- Food Safety Modernization Act (FSMA)
- Food Traceability Rule
FSMA Rule 204: Food Traceability Rule
The Food Traceability Rule requires enhanced recordkeeping for facilities handling high-risk foods prone to foodborne illness. Standardized data tracking prevents illness and death by enabling rapid identification and communication of contamination sources throughout the supply chain.
To comply with the law, manufacturers must:
- Develop traceability plans
- Maintain locked original records
- Provide electronic data records to the FDA in 24 hours
Compliance requirements were set to begin in January 2026. However, the FDA delayed the implementation by 30 months in part to allow more time for small grocers to comply without undue financial and logistical strain. Compliance now become mandatory in mid-2028.
The FDA announced the delay in March 2025 with intention to officially extend the compliance date using "appropriate procedures," which includes publication of a proposed rule in the Federal Register, "at a later time."
The Food Traceability Rule is part of the Food Safety Modernization Act (FSMA). It is enforced by the U.S. Food and Drug Administration (FDA).
How the Rule achieves its goal
The Rule requires standardized data requirements to ensure accurate, reliable, transparent, and readily available information throughout the supply chain. This protocol helps the FDA quickly execute recall investigations and communicate with consumers.
Food traceability requirements
The Food Traceability Rule requires traceability for high-risk foods on the Food Traceability List (FTL). Facilities must track Key Data Elements (KDE) during Critical Tracking Events (CTE) at each supply chain step. KDEs at every step must each link to a unique Traceability Lot Code (TLC).
These comprehensive traceability systems ensure facilities are prepared to identify contaminated batches and avoid additional cases of illness. They also reduce financial losses from recalls by eliminating the risks of manual measurements or errors.
Who must comply with the Food Traceability Rule?
The Food Traceability rule applies mainly to those manufacturing, processing, packaging, or storing:
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The FDA’s Risk Ranking matrix presents the risk scores used for foods included in this list, plus others that were analyzed but not included.
Exemptions
Full and partial exemptions exist for extremely small operations or ones with very limited operational focus. These include:
- Shell egg producers with fewer than 3,000 hens
- Nonprofit food establishments
- Facilities that hold food on behalf of individual consumers
- Food held for research or evaluation.
The FDA’s Traceability Exception Flow Chart provides more details.
Noncompliance
Noncompliance risks reputational and financial damage. The FDA will initially work with facilities through good-faith resolutions. If a facility rejects voluntary recalls, it can issue warnings and mandate recalls, publishing violations on the public FSMA dashboard.
How can food facilities comply with the FSMA 204 food traceability rule?
Food facilities can meet FSMA 204 requirements by integrating automated tracking systems with existing production lines. ifm offers scalable solutions for data collection, record-keeping, traceability compliance, and preventive controls, from individual sensors to complete facility systems.
Traceability Lot Code: data collection and recordkeeping with RFID
Food manufacturing facilities can meet Transformation KDE requirements using ifm’s automated solutions for historical data logging of batch production:
- moneo Track & Trace software automates record-keeping of production data by Traceability Lot Code.
- IO-Link technology unlocks more process data and improves data accuracy via a digital signal.
- RFID technology tracks and stores shipment data for packing, shipping, and receiving food products requiring additional record-keeping. With RFID over IO-Link solutions, manufacturers can simplify implementation of RFID hardware by leveraging existing IO-Link networking.
- Dock door automation solutions improve shipment accuracy and eliminate manual inventory recordkeeping by sending data directly to ERP or MES.
- Image-based code readers with embedded OCR make it simple and cost-effective to monitor various code types with one reader.
Transformation KDE: Food Processing data tracking with smart sensors
- Sanitary process sensors designed for food and beverage production deliver precise process control, parameterization, and real-time data.
- IO-Link technology embedded in smart sensors and code readers enables real-time collection and timestamping of Key Data Elements, including temperature measurements, and transfers the data to higher-level software systems.
- The IIoT port on ifm IO-Link masters provides simple, seamless transmission of critical data to different software systems through various standard industrial communication protocols. Explore the Y-Path of IO-Link to leverage sensor data for automation of machine control without burdening a PLC for additional data analysis.
Maintaining electronic, searchable records with moneo software
Food manufacturers can use the moneo Track & Trace software to integrate with existing system architecture using:
- Smart process sensors durable enough for food production
- IO-Link technology for easy data connectivity and increased data accuracy
- IIoT port with MQTT or OPC UA to broker production data
Reason for the Rule
Numerous high-profile U.S. foodborne illness outbreaks exposed vulnerabilities in traditional traceability systems. Standardized, comprehensive tracing accelerates response times to protect public health and prevent consumer panic while creating a transparent, accountable food supply chain that builds public confidence.
History of the Rule
The Food Safety Modernization Act (FSMA) was passed in 2011. Section 204 of the law explicitly mandates the FDA implement enhanced recordkeeping requirements for certain high-risk foods.
Timeline
- November 2022: The Final Rule is published.
- January 2023: The Rule went into effect.
- 2023 - present: Businesses and supply chain partners begin preparing for compliance.
Required compliance begins January 20, 2026, but routine inspections will not begin until 2027. However, the FDA aims to create a safer food supply chain before the deadline. 2025 is the year to finalize traceability plans and test their effectiveness before the approaching deadlines.
In the news
Updated: March 2025
- FDA pushes back Food Traceability Rule compliance to 2028 (March 2025)
- Food Safety Modernization Act Update – One Year Out (February 2025)
- It’s the Competition — Not the Regulation — Forcing Retailers to Take on Traceability (January 2025)
- How grocers can prepare for food traceability requirements coming in early 2026 (January 2025)
- Food Safety in Transition: Looking Toward FSMA 204 Compliance (January 2025)
- The time is now for the upcoming FDA Food Traceability Rule (December 2024)
- Navigating The FDA’s Food Traceability Mandate: What Restaurants Need To Know (December 2024)
- The clock is ticking to get FSMA 204 compliant (October 2024)
- How retailers can prepare for the FDA’s Food Traceability Rule (October 2024)
- Food Traceability Rule compliance threatened by too much tech, over-eager retailers (October 2024)
- FDA: Be ready to comply on food traceability (October 2024)
- Ensuring Safety from Farm to Fork: The Role of Technology in Food Manufacturing Traceability (October 2024)
- Experts guide distributors on food safety regulation compliance (September 2024)
- The FDA Is Launching New Traceability Rules for Added Food Safety — and Everyone Is Confused (September 2024)
- Seafood industry isn’t ready for Food Safety Modernization Act updates, trade experts warn (September 2024)
- Public-Private Partnership Aims to Fill Gaps in Supply Chain Interoperability (September 2024)
- Report Highlights Industry Concerns With FSMA 204 Compliance, Barriers to Implementation (September)
- Enhancing Food Safety: The Impact of FSMA’s Traceability Rule on the Supply Chain (August 2024)
