FSMA 204: Food Traceability and Safety Guide
Apr 8, 2025
Food Safety Modernization Act, abbreviated as FSMA, came into practice with the purpose of overhauling the food safety system in the U.S. into a proactive instead of a reactive framework.
FSMA 204 targets the requirement for traceability of foods, providing more openness in the food chain.
Throughout this text, we will detail the essential FSMA 204 requirements, provide real-world advice on applying traceability systems, and provide actionable approaches for the food facilities to comply with the current FDA regulations for food safety and traceability.
Let’s begin!
Understanding FSMA 204: Key Requirements for Food Traceability
FSMA Section 204 is one component of the FDA's larger 'New Era of Smarter Food Safety' program, which takes advantage of technology in building a safer, more digitized food system.
FSMA 204 introduces new traceability record-keeping requirements for certain high-risk foods, aiming to create a more transparent food supply chain.
These requirements help both the FDA and food producers quickly track and trace the movement of products in the event of a contamination incident.
How FSMA Section 204 Enhances Food Traceability?
The finalized Food Traceability Rule under FSMA Section 204 introduces several key measures aimed at improving food traceability:
Food Traceability List (FTL): The FDA has identified certain high-risk foods, including fresh produce, seafood, nut butters, and ready-to-eat deli salads, that require additional traceability records. These foods are more susceptible to contamination and outbreaks.
Key Data Elements (KDEs) and Critical Tracking Events (CTEs): Businesses involved in manufacturing, processing, packing, or holding foods on the FTL must maintain detailed records of KDEs for CTEs. These records must be electronically sortable and provided to the FDA within 24 hours upon request during an outbreak or recall.
Provisions for Processed Foods: Foods that undergo "kill steps" (e.g., pasteurization) or are transformed into frozen or dried states may be exempt from traceability requirements.
Why FSMA 204 Matters
Here are the reasons why FSMA 204 is important:
Quick Identification of Contaminated Products: FSMA 204 ensures that food facilities can quickly identify which products are contaminated by tracking them through detailed traceability records.
Faster and More Efficient Recalls: With up-to-date traceability data, manufacturers and distributors can efficiently locate and remove contaminated food products from the market, preventing further spread.
Enhanced Consumer Protection: By enabling faster responses, FSMA 204 helps protect consumers from consuming unsafe food, reducing the risk of illness or injury.
Improved Compliance with Regulatory Standards: Compliance with FSMA 204 ensures that food facilities meet the FDA’s stringent food safety regulations, promoting industry-wide safety and transparency.
Increased Trust and Accountability: Accurate traceability fosters greater accountability across the supply chain, building consumer confidence in food safety practices.
The Evolution of FSMA and Its Focus on Traceability
The Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, represents the most comprehensive reform of U.S. food safety laws in over 70 years.
Its primary goal is to shift the focus from responding to food contamination to preventing it.
FSMA has undergone refinements over time, with new rules added to address emerging food safety challenges and adapt to technological advancements.
Among these, FSMA Section 204, finalized in November 2022, emphasizes traceability for high-risk foods, marking a significant step forward in modernizing food safety systems.
Additionally, the FDA finalized the Pre-Harvest Agricultural Water Final Rule in May 2024, which complements FSMA’s preventive approach by addressing microbial contamination risks in water used for produce cultivation.
This rule requires farms to conduct annual systems-based assessments of pre-harvest agricultural water to identify hazards and implement mitigation measures when necessary, further enhancing the safety of high-risk foods and aligning with FSMA's broader goals.
Key Components of FSMA 204 and How They Impact Your Facility
1. Traceability Record-Keeping Requirements
One of the FSMA Section 204 primary requirements is the necessity for strong traceability records.
Food facilities have to trace and keep detailed records on the movements of the foods, from farm through final product.
All the related processing, packaging, and distribution activities, as well as the origin, handling, and location of the foods, have to be recorded.
All these conditions are specified in the FDA's Food Traceability Final Rule.
➸ Regulatory Basis:
FSMA Section 204 requires food producers to maintain detailed traceability records for high-risk foods listed on the Food Traceability List (FTL), including fresh produce, seafood, nut butters, and ready-to-eat deli salads.
These records help quickly identify and remove contaminated products during investigations.
To comply, businesses must track Key Data Elements (KDEs) and Critical Tracking Events (CTEs) as the FDA specifies.
➸ Practical Example:
A produce supplier must document key details such as where crops were grown, who harvested them, the processing steps, and their shipping destinations.
If contamination occurs, these records enable rapid identification of the source and affected batches.
➸ Implementation Tips:
Use real-time tracking software, such as blockchain or supply chain mapping tools, to ensure compliance with traceability requirements.
Regularly audit records for accuracy and ensure they are easily accessible for FDA inspections.
Develop a comprehensive Traceability Plan (for farms, restaurants, and sprouter) that meets FDA standards, ensuring readiness for audits and investigations.
Pro Tip
Signify automatically identifies conformity gaps by analyzing your documentation, processes, and products against regulatory requirements, helping you spot potential issues early.
With real-time insights, Signify provides specific remediation guidance to address non-conformities before they affect your certification status or market access.
2. Traceability for High-Risk Foods
FSMA Section 204 specifically targets high-risk foods, which include fresh produce, seafood, deli salads, and ready-to-eat foods.
These foods pose a higher risk to public health due to their susceptibility to contamination and frequent implication in foodborne illness outbreaks.
FSMA 204 establishes stringent traceability requirements for these categories to ensure faster and more accurate responses during contamination incidents.
The requirements are part of the FDA's Food Traceability Final Rule within The Food Traceability List.
➸ Regulatory Basis:
The FDA designates certain foods as high-risk based on contamination potential, consumption rates, and illness severity.
These foods, listed on the Food Traceability List (FTL), include items like leafy greens, melons, nut butters, and non-pasteurized cheeses.
FSMA 204 requires businesses handling these foods to maintain detailed records of Key Data Elements (KDEs) for Critical Tracking Events (CTEs) to enhance transparency and control during food safety investigations.
➸ Practical Example:
A seafood processing facility must ensure that traceability records for each batch of fish are linked to the exact supplier and shipping details.
This ensures that if a contamination issue arises, the facility can trace the affected products back to the supplier, minimizing the scope of the recall.
➸ Implementation Tips:
Focus on strengthening traceability for high-risk foods in your facility by ensuring all necessary data is captured.
Use industry-specific solutions like blockchain or digital supply chain mapping to track the movement and handling of high-risk products.
Regularly audit traceability records for completeness and accuracy to ensure compliance with FDA standards.
3. Traceability Lot Codes and Sources: Ensuring Precise Tracking in the Supply Chain
FSMA 204 requires food producers to implement traceability lot codes (TLC) and document the traceability lot code sources to ensure the precise tracking of food products through the supply chain.
The traceability lot code is a unique identifier that links food products to specific handling and processing events, while the traceability lot code source provides the physical location where the TLC is assigned.
➸ Regulatory Basis:
FSMA 204 mandates that traceability lot codes be assigned at key stages, such as when raw agricultural commodities are packed, when the first land-based receiver handles a food obtained from a fishing vessel, or when a food product is transformed.
Additionally, documentation of the traceability lot code source or reference (e.g., the FDA Food Facility Registration Number or a web address) is required for compliance.
➸ Practical Example:
A seafood processor must assign a traceability lot code when they receive a shipment of fish from a fishing vessel.
The processor would also document the traceability lot code source, which could include key information such as the business name, phone number, and location address.
➸ Implementation Tips:
Develop a Traceability Plan that outlines the process for assigning traceability lot codes and documenting the TLC source.
Ensure the TLC is included in all relevant tracking documents, such as bills of lading or invoices, and not necessarily on the product packaging itself.
Implement systems for maintaining and sharing traceability information, such as digital platforms or QR codes, to streamline the tracking process across the supply chain.
4. Integration with the Supply Chain: Traceability Beyond Your Facility
FSMA 204 also requires food producers to work closely with suppliers and distributors to ensure traceability extends across the entire supply chain.
Collaboration between all parties involved in the production, handling, and transportation of food is critical to maintaining the integrity of traceability records.
➸ Regulatory Basis:
FSMA 204 emphasizes the need for traceability across the entire supply chain, which requires facilities to coordinate with suppliers to ensure that traceability data is consistently captured and shared.
➸ Supply Chain Examples:
Produce Supply Chain Example: Fresh cucumbers are harvested, cooled, packed, and distributed through several stages, with Key Data Elements (KDEs) maintained at each Critical Tracking Event (CTE) to ensure effective traceability.
Seafood Supply Chain Example: The supply chain for fresh tuna, from the fishing vessel to the restaurant, involves multiple Critical Tracking Events where Key Data Elements are required, including the assignment of Traceability Lot Codes (TLCs) at the first land-based receiver and the seafood processor.
Cheese Supply Chain Example: In the soft cheese supply chain, the cheese manufacturer must maintain transformation Key Data Elements (KDEs) and assign a Traceability Lot Code (TLC) to the cheese as it moves through the processing and distribution stages.
Deli Salad Supply Chain Example: Deli salads made with Food Traceability List (FTL) ingredients like fresh-cut celery and onions must have Key Data Elements maintained at each stage, from receiving to transformation and shipping, to comply with FSMA 204.
Sprouts Supply Chain Example: In this example, sprout growers must maintain Key Data Elements for growing, conditioning, and packing, while later stages in the supply chain track the transformation of the sprouts for retail sale.
Additional Supply Chain Examples: Various other examples, such as canned tomatoes or tilapia, demonstrate the application of FSMA 204's traceability requirements, including the maintenance of Key Data Elements at critical points like receiving, transformation, and shipping stages.
➸ Implementation Tips:
Establish clear agreements with suppliers and distributors regarding the exchange of traceability data.
Automate systems ensure that traceability information is accurately and consistently recorded at each stage of the supply chain.
How Can Signify Streamline the Food Manufacturing Process?
Signify is an AI-powered compliance AI agent for consumer goods that simplifies food manufacturing processes, ensuring your products meet regulatory standards, including FSMA 204, and remain compliant with industry guidelines.
By automating tasks and providing real-time insights, Signify helps food manufacturers stay ahead of regulatory changes, reduce the risk of non-compliance, and streamline their labeling and traceability workflows.
Key Benefits of Using Signify for FSMA 204 Compliance in Food Manufacturing:
1. Proactive Compliance Monitoring
With Signify, you can stay ahead of potential compliance issues.
Our AI-driven analysis automatically reviews your product labeling, traceability records, and documentation to spot any inconsistencies early.
This helps you address issues before they become problems, saving you time and reducing the risk of non-compliance.
2. Smart Documentation Management
Forget about scrambling to find the right documents when you need them most.
Signify organizes and links all your traceability records in one place, making it easy to access them for audits or inspections.
This streamlined process ensures you're always ready and helps maintain clear traceability, which is crucial for meeting FSMA 204’s Key Data Elements (KDEs) and Critical Tracking Events (CTEs).
3. Regulatory Risk Intelligence
Stay in the loop with real-time updates.
Signify constantly monitors regulatory changes and alerts you to any new risks or updates.
This way, you can make sure your labeling and traceability practices are always aligned with the latest regulations, with no surprises down the line.
4. Guided Remediation Actions
If a compliance gap is detected, Signify won’t just leave you hanging.
It provides clear, actionable recommendations on resolving any issues, helping you align with FSMA 204’s strict requirements.
You’ll always know exactly what steps to take to keep your practices up to date and compliant.
5. AI Compliance Agents for Consumer Goods
Signify’s Compliance AI agents are like having a dedicated team monitoring your business.
These agents are specially designed for industries like food manufacturing, and they autonomously track and evaluate compliance standards.
With them on your side, you’ll be assured that your labeling and traceability systems meet the highest regulatory standards, leaving you with one less thing to worry about.
Additionally, Signify extends its capabilities beyond food manufacturing, serving industries such as:
Personal Care & Cosmetics
Household Goods
Pet Care
Tobacco
Consumer Electronics & Appliances
Furniture
Tools & DIY Equipment
Sporting Goods
Ready to streamline your FSMA 204 compliance and food manufacturing workflows?
Book a demo today to discover how Signify automates compliance, mitigates risks, and ensures your labeling and traceability processes always align with regulatory standards.
