Thematic Consultation on Potential Amendments to the Human Pathogens and Toxins Regulations: Closed consultation

From Public Health Agency of Canada

Canada's biomanufacturing sector has rapidly expanded, drawing attention to growth and new challenges to the oversight of Canada's biosafety and biosecurity program. In response to this expansion, we sought input from interested and affected parties, to inform potential regulatory amendments under the Human Pathogens and Toxins Regulations (the Regulations).

Goal of the consultation

The goal of the consultation was to gather meaningful input and advice to strengthen Canada's biosafety and biosecurity oversight framework. Biosafety and biosecurity protect the health and safety of the public against risks posed by human pathogens and toxins. The online thematic questionnaire touched on the following themes:

• foreign ownership, control or influence
• enhancing protections for cyber and IT security
• enhancing protections for physical or tangible assets
• mitigating the risk of insider threats
• research security and collaboration
• prescribed (or most security sensitive) human pathogens and toxins
• compliance, enforcement, and penalties
• international best practices

Who was the focus of this consultation?

We sought input from persons or organizations subject to the Human Pathogens and Toxins Act (the Act) and the Regulations for possessing, handling or otherwise manipulating a human pathogen or toxin. This included public, private and academic facilities. The consultation also sought input from:

• licence holders
• biosafety officers
• alternate biosafety contacts
• licence holder representatives

We were also interested in input from other interested parties, such as:

• health professionals
• biosafety professionals
• biosecurity professionals
• professional associations
• laboratory researchers and workers
• consumer and industry organizations
• provincial, territorial and municipal governments
• First Nations, Inuit and Métis partners and organizations
• members of the public with an interest in the subject matter

What we heard

To access the summary report of the consultation, please see What we heard: Consultation on potential amendments to the Human Pathogens and Toxins Regulations.

Background

The COVID-19 pandemic highlighted the significant risks and devastating consequences that infectious disease outbreaks pose to public health, safety and security. Recognizing the need for resources in the biomanufacturing and life sciences sector, we announced an investment of over $3 billion in 2021. As a result, the life sciences and biomanufacturing sector is rapidly expanding in Canada.

We recognize the importance of:

• protecting the health, safety and security of people in Canada against risks posed by human pathogens and toxins
• providing oversight for Canadian organizations researching new and emerging diseases

The Public Health Agency of Canada has a critical role in supporting both the biomanufacturing and global health security agendas. We achieve this through licensing and oversight of all organizations that work with human pathogens and toxins in Canada.

The Act and Regulations came into full force in 2015, providing oversight for the regulation of pathogenic microorganisms and toxins in Canada. Since 2015, biosciences and biosecurity have become more complex as our world evolves.

Forward Regulatory Plan

The Forward Regulatory Plan for 2022 to 2024 is a list of regulatory changes that we intend to propose or finalize within a 2-year period.

Formal consultations on proposed Regulations will be available through the Canada Gazette Part I process. This will provide affected and interested parties an opportunity to express their view on the proposed regulatory amendments.

Applicable updates will be made through the standard Canada Gazette Part I process over the fall 2023 to winter 2024 timeframe.

This consultation will help inform what would be proposed in upcoming potential regulatory amendments.

Forward Regulatory Plan: 2022 to 2024

Related information

• Canadian Biosafety Standard, Third Edition
• Evaluation of the Human Pathogens and Toxins Act and Regulations Framework

Contact us

Email: cb.engagement-mobilisation.cb@phac-aspc.gc.ca

Public Health Agency of Canada
100 Colonnade Road
Ottawa, ON K1A 0K9

Telephone: 613-957-1779