Laboratory Biosafety Guidelines
2nd Edition 1996

CHAPTER 3

REGULATIONS

3.1 IMPORTATION

The importation of human pathogens is regulated by the Importation of Human Pathogens Regulations (1994). Permits are required for the importation of all infectious substances into Canada regardless of whether they infect humans, animals or plants. The importation of infectious agents which are predominantly pathogenic to animals is regulated by means of the Health of Animals Act and Regulations administered by Agriculture and Agri-Food Canada. It may also be necessary to obtain permission to transfer listed pathogens within Canada from one scientist or laboratory to another. Requests for single-entry and long-standing permits to import infectious substances affecting humans should be directed to Director, Office of Laboratory Security, Laboratory Centre for Disease Control, Ottawa, Ontario K1A 0L2, tel: (613) 957-1779. Information regarding veterinary pathogens and permits may be obtained from Agriculture and Agri-Food Canada, 59 Camelot Drive, Nepean, Ontario K1A 0Y9, tel.: (613) 952-8000.

3.2 EXPORTATION

Permits are required for the export from Canada of certain microorganisms and associated equipment. Canada presently controls certain toxicological and biological agents, as well as their related equipment, components, materials and technology under item 2007 of the Export Control List. For assistance or advice, contact Foreign Affairs and International Trade Canada, Export Control Division, Lester B. Pearson Building, 125 Sussex Drive, Ottawa, Ontario K1A 0G2, tel: (613) 996-2387.

3.3 TRANSPORTATION

The careful handling, transfer and shipment of diagnostic specimens and infectious agents is absolutely essential if Canada is to maintain an effective health care system. Transportation methods must minimize risks to employees of the carrier, the public and the staff of the receiving laboratory. Hazards are compounded by improper packaging; a broken specimen container may lead to contamination of both laboratory and non-laboratory personnel, and an improperly labelled package may be opened inadvertently by secretarial, clerical or other untrained staff.

In Canada, effective July 1, 1985, Transport Canada has become responsible for regulations concerning the transportation of dangerous goods. Any person handling, offering for transport or transporting dangerous goods must comply with the Transportation of Dangerous Goods Act and Regulations, RegistrationSOR 85-77 as amended in 1994. Inquiries regarding these Regulations should be directed to the Director General of the Transport of Dangerous Goods Directorate of Transport Canada, Canada Building, 344 Slater Street, 14th Floor, Ottawa, Ontario K1A 0N5, tel.: (613) 998-0517.

The efficient and safe transfer of infectious substances requires good coordination between the sender, carrier, and receiver to ensure safe and prompt transport and arrival in proper condition. It is important that the sender make advance arrangements with the carrier and the receiver to ensure that specimens will be accepted and promptly processed. In addition, the sender must prepare the appropriate dispatch documents according to the Transportation of Dangerous Goods Act and Regulations. The sender should also forward all transportation data to the receiver. No infectious substances should be dispatched before advance arrangements have been made between the sender, the carrier and the receiver, or before the receiver has confirmed with national authorities that the substance can be imported legally and that no delay will be incurred in the delivery of the consignment to its destination.

In addition, information may be routinely obtained from the Canadian Transport Emergency Centre (CANUTEC) during working hours at (613) 992-4624 and IN AN EMERGENCY at (613) 996-6666 (24 hours per day).

3.4 THE HEALTH OF ANIMALS ACT 1990

The Health of Animals Act 1990 and its Regulations gives Agriculture and Agri-Food Canada (AAFC) the legislative authority to control the distribution and use of any pathogen which may cause infectious or contagious disease in animals. This includes materials of animal origin which contain potential pathogens. In practical terms, this means that AAFC approval must be obtained for the importation of every animal pathogen. In the case of pathogens which affect both humans and animals, importation permits are required from both Health Canada and AAFC. If an agent was brought into Canada under an import permit which restricts its distribution, further approval must be obtained before transferring it to another scientist or laboratory. Recombinant organisms and their release into the environment may also be restricted. AAFC will also establish for animal pathogens, the conditions under which they will be maintained and work will be carried out. It is necessary to consider not only the risk to human health, but also the level of containment needed to prevent escape of an animal pathogen into the environment where it may constitute a risk to any indigenous animal species.

Animal pathogens, including pathogens which affect both humans and animals, under the control of AAFC, are listed in a database maintained by the Animal & Plant Health Directorate, AAFC. This is a dynamic listing which is continuously amended to include emerging pathogens that may require restriction. Animal disease agents considered as not indigenous to Canada forma portion of this database and are severely restricted. Table 1 provides a partial list of these organisms. For each animal pathogen, AAFC must be consulted for its importation, use and distribution. Information on the status of veterinary pathogens may be obtained from AAFC, Animal Health Division, 59 Camelot Drive, Nepean, ON K1A 0Y9, (613) 952-8000.

3.4.1 NON-INDIGENOUS AGENTS

The following partial list is provided as an example of animal pathogens under AAFC control and is not complete.

TABLE 1

AGENTS NOT INDIGENOUS TO CANADA

BACTERIA
Mycoplasma agalactiae
Mycoplasma mycoides
Rickettsia ruminantium

PARASITES
Besnoitia besnoiti
Theileria annulata
Theileria bovis
Theileria hirci
Theileria lawrencei
Theileria parva
Trypanosoma equiperdum
Trypanosoma evansi
Trypanosoma vivax

VIRUSES
Bornaviridae

Borna disease virus
Bunyaviridae

Nairobi sheep disease virus

Rift Valley fever virus
Caliciviridae

Swine vesicular disease

Vesicular exanthema virus
Herpesviridae

Pseudorabies virus
Iridoviridae

African swine fever virus
Orthomyxoviridae

Fowl plague virus
Paramyxoviridae

Rinderpest, Newcastle disease virus (mesogenic, velogenic strains),

Peste des petits ruminants
Picornaviridae

Genus Aphthovirus: Foot-and-mouth disease virus

Genus Enterovirus: Teschen disease virus
Poxviridae

Chordopoxvirinae (poxviruses of vertebrates),

Small pox (Alastrim)

Genus Capripoxvirus

Sheeppox

Goatpox

Lumpy skin disease

Genus Suipoxvirus

Swinepox

Camelpox virus
Reoviridae

Genus Orbivirus

Bluetongue virus

African horsesickness virus
Rhabdoviridae

Genus Vesiculovirus

Ephemeral fever virus

Vesicular stomatitis virus (Animal inoculation)
Togaviridae

Hog Cholera virus

Louping III virus (Animal inoculation)

Wesselsbron disease virus

Venezuelan Equine Encephalitis (VEE)