Publication of the Biosecurity Addendum and updates to the Canadian Biosafety Standard, Third Edition

The Public Health Agency of Canada, in collaboration with the Canadian Food Inspection Agency, is pleased to announce the release of the Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition (the Biosecurity Addendum). The Biosecurity Addendum was published on the Public Health Agency of Canada Training Portal on December 23, 2024.

As an extension of the Canadian Biosafety Standard, Third Edition, the Biosecurity Addendum establishes additional requirements for Containment Level 4 facilities to strengthen biosecurity oversight. The requirements found in the Biosecurity Addendum apply not only to the containment zone, but also to the premises on which the containment zone is housed. Those who hold a Risk Group 4 Pathogen and Toxin Licence, issued by the Public Health Agency of Canada, and/or one or more Terrestrial Animal Pathogen Import/Transfer Permit(s), issued by the Canadian Food Inspection Agency, must comply with applicable requirements set out in the Canadian Biosafety Standard, Third Edition, including the Biosecurity Addendum. The Biosecurity Addendum will come into effect as a condition of Risk Group 4 licences and/or permit(s) on January 5, 2026.

Failure to bring your facility into compliance with these additional requirements by January 5, 2026 may result in enforcement actions. These actions are taken in accordance with the Centre for Biosecurity Compliance and Enforcement Policy.

In the coming months, resources to support implementation of the Biosecurity Addendum, such as information sheets and training, will be available on the Public Health Agency of Canada’s Training Portal.

For alignment between the Canadian Biosafety Standard, Third Edition and the Biosecurity Addendum, minor changes were made to the Canadian Biosafety Standard, Third Edition on Canada.ca on December 23, 2024. These amendments elaborate on biosecurity terms and concepts, while clarifying biosecurity intent. This update does not affect any Canadian Biosafety Standard, Third Edition requirements. The changes to the Canadian Biosafety Standard, Third Edition include:

•         amending the glossary definitions for “authorized personnel” and “key control”
•         adding glossary terms and definitions for “intrusion detection system”, “need-to-know”, “security system”, and “sensitive information”
•         removing the glossary terms and definitions for “biosecurity event” and “security barrier”
•         replacing the term “controlled access system” with “access control system” throughout the Canadian Biosafety Standard, Third Edition