Food Traceability Workflow | GMPify Training

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Food Traceability - Tracking Listed Foods One Step Back and One Step Forward

The Food Traceability Rule requires anyone who manufactures, processes, packs, or holds foods on the FDA Food Traceability List to keep additional records at defined critical tracking events and to pass key data elements to the next party in the supply chain. A traceability lot code links the records, and the facility must be able to give FDA an electronic sortable spreadsheet within 24 hours during an outbreak or recall. This map follows the pathway from scoping and planning through lot code assignment, record capture, sharing, and readiness.

21 CFR Part 1 Subpart S · FSMA Section 204 · Food Traceability List

21 CFR 1 Subpart S

FSMA Section 204

Traceability Lot Code

Food Traceability List

The foods for which additional traceability records are required, including foods that contain a listed food in its listed form.

Basis: Scope of the rule

Critical Tracking Event

A supply-chain event, such as harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, or transformation.

Basis: Where records are made

Key Data Element

Information tied to a critical tracking event that must be maintained and, in some cases, provided to the next party.

Basis: What is recorded

Traceability Lot Code

A descriptor, often alphanumeric, that uniquely identifies a traceability lot and links the records.

Basis: Assigned at set events

Phase 1

Scope and Plan

1Determine whether you handle listed foods

Foods you make, process, pack, or hold compared to the Food Traceability List, including listed foods used as ingredients in listed form.

21 CFR 1.1300 · 1.1310

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2Check exemptions and partial exemptions

Size, kill step, USDA jurisdiction, and other exemptions assessed and the basis documented, with any required records kept.

21 CFR 1.1305

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3Write the traceability plan

Record procedures and location, how listed foods are identified, TLC assignment, a point of contact, and a farm map where applicable.

21 CFR 1.1315

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4Map your critical tracking events

Which events apply to your role, so each knows which key data elements it must capture and pass on.

21 CFR 1.1325 to 1.1350

Phase 2

Lot Codes and Record Capture

Does this event require a new traceability lot code?

YES → Assign a new TLC NO → Carry the existing TLC forward

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5Assign lot codes at the required events

A TLC is assigned at initial packing of a raw agricultural commodity, first land-based receiving of fish, and transformation.

21 CFR 1.1320

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6Record the key data elements

For each applicable critical tracking event, the required elements are captured and tied to the TLC.

21 CFR 1.1325 to 1.1350

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7Link inputs and outputs at transformation

Input TLCs and quantities recorded alongside the new output TLC, so lots can be traced through the process.

21 CFR 1.1350

Phase 3

Sharing and Maintaining Records

8Provide key data elements when shipping

Required information sent to the immediate subsequent recipient with the shipment, with a reference document.

21 CFR 1.1340

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9Record the receipt of food

TLC, quantity, product description, immediate previous source, receiving location, and date captured when food arrives.

21 CFR 1.1345

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10Maintain records

Records legible, protected from loss, and kept for 2 years from creation or receipt.

21 CFR 1.1455(a) · (d)

Phase 4

Readiness and Review

11Test 24-hour retrieval

Records, with the information needed to understand them, can be provided to FDA within 24 hours of a request.

21 CFR 1.1455(c)

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12Prepare the electronic sortable spreadsheet

A process to produce a sortable spreadsheet for outbreak or recall requests, unless an exception applies.

21 CFR 1.1455(c)(3)

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13Update the plan as things change

Plan revised as operations, partners, or the Food Traceability List change, with the prior plan kept for 2 years.

21 CFR 1.1315 · 1.1465

Critical Tracking Events (Overview)

Origin Events

Harvesting, cooling, initial packing, and first land-based receiving of fish, where lots are created and the first records are made.

21 CFR 1.1325 to 1.1335

Movement Events

Shipping, where key data elements go to the next recipient, and receiving, where the previous source and lot are recorded.

21 CFR 1.1340 · 1.1345

Transformation

A new lot is created when food is changed, with the input lots and the new output lot linked in the records.

21 CFR 1.1350

Outbreak or Recall Record Request (Overview)

Receive and scope The request identifies the foods and date ranges, or specific lot codes, and the time FDA expects the records.

Locate the records Records are found, wherever stored, including those held by another entity that keeps them for you.

Produce within 24 hours Records and the information needed to understand them reach FDA within 24 hours, or a reasonable time FDA agrees to.

Provide the spreadsheet An electronic sortable spreadsheet of the relevant records is supplied, unless the entity qualifies for an exception.

Key Traceability Outputs (Overview)

Traceability plan Written plan covering procedures, listed foods, lot code assignment, a point of contact, and a farm map where needed.

Key data element records Records for each critical tracking event, tied to a traceability lot code.

Lot code assignment records Evidence of when and where each traceability lot code was assigned.

Electronic sortable spreadsheet A ready method to provide relevant records to FDA in a sortable format within 24 hours.

Traceability Quality Elements

Clear Scope Listed foods, exemptions, and the basis for each decision are documented and reviewed.

Documented Plan A written plan that meets the required contents and is kept current.

Consistent Lot Codes Lot codes assigned at the right events, in a consistent format, and never at events that should not create a lot.

Complete Key Data Elements Every required element captured for each event, not just the ones that are convenient.

Partner Data Exchange Reliable, timely exchange of key data elements with suppliers and customers.

Record Integrity Records legible, protected from loss, and linked by lot so the chain does not break.

24-Hour Retrieval Practiced ability to locate and produce records and a sortable spreadsheet within 24 hours.

Change Management Plan and records updated when operations, partners, or the Food Traceability List change.

Never do this

Create a new lot code when you only ship food. Combine lots without recording the link at transformation. Assume a partner has your records without confirming you can get them within 24 hours. Treat an exemption as permanent without documenting the basis. Hold records in formats that cannot be sorted or searched.

KDEs, CTEs, and TLCs

Critical tracking events are the moments in the supply chain that create records. Key data elements are the specific information recorded at each event. The traceability lot code is the identifier that ties the records together from one event to the next.

Exemptions and timing

Examples include produce farms at or below $25,000 in average annual sales, small retail and restaurants at or below $250,000, and foods receiving a kill step with records. FDA originally set a January 2026 compliance date, and Congress has directed FDA not to enforce before 20 July 2028, so check FDA for current status.

Key regulations

21 CFR Part 1 Subpart S, 1.1300 to 1.1465. FSMA Section 204. 21 CFR 1.1315 - traceability plan. 21 CFR 1.1320 - lot code assignment. 21 CFR 1.1325 to 1.1350 - critical tracking events and key data elements. 21 CFR 1.1455 - records maintenance and availability.