FSMA Section 204 Food Traceability Guide

What Is FSMA Section 204?

Section 204 of the FDA Food Safety Modernization Act (FSMA) directed the FDA to establish additional traceability recordkeeping requirements for foods the agency designated as "high-risk." The resulting rule — officially titled the "Requirements for Additional Traceability Records for Certain Foods" (21 CFR Part 1, Subpart S) — was finalized in November 2022.

The rule builds on existing recordkeeping obligations by requiring entities throughout the food supply chain to maintain standardized records that link each step a food product takes from source to retail. The goal is to enable the FDA to rapidly trace the origin and distribution of contaminated products during foodborne illness outbreaks, potentially reducing investigation time from weeks to hours.

Which Foods Are on the Food Traceability List?

The Food Traceability List (FTL) identifies the foods subject to additional recordkeeping under Section 204. The FDA selected these foods based on a risk-ranking model that considered the frequency and severity of outbreaks, the likelihood of contamination, and the potential for widespread public health impact. The FTL includes:

What Are Key Data Elements (KDEs)?

Key Data Elements are the specific pieces of information you must record for each Critical Tracking Event. KDEs create the data "trail" that allows a food to be traced through the supply chain. The exact KDEs required vary depending on the CTE, but the core elements include:

• Traceability Lot Code: A unique descriptor assigned to the food that links it to the originating location and, where applicable, the date of production
• Quantity and Unit of Measure: The amount of food associated with the CTE (e.g., 500 cases, 2,000 pounds)
• Product Description: The commodity, variety, and brand name (if any) of the food
• Location Identifiers: The specific facility or farm where the CTE occurred, identified by FDA registration number, DUNS number, or other unique identifier
• Dates: Ship date, receipt date, harvest date, cooling date, or transformation date depending on the CTE
• Reference Document Information: Purchase order numbers, bill of lading numbers, or other business records linking the transaction

What Are Critical Tracking Events (CTEs)?

Critical Tracking Events are the key points in the supply chain where traceability records must be created. Each CTE represents a moment when a food's custody, form, or location changes. The rule identifies the following CTEs:

How Do Traceability Records Work?

The Section 204 recordkeeping system is designed to create an unbroken chain of documentation from origin to retail. Each entity that handles an FTL food must maintain a Traceability Plan and keep CTE-specific records.

The Traceability Plan

Every person subject to the rule must establish and maintain a written traceability plan that describes how they will record KDEs for each CTE, assign traceability lot codes, and make records available to FDA. The plan must be kept current as operations change.

Record Format and Retention

• Records may be maintained in any format (paper or electronic) as long as they contain all required KDEs
• Records must be retained for two years from the date they were created
• Records must be made available to FDA within 24 hours of a request (or a reasonable time during business hours)
• Electronic sortable spreadsheets are required when submitting records to FDA

Traceability Lot Code Assignment

A traceability lot code is a descriptor used to link a food to its originating location and, where applicable, production date. Companies may use existing lot code systems as long as they meet the rule's requirements for uniqueness and linkage.

Who Must Comply with Section 204?

The rule applies broadly to anyone who manufactures, processes, packs, or holds foods on the Food Traceability List. This includes:

• Growers and farms: Those that grow, harvest, and perform initial packing of FTL raw agricultural commodities
• Manufacturers and processors: Facilities that transform, cut, commingle, or repack FTL foods
• Distributors and warehouses: Entities that receive, hold, and ship FTL foods
• Importers: US owners or consignees of imported FTL foods
• Retailers: Grocery stores and food service operators that receive FTL foods (limited receiving records only)

Exemptions

Certain entities and situations are exempt from the additional traceability requirements:

• Farms and small businesses with average annual food sales below $250,000 (adjusted for inflation) in the previous three years
• Foods that receive a kill step (such as full cooking) that adequately minimizes the identified hazard
• Commingled raw agricultural commodities (in limited circumstances)
• Persons who hold food on behalf of individual consumers (e.g., personal storage units)
• Transporters who only transport food without holding it

What Is the Compliance Timeline?

The final rule was published on November 21, 2022. The original compliance date was January 20, 2026, but Congress enacted a legislative directive extending the deadline to July 20, 2028. This extension was not a discretionary FDA action but a legislative mandate, giving the industry additional time to build compliant traceability systems.

Key Milestones

• November 2022: Final rule published
• 2023–2025: Industry preparation period; FDA issued guidance documents and conducted outreach
• January 2026: Original compliance date (superseded by legislative extension)
• July 20, 2028: New compliance date for all covered entities (legislative directive)
• 2028 onward: FDA inspections and enforcement begin

What Are the Penalties for Non-Compliance?

FSMA gives the FDA robust enforcement authority. Failure to maintain required traceability records can result in:

• Warning letters: FDA may issue a formal warning requiring corrective action within 15 business days
• Import refusal: Imported FTL foods may be detained or refused entry if traceability records are inadequate
• Injunctions: FDA can seek court orders to halt operations until compliance is achieved
• Seizure: Products without adequate traceability documentation can be seized by the FDA
• Civil penalties: Monetary fines for willful violations

How Should Companies Prepare?

Building a compliant traceability system requires planning and coordination across your supply chain. Here is a step-by-step preparation checklist:

Technology Considerations

While the rule does not mandate any specific technology, most companies will benefit from electronic systems that can capture KDEs at each CTE, link lot codes across transformations, and generate sortable spreadsheets for FDA. Common approaches include barcode/QR code scanning, ERP system enhancements, and dedicated traceability software platforms.

How Can Assurentry Help with FSMA Compliance?

Assurentry provides end-to-end FDA compliance support for food companies. Our team can help you navigate Section 204 and the broader FSMA landscape:

• Traceability gap analysis: We review your current recordkeeping against Section 204 requirements and identify gaps
• Traceability Plan development: Our compliance specialists draft a customized plan tailored to your supply chain
• Food facility registration: We handle your FDA food facility registration and renewals
• FSVP compliance: For importers, we integrate traceability with your Foreign Supplier Verification Program
• Mock trace exercises: We conduct simulated traceback exercises to test your system before FDA does
• Ongoing compliance monitoring: Stay up to date as FDA updates guidance and the FTL evolves