Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)

Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353), representing the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS). Among its many provisions, FSMA expanded FDA’s authority to conduct a mandatory recall of contaminated food products; enhanced surveillance systems to investigate foodborne illness outbreaks; established new preventive controls and food safety plans at some food processing facilities and farms; enhanced FDA’s traceability capacity within the nation’s food distribution channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign facilities); and expanded FDA’s authority and oversight capabilities with regard to foreign companies that supply food imports to the United States. Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. This included seven “foundational” rules required to fully implement FSMA covering: Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Produce Safety: Establishes science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms. 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. 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. Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. These regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, many of these regulations did not become final until 2016. Other FDA actions under FSMA were also delayed. Several factors contributed to these delays, including the Office of Management and Budget’s (OMB's) review process, extensions in the public comment and response period for many of FDA’s proposed rules and the agency’s re-proposal of key provisions of some major regulations, and also, according to FDA, limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA’s rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety. Full implementation of the most FSMA regulations will be phased in over the next several years, mostly to provide flexibility to farms and food businesses to comply with the new requirements, as provided for in the enacted law. In addition, in September 2016, FDA further extended the compliance dates for many regulated facilities, especially small and very small businesses.