Backgrounder Article from  Health Canada

Implementation of the Human Pathogens and Toxins Act and Regulations - Fact Sheet

December 2015

What are human pathogens and toxins?

  • Human pathogens are infectious substances, such as viruses, bacteria and parasites.  Human pathogens and toxins can pose a significant risk to human health and safety and are capable of causing significant illness or death in humans. Many animal pathogens can also infect humans. These are called zoonotic pathogens.
  • Whether located in academic settings, hospitals, government departments or within private industry, many Canadian laboratories work with human pathogens and toxins, such as Anthrax and Listeria.
  • Pathogens can be used to develop new vaccines, to study diseases, and to develop new therapies to treat diseases.

What are the Human Pathogens and Toxins Act and Regulations?

  • The Human Pathogens and Toxins Act (HPTA) and the supporting Human Pathogens and Toxins Regulations (HPTR) regulate the safe handling of toxins and human pathogens in Canada.
  • The HPTR improve the oversight of human pathogens and toxins in Canada, establish national requirements for the safe handling of human pathogens and toxins, and provide assurance that individuals with access to a prescribed list of security-sensitive human pathogens and toxins would hold an appropriate security clearance.
  • To achieve this, the HPTR set out a risk-based licensing process for facilities conducting controlled activities with human pathogens and toxins. The Regulations also prescribe a list of specific Risk Group 3 and 4 human pathogens and selected toxins that pose the highest risk of intentional misuse, and will set out security clearance requirements for persons who have access to these agents.
  • The Act and Regulations balance the need for increased security with Canada's ability to advance science, conduct innovative research, and respond to disease outbreaks.
  • The HPTR and HPTA replace and extend the authority of the Public Health Agency of Canada beyond the previous Human Pathogen Importation Regulations (HPIR) and Canadian Biosafety Standards and Guidelines (CBSG) which were in effect until December 1, 2015, when the HPIR were repealed and the CBSG replaced by the Canadian Biosafety Standard (CBS).
  • The CBSG were used by laboratory researchers and workers in facilities possessing, handling, storing or using pathogens and toxins. The HPIR covered the importation of human and terrestrial animal pathogens.

What are the objectives of the Human Pathogens and Toxins Regulations (HPTR)?

  • The key objective is to make working with human pathogens and toxins safer, more secure and less burdensome for those dealing with lower risk pathogens.
  • The HPTR are complemented by additional non-regulatory facility and operational standards for activities conducted with human pathogens and toxins in Canada.

Who will be subject to the HPTR?

  • The HPTR is applicable to approximately 8,500 laboratories in Canada. Stakeholders from academia, and the private and public sectors were extensively consulted during the development of the HPTR
  • The Agency is developing implementation tools and products to support these companies in meeting their regulatory requirements.

When will the HPTR come into force?

  • The Human Pathogens and Toxins Regulations (HPTR) along with the remaining sections of the Human Pathogens and Toxins Act (HPTA) came into force December 1, 2015. The Human Pathogens Importation Regulations and Canadian Biosafety Standards and Guidelines remained in effect until December 1, 2015.

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Hon. Jane Philpott Health Canada Health and Safety

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