Results at a Glance - Evaluation of the Human Pathogens and Toxins Act and Regulations Framework

Office of Audit and Evaluation
March 2022

Table of Contents

• Program context
• Evaluation approach
• What the evaluation found
• Recommendations

Program context

Human pathogens and toxins pose a significant risk to human health and safety. To address these concerns, the Public Health Agency of Canada (PHAC) established a national safety and security program to protect the health and safety of the public against risks posed by human pathogens and toxins.

The Human Pathogens and Toxins Act and Regulations (HPTAR) Framework came into full force in 2015. The Centre for Biosecurity delivers the national biosafety and biosecurity regulatory program that includes a licensing framework, an inspection program, inventory requirements, incident and exposure reporting, security clearance requirements, standard and guidelines development and implementation, as well as compliance and enforcement.

Evaluation approach

The evaluation focused primarily on issues of effectiveness and efficiency and covered activities related to the implementation of the HPTAR for the period from 2015-16 to 2020-21.

This evaluation was conducted to help support a commitment to adhere to the Government’s life-cycle approach to regulatory development as part of a legislative review process.

What the evaluation found

According to the 2021 Global Health Security Index, Canada ranks very highly in the world in terms of both biosecurity and biosafety, ranking #1 globally in terms of biosafety and #3 in terms of biosecurity.

The HPTAR Program has shown early signs of success. Regulated organizations covered by the Act:

• have the information they need to understand and comply with legislative and regulatory requirements;
• comply with legal and regulatory requirements and improve biosafety and biosecurity in their facilities; and
• identify and proactively address risk to improve institutional biosafety and biosecurity.

There has been a decrease in risk of accidental or deliberate release of pathogens and toxins, leading to a reduced public health risk related to pathogens and toxins. We also found evidence of solid knowledge exchange, effective inspection and enforcement, and good compliance rates.

Issues were raised regarding security clearance requirements, including expanding the criteria for who should have a security clearance (beyond those who work with or have access to RG3 and RG4 pathogens), as well as increasing the level of scrutiny prior to issuing security clearance for foreign nationals. Licensing challenges were also raised, including clearly defining roles and responsibilities between Biological Safety Officers and Licence Holders. Addressing administrative burden for regulated organizations in the areas of licensing, security clearances and inspections was also identified as a key area of focus (e.g., streamlining application process and the information needed from applicants; harmonization of HPTA requirements with the Health of Animals Act requirements. Finally, the appropriateness of using virtual inspections and how they could complement existing on-site inspections was identified as an area for further consideration.

Recommendations

Recommendation 1: Review current security clearance requirements to ensure appropriate level of scrutiny for individuals who are, or may be, working with or accessing human pathogens and toxins.

Response: The Centre for Biosecurity will conduct a Threat Risk Assessment on the HPTA that would respond to changes in the threat risk landscape posed by human pathogens and toxins, including amendments to strengthen the HPTA security clearance program and requirements regarding information management for Security Sensitive Biological Agents. The Centre for Biosecurity will also review the HPTAR and seek opportunities to strengthen the security clearance process and the biosecurity program.

Recommendation 2: Consider how virtual inspections can complement current on-site inspections, and under what circumstances they may be appropriate.

Response: The Centre for Biosecurity will review its current use of virtual inspections and leverage other departments’ experience and lessons learned to determine the mix of delivery models for inspections (virtual, hybrid, or on-site). The use of delivery model should be sustainable, effective, and appropriate to monitor and verify compliance and to prevent or address non-compliance with the relevant legislative requirements with the HPTAR. The Centre for Biosecurity will also review the HPTAR to identify any barriers to virtual inspections.

Recommendation 3: Clearly define and communicate roles and responsibilities related to Biological Safety Officers and Licence Holders.

Response: The Centre for Biosecurity will review the Human Pathogens and Toxins Act and Regulations to identify opportunities to clarify the roles of Biological Safety Officers (BSO) and Licence Holders, including required qualifications of BSOs.