48 Million Cases of Foodborne Illness: How the US Manages Food Safety

Published in Sohu
(China) on 14 June 2013
by Wuxin Yun (link to originallink to original)
Translated from by Diana Xin. Edited by Kyrstie Lane.
Every time there is an issue with food safety, a wave of demands to strengthen legislation and regulation rises and then falls away. Without a doubt, legislation and regulation are important factors for food safety, but far from the full picture. In order to improve food safety, we must begin with prevention.

The history of the Food and Drug Administration provides a broad overview of how the U.S. has developed food regulation standards. After more than 100 years of work, the FDA has formed a comprehensive regulatory system, which many other countries have now emulated. The core concept of the system is to protect those that abide by the rules and punish those that break the law, using penalization to prevent further incidents from occurring.

The regulations have been very efficient in decreasing instances of food contamination. However, the FDA believes there is still much to do. According to the Centers for Disease Control and Prevention, the U.S. still has 48 million cases of foodborne illness each year, striking roughly one in six Americans. Of that number, there are about 128,000 hospitalizations and 3,000 fatalities annually.

This goes to show that strict laws and regulations can prevent the deliberate creation of food contamination crises, but the food production industry is still very prone to errors and mistakes. Any type of accident or negligence is liable to cause product contamination, leading to a wide-scale health crisis.

The FDA believes it still has to address the root causes of food contamination incidents, pushing through the Food Safety Modernization Act in 2011. This is the biggest change in legislation the FDA has made since 1938, with a focus on preventing food safety problems, rather than responding to incidents when they occur.

In 2013, the FDA issued two coinciding Food Safety Modernization Act laws, one directed toward farmers and one directed toward food processing plants. In a nutshell, each law requires that all producers have a basic knowledge of science, identify the risks associated with each part of the production process and take measures to minimize these risks.

From a scientific perspective, safe food is created through production, not testing and inspection. There are many factors for why a food product can become unsafe, and testing for each of those factors would lead to astronomical and insupportable costs. However, if the quality of raw materials, the efficiency of the production chain and the cleanliness of the work environment are all properly managed during the production process, many risks for food contamination can be drastically reduced. These [measures] would greatly lower the possible problems with a product, and testing and inspection could more efficiently stop suspicious items from entering the market. For instance, because France has such a refined manufacturing practice for milk production, there is no need to test milk for aflatoxins. Of course, this is not to detract from the importance of inspection, which can be very valuable for evaluating products for their associated risk factors.

Another aspect worth noting about these two regulations is that they are both directed toward mass producers. These laws apply to about 40,000 large-scale farms across the U.S. There are 70,000 more farms operating on a smaller scale that sell their products directly to consumers or restaurants. These farms only have to comply with a portion of the laws. As for the 30,000 or so small farms that sell less than $250,000 a year, neither law is enforced.

This requirement is very reasonable and practical. With large-scale production, the cost of production per unit falls. If large-scale producers perfect manufacturing processes, this guarantees that the vast majority of products on the market are safe. As for small-scale producers, their low production rate has a smaller impact on the market. If they are required to comply with the laws regardless, they may have difficulty meeting the requirements and bearing the necessary costs.

Simply by regulating large-scale producers, the FDA provides a much higher guarantee of safety for consumers. This is of great importance to consumers. Small-scale producers, regulators acknowledge, are outside the scope of regulation. If consumers want to buy products from these producers, they will have to decide for themselves whether to take the risk.


  每次出现食品安全事件,“加强立法”“加强监管”的呼声总是此起彼伏。毫无疑问,立法与监管是保障食品安全至关重要的一环。但,它不是全部。要进一步提高食品安全状况,预防才是根本。
  美国食品和药品管理局(FDA)的历史大概代表了政府监管食品的发展历程。经过一百多年的发展,FDA形成了相当完善的监管制度,世界其他国家也都建立了类似的监管体系。这一套体系的核心是:保护守法、惩治犯法,通过“惩前”来实现“毖后”。
  相比于以前,这一套体系在减少食品安全事故方面也算卓有成效。不过,FDA认为这还远远不够。根据美国疾控中心公布的数据,目前美国每年也还有4800万人次因为食物得病,相当于美国人口的六分之一。其中12.8万人次严重到入院治疗,3000人死亡。
  也就是说,严刑峻法能够有效地阻止故意制造的食品安全事故,但食品生产是一个很容易出现“过失事故”的行业。任何环节的“无意犯错”都有可能导致后续的所有食品受到污染,从而导致大规模的事故。
  FDA认为还需要从根源上避免食品安全事故的出现,为此在2011年推动通过了《食品和药品管理局食品安全现代化法》,简称FSMA。这一法案堪称是1938年以来FDA最重大的法案改变,其核心是“更多地致力于食品安全问题的预防,而不是主要依靠事发后作出反应。”
  2013年,FDA发布了两个FSMA的配套规则,一个针对农场,一个针对食品加工厂。规范的核心内容都是要求生产者基于科学认识,识别出每一个生产环节可能存在的风险因素,然后采取措施来避免这种风险。
  从科学的角度来说,安全食品是生产出来的,而不是靠检测出来的。一种食品中可能存在的不安全因素很多,如果一一检测,生产成本会高到大众无法接受。而在生产过程中,生产者积极地控制原料品质、生产流程、环境卫生,就可以降低回避各种风险。这样生产出来的产品,出问题的可能性就大大降低,再通过检测就能减少问题产品的上市。比如欧洲的牛奶,执行了良好的生产规范,就用不着每批都去检测黄曲霉毒素的含量。当然,这并不是说检测不重要。检测的价值在于对风险最高的因素进行“复查”,确认它在安全范围内。
  这两份规则还有一个值得我们参考的地方,就是这规定都只针对大型生产者。比如农场,这些规则覆盖了全美国的4万多个大型农场,此外还有7万多个农场年销售额比较小、产品主要直销给消费者或者餐馆,被特许只遵守一部分。而针对3万多家年销售额少于2.5美元的小型农场,则可以不执行这一规则。
  这是一个很现实的规定。生产规模越大,单位产品的执行成本就越低。大规模生产者执行好了,市场上大多数的产品安全性也就有了保障。至于那些小规模的生产者,产量少,对食品市场的影响不大。真要他们执行规则,他们可能无法承受,而监管所需的成本也很大。
  只要管好了大生产者,就为消费者提供了安全性高的渠道——对于消费者来说,这是至关重要的。至于那些小规模的生产者,监管部门明确承认它们并没有出现在管理范围的监控之内。所以,是否要购买他们的产品,就交由消费者自己判断、做出“愿赌服输”的选择了。
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