What Is FSMA 204?
FSMA 204 is the FDA's Food Traceability Rule. It requires businesses that handle foods on the Food Traceability List to record key details each time those foods are received, shipped, or transformed, and to hand those records to the FDA within 24 hours when asked.
Who Must Comply With FSMA 204?
The rule applies to any business, in the U.S. or abroad, that manufactures, processes, packs, or holds a food on the FDA's Food Traceability List for U.S. consumption. That includes farms, packers, processors, distributors, warehouses, retailers, and restaurants.
Produce
Leafy greens, fresh herbs, cucumbers, tomatoes, peppers, melons, sprouts, tropical tree fruits, and fresh-cut fruits and vegetables.
Dairy and Eggs
Shell eggs and soft cheeses, including fresh soft and soft unripened cheeses.
Seafood
Fresh and frozen finfish, smoked finfish, crustaceans, and molluscan shellfish.
Prepared Foods
Nut butters and ready-to-eat deli salads, plus foods that contain a listed food in the same form.
This is a summary. Check the FDA's current Food Traceability List for exact definitions and exclusions.
Critical Tracking Events and Key Data Elements
FSMA 204 defines the events where records are required and the details to keep at each one. Most distributors and manufacturers deal mainly with receiving, shipping, and transformation.
| Critical Tracking Event | Who Records It | Example Key Data Elements |
|---|---|---|
| Harvesting | Farms | Commodity, quantity, harvest date, field or growing area |
| Cooling | Farms and coolers | Quantity, cooling location, cooling date |
| Initial Packing | Packers of raw agricultural commodities | Traceability lot code assigned, packing date and location |
| First Land-Based Receiving | First receiver of seafood from a fishing vessel | Traceability lot code, harvest area, landing date |
| Shipping | Anyone shipping a listed food | Lot code, quantity, ship-to and ship-from locations, ship date |
| Receiving | Anyone receiving a listed food | Lot code, quantity, previous source, receiving location, date |
| Transformation | Processors and manufacturers | Input lot codes, new lot code, quantity, date |
FSMA 204 Example: A Receiving Record
A foodservice distributor receives a pallet of shell eggs, a Food Traceability List food. These are the key data elements it records for the receiving event:
| Key Data Element | Recorded Value | Why It Matters |
|---|---|---|
| Traceability lot code | EG-0927-14 | Identifies exactly which lot was received |
| Traceability lot code source | Egg packer, Modesto, CA | Points the FDA to where the lot was created |
| Quantity and unit of measure | 30 cases of 15 dozen | Shows how much of the lot came in |
| Product description | Large white shell eggs, Grade A | Confirms which food was received |
| Immediate previous source | Supplier warehouse, Fresno, CA | The one step back in the chain |
| Receiving location | Distribution center, Ontario, CA | Where the lot now sits |
| Date received | Sep 29, 2026 | Places the event on the timeline |
| Reference document | BOL 448215 and PO-8821 | Links the record to the shipment paperwork |
When the distributor later ships these eggs, it records a shipping event with the same lot code, the quantity, and the customer location. Together, the receiving and shipping records give the FDA one step back and one step forward.
What Else FSMA 204 Requires
A Written Traceability Plan
Procedures for keeping records, identifying listed foods, assigning lot codes, and a point of contact. Farms that grow listed foods also need a farm map.
Records Within 24 Hours
Records must be provided within 24 hours of an FDA request, or a longer time the FDA agrees to.
Sortable Spreadsheet on Request
During an outbreak or recall, the FDA can require an electronic sortable spreadsheet of the relevant records.
Two Years of Records
Traceability records must be kept for two years and can be paper or electronic, as long as they can be produced on time.
How to Prepare for FSMA 204
-
1
Check what you handle. Compare your products and ingredients to the Food Traceability List and use the FDA's exemption tool.
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2
Map your tracking events. List each point where listed foods are received, transformed, and shipped in your operation.
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3
Capture lot codes everywhere. Require a lot code on every receipt, production run, and shipment of covered foods.
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4
Get data from suppliers. Ask suppliers to send lot codes and lot code sources on packaging, bills of lading, or advance ship notices.
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5
Write the traceability plan. Document procedures, lot code assignment, record locations, and a contact person.
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6
Practice producing records. Run a mock request and time how long it takes to build a sortable spreadsheet for one lot.
Common FSMA 204 Mistakes to Avoid
Waiting for the Deadline
Supplier data, system changes, and staff training take time. Gaps are easier to fix before enforcement begins.
Recording Your Own Lot Codes Only
Receiving records need the traceability lot code assigned upstream, not just an internal receiving number.
Breaking the Chain in Production
Transformation records must link input lots to the new lot. Without that link, a single bad ingredient can implicate everything made that day.
Keeping Records You Can't Sort
Paper files and scattered spreadsheets are hard to turn into a sortable spreadsheet within 24 hours.
Who Is Affected by FSMA 204?
Every link in the chain that handles a listed food has a role:
Food & Beverage Manufacturers
Processors and co-packers that transform listed foods and must link input and output lots.
Food Distributors
Wholesalers and foodservice distributors that receive and ship listed foods daily.
Ingredient Suppliers
Producers of cheeses, nut butters, and deli salads sold to manufacturers and retailers.
Food Banks and Meal Programs
Nonprofits that hold and distribute listed foods and need to act fast on recalls.
Preparing for FSMA 204 With Kechie ERP
Kechie Inventory Management records lot numbers, quantities, suppliers, locations, and dates on receipts, transfers, and shipments, many of the same details FSMA 204 key data elements call for. With Kechie Manufacturing, input lots are linked to the finished lots they produce, supporting transformation records. Lot history can be searched and reported from one system, and data entered once is available in every relevant module in real time.
Frequently Asked Questions
What is FSMA 204 in simple terms?
FSMA 204 is the FDA's Food Traceability Rule. Companies that handle certain higher-risk foods must record specific details each time those foods are received, shipped, or transformed, so the FDA can trace them quickly during an outbreak.
When do companies have to comply with FSMA 204?
The original compliance date was January 20, 2026. Congress directed the FDA not to enforce the rule before July 20, 2028, and the FDA has said it will follow that timeline.
Which foods are covered by FSMA 204?
Foods on the FDA's Food Traceability List, such as leafy greens, fresh herbs, cucumbers, tomatoes, peppers, melons, fresh-cut fruits and vegetables, shell eggs, soft cheeses, nut butters, finfish, crustaceans, molluscan shellfish, and ready-to-eat deli salads. Foods that contain a listed food as an ingredient in the same form are also covered.
What are critical tracking events?
Critical tracking events (CTEs) are the points where records must be kept: harvesting, cooling, initial packing, first land-based receiving of seafood, shipping, receiving, and transformation.
What are key data elements?
Key data elements (KDEs) are the specific details recorded at each critical tracking event, such as the traceability lot code, quantity, product description, locations, and dates.
What is a traceability lot code source?
It is the place where a traceability lot code was assigned, such as the packer or processor. Recording it lets the FDA go straight to the business that created the lot.
What is the 24-hour requirement?
Covered businesses must provide traceability records to the FDA within 24 hours of a request. During an outbreak, recall, or other public health threat, the FDA can require the information as an electronic sortable spreadsheet.
Are any businesses exempt from FSMA 204?
Yes. The rule includes full and partial exemptions, including certain small farms, certain small retail food establishments and restaurants, and some foods that receive a kill step. The FDA offers an online tool to check whether an exemption applies.
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Record lot codes on every receipt, production run, and shipment in one system.