Public Health Agency of Canada's Forward Regulatory Plan 2025 to 2027: Regulations to Amend Schedule 1 of the Human Pathogens and Toxins Act
Title of regulatory initiative
Regulations to Amend Schedule 1 of the Human Pathogens and Toxins Act
Enabling act
Human Pathogens and Toxins Act
Description
The Public Health Agency of Canada is proposing amendments to Schedule 1 of the Human Pathogen and Toxins Act to include a comprehensive list of toxins produced by microorganisms that present a demonstrated or postulated role in human disease. While creating an exhaustive list is challenging, the toxin list being assembled is believed to represent the vast majority of clinically relevant toxins from microorganisms. Proposed amendments may also include newly regulated prescribed toxins resulting in updates to subsection 10(2) of the Human Pathogens and Toxins Regulations.
Pursuant to the Act and Regulations, a toxin is defined as "substance[s] that [are] listed in Schedule 1 or in Part 1 of Schedule 5". As such, only toxins listed in the Schedules to the Act and Regulations are included in the regulatory scope, and the regulation of human toxins is only as consistent and comprehensive as the toxin lists found in the Schedules to the Act. The current regulations are limited to a list of 35 bacterial toxins.
This regulatory initiative is associated with the Public Health Agency of Canada's Regulatory Stock Review Plan.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on people, including businesses
The proposed changes will impact parties such as academia, government, and industry working with human pathogens and toxins.
Consultations
A Toxin Risk Assessment sub-committee was established to provide technical expertise and support to the Public Health Agency of Canada and the Advisory Committee on Human Pathogens and Toxins. The Toxin Risk Assessment sub-committee recommendations were shared with the advisory committee who endorsed scheduling recommendations.
The Public Health Agency of Canada will publish proposed amendments to the regulations in the Canada Gazette, Part I, which will provide an opportunity for the Canadian public to comment. The timing and approach for consultations will be added to this section once known.
Further information
- Evaluation of the Human Pathogens and Toxins Act and Regulations Framework 2015-16 to 2020-21
- Government of Canada biosafety and biosecurity information
Departmental contact information
Natasha Kuran
Director
Office of Stakeholder Engagement and Regulatory Affairs
Regulatory, Operations and Emergency Management Branch
Public Health Agency of Canada
613-852-1035
Email: cb.engagement-mobilisation.cb@phac-aspc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
Fall 2019