Food Safety Modernization Act

What is the Food Safety Modernization Act?

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. 

What does FSMA cover?

There are five major elements included in the Food Safety Modernization Act:

  • 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.

There are seven foundational rules that FDA has proposed to implement FSMA which became final in 2015 and 2016 including: 

  1. Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Original rule proposed January 2013; supplemental rule to add specific language for important provisions proposed September 2014. Final rule issued: Sept. 10, 2015.
  2. Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Original rule proposed October 2013; supplemental rule to add provisions geared specifically to animal foods proposed September 2014. Final rule issued: Sept. 10, 2015.
  3. Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Original rule proposed January 2013; supplemental rule to amend key areas proposed September 2014. Final rule issued: Nov. 13, 2015.
  4. Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Original rule proposed July 2013; supplemental rule to provide, among other provisions, more flexibility in determining appropriate verification measures proposed September 2014. Final rule issued: Nov. 13, 2015.
  5. Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Proposed July 2013. Final rule issued: Nov. 13, 2015.
  6. Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Proposed January 2014. Final rule issued: Apr. 5, 2016.
  7. Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Proposed December 2013. Final rule deadline: May 31, 2016.

What is FDA's strategy for providing training opportunities to the food industry?

FSMA training will encompass various members of the food industry, including domestic and foreign food producers and domestic importers. The FDA will work with partners around the world—including the Alliances, regulatory counterparts, and multinational organizations—to promote training to the global community of food suppliers. Read more about the FDA's strategy in the link below.