Report Date: September 24, 2026
Audience: Domestic and foreign firms that manufacture, process, pack, or hold foods on the Food Traceability List (FTL)

Executive Summary

FSMA 204 (the Food Traceability Final Rule) is the implementing regulation for Section 204(d) of the FDA Food Safety Modernization Act. It establishes traceability recordkeeping requirements—beyond those in existing regulations—for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The core objective is to enable FDA to rapidly identify and remove potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

Key Compliance Date Update: The original compliance date was January 20, 2026. FDA has proposed extending the compliance date by 30 months to July 20, 2028, and Congress has directed FDA not to enforce the rule prior to that date. Despite the extension, manufacturers should not delay—system implementation, process redesign, and supplier coordination typically require 18 to 24 months, so firms that have not yet started are already working against a tight timeline.

Part 1: Scope and Covered Foods

1.1 The Food Traceability List (FTL)

FSMA 204 requirements apply only to specific foods listed on the Food Traceability List (FTL), and to foods that contain listed foods as ingredients—provided the listed food used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.

Major FTL Food Categories:

Important Coverage Rules:

• Multi-ingredient foods containing an FTL food as an ingredient are covered in their entirety if the food has not undergone a kill step and the ingredient has not changed form (e.g., peanut butter in peanut butter crackers)
• If an FTL food has undergone a kill step (a lethal treatment that significantly reduces pathogens) with documented evidence, it is no longer subject to the rule during subsequent distribution
• If an FTL food will later receive a kill step (performed by someone other than a retail food establishment or restaurant), and the shipper and receiver have a written agreement, the food is partially exempt

1.2 Who Must Comply?

The rule applies to domestic and foreign firms that manufacture, process, pack, or hold FTL foods:

• Manufacturers and processors
• Packers and co-packers
• Warehouses and cold storage facilities
• Distributors handling FTL foods
• Importers of FTL foods

Exemptions and Modified Requirements: The rule includes several exemptions and partial exemptions, including for small businesses (below sales thresholds), farm-direct sales, and other specific situations. FDA provides an online tool to help determine whether an exemption applies.

Part 2: Core Concepts—CTEs, KDEs, and TLCs

2.1 Critical Tracking Events (CTEs)

CTEs are specific points in the food supply chain where records must be maintained. CTEs that manufacturers need to identify include:

2.2 Key Data Elements (KDEs)

KDEs are the specific data points that must be recorded for each CTE. Manufacturers must maintain the applicable KDEs at each CTE and pass relevant information downstream.

Examples of Core KDEs by CTE:

Shipping

• Traceability Lot Code (TLC)
• Quantity
• Location where shipped from
• Location where shipped to
• Date shipped

Receiving

• TLC
• Product description
• Quantity
• Location where shipped from
• Date received

Transformation

• Newly assigned TLC
• TLCs of all input foods
• Date of transformation
• Location of transformation
• Product description

2.3 Traceability Lot Code (TLC)

A TLC is a descriptor (often alphanumeric) used to uniquely identify a traceability lot within the records of the firm that assigned it.

Manufacturers must assign a TLC when they:

1. Initially pack an RAC (other than food obtained from a fishing vessel)
2. Perform the first land-based receiving of food obtained from a fishing vessel
3. Transform an FTL food

Key Rules:

• If you receive an FTL food from an exempt entity and no TLC has been assigned, you must assign one (unless you are a retail food establishment or restaurant)
• You must not create a new TLC when conducting other activities (e.g., shipping)
• Once assigned, all subsequent CTE records must include that TLC, and all KDEs must be linked to the relevant traceability lot

Part 3: The Traceability Plan

Under § 1.1315, covered manufacturers must establish and maintain a traceability plan containing the following:

1. Record maintenance procedures: A description of the procedures used to maintain required records, including format and location
2. FTL food identification procedures: A description of procedures used to identify FTL foods you manufacture, process, pack, or hold
3. TLC assignment procedures: If applicable, a description of how you assign TLCs to FTL foods
4. Point of contact: A statement identifying a contact person for questions regarding your traceability plan and records
5. Farm map (if you grow or raise an FTL food, other than eggs):
   • Show the location and name of each field or growing area
   • Include geographic coordinates and any other information needed to identify each location
   • For aquaculture farms, show the location and name of each container (pond, pool, tank, cage), including geographic coordinates

Industry Best Practice: The traceability plan should reflect actual operational processes, not an idealized future state. Involve operations, IT, food safety/quality, supply chain, and the teams that actually generate traceability data in plan development—if they don't recognize the processes described in the plan, it isn't ready yet.

Part 4: Recordkeeping and FDA Data Submission Requirements

4.1 Record Format and Retention

• Records must be maintained as original paper or electronic records, or true copies
• All records must be legible and stored to prevent deterioration or loss
• Electronic records may include valid, working electronic links to required information

4.2 FDA Data Submission Requirements

• All records required under the rule, along with any information needed to understand them, must be made available to FDA within 24 hours of a request (or within a reasonable time to which FDA has agreed)
• During an outbreak, recall, or other public health threat, an electronic sortable spreadsheet containing relevant traceability information must be provided within 24 hours if requested
• FDA provides an electronic sortable spreadsheet template organized by CTE tabs, with each column header representing a required KDE and hyperlinked to the corresponding provision

Part 5: Manufacturer Compliance Roadmap

5.1 Gap Assessment and Preparation

Step 1: Confirm Applicability

• Do you manufacture, process, pack, or hold an FTL food?
• Does any exemption apply?
• What CTEs do you conduct?
• What KDEs do you already maintain? What additional KDEs are needed?

Step 2: Establish a Cross-Functional Team

• Designate an FSMA 204 compliance lead
• Build a cross-functional team spanning operations, IT, food safety/quality, and supply chain
• Provide training for personnel involved in each CTE

Step 3: Assess Existing System Capabilities

• Identify where KDEs currently reside (ERP, WMS, inventory systems, production systems, labeling systems, EDI/ASN, etc.)
• Evaluate whether systems support lot-level tracking
• Identify manual processes, data gaps, and unclear ownership

5.2 System Implementation and Integration

Recommended Timeline Planning:

System Integration Guidance:

• The goal is not to replace existing systems but to connect information generated by existing systems to the traceability system
• Prioritize connecting systems that support highest-priority CTEs and customer requirements
• Starting with shipping data is often a logical entry point for suppliers
• You don't need to standardize every facility by the end of 2026, but you should begin defining the approach to scale in 2027

5.3 Traceability Plan Development

Translate lessons learned from early testing into formal, documented processes. The plan should clarify:

• Where KDEs are generated
• Which systems contain the data
• Who owns and maintains the data
• How information flows between teams and systems
• How records will be retrieved when needed

5.4 Supply Chain Coordination

FSMA 204 requires firms to share information with supply chain partners, so all parties should ideally be ready by the same compliance date:

• Communicate with supply chain partners to understand each other's recordkeeping systems and capabilities
• Determine the best methods for communicating information
• Discuss potential solutions
• Industry pilots have found that hidden third-party handlers, brokers, and foreign sources are often not mapped to rule requirements, requiring continuous adjustment
• Manual data entry is error-prone and can lead to mismatched lot codes at ordering and receiving; consider automated scanning solutions and more frequent audits

Part 6: Industry Resources and Training

6.1 FSPCA Official Training Course

FDA, in collaboration with the Food Safety Preventive Controls Alliance (FSPCA), developed the FTR Training for the Food Industry Course, which provides the foundational knowledge needed to understand and comply with the rule. The course covers:

• FTR recordkeeping requirements
• How to identify applicable requirements based on supply chain activities
• How traceability data flows through the supply chain
• Required contents of a traceability plan
• Methods for building a food traceability plan

6.2 FDA Official Resources

FDA provides extensive compliance tools:

• Small Entity Compliance Guide
• Traceability plan examples (farms, restaurants, food processors, distribution centers, seafood processing facilities, aquaculture farms)
• Electronic sortable spreadsheet template (with sample data)
• Supply chain examples (cucumbers, tuna steaks, soft cheese, deli salads, sprouts, etc.)
• Exemption determination tool
• FAQs

6.3 Industry Collaboration Platforms

The Partnership for Food Traceability (PFT) is an independent, sector-neutral forum that brings together industry, regulators, trade associations, technology experts, and solution providers to:

• Define consistent traceability business and functional requirements
• Establish industry mechanisms for traceability implementation decisions
• Coordinate future pilot projects

Part 7: Key Challenges Manufacturers Should Anticipate

7.1 Intracompany Shipments

The rule requires shipping and receiving records even for food transported between different addresses of the same company. For large manufacturers with complex internal manufacturing and warehousing networks, this requires significant system and process changes, potentially involving case-level and unit-level scanning.

7.2 Warehouse Management System (WMS) Capability Limitations

Many retail and foodservice distribution center WMS platforms are not currently designed to handle supplier-provided TLCs and TLC sources. For the foreseeable future, these systems will need to calculate or estimate lot codes based on inventory and receiving records. Industry has recommended that FDA allow both "scan and calculate" methods and permit end-of-line distributors flexibility.

7.3 TLC Source Identification Standardization

FDA currently does not mandate standardized location identifiers, leaving industry inconsistent across GLN, FFRN, EIN, LEI, DUNS, and customer-specific IDs. Existing barcodes (e.g., GS1-128) cannot accommodate TLC source, causing it to appear in human-readable format on cases, which is unreliable.

7.4 Small Supplier Capability

Industry roundtables found that many FTL food producers remain unaware the rule exists. Small and mid-sized suppliers, foreign suppliers, independent restaurants, and businesses not affiliated with trade associations have lower awareness of the rule and its specific requirements.

7.5 Cost Impact

Compliance costs may exceed estimates in the rule's impact analysis. Large manufacturers expect to spend tens of millions of dollars on compliance efforts. Firms should ensure they implement the right systems the first time and avoid rushing into solutions that meet compliance but are ineffective.

Part 8: Compliance Checklist

Manufacturer FSMA 204 Compliance Self-Assessment

Scope Confirmation

• [ ] Confirm whether foods you manufacture, process, pack, or hold are on the FTL
• [ ] Confirm whether finished products containing FTL ingredients are covered (check ingredient form and kill steps)
• [ ] Use FDA's exemption determination tool to confirm whether exemptions or partial exemptions apply

CTEs and KDEs

• [ ] Identify all CTEs you conduct (harvesting, cooling, initial packing, shipping, receiving, transformation, etc.)
• [ ] Determine required KDEs for each CTE
• [ ] Establish TLC assignment procedures (at initial packing, first land-based receiving, and transformation)
• [ ] Ensure TLCs are linked in all subsequent CTE records

Traceability Plan

• [ ] Establish a written traceability plan (§ 1.1315)
• [ ] Include record maintenance procedures, FTL identification procedures, and TLC assignment procedures
• [ ] Designate a point of contact
• [ ] If applicable, create a farm map with geographic coordinates

Recordkeeping and FDA Submission

• [ ] Ensure records are maintained as originals or true copies, legible and protected
• [ ] Ability to provide records to FDA within 24 hours
• [ ] Ability to provide an electronic sortable spreadsheet
• [ ] Consider using FDA's provided template

Systems and Processes

• [ ] Assess lot-level tracking capabilities of existing ERP/WMS/inventory systems
• [ ] Connect business systems to traceability systems to reduce manual processes
• [ ] Establish supplier data exchange agreements
• [ ] Conduct mock FDA data request exercises

Supply Chain Coordination

• [ ] Communicate with upstream and downstream partners on traceability data transmission methods
• [ ] Identify hidden third-party handlers and brokers
• [ ] Coordinate KDE and TLC information exchange formats

Conclusion

FSMA 204 represents a fundamental shift in food traceability—from "one step forward, one step back" to end-to-end, lot-level, digital traceability. While the compliance date has been extended to July 20, 2028, the long lead times required for system implementation and supply chain coordination mean that manufacturers must begin preparing now. Successful compliance requires cross-functional collaboration, system integration investment, supply chain partner coordination, and deep understanding of the core concepts of CTEs, KDEs, and TLCs.

FDA and industry partners provide extensive resources—from FSPCA training courses to traceability plan templates—and manufacturers should leverage these tools to turn compliance requirements into a strategic opportunity to enhance supply chain transparency and food safety capabilities.

FSMA Final Rule on Requirements for Additional Traceability Records

The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FSMA.

FDAHuman Foods Program