The Laboratory Biosafety Guidelines: 3rd Edition 2004

Chapter 10
Regulatory Aspects for Handling Infectious Substances

10.1 Importation and Transfer of Human Pathogens

The Human Pathogens Importation Regulations (SOR/94-558) (HPIR) are the regulatory authority for facilities wishing to import human pathogens into and transfer specimens within Canada. These regulations were developed to ensure that facilities have appropriate containment for the pathogens they wish to handle. Any facility wishing to import a human pathogen requiring containment levels 2, 3 or 4 must have a valid Health Canada permit before importation. Pathogens requiring containment level 1 facilities are not regulated by the HPIR, and therefore a permit is not required for their importation. Applications for permits to import human pathogens can be obtained either by calling the Office of Laboratory Security directly at (613) 957-1779 or by downloading the application form from the Office of Laboratory Security's Website at http://www.phac-aspc.gc.ca/ols-bsl/

Similarly, a copy of the HPIR and frequently asked questions about the importation process can also be accessed at the Office of Laboratory Security's Website.

Applicants wishing to import and transfer human pathogens must have facilities that comply with the operational practices and physical requirements for a containment laboratory detailed in these Guidelines. For facilities wishing to import pathogens requiring containment levels 3 and 4, Health Canada certification that the laboratory meets the requirements of the Laboratory Biosafety Guidelines is required before a permit is issued. The requirements for certification of a containment laboratory are detailed in Chapter 5. Facilities wishing to import pathogens requiring containment level 2 are to perform a self-inspection to ensure that the facility meets the Laboratory Biosafety Guidelines' requirements and the self-inspection is subject to verification by Health Canada inspectors at any time. Additionally, the Office of Laboratory Security's Website (given above) hosts a Risk Group listing of human pathogens, detailing the recommended Risk Group for each pathogen.

Many human pathogens are pathogens of animals as well. Animal pathogens are regulated by the Canadian Food Inspection Agency (CFIA) (see section 10.4, Importation of Animal Pathogens, in this chapter). For importation of pathogens that are common to both animals and humans, an import permit is required from the CFIA as well as Health Canada. It is the responsibility of the importer to ensure that all appropriate import permit documentation has been obtained prior to importation of any pathogen into Canada.

10.2 Export of Pathogens

Many pathogens and associated equipment that are destined for export from Canada require permits. Canada is a signatory to the 1972 Biological and Toxin Weapons Convention. This international Convention stresses the goal of non-proliferation of biological and toxin weapons through the prohibition of the development, production, stockpiling or acquisition of microbiological (biological) and toxin weapons and their destruction. The Department of Foreign Affairs and International Trade Canada currently controls certain toxicological and biological agents as well as their related equipment, components, materials and technology, under item 2007 of the Export Control List of this international Convention. For assistance or advice, contact the Department of Foreign Affairs and International Trade Canada, Export Control Division, tel. (613) 996-2387 or contact their Website at http://www.dfait-maeci.gc.ca/eicb/

10.3 Transportation

The transportation of infectious substances is an essential part of routine laboratory procedures in both research and diagnostic settings. Samples must be transported by road and/or air to assist researchers collaborating with other researchers at removed locations, or to carry out primary diagnostic tests on samples obtained from ill patients. Although there has never been a reported case of illness associated with a transportation accident involving an infectious substance⁽¹⁾ , transportation accidents involving infectious substances do occur⁽²⁾. Therefore, it is important that infectious substances be packaged and transported according to tested and approved methods.

The transportation of infectious substances within Canada is regulated by the Transportation of Dangerous Goods Regulations (SOR/85-77), administered by Transport Canada. Transport Canada defines the labeling, packaging and documentation requirements necessary for shipping infectious substances, including diagnostic specimens, within Canada. Their regulation also requires that any individual transporting an infectious substance be trained in the transportation of dangerous goods (infectious substances). Additionally, shippers of risk group 4 materials are required to have an emergency response assistance plan to respond to any shipping emergency occurring anywhere in Canada. More information regarding the transportation of infectious substances within Canada can be obtained by calling Transport Canada, Dangerous Goods Standards, at (613) 990-1059, by writing to them at Place de Ville, Tower C, 330 Sparks St., 4th Floor, Ottawa ON K1A 0N8, or by visiting the Transport Canada Dangerous Goods Website at http://www.tc.gc.ca/civilaviation/commerce/dangerousgoods/

The air transportation of infectious substances internationally is regulated by the International Civil Aviation Organization (ICAO)⁽³⁾. As the majority of carriers (both passenger and courier/cargo) around the world are members of this organization, anyone shipping infectious substances internationally is likely subject to ICAO regulations. The ICAO regulations define the labeling, packaging and documentation requirements necessary for international shipping of infectious substances by air. It also requires that any individual transporting an infectious substance be trained in the transportation of dangerous goods (infectious substances). The ICAO requirements are based upon the United Nations Recommendations on the Transportation of Dangerous Goods. For further information regarding international shipping requirements, please contact the ICAO Canadian representative directly: Judith Code, Chief, Dangerous Goods Standards, Commercial and Business Aviation, Transport Canada, at (613) 990-1060 (mailing address as indicated for Transport Canada above).

Shipping infectious substances by air also falls under the Dangerous Goods Regulations (DGR) of the International Air Transport Association (IATA)⁽⁴⁾. These regulations set out all the ICAO mandates and the airline industry's universal rules on how to safely package and transport infectious substances. A copy of the DGR may be obtained from IATA by calling 1-800-716-6326 or through their Website at http://www.iata.org/

10.4 Importation, Transfer and Containment of Animal Pathogens

The Health of Animals Act , 1990, and the Health of Animal Regulations give the CFIA the legislative authority to control the use of imported animal pathogens and pathogens associated with reportable animal diseases. These include materials of animal origin that contain potential pathogens. Please refer to the Health of Animals Act and the Regulations for complete information.

Permits are required for the importation of all animal pathogens into Canada. In the case of pathogens that affect both humans and animals, import permits are required from both Health Canada and the CFIA. If an agent is brought into Canada under an import permit that restricts its distribution, further approval must be obtained from the CFIA before transferring the agent to another location.

The CFIA also establishes the conditions under which animal pathogens 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. The CFIA publication Containment Standards for Veterinary Facilities⁽⁵⁾ outlines the minimum design, and physical and operational requirements for Canadian laboratories and animal facilities that import and work with animal or zoonotic pathogens. Laboratories that apply to import animal or zoonotic pathogens must demonstrate that they meet these requirements before the CFIA can issue an import permit.

Animal pathogens, including pathogens that affect both humans and animals, under the control of the CFIA are listed in a database maintained by the Biohazard Containment and Safety Division, CFIA. This is a dynamic list that is continuously amended to include emerging pathogens that may require restriction. Animal pathogens that are considered nonindigenous to Canada form a portion of this database and are severely restricted. For each animal pathogen, the CFIA must be consulted for its importation, use and distribution.

Information on the status of animal pathogens may be obtained from

Biohazard Containment and Safety Division
Canadian Food Inspection Agency
159 Cleopatra Drive
Ottawa, Ontario
K1A 0Y9
Tel.: (613) 221-7068
Fax: (613) 228-6129
http://www.inspection.gc.ca/english/sci/bio/bioe.shtml

Information on the status of plant pathogens under the Plant Protection Act and Regulations can be obtained by contacting:

Plant Health and Production Division
Permit Office
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Tel.: (613) 228-2342 (ext. 4334 or 4333)
Fax: (613) 228-6605

References

1. WHO. Guidelines for the safe transport of infectious substances. Geneva: Division of Emerging and Other Communicable Diseases Surveillance and Control, WHO/EMC/97.3, 1997.

2. Transport Canada. 1999 statistics. Canadian Transport Emergency Centre, 2000.

3. International Civil Aviation Organization. Technical instructions for the safe transport of dangerous goods by air. 2001-2002. Doc 9284-AN/905, 2000.

4. International Air Transport Association. Dangerous goods regulations. 43^rd edition. January 2003.

5. Containment standards for veterinary facilities. Ottawa: Agriculture and Agri-Food Canada, Minister of Supply ans Services Canada, No. 1921/E, 1996.

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