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In Canada, facilities where Risk Group 2, 3, and 4 human pathogens or toxins are handled and stored are regulated by the Public Health Agency of Canada (PHAC) under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). The importation of animal pathogens, infected animals, animal products or by-products (e.g., tissue, serum), or other substances that may carry an animal pathogen or toxin or parts thereof are regulated by the PHAC or the Canadian Food Inspection Agency (CFIA) under the Health of Animals Act (HAA) and Health of Animals Regulations (HAR).

In Canada, facilities where Risk Group 2, 3, and 4 human pathogens or toxins are handled and stored are regulated by the Public Health Agency of Canada (PHAC) under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). The importation of animal pathogens, infected animals, animal products or by-products (e.g., tissue, serum), or other substances that may carry an animal pathogen or parts thereof (e.g., toxin) are regulated by the PHAC or the Canadian Food Inspection Agency (CFIA) under the Health of Animals Act (HAA) and Health of Animals Regulations (HAR).

The Public Health Agency of Canada (PHAC) conducts biosafety and biosecurity inspections to verify organizations’ compliance with the Human Pathogens and Toxins Act (HPTA), the Human Pathogens and Toxins Regulations (HPTR), and the applicable sections of the Health of Animals Act and Health of Animals Regulations (HAA/HAR).

The inspections allow PHAC to determine if an organization meets the conditions of its
Pathogen and Toxin Licence, as well as to identify deficiencies and provide corrective
measures to prevent serious safety risks.

"The Canadian Biosafety Guidelines have been developed by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) as an ongoing series of biosafety and biosecurity themed guidance documents. In Canada, most facilities where human and terrestrial animal pathogens or toxins are handled and stored are regulated by the PHAC and the CFIA under the Human Pathogens and Toxins Act (HPTA), Human Pathogens and Toxins Regulations (HPTR), Health of Animals Act (HAA), and Health of Animals Regulations (HAR). Regulated facilities are required to develop and maintain a biosecurity plan, in accordance with the requirements established in the Canadian Biosafety Standard (CBS), 2nd Edition. The Canadian Biosafety Handbook (CBH), 2nd Edition aims to provide stakeholders with support and guidance on how to conduct biosecurity risk assessments and the core components of a robust biosecurity plan to appropriately address biosecurity risks with the pathogens and toxins in their possession.

The Centre for Biosecurity (the Centre) delivers a national Compliance and Enforcement Program under the Human Pathogens and Toxins Act and the Human Pathogens and Toxins Regulations (HPTR), as well as of certain provisions of the Health of Animals Act and associated regulations (HAA/HAR) in order to promote safety and security with respect to human pathogens, terrestrial animal pathogens (excluding pathogens that cause emerging or foreign animal diseases (FAD), and toxins.

The Biosecurity Program (the Program) is Canada's national authority for the biosafety and biosecurity of human and animal pathogens and toxins. The objective of the Program is to establish and maintain a strong and comprehensive safety and security regime which prevents, detects, and responds to the health risks posed by the use of human pathogens and toxins.

This guideline describes best practices for conducting a biosecurity risk assessment in an organization where human or animal pathogens, toxins, or other regulated infectious material are handled or stored. The biosecurity risks associated with the handling and storing of pathogens and toxins can be minimized through the application of appropriate mitigation measures identified through the risk assessment process.

Canada’s Canadian Biosafety Standard (CBS), 2nd Edition, 2015, is a harmonized national standard for the handling or storing of human and terrestrial animal pathogens and toxins in Canada.

The human immunodeficiency virus (HIV) and the human T-cell lymphotropic virus type 1 (HTLV-1) are examples of RG3 pathogens where the pathogen risk and CL assessments have been revisited by the Agency in conjunction with HIV/HTLV specialists based on current risks associated with activities involving these pathogens. It has been determined that HIV & HTLV-1 can be safely handled at CL2/CL2-Ag with specific additional operational requirements (see Section 4.0). This Biosafety Directive is intended to provide a comprehensive overview of the risk assessment outcomes, subsequent CL decisions, and considerations that have been made for those working with HIV and HTLV-1. The Biosafety Directive for HIV and HTLV-1 is to be used in conjunction with the CBSG.

The Local Risk Assessment guideline describes best practices for conducting a local risk assessment (LRA) in an organization where human or animal pathogens, toxins, or other regulated infectious material are handled or stored.