Pathogen Risk Assessment Guideline

Overview

The ePATHogen database is a searchable database of biological material, including nomenclature, risk group classifications, containment requirements, and other regulatory insights. It includes the Registry of Human Pathogens and Toxins, which is a subset of human pathogens and toxins that are subject to the Human Pathogens and Toxins Act (HPTA). If a biological agent of interest is not listed in ePATHogen or the Registry, a pathogen risk assessment must be conducted to determine the human and animal risk group classification.

This Guideline describes how to conduct a pathogen risk assessment to evaluate the risks associated with human or animal pathogens, or other regulated infectious material. It provides comprehensive guidance on how to assess the risk of pathogens that are uncharacterized in ePATHogen or the Registry, or that may have been modified, to determine the likelihood and consequences of exposure to the pathogen, or its release. This guideline is intended for interested parties, already familiar with the concepts of biosafety and risk assessment, to use to classify the pathogens in their inventories. The guideline comes with a pathogen risk assessment template.

To request the risk group classifications of a biological agent, complete a pathogen risk assessment template using this guidance and peer-reviewed publications and scientific literature as sources of information. The editable Word template allows you to use your own referencing software.

Access the Pathogen Risk Assessment Template: Pathogen risk assessment template

Completed templates should be submitted to the Public Health Agency of Canada (PHAC) at pathogens.pathogenes@phac-aspc.gc.ca for validation, confirmation of risk groups, and addition to ePATHogen or the Registry, as appropriate.

Who this guide is for

• Pathogen and Toxin Licence holders
• Biological Safety Officers
• Personnel in regulated facilities

In this guide

• Preface
• Abbreviations and acronyms
• Chapter 1 - Introduction
  • 1.1 Scope
  • 1.2 Overview
  • 1.3 Risk analysis and risk assessment
  • 1.4 How to use the Pathogen Risk Assessment guideline
• Chapter 2 - Principles of pathogen risk assessment
  • 2.1 Quantitative versus qualitative risk assessment
  • 2.2 Acceptable risk
  • 2.3 Evidence-based risk assessment
  • 2.4 Uncertainty and assumptions
  • 2.5 Precautionary principle
• Chapter 3 - Components of a pathogen risk assessment
  • 3.1 Hazard identification
  • 3.2 Hazard characterization
  • 3.3 Exposure assessment
  • 3.4 Other considerations
  • 3.5 Review and continual improvement
• Chapter 4 - Glossary
• Chapter 5 - References and resources

View complete guide

Download PDF (1.09 MB, 46 pages)

Details and history

Published: April 27, 2018

For assistance

Contact the Public Health Agency of Canada (PHAC) if you need assistance:

By phone: 1-613-957-1779

By e-mail: pathogens.pathogenes@phac-aspc.gc.ca

The PHAC’s service hours are Monday to Friday from 8 am to 4 pm (eastern time). They are closed on statutory holidays.

Contact us by mail:

100 Colonnade Road
Ottawa, Ontario
K1A 0K9

Service standards: We respond to mail and email within two business days. If we can’t answer your question right away, we will send you an estimated date.