Forward Regulatory Plan 2024-2026: Regulations to Amend Schedule 1 of the Human Pathogens and Toxins Act
Accurate as of October 30, 2024
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 part of the Public Health Agency of Canada's Regulatory Stock Review Plan.
Domestic and international regulatory cooperation efforts
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on people and businesses
The proposed changes will impact laboratories, manufacturers, importers, and retailers who may be required to apply for or adjust a licence based on any changes to toxins they are handling.
Consultations
A Toxins 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 the recommendations.
Regulated parties and impacted stakeholders will have the opportunity to provide comments on the proposed Schedule 1 amendments during the Canada Gazette, Part I, public comment period.
Contact us
Natasha Kuran
Director
Office of Stakeholder Engagement and Regulatory Affairs
Public Health Agency of Canada
613-852-1035
Email: pathogens.pathogenes@phac-aspc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
Fall 2019
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