Traceability Lot Code: FDA Rules, Exemptions, and Penalties

A traceability lot code is a unique alphanumeric identifier assigned to a specific batch of food so that every business handling it can track that batch from origin to point of sale. Under the FDA’s Food Traceability Rule at 21 CFR Part 1, Subpart S, companies that manufacture, process, pack, or hold certain higher-risk foods must assign these codes, keep them attached to the product through the supply chain, and record detailed information about each hand-off. The original compliance date was January 20, 2026, but Congress directed the FDA not to enforce the rule before July 20, 2028, and the FDA has stated it will comply with that directive.¹

The regulation defines a traceability lot code as a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the entity that created it.² Think of it as a serial number for a batch. No two different batches of the same product should share the same code, and once a code is assigned it must stay with the product through every subsequent handler until the food is transformed into something new. The FDA does not prescribe a specific format.

Every code is tied to a traceability lot code source, which is the physical location where the code was first assigned. That source must be identifiable through a location description with the business name, phone number, physical address, city, state, and zip code for domestic locations.³ Rather than repeating the full description in every record, a company can use a source reference such as an FDA food facility registration number or a web address where the FDA can look up the location.

Which Foods Trigger the Requirement

The rule does not apply to all food. It covers only items on the FDA’s Food Traceability List, plus any food that contains a listed food as an ingredient in the same form as it appears on the list (fresh leafy greens in a packaged salad, for example).⁴ The listed categories are:⁵

Fresh fruits and vegetables including leafy greens, herbs, cucumbers, peppers, melons, sprouts, and tomatoes
Soft and semi-soft cheeses such as ricotta, cottage cheese, queso fresco, brie, mozzarella, and feta, plus cheeses made from unpasteurized milk other than hard cheeses
Shell eggs from domesticated chickens
Nut butters, including all tree nut and peanut butters
Several categories of finfish, crustaceans, and mollusks, fresh, frozen, or smoked
Certain fresh tropical tree fruits
Ready-to-eat deli salads containing a listed food as an ingredient

The boundaries are narrow and worth reading carefully. Frozen, shelf-stable, and aseptically processed versions of the listed cheeses are excluded. Hard cheeses are excluded regardless of how they are made. Whole-head cabbage is not a leafy green under the rule, and soy or seed butters are not nut butters.

When You Must Assign a New Code

A new traceability lot code has to be created at exactly three points in a food’s life: initial packing of a raw agricultural commodity, first land-based receiving of seafood, and transformation.⁶ Outside of those moments, the existing code must remain intact. A distributor cannot swap in a new code just because a case of lettuce entered a new warehouse.

Initial Packing

When a raw agricultural commodity other than seafood from a fishing vessel is packed for the first time, the packer assigns the code. For fresh produce that usually happens at a packinghouse shortly after harvest. The initial packer becomes the traceability lot code source, and its facility address anchors the code for every downstream recipient.

First Land-Based Receiving

For seafood harvested from fishing vessels, the first land-based receiver assigns the code when the catch comes ashore. That receiver records the species or market name, the harvest date range, the fishing location, the landing date, and the quantity received.⁷ The fishing location must be identified using a recognized standard such as the National Marine Fisheries Service Ocean Geographic Code or the UN FAO Major Fishing Area list.

Transformation

Transformation happens when a food is manufactured, processed, or otherwise changed in a way that produces a new product on the Food Traceability List. Chopping whole romaine into a bagged mix counts. Relabeling or repacking can also count. The entity performing the transformation assigns a new code to the output and links it back in its records to the codes of the input ingredients, so the FDA can trace backward through the transformation to the original source.

What Has to Travel With the Code

The rule is built around Critical Tracking Events (CTEs) and Key Data Elements (KDEs). A CTE is a point in the supply chain where something happens to the food that triggers a new set of records. A KDE is a specific data point recorded at that event. There are seven CTEs: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation.¹

The specific KDEs vary by event, but the pattern is consistent. At a receiving event a company records the traceability lot code, product description, quantity and unit of measure, the location where the food was received, information identifying the immediate previous source, and a reference document type and number such as a bill of lading or purchase order. The lot code source or its reference must also be linked. Shipping events record the lot code, product description, quantity, ship-from and ship-to locations, and the shipment date. In each case the requirement is the same in shape: identify the product, identify where it is, identify when the event happened, and tie it all to the traceability lot code.

The Written Traceability Plan

Every covered entity must maintain a written traceability plan describing how it complies with the rule. The plan must include:⁸

Procedures for maintaining traceability records, including format and storage location
Procedures for identifying which foods you handle are on the Food Traceability List
Procedures for assigning traceability lot codes, if applicable
A named point of contact who can answer questions about the plan and records
For farms, a map showing the location, name, and geographic coordinates of each field, growing area, or aquaculture container where covered foods are produced

The plan must be updated when practices change, and the previous version has to be kept for two years.

The 24-Hour Records Request

When the FDA requests traceability records, you have 24 hours to provide them, unless the FDA agrees to a longer timeframe. Records must come with whatever a reviewer needs to interpret them, including coding glossaries, abbreviation keys, and explanations of how your records map to the rule’s requirements.⁹

During an outbreak, recall, or other public health threat, the FDA can request an electronic sortable spreadsheet with the relevant traceability information for specific foods, date ranges, or lot codes, and that spreadsheet is also due within 24 hours. Small farms with average annual produce sales or holdings of no more than $250,000 (adjusted for inflation from a 2020 baseline) can provide the information in a different format.⁹ Records must be retained for two years from the date you created or obtained them.¹⁰

Who Is Exempt or Partially Exempt

Not every business handling a listed food carries the full weight of the rule.

Small Operations

Produce farms with average annual sales and holdings of $25,000 or less (adjusted for inflation from a 2020 baseline) are fully exempt. Retail food establishments and restaurants with average annual food sales of $250,000 or less (same inflation-adjusted baseline) are also exempt. Both thresholds run on a rolling three-year average.¹¹

Direct Farm Sales

When a retail food establishment or restaurant buys food directly from the farm that produced it, the buyer only needs to keep a record of the farm’s name and address for 180 days. This is a partial exemption for the buyer. The farm itself still has to comply with whatever CTEs apply to its operations. A similar partial exemption applies to farm-to-school programs.¹¹

Kill Step

If a listed food has already undergone a kill step, meaning lethality processing such as pasteurization or retort cooking that significantly reduces pathogens, downstream handlers do not need to keep Subpart S records for that food. A distributor that applies a kill step to a listed food is exempt from transformation and shipping records for the output but still has to keep receiving records and document the kill step. If a food is merely destined for a kill step further down the chain, the current handler can claim the exemption only with a signed, dated written agreement from its supplier confirming that the kill step will occur before the food reaches a consumer, restaurant, or retail establishment. Those agreements must be renewed at least every three years.

Commingled Raw Agricultural Commodities

A partial exemption exists for raw agricultural commodities that will be combined after harvest with commodities from different farms or different fishing vessels. Recipients have reduced recordkeeping obligations, but only if a written agreement in the supply chain confirms the commingling. The exemption does not apply to produce covered by the FDA’s Produce Safety Rule. Registered food facilities claiming this exemption still have to keep basic one-up, one-back records identifying their immediate supplier and buyer for two years.¹¹

Retailers and Restaurants Receiving From Exempt Suppliers

A non-exempt retail food establishment or restaurant that receives a listed food from a supplier that was itself exempt, with no traceability lot code assigned yet, is not required to assign one. This carve-out applies only to retailers and restaurants. Other entities in the supply chain receiving food from an exempt supplier must assign a code themselves.¹

Penalties for Non-Compliance

Violating the traceability recordkeeping requirements is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act. A first offense can bring up to one year of imprisonment, a fine of up to $1,000, or both. Repeat offenses or violations committed with intent to defraud raise the exposure to up to three years of imprisonment and a fine of up to $10,000.¹² Imported food carries an additional risk: the FDA can refuse admission to any article of food where the traceability recordkeeping requirements have not been met.⁴ Farms are the one exception; recordkeeping violations by a farm are not treated as prohibited acts under this provision.

The practical cost of poor traceability often exceeds the statutory penalty. If the FDA cannot trace a contaminated product back through your facility quickly, it may cast a wider net during a recall, pulling in product that was never actually affected. An over-inclusive recall can cost a business far more than any fine on the books.

1
U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
2
eCFR. 21 CFR 1.1310
3
Food and Drug Administration. Requirements for Additional Traceability Records for Certain Foods – What You Need to Know About the FDA Regulation
4
eCFR. 21 CFR Part 1 Subpart S – Additional Traceability Records for Certain Foods
5
U.S. Food and Drug Administration. Food Traceability List
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eCFR. 21 CFR 1.1320
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eCFR. 21 CFR 1.1335
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eCFR. 21 CFR 1.1315
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eCFR. 21 CFR 1.1455
10
Food and Drug Administration. What Records Do I Need to Keep for the Food Traceability Rule
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U.S. Food and Drug Administration. Frequently Asked Questions – FSMA Food Traceability Rule
12
Office of the Law Revision Counsel. 21 USC Chapter 9, Subchapter III – Prohibited Acts and Penalties