How to Achieve FSMA 204 Compliance Before the Deadline

After many deadline postponements, the countdown to the 2028 compliance date for the FDA’s Food Safety Modernisation Act (FSMA) 204 is fast approaching.

The FDA is increasing requirements on traceability for certain food items to help ensure the health of the United States. The deadline for compliance with this new regulation is now just two years away, in July of 2028.

FSMA 204 isn’t just a singular mandate. It’s a food traceability process that may require foundational changes to many food supply chains across the country. For most, the process of attaining compliance with FSMA 204 will begin in 2027, and with the third quarter of 2026 already underway, budgeting decisions are just around the corner.

enVista’s traceability experts have read all 597 pages of the FSMA 204 ordinance so you don’t have to. In this blog, they’ll share all of the important information you need to know, and the next steps that will set you on track for FSMA compliance by July of 2028.

What is FSMA 204?

FSMA 204 requires businesses that manufacture, process, pack, and hold foods on the food traceability list (FTL) to maintain detailed records of key data elements (KDEs) associated with specific critical tracking events (CTEs). These records must be readily accessible and provided to the FDA within 24 hours upon request. FSMA 204 encompasses both domestic and foreign firms involved in the U.S. food supply chain.

That’s a lot of acronyms to digest, so let’s break them down, as well as the other key terms you’ll need to become familiar with as you navigate FSMA 204 compliance.

• Food Traceability List (FTL) – A comprehensive list of items identified by the FDA as having a higher food safety risk. Foods may be added to or removed from this list at any point. A few items on the FTL are fish, eggs, nut butters, and cheese.
• Critical Tracking Events (CTE) – Individual events in the supply chain where an FTL item is harvested, packed, shipped, received, or transformed.
• Key Data Elements (KDE) – Data attributes specific to each CTE such as product identifier, product source and destination location, lot code, and lot code source location.
• Traceability Lot Code (TLC) – A unique identifier, typically in an alphanumeric format, that designates a specific time and grouping of product created by the producer or transformer. The TLC is the least present KDE transferred throughout food supply chains.
• Traceability plan – The description of procedures used to maintain and share records.

How Will FSMA 204 Impact Your Supply Chain?

Once the FDA deadline arrives, all food supply chains that work with any items on the FTL will need to produce, maintain, and keep records of the KDEs for each CTE throughout the supply chain. The FDA has established seven possible CTEs that you will be required to monitor. These seven CTEs are:

1. Harvesting
2. Cooling
3. Initial packing of raw agricultural commodities
4. First land-based receiver
5. Transformation
6. Shipping
7. Receiving

Several aspects of the supply chain will more than likely need to be audited and improved to meet tracking standards across each of these CTEs.

FSMA 204 Requirements

These requirements dictate lot-level granularity at each node within the supply chain as outlined in the above list of critical tracking events. To be fully compliant with regulations, lot codes and other key data elements must be captured and maintained internally and then shared with the next node in the supply chain. Federal regulators reserve the right to request data at any time should there be a food safety incident, so it’s important that your data be made readily available to the FDA within 24 hours of a formal request.

Most companies today aren’t capturing the level of data granularity across the food traceability list that FSMA 204 will require, and those companies will need to develop the necessary systems and processes to achieve compliance. This may mean needing to upgrade or invest in supply chain execution systems like WMS, TMS, ERP, OMS, etc. If you already use one or more of these systems, make sure to be in close communication with your vendor and systems integrator if you have one. Technology providers are aware of pending regulations, and most are ensuring their products can support full compliance by the July 2028 deadline.

It’s important to remember that system providers are only enablers of FSMA compliance. Capturing key data elements at the various nodes depends on how well you communicate with your supply chain partners to understand their methods of compliance and how thoroughly you upgrade your internal processes to ensure sufficient data capture and storage.

Food traceability data monitoring and recording

Recordkeeping is one of the pillar responsibilities of FSMA 204. Most supply chains we work with can trace at least one of their primary operational pain points back to poor data management, pointing to a key area that needs to receive early attention on the path to FSMA 204 compliance.

For items on the food traceability list, you’ll need the right tools to monitor and record all key data elements across each critical tracking event. Documentation companies could be required to maintain for two years include:

• Bills of lading: For shipping events, including details like the origin, destination, and date of shipment
• Invoices: Which can provide information on the sale and transfer of food products
• Purchase orders: To document the request and intended purchase of food items
• Receiving records: Which log the acceptance of food products at a location
• Traceability lot codes: Assigned to food items to track them through the supply chain
• Production records: Detailing the processing or transformation of food items

Key Steps to Achieve FSMA 204 Compliance

Implementing comprehensive traceability systems across a supply chain is a bigger initiative than you might think. Delaying preparations could result in non-compliance, either because you don’t have the systems in place or your workforce hasn’t had enough time to train and adapt to new processes.

Regulatory actions from non-compliance, as well as the added risk of food safety events, can put the health of your customer base, your brand reputation, and your profitability at risk. The FDA will also likely begin to implement penalties for companies that aren’t compliant. Penalties have not yet been defined but could range from monetary fines to removal from partner networks or even being shut down by the FDA for repeat issues.

While this isn’t a comprehensive list, take a look at just a few of the key steps you’ll need to take on your path to FSMA 204 compliance:

1. Assess applicability: Determine if your products are included on the FTL. The list covers a wide range of items, including soft cheeses, shell eggs, nut butters, fresh produce, and certain seafood.
2. Map supply chain: Identify all points within your supply chain where CTEs occur, such as harvesting, processing, packing, and shipping. Understanding these points is crucial for effective traceability.
3. Engage with supply chain partners: Collaborate with suppliers and distributors to ensure they understand and comply with traceability requirements, facilitating seamless data exchange.
4. Implement food traceability solutions: Develop or upgrade systems to capture and store KDEs for each CTE. This may involve adopting digital solutions that facilitate real-time data entry and retrieval.
5. Develop a traceability plan: Document procedures for maintaining records, including formats, responsibilities, and protocols for sharing information with the FDA and supply chain partners.
6. Train personnel: Ensure that all employees involved in the handling of FTL foods are trained on FSMA 204 requirements and the importance of accurate record-keeping.

Together, these steps could take months to years, depending on your starting point, so kicking off the project early is critical.

enVista’s Traceability Consultants Can Help

Becoming FSMA 204 compliant can be a big undertaking depending on how many partners and vendors you work with and how much visibility, data monitoring, and partner collaboration is already in place throughout your supply chain. The stakes are high, so don’t go it alone. Bring in the right partners and advisors to guide you throughout your assessments, selections, and implementations.

enVista’s traceability consultants are seasoned veterans in implementing traceability programs to suit various partner’s needs and are knowledgeable in GS1 standards, from national quick service restaurants to grocery chains.

We’ll not only make you FSMA 204 compliant by July 2028 we’ll make you the business your customers trust with their health above all the rest. Ready to get started? Contact us today.