FSMA 204: A New Era of Food Traceability and Safety

The Food and Drug Administration (FDA) has recently implemented a groundbreaking Food Traceability Rule (FSMA 204), a significant step forward in enhancing food safety standards. The FDA’s enactment of the new Food Traceability Rule is a response to a critical ...

FSMA 204 traceability

The Food and Drug Administration (FDA) has recently implemented a groundbreaking Food Traceability Rule (FSMA 204), a significant step forward in enhancing food safety standards.

The FDA’s enactment of the new Food Traceability Rule is a response to a critical need for enhanced safety and transparency in the food supply chain. This initiative stems from a history of significant foodborne illness outbreaks, which have highlighted vulnerabilities in tracking and tracing food products. Traditional methods of tracking food origins and distribution paths proved insufficient during these crises, often leading to delayed responses, widespread consumer panic, and substantial economic losses for the food industry.

The rule is part of the broader FDA Food Safety Modernization Act (FSMA), which represents a paradigm shift from reacting to food safety incidents to preventing them.

By requiring more detailed record-keeping and traceability for certain high-risk foods, the FDA aims to rapidly identify and isolate the source of contamination during an outbreak, thereby minimizing public health risks and ensuring quicker, more targeted recalls. This proactive approach not only protects public health but also bolsters consumer confidence in the food supply, ensuring that food safety is maintained from farm to table.

Here’s what you need to know:

Overview of the New Rule

The rule introduces additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods listed on the FDA’s Food Traceability List (FTL). These requirements are designed to trace critical tracking events (CTEs) in the supply chain of designated foods, including their packing, shipping, receiving, and transformation.

Critical Tracking Events (CTEs)

Under this rule, specific events in the food supply chain, known as Critical Tracking Events (CTEs), require maintaining records with Key Data Elements (KDEs). The CTEs include:

  1. Harvesting: Activities on farms or farm mixed-type facilities for removing and preparing raw agricultural commodities (RACs) for food use.
  2. Cooling: Active temperature reduction processes like hydro cooling or vacuum cooling for RACs.
  3. Initial Packing: First-time packing of an RAC, excluding foods from fishing vessels.
  4. First Land-Based Receiver: The first entity taking possession of food from a fishing vessel on land.
  5. Shipping: Arranging the transport of food from one location to another, excluding direct consumer sales or food donations.
  6. Receiving: Taking possession of food after transport, including intracompany shipments.
  7. Transformation: Manufacturing or processing that changes a food or its packaging when the output is on the Food Traceability List (FTL).

Traceability Lot Code (TLC)

Businesses must assign a unique Traceability Lot Code (TLC) to FTL foods during initial packing, first land-based receiving, or transformation. This code, often alphanumeric, ensures traceability throughout the supply chain.

Traceability Plan

Entities subject to this rule must establish and maintain a traceability plan detailing:

  • Recordkeeping procedures, including format and location of records.
  • Methods to identify FTL foods and assign TLCs.
  • A point of contact for traceability-related queries.
  • For farms, a detailed farm map indicating the growing or raising areas.

Additional Requirements

  • Records must be original, legible, and well-preserved, with electronic records having valid links.
  • Upon FDA’s request, records and an electronic sortable spreadsheet with traceability information must be provided within 24 hours or a reasonable agreed time.

Purpose and Benefits

  • Rapid Response: By maintaining detailed records, the FDA can quickly identify the recipients of foods implicated in foodborne illness outbreaks.
  • Preventive Measure: The rule is a proactive approach to prevent or mitigate the spread of foodborne diseases.
  • Consumer Safety: Enhanced traceability ensures greater consumer protection against health threats from adulterated or misbranded foods.

Key Compliance Dates

The rule officially took effect on January 20, 2023. However, the FDA will not be enforcing compliance until January 20, 2026, at which point all persons subject to the Food Traceability Rule must be compliant.

Impact on Small Businesses

Recognizing the diverse landscape of the food industry, the FDA has also released a Small Entity Compliance Guide. This guide offers a comprehensive breakdown of the rule, providing clarity and guidance to small businesses on how to navigate these new requirements.

Action Steps for Compliance

  1. Review the Food Traceability List: Familiarize yourself with the foods on the FTL to determine if your business is impacted.
  2. Understand Recordkeeping Requirements: Ascertain the specifics of the recordkeeping process for the critical tracking events associated with your products.
  3. Implement Changes: Adjust your current tracking and recordkeeping systems to comply with the new regulations.

Looking Ahead

The FDA’s Food Traceability Rule marks a significant stride in food safety. It underscores the importance of transparency and accountability in the food supply chain. As the industry adapts to these changes, we can expect to see a stronger, more resilient food system, ultimately benefiting both businesses and consumers.

For businesses in the food industry, staying ahead of regulatory changes is crucial. This new rule is not just a compliance requirement but an opportunity to enhance food safety and consumer trust. Let’s embrace these changes for a healthier future!

FoodReady has FSMA 204 Consultants which can make compliance with FSMA 204 an easy task. 


Begin by reviewing the FDA’s Food Traceability List to identify if your products are covered under the new rule. Next, understand the requirements for recording Critical Tracking Events and Key Data Elements associated with your products. Finally, assess your current traceability system to identify necessary adjustments to meet the new regulations.
A Traceability Lot Code (TLC) is assigned to identify foods on the Food Traceability List during critical handling stages, such as initial packing or transformation. This unique identifier enables precise tracking of food products through the supply chain, facilitating quick identification and action in the event of a food safety concern.
Businesses must comply with the FDA’s Food Traceability Rule by January 20, 2026. Non-compliance may result in enforcement actions by the FDA, including recalls, fines, or legal action, and can significantly impact a business’s reputation and consumer trust.

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Radojka Barycki

Radojka Barycki is an Award-Winning Quality Assurance, Food Safety, Training and Consulting Professional with 24+ years’ experience with demonstrated success in the development, implementation, and improvement of Quality and Food Safety Management Systems (SQF, BRCGS, FSSC2200)
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