Language selection

Search

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

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

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:

Sections 51 and 160 of the Health of Animals Regulations:

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:

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

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 (OIE) 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:

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:

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:

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
OIE-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:

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:

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:

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:

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:

Date modified: