitted to the Canadian Food Inspection Agency for assessment. 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 considered to be non-pathogenic as it was completely inactivated using a validated and routinely verified inactivation method , a permit will not be issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Animal Pathogen Import Program . However, to facilitate the import or transfer of the material, a courtesy ("non-pathogenic") letter may be issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety.

If it is determined that the material remains or may remain pathogenic following the treatment applied and was therefore not completely inactivated, an Animal Pathogen Import Permit or Animal Pathogen Transfer Permit will be issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety provided that the recipient facility meets applicable facility containment requirements.

Refer to Annex A for the procedures to follow for submitting a Canadian Food Inspection Agency-Office of Biohazard Containment and Safety application to import.

Refer to Annex B for the procedures to follow for submitting a Canadian Food Inspection Agency-Office of Biohazard Containment and Safety application to transfer.

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14. What packaging is required to ship avian influenza A(H5N1) samples between various locations?

The transportation (packaging, shipping, receiving) of infectious substances is subject to the Transportation of Dangerous Goods Act and Regulations, administered by Transport Canada. Personnel shipping materials that contain or may contain avian influenza A(H5N1) require Transportation of Dangerous Goods training.

Materials that contain or may contain avian influenza A(H5N1) are assigned to UN2814, INFECTIOUS SUBSTANCE, AFFECTING HUMANS, Class 6.2, Category A, for transport. Cultures of avian influenza A(H5N1) are always classified as Category A. However, to facilitate patient care, patient specimens that contain or may contain avian influenza A(H5N1) may be shipped as Category B. Patients include both animals and humans.

For further information, please refer to the Transport Canada Shipping Infectious Substances bulletin . To obtain further assistance, contact Transport Canada at: TDG-TMD@tc.gc.ca .

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C. Veterinary Biologics and Animal Vaccines

15. Can my facility import veterinary biologics, or manufacture and produce an animal vaccine for avian influenza A(H5N1)?

Veterinary biologics, which includes animal vaccines, are regulated by the Canadian Food Inspection Agency under the Health of Animals Act and Regulations. The veterinary biologics regulatory program is administered by the Canadian Centre for Veterinary Biologics, in collaboration with the Canadian Food Inspection Agency's Veterinary Biologics Operations. Please consult their website for information.

An Animal Pathogen Import Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety and/or a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada- Centre for Biosecurity does not authorize the importation of avian influenza A(H5N1) veterinary biologics into Canada. A separate Permit to Import Veterinary Biologics issued by the Canadian Food Inspection Agency - Canadian Centre for Veterinary Biologics is required.

Neither a Canadian Food Inspection Agency-Office of Biohazard Containment and Safety containment level 3 facility certification and/or a risk group 3 security sensitive biological agent Pathogen and Toxin Licence issued by the Public Health Agency of Canada- Centre for Biosecurity alone authorize the production of an animal vaccine. The manufacturing, production, distribution, and sale of animal vaccines is regulated by the Canadian Food Inspection Agency ’s veterinary biologics regulatory program administered by the Canadian Centre for Veterinary Biologics and requires a licence for animal vaccine production or use and development of other veterinary biologics. It is important to note that depending on the stage of development and production of human or animal vaccines, it may also require security sensitive biological agent Pathogen and Toxin Licence which authorizes production as a controlled activity.

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D. Surveillance and Diagnostic Testing

16. What type of facility is needed to conduct animal surveillance studies or diagnostic testing for avian influenza A(H5N1)?

Animal surveillance studies and diagnostic testing for avian influenza A(H5N1) is permitted as long as there is no suspicion of disease caused by the virus in the tested animal or animal specimen or sample.

Surveillance studies, diagnostic testing, clinical work and any other non-propagative activities with primary specimens collected domestically from animals are recommended to occur in a facility that, at minimum, meets the:

physical containment, operational practices, and performance and verification testing requirements for containment level 2 laboratory work area as detailed in the Canadian Biosafety Standard , and
additional operational practices that are detailed in the Biosafety Directive for New and Emerging Influenza A Viruses .

17. What if avian influenza A(H5N1) is suspected, detected, or diagnosed as part of my facility’s animal surveillance and diagnostic testing activities?

The Public Health Agency of Canada and Canadian Food Inspection Agency have different reporting requirements:

Canadian Food Inspection Agency Reporting:

Under the Health of Animals Act and the Reportable Diseases Regulations, avian influenza is a federally reportable disease in any species of animals. Reportable diseases can impact human health, animal health, and the Canadian economy, and are to be reported by animal owners, veterinarians, laboratories , and any person with care or control of animals to the Canadian Food Inspection Agency . As such, once avian influenza A(H5N1) is suspected, detected, or diagnosed in an animal, an animal primary specimen or sample (e.g. tissue, serum, blood) , an animal product or by-product (e.g., milk), or an environmental sample associated with an animal (e.g. animal pen bedding) by a facility, it must be immediately reported to a Canadian Food Inspection Agency district veterinarian . Please consult the Canadian Food Inspection Agency ’s website on Avian influenza (bird flu) for additional information.

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The Public Health Agency of Canada Reporting:

In contrast to the Canadian Food Inspection Agency, suspicion, detection, or diagnosis of avian influenza A(H5N1) in an animal, an animal primary specimen or sample, an animal product or by-product, or an environmental sample associated with an animal does not need to be reported to the Public Health Agency of Canada .

However, laboratory incidents involving inadvertent release, inadvertent production, or inadvertent possession of avian influenza A(H5N1) does require a notification to the Public Health Agency of Canada by completing a report in the Biosecurity Portal .

18. What type of facility is needed to conduct human surveillance or diagnostic testing for avian influenza A(H5N1) ?

Human surveillance studies and diagnostic testing for avian influenza A(H5N1) is permitted.

It is recommended to handle the primary specimen in a containment level 2 laboratory work area facility, but depending on the type of test being performed, tests could be done outside a laboratory. Where diagnostic activities are performed outside of a traditional laboratory setting (e.g., point-of-care molecular testing), risk mitigation measures should be taken to prevent potential exposure to pathogens and the spread of contamination.

Suspicion, detection, or diagnosis of avian influenza A(H5N1) in a human or a human specimen or sample does not need to be reported to the Canadian Food Inspection Agency.

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19. What type of facility is needed to conduct environmental surveillance or testing for avian influenza A(H5N1)?

Environmental surveillance and testing for avian influenza A(H5N1) is permitted.

Surveillance studies, testing, and any other non-propagative activities with environmental samples associated with animals (e.g., bedding from an animal pen) are recommended to occur in a facility that, at a minimum, meets the:

physical containment, operational practices, and performance and verification testing requirements for containment level 2 laboratory work area as detailed in the Canadian Biosafety Standard , and
additional operational practices that are detailed in the Biosafety Directive for New and Emerging Influenza A Viruses .

If test results suggest that a specific animal may be infected, the person who owns or has the possession, care, or control of the animal must immediately report it to a Canadian Food Inspection Agency district veterinarian .

For questions on human related environmental surveillance and testing activities please contact the Public Health Agency of Canada at biosafety.biosecurity@phac-aspc.gc.ca .

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E. Applying for Permits and/or Licences

20. How do you apply for a Pathogen and Toxin Licence to work with avian influenza A(H5N1) from the Public Health Agency of Canada?

The process to follow for a Pathogen and Toxin Licence application to work with avian influenza A(H5N1) is fully dependent on the current status of the Pathogen and Toxin Licence that your organization holds. All Pathogen and Toxin Licence applications for work with avian influenza A(H5N1) will be prioritized for review and Pathogen and Toxin Licence issuance.

No risk group 3 Pathogen and Toxin Licence:

In this scenario, you must submit a full application for both the risk group 3 security sensitive biological agent Pathogen and Toxin Licence for avian influenza A(H5N1) and the Human Pathogens and Toxins Act Security Clearance.

If you hold a risk group 3 Pathogen and Toxin Licence for similar enveloped viruses but not security sensitive biological agents:

This scenario will require a few steps. First, you will need to submit a new licence application for a risk group 3 security sensitive biological agent Pathogen and Toxin Licence for avian influenza A(H5N1) via the Public Health Agency of Canada’s Biosecurity Portal . A facility cannot be licensed until at least one individual at the facility holds a security clearance issued under the Human Pathogens and Toxins Act .

Please contact the Public Health Agency of Canada-Centre for Biosecurity for more guidance if you want to apply for a risk group 3 security sensitive biological agent Pathogen and Toxin Licence (see contact information below).

If you have a risk group 3 security sensitive biological agent Pathogen and Toxin Licence authorizing work with or without enveloped viruses:

This is the most simple and straight forward scenario as it is not dependent on the security clearance process. You will need to submit an amendment to add avian influenza A(H5N1) to your existing risk group 3 security sensitive biological agent Pathogen and Toxin Licence via the Public Health Agency of Canada’s Biosecurity Portal . As part of the licensing process, your organization may be required to submit additional documentation to demonstrate compliance with the conditions of the Pathogen and Toxin Licence, which includes adhering to the applicable requirements described in the Canadian Biosafety Standard, 3rd Edition for containment level 3 and security sensitive biological agents, as well as the Biosafety Directive on New and Emerging Influenza A Viruses .

For any questions on Human Pathogens and Toxins Act licensing , please contact: licence.permis@phac-aspc.gc.ca or 613-957-1779. Your query will be prioritized for response.

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F. Additional Information

21. Will the Public Health Agency of Canada and the Canadian Food Inspection Agency be publishing a Biosafety Advisory for avian influenza A(H5N1)? What other information/guidance is currently available?

Yes , the Public Health Agency of Canada and the Canadian Food Inspection Agency are working on an avian influenza A(H5N1) Biosafety Advisory and we will share this as soon as it is available.

Here are some additional existing regulatory tools, guidance materials, and directives for avian influenza A(H5N1):

ePATHogen

Local Risk Assessment

Avian influenza (bird flu)

Human Diagnostic Activities

Avian influenza A(H5N1): For health professionals

Exclusions from the Human Pathogens and Toxins Act

Biosafety Directive for New and Emerging Influenza A Viruses

Pathogen Safety Data Sheet on Influenza A virus subtypes H5, H7, and H9

Annex A : Steps to Follow to Obtain an Animal Pathogen Import Permit

1. Complete CFIA/ACIA Application Form 5858 .

Provide complete information and details regarding the material to be imported.

**Specify any/all animal-origin products, including ingredients in the culture media. **If applicable, provide documentation detailing the protocol(s) used for inactivation and/or validation of inactivity

2. Complete Terrestrial Foreign Animal Disease and Emerging Animal Disease Request Form.

You can obtain this form by contacting the National Centre for Permissions ( permission@inspection.gc.ca)

3. Submit your completed documents through a MyCFIA account or directly to the National Centre for Permissions ( permission@inspection.gc.ca ).

The Animal Pathogen Import Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Animal Pathogen Import Program will specify the conditions under which the material is to be maintained . The permit will also specify the work that the facility will be able to carry out.

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Annex B : Steps to Follow to Obtain an Animal Pathogen Transfer Permit

1. Complete a Transfer Permit Request Form.

You can obtain this form from the National Centre for Permissions ( permission@inspection.gc.ca ).

Include the original Animal Pathogen Import Permit number as well as any details regarding the material to be transferred.

**This form must be reviewed and signed by the Biological Safety Officers from both the sending and receiving facilities.

**If applicable, provide documentation detailing the protocol(s) used for inactivation and/or validation of inactivity.

2. Submit your completed documents through a MyCFIA account or directly to the National Centre for Permissions ( permission@inspection.gc.ca ).

The Animal Pathogen Transfer Permit issued by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Animal Pathogen Import Program will specify the conditions under which the material is to be maintained. The permit will also specify the work that the facility will be able to carry out.

I. Annex C: Overview of the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Containment Level 3 Facility Certification and Recertification Process

New facilities

A new containment level 3 facility certification from the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety involves the following:

Program Intent evaluation
As-Built Facility Drawings and Specifications review
Biosafety Manual, Standard Operating Procedures, Overarching Risk Assessments, Local Risk Assessments, etc. review
Requested Performance Verification and Test Reports review
On-Site Inspection with Physical and Operational Verifications

Existing facilities

For existing containment level 3 facilities already certified to work with other Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen s, a request to add avian influenza A(H5N1) virus or other Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogens to their program intent must be submitted to the Canadian Food Inspection Agency’s Office of Biohazard Containment and Safety Biocontainment and Certification Program . Moreover, the facility must submit a request to the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety if they are seeking changes to their current program intent which includes avian influenza A(H5N1) virus. The request must be accompanied by the necessary supporting documentation (for example, updated Standard Operating Procedures, Local Risk Assessments where applicable, updated training records, etc.). Once all the documentation has been reviewed and approved, confirmation of facility approval will be communicated by the Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Biocontainment and Certification Program.

Examples of program changes include, but are not limited to:

addition of new pathogens, strains
moving from in vitro only activities to in vivo activities
moving from work with small animals in primary containment caging to work with large animals in animal cubicles
addition of new animal species
addition of activities which can generate aerosols

The facility must maintain its facility certification status if it is in possession of Canadian Food Inspection Agency-Designated Terrestrial Animal Pathogen s and Canadian Food Inspection Agency -regulated materials. Documentation required for annual renewal must be submitted at minimum 2 months before the expiry of their current Certification Letter.

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Annex D: Steps to Follow to Obtain a Canadian Food Inspection Agency-Office of Biohazard Containment and Safety Containment Level 2 Facility Compliance Letter

1. Complete the self-assessed Level 2 In Vitro Only Inspection Checklist.

You can obtain this checklist from the National Centre for Permissions ( permission@inspection.gc.ca ) .

**This form must be completed and signed by the applicant as well as the Biological Safety Officer.

**Depending on the planned work activity with the virus, you may also need to complete an Addendum.

2. Submit your completed documents through a MyCFIA account or directly to the National Centre for Permissions ( permission@inspection.gc.ca ).

Last modified: Wednesday, September 4, 2024 9:10 AM

June 24, 2024

11. Can my facility submit a request to the Canadian Food Inspection Agency to transfer previously imported avian influenza A(H5N1) to another facility within Canada?

12. Can avian influenza A(H5N1) strains be transferred to provincial labs?

14. What packaging is required to ship avian influenza A(H5N1) samples between various locations?

15. Can my facility import veterinary biologics, or manufacture and produce an animal vaccine for avian influenza A(H5N1)?

Canadian Food Inspection Agency Reporting:

The Public Health Agency of Canada Reporting:

No risk group 3 Pathogen and Toxin Licence:

If you hold a risk group 3 Pathogen and Toxin Licence for similar enveloped viruses but not security sensitive biological agents:

If you have a risk group 3 security sensitive biological agent Pathogen and Toxin Licence authorizing work with or without enveloped viruses:

New facilities

Existing facilities