食品致病菌風險評估

1. 食品致病菌風險評估 黃顯宗

2. 微生物有很多是人類重要的病原菌，影響人類健康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

3. 落實？ • Since Microbiological Risk Assessment is a developing science, implementation of these guidelines may require a period of time and may also require specialized training in the countries that consider it necessary.

4. References

5. 名詞定義 • Dose-Response Assessment劑量反應評估- The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response). • Exposure Assessment暴露評估- The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.

6. 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 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.

7. 名詞定義 • Hazard Identification危害鑑定- The identification of biological, chemical, and physical agents capable of causing adverse 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).

8. 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 descriptive 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.

9. 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.

10. 名詞定義 • Risk Characterization風險特徵描述- The process of determining the qualitative and/or quantitative estimation, including 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 opinions concerning risk and risk management among risk assessors, risk managers, consumers and other interested parties.

11. 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 required, selecting and implementing appropriate control 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.

12. 名詞定義 • Transparent透明度- Characteristics of a 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 estimate the uncertainty associated with model inputs, assumptions and structure/form.

13. 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 conducted 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.

14. 微生物風險評估準則 • 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 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.

15. 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後遺症) 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 information becomes available.

16. 腸炎弧菌風險評估

17. 風險分析與管理

18. 腸炎弧菌風險評估 • Anonymous. 2011. Risk assessment of Vibrio parahaemolyticus in seafood. WHO/FAO of the United Nations. • Anonymous. 2000. Draft risk assessment on the public health impact of Vibrio parahaemolyticus in raw molluscan shellfish. FDA, USA.

19. 日本 • Wahori J, Yamamoto A, Suzuki H, Yamamoto T, Tsutsui T, Motoyama K, Sawada M, Matsushita T, Hasegawa A, Osaka K, Toyofuku H, Kasuga F. 2010. Quantitative risk assessment of Vibrio parahaemolyticus in finfish: a model of raw horse mackerel consumption in Japan. Risk Anal. 30:1817-1832. • Hara-Kudo Y, Saito S, Ohtsuka K, Yamasaki S, Yahiro S, Nishio T, Iwade Y, Otomo Y, Konuma H, Tanaka H, Nakagawa H, Sugiyama K, Sugita-Konishi Y, Kumagai S. 2012. Characteristics of a sharp decrease in Vibrio parahaemolyticus infections and seafood contamination in Japan. Int.J.Food Microbiol. 157:95-101.

20. 降低原因 • 10oC以下冷藏保存 • 使用衛生的海水或清水處理 • 設定腸炎弧菌的限量（25g熟鱆魚螃蟹零檢出，生食海產低於100 MPN/g等） • 海產離冷藏後兩小時內食用 • 2001年後四分一的廚房換了新冰箱，半數廚房使用時直接從冷藏取海產 • 半數以上海產賣場與餐廳檢驗員工糞便中腸炎弧菌

21. 聯合國報告 • To estimate risk of illness from VP due toconsumption of oysters in Australia, Canada, Japan and New Zealand • The Bloody clam risk assessment：Acase study of performing aquantitative risk assessment in a developing country using local data. It focused onone city in Thailand • The purpose of the finfish risk assessment was to estimate the risk of V. parahaemolyticusinfection from raw horse mackerel consumption in Japan, and toestimate the risk reduction from washing this fish after harvest or duringpreparation.

22. 風險評估限制Constraints • 大部分缺乏在地數據，只得引用美國數據

23. Hazard identification • 致病情形 • 病人與案件 • 病人與案件數

24. Exposure assessment for raw oysters • Four factors were used to model exposure: • level of pathogenic VP in seafood at harvest • effect of post-harvest handling and processing • ability of the organism to multiply to an infective dose • number of pathogenic VP consumed

25. Harvest Module of the V. parahaemolyticus

26. Exposure assessment for raw oysters • Factors considered as influencing the numbers of pathogenic V. parahaemolyticus at consumption include: • ambient air temperatures at time of harvest • time from harvest until oysters are placed under refrigeration • time it takes for oysters to cool once under refrigeration • length of refrigeration time until consumption

27. Post-harvestModule of the V. parahaemolyticus

28. Exposure assessment for horse mackerel

29. Hazard characterization

30. Risk characterization • 牡蠣，基於各地生產與溫度狀況，預測年度病例：

31. Risk characterization • Horse mackerel • The risk assessment model estimated that the probability of becoming ill per servingof raw horse mackerel was 8.77 × 10-7 (best scenario) to 3.75 × 10-5 (worst scenario). • For the Japanese population, the estimate was 70–1300 cases per year. • Epidemiological data indicates around 10 000 cases annually, but the implicatedseafoods are not always identified.

32. Horse mackerel日本竹筴魚 http://zukan.com/fish/leaf4508

33. Risk characterization • Horse mackerel • 各情境下病例預測

34. Impact of establishing limits for the level of V. parahaemolyticusin oysters

35. 風險評估 • Harvest Module • Post-harvest Module • 收穫後至食用時的處理 • Public Health Module • 國人食用生海產頻率

36. 美國牡蠣VP風險評估模式

37. 有關牡蠣，尚有許多研究工作需要進行 • 1、環境影響因子，如溫度、鹽度、獵食者、動物passage、外地來菌種等，影響腸炎弧菌在所有的區域與季節的分佈與茲長。 • 2、換水速率，如淡水、潮汐、養殖深淺、風等。 • 3、收穫時致病性腸炎弧菌的分佈與菌數。 • 4、在不同溫度的水產中致病性腸炎弧菌的茲長與存活。

38. 有關牡蠣，尚有許多研究工作需要進行 • 5、工業上收穫後處理的情形，如：至冷藏的時間、冷藏速率與時間、冷藏的長短等。收穫後處理的程序對於腸炎弧菌茲長的影響，這裡包含在海水箱中淨化（depuration），或在乾淨的養殖環境中重新安置（relaying）等程序。 • 6、人們攝食的模式，季節與區域的生吃頻繁程度、危險（易感染）人口的攝食情形。 • 7、從集體中毒事件、流行病學、動物與其他研究中得到菌量與致病的關係（dose-response relations），這裡指不同的菌株、不同感受性（susceptibility）的消費者。

39. 有關牡蠣，尚有許多研究工作需要進行 • 8、TDH外可能的病原因子，如TRH、urease、腸毒素、酸適應、腸道入侵等。 • 9、不同菌株的致病性監測assay。 • 10、海產生物的生理與免疫狀態與腸炎弧菌數量的關係。 • 11、消費者在食用前之處理。 • 12、改進全球對新型致病菌的監測。