Pathogen Risk Assessment

Overview

This Guideline describes how to conduct a pathogen risk assessment to evaluate the risks associated with human or animal pathogens, toxins, or other regulated infectious material. It provides comprehensive guidance on how to conduct a pathogen risk assessment on pathogens that are uncharacterized or that may have been modified, to determine the likelihood and consequences of exposure to the pathogen, or its release.

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.