The Food Safety and Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.
Since mid-March 2020, FDA operations and FDA oversight of the U.S. food supply have been significantly impacted by the COVID-19 pandemic. The Agency's priorities during this time period have been the safety of our staff, safety of employees at regulated firms, conducting mission-critical activities, including inspections, responding to foodborne disease outbreaks, sampling and testing of imported food, and managing recalls. We have also worked to support continuity of the food supply chain, which includes keeping food and agricultural workers safe to allow continued production of food. Given these priorities, and state and local travel restrictions, FDA adjusted its approach to oversight activities.
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The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.
FSMA requires special reports to Congress and studies on FDA's activities and impact of FSMA. Below is a subset of measures from those reports and studies.
FSMA Domestic Facility Inventory
Domestic human food facilities are scheduled for inspection each fiscal year (FY - October 1st to September 30th) based on their risk classification (high or non-high) and corresponding inspection frequency of 3 or 5 years. The cumulative impact of facility coverage, including both FDA and state contracted inspections to satisfy FSMA mandates, and attempted inspections to clean-up the facility inventory, can be seen in the status of the Total FSMA Domestic Human Food Inventory. As the human food industry changes over time, FDA’s dynamic FSMA inventory experiences constant turnover, requiring continual inspection reprioritization.
FDA tracks each facility on its own frequency clock using the Cover-By Date. Facilities not inspected the year they are due become Past-Due and are rolled over into the next year’s goals. The percent covered is depicted for annual goals, comprised of Past-Due and Due facilities in a given year.
* In FY 2019, a 35-day government shutdown took place between December 22, 2018, and January 25, 2019. During the shutdown, FDA activities were limited to emergencies involving the safety of human life or the protection of property, as well as user-fee funded activities. This led to a reduction in the annual number of domestic inspections.
** Beginning in FY 2020, in accordance with national guidelines due to the COVID-19 pandemic restrictions, FDA targeted resources to the highest risk facilities. COVID-19 challenged FDA’s ability to complete surveillance inspections and required the Agency to think differently about how to meet oversight responsibilities and fulfill its public health mission going forward. FDA has outlined the Agency’s approach to addressing these challenges in the Resiliency Roadmap for FDA Inspectional Oversight. As noted in An Update to the Resiliency Roadmap for FDA Inspectional Oversight, as of September 30, 2021, FDA has exceeded the Base-Case projections for FY 2021 mission critical and prioritized human and animal food inspections. Base-Case projections are not exclusive to the human food facility inventory displayed in the chart.
FSMA Mandatory Recall Authority
Under FSMA, FDA has several effective enforcement tools to protect the food supply. These enforcement tools include the authority to issue a mandatory recall order under section 423 of the FD&C Act for an article of food, other than infant formula, for which FDA determines there is a “reasonable probability” that the food is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act and that the use of or exposure to that food will cause serious adverse health consequence or death to humans or animals. FSMA requires the Department of Health and Human Services to submit an annual report on the use of this recall authority under section 423 of the FD&C Act and any public health advisories issued by FDA that advise against the consumption of an article of food on the grounds that it is adulterated and poses an imminent danger to health.
Fortunately, most companies collaborate with the FDA to rapidly initiate voluntary recalls of hazardous food products. On average, a recall occurs within four calendar days of the problem being discovered. Most recalls are conducted in close coordination with the FDA’s food program staff. All recalls monitored by FDA are included in the Enforcement Report once they are classified.
To date, FDA has only needed to issue a Mandatory Recall Order once.
FSMA User Fees Collected
Section 107 of FSMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add new section 743 (21 U.S.C.379j-31) giving the FDA authority to collect fees from the responsible party for each domestic and foreign food facility subject to a reinspection, importers subject to a reinspection, domestic facilities or importers who do not comply with a recall order, and importers participating in the voluntary qualified importer program (VQIP).
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.