Every year, one in six people get sick from a foodborne illness. As a result, 128,000 will be hospitalized. The goal of the FDA is to bring both of these numbers to zero. Until that happens, much of their efforts are focused on understanding how outbreaks happen, where they come from, and what must change to prevent future harm.
This is where the FDA’s traceback program comes in. The program is designed to follow contamination from where it is discovered (often once a consumer has been exposed) all the way back to the source. This isn't just an academic exercise; finding the source of the problem can prevent further harm from the outbreak and even prevent future ones.
It's important for food manufacturers, processors, packagers, and handlers to know how this process works because each link in the chain is integral to the traceability of an outbreak (and could face major penalties if they fail to do their due diligence).
What is the FDA traceback program?
The Food and Drug Administration’s traceback program is how the agency identifies where a foodborne illness originated, how and why it happened, what needs to be done about it, and how to prevent similar future events. The process generally begins with the endpoint (sick consumers), working its way backward to the source, and then forward from there to a solution.
The steps of the process can be summarized as:
- Along with the CDC, diagnosing and interviewing patients
- Identifying common points of exposure and investigating them for contamination
- Following the transportation and distribution networks to processors and producers
- Identifying and investigating food sources, including sampling to find the true source of the specific pathogens involved
- Presenting information and warnings to consumers, up to and including recalls and stop-sales
- Determining appropriate corrective actions and reviewing existing rules and regulations for potential necessary changes
How does the FDA traceback program work?
Investigating an illness outbreak might sound simple when reduced to high-level bullet points. In actuality, it’s a complex set of investigative techniques, all being performed simultaneously, many using state-of-the-art science and technology.
The first step is to figure out that an outbreak is happening. Consider how many people there are in the U.S. (about 330 million in 2024) and how many hospitals, clinics, urgent care centers, and pharmacies serve them, to say nothing of the large percentage of people who may not seek treatment for an illness unless it's extremely serious.
Public health officials comb through terabytes of data daily with strict reporting criteria for specific diagnoses and symptoms to identify when a spike in foodborne illness occurs.
Once an outbreak is suspected, it's a race against the clock to figure out exactly what's happening. The CDC and FDA send agents to identified locations to try to identify commonalities and intersections where the spread may have happened. Meanwhile, samples of the infection are rushed to labs to be sequenced and identified to pinpoint the exact strain causing the outbreak.
As commonalities emerge, agents are dispatched to restaurants, grocery stores, farmers' markets, and any other points where patients may have crossed paths with contaminated food, taking samples and looking for contaminated products that match the outbreak.
At this point in the process, companies begin to get involved. When contaminated food is discovered, the point of discovery is thoroughly investigated to ensure the outbreak didn't start there. These establishments must produce records showing where every single food item sold or served came from. This is why it's so critical for food businesses to maintain traceability documentation and follow good traceability practices: The FDA often relies on these records to identify the ultimate source of contamination.
When they finally reach that source, the FDA thoroughly reviews food safety documentation, investigates the facility, and documents any potential breaks in procedure. While the goal is to protect public health, facilities that are found to be deficient can risk significant costs: penalties for improper food handling, costly recalls and stops in production, and potential lawsuits from affected consumers can all add up to tens or even hundreds of millions of dollars in costs.
What can food producers or handlers do?
The number one responsibility of food manufacturers and other stakeholders is to follow relevant food safety and traceability rules and regulations to the letter. Of specific importance are:
- Maintaining, following, and training on a facility-specific food safety plan.
- Ensuring best practices for traceability and supply chain management, including regular training.
- Keeping detailed records on all food that moves through a facility, with sources, dates, times, quantities, and specific details clearly recorded.
- Regularly auditing food safety and traceability systems to ensure everything is working.
- Identifying potential contamination points and risks, and taking corrective actions with full documentation as required.
- Cooperating fully and promptly with FDA investigators looking for the source of an outbreak.
After the Outbreak
The conclusion of an investigation may feel like an ending, but it's really just the beginning of the next phase: public awareness and future prevention. The FDA will release its findings to the public, warning them to avoid certain foods that may have been contaminated.
Of more relevance to food manufacturers, the FDA will also issue a report of its findings on how the contamination occurred in the first place. In rare cases, this may just be a matter of bad luck where no existing process could have prevented the outbreak. That's incredibly unlikely, though, and it’s more common that specific code violations were responsible.
The facilities in question will be required to take corrective action and may be shut down until they do. Facilities along the supply chain will likely also be told to update their processes. In the most extreme cases, entire supply chains may be paused until the problem is resolved or new rules are formulated to prevent the issues from recurring.
Ultimately, the goal is not to punish. The goal is to ensure the public food supply remains safe and consumers trust they can buy food knowing it's safe to eat. Food producers are crucial to building that trust, and it's important they adopt a food safety culture of collaboration, innovation, and transparency to maintain it.
