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The FDA Food Safety Modernization Act of 2010 (FSMA) was signed into law by President Barack Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. The law was prompted after many reported incidents of food-borne illnesses during the first decade of the 2000s. Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses. This bill is similar to the Food Safety Enhancement Act which passed the House in 2009. It is considered the first major piece of federal legislation addressing food safety since 1938. It is also the first piece of legislation to address intentional adulteration and Food Defense. 〔(【引用サイトリンク】title=FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration )〕 ==Background== The Center for Disease Control and Prevention (CDC) estimated in 2011 that each year 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.〔(【引用サイトリンク】title=CDC Estimates of Foodborne Illness in the United States )〕〔(【引用サイトリンク】url=http://www.fda.gov/Food/FoodSafety/FSMA/ucm239907.htm )〕 The CDC estimates that there are two major groups of foodborne illnesses: Known foodborne pathogens and Unspecified agents. 31 pathogens are notorious for causing foodborne illness.〔 Unspecified agents have insufficient data to estimate with certainty the agent-specific burden. Known agents that have not been identified as causing foodborne illness include microbes, chemicals, or other substance known to be in food. The ability for these known agents to cause illness has not been proven so they remain unidentified. Considering the fact that, about 30% of the population is at risk for food borne sicknesses, over 14% of food supply to the United States is imported from other countries, and also new and more food items are becoming more complex or intricate, the FSMA was indeed needed. 〔(【引用サイトリンク】url=http://fda.yorkcast.com/webcast/Viewer/?peid=886494cb24a741299e6a4578f40624721d )〕 The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.〔 Over the past few years, high-profile outbreaks related to various foods, from spinach and peanut products to eggs, have underscored the need to make continuous improvements in food safety.〔(【引用サイトリンク】title=Food Bill Aims to Improve )〕 Under this law the FDA will be allowed to mandate a system that is based on science and addresses the hazards from farm to table. This means that the FDA has the power to oversee how foods are produced and how they are maintained in food markets. This puts greater emphasis on preventing food-borne illness. The reasoning is simple: The better the system handles producing, processing, transporting, and preparing foods, the safer our food supply will be.〔 Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in their approach to food safety.〔 For example, for the first time, FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain. Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring. The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year. 抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「FDA Food Safety Modernization Act」の詳細全文を読む スポンサード リンク
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