Policy on the importation of terrestrial foreign or emerging animal disease agents into Canada by external facilities

1.0 Scope

This policy applies to requests from facilities other than federal government laboratories seeking to import terrestrial foreign or emerging animal disease agents into Canada for research or any other use.

2.0 Purpose

The purpose of this document is to provide guidance to the CFIA Office of Biohazard Containment and Safety (OBCS) in responding to requests from external facilities to import terrestrial foreign or emerging animal disease agents into Canada.

3.0 Authority

CFIA's authority to restrict the importation of foreign or emerging animal disease agents resides in:

Sections 14 and 64(1) of the Health of Animals Act:

14. The Minister may make regulations prohibiting the importation of any animal or other thing into Canada, any part of Canada or any Canadian port, either generally or from any place named in the regulations, for such period as the Minister considers necessary for the purpose of preventing a disease or toxic substance from being introduced into or spread within Canada.
64. (1) The Governor in Council may make regulations for the purpose of protecting human and animal health through the control or elimination of diseases and toxic substances and generally for carrying out the purposes and provisions of this Act, including regulations
- (a) prohibiting or regulating the importation, exportation and possession of animals and things in order to prevent the introduction of any vector, disease or toxic substance into Canada or into another country from Canada

Sections 51 and 160 of the Health of Animals Regulations:

51. Subject to section 51.2, no person shall, except under and in accordance with a permit issued by the Minister under section 160, import into Canada any (a) animal pathogen;
160. (1.1) Subject to paragraph 37(1)(b) of the Canadian Environmental Assessment Act, the Minister shall issue a permit or license required under these Regulations if the Minister is satisfied that, to the best of the Minister's knowledge and belief, the activity for which the permit or license is issued would not, or would not be likely to, result in the introduction into Canada, the introduction into another country from Canada or the spread within Canada, of a vector, disease or toxic substance.

(2) Any permit or license required under these Regulations shall
(b) contain such conditions as the Minister considers advisable to prevent the introduction of communicable disease into Canada or into any other country from Canada and the spread of communicable disease within Canada.

CFIA's authority to restrict the subsequent movement and use of imported foreign or emerging animal disease agents resides in Section 51.1 of the Health of Animals Regulations:

51.1 Where any animal pathogen, animal or other organism, animal blood or animal serum referred to in section 51 is imported into Canada under a permit, no person shall
- (a) move the imported pathogen, animal or other organism, blood or serum from the place or places specified in the permit to any other place, except under and in accordance with that permit or another permit issued for that purpose by the Minister under section 160; or
- (b) introduce into an animal the imported pathogen, animal or other organism, blood or serum, except under and in accordance with that permit or another permit issued for that purpose by the Minister under section 160.

CFIA's authority in relation to permits for terrestrial animal pathogens as defined in the Order in Council:

His Excellency the Governor General in Council, on the recommendation of the Prime Minister, pursuant to paragraph 2(a) of the Public Service Rearrangement and Transfer of Duties Act, transfers
(a) to the Minister of Health the powers, duties and functions of the Minister of Agriculture and Agri-Food set out in section 160 of the Health of Animals Regulations in relation to permits referred to in paragraphs 51(a) and 51.1(a) and (b) of those Regulations as they relate to terrestrial animal pathogens, including those from avian and amphibian animals, except for those pathogens
- (i) that cause an animal disease included on the list of the World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)), entitled WOAH-Listed diseases, infections and infestations, as amended from time to time, that is not indigenous to Canada, or
- (ii) that cause an emerging animal disease

4.0 Background

Facilities other than federal government laboratories (private, provincial or university laboratories) may seek access to certain foreign or emerging animal disease agents for scientific research or other purposes. The value of this work may include increased knowledge of the agent, leading to more effective disease prevention strategies, improved disease control, diagnostics or treatment.

Although biohazard containment certification of animal health facilities confirms that specific physical design requirements have been met and the necessary mechanical systems are in place to prevent escape of biological agents into the environment, breaches in biosafety and bio-containment may still occur. High risk biological agents have disseminated from high level containment facilities in the past and led to significant consequences to human and/or animal health, or the economy of the affected country. For example, in August 2007, foot-and-mouth disease virus was accidentally released from a high level containment laboratory in the United Kingdom, with serious economic consequences. For this reason, most countries including Canada restrict work on certain pathogens to single high containment federal government facilities.

5.0 Abbreviations and definitions

CBSG:: Canadian Biosafety Standards Guidelines
CFIA:: Canadian Food Inspection Agency
Emerging Animal Disease:: a new infectious disease resulting from the evolution or change of an existing pathogenic agent, a known infectious disease spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which may have a significant impact on animal health, as determined by the CFIA.
External facility:: for the purpose of this document, a laboratory or other facility that is not operated by a federal government department or agency.
Foreign Animal Disease:: any disease that appears in the World Organisation for Animal Health (WOAH) Listed Diseases and that is not indigenous to Canada, or any other animal disease that is not indigenous to Canada, as determined by the CFIA.
OBCS:: CFIA's Office of Biohazard Containment and Safety
PHAC:: Public Health Agency of Canada
Reportable disease:: disease prescribed as a reportable disease by the Minister, pursuant to subsection 2(2) of the Health of Animals Act, and listed in the Schedule of the Reportable Diseases Regulations.

6.0 Policy

6.1 Higher risk terrestrial foreign animal disease agents (category I)

The following terrestrial foreign animal disease agents have the potential to pose a severe threat to animal health.

The introduction or spread of these agents within Canada would also have severe economic consequences.

The criteria for inclusion in this category include rapid transmission within and/or between species, stability within the environment, and/or high negative impact on international trade.

Some of these agents have never been seen in this part of the world. For these reasons, importation of these agents by facilities other than approved high containment federal government facilities is strictly prohibited:

African horse sickness virus
African swine fever virus
Bluetongue virus (serotypes other than 2, 10, 11, 13 and 17)
Classical swine fever virus
Crimean-Congo haemorrhagic fever virus^Footnote 1
Epizootic haemorrhagic disease virus (serotypes other than 1 and 2)
Foot and mouth disease virus
Hendra virus^Footnote 1
Lumpy skin disease virus
Mycoplasma mycoides (contagious bovine pleuropneumonia)
Newcastle disease virus
Nipah virus^Footnote 1
Peste des petits ruminants virus
Pseudorabies virus
Rinderpest virus
Rift valley fever virus^Footnote 1
Sheep and goat pox virus
Swine vesicular disease virus
Any other foreign or emerging animal disease pathogen that meets the criteria above, as determined by the CFIA

6.2 Select higher risk terrestrial foreign animal disease agents with zoonotic potential (category II)^Footnote 2

As in the previous category, the following terrestrial foreign animal disease agents have the potential to pose a severe threat to animal health, and the introduction or spread of these agents within Canada would have severe economic consequences.

However, as these agents also have zoonotic potential, external facilities that are certified to the appropriate biohazard containment level may seek access to these risk group 3 agents for the purpose of vaccine development or to perform other work in the public health interest.

Requests for importation of these zoonotic risk group 3 foreign animal disease agents will be evaluated on a case-by-case basis, by considering the risks to animal health associated with the specific research project (see Annex A).

Depending on the result, importation of these agents may be permitted, subject to strict monitoring of the facility and enhanced regulatory oversight (see Annex B), and if the facility has been certified to the appropriate biohazard containment standard, as defined by the Office of Biohazard Containment and Safety, CFIA:

Burkholderia mallei (glanders)^Footnote 1
Highly pathogenic avian influenza virus (HPAIV)^Footnote 1
Japanese encephalitis virus^Footnote 1
Venezuelan equine encephalomyelitis virus^Footnote 1
Vesicular stomatitis virus^Footnote 1

6.3 Lower risk terrestrial foreign animal disease agents (category III)

The following terrestrial foreign animal disease agents are considered to pose less risk and fewer consequences than those in the previous category. Some are transmitted primarily by insect vectors and therefore are not expected to spread rapidly if introduced.

Requests for importation of these agents will be evaluated on a case-by-case basis, by considering the risks to animal health associated with the specific research project (see Annex A).

Depending on the result, importation of these agents may be permitted under certain conditions, as long as the facility has been certified to the appropriate biohazard containment standard, as defined by the Office of Biohazard Containment and Safety, CFIA:

Aino virus
Akabane virus
Avian metapneumovirus (turkey viral rhinotracheitis)
Babesia bovis (bovine babesiosis)
Babesia caballi, Theileria equi (equine piroplasmosis)
Bovine ephemeral fever virus
Borna disease virus^Footnote 1
Brucella abortus, B. melitensis, and B. suis (brucellosis)^Footnote 1
Camelpox virus
Duck hepatitis virus
Ehrlichia ondiri (bovine petechial fever)
Ehrlichia ruminantium (heartwater)
Ibaraki disease virus
Louping ill virus
Mycoplasma agalactiae (contagious agalactia)
Mycoplasma capricolum (contagious caprine pleuropneumonia)
New world screwworm (cochliomyia hominivorax)
Nairobi sheep disease virus
Notifiable avian influenza virus other than HPAIV^Footnote 1
Old world screwworm (chrysomya bezziana)
Porcine teschovirus serotype 1 (Teschen disease)
Rabbit haemorragic disease virus
Salmonella gallinarum (fowl typhoid)
Salmonella pullorum (pullorum disease)
Taylorella equigenitalis (contagious equine metritis)
Theileria annulata and parva (theileriosis)
Trypanosoma equiperdium (dourine)
Trypanosoma evansi (surra)
Trypanosoma congolense, T. vivax and T. brucei brucei (tsetse transmitted trypanosomosis)^Footnote 1
Wesselsbron disease virus^Footnote 1

7.0 References and resources

Order in Council (OIC)
Canadian Biosafety Standards and Guidelines (CBSG)
Health of Animals Act
Health of Animals Regulations
Reportable Disease Regulations
WOAH-Listed diseases, infections and infestations

Annex A – Criteria for evaluating requests for the importation of category II and category III terrestrial foreign or emerging animal disease agents into Canada by external facilities

Approval requests from Canadian facilities seeking to import foreign or emerging animal disease agents are sent to CFIA's Office of Biohazard Containment and Safety (OBCS) for review. Only requests for Category II or III agents will be considered, as importation of Category I agents is strictly prohibited. The importing facility must include the following information in their application:

Program intent (for example diagnostics, surveillance, research, in vitro vs in vivo, challenge studies)
Duration of project(s)
Type of facility (for example laboratory work area only, small or large animal)
Location of facility
Procedures to be conducted, with identification of any potential impacts on the pathogenicity and virulence of the agent, host immunity and host range
Characteristics of the agent (for example strain type, country of origin)
Background, training and qualifications of individuals that would be handling the agent
Control procedures in place to prevent unauthorized access to the agent

OBCS then forwards the request to the appropriate CFIA subject matter experts for review. A formal risk assessment may be conducted to assist in the decision process. Some key considerations would include:

Risk to Canada (impact to animal health and the Canadian economy in the event of a breach in containment)
International impact (potential trade implications of allowing importation of the foreign or emerging animal disease agent into Canada)
Location of the facility relative to susceptible animal populations
Mitigation measures available

Annex B – Enhanced regulatory oversight of external facilities importing category II terrestrial foreign or emerging animal disease agents into Canada

The importation of Category II zoonotic foreign or emerging animal disease agents is regulated by both the CFIA and the Public Health Agency of Canada (PHAC) and is subject to the operational and physical requirements outlined in the Canadian Biosafety Standards and Guidelines (CBSG).

Operational practice compliance verification for biological agents, including zoonotic agents, generally consists of:

Review of standard operating procedures prior to certification, during on-site inspections, and through document review requests
Review of the biosafety manual of the facility (this includes the program intent, documentation of their biosafety program, standard operating procedures, biosecurity plan, training program, medical surveillance program, emergency response plan, and the facility maintenance program)
Review of training records
Review of decontamination and infectious waste management procedures
Review of risk assessments (local risk assessments, overarching risk assessments, and biosecurity risk assessments)
Review of records pertaining to inventories, importations, and transfers of infectious material

Physical requirement compliance verification for biological agents, including zoonotic agents, generally consists of an annual documentation review of performance and verification tests, certification tests, as outlined in the CBSG. These include the review of critical biohazard containment systems such as:

Heating, ventilation and air conditioning control systems
Decontamination systems (autoclaves, effluent decontamination, tissue digesters, and space decontamination systems)
Annual testing of primary containment devices (for example biological safety cabinets), HEPA filters, backflow prevention and emergency generators
Access control systems
Integrity of the containment barrier (including directional airflow).

Following the results of a case-by-case assessment (see Annex A), facilities that are authorized by the CFIA to import Category II zoonotic foreign or emerging animal disease agents will be subject to an enhanced regulatory oversight.

These enhancements include, but are not limited to:

Increasing the frequency of on-site inspections
Increasing the on-site document and operational review in addition to paper-based compliance verification
Conducting detailed reviews of training records of personnel handling Category II zoonotic foreign or emerging animal disease agents prior to when work begins and during on-site inspections thereafter
Increasing the frequency of record reviews (for example inventories, transfers, importations) in addition to during on-site inspections
Review of access records (for example records of persons accessing the facility where Category II zoonotic foreign or emerging animal disease agents are handled or stored)
Inclusion of a review of ongoing research to verify that it is consistent with the information provided for the case-by-case review under Annex A
Increasing communication with the facility's biological safety officer, senior management, and institutional biosafety committee through regular meetings and teleconferences to facilitate compliance with requirements
Increasing information sharing between PHAC and the CFIA with respect to reports of any incidents or laboratory acquired infections that occur at the facility as well as their compliance verification history
Addition of project specific conditions for work with Category II zoonotic foreign or emerging animal disease agents, as determined by the CFIA (for example work restricted to a certain part of a facility, to in vitro work only, single entry permit)