FSMA Food Traceability Rule: Complete Guide to Section 204

Overview of the Food Traceability Rule

Section 204 of FSMA directed the FDA to establish additional traceability recordkeeping for high-risk foods. The final rule, published in November 2022, requires standardized records throughout the food supply chain to enable rapid traceback during foodborne illness outbreaks. The goal is to reduce investigation time from weeks to hours.

Unlike general food recordkeeping requirements, Section 204 mandates specific data elements at defined tracking points, creating an unbroken chain of documentation from farm to retail. For the detailed original rule, see our in-depth FSMA 204 guide.

The Food Traceability List (FTL)

The FTL identifies foods subject to additional traceability requirements. These were selected based on a risk-ranking model considering outbreak frequency, contamination likelihood, and public health impact:

• Leafy greens and fresh herbs: Lettuce, spinach, kale, cilantro, parsley, basil
• Fresh-cut fruits and vegetables: Pre-cut melons, pre-packaged salad mixes
• Soft and semi-soft cheeses: Brie, feta, mozzarella, queso fresco
• Shell eggs: From chickens (excluding USDA-regulated egg products)
• Nut butters: Peanut butter, almond butter, other tree nut butters
• Cucumbers and peppers: Fresh cucumbers, bell peppers, hot peppers
• Tomatoes and sprouts: Fresh tomatoes, bean sprouts, alfalfa sprouts
• Finfish and crustaceans: Fresh/frozen finfish, shrimp, crab, lobster
• Tropical tree fruits: Mangoes, papayas, guava, lychee

Key Data Elements (KDEs)

KDEs are the specific data points you must record at each CTE:

• Traceability Lot Code: Unique descriptor linking food to originating location and production date
• Quantity and Unit of Measure: Amount associated with each event
• Product Description: Commodity, variety, and brand name
• Location Identifiers: Facility identified by FDA registration number, DUNS, or other unique ID
• Dates: Ship date, receipt date, harvest date, cooling date, or transformation date
• Reference Documents: Purchase orders, bills of lading, or other linking business records

Critical Tracking Events (CTEs)

Who Must Comply?

The rule applies to anyone who manufactures, processes, packs, or holds FTL foods, including growers, manufacturers, distributors, importers, and retailers. Key exemptions include:

• Small businesses with less than $250,000 in average annual food sales
• Foods that receive a kill step (full cooking) that adequately minimizes identified hazards
• Transporters who only transport food without holding it
• Persons who hold food on behalf of individual consumers

The Traceability Plan

Every covered entity must establish a written Traceability Plan describing 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 paper or electronic as long as they contain all required KDEs
• Records must be retained for two years from creation
• Records must be available to FDA within 24 hours of request
• Electronic sortable spreadsheets are required when submitting records to FDA

Compliance Timeline

Preparing Your Business

How Assurentry Can Help

Assurentry provides end-to-end FSMA 204 compliance support:

• Traceability gap analysis: Review your current recordkeeping against Section 204 requirements
• Traceability Plan development: Customized plans tailored to your supply chain
• Food facility registration: We handle your FDA registration and renewals
• Mock trace exercises: Simulated traceback exercises to test your system
• Ongoing monitoring: Stay up to date as FDA updates guidance and the FTL evolves