Produce Safety: Requirements, Implementation, and Issues for Congress

In the United States, fruits, vegetables, nuts, and sprouts continue to be associated with a series of foodborne illness outbreaks across the country, resulting in hundreds of illnesses and hospitalizations, as well as kidney failure and death. Many in Congress have expressed concern that foodborne illness outbreaks are occurring despite enhanced authorities and resources provided to the Food and Drug Administration (FDA) and state public health authorities following the 2010 enactment of comprehensive food safety legislation as part of the FDA Food Safety Modernization Act (FSMA; P.L. 111-353). FSMA amends the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), which required FDA to develop produce safety standards for certain fruits, vegetables, nuts, and sprouts, as well as other rules to enhance food safety. To provide FDA with the means to implement FSMA, Congress has provided more than $300,000,000 in FDA’s base appropriation for FSMA since FY2011 (H.Rept. 115-232). FDA published the Final Produce Safety Rule (PSR) in November 2015 to fulfill FSMA produce safety requirements. The PSR establishes science-based minimum standards to prevent microbial contamination of produce (fruits, vegetables, nuts, and sprouts) grown, harvested, packed, and held for human consumption. The PSR specifically applies to certain fruits and vegetables that are expected to be consumed without being cooked or otherwise prepared in a method that decreases the presence of harmful microbes. FSMA gives FDA the authority to conduct surveillance inspections on farms. Through a cooperative agreement with the National Association of State Departments of Agriculture (NASDA), FDA shares in-person inspectional authority of domestic farms with states (foreign farms are inspected by FDA only); however, the autonomy of enforcement held by each state has eroded the ability of FDA and NASDA to collect, analyze, and communicate inspection results. Some in Congress have questioned whether implementation delays and inconsistent interpretation of PSR requirements between FDA and state inspectional authorities are adversely affecting produce safety. If FDA and NASDA were to build a central database, it could allow for consistent information sharing among state and federal authorities. FDA has dispersed more than $112 million to NASDA via the State Produce Implementation Cooperative Agreement Program (State CAP) in a package deal to conduct inspections and provide educational resources to farmers. In addition to the State CAP, FDA collaborates with other government and nongovernment partners to develop programs that foster PSR implementation through education. FDA’s partnerships with organizations such as the U.S. Department of Agriculture’s National Institute of Food and Agriculture (USDA-NIFA), Association of Food and Drug Officials (AFDO), and university extension services provide a scaffold to accomplish education and training goals established under PSR implementation. Compliance dates for the FSMA rules are being phased in according to the sales of each business. Very small farms (those for which the average annual monetary value of produce sold during the previous three-year period is no more than $250,000) generally have more time to comply with rule requirements than larger farms. Farms beneath the $25,000 monetary threshold are exempt from the PSR and do not have to implement FSMA standards or maintain paperwork to prove their standing as exempt. In May 2019, FDA extended water quality-related compliance dates by an additional two years past their original compliance dates due to continued stakeholder feedback questioning the adequacy of water testing requirements. As of January 2020, all farms that grow produce subject to the PSR were to be in compliance with the requirements. Notwithstanding changes enacted as part of FSMA, large-scale foodborne illness outbreaks related to fresh produce continue to occur, according to FDA data. As foodborne illness outbreaks continue, some question the effectiveness of FDA’s food safety implementation of FSMA. FDA’s repeated delays in fully implementing key FSMA produce standards point to several possible contributing factors. FDA’s authority to conduct inspections on farms and annual reporting requirements is limited compared with its authority to carry out these activities in food facilities. FDA also has postponed compliance with certain key PSR requirements and has not fully implemented FSMA’s traceability requirements for high-risk foods. Additionally, the lack of coordination over inspection data between FDA and state and local authorities, which often bear most of the responsibility for inspecting farms and food facilities within their jurisdictions, may lead to inconsistent implementation of rule requirements on farms. A future consideration for Congress could include expanding FDA’s inspectional and reporting authorities on farms, thus limiting exemptions from the traceability rule. Congress could also consider authorizing FDA and states to build a unified farm registry and inspection database.