危險(xiǎn)性分析的原則及其在食品安全中的應(yīng)用(共40頁).ppt

1、1【W(wǎng)ORKSHOP ON AGRO-FOOD SAFETY ISSUES 2002.10.9-11】General Principle & Application of Risk Analysis on Food Safety 危險(xiǎn)性分析的原那么及其在食品危險(xiǎn)性分析的原那么及其在食品平安中的應(yīng)用平安中的應(yīng)用2Food safety a global concernnFood ingredients and products sourced around the worldn食物原料和產(chǎn)品來源于世界各地nFood control measures not the same everyw

2、heren各地的食品平安控制措施不同nFood safety may be perceived differently in different parts of the worldn不同地域?qū)κ称菲桨驳恼J(rèn)識(shí)不同nCan obstruct international traden國際貿(mào)易受阻3CAC & WTOnSPS和TBT協(xié)議是WTO成員在國際貿(mào)易中必須遵循的多邊協(xié)定n應(yīng)用衛(wèi)生與植物衛(wèi)生措施協(xié)定, SPS Sanitary / Phytosanitary Measures Agreement n貿(mào)易技術(shù)壁壘協(xié)議, TBT The Agreement on Technical Bar

3、riers to Trade4WHO要求各會(huì)員國：在食品平安行動(dòng)之下，重點(diǎn)制定和評(píng)估國家的控制戰(zhàn)略，支持開展評(píng)估與食品相關(guān)風(fēng)險(xiǎn)的科學(xué)，包括分析與食源性疾病相關(guān)的高危因素；要最大可能利用開展中國家在食源性因素危險(xiǎn)性評(píng)估方面的信息以制定國際標(biāo)準(zhǔn)。5Risk analysis why ?為什么要進(jìn)行危險(xiǎn)性分析為什么要進(jìn)行危險(xiǎn)性分析nFood safety of increasing concernn食品平安被廣為關(guān)注食品平安被廣為關(guān)注nMove towards a risk based approachn趨向于對(duì)危險(xiǎn)性的研究趨向于對(duì)危險(xiǎn)性的研究nDecision making based on so

4、und sciencen基于科學(xué)根底上的決策基于科學(xué)根底上的決策6Risk Analysis - what is it?A process consisting of 3 components: nrisk assessment 危險(xiǎn)性評(píng)估危險(xiǎn)性評(píng)估 nrisk management 危險(xiǎn)性管理危險(xiǎn)性管理 nrisk communication 危險(xiǎn)性信息交流危險(xiǎn)性信息交流7Risk Analysis ParadigmRisk Analysis ParadigmRisk AssessmentRisk ManagementRisk Communication Science based Poli

5、cy based Interactive exchange of information and opinions 8Risk Assessment Risk Assessment (CAC, 1997)(CAC, 1997)危險(xiǎn)性評(píng)估危險(xiǎn)性評(píng)估nA scientifically based processn科學(xué)評(píng)估的程序nThe evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxin

6、s or disease-causing organisms in food, beverages or feedstuffs. (WTO)n評(píng)估食品、飲料、飼料中的添加劑、污染物、毒素或病原菌對(duì)人群或動(dòng)物潛在副作用的科學(xué)程序。9Risk Management Risk Management (CAC, 1997)(CAC, 1997) 危險(xiǎn)性管理nThe process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, co

7、nsidering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.n在危險(xiǎn)性評(píng)估的科學(xué)根底上，為保護(hù)消費(fèi)者健康、促進(jìn)國際食品貿(mào)易而采取的預(yù)防和控制措施。 10Risk CommunicationRisk Communication危險(xiǎn)性信息交流危險(xiǎn)性

8、信息交流nThe interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explana

9、tion of risk assessment findings and the basis of risk management decisionsn在危險(xiǎn)性評(píng)估者，危險(xiǎn)性管理者，消費(fèi)者，企業(yè)，學(xué)術(shù)團(tuán)體和其他組織間就危害、危險(xiǎn)性，與危險(xiǎn)性相關(guān)的因素和理解等進(jìn)行廣泛的信息和意見溝通，包括危險(xiǎn)性評(píng)估的結(jié)論和危險(xiǎn)性管理決策。 11危險(xiǎn)性評(píng)估程序危險(xiǎn)性評(píng)估程序Risk AssessmentRisk Assessment危害確實(shí)定危害確實(shí)定Hazard Identification 危害的特征描述危害的特征描述Hazard Characterization暴露量評(píng)估暴露量評(píng)估Exposure Asse

10、ssment危險(xiǎn)特征的描述危險(xiǎn)特征的描述Risk Characterization12Hazard Hazard (CAC, 1997)(CAC, 1997)危害nA biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. n食品中可能存在的影響人體健康的生物、化學(xué)、物理因素，或狀況。13Hazards in FoodHazards in FoodnMicroorganismsn細(xì)菌nFungi and mycot

11、oxinsn真菌和真菌毒素nViruses and parasitesn病毒和寄生蟲nToxic plants and animalsn有毒動(dòng)植物nPotential environmental toxicantsn潛在的環(huán)境有毒化學(xué)污染物14Hazard characterisation Hazard characterisation (CAC, 1997)(CAC, 1997)危害特征的描述nThe qualitative and/or quantitative evaluation of the nature of the adverse health effects associate

12、d with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and their toxins. n微生物危害的定性半定量、定量評(píng)估15Exposure Assessment Exposure Assessment (CAC, 1997)(CAC, 1997)暴露評(píng)估nThe qualitative and/or quantitative evaluation of the likely intake of biological, chemi

13、cal and physical agents via food as well as exposures from other sources if relevant. n從食物或相關(guān)來源攝入生物、化學(xué)和物理因子的定性、定量評(píng)估16Risk CharacterizationRisk Characterization(CAC,1997)(CAC,1997)危險(xiǎn)性特征的描述nThe process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of

14、 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. n在危害的識(shí)別、危害的特征描述和暴露評(píng)估的根底上確定事件爆發(fā)的概率和嚴(yán)重性，或?qū)】诞a(chǎn)生潛在不良影響的定性和/定量評(píng)估的過程。17 Risk management 危險(xiǎn)性管理4 Elements：Risk evalu

15、ation危險(xiǎn)性評(píng)價(jià)危險(xiǎn)性評(píng)價(jià)Risk management options assessment危險(xiǎn)性管理選項(xiàng)評(píng)估危險(xiǎn)性管理選項(xiàng)評(píng)估Implementation 執(zhí)行執(zhí)行Monitoring and review監(jiān)測和回憶監(jiān)測和回憶18ImplementationImplementation執(zhí)行執(zhí)行nCan be done by both government officials and the food industryn可被政府官方和食品企業(yè)執(zhí)行nImplementation will take different forms depending what decisions have

16、been takenn執(zhí)行將根據(jù)已定的決議采取不同形式nMRA may be useful in implementationninformation on product pathogen pathwaynin particular exposure assessment can be a valuable information sourcenMRA在執(zhí)行中的作用n病原菌產(chǎn)生的途徑n特別是暴露評(píng)估可作為有價(jià)值的信息來源19Monitoring and ReviewMonitoring and Review監(jiān)測與評(píng)議監(jiān)測與評(píng)議nAssess effectiveness of measures

17、 takenn評(píng)估所用方法的效率評(píng)估所用方法的效率nprovides more datan提供更多數(shù)據(jù)提供更多數(shù)據(jù)nprovides information need to review risk management decision and if needed risk assessmentn提供信息，以便評(píng)議危險(xiǎn)性管理決議及是否需提供信息，以便評(píng)議危險(xiǎn)性管理決議及是否需要危險(xiǎn)性評(píng)估要危險(xiǎn)性評(píng)估20Risk Analysis-who uses itnA tool for use primarily by governments 各國政府 nprotect consumer health保護(hù)

18、消費(fèi)者健康nmaintain confidence in internationally traded food (market maintenance) - harmonization, mutual recognition, equivalence 維持在國際食品貿(mào)易中的信心-一體、共識(shí)、平等nAt international level 國際水平nWTO - use risk assessment techniques developed by relevant international organizations 國際貿(mào)易中采用由相關(guān)國際組織建立的危險(xiǎn)性評(píng)估技術(shù)nused by st

19、andard setting bodies (Codex)被國際標(biāo)準(zhǔn)指定團(tuán)體所采用21CAC CAC 常遇到的問題常遇到的問題nDifferent opinions on methods or outputs of assessment, eg., using “As low as reasonably achievable (ALARA) for contaminantsn對(duì)專家評(píng)價(jià)方法或結(jié)果有不同看法，如污染物到達(dá)盡可能低的水平n黃曲霉毒素總量、B1、M1nWhen there is scientifically uncertaintyn當(dāng)存在科學(xué)不確定性時(shí)n食品中的單增李斯特菌100cf

20、u/g n氯丙醇22nJECFA，Joint FAO/WHO Expert Committee on Food AdditivesnFAO/WHO聯(lián)合食品添加劑專家委員會(huì)nJMPR，Joint FAO/WHO Meeting on Pesticide ResiduesnFAO/WHO聯(lián)合農(nóng)藥殘留專家委員會(huì)nJEMRA, Joint FAO/WHO Expert Consultation on Microbiological Risk AssessmentnFAO/WHO聯(lián)合微生物危險(xiǎn)性評(píng)估專家咨詢委員會(huì)23FAO/WHOFAO/WHO專家咨詢組織與專家咨詢組織與CACCAC有關(guān)委員會(huì)關(guān)系有關(guān)委

21、員會(huì)關(guān)系 Relationship between expert consultation and Codex relevant committees 專家咨詢?cè)u(píng)估專家咨詢?cè)u(píng)估 制定標(biāo)準(zhǔn)管理制定標(biāo)準(zhǔn)管理 Expert consultation Standard formulation (assessment) (management) JECFA CCFAC CCRVDF JMPR CCPR JEMRA CCFH24FAO/WHO activities on risk analysisFAO/WHO召開的危險(xiǎn)性分析專家咨詢會(huì)議1995 - Expert Consultation on Risk

22、 Analysis and Food Safety危險(xiǎn)性分析與食品平安危險(xiǎn)性分析與食品平安1997 - Expert Consultation on Risk Management and Food Safety 危險(xiǎn)性管理與食品平安危險(xiǎn)性管理與食品平安1998 - Expert Consultation on the Application of Risk Communication to Food Standards and Safety Matters危險(xiǎn)性信息交流在食品標(biāo)準(zhǔn)和平安中的應(yīng)用危險(xiǎn)性信息交流在食品標(biāo)準(zhǔn)和平安中的應(yīng)用251999 - Expert Consultation on

23、 Risk Assessment of Microbiological Hazards in Foods n 食品中微生物危害的危險(xiǎn)性評(píng)估2000 - Expert Consultation on Interaction between Risk assessors and risk managers of Microbiological Hazards in Foodn食品中微生物危害的危險(xiǎn)性評(píng)估者與管理者間的相互作用2001 - Expert Consultation on Exposure Assessment of Microbiological Hazards in foodsn食品

24、中微生物危害的暴露評(píng)估食品中微生物危害的暴露評(píng)估2002 - Expert Consultation on Incorporating Quantitative Risk Assessment in the Development of Microbiological Food Hygiene Standardsn運(yùn)用定量微生物危險(xiǎn)性評(píng)估制訂食品衛(wèi)生標(biāo)準(zhǔn)運(yùn)用定量微生物危險(xiǎn)性評(píng)估制訂食品衛(wèi)生標(biāo)準(zhǔn)26危險(xiǎn)性評(píng)估(專家)添加劑 ADIRisk Assessment污染物 PTWI獸藥殘留 ADI 危險(xiǎn)性管理(政府政府) 添加劑 范圍,用量Risk Management污染物 限量 危險(xiǎn)性管理(政府政

25、府) 獸藥殘留 限量 Risk ManagementRelationship between JECFA and CCFAC or CCRVDCCRVD27CCFAC & JECFACCFAC & JECFA Example: Example: Aflatoxin B1n1994, CCFAC asked JECFA: (26th Session) to provide estimates of the toxicological potency of aflatoxins and to derive estimates of the potential risks for d

26、ifferent populationsn1996, JECFA (46th meeting): Aflatoxins were consideredn1997, JECFA (49th meeting): Aflatoxins were carried over 28 Quantitative risk assessment at 49Quantitative risk assessment at 49thth JECFA Meeting JECFA Meeting in in 19971997JECFA 49JECFA 49次會(huì)議的定量危險(xiǎn)性評(píng)價(jià)次會(huì)議的定量危險(xiǎn)性評(píng)價(jià)致癌作用強(qiáng)度：致癌作用

27、強(qiáng)度：nHBsAg() :0.3個(gè)肝癌/年/10萬人/ ng AF/ kg bw/天nHBsAg () :0.01個(gè)肝癌/年/10萬人/ng AF/kg bw/天n人群危險(xiǎn)度 = 作用強(qiáng)度 攝入量29例例1. 1. HBsAg(HBsAg() 1%; ) 1%; 歐洲污染水平歐洲污染水平/ /歐洲膳食結(jié)構(gòu)歐洲膳食結(jié)構(gòu) 攝入量 人群危險(xiǎn)度 (ng/人/天) (個(gè)肝癌/年/10萬人)限量20 g/kg 19 0.0041 (0.0006-0.01)限量10 g/kg 18 0.0039 (0.0006-0.01) 相差 2個(gè)肝癌/年/億人30例例2. 2. HBsAg(HBsAg() 25%; )

28、 25%; 中國污染水平中國污染水平/ /遠(yuǎn)東膳食結(jié)構(gòu)遠(yuǎn)東膳食結(jié)構(gòu) 攝入量 人群危險(xiǎn)度 (ng/人/天) (個(gè)肝癌/年/10萬人)限量20 g/kg 125 0.17 (0.03-0.3)限量10 g/kg 103 0.14 (0.02-0.3) 相差 300個(gè)肝癌/年/億人*1990-92年全國肝癌死亡率20/10萬31CCFH ACTIVITIESn32nd CCFH 1999 nDecided to proceed in MRA on the basis of pathogen/commodity combinations；Elaborated and agreed on tentati

29、ve priority list of pathogen / commodity combinationsn決定對(duì)病原食品組合進(jìn)行微生物危險(xiǎn)性評(píng)估，并提出暫定優(yōu)先組合32CCFH Drafting groups食品衛(wèi)生法典委員會(huì)起草工作組nL. monocytogenes in ready-to-eat food(Germany)n即食食品中的單增李斯特菌nSalmonella spp. in poultry (Sweden)n禽肉中的沙門氏菌nCampylobacter spp. in poultry (Netherlands)n禽肉中的空腸彎曲菌nVibrio spp. in seafoo

30、d(United States)n海產(chǎn)品中的副溶血性弧菌nEnterohemorrhagic E. coli in meat(United States)n肉食品中的出血性大腸桿菌33Why RA is needed in China？我國為什么要進(jìn)行危險(xiǎn)性分析？我國為什么要進(jìn)行危險(xiǎn)性分析？nWTOnCODEX / GBnFOOD INDUSTRYn nFOOD SAFETY CONTROLnGovernmentnConsumersnHEALTH PROTECTIONnLife qualitynknowledgen國際貿(mào)易n食品法典 / 國家標(biāo)準(zhǔn)體系n食品工業(yè)n食品平安控制n政府n消費(fèi)者n保護(hù)

31、消費(fèi)者健康n生活質(zhì)量的提高n對(duì)食品平安知識(shí)的需求34Case in China The Control of the Deteriorated Sugarcane Food PoisoningnFresh sugarcane grown in southern area of Chinan nShipped, stored and sold through the winter season in the northern parts of Chinan nContaminated sugarcane could cause fatal food poisoning when sold in

32、the next spring35Sugarcane poisoningnThe first outbreak of unknown causes sugarcane poisoning occurred in Henan Province in 1972nFrom 1972 to 1989:nNo. of outbreak: 217nNo. of cases: 884nNo. of deaths: 88 nAverage fatality: 10%nIdentified as a priority to assess and control by MOH36Etiology and risk

33、 assessmentnEtiology and causes study were been carried out by the Chinese Academy of Preventive Medicine in 1980snArthrinium spp. was the pathogenic fungus;n3-nitropropionic acid (3-NPA) produced by A. spp. was proved to be the causative compoundnAssessment was made according to case-based studies, epidemiological and laboratory studies37Decision making and management activitiesnBased on discovery and assessment, MOH promulgated:nDiagnostic criteria and principles for the management of deteriorate