Traceability: FSMA 204 vs. The Produce Industry

Jennifer McEntire (Fresh Produce)
Contributing Writer

Traceability is a tool, and as such, it is not an answer or the solution; it’s a means of getting there. Companies often state that they wish to have greater traceability. It is crucial that companies identify what they hope to achieve with traceability because understanding the goal can guide them in how best to use traceability. As a tool, traceability can be an effective marketing technique or a way to authenticate a product. Companies can also use traceability to increase supply chain efficiency or facilitate simpler and easier recalls. Many companies are examining traceability as a way to improve in all of these areas. The technology exists to support all of these goals, but it is helpful for companies to clarify the goals first before attempting to implement traceability. 

Regulatory Compliance with FSMA 204

When regulators such as the Food and Drug Administration (FDA) step in and create regulations around traceability, it can be beneficial for compliance to consider why regulators are requiring it. Traceability is a way to clarify the supply chain in order to increase the speed of recalls, which can limit the opportunities for people to consume contaminated foods. It also speeds up the ability to trace back when an outbreak has already occurred, so there is clarity around which food caused illness, enabling manufacturers to target the recall more precisely to remove the appropriate foods and omit safe products from a recall. Due to current FDA requirements, the industry has implemented one up/one down (or one forward/one back) recordkeeping and has for many years. Because of these existing regulations, many in the food industry are asking why there is a need for FSMA 204. 

The Difference Between Recalls and Tracebacks

Both recalls and tracebacks use traceability records to achieve a goal, but each process is vastly different. 

Recalls are:

  • Industry-led

  • Based on an identified food

  • Adding “buffers” is a protective measure

Tracebacks are

  • FDA-led

  • Food has not yet been identified

  • Adding “buffers” can cause confusion

The goal of a traceback is to connect the dots and hopefully answer the questions that often begin with an outbreak investigation process. The outbreak investigation may start with people who see a doctor after becoming ill. The doctor may order a sample analysis. When there are multiple reports, the Centers for Disease Control (CDC) may get involved and will then examine if there is evidence of an outbreak and will work with state and local health departments to determine what affected people have been eating. The FDA then focuses on common food sources to try to determine supply chain commonalities between the food affected people consumed. It is easier to test the product if it is shelf-stable and if people could identify exactly which food made them ill, allowing regulators to tap into traceability records immediately. But often, the product is perishable, and so tracebacks are usually the path regulators and manufacturers must take. 

Solving the Complexity Problem with FSMA 204

Tracebacks can become highly complicated when trying to sort through today’s complex supply chain, crossing industries and borders and spanning days, weeks, or even months. The traceability lot code, proposed by FDA to implement FSMA 204 is meant to provide regulators and manufacturers with critical source information that lets tracebacks skip tracking events that are not relevant to answering the contamination question. 

The Proposed Rule from the FDA

The proposed rule does not apply to all foods but FDA has designated a long list of foods that they have deemed as requiring additional recordkeeping. There is a significant amount of information that the FDA is proposing growers, manufacturers, and other food handlers capture through critical tracking events (CTEs) and key data elements (KDEs). Currently, there is existing technology that could handle this increased quantity of data. However, many in the industry are concerned that gathering this vast amount of data may not be the most useful way to solve the problem.

Preparing for the Implementation of FSMA 204

Many food industry members across the supply chain are wondering how to prepare for possible changes that may result from the full implementation of FSMA 204. At this time, it may not be prudent to overhaul systems completely. The final rule is expected in November 2022. However, the industry can expect that lot codes will be critical. It is a good idea to be proactive about identifying and aligning on what problems manufacturers and trading partners are trying to solve. The technology is there to adapt to the additional data gathering proposed by FSMA 204, but the processes may not be. 

What Happens Next with FSMA 204

The supply chain for many foods continues to grow and evolve in complexity and scale. Traceability is undoubtedly a critical tool, but there may be a more minimalist path to the common goal that manufacturers and regulators share of providing safe products to customers. It is also essential to identify how companies can communicate through the complex supply chain. When the supply chain is global, global standards can ensure that everyone involved speaks the same regulatory language. 

Further Traceability Resources for Food Manufacturers

Applying the same technology across the board may be ineffective or cumbersome for some companies that require greater or fewer functions. The food industry has many resources already available to help manufacturers and suppliers proactively facilitate and increase traceability in their supply chains, such as the Produce Traceability Initiative and the Leafy Greens Traceability Pilot. Finally, implementing a software platform that is customizable and can track data and compliance issues in real-time is key.