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1、食品致病菌風險評估,黃顯宗,微生物有很多是人類重要的病原菌，影響人類健康 微生物風險評估含：Risk Assessment, Risk Management, and Risk Communication Overall objective to ensure public health protection,落實？,Since Microbiological Risk Assessment is a developing science, implementation of these guidelines may require a period of time and may also
2、require specialized training in the countries that consider it necessary.,References,名詞定義,Hazard危害 - A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Hazard Characterization危害特徵描述 - The qualitative and/or quantitative evaluation
3、 of the nature of the adverse health effects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and/or their toxins.,名詞定義,Hazard Identification危害鑑定 - The identification of biological, chemical, and physical agents capable of causing a
4、dverse health effects and which may be present in a particular food or group of foods. Quantitative Risk Assessment量化風險評估 - A Risk Assessment that provides numerical expressions of risk and indication of the attendant uncertainties (stated in the 1995 Expert Consultation definition on Risk Analysis)
5、.,名詞定義,Qualitative Risk Assessment 質化風險評估- A Risk Assessment based on data which, while forming an inadequate basis for numerical risk estimations, nonetheless, when conditioned by prior expert knowledge and identification of attendant uncertainties permits risk ranking or separation into descriptiv
6、e categories of risk. Risk風險 - A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.,名詞定義,Risk Analysis風險分析 - A process consisting of three components: risk assessment, risk management and risk communication. Risk Assessment風
7、險評估 - A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.,名詞定義,Risk Characterization風險特徵描述 - The process of determining the qualitative and/or quantitative estimation, in
8、cluding attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment. Risk Communication風險溝通 - The interactive exchange of information and opin
9、ions concerning risk and risk management among risk assessors, risk managers, consumers and other interested parties.,名詞定義,Risk Estimate 風險特徵描述結果- Output of Risk Characterization. Risk Management風險管理 - The process of weighing policy alternatives in the light of the results of risk assessment and, if
10、 required, selecting and implementing appropriate control2 options, including regulatory measures. Sensitivity analysis敏感性分析 - A method used to examine the behaviour of a model by measuring the variation in its outputs resulting from changes to its inputs.,名詞定義,Transparent透明度 - Characteristics of a
11、process where the rationale, the logic of development, constraints, assumptions, value judgements, decisions, limitations and uncertainties of the expressed determination are fully and systematically stated, documented, and accessible for review. Uncertainty analysis 不確定性分析- A method used to estimat
12、e the uncertainty associated with model inputs, assumptions and structure/form.,微生物風險評估準則,1. Microbiological Risk Assessment should be soundly based upon science. 2. There should be a functional separation between Risk Assessment and Risk Management. 3. Microbiological Risk Assessment should be cond
13、ucted according to a structured approach that includes Hazard Identification, Hazard Characterization, Exposure Assessment, and Risk Characterization. 4. A Microbiological Risk Assessment should clearly state the purpose of the exercise, including the form of Risk Estimate that will be the output.,微
14、生物風險評估準則,5. The conduct of a Microbiological Risk Assessment should be transparent. 6. Any constraints that impact on the Risk Assessment such as cost, resources or time, should be identified and their possible consequences described. 7. The Risk Estimate should contain a description of uncertainty
15、and where the uncertainty arose during the Risk Assessment process. 8. Data should be such that uncertainty in the Risk Estimate can be determined; data and data collection systems should, as far as possible, be of sufficient quality and precision that uncertainty in the Risk Estimate is minimized.,
16、微生物風險評估準則,9. A Microbiological Risk Assessment should explicitly consider the dynamics of microbiological growth, survival, and death in foods and the complexity of the interaction (including sequelae) between human and agent following consumption as well as the potential for further spread. 10. Wherever possible, Risk Estimates should be reassessed over time by comparison with independent human illness data. 11. A Microbiological Risk Assessment may need reevaluation, as new relevant informati
