FDA’s New Final Food Product Traceability Rule: FSMA 204 Explained

• Traceability is a critical aspect of modern food supply chain management, contributing to food safety, quality assurance, and the overall integrity of the food industry.
• The Final Rule of the FSMA 204 focuses on detailed and rapid communication of information on food products on the Food Traceability List to trace and remove unsafe food.
• The crucial elements of the traceability rules are Key Data Elements (KDEs) for Critical Tracking Events (CTEs), Traceability Plan, and Additional Requirements for record-keeping.

Effective food product traceability can aid in removing contaminated or adulterated food from the supply chain. The Final Rule of 2022 by the FDA for products on the Food Traceability List (FTL) aims to rapidly identify and remove unsafe food to prevent and reduce food-borne illnesses and deaths. Additional benefits include improved product and quality monitoring, supply chain management, and reduced food waste. Find out more about the new rule that will take effect in 2026.

What is Food Traceability

Traceability in the food industry, an essential aspect of FSMA 204, refers to tracking and tracing food movement through the entire supply chain.

• Tracing follows a product backward from the retailer to the supplier and producer of a product or ingredient.
• Tracking follows ingredients and products from producers and suppliers to their destinations.

The two documentation routes cover the origin of supplies, materials, ingredients, processing history, distribution chains, and sale locations.

Traceability is crucial for quick identification and response to contamination or product recalls, contributing to effective risk management and overall integrity in the food supply chain.

The regulations on food product traceability will differ according to country and certification standards, even though the aims are universal.

Need for Food Product Traceability

According to the World Health Organization (WHO), 200 diseases, from diarrhea to cancers, are caused by unsafe food. These cause 420,000 deaths and make 600 million ill annually. Sadly, each day, 340 children under five years die due to preventable food diseases.

These health issues associated with unsafe food make it imperative that all stakeholders work to make food safe for consumers.

Food safety issues and consumer concern for safe and nutritious food have increased the need for traceability. Other commercial and regulatory reasons for food traceability include quality assurance, regulatory compliance, risk management, consumer confidence, and market access.

1. Food Safety: Quick and precise identification of affected products during outbreaks and the ability to trace the origin of food can help the industry identify and handle the cause of problems and address safety concerns. It can help in minimizing the impact of unsafe on public health. Guaranteeing safety by providing a transparent view of each product’s journey ensures consumers get fresh and safe food.
2. Quality Assurance: Traceability ensures consistent quality by identifying and rectifying inconsistencies and deviations to ensure products meet set standards. It monitors and maintains high-quality standards throughout the supply chain, from source to sale.
3. Production Optimization: Traceability optimizes the production process efficiently and reduces resource wastage by ensuring efficient use. It streamlines processes, reduces waste, and enhances productivity and sustainability.
4. Regulatory Compliance: The records maintained for tracking and tracing are essential for legal and ethical business operations and adherence to quality standards. Food traceability helps companies adhere to regulatory standards through documentation and records.
5. Risk Management: Traceability helps businesses and the industry enhance the capability to isolate and address issues promptly. Doing so reduces potential financial and reputational risks associated with recalls.
6. Consumer Confidence: Transparent traceability practices that give consumers information regarding the origin of ingredients, products, processing, etc, build trust. It demonstrates a commitment to quality, safety, and accountability.
7. Market Access: Traceability is required for accessing specific markets or obtaining certifications. Companies can get a competitive advantage in the market by following traceability practices.

Earlier Traceability Legislations

In the USA, the enhancement of food product recall and traceability has been supported in the past by various legislative actions, including the following:

• 2002- Bioterrorism Act
• 2009- Country of Origin Labeling (COOL)
• 2011- Food Safety Modernization Act (FSMA)
• 2012- USDA Food Safety and Inspection Service amendment to 9 CFR
• 2015- Produce Safety Rule (part of FSMA)

These regulations mandate traceability at least one step forward and one step backward in the food supply chain. The goal is to prevent contamination and ensure transparency.

There has been a growing interest in achieving “farm to fork” or end-to-end traceability, indicating a collective effort from industry leaders and regulatory agencies, like the FDA, to strengthen the capacity to trace food products throughout the entire supply chain for improved safety, which is now provided by the new FSMA 204.

Table 1: The condensed Food Traceability List by Nicholas, K (2023). (Credits:  https://foodsafetyprocessors.ces.ncsu.edu/2023/02/fda-releases-the-food-traceability-final-rule/List of food)

The Final Traceability Rule of FDA 204

The new Food Safety Modernization Act, Section 204 (FSMA 204) by the US FDA, published in November 2022, aims to reduce illness and deaths due to unsafe food. The act has been further strengthened by the “FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule),” which comes into effect on 20^th January 2026. The Final Rule aligns with best practices in the food industry and applies a farm-to-table approach to domestic and foreign companies in the entire food supply chain.

The rule applies to companies producing, processing, packing, and holding food on the Food Traceability List (FTL), listed in Table 1, at a higher risk of foodborne illness. These are foods that remain in the same form as detailed in FTL. The list is expected to be updated once in five years.

Exemptions from the Food Traceability Rule exist for companies based on size, operations, processing type, and food safety considerations.

The Final Rule has introduced new requirements and documentation and requires information submission within 24 hours to ensure fast source identification through tracking and rapid recall of potentially contaminated food to prevent illness and deaths.

Figure 1: The KDEs for the Critical Tracking Event – Initial packing, FDA. (Image credits: https://www.fda.gov/media/163132/download?attachment)

The Main Components of the Final Traceability Rule

The Rule expects companies and people who manufacture, process, pack, and store food on the FTL to maintain records with Key Data Elements (KDEs) for Critical Tracking Events (CTEs), Traceability Plan, and provide the information within 24 hours to the FDA.

Critical Tracking Events and Key Data Elements

As the Final Traceability Rule of FSMA 204 outlines, Critical Tracking Events (CTE) are food harvesting, cooling before packing, shipping, receiving, and transformation.

Harvesting: Activities performed on farms to remove raw agricultural commodities (RACs) from where they are grown or raised and prepare them for use as food.

Cooling: Active temperature reduction of a raw agricultural commodity (RAC) using hydro cooling, icing, forced air cooling, vacuum cooling, or similar methods.

Initial Packing: Packing a raw agricultural commodity (RAC) for the first time, excluding foods obtained from a fishing vessel.

First Land-Based Receiver: The person who takes possession of food for the first time on land directly from a fishing vessel.

Shipping: The event in a food supply chain where the food is transported (e.g., by truck or ship) from one location to another. Excludes direct sale or shipment to consumers and the donation of surplus food.

Receiving: The event in a food supply chain where food is received by someone other than a consumer after being transported from another location. It includes intracompany shipments between different addresses of the same firm.

Transformation: An event in a food supply chain involving manufacturing/processing or changing food and its packaging, resulting in food on the Food Traceability List (FTL). It excludes initial packing and activities preceding it, such as harvesting and cooling.

The information or Key Data Elements that firms must maintain and share depends on the specific supply chain activities, such as harvesting, processing, distribution, and retail receipt. Figures 1 and 2, which show the KDEs required for harvesting and transformation, highlight the difference in information needed at each stage.

Central to these requirements are traceability lot codes for FTL foods. These codes are assigned, recorded, and shared throughout the supply chain, linking them to other information identifying the foods as they move through different stages.

Figure 2: KDEs for Critical Tracking Event- Transformation, FDA. FSMA 204 (Image credits: https://www.fda.gov/media/163132/download?attachment)

Traceability Lot Code

Traceability Lot Code (TLC) is crucial in food traceability by helping to identify and track specific lots throughout the supply chain. This is especially important for maintaining food safety standards and responding effectively to any issues or recalls.

A Traceability Lot Code is a descriptor, typically alphanumeric, used to uniquely identify a traceability lot within a firm’s records. This code is a specific identifier for traceability purposes throughout the supply chain.

Assignment of Traceability Lot Code (TLC)

It is essential to know when TLC must be assigned in the supply chain, and these include the following situations:

• When packing a raw agricultural commodity (RAC) that is not food obtained from a fishing vessel.
• During the first land-based receiving of food obtained from a fishing vessel.
• When transforming a food.

TLC should not be alloted in the following cases:

• If you receive food from an entity exempt from the final rule, you must still assign a TLC unless you are a retail food establishment or restaurant.
• Shipping food on the Food Traceability List should not lead to establishing a new TLC.

Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must include that specific TLC.

All Key Data Elements (KDEs), including the TLC, must be linked to the relevant traceability lot. This linkage ensures that comprehensive information, including the unique identifier (TLC), is associated with the traceability lot throughout its journey in the supply chain.

Traceability Plan

People or companies subject to the Final Rule must create and maintain a traceability plan that covers the following information:

Description of Record-Keeping Procedures: Explain the procedures used to maintain records required by the rule and specify the location and format of the records.

Procedures for Identifying Foods:  Describe the procedures used to identify foods on the Food Traceability List that your business manufactures, processes, packs, or holds.

Traceability Lot Codes: If applicable, describe how traceability lot codes are assigned to foods on the Food Traceability List.

Point of Contact: Include a statement identifying a point of contact for any questions related to your traceability plan and records.

Farm Map (for Growers/Raisers): If you grow or raise food on the Food Traceability List (excluding eggs), provide a farm map with the following details:

• Location and name of each field or growing area.
• Geographic coordinates for each field or growing area.
• Any other necessary information to identify the location of each field or growing area.

For aquaculture farms:

• The farm map should show the location and name of each container (pond, pool, tank, cage) where the seafood on the Food Traceability List is raised.
• Include geographic coordinates and any other information needed to identify the location of each container.

No specific format for the traceability plan is specified, but the information required under § 1.1315 of the Food Traceability Rule must be provided.

Additional Requirements

The Additional Requirements (§ 1.1455) of the Final Rule of FSMA 204 are about record-keeping, which are as follows:

Record Maintenance: Legible records must be maintained on original paper, in electronic format, or as true copies. All records must be stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information the rule requires.

Accessibility to FDA: All records required under the rule and any necessary information to understand those records must be made available to the FDA within 24 hours after a request is made. Alternatively, the timeframe for making records available may be within a reasonable time, as agreed upon by the FDA.

Electronic Sortable Spreadsheet: Unless exempt from this requirement, a specific provision mandates the provision of an electronic sortable spreadsheet containing relevant traceability information. This spreadsheet must be provided to the FDA within 24 hours of a request. The provision of the spreadsheet can be delayed to a reasonable time agreed upon by the FDA if necessary to assist the FDA during an outbreak, recall, or other threat to public health.

Technology Can Help with FSMA 204

Since the emphasis of the Final Rule is on information to track and trace food safety, objective data about the internal quality of food can be helpful. Loss of fresh produce in the supply chain before it reaches the consumer is higher than in other food types since they are perishable and sensitive. Microbial spoilage is a common risk that affects quality and makes fresh produce unsafe. Contamination can occur at harvesting and initial packaging and worsen under improper storage conditions.

Attributes like internal and external color detected by near-infrared spectroscopy tools like Felix Instrument- Applied Food Science’s F-750 and F-751 range can help describe the product, a KDE for initial packaging and transformation. Also, monitoring the storage gas atmosphere with gas analyzers regarding the three gases ethylene, carbon dioxide, and oxygen can provide clues on reasons for fresh produce spoilage for tracking, tracing, and maintaining holding measures to aid the new Final Rule.

Source

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Karanth, S., Feng, S., Patra, D., & Pradhan, A. K. (2023). Linking microbial contamination to food spoilage and food waste: The role of Smart Packaging, spoilage risk assessments, and date labeling. Frontiers in Microbiology, 14. https://doi.org/10.3389/fmicb.2023.1198124

Keogh, J.G., Manning, L., & Simske, S. (2023, April 10).  Global Food Chain Traceability—Reflections on the Past, Present, and Insights into Future Directions. Retrieved from https://www.food-safety.com/articles/8494-global-food-chain-traceabilityreflections-on-the-past-present-and-insights-into-future-directions

Nicholas, K. (2023, Feb 3). FDA Releases the Food Traceability Final Rule. Retrieved from https://foodsafetyprocessors.ces.ncsu.edu/2023/02/fda-releases-the-food-traceability-final-rule/

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