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Food recalls in the United States have reached alarming levels in 2024, underscoring significant gaps in how food products are handled, traced, and documented. In November, organic carrots and baby carrots were recalled due to an E. coli outbreak, tragically leading to 1 death and 15 hospitalizations. Just a month earlier, yellow slivered onions linked to fast-food chains were pulled from shelves after another E. coli outbreak, resulting in 1 death and over 30 hospitalizations. In September, the FDA investigated a massive salmonella outbreak tied to more than 4 million eggs. Even green onions saw a voluntary recall in October, with over 1,200 cases removed from circulation.
These examples show the vulnerabilities in handling fresh produce, which involves relatively simple processing steps like harvesting, cleaning, sorting, and packaging—all typically occurring in one facility. When we consider more complex products like toaster waffles, deli meats, or cheeses (all of which faced recalls in October due to Listeria contamination), the risk multiplies.
The recent wave of food recalls highlights the critical need for enhanced traceability, as inadequate protocols and poor documentation create dangerous gaps in the food supply chain—jeopardizing consumer safety and exposing manufacturers, processors, and packagers to significant risks.
FSMA Rule 204 is thus not just a regulatory requirement; it’s a lifeline for protecting public health and maintaining business continuity.
In addressing broken food traceability challenges, the rule empowers businesses to safeguard their customers, streamline operations, and reduce vulnerabilities. Let’s explore what this regulation means for your operations, the documentation required, and the risks of falling short in compliance.
The FDA's Food Traceability Final Rule strengthens food safety by requiring enhanced traceability records for foods on the Food Traceability List (FTL). This rule applies to manufacturers, processors, packagers, and others handling FTL foods, aiming to speed up the identification and removal of contaminated products to reduce foodborne illnesses and deaths.
A key element of the rule is maintaining Key Data Elements (KDEs) tied to Critical Tracking Events (CTEs) throughout the supply chain. These records, covering activities like receiving, processing, and shipping, must be accessible to the FDA within 24 hours of a request. This standard applies to domestic and foreign entities supplying food to the U.S., creating a unified system to safeguard public health.
Businesses must meet the rule’s requirements by January 20, 2026. Start now by assessing gaps, creating a traceability plan, and collaborating with supply chain partners to ensure compliance. FSMA Rule 204 is not just a requirement—it’s a step toward a safer and more reliable food system.
Despite advances in food safety, significant gaps in current traceability methods leave the supply chain vulnerable to inefficiencies and risks. These shortcomings, particularly in meeting FSMA Rule 204 requirements, highlight the urgent need for more robust systems to ensure both consumer safety and compliance:
Addressing the gaps in current traceability methods is essential for creating a transparent and responsive system that not only meets FSMA Rule 204 requirements but also safeguards consumers and businesses.
After more than twenty years of software-based food traceability systems being in existence, food retail companies are still complaining about not believing traceability data. This is because many food traceability systems use less than optimal ways, such as surveys or data integration and mining methods to collect data from suppliers beyond tier 1. Issues with surveys as a means of data collection are manifold and not limited to low response rates, not cost-scalable to all tiers, and incorrect data due to respondents in compliance often do not belong to the operations group. Downsides depending on integrating data from existing systems include and are not limited to: bad and missing source data and unsuitability to the millions of small and micro suppliers with different technology stacks.
Peer Ledger’s Traceability Platform is a cutting-edge solution designed to address such critical gaps and deficiencies in present-day food traceability systems while meeting the rigorous demands of FSMA Rule 204. Peer Ledger uses a new approach to collect and assure bilaterally validated data across every supplier tier. Unlike basic solutions that rely on incomplete data, Peer Ledger delivers unparalleled value through its embedded governance processes that ensure the integrity of collected data, enhance transparency, improve compliance, and safeguard public health. With the 2026 compliance deadline approaching, Peer Ledger empowers food companies to gain new traceability capabilities, ensuring they are prepared to meet evolving food safety challenges.
Features and Use Cases
FSMA Rule 204 introduces Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as the backbone of its traceability framework. These requirements ensure comprehensive tracking of food items through every stage of the supply chain, providing the FDA with the tools to rapidly trace contaminated food back to its source.
Understanding Critical Tracking Events (CTEs)
The rule identifies seven CTEs where recordkeeping is mandatory and which Peer Ledger digitizes:
Each event requires specific KDEs to document essential details like product identification, dates, and locations.
The Traceability Lot Code (TLC) is central to FSMA Rule 204. This unique alphanumeric identifier links a specific food lot to its source, providing clarity and consistency across the supply chain.
When to Assign a Traceability Lot Code
A TLC must be assigned during:
Once assigned, the TLC remains unchanged unless the food undergoes transformation. This continuity allows for accurate tracking and efficient identification during recalls or outbreak investigations.
How TLCs Drive Efficiency
TLCs allow the FDA to skip intermediary steps during outbreak investigations, linking foods directly to their origins. Peer Ledger’s Traceability platform can give the FDA the ability to know all suppliers within a food item trace in milliseconds. Its precise tracking minimizes the scope of recalls, limits food waste, and protects public health.
Sharing TLCs Across the Supply Chain
While TLCs don’t need to appear on food labels or packaging, they must be communicated effectively. Options include:
Peer Ledger enables secure sharing of any business documents on one scalable immutable platform, sends notification emails, texts, or via other web hooks on shipments and recalls, and digitally links QR codes on products to traceability records on the Peer Ledger platform.
A robust traceability plan is mandatory under FSMA Rule 204. It outlines how your business identifies, tracks, and manages foods on the Food Traceability List (FTL).
Key elements of a traceability plan that must be included:
Peer Ledger’s provides a single platform that digitizes procedures for record-keeping, keeping your inventory of FTL identifiable, record of TLC assignments, point of contact, and farm and field maps.
Compliance with FSMA Rule 204 isn’t just about meeting legal requirements—it’s a cornerstone for safeguarding public health, maintaining business continuity, and strengthening consumer trust. By implementing a robust food traceability system in compliance with Rule 204, manufacturers, processors, and packagers can quickly pinpoint and address safety concerns, minimizing the impact of foodborne illnesses and recalls. This proactive approach reduces business disruptions and demonstrates a commitment to food safety that resonates with retailers and consumers alike, building trust in your brand in an increasingly transparent market.
On the flip side, non-compliance can lead to severe consequences that jeopardize both your operations and reputation. Regulatory penalties such as warning letters, fines, or product seizures can cripple your business. Insufficient traceability makes it harder to identify contamination sources, often leading to broader, more costly recalls that waste product and tarnish your brand image. Non-compliance also risks market disruption, as retailers and distributors prefer partners who prioritize food safety, potentially cutting off your access to critical markets. Moreover, news of foodborne illnesses tied to your products can shatter consumer trust and cause long-term reputational harm.
Compliance with FSMA Rule 204 is not optional—it’s a strategic imperative for mitigating risks, protecting public health, and ensuring your business thrives in today’s accountability-driven food industry.
FSMA Rule 204 compliance isn’t just about avoiding penalties—it’s about safeguarding the future of your business and the trust of your consumers. By embracing robust traceability practices, manufacturers, processors, and packagers can turn compliance into a strategic investment in food safety, transparency, and operational resilience.
Peer Ledger offers more than just compliance solutions; it transforms the way businesses approach traceability and sustainability. With advanced tools like real-time data sharing, ESG reporting, and secure supply chain governance, Peer Ledger empowers companies to thrive in a demanding regulatory environment while fostering trust across the food industry.
Take the next step toward seamless compliance and enhanced food safety. Reach out to Peer Ledger today for expert guidance and innovative tools to simplify FSMA Rule 204 compliance and protect what matters most—your business and your consumers.
