Organism Lists

The Human Pathogens Importation Regulations (SOR/94-558) are the regulatory authority for facilities wishing to import human pathogens into and transfer of specimens within Canada. Any facility wishing to import human pathogens requiring containment levels 2, 3, or 4 must have a valid Public Health Agency of Canada permit prior to importation. Pathogens requiring containment level 1 facilities are not regulated by the HPIR, and therefore a permit is not required for their importation.

The accompanying list of human pathogens (Bacteria, Viruses and Fungi) is a dynamic list detailing required containment levels for manipulation. This list is regularly updated, and the required containment levels are continually reassessed as new information becomes available. It must also be understood that the accompanying list of human pathogens is not complete. The containment level for unlisted organisms must be verified in consultation with the Office of Laboratory Security, Public Health Agency of Canada.

Among the listed human pathogens, those classified as potentially harmful to animals have also been indicated. Animal pathogens are regulated by the Canadian Food Inspection Agency (CFIA). For importation of pathogens common to both humans and animals, an import permit is required from the CFIA as well as the Public Health Agency of Canada.

Non-Pathogenic Organisms 35 KB Adobe Downloadable Document

Containment Levels

The Public Health Agency of Canada is now moving away from classifying organisms according to risk group towards a classification system based on containment level. Containment levels are more appropriate and give the end-user an indication of the containment required for handling the organism safely in a laboratory setting. The containment level required for work with a particular agent is based on the manipulations generally associated with laboratory-scale research and clinical procedures.

Containment Level 1 (CL1)

This level applies to the basic laboratory handling agents requiring containment level 1. CL1 requires no special design features beyond those suitable for a well-designed and functional laboratory. Biological safety cabinets are not required. Work may be done on an open bench top, and containment is achieved through the use of practices normally employed in a basic microbiology laboratory

Containment Level 2 (CL2)

This level applies to the laboratory handling agents requiring containment level 2. The primary exposure hazards associated with organisms requiring CL2 are through the ingestion, inoculation, and mucous membrane route. Agents requiring CL2 facilities are not generally transmitted by the airborne route, but care must be taken to avoid the generation of aerosols (aerosols can settle on benchtops and become an ingestion hazard by contamination of the hands) or splashes. Primary containment devices such as biological safety cabinets and centrifuges with sealed rotors or safety cups are to be used, as well as personal protective equipment (gloves, laboratory coats, protective eyewear). Environmental contamination must also be minimized by the use of hand washing sinks and decontamination facilities (autoclaves).

Containment Level 3 (CL3)

This level applies to diagnostic, research and clinical laboratories, production facilities, or teaching laboratories handling agents requiring containment level 3. These agents may be transmitted by the airborne route, often have a low infectious dose to produce effects, and can cause serious or life-threatening disease. CL3 emphasizes additional primary and secondary barriers to minimize the release of infectious organisms into the immediate laboratory and the environment. Additional features to prevent transmission of CL3 organisms are appropriate respiratory protection, HEPA filtration of exhausted laboratory air, and strictly controlled laboratory access.

Containment Level 4 (CL4)

This is the maximum containment available and is suitable for facilities manipulating agents requiring containment level 4. These agents have the potential for aerosol transmission, often have a low infectious dose, and produce very serious and often fatal disease; there is generally no treatment or vaccine available. This level of containment represents an isolated unit, functionally and, when necessary, structurally independent of other areas. CL4 emphasizes maximum containment of the infectious agent through complete sealing of the facility and testing to pressure decay; isolating the researcher from the pathogen by containing the individual in a positive pressure suit (most common) or containing the pathogen in a Class III biological safety cabinet line (rare); and decontaminating air and other effluents produced in the facility.