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FDA Food Safety Modernization Act

FDA Food Safety Modernization Act
Great Seal of the United States
Long title To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
Acronyms (colloquial) FSMA
Enacted by the 111th United States Congress
Effective January 4, 2011
Citations
Public law 111-353
Codification
Acts amended Federal Food, Drug, and Cosmetic Act
Titles amended 21 U.S.C.: Food and Drugs
U.S.C. sections created 301 et seq.
Legislative history
  • Introduced in the House of Representatives as H.R.2751 by Betty Sutton (DOH) on June 8, 2009
  • Committee consideration by House Energy and Commerce and House Ways and Means
  • Passed the House on June 9, 2009 ([1])
  • Passed the Senate on December 19, 2010 (Passed by Voice Vote)
  • Reported by the joint conference committee on December 21, 2010; agreed to by the House on December 21, 2010 ([2]) and by the Senate on December 19, 2010 (Passed by Voice Vote)
  • Signed into law by President Barack Obama on January 4, 2011

The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. 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 the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the 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 foodborne 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.

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. 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. The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

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