食品安全相关标准
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Food Safety Risk Surveillance and Assessment — Countermeasures and Practice 食品安全风险监测与评估 — 对策与实践 Yang Xingfen M.D., Ph.D Guangdong Centre for Disease Control and Prevention yangxingfen@cdcp.org.cn 提 纲 1 2 背 景 Overview 完善立法: 食品安全法及配套法规 Improved Legislation: Food Safety Law and Regulations 3 科学实践: 食品安全风险监测评估与应急管理 Food Safety Risk Surveillance, Risk Assessment and Risk Management 1. 背 景 Overview Food safety incidents The Sanlu tainted milk incident is a major food safety event 2008年6~9月甘肃发 现14例婴儿肾结石； 多省现病例 Cases appeared in several provinces 14 cases of infant urinary stone in Gansu, June to Sep, 2008 2008年9月11日三鹿 公司发出产品召回令 Recall of SanLu products, Sep, 2008 相似事件指向 三鹿奶粉 Sanlu powdered milk was suspected to have been tainted 截至2008.12，全国累 计诊断患儿29.6万人 296,000 infants had been diagnosed with urinary stones by Dec, 2008 多名患儿家长反映孩 子长期食用某奶粉 专家分析结石样本 Parents referred to a certain milk powder Stone analysis 发现状况极其罕见 showed rare type About 296,000 infants had been diagnosed with urinary stones till 2nd Dec,2008 接踵而至 Following closely 个人、作坊、试剂店 personal workshops 三聚氰胺和麦芽糊精为 原料制作“蛋白粉” 销售“蛋白粉” Produced and sold protein powder made from melamine and maltodextrin “蛋白粉”购买者 Protein powder purchaser 2008年8月2日接到企业 报告，9月9日上报省政府 Received reports from firms on 2ndAug, reported to provincial government on 9th Sep 蛋白粉加入原奶虚增原 奶蛋白检出量牟取暴利 Added the powder into raw milk to make it appear richer in protein during tests 地方政府 Local government 石家庄等地奶站 Dairy farms 加价转销“蛋白粉” Resold protein powder with raised price 三鹿集团 Sanlu Group 接到投诉，自检发现问题 问题原奶继续用于奶粉生产 含三聚氰胺奶制品持续上市 Received complaints, recognized contamination through test, but kept on producing and selling products with tainted raw milk 奶制品企业 Dairy firms 生产婴幼儿配方奶粉及其他 奶制品 接到消费者投诉 产品下架召回 Produced dairy products with tainted raw milk; received complaints; recalled products 医疗机构：识别异常情况的敏感性 婴幼儿（特殊人群）发生泌尿系结石（常见）； 短时间内类似病例明显增多，超过既往水平， 及时报告卫生行政部门； 单一饮食结构人群进食史查因。 Hospital: Sensitivity to recognize abnormal situation Common disease in special population (infant, single dietary) Increased cases timely report from hospital to Health authorities 卫生部门：接收医院报告，各地相互通报及逐级上报 Health authorities: received report from hospital, further report and notification 技术部门：流行病学调查及可疑食品抽查检验 Technical institutes: epidemiological survey and product inspection 涉及家庭：患儿家长相互交流，病因推断，自觉反映患儿进食史 Suffered families: parents communication, cause deduction, Report dietary history of their babies 媒体报告：不同地区间类似事件建立联系 Media coverage: establish association among similar events in different areas Major food safety incident 重大食品安全事故 Incident identification 事件识别 病因确认 Cause confirmation 添加三聚氰胺 的婴幼儿奶粉 Melamine-tainted baby milk 应急处置 Emergency Response 应急组织 Emergency Organization 事故调查 Investigation 医疗救治 Medical Treatment 产品检验 Product Inspection 市场安全 Market Security 患者赔偿 Sufferers’ Compensation 信息发布 Information Releasing 对策措施 Countermeasures Improved laws, regulations and standards for food safety 完善食品安全法律法规和标准 Established comprehensive coordination mechanism for food safety 建立食品安全综合协调机制 Strengthened capacity of risk surveillance and assessment 加强风险评估和监测能力建设 Improved emergency response for food safety incidents 完善食品安全事故应急处置 Source control of the melamine contamination 三聚氰胺污染的源头治理 Reinforced credits in food safety area 食品安全诚信教育 Enhanced international cooperation and communication 加强国际合作与交流 食品安全问题引起广泛关注 Food safety issues have aroused a wide public concern 危及消费者健康 Endanger consumer’s health 造成重大经济损失 Bring about huge economic losses 食品安全 问题 往往导致政治后果 Always lead to political consequences 发生国际食品贸易争端 International food trade disputes occur 整体规划，源头治理 Integrated planning, source management 建立食品安全责任共担的社会治理格局 保障食品安全 Establish food safety responsibility sharing mechanism 的对策 构建“权责一体的行政执法体系” Countermeasures Establish administrative law executing system with both authorities and responsibilities for 风险管理关键技术应用 food safety Application of crucial risk management technologies 构建公开共享的食品安全信息平台 Establish open and shared food safety information platforms 提高全民食品安全认识水平 Raise the public awareness of food safety 2. 完善立法 Improved legislation Drew up a new law, collaborating with other laws to ensure food safety 制定颁布新法，联合其他相关法律共同保障食品安 全 NATIONAL FOOD SAFETY LAW - issued on 28th Feb, 2009 and come into effect on 1st June, 2009. 2009.2.28 中华人民共和国食品安全法颁布，6月1日起实施 - aims to improve the food safety supervision system from farm to fork 完善从农田到餐桌的食品安全监管体系 8 other legislations related to food safety 其他相关法律：8项 Improved regulations for food safety 制定发布《食品安全法实施条例》及其他配套法规 IMPLEMENTING RULES OF FOOD SAFETY LAW 《食 品安全法实施条例》 Other supporting rules and regulations - about 16 administrative regulations 食品安全相关行政法规约16项 - more than 40 departmental rules 食品安全相关部门规章逾40项 Unified food safety standards: standards sorting and integrating, new standards’ developing 统一食品安全标准：标准清理整合、新制定标准 66 National Dairy Standards 食品安全相关标准： Food safety basic standards covered 6 aspects 乳品相关国家标准 A series of food products safety standards are being developed 66项； 食品安全基础标准 -涵盖6个方面； 拟制定一批新的食品产品 安全标准 食品安全法科学性 The scientific nature of legislation Scientific Administration: Establish scientific systems and principles 科学管理：建立科学制度与准则 Food safety risk surveillance 新制度之一：食品安全风险监测制度 Food safety risk assessment 新制度之二：食品安全风险评估制度 Unified food safety standards 统一食品安全标准 Emergency Management: Base food safety incidents response on precaution 应急管理：食品安全事故应对立足于预防 Surveillance and assessment support early warning 监测与评估支持早期预警 Unified standards benefit for effective supervision 统一标准利于有效监管 Supporting policies and protocols improve emergency management (8 supporting procedures, among which 2 are under development) 配套制度及方案完善应急管理 （现有制度及方案8项，其中2项在制订中） 我们的工作 Our Work Participate in the development of national supporting regulations 参与制订国家配套法规 • Food Safety Risk Surveillance Administrative Regulation 食品安全风险监测管理规定 • Food Safety Incidents Emergency Plan 食品安全事故应急预案 • Technical criteria on Epidemiological Investigation and Field Sanitization of Food Safety Incidents (under development) 食品安全事故流行病学调查与现场卫生处理技术规范 食品安全事故应急预案体系 System of Food Safety Incidents Emergency Plan Plan of National Administrative Department National Plan 行业预案 国家预案 部门预案 地方预案 Plan of Local Government Plan of Food Industry 编制目的、依据 总 适用范围 则 分级 组织机构 国 家 食 品 安 全 事 故 应 急 预 案 食品安全事故 重大事故 工作原则 指导 依据 Ⅰ、Ⅱ、Ⅲ、Ⅳ级 办公室 应急指挥部 事故处置工作小组 成员单位 专家咨询委员会 应急保障 信息、医疗、人员及技术、物资经费、社会动员、演习演练、宣教培训 公示风险警示信息 监测体系 监测预警、 报告与评估 上报通报 报告举报 事故信息 初步核实 事故评估 核定级别 应急响应 分级响应 应急处置 应级响应级别调整 动态监测 响应终止 后期处置 善后处置 奖惩 总结 附 预案管理 名词术语 实施时间 则 运 行 机 制 Framework of the National Emergency Plan 我们的工作 Our Work Participate in the sorting and integrating, developing and revising of the National Food Safety Standards 参与食品标准清理及制修订 Undertake 20 items of National food safety standards’ sorting and revising , including 10 Product standard, 8 Testing method standards and 2 Food related product standards 新承担（2010年）食品安全国家标准清理完善工作 20项 （产品标准10项，检验方法标准8项，食品相关产品标准2项） Accomplished and undertook formulation and revision of 22 items of food safety standards in recent 5 years.(Formulating and revising 14 National standards and developing 2 Local standards as the leading institute; developing and revising 6 National standards as the participating institute) 近5年完成的和正在承担的标准研制和修订 22项（主持制修订国家标准14 项，参加制修订国家标准 6项，主持制定地方标准2项） 3. 科学实践—食品安全风险监测与评估 Practice ：Food Safety Risk Surveillance and Assessment 食品安全法 Food Safety Law 国家建立食品安全风险监测制度，对食源性疾病、食品污 染以及食品中的有害因素进行监测。 A national surveillance system for food safety risks has been established to monitor food-borne diseases, food contamination and other food-related hazards. 食品安全法 Food Safety Law 国家建立食品安全风险评估制度，对食品、食品添加剂 中生物性、化学性和物理性危害进行风险评估。 A national assessment system for food safety risks has been established to assess the risks on biological, chemical and physical hazards in foods and food additives. 工作基础 Foundation 2010 2003~2009 2000~ 制定下发国家食品安全风险监测计划，开展食品污染物、 食源性致病菌及食源性疾病监测（“三网”监测） Drew up and issued national food safety surveillance plan for surveillance of food contaminants, foodborne pathogens and diseases 2008年16个省、直辖市参加食品污染物监测网； 21个省、直辖市参加食源性疾病监测网。覆盖全国人口80%以上 16 provinces joined food contaminants surveillance networks and 21 provinces joined foodborne pathogens surveillance networks in 2008, covered 80% population 全国范围建立食品污染物监测网、食源性疾病监测网（“两网 ”） China established surveillance networks for food contaminants and foodborne pathogens 1980s 1976 中国加入全球环境监测系统/食品污染物监测和评估计划 （GEMS/Food），全球已有68个国家参与 China joined GEMS/Food which already had 68 countries 联合国环境规划署、联合国粮食与农业组织和世界卫生组织制定 全球环境监测系统/食品污染物监测和评估计划。 UNEP, FAO and WHO drew up GEMS/Food. 基础工作：“两网一总” two networks and TDS -食源性疾病监测网 -总膳食研究 食 品 污 染 物 监 测 网 (Food contaminants) -食品化学污染物监测网 (Foodborne pathogens) 食 源 性 疾 病 监 测 网 广东省食品安全风险监测工作基础 Foundation of Food safety risk surveillance in Guangdong Guangdong was one of the first 5 provinces which joined the two networks in 2000. 广东省自2000年加入国家食品污染物和食源 性疾病监测点，是全国首批“两网”监测 的5个省份之一 Now the whole province has built 27 surveillance sites (with 21 at prefecture level and 6 at county level) 迄今全省共建立食品污染物和食源性疾病监 测点27个（21个市和6个县区） Surveillance and testing of food safety：the Key Medical program of Guangdong Province since 2007 广东省医学重点专科：食品安全监测检验 监测网点 Surveillance sites 中山、佛山、东莞、江门、肇庆、 深圳、广州、韶关、珠海、湛江、 汕头、清远、惠州、河源、始兴、 阳东、清新、增城、惠东 法律法规及工作计划 Law, regulation and work plan 食品安全法 Food Safety Law 1 食品安全法实施条例 2 Implementing Rules of Food Safety Law 食品安全风险监测管理规定 3 Administrative Regulation of Food Safety Risk Surveillance 4 国家食品安全风险监测计划 National Food Safety Risk Surveillance Plan (2010) 省卫生厅(DOH) 省经济和信息化委员会 Economy and Information Commission 省农业厅(DOA) 省工商行政管理局 Administration for Industry and Commerce 省海洋与渔业局 Bureau of Oceans and Fisheries 省质量技术监督局 Administration of Quality and Technology supervision Implementing Program of 省食品药品监督管理局(FDA) Food Safety Surveillance 广东出入境检验检疫局 (Guangdong) Entry-Exit Inspection and Quarantine Bureau We are now doing — 1 食品监测 食品中化学污染物 暴露 与有害因素监测 评估基础 Chemical contaminants Basis of exposure level and harmful factors “两网” Food surveillance --Original 人群监测 新增 2 3 食源性致病菌监测 食品 安全性预警 Foodborne pathogens Early warning of food safety 食源性疾病监测 Foodborne diseases Population surveillance--New 疾病暴发预警 早期报告 Early warning of foodborne outbreaks and early reporting The Practice Food safety Risk Surveillance 1.Food contaminants surveillance: Monitor major chemical food contaminats and harmful factors to gain the contamination condition of chemicals . Total Surveillance Items 132 Pesticide residue Elements (Heavy metels, REE) 农药残留 元素 43 31 Veterinary drug residue 兽药残留 27 Mycotoxin 真菌毒素 11 食品添加剂 非法添加物质 12 6 Harmful substance forming in food processing 加工过程形成的有害物质 2 Food additives Illegal-added substance 2. Foodborne pathogens surveillance: Collect pathogens isolated from animals, food and environments, analyze the similarity and drug resistance, thus to confirm the source and point of contamination. Surveillance Contents Routine 常规监测 Specific Producing and processing 专项监测 生产加工过程 Major foodborne pathogens Foodborne pathogens of anmial and in environment 动物、环境食源性致病菌 Drug-resistance Salmonella, staphylococcus aureus, list of antibiotics 沙门氏菌，金黄色葡萄球菌，抗生素名单 耐药菌 Tracing Analyze 溯源分析监测 DNA fingerprint isolates of pathogens from routine and specific surveillance DNA指纹图谱，常规和专项监测中分离株 3.Foodborne diseases surveillance: To establish a surveillance and report platform of FBD covering provincial, prefectural and county level by collecting, reporting and managing data. 建立食源性疾病监测示范医院与疾控机构的互动机制 (2010年 20家试点医院与CDC) Establish communication and collaboration system between hospitals and CDCs (Choose 20 hospitals as pilots, with local and provincial CDC) 实施食源性疾病（包括食物中毒）事件网络直报 FBD(including food poisoning) reporting system comes into effect 建立食源性疾病监测工作制度 Establish working system of FBD surveillance 加强食源性疾病监测培训 Encourage more traing on FBD surveillance both for hospitals and CDCs The practice food safety risk assessment Risk Assessment of Hazards in food 食品中有害物质风险评估 开展环境及食物中主要重金属污染物暴露评估工作，获得人群重金属污染物的暴露基 准剂量及其下限值。 Exposure assessment of major heavy metal contaminants in environment and food for the benchmark dose and limited value of populations. 调查分析重点污染地区食品污染物来源和存在形态，结合人群流行病学调查，开展生 物学标志物的筛选工作。 Investigation and analysis of source and existing forms of food contaminants in key areas, combined with epidemiological survey for the biomarkers screening . 逐步启动海产品中常见致病菌（如创伤弧菌、副溶血性弧菌和单核细胞增生性李斯特 氏菌）定量危险性评估工作。 Quantitative analysis of risks on common pathogens (Vibrio vulnficus, Vibrio parahemolyticus, Listeria monocytogenes ) in seafood. (planning) 总膳食研究 Total Dietary Study (planning) 专项评估和应急评估 Specific and emergency assessment Health hazard risk assessment of Cd, Pb 广东省食品中镉、铝的健康危害风险评估 依据广东省食品污染物连续10 年监测结果，评估食品中主要金属污染物镉、铝的健康 危害风险 Health hazards risk assessment of Cd, Pb, based on results of 10 years continuous surveillance on food contaminants 每日耐受摄入量（TDI）的不确定性研究——暴露评估 Exposure assessment: Uncertainty analysis of TDI 建立精确暴露评估模型，校正模拟摄入量 Establish exact model of exposure assessment to adjust imitated intakes 我省食物中镉、铝污染的风险评估和跟踪溯源——风险特征描述 Risk characterization: Risk assessment, tracking and tracing of Cd, Pb 已完成 Completed 部分区域食品污染物污染水平调查（食物样本） food contamination level 部分区域污染物人群摄入水平调查（生物样本）contaminant intake level Click to edit company slogan .
