How to Implement the FSMA 204 Traceability Rule

Critical Tracking Events (CTEs) are key points in your supply chain where products undergo significant changes. This can be events such as harvesting, cooling, packing, transforming, shipping, and receiving.

To comply with FSMA 204, start by identifying and mapping out every CTE in your operations. This step is crucial because each CTE will require specific data to be collected, ensuring that you have a comprehensive view of your product’s journey. Note that CTEs may differ depending on the commodity. 

Key Data Elements (KDEs) are essential pieces of information that need to be recorded at each CTE. These can include batch numbers, production dates, locations, and quantities.

Ensuring your systems can capture and store KDEs accurately is vital for effective traceability. The more precise and detailed your data collection, the better equipped you’ll be to trace any product through your supply chain (and the better your FSMA 204 implementation will be).

Traceability Lot Codes (TLCs) are identifiers that track products from origin to sale. According to the rule, TLCs must be sufficiently unique so as to uniquely identify a particular batch or lot of food at any point in the supply chain.

This rule ensures that the TLC can be linked to specific production, processing, or shipping information, enabling effective tracking of the food item.

The level of granularity you choose for TLCs – whether at the lot, batch, or item level – will determine how precisely you can trace your products. Lot-level TLCs cover broader groups, while item-level TLCs offer the highest precision. Deciding on the appropriate level is key to balancing traceability needs with operational complexity.

Once you have identified your KDEs, CTEs, and designed protocols for TLC generation you will want to document these within a required Traceability Plan.

This plan should also include a description of your procedures to identify the foods subject to the Food Traceability List (FTL), key contacts for any questions regarding your traceability plan and records, and how you intend to maintain the records required by the 204 Rule. Additionally, it should outline how you will maintain the records required by the FSMA 204 Rule.

Farms must meet extra record-keeping requirements, such as identifying and providing coordinates for growing areas. Aquaculture farms must also include the identification and coordinates of their containers.

While there is no technology recommendation – you can comply by maintaining paper records – the reality is that seamless data integration is critical for a successful FSMA 204 implementation. As such, it’s key to know that you likely may already have systems which independently host portions of the data required for compliance.

The challenge, however, lies in bringing this data together under one system to enable one-click, single-source traceability. As part of an industry-wide commercial ecosystem, your systems also must communicate and share data across the entire supply chain.  So it’s important to invest in traceability software that fulfills the following criteria: scalable, interoperable, and integrable. 

Keep your records up-to-date and ready for FDA requests. Conduct regular audits to ensure compliance. The FDA can request your traceability records at any time, and you must be prepared to provide them within 24 hours.

To stay ready, keep your records organized. Make sure you regularly audit your traceability systems, and identify and fix any gaps in compliance. This will ensure your business can respond quickly to FDA requests.