1、Food Risk Analysis 食品風(fēng)險(xiǎn)分析Lecture 4第一節(jié) 食品風(fēng)險(xiǎn)分析實(shí)際概述一：風(fēng)險(xiǎn)的根本概念二：食品中的危害和食品平安風(fēng)險(xiǎn)三：食品平安風(fēng)險(xiǎn)分析四：食品平安風(fēng)險(xiǎn)分析實(shí)際框架一：風(fēng)險(xiǎn)的根本概念風(fēng)險(xiǎn)是由兩個(gè)要素共同組合而成的：1.危險(xiǎn)發(fā)生的能夠性即危險(xiǎn)概率；2.危險(xiǎn)事件發(fā)生產(chǎn)生的后果。二：食品中危害和食品平安風(fēng)險(xiǎn)食品危害的種類：生物性危害化學(xué)性危害物理性危害 GMPNO ZERO RISK 躲避風(fēng)險(xiǎn)分析食源性危害，確定食品平安性維護(hù)程度，采取風(fēng)險(xiǎn)管理措施，使食品在食品平安性風(fēng)險(xiǎn)處于可接受的程度。三；食品平安風(fēng)險(xiǎn)分析風(fēng)險(xiǎn)分析概念：就是對(duì)風(fēng)險(xiǎn)進(jìn)展評(píng)價(jià)，進(jìn)而根據(jù)風(fēng)險(xiǎn)程度來采取相應(yīng)的風(fēng)

2、險(xiǎn)管理措施去控制或者降低風(fēng)險(xiǎn)，并且在風(fēng)險(xiǎn)評(píng)價(jià)和風(fēng)險(xiǎn)管理的全過程中保證風(fēng)險(xiǎn)相關(guān)各方堅(jiān)持風(fēng)險(xiǎn)交流的形狀。也就是說，風(fēng)險(xiǎn)可以經(jīng)過運(yùn)用風(fēng)險(xiǎn)分析原理進(jìn)展控制。思索：試圖預(yù)測假設(shè)采取或者不采取某種做法會(huì)產(chǎn)生怎樣的后果。我們要回答：假設(shè)我們采取某種做法能夠發(fā)生什么樣的危害？這種危害發(fā)生的能夠性有多大？發(fā)生這種危害能夠產(chǎn)生什么樣的后果？食品平安風(fēng)險(xiǎn)的主要決議要素風(fēng)險(xiǎn)f概率，影響，危害三方面：食物中含有對(duì)安康有不良影響的物質(zhì)的能夠性 概率這種影響的嚴(yán)重性 影響由此而導(dǎo)致的危害 危害Realistic Risk “Analysis Framework四、現(xiàn)行的風(fēng)險(xiǎn)分析框架Risk Assessment風(fēng)險(xiǎn)評(píng)價(jià)Ri

3、sk Perception風(fēng)險(xiǎn)了解Risk Management風(fēng)險(xiǎn)處置Risk Communication風(fēng)險(xiǎn)信息Society,Regulation社會(huì)，法規(guī)Consumer“interests消費(fèi)者利益Science,Fact finding科學(xué)，發(fā)現(xiàn)現(xiàn)實(shí)Information,Dialogue信息，對(duì)話一風(fēng)險(xiǎn)評(píng)價(jià)指對(duì)人體接觸食源性危害而產(chǎn)生的知或潛在的對(duì)安康產(chǎn)生不良影響的科學(xué)評(píng)價(jià)，是一種系統(tǒng)地組織科學(xué)技術(shù)信息及其不確定性信息，來回答關(guān)于安康風(fēng)險(xiǎn)的詳細(xì)問題的評(píng)價(jià)方法。二風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理就是根據(jù)風(fēng)險(xiǎn)評(píng)價(jià)的結(jié)果，選擇和實(shí)施適當(dāng)?shù)墓芾泶胧M能夠有效地控制食品風(fēng)險(xiǎn)，從而保證公眾安康風(fēng)險(xiǎn)評(píng)價(jià)、對(duì)

4、風(fēng)險(xiǎn)管理選擇的評(píng)價(jià)、執(zhí)行風(fēng)險(xiǎn)管理決議、監(jiān)控和審查三風(fēng)險(xiǎn)交流風(fēng)險(xiǎn)交流就是在風(fēng)險(xiǎn)評(píng)價(jià)人員、風(fēng)險(xiǎn)管理人員、消費(fèi)者和其他有關(guān)的團(tuán)體之間就與風(fēng)險(xiǎn)有關(guān)的信息和意見進(jìn)展相互交流。風(fēng)險(xiǎn)交流該當(dāng)與風(fēng)險(xiǎn)管理和控制的目的相一致危害識(shí)別暴露評(píng)價(jià)危害特征描畫風(fēng)險(xiǎn)特征描畫風(fēng)險(xiǎn)評(píng)價(jià)過程的四個(gè)步驟Risk Analysis (and Control)according to Codex基于法典的風(fēng)險(xiǎn)分析和控制Hazard IdentificationRisk Assessment Policy風(fēng)險(xiǎn)定義，風(fēng)險(xiǎn)評(píng)價(jià)政策ExposureAssessment暴露評(píng)價(jià)RiskCharacterization風(fēng)險(xiǎn)特征OptionImpl

5、ementation選擇性實(shí)施OptionAssessment選擇性評(píng)價(jià)Monitoring& Review監(jiān)控和回想RiskEvaluation風(fēng)險(xiǎn)評(píng)價(jià)Risk Communication風(fēng)險(xiǎn)信息RiskManagement風(fēng)險(xiǎn)處置Risk Assessment風(fēng)險(xiǎn)評(píng)價(jià)HazardCharacteri-Zation危害特征Consumers &other interested parties消費(fèi)者和其他利益團(tuán)體第二節(jié) 食品風(fēng)險(xiǎn)分析的產(chǎn)生背景和開展過程一、食品風(fēng)險(xiǎn)分析產(chǎn)生的背景二、食品風(fēng)險(xiǎn)分析主要的運(yùn)用領(lǐng)域三、食品風(fēng)險(xiǎn)分析與HACCP一、食品風(fēng)險(xiǎn)分析產(chǎn)生的背景食品風(fēng)險(xiǎn)分析是針對(duì)國際食品平安性應(yīng)

6、運(yùn)而生的一種宏觀管理方式。一門正在開展中的新興學(xué)科。風(fēng)險(xiǎn)分析的概念首先出如今環(huán)境科學(xué)危害的控制中20世紀(jì)80年代末出如今食品平安領(lǐng)域1995年FAO/WHO第一次提出在食品平安領(lǐng)域里進(jìn)展風(fēng)險(xiǎn)分析的新概念。國際食品法典運(yùn)用風(fēng)險(xiǎn)分析原那么的重要意義表達(dá)在：1.建立一整套科學(xué)系統(tǒng)的管理實(shí)際；2.加強(qiáng)政府管理者和企業(yè)的有機(jī)結(jié)合；3.有效的防止旨在維護(hù)本國貿(mào)易利益的非關(guān)稅貿(mào)易壁壘；4.簡化食品進(jìn)出口檢驗(yàn)程序，促進(jìn)雙邊或多邊互認(rèn)。進(jìn)入WTO之后，我國產(chǎn)品批批檢驗(yàn)的管理方式曾經(jīng)落后基于風(fēng)險(xiǎn)分析的CAC規(guī)范已變成強(qiáng)迫性的食品風(fēng)險(xiǎn)分析已被以為是制定食品平安規(guī)范的根底。在食品風(fēng)險(xiǎn)分析三個(gè)組成部分中，風(fēng)險(xiǎn)評(píng)價(jià)是整個(gè)

7、食品風(fēng)險(xiǎn)分析體系的中心和根底。Risk Management of Food食品的風(fēng)險(xiǎn)處置Identification定義Quantification量化Decision決議Reduction約簡Control控制Government政府Industry工業(yè)HACCP危害分析與關(guān)鍵點(diǎn)控制Assessment評(píng)價(jià)Management處置RISK風(fēng)險(xiǎn)第三節(jié) 食品風(fēng)險(xiǎn)分析實(shí)際的主要內(nèi)容Risk & Hazard風(fēng)險(xiǎn)與危害Hit likely ?能夠碰撞嗎？Effect serious ?結(jié)果嚴(yán)重嗎？Hazard危害Risk風(fēng)險(xiǎn)Risk Assessment風(fēng)險(xiǎn)評(píng)價(jià)A scientifically b

8、ased processconsisting of the following steps:包含以下幾方面的科學(xué)過程：Hazard identification 危害定義Hazard characterisation 危害特征Exposure assessment 暴露評(píng)價(jià)Risk characterisation 風(fēng)險(xiǎn)特征 Codex AlimentariusRisk assessment procedure風(fēng)險(xiǎn)評(píng)價(jià)過程Risk charac-Terization風(fēng)險(xiǎn)特征Hazard Identification危害定義Hazard charac-terization 危害特征Exposur

9、e Assessment暴露評(píng)價(jià)Chance of getting accident: Estimate: 事故發(fā)生的幾率計(jì)算：P=0.001% 0.0005Hazard Identification (1)危害定義1Determination of thepathogen / food combinationthat will be the subjectof the MRAMRA的主題：測定致病源/食品的結(jié)合物Purpose目的Normally Risk Managers will include thisin their briefing of the Risk Assessors普通地

10、說，風(fēng)險(xiǎn)經(jīng)理睬要求他的風(fēng)險(xiǎn)評(píng)價(jià)員在簡報(bào)中能反映出這一點(diǎn)Hazard identification危害定義Normally microbiological hazards are identified as a consequence of a case or an outbreak of foodborne disease普通根據(jù)食源性疾病迸發(fā)的結(jié)果來定義微生物危害Hazard Analysis as part of HACCP is not the same as Hazard Identification in MRA作為HACCP的一部分，危害分析不同于MRA中的危害定義The qual

11、itative and/or quantitative evaluation of the nature of the adverse effects associated with one or different levels (numbers, sizes) of biological, chemical and physical agents that may be present in a food對(duì)與食品中的生物、化學(xué)和物理危害有關(guān)的天然不利要素進(jìn)展定性、定量評(píng)價(jià)Hazard Characterisation (1)危害特征1Purpose 目的Factors influencin

12、g risk風(fēng)險(xiǎn)的影響要素:the food ( fatty, liquid ) 食品脂肪狀、流體 the pathogen ( number, pathogenicity )病菌數(shù)目、致病性 the consumer ( age, health ) 消費(fèi)者年齡、安康Hazard Characterisation (2)危害特征2Hazard (Impact) Characterisation危害影響特征Two categories of consumers have to be distinguished:消費(fèi)者分成兩類：“normal population 普通人群“susceptible

13、 individuals 敏感個(gè)體Susceptible consumers敏感消費(fèi)者Young 小孩Old 老年人Diseased 病人Immuno-compromised 免疫力低下者M(jìn)alnourished 營養(yǎng)不良者Tourists 旅游者Effect 影響e.g. infection with diarrhea腹瀉Dynamics of infection 影響動(dòng)力學(xué)e.g. log-linear dose-effect curve 線性劑量反響曲線Host 宿主Sensitive 敏感性 e.g. hazardous level: 100 cells/serving 危害程度Is

14、the assumption of log-linearity correct?What is the hazardous level?Hazard Characterisation危害特征Hypothetical Hazard Characterisation curve 1假設(shè)的危害特征曲線 10101001000abs. in100 gabs. in 10 gabs. in 1 g10 / g100 /gNo. of cases/ 100.000/ yearEffect Dose影響劑量Exposure暴露量Hypothetical Hazard Characterisation cur

15、ve 2假設(shè)的危害特征曲線 20101001000abs. in100 gabs. in 10 gabs. in 1 g10 / g100 / gNo. of cases / 100.000 / yearEffect DoseHazard with MID 1ExposureHypothetical Hazard Characterisation curve 3假設(shè)的危害特征曲線 30101001000abs. in100 gabs. in 10 gabs. in 1 g10 / g100 / gNo. of cases / 100.000 / yearEffect DoseHazard mo

16、re virulent than in curve 1and / orFood less protectiveand / or Population more susceptibleExposureHypothetical Hazard Characterisation curve 4假設(shè)的危害特征曲線 40101001000abs. in100 gabs. in 10 gabs. in 1 g10 / g100 / gNo. of cases / 100.000 / yearEffect DoseExposureHazard less virulent than in curve 1and

17、/ orFood more protectiveand / or Population less susceptibleHazard characterization curve ofListeria monocytogenes李斯特菌的危害特征曲線Log Noof casesper 100,000Log No of ingested L.m., all servings contaminatedworst - casescenarioBuchanan e.a.1997availability and use of epidemiological data 流行病學(xué)數(shù)據(jù)的有效性和適用價(jià)值use

18、 of animal models and data 動(dòng)物模型和數(shù)據(jù)的適用價(jià)值use of human feeding trials data 人體實(shí)驗(yàn)數(shù)據(jù)的適用價(jià)值Issues in Hazard Characterisation危害特征中的問題pathogen virulence data 病菌的毒性數(shù)據(jù)pathogen-food matrix knowledge 有關(guān)食品病菌的交叉知識(shí)data concerning susceptibility of consumers 有關(guān)消費(fèi)者敏感度的數(shù)據(jù)and more .Issues in Hazard Characterisation危害特征中

19、的問題Exposure Assessment暴露量評(píng)價(jià)The estimation of the prevalence of a hazard and / or certain levels of a hazard in a certain food by the population or part of the population at the moment of consumption 評(píng)價(jià)某些人在消費(fèi)某些食物時(shí)的危害及其程度Purpose目的Pathogen / Product / Pathway analysis病菌/產(chǎn)品/分析途徑Determination and quantif

20、ication of : 檢測與量化prevalence in raw materials 在原料中的存在情況survival during processing 加工過程的殘留Recontamination 再次污染Pathogen / Product / Pathway analysis病菌/產(chǎn)品/分析途徑Growth 繁衍survival during preparation 預(yù)備過程的殘留contamination and growth prior to consumption 消費(fèi)前的污染和繁衍The data are used in mathematical models這些數(shù)據(jù)將

21、用于數(shù)學(xué)模型 Exposure Assessment example暴露評(píng)價(jià)例子Hypothetical production process假定的消費(fèi)過程Frequency of contamination 污染的頻率Level of contamination 污染的程度Factory:工廠Mixing混合Pasteurisation巴氏殺菌cool/freeze冷卻/冷凍Packing包裝Distribution保送time/temperature時(shí)間/溫度Use of product食用產(chǎn)品child / healthy adult小孩/安康成人portion size消費(fèi)量consu

22、mption frequency消費(fèi)頻率Issues in Exposure Assessment暴露評(píng)價(jià)中的問題Consumer use and dietary intakes often not well known 消費(fèi)者的消費(fèi)和每日消費(fèi)量是未知的Data are scarce ( non-existent ) for certain food categories / outlets ( e.g. retail, catering, street vending, small kitchens ) or for new food categories / markets 有關(guān)食品分類/

23、銷售包括零售、公共飲食業(yè)、街道攤販、小廚房或新食品/市場方面的數(shù)據(jù)非常缺乏Issues in Exposure Assessment暴露評(píng)價(jià)中的問題Normal levels of hazards at the moment of consumption for foods that are not sold as ready-to-eat are hardly known. Some data have been collected as a result of an outbreak, this is not a normal situation 無法知道非即食食品銷售后的食用時(shí)的危害程度

24、，只需在迸發(fā)食源性疾病后，才干搜集到的數(shù)據(jù)，這時(shí)曾經(jīng)不能正確反響常規(guī)情況。Issues in Exposure Assessment 暴露評(píng)價(jià)中的問題Available data and models on inactivation and / or growth of pathogens do not apply across the whole food chain up to the point of consumption 有關(guān)失活的或生長的病菌的可用數(shù)據(jù)和模型不能代表整個(gè)食品鏈最終到食用Issues in Exposure Assessment 暴露評(píng)價(jià)中的問題Recontamina

25、tion after production or preparation often not considered 經(jīng)常不思索消費(fèi)和制備過程中的再污染Uncertainty and variability in data and models are often not transparent 不能明確數(shù)據(jù)和模型的不確定性和可變性The quantitative and/or qualitative estimation of the probability of occurrence and severity of defined adverse health effects in a gi

26、ven population due to the consumption of a certain pathogen / food combination特定人群食用了含病菌食品后，定量、定性估計(jì)產(chǎn)生不利影響的的能夠性及其嚴(yán)重程度Risk Characterisation (1)風(fēng)險(xiǎn)特征1Purpose目的Risk Characterization (2)風(fēng)險(xiǎn)特征2Estimated number of cases of a certain illness per year per 100.000 persons in a given population caused by a certa

27、in microorganism (or number of microorganisms) in a certain food 測定特定人群由特定食物中特定微生物引起的特定疾病的每年每10萬人的發(fā)病次數(shù) Should include attendant uncertainties應(yīng)包括效力員的不確定性Risk Estimate for a food某種食品的風(fēng)險(xiǎn)估計(jì)Define microorganism and its virulence 定義微生物及其毒性Define target consumer group and effect 定義目的消費(fèi)群和影響Determine fate of

28、 microorganism during production, distribution, preparation & use 測定微生物在消費(fèi)、運(yùn)輸、制備和食用過程中的命運(yùn)Calculation of Risk Estimate風(fēng)險(xiǎn)估計(jì)的計(jì)算Determine consumption habits 測定消費(fèi)習(xí)慣Use specific dose-response data 運(yùn)用特定的劑量-反響數(shù)據(jù)Calculate risk estimate with attendant uncertainties (assumptions specified!) 用伴隨物的不確定性特殊的消費(fèi)計(jì)算風(fēng)險(xiǎn)評(píng)

29、價(jià)Calculation of Risk Estimate風(fēng)險(xiǎn)評(píng)價(jià)的計(jì)算Exemples of risk estimate風(fēng)險(xiǎn)估計(jì)的例子Variability可變性Variability is a property of nature, the diversity of things. Cannot be reduced through further study or additional measurements.可變性是自然天性，表達(dá)了事件的多樣性。即使經(jīng)過深化研討或額外的測定也不能降低。Lammerding, 1999Uncertainty不確定性?Uncertainty is our

30、 ignorance - lack of knowledge. In many cases, it can be reduced through further study or expert information.不確定性由缺乏知識(shí)呵斥，在許多案例中，可以經(jīng)過深化研討或?qū)＜倚畔斫档汀ammerding, 1999Scenarios 方案During Risk Assessment many assumptions have to be made, because precise data are lacking. These assumptions have an important

31、influence on the outcome. Worst-case scenarios are those aimed at being on the safe side.在風(fēng)險(xiǎn)評(píng)價(jià)中，由于缺乏準(zhǔn)確數(shù)據(jù)，需求設(shè)定消費(fèi)群，這往往對(duì)結(jié)果由重要影響。“最差案例的方案是以“平安邊緣為目的。Scenarios 方案Different scenarios may also reflect different possibilities for production, processing, distriburion preparation and use.不同的方案反映了消費(fèi)、加工、保送、制備和食用

32、的不同能夠The outcomes of these scenarios may the Risk Managers in selecting the most (cost)- effective control measure(s). 得到的結(jié)果可以協(xié)助風(fēng)險(xiǎn)管理者選擇最有效的控制措施。E.g. probability of illness associated with one serving例：與某一食物有關(guān)的疾病的能夠性 low-risk population 低風(fēng)險(xiǎn)人群high-risk population 高風(fēng)險(xiǎn)人群Sensitivity analysis 敏感性分析When th

33、e pathogen / product pathway analysisis modelled, sensitivity analysis allows todetermine which factor(s) have the greatest influence on the risk estimate 當(dāng)確定了病菌/產(chǎn)品模型后，敏感性分析可測定風(fēng)險(xiǎn)估計(jì)中最有影響的因子This may be helpful for Risk Managers to selectcontrol measures with the best cost - benefit ratio可以協(xié)助風(fēng)險(xiǎn)管理人員選擇最經(jīng)

34、濟(jì)、有效的控制措施 Use of worst case scenarios 運(yùn)用最壞案例的方案(biological) variability and attendant uncertainties are often not considered or expressed 經(jīng)常不思索或不表示生物可變性和伴隨物的不確定性Validation of the models 模型確實(shí)認(rèn)Issues in Microbiological Risk Characterisation微生物風(fēng)險(xiǎn)特征中的問題Summary 總結(jié) MRA is a useful tool in Risk Management

35、MRA是風(fēng)險(xiǎn)管理中的一種有用工具 MRA makes the product / pathogen / pathway transparent MRA明確了產(chǎn)品/病菌途徑 Models can be used to simulate reality, when real data are not available 在沒有可用的真實(shí)數(shù)據(jù)時(shí)，模型可用于模擬真實(shí)情況 Summary 總結(jié)Risk estimates expressed without attendant uncertainties should be interpreted with care 沒有闡明伴隨物不確定性的風(fēng)險(xiǎn)估計(jì)應(yīng)該

36、解釋了案例 MRA is still in its infancy, to conduct MRA needs a considerable amount of expertise MRA剛剛起步 ，需求大量專家的支持 MRA or HACCP ?Food manufacturing industries control hazards in food products, not their risks, they may perform a safety assessment 食品制造業(yè)控制食品危害，而不是風(fēng)險(xiǎn)，只能選擇平安評(píng)價(jià)MRA according to Codex is a governmental activity制定MRA的法規(guī)是政府行為Confusion in terminology術(shù)語上的混淆Hazard identification in HACCP and in RA is not the sameHACCP 和RA中的危害定義不是同一概念I(lǐng)n HACCP it is determining which agents may be present in the raw materials, line and line-environment , in order to establish how and where