Public Health Agency of Canada's Forward Regulatory Plan 2025 to 2027: Amendments to the Human Pathogens and Toxins Regulations
Title of regulatory initiative
Amendments to the Human Pathogens and Toxins Regulations
Enabling act
Human Pathogens and Toxins Act
Description
The Public Health Agency of Canada is proposing regulatory amendments to the Human Pathogen and Toxins Regulations (HPTR) to provide more regulatory flexibility, to improve biosafety and biosecurity oversight in response to the expanding biomanufacturing sector in Canada. This is an important regulatory initiative to meet objectives announced in Budget 2024 under the Government of Canada's (GoC's) efforts to strengthen oversight of human pathogens and toxins.
An evaluation was completed on the effectiveness and efficiency of activities related to the implementation of the Human Pathogens and Toxins Act and Regulations for the period from 2015-2016 to 2020-2021. Proposed regulatory amendments will also respond to the evaluation recommendations as applicable.
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
The proposed changes will impact regulated parties such as academia, government, and industry working with human pathogens and toxins.
Consultations
The Public Health Agency of Canada held pre-consultations on Potential Amendments to the Human Pathogens and Toxins Regulations to gain a better understanding of what changes and improvements could be made to the HPTR, specifically biosafety and biosecurity measures in the context of non-GoC higher level risk facilities. Consultations took place through an online questionnaire that was made available on the GoC's website between August 4, 2023 and September 5, 2023. A What we heard report was published with a summary of the findings.
The Public Health Agency of Canada also conducted stakeholder pre-consultations between November 20, 2023 and December 15, 2023 to determine the possible costs and benefits of the proposed regulatory amendments and overall impacts across regulated parties.
The Public Health Agency of Canada is targeting spring 2026 to 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
- What we heard: Consultation on potential amendments to the Human Pathogens and Toxins Regulations
- Evaluation of the Human Pathogens and Toxins Act and Regulations Framework 2015-16 to 2020-21
- Government of Canada biosafety and biosecurity information
- Federal Budget 2024
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