FSMA Compliance

According to the Center for Disease Control and Prevention, approximately 48 million people in the United States alone (1 in 6) get sick, 1280,000 are hospitalized and 3,000 people die each year from foodborne illnesses, with the most common being E.coli, Norovirus, Salmonella, Campylobacter, Listeria and Hepatitis A.

The US Food and Drug Administration (FDA) originally developed a sweeping food safety law, called the Food Safety Modernization Act (FSMA) that came into effect under the Obama administration in early 2011. Since then, the FDA has been diligently working to finalize certain rules that will necessitate compliance from all stakeholders in the food and beverage supply chain.

FSMA compliance


The FSMA is a complete revamp of the United States’ food safety regulatory framework and provides directives as to how food is grown, raised, packaged, processed, transformed, shipped and imported into the US. Rather than only governing how a problem is addressed after it has occurred, such as when a major foodborne illness outbreak happens, the FSMA focuses on the prevention of microbial food contamination and tackling food safety risks at the source. Under the FSMA, the FDA has to continuously develop recordkeeping requirements to ensure that food products can be traced from farm to fork.

In July 2020, the FDA announced a new approach to food safety, entitled the New Era of Smarter Food Safety Blueprint. As the FDA states on its website, this blueprint “outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures.” The FDA’s Deputy Commissioner for Food Policy and Response offered a compelling overview of the initiative in an announcement video.

Later on, in that same year, the FDA indicated that it would implement Section 204 of the FSMA. Simply put, Section 204 of the FSMA hones in on F&B businesses that manufacture, transform, handle or pack high-risk foods on the Food Traceability List (FTL), such as cheeses, leafy greens, shell eggs, sprouts, other fruits and vegetables, finfish, crustaceans, and ready-to-eat deli salads. These companies will soon have to keep additional traceability records that contain Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs).

CTEs are events that are recorded throughout a food product’s supply chain in order to attain complete, end-to-end food traceability. Information pertaining to these events, or KDEs, provides the data crucial for analysis, including time, location, lot or palette code, producer or handler identification numbers, ingredients and more.

Different KDEs apply to food companies depending on where they are situated in the global supply chain. There are five main KDEs as stipulated in the FSMA’s proposed rule for food traceability:

FSMA compliance


Growing is often the first step in the supply chain for products like fruits and vegetables. Growers must provide traceability data between the lot code of the food and growing area coordinates. Sprout growers face additional KDEs.


This is an event whereby a food product is purchased and received at a specific location. First receivers will have additional KDE requirements that depend on the type of food product. For example, there are particular KDEs for the first receivers of seafood obtained from a fishing vessel.

FSMA compliance


This KDE focuses on the creation of a food product that falls under the FTL list as well as its packaging and/or label. Information on these FSMA KDEs is available here.


Transforming events are when a food product on the FTL, its packaging and/or labeling is changed. Transforming can include combining food products to make a new product or processing a food product by cooking, cutting, etc. They are not the same as creating a new food product, as explained above. More details on Transformation rules can be found here.


Shipping KDEs govern how a food product is prepared and shipped from one entity or location to another.

What does FSMA – Section 204 compliance mean for F&B businesses?

The FDA is hoping to submit a final rule to the Office of the Federal Register by November 7, 2022. In January 2025, the rule will enter law, companies in the food and beverage supply chain will inevitably have a deadline to meet—and tech-enabled traceability (both backward and forward) will be the foundation for the transition.

Not only will companies of all sizes need to digitalize existing traceability workflows, thereby eliminating paper-based systems, but they will also have to develop new electronic workflows, processes and business models. These major transformations cannot be viewed as only a means to prove FSMA compliance during ad-hoc audits. Based on the FDA’s regulation, when a foodborne contamination or illness outbreak occurs, rapid product tracing will be necessary; in fact for fast removal of bad items from retail outlets and the entire supply chain, stakeholders will have to provide food traceability data to the FDA in as little as one day.

To guarantee such a quick response, stakeholders will need to develop FSMA-compliant food safety plans to assess risks associated with possible hazards, such as chemical, biological and physical risks, in the supply chain and when they are most likely to occur. Preventative controls will also have to be updated.

As a further step in ensuring FSMA compliance, real-time and continuous monitoring, thanks to intelligent supply chain platforms, will be paramount in any robust food safety plan. With these platforms, end-to-end traceability and visibility can be achieved, bringing better and more widespread transparency to the food supply chain, food origins, and all events that a food product flows through before reaching our tables.

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