Food Traceability and FDA FSMA 204 Implementation Summary

Effective Traceability

• Hard copy or electronic recording of inventory at receipt, within processing and finished product/services in operations
• Employees responsible for recording and tracking inventory are properly trained and can call up inventory upon request
• Food Facilities in the supply chain that have strong trace love talking about it
• Food Facilities in the supply chain that do not have strong trace hate talking about it

Free Traceability Video Series

For an overview of Traceability watch our free traceability for the food industry video series.  The free video series covers the following information:

Episode 1: The Importance of a Traceability Program

Episode 2: Traceability During the Supplier Approval Process

Episode 3: Traceability During Receiving and Stock Rotation Practices

Episode 4: Traceability During Work-in-Process and Rework

Episode 5: Tests of the Traceability System and Recall Program

Episode 6: Traceability in GFSI

Traceability For Bulk Products

• We need to estimate the operational time to deplete the entire bulk holding vessel
• For example, if I fill a 10,000 Gallon tank, and run continuously, it will take 4 days of operation to run it dry
• We do make considerations for the fact that most tanks or silos are not depleted to empty.
• Tracing of bulk requires careful recording of receiving/filling dates and the use of the estimated time it takes to use up that material

FSMA 204 Compliance Dates in Industry

• FDA’s current compliance date for FSMA 204 Final Rule on Requirements for Additional Traceability Records for Certain Foods is Tuesday, January 20, 2026. The food industry is starting to require compliance well ahead of this date.
• Companies, such as Walmart, have started to require enhanced traceability in 2024 regardless of product type. Walmart’s enforcement is starting with foods on the Food Traceability List (FTL).
• Kroger also announced their intent to collect and record traceability information for all food products, not just those on the FTL by the end of June 2025.
• Other large companies, such as Whole Foods Market and Sysco are now requiring FSMA 204 compliance for foods on the FTL.
• Kellerman Consulting is advising businesses that intended to sell into major corporate supply chains to be FSMA 204 compliant in 2025.

Summary of FDA’s Food Traceability List (FTL)

• Cheeses other than hard cheeses
• Shell eggs
• Nut butters
• Cucumbers (fresh), Herbs (fresh), Leafy greens (fresh), Melons (fresh), Peppers (fresh), Sprouts (fresh), Tomatoes (fresh), Tropical tree fruits (fresh), Fruits (fresh-cut), Vegetables (fresh-cut)
• Finfish (fresh and frozen); Smoked finfish (refrigerated and frozen); Crustaceans (fresh and frozen); Molluscan shellfish, bivalves (fresh and frozen)
• Ready-to-eat deli salads (refrigerated)

FSMA 204 Status in Industry

Biggest Issues of Concern:

• Retailers are creating their own online portals (or hiring specific software companies to collect the FSMA 204 data).
• There is no standard for submissions across retailers.
• The biggest challenges are companies’ ability to collect data from production and submit it to retailers.
• For many fish and pack houses, their traceability is manual, and they create spreadsheets when invoices are prepared.

FSMA 204 Implementation

For the implementation of FSMA 204 the following information is required:

• Critical Tracking Events (CTEs): Receiving, processing/rework, pack/repack, shipping
• Key Data Elements (KDEs): Address, Phone Number, Lot Codes, Pack Sizes and Amounts, Etc.
• An electronic sortable spreadsheet containing relevant traceability information (unless exempt).
• Businesses who are required to implement FSMA 204 must also keep controlled electronic or written records.

How to Implement FSMA 204

Our clients have found success with the following FSMA 204 implementation process:

1.Barcode creation/ Traceability Lot Code (TLC) creation

2.Development of Standard Operating Procedures (S.O.P.) for traceability

3.Creation and development of the Traceability Plan

4.Updates to food safety certification programs focusing on the following:

• Traceability Program
• Supplier Approval Program
• Crisis Plan
• Food Defense Plan
• Recall Plan

5.Mock recall

6.Trace exercises (at least 2 events to ensure the Critical Tracking Events (CTEs) are in place and that the FSMA 204 program is working as intended).

If you have additional questions about traceability or if you would like assistance from our food safety consulting team, contact us for your free 30 minute consultation at: (800) 535-1376 or INFO@KELLERMANCONSULTING.COM