Application of risk analysis to food standards issues

WHO/FNU/FOS/95.3

APPLICATION OF RISK ANALYSIS TO FOOD STANDARDS ISSUES

Report of the Joint FAO/WHO Expert Consultation

Geneva, Switzerland
13 - 17 March 1995

This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.

The views expressed in documents by named authors are solely the responsibility of those authors.

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Les opinions exprimées dans les documents par des auteurs cités nommément n'engagent que lesdits auteurs.

EXECUTIVE SUMMARY

1. INTRODUCTION

2. BACKGROUND

3. RISK ANALYSIS DEFINITIONS

3.1 Context of definitions

3.2 Definitions of risk analysis terms related to food safety

4. CURRENT PRACTICES IN THE CODEX ALIMENTARIUS COMMISSION AND RELATED EXPERT COMMITTEES

4.1 Food additives

4.2 Chemical contaminants

4.3 Pesticide residues

4.4 Veterinary drug residues

4.5 Biological agents

4.6 Other Codex Committees

5. RISK ASSESSMENT OF CHEMICAL AGENTS IN FOOD

5.1 Introduction

5.2 Hazard identification

5.2.1 Epidemiological studies

5.2.2 Animal studies

5.3 Hazard characterization

5.3.1 Dose-response extrapolation

5.3.2 Dose-scaling

5.3.3 Genotoxic and non-genotoxic carcinogens

5.3.4 Threshold approaches

5.3.5 Non-threshold approaches

5.4 Exposure assessment

5.5 Risk characterization

6. RISK ASSESSMENT OF BIOLOGICAL AGENTS IN FOOD

6.1 Introduction

6.2 Risk assessment of biological hazards

6.3 Risk assessment of bacterial hazards

6.3.1 Hazard identification

6.3.2 Hazard characterization

6.3.3 Exposure assessment

6.3.4 Risk characterization

6.4 Risk assessment of other biological hazards

6.5 Role of the CAC in risk assessment of biological hazards

7. UNCERTAINTY AND VARIABILITY IN THE RISK ASSESSMENT PROCESS

7.1 Introduction

7.2 Uncertainty versus variability

7.3 Model uncertainty versus input (parameter) uncertainty

7.3.1 Nature of models

7.3.2 Methods for addressing model uncertainty

7.3.3 Methods for representing and propagating input variance

7.4 Uncertainty and variability in hazard identification

7.5 Uncertainty and variability in hazard characterization

7.6 Uncertainty and variability in exposure assessment

7.7 Uncertainty and variability in risk characterization

8. CONCLUSIONS AND RECOMMENDATIONS

8.1 General

8.2 Chemical hazards

8.3 Biological hazards

8.4 Uncertainty and variability

ANNEX 1 List of Participants

ANNEX 2 List of Working Papers

ANNEX 3 List of References

LIST OF ABBREVIATIONS
ADI	Acceptable Daily Intake
ALARA	as low as reasonably achievable
BHA	butylated hydroxyanisole
CAC	Codex Alimentarius Commission
CCFAC	Codex Committee on Food Additives and Contaminants
CCFH	Codex Committee on Food Hygiene
CCFICS	Codex Committee on Import and Export Food Inspection and Certification Systems
CCMH	Codex Committee on Meat Hygiene
CCPR	Codex Committee on Pesticide Residues
CCRVDF	Codex Committee on Residues of Veterinary Drugs in Foods
EMDI	Estimated Maximum Daily Intake
EPA	U.S. Environmental Protection Agency
FAO	Food and Agriculture Organization of the United Nations
FDA	U.S. Food and Drug Administration
GAP	Good Agricultural Practice
GEMS/Food	Joint UNEP/FAO/WHO Food Contamination and Monitoring Programme
GLP	Good Laboratory Practices
GPVD	Good Practice in the Use of Veterinary Drugs
GSC	General Standard for Contaminants
GSFA	General Standard for Food Additives
HACCP	Hazard Analysis Critical Control Point
ICMSF	International Commission on Microbiological Specifications for Food
JECFA	Joint FAO/WHO Expert Committee on Food Additives
JMPR	Joint FAO/WHO Meeting on Pesticide Residues
MRL	Maximum Residue Limit
MTD	Maximum Tolerated Dose
NGOs	nongovernmental organizations
NOAEL	no-observed-adverse-effect level
NOEL	no-observed-effect level
NRC	U.S. National Research Council
OECD	Organization for Economic Co-operation and Development
PMTDI	Provisional Maximum Tolerable Daily Intake
PTWI	Provisional Tolerable Weekly Intake
QA	Quality Assurance
QC	Quality Control
SPS Agreement	Agreement on the Application of Sanitary and Phytosanitary Measures
TBT Agreement	Agreement on Technical Barriers to Trade
TMDI	Theoretical Maximum Daily Intake
WHO	World Health Organization
WTO	World Trade Organization

TABLE OF CONTENTS