The FDA doesn’t guess when a foodborne illness breaks out. It doesn’t wait weeks to trace back where contaminated lettuce came from. Instead, it uses something called the Traceability Lot Code - or TLC - to find the exact source of a problem in hours, not days. This system, born from the Food Safety Modernization Act (FSMA) in 2022, changed how food gets tracked from farm to table. And it’s not just paperwork. It’s a lifeline.
What Is a Traceability Lot Code (TLC)?
A TLC is a unique code - usually a mix of letters and numbers - assigned to a batch of food at key moments in its journey. Think of it like a birth certificate for a shipment of spinach or a carton of eggs. Unlike old-school lot numbers that companies used internally for quality checks, a TLC must be passed along the entire supply chain. When a foodborne illness hits, the FDA can ask for that code and instantly see every stop the product made: where it was packed, who shipped it, where it was stored, and who sold it.
The FDA doesn’t let companies pick any code they want. The code must be unique within the food system, not just inside one company’s database. That means if two farms use the same code, it’s a problem. The code must also stay the same unless the food changes form - like when tomatoes are chopped into a salad mix. Then, the new processor creates a new TLC but must link it back to the original.
Where and When Is the TLC Assigned?
The rule is strict about when and where this code gets applied. There are only three points in the supply chain where a TLC must be assigned:
- When raw agricultural commodities - like leafy greens or onions - are first packed (except seafood from fishing vessels).
- When seafood from fishing vessels reaches land for the first time.
- When food is transformed - meaning it’s chopped, cooked, mixed, or repackaged into a new product.
This is a big shift. Before, companies might assign lot codes at every step - packing, shipping, warehousing - just to keep internal tabs. Now, the TLC only gets added at these three critical points. That cuts down on clutter and confusion. It also means if a problem shows up, investigators don’t have to dig through dozens of codes. They follow one clear trail.
What Data Is Linked to the TLC?
The TLC itself is just the starting point. It’s tied to seven other key data elements - or KDEs - that paint the full picture of the product’s journey:
- The TLC source (where and when it was assigned)
- Product description (what the food is)
- Quantity and unit of measure (how much was shipped)
- Transaction information (who sent it, who received it, when)
- Location of each handling event
- Time stamps for each transfer
- Any changes made to the product (like blending or repackaging)
When the FDA requests records during an outbreak, companies have 24 hours to deliver all of this data. It doesn’t have to be on a fancy system - paper records are still allowed. But if you use digital records, they must be sortable and exportable in common formats like CSV. No locked-down software. No proprietary formats. The FDA needs to be able to read it.
Which Foods Are Covered?
Not everything is tracked. The FDA drew a line with the Food Traceability List (FTL). This list includes high-risk foods that have caused the most outbreaks. Right now, it covers:
- Leafy greens (lettuce, spinach, kale)
- Tomatoes
- Onions
- Fresh-cut fruits and vegetables
- Cheeses (especially soft cheeses)
- Eggs
- Nut butters
- Certain seafood like shrimp, crab, and mollusks
These foods make up about 15% of the U.S. food supply by volume - but they’re responsible for nearly half of all foodborne illnesses. The FDA chose them based on outbreak data from the last 15 years. Melons, for example, are not on the list yet - even though they’ve been linked to outbreaks - because the agency is still reviewing them. Critics say that’s a gap. The FDA says it’s just the first step.
How Is This Different from Old Systems?
Before the TLC, companies used their own lot codes. Some followed the Produce Traceability Initiative (PTI), which used GS1 barcodes. But PTI was voluntary. If a company didn’t use it, there was no penalty. The FDA couldn’t force them to share data.
The TLC changes that. It’s mandatory for FTL foods. And unlike the Drug Supply Chain Security Act (DSCSA) for medicines - which tracks every single pill - the TLC works at the lot level. One code for a truckload of spinach, not each individual bag. That keeps it practical for bulk food.
One major concern from industry? Tandem coding. Companies worried they’d have to keep both their old internal codes and the new TLC. The FDA heard that. In response, they made it clear: your existing code can be your TLC - if it meets the rules. No need for double work. Just make sure it’s unique, traceable, and passed along.
How Fast Does It Work?
Before TLC, tracing a contaminated product could take weeks. Investigators had to call dozens of suppliers, dig through paper logs, and guess where contamination happened. Now, with digital records and a single code, the FDA can trace back to the source in under 24 hours.
That speed saves lives. The FDA estimates that better traceability could cut foodborne illness outbreaks by 20-30%. In pilot programs from 2019 to 2021, they saw outbreaks resolved 60% faster. One case in 2021 showed a single contaminated batch of romaine lettuce being traced back to a farm in California within 17 hours. Without the TLC, it would have taken over 10 days.
Who Has to Comply - and When?
The rule applies to any business that manufactures, processes, packs, or holds food on the FTL. That’s about 15,000 facilities across the U.S. - from small farms to giant food processors.
Initial compliance was set for January 20, 2026. But in September 2023, the FDA proposed pushing that deadline to July 20, 2028. Why? Because many companies, especially small ones, said they needed more time. The FDA agreed. This extension gives businesses nearly two extra years to build systems, train staff, and update software.
Still, 78% of produce companies surveyed in early 2023 had already made changes. Many upgraded their ERP systems. Others bought traceability software. A few still use spreadsheets - but they’re risky. The FDA doesn’t care how you do it, as long as the data is accurate and accessible.
What Happens If You Don’t Comply?
The FDA doesn’t have a fine system like the EPA. Instead, they use enforcement tools: warning letters, import alerts, and product seizures. If you can’t produce TLC records during an investigation, your product could be pulled from shelves. Retailers like Walmart and Kroger already require TLC compliance from suppliers. If you don’t meet the standard, you lose contracts.
For small farms, the FDA offers help. The Traceability Assistance Program launched in January 2023 gives free technical support, templates, and training. The 2023 Farm Bill also set aside $25 million to help small businesses get ready.
What’s Next?
The system isn’t finished. The FDA is working on standardized data formats for KDEs - expected in mid-2024. That means every company will eventually send data in the same way, making it easier to compare and analyze. Blockchain and IoT sensors are being tested too. Imagine a sensor on a pallet of spinach that logs temperature and location in real time - and links that data to the TLC.
Internationally, the EU is launching its own Digital Product Passport. It’s similar, but not the same. The FDA is talking with European regulators to align standards. That’s important - because food doesn’t stop at borders.
One thing’s clear: the TLC isn’t perfect. But it’s the most powerful tool the U.S. has ever had to stop foodborne illness before it spreads. It’s not about control. It’s about safety. And for families eating dinner, that’s everything.
What foods are covered by the FDA’s Traceability Lot Code system?
The FDA’s Traceability Lot Code system applies to foods on the Food Traceability List (FTL), which includes leafy greens, tomatoes, onions, fresh-cut fruits and vegetables, cheeses, eggs, nut butters, and certain seafood like shrimp and mollusks. These are high-risk foods linked to the most frequent outbreaks. Melons and other items are under review for future inclusion.
Do I need a new lot code if I already have one?
No, you don’t need a new code if your existing lot code meets the FDA’s requirements. The FDA allows companies to use their current internal lot codes as the Traceability Lot Code (TLC), as long as it’s unique across the supply chain and properly passed along with each transaction. You just need to document how you generate and track it.
How does the FDA get the traceability data during an outbreak?
When the FDA investigates a foodborne illness, they issue a formal request for records. Companies must provide all Key Data Elements (KDEs) linked to the Traceability Lot Code within 24 hours. This includes where the product was handled, who received it, when, and in what quantity. Records can be paper or digital - but digital ones must be exportable in standard formats like CSV.
Is blockchain required for TLC compliance?
No, blockchain is not required. The FDA does not mandate any specific technology. Companies can use ERP systems, specialized software, spreadsheets, or even paper records - as long as they can produce the required data quickly. Some large retailers like Walmart use blockchain voluntarily, but it’s not part of the FDA’s rule.
What happens if a company can’t provide TLC records?
If a company fails to provide TLC records during an FDA investigation, the agency can issue warning letters, place import alerts on their products, or seize contaminated shipments. Retailers and distributors may also cut ties with non-compliant suppliers. For small businesses, the FDA offers free assistance, but compliance is still mandatory for all entities handling FTL foods.