Section 204(d) of the Food Safety Modernization Act (FSMA) includes additional recordkeeping requirements of certain foods throughout the food’s supply chain otherwise known as the farm-to-table journey. This rule covers food produced for U.S. consumption, regardless if the company in the food item’s supply chain is domestic or foreign.
All those subject to this food traceability rule must comply by the deadline and have their recordkeeping ready within 24 hours of a request by the FDA. The original deadline was January 20, 2026, but the FDA has announced its intentions to extend the deadline to July 2028. With this increased visibility, the FDA can identify and remove potentially contaminated food from the market to help reduce the number of foodborne illnesses and deaths.
What food does FSMA impact?
The following are examples of food items included in FSMA 204(d) which require additional traceability records for those who manufacture, process, pack, or hold the food item either as an end-product or an ingredient.
Includes all cheeses made with unpasteurized milk, other than hard cheeses as well as cheese made from pasteurized milk that is fresh soft, soft unripened, or semi-soft.
Examples of cheese included but not limited to this list are: queso blanco, cottage, cream cheese, mozzarella, brie, blue and monterey jack
This includes varieties of fresh cucumbers, fresh herbs, fresh peppers, fresh sprouts, fresh tomatoes, and fresh-cut vegetables.
Examples included but not limited to this list are parsley, cilantro, basil, sprouts like alfalfa, allium and bean sprouts as well as other fresh sprouted grains, nuts and seeds.
This includes fresh leafy greens as well as fresh-cut leafy greens regardless if it is single or mixed greens. There are exemptions to this including collards, whole head cabbages and leaves grown on trees.
Examples included but not limited to this list are red and green leaf, iceberg lettuce, kale, arugula, chard, escarole, Romaine, spinach, and sorrel.
This includes fresh melons as well as some tropical tree fruits and fresh-cut fruits, however it does not include tree nuts, citrus, or pit fruits.
Examples included but not limited to this list are melons like cantaloupe, honeydew, muskmelon and watermelon, as well as mango, papaya, guava, lychee and starfruit.
This includes finfish, crustaceans, and molluscan shellfish but does not include siluriformes fish.
Examples included but not limited to this list are tuna, mahi mahi, mackerel, amberjack, swordfish, grouper, barracuda, cod, haddock, salmon, shrimp, crab, lobster, oysters, clams and mussels.
Information must be ready to be collated and presented in electronic format to the FDA upon request. Creating a traceability plan is no easy task if we take into account data fragmentation and the large volume of unique data points across a multiplicity of SKUs. Therefore, metadata flexibility should be a key factor for companies that oversee a wide portfolio of diverse products. With the metadata, the platform could enable the attribution of different product information profiles, KDEs and CTEs.
Process Readiness:
Track and trace is the process of integrating raw material, manufacturing, logistics and point-of sale technologies to provide end-to-end visibility into how a product was made and where it's been distributed. It is critical to take steps now before the compliance deadline.
Stakeholder Readiness:
Consider harmonizing data across all suppliers with GS1 standards to make it easier to get the needed information from suppliers.
Technology Readiness:
Different pieces of data required by FSMA 204 live in very different systems that do not talk to each other. Since no one system has all the data needed for compliance, implementing a traceability layer to unify the fragmentation of information is needed.
What data do I collect to comply with FSMA 204?
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For those food items listed in the FSMA 204 rule, the FDA requires Key Data Elements (KDEs) to be tracked during Critical Tracking Events (CTEs) in a sortable spreadsheet when necessary to provide greater visibility of the food item’s journey.
CTEs are specific activities performed throughout the supply chain of the food item and include events such as harvesting, packing, shipping, and more.
The information required to inform the FDA and other members of the food item’s supply chain is known as Key Data Elements. For each CTE, the KDEs required vary due to the different activities being performed.
Examples of Key Data Elements are the following:
Location name and description
Date of harvesting, cooling, packing, shipping, receiving, and transforming
Product description
Traceability lot code
See the full list of KDEs required for each CTE performed here.
Learn how Teddie Peanut Butter updated their operations from paper-based to real-time performance and visibility by leveraging Plex ERP and MES solutions.
Complying with FSMA 204(d) through paper records of data is difficult because sortable spreadsheets must be available within 24 hours of an FDA request. Implementing a digital system that can review the data in real time can support this request and make the review process smoother. For example, incorporating the data into the cloud through a Manufacturing Execution System (MES) helps provide greater visibility into your production lifecycle and connection to your manufacturing ERP.
How can I trace data across systems and organizations?
Transparency is key to building trust with your consumers today. Learn more about the importance of connected products in infant nutrition manufacturing.
The importance of traceability marks the evolution within the food supply chain industry. Learn more about why traceability matters, how to comply with the FSMA 204 ruling, and the benefits involved with FSMA 204 compliance in this Kezzler and Rockwell Automation ebook.
Alongside one of our Digital Partners Kezzler, we can provide the hardware, software and services to design and implement a serialization and traceability solution. This helps extend traceability needs beyond the four walls of the manufacturing plant to more easily inform the rest of the food item’s supply chain.
Building a Digital Strategy for FSMA and Food Traceability Compliance Report
Explore the analyst report to better understand the FSMA updates and ways they impact your operations, including:
