FSMA Rule 204 is a government-mandated FDA regulation requiring enhanced ingredient traceability across the food supply chain, taking effect January 20, 2026. It targets high-risk foods and imposes stricter tracking, documentation, and reporting requirements.

Approximately 48 million Americans experience foodborne illness annually, resulting in 128,000 hospitalizations and approximately 3,000 deaths.

Foods on the Traceability List (FTL)

High-risk foods requiring enhanced tracking include:

Soft cheeses, shell eggs, nut butters
Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits
Finfish, crustaceans, molluscan shellfish
Refrigerated ready-to-eat deli salads

Background: What Is FSMA?

The Food Safety Modernization Act (2011) shifted the U.S. approach from reacting to contamination toward preventing it. Section 204 specifically addresses supply chain traceability gaps that slow recall responses.

Key Changes in 2026

Change	Detail
Expanded scope	High-risk foods on FTL require step-by-step tracking
Standardized requirements	CTEs and KDEs introduced
Accelerated timelines	Records must be submitted to FDA within 24 hours of request
Modernization push	Manual systems insufficient; automation required

Core Concepts

Critical Tracking Events (CTEs)

Defined points where traceability data must be recorded:

Receiving — accepting ingredients/goods from a supplier
Transformation — processing, combining, or repackaging
Creation — making a product from scratch
Shipping — dispatching to the next supply chain point

Key Data Elements (KDEs)

Required data captured at each CTE:

Lot/batch number
Product description
Quantity and unit of measure
Location identifiers (facility/farm)
Dates and times
Supplier or recipient information

Records must be stored electronically and retrievable within 24 hours.

Traceability Lot Code

A unique identifier assigned to a batch at a specific supply chain step, linking CTEs together. New codes are generated during Creation or Transformation events.

Seven Key Rules in FSMA 204

Produce Safety Rule — Standards for growing, harvesting, packing fresh produce
Foreign Supplier Verification Programs (FSVP) — Importers must verify supplier compliance
Sanitary Transportation Rule — Temperature control and sanitation during transit
Intentional Adulteration Protection — Food defense plans for vulnerable products
Accredited Third-Party Certification — FDA-recognized bodies certify foreign facilities
Preventive Controls for Human Food — Hazard identification and control in production
Preventive Controls for Animal Food — Same framework applied to pet/animal food

Compliance Challenges

Adapting existing workflows to incorporate CTEs/KDEs
Managing traceability data across multiple suppliers
Staff training on documentation and 24-hour response requirements
Cost and time burden for companies relying on manual systems

Step-by-Step Compliance Guide

Audit current traceability and documentation processes
Identify whether your products appear on the FTL
Invest in automation tools (e.g., ERP software)
Train employees on compliance workflows
Conduct mock recalls to test systems
Collaborate with supply chain partners
Monitor regulations and update systems regularly

Penalties for Non-Compliance

Financial fines (severity-dependent)
Operational disruptions (production halts, facility shutdowns)
Reputational damage and loss of consumer trust
Increased legal liability and regulatory scrutiny

Exemptions

Businesses potentially exempt from FSMA 204:

Farms with $25,000 or less in average annual produce sales
Farms selling directly to consumers (with proper labeling)
Products undergoing a documented “kill step” (e.g., pasteurization, baking)
Retail establishments with 10 or fewer full-time employees
Food grown/packaged solely for on-farm use (not for sale)

FAQ Highlights

Compliance deadline: January 20, 2026
Who must comply: Any business growing, processing, packing, shipping, or selling FTL-listed foods
System requirements: Software must log KDEs per CTE, support cross-supply-chain record linking, and generate electronic spreadsheets shareable with FDA within 24 hours

FlexiBake Software Solution

Automated recalls completed in approximately 5 seconds vs. 8+ hours manually
Mock recall support for FSMA, SQF, and BRC certifications
Inventory control with single-click pick lists and packing documents
Automatic logging of CTEs and KDEs

“FlexiBake has become indispensable in our ever-changing food industry environment.” — Susan Zink, Heartland Gourmet

FDA FSMA Rule 204 Takes Effect January 2026: Critical Changes in Food Traceability