Human Pathogens and Toxins Act and Regulations: Evaluation Report and Consultations

The Human Pathogens and Toxins Act (the Act) and associated Regulations came into full effect on December 1, 2015. Their purpose is to protect the health and safety of the public from risks posed by human pathogens and toxins.

The Public Health Agency of Canada (the Agency) committed to a legislative review every 5 years as part of the regulatory life-cycle of the Act and Regulations to ensure that the regulations continue to be appropriate and effective, and achieve their intended policy objectives. The COVID-19 pandemic delayed the first review.

The Agency’s Office of Audit and Evaluation led an evaluation on the Act and Regulations, which focused primarily on issues of effectiveness and efficiency related to the implementation of the Act and Regulations from 2015 to 2021. The evaluation identified 3 recommendations related to:

•         security clearance requirements
•         virtual inspections
•         roles and responsibilities of Biological Safety Officers and Licence Holders

The Centre for Biosecurity developed a Management Action Response Plan, which identified key actions to address the recommendations. This included a commitment to complete a comprehensive legislative review of the Act and Regulations in these areas.

The final Act and Regulations evaluation report, including the Management Action Response Plan, is now available.

In accordance with the Cabinet Directive on Regulations, the Agency will consult with stakeholders and interested parties about the policy development and proposed regulatory amendments to the Act and Regulations. We'll keep you posted as we plan these consultations.