【美国政府信息网站文章】美国食品安全体系

食品安全治理协同创新中心

往往食品安全问题出现之后我们才会意识到保证食品安全是政府职能之一。鉴于美国是世界上食品状况最好的国家之一，大范围的食源性疾病很少爆发，并且通常很快就能控制住病情。然而，批判美国食品安全体系的群体通常会针对食品安全体系的多部门机构，他们说这种多部门机构太过于妨碍食品安全体系反应的敏捷性和效率性。的确，在美国，规范食品安全和质量的联邦法律法规不少于30种，并由15个联邦机构来执行。

美国农业部（USDA）和食品药品监督管理局（FDA）共同承担监督美国食品供应安全的主要职责。此外，每个州都有它们自己的关于食品安全的法律、法规和专门机构。美国疾病预防控制中心（CDC）主要负责州以及全国范围的食源性疾病爆发的调查工作。

在很多案例中，食品药品监督管理局和美国农业部的食品安全职能具有重叠的部分，特别是对国产和进口的食品进行监察/执行、培训、研究和规则制定。美国农业部和食品药品监督管理局目前对1500个双重管辖部门，即这两个机构同时管理的生产食品的单位，实施类似监管。

美国农业部（USDA）的职能

美国农业部主要负责肉类、家禽和一些蛋类产品的安全。美国农业部管理的权力来自于联邦肉类监察法案，家禽产品监察法案，蛋类产品监察法案和家畜屠宰的人道主义方式法案。美国农业部监察所有肉类、家禽和蛋类产品在州际贸易中的销售以及复验进口的肉类、家禽和蛋类产品以确保它们符合美国的安全标准。在鸡蛋加工厂，美国农业部监察用于进一步加工的鸡蛋打碎的前后过程。

食品药品监督管理局（FDA）的职能

经美国食品、药品和化妆品法案以及公共卫生服务法案授权，食品药品监督管理局管理除了由美国农业部监管的肉类和家禽类产品之外的其他食品。食品药品监督管理局同时也负责药品、医疗器械、生物制剂、动物饲料和药品、化妆品以及放射物发射装置。

2010年7月9日生效的新法规赋予了食品药品监督管理局监督大型商业鸡蛋农场权力。在该法规之前，食品药品监督管理局是依据适用所有食品的宽泛权力来监察鸡蛋农场，关注与已经同召回事件有关的农场。很显然，新法规并没有立刻完全生效以允许食品药品监督管理局先前的对于涉及2010年8月因为感染沙门氏菌而召回将近5亿鸡蛋的鸡蛋农场的监察行为。

美国疾病预防控制中心（CDC）的职能

美国疾病预防控制中心领导各州收集食源性疾病的数据，调查食源性疾病及爆发情况，实施监测、预防和控制措施以减少食源性疾病。联邦疾病控制中心在建立用以支撑食源性疾病监测以及疫情应对的州和地区卫生部门流行病学、实验室和环境卫生能力中也扮演着关键的角色。

权限区分

美国法律授权美国农业部和食品药品监督管理局不同的管理和执行权限。比如，食品药品监督管理局管辖下的食品可以在没有相关机构事前批准的情况下卖给公众。然而，美国农业部管辖下的食品进入市场前一般必须经过符合联邦标准的监察和批准。

在现行法律下，美国农业部不断地检查屠宰设备和逐一检验屠宰后的肉和家禽。他们也会在每个工作日至少视察每件加工设备一次。然而，美国法律并没有授权食品药品监督管理局对其管辖下的食品进行经常性检查。

应对生物恐怖主义

2001年9.11恐怖袭击之后，美国食品安全机构开始承担处理潜在人为污染农业和食品——生物恐怖主义的额外职责。

乔治•沃克•布什总统在2001年签署的一项行政命令增加了食品行业需要预防可能的恐怖主义袭击的重要领域清单。由于这项命令，国土安全部门在2002年制定的国土安全法现在规定统筹协调保护美国食品供应避免人为污染。

最后，2002年的公共卫生安全和生物恐怖预防以及应急法案授权食品药品监督管理局额外的类似于美国农业部的食品安全执行权限。

美国食品药品监督管理局的食品安全计划拥有了实际权利

多年以来，美国食品药品监督管理局（FDA）在美国食品安全系统中的角色是被动的而不是积极主动的。当美国农业部忽略或者未检测被污染食品时，FDA主要责任则是发布和召回这些产品。奥巴马总统于2011年1月签署的《食品安全现代化法案（2010）》，该法案明确规定FDA的食品安全职责是：预防并确保不安全食品不进入商店、餐馆以及学校食堂。

除了由美国农业部监管的肉类和家禽外，《食品安全现代化法案（2010）》覆盖了国内及进口食品、饮料和食品添加剂的监管。

FDA的副署长Michael R. Taylor在相关食品新闻发布会上说道：“这些新的机构对法律的成功实施至关重要。它们给予食品公司很大的额外激励与督促，确保公司产品安全，同时帮助我们实现实施新法律的目标以保护消费者远离不安全的食品。”

根据美国疾病控制与预防中心的数据，每年有四千八百万美国人患有食源性疾病，超过10万人到医院就医并且有数千人死亡。

2006-2009年期间消费者要求大规模召回受污染菠菜、番茄和花生酱，此举促使《食品安全现代化法案（2010）》（FSMA）的通过。2009年3月，奥巴马总统对于召回的回应中称美国食品安全系统存在着消费者无法接受的风险，并随后创建了最后制定FSMA的蓝丝带委员会。

预防重于治理

根据FSMA条款，国会要求FDA在美国食品供应的各方面运用“全面、基于预防的控制”。

在法案下，FDA在食品安全体系中的角色发生了转变，即从应对因食品受污染或错误标识而爆发的疾病转变为首先预防其爆发。FSMA要求建立和保持食品加工和分销设施，并需经FDA同意，进而详细评估食品加工过程中潜在的危险，并提出预防污染和治理方案。

FSMA同时要求FDA建立和应用新的“基础科学标准”以供水果和蔬菜生产者和分销商遵守，而在2006菠菜和2008年番茄召回期间是不存在任何标准的。

这也是FDA第一次拥有权利使食品公司承担预防食品被污染的责任。“预防并不是新的想法，”FDA局长Margaret A. Hamburg在FSMA签字仪式上提到。“类似于美国农业部针对肉类和家禽类制定标准和规则，FDA已经为海鲜、果汁和鸡蛋建立了以预防为导向的标准和规则，并且在食品行业中，很多标准与规则为食品预防开创“最佳实践”。对于所有美国食品安全体系群体来说，公认的最新观点是：从农场到餐桌过程中，每一个节点的失误都可能对消费者健康造成灾难性的损害，以及为食品工业带来巨大的破坏和经济损失。

新的检查权利

FSMA赋予了FDA更多的权利来获得食品公司有关潜在风险或者污染食品的记录。此外，不论公司食品是否被污染，FDA均可检查食品公司任何可能受影响的食品。

进口食品安全

对于进口食品的监督和控制，FSMA采取了措施以弥补美国食品安全体系中最明显的漏洞之一。根据美国农业部的数据，每年约15%的食品供应是从外国进口，当中包括60%的新鲜水果和蔬菜以及80%的海鲜。

n  FSMA要求所有的食品进口商落实外国供应商验证计划，要求严格逐项地检验产品安全。

n  如果外国食品生厂商或者国家拒绝让FDA检查其产品，FDA可拒绝允许该国家或该食品厂商任何食品进入美国。

n  FDA被授权要求检验进口食品和饮料等符合所有的食品安全要求。

n  申请由FDA同意的附加食品安全措施的食品进口商所进口的食品可能获得更快地检查与检验。

加强突发事件的应对

根据FSMA规定，FDA首次拥有宣布即时强制召回食品的权利。在颁布FSMA之前，FDA只能要求食品生产商自愿实施召回。

美国食品药品监督管理局

生活中我们更需关注摄入我们体内的食物：供养我们的食物，身体消耗的动食物，治疗疾病的药物及延长和提升寿命的医疗器械。FDA就是确保我们食物安全的机构。

美国食品药品监督管理局的过去和现在

FDA是美国成立最久的消费者保护机构。1906年，从当时政府机构中分离出食品药品部门成立了FDA，并赋予其监管权力。FDA之前叫过做化学处、化学局以及食品、药品和杀虫剂管理局，其首要职责是确保美国食物安全。

如今，除了肉类和家禽类（由美国农业部食品安全检验局监管）之外，其他所有食品的标识、洁净和无污染均由FDA管理。FDA业确保国家血液供应和其他生物制剂的安全，例如疫苗及移植器官。药物销售之前或者成为处方药之前必须根据FDA的标准经过检测，加工和标识。像心脏起搏器、隐形眼镜、助听器以及乳房假体的医疗器械都由FDA管理。

X光机、CT扫描仪、乳腺扫描仪和超声设备也都在FDA监管之下。化妆品同样也位列监管范畴之下。FDA通过确保牲畜饲料、宠物食品以及兽药和设备的安全来管理牲畜和宠物。

美国食品药品监督管理局的部门

FDA是内阁级美国健康与人口服务机构的下属部门，由八个中心组成：

· 生物制品评价和研究中心

· 设备和放射卫生中心

· 药品评价和研究中心

· 食品安全与应用营养中心

· 兽医医学中心

· 行政办公厅

· 监管事务办公室

总部设在马里兰州洛克维尔，FDA办事处和实验室已经遍布国家的所有地区。全国共雇佣了10000名职员，包括生物学家、化学家、营养学家、医生、药剂师、药理学家、兽医和公共卫生专家。

消费者的守护者

当出现食品污染或者召回事件时，FDA会及时向公众发布信息。FDA估计，每年会收到来自公众的投诉40000余件，并且需处理这些投诉。FDA还要继续对先前已检产品进行监查。美国食品药品监督管理局可以撤回已批准的产品，迫使产品下架。同时，FDA需跟外国政府和机构合作以确保进口产品也符合本国标准。

FDA每年会出版几种消费者出版物，包括美国食品药品监督管理局消费者杂志、小册子、健康与安全指南以及公益宣传公告等，促使公众通过出版物以及指导性标签更好的获知信息，使消费者做出相关决策。而且，在9.11事件之后，通过反恐来确保美国食品供应不会有损害和受污染。

原文：

The US Food Safety System

Ensuring food safety is one of those government functions we only notice when it fails. Considering that the United States is one of the best-fed nations in the world, widespread outbreaks of food-borne illness are rare and usually quickly controlled. However, critics of the U.S. food safety system often point to its multi-agency structure which they say too often prevents the system from acting swiftly and efficiently.

Indeed, food safety and quality in the United States is governed by no less than 30 federal laws and regulations administered by 15 federal agencies.

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) share primary responsibility for overseeing the safety of the U.S. food supply. In addition, all states have their own laws, regulations and agencies dedicated to food safety. The federal Centers for Disease Control (CDC) is mainly responsible for investigating localized and nationwide outbreaks of foodborne illnesses.

In many cases, the food safety functions of the FDA and USDA overlap; particularly inspection/enforcement, training, research, and rulemaking, for both domestic and imported food. Both USDA and FDA currently conduct similar inspections at some 1,500 dual jurisdiction establishments -- facilities that produce foods regulated by both agencies.

Role of the USDA

The USDA has primary responsibility for the safety of meat, poultry and certain egg products.

USDA's regulatory authority comes from the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act and the Humane Methods of Livestock Slaughter Act.

USDA inspects all meat, poultry and egg products sold in interstate commerce, and re-inspects imported meat, poultry and egg products to makes sure they meet U.S. safety standards. In egg processing plants, the USDA inspects eggs before and after they are broken for further processing.

Role of FDA

The FDA, as authorized by the federal Food, Drug and Cosmetic Act, and the Public Health Service Act, regulates foods other than the meat and poultry products regulated by the USDA. FDA is also responsible for the safety of drugs, medical devices, biologics, animal feed and drugs, cosmetics, and radiation emitting devices.

New regulations giving the FDA the authority to inspect large commercial egg farms took effect on July 9, 2010. Prior to this rule, FDA inspected egg farms under its broad authorities applicable to all food, focusing on farms already linked to recalls. Apparently, the new rule did not take effect soon enough to allow for proactive inspections by the FDA of the egg farms involved in the August 2010 recall of nearly half a billion eggs for salmonella contamination.

Role of the CDC

The Centers for Disease Control leads federal efforts to gather data on foodborne illnesses, investigate foodborne illnesses and outbreaks, and monitor the effectiveness of prevention and control efforts in reducing foodborne illnesses. CDC also plays a key role in building state and local health department epidemiology, laboratory, and environmental health capacity to support foodborne disease surveillance and outbreak response.

Differing Authorities

All of the federal laws listed above empower the USDA and FDA with different regulatory and enforcement authorities. For example, food products under FDA's jurisdiction may be sold to the public without the agency's prior approval. On the other hand, food products under USDA's jurisdiction must generally be inspected and approved as meeting federal standards before being marketed.

Under current law, UDSA continuously inspects slaughter facilities and examines each slaughtered meat and poultry carcass. They also visit each processing facility at least once during each operating day. For foods under FDA's jurisdiction, however, federal law does not mandate the frequency of inspections.

Addressing Bioterrorism

Following the terrorist attacks of September 11, 2001, the federal food safety agencies began taking on the added responsibility of addressing the potential for deliberate contamination of agriculture and food products - bioterrorism.

An executive order issued by President George W. Bush in 2001 added the food industry to the list of critical sectors that need protection from possible terrorist attack. As a result of this order, the Homeland Security Act of 2002 established the Department of Homeland Security, which now provides overall coordination for protecting the U.S. food supply from deliberate contamination.

Finally, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 granted the FDA additional food safety enforcement authorities similar to those of the USDA.

The Fight Against Foodborne Illnesses Continues With Safe Meat And Poultry Act

FDA's Food Safety Program Gets Real Teeth

For many years, the role of the Food and Drug Administration (FDA) in the U.S. food safety system was reactive, rather than proactive. When a tainted food product slipped by or otherwise avoided detection by the U.S. Department of Agriculture (USDA), the FDA was largely responsible for issuing and enforcing recalls of the product. The Food Safety Modernization Act of 2010 (FSMA), signed into law by President Obama in January 2011, placed the FDA's food safety focus on prevention - ensuring that unsafe foods never make it into stores, restaurants and school cafeterias in the first place.

The Food Safety Modernization Act covers all domestic and imported foods, beverages and food ingredients except meat and poultry, which are regulated by the U.S.

"These new authorities are critical for the law's success," said Michael R. Taylor, FDA's deputy commissioner for foods in a press release. "They give the food companies strong additional incentives for keeping their products safe, and that helps us achieve the new law's goal, which is to protect consumers from unsafe food."

According to the Centers for Disease Control and Prevention, foodborne illness strikes 48 million Americans every year, hospitalizing more than 100,000 and killing thousands.

Impetus for passage of the Food Safety Modernization Act of 2010 came largely from public reaction to the massive recalls of tainted spinach, tomatoes and peanut butter required between 2006 and 2009. In March 2009, President Obama reacted to the recalls by calling the U.S. food safety system an "unacceptable hazard to public health," and creating blue ribbon commission that ultimately created the FSMA.

Prevention Rather than Reaction

Through provisions in the Food Safety Modernization Act (FSMA), the FDA is required by Congress to apply "comprehensive, prevention-based controls" across all aspects of the U.S.

Under the FSMA, the FDA's role in the food safety system shifts from one of responding to outbreaks of contaminated or misbranded food-related illnesses to preventing those outbreaks in the first place. FMSA requires food processing and distribution facilities to create and maintain, subject to FDA approval, a detailed evaluation of contamination hazards in their operation, as well as contamination prevention and corrective action plans.

The FSMA also requires the FDA to establish and apply new "science-based standards" to be followed by producers and distributors of fruits and vegetables, standards that did not exist at the time of the 2006 raw spinach or the 2008 tomato recalls.

For the first time, the FDA has the authority to hold food companies accountable for preventing contamination of their products.

"The idea of prevention is not new," said FDA commissioner Dr. Margaret A. Hamburg at the FSMA signing ceremony. "FDA has established prevention-oriented standards and rules for seafood, juice, and eggs, as has the U.S. Department of Agriculture for meat and poultry, and many in the food industry have pioneered 'best practices' for prevention. What's new is the recognition that, for all the strengths of the American food system, a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry."

New Inspection Powers

The FSMA gives FDA more authority to gain access to food company records related to potentially hazardous or contaminated foods. In addition, the FDA can now inspect company records related to any other food it believes may be similarly affected, whether it has be found to be contaminated or not.

Imported Food Safety

The legislation takes steps to close one of the most glaring gaps in the U.S. food safety system, oversight and control of imported foods. According to the USDA, an estimated 15% of the U.S. food supply, including 60% of fresh fruits and vegetables and 80% of seafood enters the United States from foreign countries each year.

The FSMA requires all food importers to implement a Foreign Supplier Verification Program, requiring strict item-by-item certification of product safety.

The FDA can now deny admission into the U.S. of any imported food if the foreign food producer or country refuses to allow the FDA to inspect its products.

FDA is now authorized to require certification that imported foods and beverages are in compliance with all food safety requirements.

Food importers who apply additional food safety measures as approved by the FDA may get expedited review and inspection of their shipments.

Enhanced Response to Outbreaks

Under the FMSA, the FDA, for the first time, has the authority to declare immediate mandatory recalls of food products. Prior to enactment of the FSMA, the FDA could only request that food producers issue voluntary recalls.

The Food and Drug Administration

There is little else in life we need to be more certain about than the things we place in our bodies: the food that sustains us, the food of the animals we consume, the drugs that heal us, and the medical devices that prolong and improve our lives. The Food and Drug Administration, or FDA, is the agency that ensures the safety of the things that keep us going.FDA Past and Present

The FDA is the oldest consumer-protection agency in the nation. It was established in 1906 from existing governmental agencies by the Food and Drug Act, which gave the agency its regulatory power. Previously called the Division of Chemistry, the Bureau of Chemistry, and the Food, Drug and Insecticide Administration, the agency's first, primary responsibility was to ensure the safety and purity of food sold to Americans.Today, the FDA regulates the labeling, cleanliness and purity of all foods except meat and poultry (which are regulated by the Department of Agriculture's Food Safety and Inspection Service). It ensures the safety of the nation's blood supply and other biologics, such as vaccines and transplant tissue. Drugs must be tested, manufactured and labeled according to FDA standards before they can be sold or prescribed. Medical devices such as pacemakers, contact lenses, hearing aids and breast implants are regulated by the FDA.X-ray machines, CT scanners, mammography scanners and ultrasound equipment also fall under FDA oversight. So do cosmetics.

And the FDA takes care of our livestock and pets by ensuring the safety of livestock feed, pet food, and veterinary drugs and devices.Also See: Real Teeth for

FDA's Food Safety Program Organization of the FDA

The FDA, a division of the Cabinet level U.S. Department of Health and Human Services, is organized into eight offices:

l  Center for Biologics Evaluation and Research

l  Center for Devices and Radiological Health

l  Center for Drug Evaluation and Research

l  Center for Food Safety and Applied Nutrition

l  Center for Veterinary Medicine

l  National Center for Toxicological Research

l  Office of the Commissioner

l  Office of Regulatory Affairs

Headquartered in Rockville, Md., the FDA has field offices and laboratories in all regions of the country. The agency employs 10,000 people nationwide, including biologists, chemists, nutritionists, physicians, pharmacists, pharmacologists, veterinarians and public-health specialists.

Consumer Watchdog

When something does go awry-such as a food contamination or a recall-the FDA gets the information to the public as quickly as possible. It receives complaints from the public-40,000 a year by its own estimate-and investigates those reports. The agency also keeps a look-out for adverse effects and other emerging problems with previously tested products. The FDA can withdraw its approval of a product, forcing manufacturers to pull it from the shelves. It works with foreign governments and agencies to ensure that imported products meet its standards as well.The FDA publishes several consumer publications each year, including FDA Consumer magazine, brochures, health and safety guides, and public-service announcements. It states that its main initiatives include: the management of public health risks; keeping the public better informed both through its own publications and through informative labeling, so that consumers can make their own educated decisions; and, in the post-9/11 era, counter-terrorism, to ensure that the U.S. food supply is not tampered with or contaminated.

 （翻译：尤猛）

网站来源：http://usgovinfo.about.com/od/consumerawareness/a/Fdas-Food-Safety-Program-Gets-Real-Teeth.htm