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The Centers for Disease Control and Prevention (CDC) estimated that 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year¹. In an effort to strengthen the current system of food safety, the Food Safety Modernization Act (FSMA) was signed into law in January 2011². Prior to the enactment of the FSMA, U.S. food safety standards were based on verifying and monitoring end results rather than using risk-based approaches to prevent contamination. As such, shortcomings in food safety primarily stem from federal regulators responding to contamination rather than preventing it³.

The FSMA is a major milestone in the nation’s history of food safety legislation – it is the first major piece of federal legislation to address food safety since the Federal Food, Drug, and Cosmetic (FDC) Act of 1938, and to address intentional food adulteration⁴. To date, federal responsibility for regulating the U.S. food supply rests primarily with the U.S. Food and Drug Administration (FDA)⁵. This new law grants the FDA new enforcement and inspection authorities³.

Since January 2013, the FDA has proposed seven foundational rules for implementing the FSMA, which entail Preventive Controls for Human Food, Preventive Controls for Animal Feed, Produce Safety, Foreign Supplier Verification Program, Third Party Accreditation, Sanitary Transportation, and Food Defense⁶. These seven rules are based on five major pillars of food safety, which reflect the shift from a reactive to a preventive approach to addressing food safety^1,7:

·         Prevention: For the first time, the FDA will have the authority to require food facilities to draft and implement preventive control plans, safety standards for production and harvesting of fruits and vegetables, and regulations to protect against intentional food adulteration. 

·         Inspection and Compliance: Mandated inspection schedules will be implemented for high-risk facilities at least every three years. Additionally, the FDA will have access to facility records and will establish programs for accrediting laboratories for food testing. 

·         Response: The FDA can authorize mandatory recalls when a company fails to voluntarily recall unsafe food as requested by the FDA. A system will be established to track and trace domestic and imported foods to quickly identify recipients of potentially contaminated food.

·         Imports: Food importers must verify adequate preventive controls that meet U.S. standards, and the FDA can deny entry of food into the U.S. if the FDA is denied access to inspection by the foreign facility.

·         Partnerships: State and local agencies will collaborate to address food safety and defense goals, and the FDA will be provided a grant to help such agencies to improve food safety at a more local level. The FDA will also rely on Federal, State, and local agencies to perform inspections in order to meet its increased inspection quota for domestic facilities.

In May 2016, the FDA finalized its last FSMA rule, and all seven FSMA rules are now complete⁸. Deadlines for general compliance (i.e. compliance from companies not considered small businesses or very small businesses, as defined by the FDA) of the seven rules will begin in September 2016^6,9.