The Role of Food Traceability
The Food Traceability Rule requires organizations that manufacture, process, pack, or hold certain ‘high-risk’ foods to carry out additional traceability recordkeeping. These additional responsibilities are being enforced so that the FDA can keep trace foods more effectively and respond to foodborne illness outbreaks in a more efficient and safe manner.
FSMA 204 thus requires a significant amount of data be stored and maintained for a wide range of foods in the supply chain. The impacted foods are named on the Food Traceability List and include such foods as fresh and fresh-cut fruit and vegetables, soft cheeses, nut butters, fish and seafood, shell eggs, and ready-to-eat deli salads.
The traceability data (the key data elements or KDEs) include the name of each food product, a description of the food, the packaging and phone number, must be stored for each food on the FTL. These must be tracked and recorded at a number of crucial points along a food’s supply chain. You may be required to track data at the harvesting stage, at the cooling stage, or at certain points in shipping and receiving. There are seven critical points in total.
One of the most important KDEs is a food’s Traceability Lot Code (TLC). This is a unique identifier that is like a serial number or ID for food. It is used to uniquely identify and track a specific batch of food through the supply chain.

What is Food Traceability Software?
The additional traceability recordkeeping requirements laid out by FSMA 204 equate to a huge amount of data. And keeping track of all of this data presents a significant challenge for many food businesses. Especially as all data is expected to be kept for a minimum of two years.
The FDA does not specify how suppliers must provide this information. It is up to the food business to create a system to store the specific data required by FSMA 204, and to assign traceability lot codes where applicable. While the FDA does not specifically state that records should be stored in digital form (data can be present physically if desired) for many, the obvious answer is to integrate with food traceability software.
Food traceability software is a type of data management software that is used to track granular information about a food at every stage of the supply chain from farm to fork. Data captured include its genealogy and handling throughout the entire food supply chain.
Food Traceability Software allows you to easily input the required information for each food and track it through your operations. In the event of a recall, you can easily see where a batch of food was used in your food products/recipes and identify which products need to be pulled to prevent further contamination.
Alternatively, if the source of the outbreak is unknown, food traceability software allows you to review the foods that were associated with an outbreak and trace each back to their origins to identify the root cause.

Make Compliance Easier With Food Traceability Software
The functions described above would be incredibly difficult to perform in a timely manner if your records were being kept solely in paper form, especially when considering the FDA’s requirement to provide data within 24 hours of an outbreak.
Unorganised digital copies would also present a significant burden on resources, if each document had to be individually searched to find the required information.
Integrating with a food traceability software system would allow minimal disruption to your current operations. While organizations will need to input certain information into the software, it is a relatively painless procedure and will help you to comply with the new rule in the first instance. But it will also protect you down the line when food needs to be recalled and the FDA requires you to provide critical data within a day’s notice.
Noncompliance within the timeframe that the FDA considers reasonable can result in a civil or criminal action in federal court. Non-compliance with FSMA is considered committing a prohibited act. In addition, imported foods that do not have the required traceability data may be refused entry into the United States.
Investing in food traceability software is a no-brainer for organizations that are affected by FSMA 204. Food traceability software will help you to easily comply with the rule, keep your food supply chain safe and streamline operations, while future-proofing your business and preventing unnecessary difficulties down the line.
Need Help Complying With FSMA 204?
If you are part of an organization that is impacted by FSMA 204 and need help to comply, we are here to help.
We can answer any questions you may have about the Food Traceability Rule, starting with whether or not you need to comply and what you need to get ready for the July 20th 2028 compliance date.
Book a consultation today and talk to a member of our FSMA 204 Compliance Support team.