MICROBIOLOGICAL RISK ASSESSMENT SERIES 3

Hazard Characterization for Pathogens in Food and Water
GUIDELINES

 
Table of Contents

For further information on joint FAO/WHO
activities on microbiological risk assessment, please contact:

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Cover design:
Food and Agriculture Organization of the United Nations
and the World Health Organization.

Cover picture:
© Dennis Kunkel Microscopy, Inc.

WORLD HEALTH ORGANIZATION

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

2003

WHO Library Cataloguing-in-Publication Data

Hazard characterization for pathogens in food and water: guidelines.

(Microbiological risk assessment series; no. 3)
1. Food microbiology 2. Water microbiology 3. Risk assessment - methods
4. Models, Statistical 5. Guidelines I. Joint FAO/WHO Secretariat on Risk
Assessment of Microbiological Hazards in Food II.Series.

ISBN 92 4 156237 4 (WHO) (LC/NLM classification: QW 85)
ISBN 92 5 104940 8 (FAO)
ISSN 1726-5274

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© WHO/FAO 2003

Table of Contents

ABBREVIATIONS USED IN THE TEXT

FOREWORD

PREFACE

ACKNOWLEDGEMENTS

CONTRIBUTORS

1. INTRODUCTION

1.1 Background
1.2 Hazard characterization in context
1.3 Purpose of the guidelines
1.4 Scope

2. THE PROCESS OF HAZARD CHARACTERIZATION

2.1 Context
2.2 Principles

3. PROCESS INITIATION

4. DATA COLLECTION AND EVALUATION

4.1 Human studies

4.1.1 Outbreak investigations
4.1.2 Surveillance and annual health statistics
4.1.3 Volunteer feeding studies
4.1.4 Biomarkers
4.1.5 Intervention studies

4.2 Animal studies
4.3 In vitro studies
4.4 Expert elicitation
4.5 Data evaluation

5. DESCRIPTIVE CHARACTERIZATION

5.1 Information related to the disease process
5.2 Information related to the pathogen
5.3 Information related to the host
5.4 Information related to the matrix
5.5 Dose-response relationship

6. DOSE-RESPONSE MODELLING

6.1 The infectious disease process

6.1.1 Exposure
6.1.2 Infection
6.1.3 Illness
6.1.4 Sequelae and mortality

6.2 Modelling concepts

6.2.1 Threshold vs non-threshold mechanisms
6.2.2 Independent action vs synergistic action

6.3 Selection of models

6.3.1 Dose-infection models
6.3.2 Infection-illness models
6.3.3 Dose-illness models
6.3.4 Sequelae and mortality

6.4 Extrapolation

6.4.1 Low dose extrapolation
6.4.2 Extrapolation in the pathogen-host-matrix triangle

6.5 Fitting dose response models to data

6.5.1 Fitting method
6.5.2 Selection of the best fitting model or models
6.5.3 Uncertainty analysis

7. REVIEW

7.1 Validation of dose-response models
7.2 Peer and public review

8. PRESENTATION OF RESULTS

9. REFERENCES CITED

APPENDIXES

A. Outline of information to include in a hazard characterization
B. Glossary

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