There are a number of requirements under the Human Pathogens Importation Regulations (HPIR) and the Human Pathogens and Toxins Act (HPTA). Some of these include registration with the Public Health Agency of Canada (the Agency), obtaining import permits, and allowing for the inspection of facilities.
Since April 2013 the Agency has also been responsible for the administration of certain provisions of the Health of Animals Act and associated regulations (HAA/HAR). It now issues import permits and transfer authorizations for terrestrial animal pathogens (excluding pathogens that cause emerging or foreign animal diseases (FAD).
When the HPTA received Royal Assent on June 23, 2009, Sections 70 and 71, along with a number of other sections, came into force. Section 70 requires any person responsible for activities involving human pathogens and toxins to register. Even if you have an importation permit under the HPIR, you still need to register under the HPTA.
Importation permits are required for the importation of human pathogens in Risk Group 2, 3 or 4 and all animal pathogens. Through the issuance of these permits, the Agency can assess and manage the risk of inadvertent release of pathogens and toxins caused by imported pathogens.
The Agency's Centre for Biosecurity Compliance and Enforcement Policy outlines how it delivers its program to promote and verify compliance with the HPIR, the HPTA and the HAA/HAR.
This policy also outlines the roles and responsibilities of the Agency and regulated parties with regards to the HPIR, HPTA, and HAA/HAR.
Compliance promotion is a proactive approach to achieving compliance through education and information sharing. It may include:
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:
Inspections are carried out by inspectors designated for the purposes of the administration and enforcement of the HPIR, HPTA, or HAA/HAR. Persons conducting activities with human and/or terrestrial animal 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 particular physical and operational requirements as described in the Canadian Biosafety Standards and Guidelines. The Agency carries out compliance monitoring and verification activities for Canadian CL2, CL3 and CL4 facilities that conduct activities with Risk Group 2, 3 or 4 human and terrestrial animal pathogens and toxins, as documented in the Compliance and Enforcement Continuum.
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 relevant Act and regulations using the most appropriate level of intervention, starting from the least intrusive level of intervention to the most serious. The Agency may respond to non-compliance through one or a combination of tools including: