Listeria monocytogenes Risk Assessment

FDA/Center for Food Safety and Applied Nutrition
USDA/Food Safety and Inspection Service
September 2003

Quantitative Assessment of Relative Risk to Public Health
from Foodborne Listeria monocytogenes
Among Selected Categories of Ready-to-Eat Foods

Table of Contents

• Interpretive Summary (also available in PDF)
• Technical Document (also available in PDF)
• List of Tables and List of Figures
• Summary of Public Comments and FDA/FSIS Revisions, Contributors, and Acknowledgements 
• Executive Summary
• Abbreviations, Acronyms, and Glossary
• I. Introduction
• II. Hazard Identification
  • Listeriosis
  • Invasive Listeriosis
  • High Risk Individuals
  • Non-Invasive Listeriosis (Listerial Gastroenteritis)
  • Asymptomatic Carriage
  • Epidemiological Patterns of Listeriosis: Sporadic versus Outbreak-Associated Cases
  • Sporadic Listeriosis
  • Outbreak-Associated Listeriosis
• III. Exposure Assessment
  • Food Category Identification
  • Food Consumption Data
  • Food Contamination Data
  • Growth Data
  • Modeling: Listeria monocytogenes Levels in Food at Retail
  • Results: Modeled Contamination at Retail
  • Modeling: Growth Between Retail and Consumption
  • Modeling: Interaction of Storage Times and Temperatures
  • Modeling: Thermal Inactivation
  • Results: Modeled Listeria monocytogenes Levels in Food at Consumption
• IV. Hazard Characterization
  • Dose-Response Modeling
  • Comparison of the FDA/FSIS Revised Dose-Response Model to Other Dose-Response Models for Listeria monocytogenes
  • Dose-Response in Animal Surrogates
  • Data Collected from Animal Studies
  • Modeling: Dose-Response in Mice
  • Dose-Response Curves for Infection and Serious Illness
  • Variability in Virulence
  • Host Susceptibility
  • Modeling: Host Susceptibility
  • Dose-Response Scaling Factor
  • Results: Dose-Response Curves for Three Population Groups
• V. Risk Characterization
  • Simulation Modeling
  • Results
  • Overview and Discussion of Food Categories
  • Summaries of the Food Categories
• VI. 'What If' Scenarios
  • Post-Retail Intervention
  • Pre-Retail and At Retail Intervention
  • Summary
• VII. Interpretation and Conclusions
• References
• Appendices (also available in PDF)
  • Appendices 1-4 (also available in PDF, 260KB)
    • Appendix 1: Chronology of Technical and Scientific Reviews of the Revised FDA/FSIS Listeria Monocytogenes Risk Assessment Document
    • Appendix 2: Summary of Public Comments and FDA/FSIS's Responses
    • Appendix 3: An Overview of the Risk Assessment
    • Appendix 4: The Foodborne Diseases Active Surveillance Network
  • Appendix 5: Food Categories Modeled Distributions and Related Information (also available in PDF, 315KB)
  • Appendix 6: Software (also available in PDF, 81KB)
  • Appendix 7: Listeria Contamination of Food Category Data Sets (also available in PDF, 1.23MB)
  • Appendix 8: Growth of Listeria Monocytogenes in Foods (also available in PDF, 153KB)
  • Appendix 9: Using Outbreak Investigations in Quantitative Risk Assessment (also available in PDF, 113KB)
  • Appendix 10: Additional Risk Characterization Information (also available in PDF, 63KB)
  • Appendix 11: Research Needs (also available in PDF, 11KB)
  • Appendix 12: Cluster Analysis for Grouping of Food Categories (also available in PDF, 45KB)