Registration, Permits and Inspection Operations

Registration under the Human Pathogens and Toxins Act

With Royal Assent in 2009, Section 70 (among a number of others) of the Human Pathogens and Toxins Act (External link) (HPTA) came into force. Section 70 requires any person responsible for activities involving human pathogens and toxins to provide the following information:

• A confirmation that they are responsible for human pathogens or toxins;
• The risk groups to which the human pathogens belong;
• The location where activities involving human pathogens or toxins are conducted;
• The name of a contact person with appropriate safety training or relevant work experience relating to human pathogens and toxins.

Even if you have an importation permit under the Human Pathogens Importation Regulations (External link) (HPIR), you still need to register under the HPTA.

Importation Permits under the Human Pathogens Importation Regulations

The HPIR allows the Public Health Agency of Canada to assess and manage the risk of inadvertent transmission of communicable diseases caused by human pathogens. Under these regulations, every person importing a human pathogen in Risk Group 2, 3 or 4 must obtain an importation permit.

Inspection (Biocontainment)

Inspections can be carried out by persons designated as inspectors with respect to either the HPIR or HPTA. Under the HPIR, persons importing human pathogens and toxins must ensure that their facility meets the containment level requirements necessary to safely store and/or manipulate this material. There are four (4) containment levels (CL1 – CL4) of increasing stringency, and each containment level has defined physical and operational requirements as described in the Laboratory Biosafety Guidelines. The Agency carries out certification of Canadian CL3 and CL4 facilities with Risk Group 3 and 4 human pathogens.