美国食品安全现代法 黄耀文Food_Safety_Modernization_Act_How_Can
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食品供应面临 不断增长的威胁,包括内部的与外部的
Developing countries are exporting more food products and ingredients from sources that are largely unregulated
发展中国家出口更多的食品与原料，大量的是不规范 的
▪ Risk-based 风险分析
Consider the probably and likely consequences of an exposure to determine if a food is unsafe
▪ Main Elements of the New Law新法律的关键要素
Risk analysis 风险分析 Biological basis for adverse effects 微生物的影响 Disease attribution 疾病归因 Risk prioritization 风险优先 “Systems thinking” 系统分析
Evolving Food Safety Frameworks
▪ 上海交通大学客座教授及陆伯勋食品安全 研究中心顾问
▪ 美国药品监督管理协会认定的HAFra Baidu bibliotekCP和 SSOP培训师
▪ 美国国家餐饮协会认定的食品安全卫生培 训检查员，美国药品监督管理局及佐治亚 州农业厅认定的海产食品加工厂审核专员
Food-borne Illness in US 美国食源性疾病
Food-borne illnesses concern consumers, government, and industry食源性疾病关系到消
▪ the transition from a hazard-based food safety system to one that is riskbased
风险评估代替危害分析为基础的食 品安全
Definitions
▪ Hazards-based 危害分析
The mere presence of a hazard is grounds for considering a food unsafe
Yao-wen Huang Professor University of Georgia Athens, Georgia, USA Shanghai Jiao Tong University Shanghai, PRC
黄耀文 教授
▪ 美国佐治亚大学食品科学与技术系，食品 安全中心与纳米科学工程中心教授。
annually
▪ FDA inspects only 1% of imported food
Monetary costs of illness经济损失:
▪ $35 billion annually
3
The U.S. food supply is facing an increasing amount of threats from both internal and external sources
1. New Responsibilities for Food Companies食品公司的新 职责 2. New Controls on Imports 进口上的新控制 3. New or Enhanced FDA Enforcement Powers新的或加强 的FDA 权力 4. New Fees on Food Companies and Importers食品公司与 进口商的新费用
析与关键控制点 ▪ Unstated regulatory goals 法规规定→ Quantitative
performance-based criteria标准 ▪ Reactive反应 → Preventative预防
Changing Food Safety Landscape
▪ FDA Modernization Act 食品现代化法案 ▪ Focus on the Global Supply Chain关注全球供应链 ▪ “Universal Adoption” of HACCP全球接受”危害分析和
关键控制点” ▪ WTO SPS Agreement 关于实施动植物卫生检疫措施的协
议 ▪ Emerging Role of International Standards
Codex Alimentarius ISO 22000食品安全管理体系 ▪ Emergence of Risk Analysis and Risk Management Metrics Concepts
费者，政府，企业
CDC estimates on food-borne illnesses:
疾病预防控制中心关于食品导致的疾病的统计数据:
▪ 3,000 American deaths annually ▪ 48 million (or 1 in 6) contract food-borne illness
Changing Food Safety ▪LaOnnedosf tchearpeceognized challenges
facing the food industry, their regulators, consumers, public health community, and academicians worldwide is 公认的变化：
60% of produce & vegetables are imported 80% of seafood imported
Evolving Food Safety Frameworks食
品安全架构的革新
▪ During the past 15 years there has been a slow evolution to a more quantitative, systems-based framework that relies more heavily on 过去15年的革新
▪ Expert-based 基于专家→ 科学数据Science-based ▪ Hazard-based基于危害分析 →基于风险分析Risk-based ▪ Qualitative 定性→ Quantitative定量 ▪ Command and Control 指令与控制→ HACCP-based危害分
Developing countries are exporting more food products and ingredients from sources that are largely unregulated
发展中国家出口更多的食品与原料，大量的是不规范 的
▪ Risk-based 风险分析
Consider the probably and likely consequences of an exposure to determine if a food is unsafe
▪ Main Elements of the New Law新法律的关键要素
Risk analysis 风险分析 Biological basis for adverse effects 微生物的影响 Disease attribution 疾病归因 Risk prioritization 风险优先 “Systems thinking” 系统分析
Evolving Food Safety Frameworks
▪ 上海交通大学客座教授及陆伯勋食品安全 研究中心顾问
▪ 美国药品监督管理协会认定的HAFra Baidu bibliotekCP和 SSOP培训师
▪ 美国国家餐饮协会认定的食品安全卫生培 训检查员，美国药品监督管理局及佐治亚 州农业厅认定的海产食品加工厂审核专员
Food-borne Illness in US 美国食源性疾病
Food-borne illnesses concern consumers, government, and industry食源性疾病关系到消
▪ the transition from a hazard-based food safety system to one that is riskbased
风险评估代替危害分析为基础的食 品安全
Definitions
▪ Hazards-based 危害分析
The mere presence of a hazard is grounds for considering a food unsafe
Yao-wen Huang Professor University of Georgia Athens, Georgia, USA Shanghai Jiao Tong University Shanghai, PRC
黄耀文 教授
▪ 美国佐治亚大学食品科学与技术系，食品 安全中心与纳米科学工程中心教授。
annually
▪ FDA inspects only 1% of imported food
Monetary costs of illness经济损失:
▪ $35 billion annually
3
The U.S. food supply is facing an increasing amount of threats from both internal and external sources
1. New Responsibilities for Food Companies食品公司的新 职责 2. New Controls on Imports 进口上的新控制 3. New or Enhanced FDA Enforcement Powers新的或加强 的FDA 权力 4. New Fees on Food Companies and Importers食品公司与 进口商的新费用
析与关键控制点 ▪ Unstated regulatory goals 法规规定→ Quantitative
performance-based criteria标准 ▪ Reactive反应 → Preventative预防
Changing Food Safety Landscape
▪ FDA Modernization Act 食品现代化法案 ▪ Focus on the Global Supply Chain关注全球供应链 ▪ “Universal Adoption” of HACCP全球接受”危害分析和
关键控制点” ▪ WTO SPS Agreement 关于实施动植物卫生检疫措施的协
议 ▪ Emerging Role of International Standards
Codex Alimentarius ISO 22000食品安全管理体系 ▪ Emergence of Risk Analysis and Risk Management Metrics Concepts
费者，政府，企业
CDC estimates on food-borne illnesses:
疾病预防控制中心关于食品导致的疾病的统计数据:
▪ 3,000 American deaths annually ▪ 48 million (or 1 in 6) contract food-borne illness
Changing Food Safety ▪LaOnnedosf tchearpeceognized challenges
facing the food industry, their regulators, consumers, public health community, and academicians worldwide is 公认的变化：
60% of produce & vegetables are imported 80% of seafood imported
Evolving Food Safety Frameworks食
品安全架构的革新
▪ During the past 15 years there has been a slow evolution to a more quantitative, systems-based framework that relies more heavily on 过去15年的革新
▪ Expert-based 基于专家→ 科学数据Science-based ▪ Hazard-based基于危害分析 →基于风险分析Risk-based ▪ Qualitative 定性→ Quantitative定量 ▪ Command and Control 指令与控制→ HACCP-based危害分