Backgrounder

Human Pathogens Legislation

April 2008

The laboratory work performed with human pathogens and toxins is vital for diagnosing the cause of diseases and for advancing science through research.  Human pathogens are micro-organisms capable of causing disease in humans, such as salmonella and influenza.  Toxins can be produced by or derived from such micro-organisms and these too are capable of causing disease in humans. 

The risk to Canadians posed by the presence of human pathogens and toxins in labs is low.  Safety guidelines exist and the laboratory community is committed to the safe handling and management of human pathogens and toxins as a part of their regular work.  Nevertheless, we must be sure the appropriate legislation, protocols and practices are in place to protect Canadians from this risk.

The proposed legislation (Bill C-54) builds on existing law and establishes legal prohibitions and authorities to govern the use of human pathogens and toxins.  It is designed to ensure the handling of human pathogens and toxins in Canadian laboratories is carried out in as safe a manner as possible and to guard against the intentional misuse of these substances.

This proposed legislation brings Canada’s laboratory legislation in line with that of our international partners, including the United States, the United Kingdom, Australia, and other countries.

Current law requires all labs that import human pathogens and toxins to adhere to the Laboratory Biosafety Guidelines, a tool developed by the Public Health Agency of Canada, in consultation with stakeholders, that promote safe laboratory practices and mitigate the risks of working with human pathogens and toxins.  These guidelines are not currently mandatory for labs that acquire human pathogens and toxins from domestic sources, although they are applied widely in these labs on a voluntary basis as an industry standard.

The proposed Bill will establish consistency by requiring all labs in Canada, including federal, provincial and private facilities, to adhere to the guidelines.

Further to that, the proposed legislation prohibits the following:

• possession of certain listed human pathogens and/or toxins (smallpox is currently the one pathogen on this list);
• the intentional misuse of human pathogens and/or toxins to cause harm; and
• any use of human pathogens and/or toxins without a licence.

The proposed Bill establishes a mandatory licensing system that will ensure the Government of Canada can more easily track what human pathogens exist, where they are, and who possesses them. 

The proposed Bill also provides inspection powers to help ensure both compliance with the guidelines, and proper and consistent application of the legislation across Canada.