Compliance: Registration, Permits, Inspection and Enforcement

There are a number of requirements to comply with the Human Pathogens Importation Regulations and the Human Pathogens and Toxins Act. Some of these include registration, obtaining permits, and enabling inspections. Failure to do these things could result in enforcement action being taken.

Registration under the Human Pathogens and Toxins Act

Section 70 of the Human Pathogens and Toxins Act (HPTA) 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 (HPIR), you still need to register under the HPTA.

Importation Permits under the Human Pathogens Importation Regulations

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

Compliance with and Enforcement of the Human Pathogens and Toxins Act and the Human Pathogens Importation Regulations

The Agency’s Compliance and Enforcement Policy outlines how it delivers its program to further compliance with the Human Pathogens Importation Regulations (HPIR) and the Human Pathogens and Toxins Act (HPTA).

This policy also outlines the roles and responsibilities of the Agency and regulated parties with regards to the HPIR and HPTA.

Compliance promotion  is a proactive approach to achieving compliance through education and information sharing. It may include:

• assisting regulated parties in understanding their obligations to comply with legislative requirements; or
• providing training on how to meet those requirements.

Compliance monitoring involves verifying that regulated activities are carried out in accordance with the provisions of the relevant Act and regulations. The Agency monitors compliance in a number of ways including:

• conducting on-site inspections;
• verifying shipping and custom declaration documents;
• evaluating biosafety programs,.

Inspections are carried out byinspectors designated  by the Minister of Health 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 hasparticular 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 or 4 human pathogens.

Enforcement action may be taken where non-compliance is identified. The primary objective of enforcement action is to manage the risk and have the regulated party comply with the Act and Regulations using the most appropriate level of intervention, starting from the least intrusive level of intervention to the most invasive. The Agency may respond to non-compliance through one or a combination of tools including:

• Notice of Non-Compliance;
• cancellation of an importation permit; 
• seizure and detention.