《食品微生物风险评估指南》-290页_6mb

Summary of Microbiological Risk Assessment Guidance for Food

Core Content

This document provides comprehensive guidance on conducting microbiological risk assessment (MRA) in the context of food safety. It is part of the FAO/WHO Microbiological Risk Assessment Series and outlines the principles, methodologies, and practical considerations for assessing microbial hazards in food.

Main Views and Key Information

1. Introduction

• The FAO/WHO series of guidelines on microbiological risk assessment was established to support member countries in managing food safety risks.
• The Codex Alimentarius Commission (CAC) previously identified MRA as a priority area.
• The Codex Committee on Food Hygiene (CCFH) developed foundational principles and guidelines, which were adopted by CAC in 1999.
• This updated guidance was developed in response to scientific advancements and new methodologies in MRA, following expert meetings in 2019.
• The guidance is intended to be science-based, ensuring that food safety measures are justified and do not unnecessarily restrict international trade.

2. General Considerations

2.1 Risk Analysis Framework

• The framework includes risk assessment, risk management, and risk communication.
• Risk assessment involves identifying hazards, estimating exposure, characterizing hazards, and characterizing risk.

2.2 Risk Management

• Involves decisions based on risk assessment outcomes to reduce risks to acceptable levels.
• These decisions are informed by scientific evidence and public health goals.

2.3 Risk Assessment

• A structured process that evaluates the likelihood and severity of foodborne illness.
• It is used to estimate baseline risk, compare risk management strategies, and support research and modeling.

2.4 Risk Communication

• The process of conveying risk information to stakeholders.
• It aims to ensure that risk assessments are understood and used appropriately.

3. Food Microbiological Risk Assessment (MRA)

• MRA is a systematic approach to evaluate the risk posed by microbial hazards in food.
• It includes:
  • Hazard identification: Determining which microorganisms are relevant.
  • Exposure assessment: Estimating the level of microbial exposure.
  • Hazard characterization: Describing the health effects of the hazard.
  • Risk characterization: Combining exposure and hazard data to estimate overall risk.

4. Hazard Identification

• Objectives: Identify the presence and potential of microbial hazards in food.
• Data sources: Include epidemiological studies, microbiological prevalence data, and other relevant scientific information.

5. Exposure Assessment

• Involves estimating the amount of pathogen that a consumer is exposed to.
• Modelling approaches include:
  • Qualitative and semi-quantitative: Based on likelihood and consequence.
  • Quantitative: Using statistical models and data.
• Production-to-consumption pathway is a key element in exposure assessment.
• Consumption is considered in terms of frequency and portion size.

6. Hazard Characterization

• Describes the health effects of microbial hazards.
• Includes:
  • Descriptive characterization: Information on disease processes, hazard properties, host susceptibility, and food matrix effects.
  • Dose-response relationship: Quantifies the relationship between the amount of pathogen and the likelihood of illness.
• Common models used in Quantitative Microbial Risk Assessment (QMRA) are listed.

7. Risk Characterization

• Combines exposure and hazard data to estimate the overall risk.
• Qualitative and semi-quantitative approaches use categorical labels to assess risk.
• Quantitative methods provide numerical estimates of risk, integrating all components of the risk assessment.

8. Examples

• A variety of examples are provided to illustrate the application of MRA in different contexts.
• These include:
  • Qualitative and semi-quantitative examples: such as antibiotic resistance, faecal pollution, and BSE risk.
  • Quantitative examples: such as E. coli O157:H7, Listeria monocytogenes, and Vibrio parahaemolyticus.

9. Qualitative and Semi-Quantitative Risk Assessment

• These methods are used when data is limited or scientific uncertainty is high.
• Qualitative methods use likelihood and consequence to categorize risk.
• Semi-quantitative methods use categorical labels and probability ranges to estimate risk.
• Limitations include the potential for subjectivity and over-simplification.

10. Data Collection

• Data sources include literature, surveillance data, industry data, and unpublished data.
• Data gaps are addressed through model restructuring, surrogate data, expert knowledge elicitation (EKE), and collection of new data.
• Recommendations on data collection and organization are provided, including searching, selecting, formatting, and combining data.

11. Quantitative Modelling Approaches

• Includes deterministic, stochastic, and Monte Carlo simulation.
• Predictive microbiology is used to model microbial growth and inactivation in food.
• Model types and tools are outlined, with an emphasis on model verification, calibration, and validation.

12. Variability and Uncertainty

• Variability refers to differences in exposure and response among individuals.
• Uncertainty refers to the confidence in the data and models used.
• Uncertainty analysis is essential for robustness and credibility of risk assessments.
• The combination of variability and uncertainty is addressed to ensure accurate risk estimation.

13. Sensitivity Analysis

• Used to determine how changes in input variables affect the final risk estimate.
• Qualitative and quantitative methods are described.
• Statistical and graphical approaches are highlighted, along with evaluation methods.

14. Quality Assurance

• Ensures the accuracy and reliability of risk assessments.
• Includes data evaluation, model quality assurance, and comparison with epidemiological data.
• Peer review and public consultation are emphasized to ensure the scientific validity and acceptability of the guidance.

Conclusion

This document is a comprehensive guide to conducting microbiological risk assessments in food, emphasizing scientific rigor, practical application, and international standards. It provides methodological guidance, examples, and tools to support risk assessment and management, ensuring that food safety decisions are evidence-based and transparent.