The Food Safety Modernization Act (FSMA) represents a fundamental shift in food safety regulation, moving from a reactive approach to preventive measures that help minimize foodborne illness outbreaks. A key component of FSMA is Rule 204, also known as the Food Traceability Rule, which establishes stricter record-keeping and traceability requirements for high-risk foods.

Enacted in response to recurring foodborne illness outbreaks, FSMA Rule 204 ensures that businesses handling high-risk foods—including fresh produce, seafood, dairy, and deli salads—can quickly track and trace products throughout the supply chain. The goal is to identify contamination sources faster, prevent widespread outbreaks, and protect public health.

To achieve this, businesses must:

• Maintain detailed records of food movement at critical points in the supply chain called critical tracking events.
• Assign Traceability Lot Codes (TLCs) to high-risk foods to link records across tracking points.
• Establish a traceability plan outlining recordkeeping, food identification, and reporting procedures.
• Provide traceability data to the FDA within 24 hours upon request.

Key Takeaway

Businesses that handle foods on the FDA’s Food Traceability List (FTL) must implement enhanced record-keeping and tracking systems to ensure compliance with FSMA Rule 204 before the January 20, 2026 deadline. Early adoption of robust traceability measures will not only help businesses meet regulatory requirements but also strengthen food safety and consumer trust.

FSMA Rule 204 Compliance: Who is Affected?

FSMA Rule 204 applies to a broad range of businesses across the food supply chain. Any entity that produces, processes, packs, holds, or distributes foods listed on the FDA’s Food Traceability List (FTL) must comply with the rule’s enhanced recordkeeping and traceability requirements.

Businesses Subject to FSMA Rule 204

The rule impacts companies at multiple points in the supply chain, including:

• Farms – Growers and producers of certain raw agricultural commodities.
• Food Manufacturers & Packers – Facilities that transform raw ingredients into consumer-ready products or simply package or label.
• Warehouses & Distributors – Businesses handling the storage of FTL-listed foods.
• Retailers & Foodservice Operators – Grocery stores, restaurants, and other establishments selling food directly to consumers.

If a business touches an FTL food at any stage—from production to sale—it must maintain detailed tracking records to ensure compliance.

Exemptions & Special Considerations

While FSMA Rule 204 has a broad reach, certain businesses and operations may qualify for exemptions, including:

• Small Farms & Low-Risk Producers – Some small-scale operations are exempt based on production volume and risk level.
• Direct-to-Consumer Sales – Farmers’ markets, roadside stands, and some direct sales models may have different requirements.
• Certain Low-Risk Activities – Businesses that handle minimal processing or distribution of FTL foods may be partially exempt.

Key Takeaway

Most food supply chain businesses must comply with FSMA Rule 204, making it critical to review the Food Traceability List and assess whether their products, operations, or exemptions apply. Early compliance planning ensures smoother implementation before the January 20, 2026 deadline.

Food Traceability List (FTL): High-Risk Foods That Require Compliance

The Food Traceability List (FTL) identifies high-risk foods that require enhanced tracking under FSMA Rule 204. These foods have been linked to recurring foodborne illness outbreaks, making traceability a priority for public safety and regulatory enforcement.

What Foods Are on the FTL?

The FDA’s Food Traceability List includes, but is not limited to:

• Dairy: Soft and semi-soft cheeses (ricotta, feta, blue cheese, mozzarella, brie).
• Eggs: Shell eggs from chickens.
• Fresh Produce: Leafy greens (romaine, spinach, kale), tomatoes, cucumbers, melons, sprouts, fresh-cut fruits and vegetables.
• Seafood: Fresh and frozen finfish (tuna, salmon, cod), crustaceans (shrimp, crab, lobster), and bivalve mollusks (oysters, clams, mussels).
• Processed Foods: Ready-to-eat deli salads (potato, egg, seafood).

Key Takeaway

If your business grows, processes, packs, ships, or sells any FTL-listed foods, you are subject to FSMA Rule 204’s traceability requirements. Understanding which products fall under these stricter regulations is the first step toward compliance.

Key FSMA 204 Requirements: What Businesses Must Do

To comply with FSMA Rule 204, businesses handling foods on the Food Traceability List (FTL) must implement a structured traceability system that allows for rapid identification of food origins, movements, and risk points. The four core requirements include:

1. Maintain Detailed Traceability Records

• Track Critical Tracking Events (CTEs) and Key Data Elements (KDEs) at each stage of the supply chain.
• Keep comprehensive records for at least two years to ensure full traceability.

2. Assign Traceability Lot Codes (TLCs)

• Apply unique lot codes to high-risk foods at designated handling points, such as initial packing or processing.
• Ensure these codes link back to traceability records, allowing seamless tracking from production to sale.

3. Implement a Traceability Plan

• Establish a formal strategy outlining:
  • Recordkeeping procedures and data management.
  • Methods for identifying FTL-listed foods.
  • Assignment and tracking of TLCs.
  • A traceability map (required for farms) detailing food production areas.

4. Ensure Rapid Response to FDA Requests

• Be prepared to submit traceability records within 24 hours of an FDA request.
• Maintain records in a sortable electronic format for quick retrieval and regulatory review.

Key Takeaway

Businesses must proactively establish a robust tracking system to meet FSMA Rule 204 compliance before the January 20, 2026 deadline. Implementing strong traceability measures now will reduce compliance risks and enhance food safety across the supply chain.

Critical Tracking Events (CTEs) and Key Data Elements (KDEs) Explained

At the core of FSMA Rule 204 compliance are two essential components: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). These ensure that businesses can accurately track food movement across the supply chain and quickly respond to food safety incidents.

What Are Critical Tracking Events (CTEs)?

CTEs are specific points in the supply chain where food undergoes a key transformation, transfer, or handling process. At these stages, businesses are required to record and maintain detailed traceability data.

Examples of CTEs:

• Harvesting – Initial collection of raw agricultural commodities.
• Cooling – Lowering food temperature for preservation.
• Packing – Placing food into containers for distribution.
• Shipping – Moving food between locations (excluding direct-to-consumer sales).
• Receiving – Taking possession of food from another entity.
• Transformation – Changing a food’s form, processing, or packaging.

What Are Key Data Elements (KDEs)?

KDEs are the specific pieces of information that must be recorded at each CTE to ensure complete traceability. These data points provide essential details about food origin, movement, and handling.

Examples of KDEs:

• Traceability Lot Code (TLC) – Unique identifier for tracking food products.
• Product Description – Name and type of food being handled.
• Transaction Details – Who shipped, received, or transformed the product.
• Timestamps – When each event occurred.
• Location Data – Where the food was harvested, packed, processed, or sold.

Key Takeaway

Understanding and documenting CTEs and KDEs is fundamental to FSMA Rule 204 compliance. Businesses must ensure that each food product’s movement and transformation are accurately recorded, enabling fast and efficient traceability in the event of a recall or safety issue.

Compliance Timeline: When Do Businesses Need to Act?

FSMA Rule 204 is already in effect, but businesses have a limited window to achieve full compliance before enforcement begins. Companies handling foods on the Food Traceability List (FTL) must ensure that their traceability systems, record-keeping processes, and reporting capabilities meet FDA standards by the final compliance deadline.

Key Dates to Know

• January 20, 2023 – FSMA Rule 204 officially goes into effect.
• January 20, 2026 – Mandatory compliance deadline for all covered businesses.

Why Acting Now is Crucial

• Avoid compliance bottlenecks – Waiting until the last minute may lead to supply chain disruptions and increased costs.
• Ensure system readiness – Businesses need time to update record-keeping systems, assign Traceability Lot Codes (TLCs), and train staff on new requirements.
• Minimize noncompliance risks – Failing to meet the deadline could result in regulatory action, supply chain penalties, or reputational damage.

Key Takeaway

The January 20, 2026, deadline is fast approaching. Businesses must take proactive steps now to implement traceability systems, data management protocols, and compliance strategies to avoid last-minute challenges and regulatory risks.

Compliance Strategies: How to Meet Food Traceability Requirements

With the January 20, 2026, deadline approaching, businesses must take proactive steps to ensure compliance with FSMA Rule 204. Implementing a structured approach now will help prevent operational disruptions, reduce compliance risks, and ensure food traceability standards are met.

1. Conduct a Traceability Audit

• Identify which foods in your supply chain are on the Food Traceability List (FTL).
• Determine where Critical Tracking Events (CTEs) occur in your operations.
• Assess existing recordkeeping practices to identify gaps in compliance.

2. Upgrade Record-Keeping Processes

• Transition from manual tracking to digital traceability solutions for better accuracy and efficiency.
• Ensure records are searchable, sortable, and easily accessible for FDA requests.
• Standardize data entry processes to streamline compliance efforts.

3. Implement a Traceability Lot Code (TLC) System

• Assign unique TLCs at initial packing, transformation, or receiving stages.
• Ensure all Key Data Elements (KDEs) are properly linked to TLCs at each tracking event.
• Maintain consistency across suppliers, distributors, and retailers to ensure seamless traceability.

4. Train Employees on Compliance

• Educate staff on CTEs, KDEs, and TLC requirements to ensure accurate recordkeeping.
• Conduct mock compliance audits to identify weaknesses in traceability processes.
• Develop standard operating procedures (SOPs) for tracking and reporting.

Key Takeaway

Businesses that act early by auditing their supply chain, upgrading tracking systems, implementing TLCs, and training employees will be best positioned to meet FSMA Rule 204 requirements well before the 2026 deadline. Taking a proactive approach now prevents costly compliance issues down the road.

Leveraging Technology for FSMA 204 Compliance

With FSMA Rule 204’s strict traceability requirements, businesses must adopt efficient and scalable tracking solutions to ensure compliance. Manual recordkeeping is no longer practical, making digital traceability systems essential for meeting regulatory demands, improving accuracy, and enhancing food safety.

The Role of Digital Traceability Solutions

Implementing technology-driven compliance tools can help businesses:

• Streamline data collection for Key Data Elements (KDEs) and Critical Tracking Events (CTEs).
• Automate recordkeeping & reporting, ensuring FDA compliance with minimal manual intervention.
• Enhance response times in case of recalls or FDA audits, reducing operational disruptions.

Tech Solutions for FSMA Compliance

Businesses can leverage various technologies to simplify traceability and reduce compliance burdens:

• Cloud-Based FSMA Compliance Software – Automates tracking, record management, and reporting, ensuring all traceability data is centralized and easily retrievable.
• AI-Driven Supply Chain Monitoring – Detects potential contamination risks, tracks food movement in real-time, and predicts compliance gaps before they become issues.
• Blockchain for Food Traceability – Provides an immutable ledger of food transactions, enhancing supply chain transparency and traceability accuracy.

Key Takeaway

Digital solutions significantly reduce the burden of FSMA 204 compliance by automating traceability, improving reporting efficiency, and ensuring data accuracy. Implementing AI, blockchain, and cloud-based tracking systems will help businesses stay compliant while minimizing operational risks.

Consequences of Noncompliance: What Happens if You Ignore Food Traceability?

Failing to comply with FSMA Rule 204 can lead to serious legal, operational, and financial consequences. Businesses that do not meet the traceability and recordkeeping requirements risk regulatory action, supply chain disruptions, and reputational damage that can impact long-term viability.

Legal Penalties

• Violation of Section 301(e) of the FD&C Act – Noncompliance is classified as a prohibited act under federal law.
• FDA Warning Letters & Advisory Actions – Initial enforcement typically involves compliance notifications, but repeated violations may escalate.
• Potential Legal Enforcement – The FDA can take civil or criminal action against businesses that refuse to comply.

Operational Risks

• Product Recalls – Inadequate traceability can lead to delays in identifying contaminated products, causing more impact to consumer safety and forcing wider, costlier recalls.
• Loss of Supplier & Retail Contracts – Many supply chain partners require FSMA compliance as a condition for doing business.
• Reputational Damage – Public exposure of traceability failures can erode consumer trust and impact brand loyalty.

Financial Impact

• Legal Costs & Business Disruptions – While the FDA does not impose direct fines, companies may face expensive lawsuits, compliance audits, and legal fees.
• Increased Operational Costs – Businesses caught unprepared may scramble to implement compliance measures under urgent deadlines, leading to higher costs and inefficiencies.

Key Takeaway

Noncompliance is a costly risk that businesses cannot afford to ignore. Proactively implementing FSMA 204-compliant traceability systems is far less expensive than facing FDA enforcement actions, supply chain penalties, and brand damage.

How to Get Ahead of FSMA Rule 204 Compliance

With the 2026 deadline fast approaching, businesses should take action now to avoid last-minute compliance challenges. Here’s what you need to do immediately:

1. Confirm if FSMA 204 Applies to Your Business
   • Review the Food Traceability List (FTL) to see if your products require compliance.
   • Determine if your business qualifies for exemptions to avoid unnecessary regulatory burdens.
2. Schedule an Internal Compliance Review
   • Conduct a traceability audit to assess CTE and KDE recordkeeping gaps.
   • Identify areas where record retention, TLC assignment, or data collection need improvement.
3. Engage with Compliance Experts & Technology Providers
   • Consult FSMA specialists to clarify legal obligations and best practices.
   • Explore traceability software solutions to streamline compliance.
4. Develop an Implementation Roadmap
   • Set a timeline for record-keeping upgrades, staff training, and system integrations.
   • Conduct mock audits to ensure your team is ready for FDA requests.

Waiting until 2026 is not an option. Businesses should start now by conducting an internal compliance review, identifying technology solutions, and training employees to ensure a seamless transition before FDA enforcement begins.

Get FSMA 204-Ready Today

Compliance with FSMA Rule 204 is complex, but you don’t have to do it alone. Registrar Corp provides the expertise and consulting needed to simplify traceability, reporting, and FDA compliance.   Contact Registrar Corp today to get started on securing your supply chain before the 2026 deadline.