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Food Safety Modernization Act (FSMA)

 

The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 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 final rule went into effect on April, 2016.

 

Five Major Elements of FSMA

  • Preventive Controls – For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.

 

  • Inspection and Compliance – The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.

 

  • Imported Food Safety – FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.

  • Response – For the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.

 

  • Enhanced Partnerships – The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

 

Source: U.S. Food and Drug Administration. Frequently Asked Questions on FSMA. Available: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm

 

Additional FSMA information can be found at: