Forward Regulatory Plan 2024-2026: 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 us with more regulatory flexibility, and to improve biosafety and biosecurity oversight in response to the expanding biomanufacturing sector in Canada.

In addition, we completed an evaluation on the effectiveness and efficiency of activities related to the implementation of the Human Pathogens and Toxins Act and Regulations for the period from 2015-16 to 2020-2021. Proposed regulatory amendments will also respond to the Evaluation recommendations as applicable.

This regulatory initiative is part of the Public Health Agency of Canada's Regulatory Stock Review Plan.

Evaluation of the Human Pathogens and Toxins Act and Regulations Framework 2015-16 to 2020-21

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 regulated parties such as academia, government, and industry working with human pathogens and toxins.

Consultations

Stakeholders were consulted through an online questionnaire that was made available on the Government of Canada's (GoC) website between August 4, 2023, and September 5, 2023. The purpose of the pre-consultation was 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. A What we heard report was published with a summary of the findings.

PHAC 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.

Regulated parties and impacted stakeholders will have the opportunity to provide comments on the proposed amendments to the regulations. We plan to publish the proposed changes in Canada Gazette, Part I in Spring 2025.

What we heard: Consultation on potential amendments to the Human Pathogens and Toxins Regulations

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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