ERP Cost Guide

FSMA 204 food traceability rule, in plain English

FSMA 204 requires companies that manufacture, process, pack or hold foods on FDA's Food Traceability List to keep Key Data Elements for each Critical Tracking Event, assign traceability lot codes, maintain a traceability plan and give FDA an electronic sortable spreadsheet within 24 hours of a request. FDA will not enforce it before July 20, 2028.

Updated 2026-09-23 · 2 sources · By the ERP Cost Guide team

At a glance

Original compliance date
Jan 20, 2026
Enforcement not before
Jul 20, 2028
FDA response window
24 hours
FTL categories
23

Critical Tracking Events

Source: [FDA](https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods), 2026-07-24
CTEWho records it
HarvestingGrowers
CoolingBefore initial packing
Initial packingPackers
First land-based receivingSeafood from vessels
ShippingAnyone shipping FTL food
ReceivingAnyone receiving FTL food
TransformationManufacturers/processors changing the food

Foods on the Food Traceability List (grouped)

  1. Cheeses (soft/soft-ripened/semi-soft; unpasteurized non-hard)
  2. Shell eggs
  3. Nut butters
  4. Cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits (fresh)
  5. Fresh-cut fruits and vegetables (incl. fresh-cut leafy greens)
  6. Finfish (histamine, ciguatoxin and other species), smoked finfish
  7. Crustaceans; molluscan shellfish (bivalves)
  8. Ready-to-eat deli salads (refrigerated)

What it means for your ERP

Your system must capture lot codes at receiving, transformation and shipping, link them to KDEs, and export a sortable spreadsheet on demand. See FSMA 204 software options and the 2028 deadline.

Informational summary of FDA materials, not legal or compliance advice. FDA provides an exemptions tool for full and partial exemptions.

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Frequently asked questions

What is FSMA 204?

FDA’s Food Traceability Rule (Section 204 of the Food Safety Modernization Act), requiring additional traceability records for foods on the Food Traceability List.

When is the FSMA 204 compliance date?

Originally January 20, 2026. FDA proposed a 30-month extension to July 20, 2028, and Congress directed FDA not to enforce the rule before that date.

Sources

  1. FDA - FSMA Final Rule on Requirements for Additional Traceability Records (accessed 2026-09-23) - Source date: 2026-07-24
  2. FDA - Food Traceability List (accessed 2026-09-23) - Source date: 2026-09-23
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