A Supply Chain Executive’s Guide to the Food Safety Modernization Act (FSMA)

Editor’s Note: On April 17, 2024, the U.S. Food and Drug Administration (the FDA ) published a blog outlining its final rule on Requirements for Additional Traceability Records for Certain Foods. A key component of the FDA’s New Era of Smarter Food Safety Blueprint, the final rule implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

With hundreds of U.S.-based food industry customers using Cleo Integration Cloud (CIC), our ecosystem integration solution, Cleo wanted to summarize these updates to aid our customers in becoming (or remaining) compliant with this FDA mandate and to illustrate how leveraging integrated, cloud-based EDI technology can be advantageous to the business in many other ways.

What Is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA) was passed in 2011 and is designed to bolster the safety of the food supply in the United States. This is done by proactively preventing food contamination instead of reacting to it after it occurs. The regulation is relevant to both human and animal food.

As part of the Act, the FDA included several rules that target specific points in the global food supply. These rules, particularly those in section 204 of the Act, outline efforts that must be taken to prevent food contamination.

Breaking Down FSMA 204: Food Traceability Rule

FSMA 204 allows for quicker identification and removal of contaminated (or potentially contaminated) food from the supply chain to minimize illnesses and deaths. We break down and review the rule below.

FSMA 204 Mandates

The Food Traceability Rule enforces more in-depth recordkeeping for businesses that manufacture, process, pack, and/or store foods that are featured on the Food Traceability List. These businesses must keep records containing key data elements (KDEs) regarding critical tracking events (CTEs)—which are specified by the FDA. Companies are required to keep this information on hand for at least two years and must provide it to the FDA via a spreadsheet within 24 hours of a request.

Adherence Deadline

Companies that are subject to the Food Traceability Rule must comply by Tuesday, January 20, 2026.

Who Is Impacted? 

Businesses that are subject to FSMA 204 include companies that manufacture, process, pack, and/or store foods that are featured on the Food Traceability List.

The Food Traceability List

The Food Traceability List outlines which foods require additional traceability and recordkeeping. Recordkeeping applies to both foods featured on the list, as well as foods that contain listed foods as ingredients.

Foods on the Food traceability list include:

• Cheeses, other than hard cheeses
• Shell eggs
• Nut butters
• Cucumbers (fresh)
• Herbs (fresh)
• Leafy greens (fresh)
• Melons (fresh)
• Peppers (fresh)
• Sprouts (fresh)
• Tomatoes (fresh)
• Tropical tree fruits (fresh)
• Fruits (fresh-cut)
• Vegetables other than leafy greens (fresh-cut)
• Finfish (fresh, frozen, and previously frozen)
• Smoked finfish (refrigerated, frozen, and previously frozen
• Crustaceans (fresh, frozen, and previously frozen)
• Molluscan shellfish bivalves (fresh, frozen, and previously frozen)
• Ready-to-eat deli salads (refrigerated)

Defining Critical Tracking Events (CTEs)

Critical Tracking Events (CTEs) are key milestones in the movement of food products from production to consumption. These events are indicators of progress and often serve as checkpoints to monitor and manage a food’s journey until it reaches its destination. FSMA requires in-depth reporting of CTEs that includes key data elements (KDEs). CTEs include: 

• Receipt of raw materials or ingredients from suppliers.
• Processing or manufacturing of food products, including any transformations or treatments applied.
• Packaging and labeling of food products for distribution.
• Shipping and transportation of food products to distribution centers or retail locations.
• Receipt by retailers or food service establishments.
• Sale or distribution to consumers.

Defining Key Data Elements (KDEs)

In regards to FSMA, Key Data Elements (KDEs) are specific pieces of information that are tied to particular CTEs. They provide essential information related to food products and their supply chain that are crucial for ensuring rapid traceability.
KDEs may include:

1. Product Identifiers: Unique identifiers such as lot numbers, batch numbers, or serial numbers that enable the tracking of specific food products throughout the supply chain.
2. Key Data Attributes: Essential information about food products, including their ingredients, packaging materials, production dates, expiration dates, and storage conditions.
3. Chain of Custody Information: Documentation of the entities involved in handling and transporting food products, including suppliers, manufacturers, distributors, and retailers.
4. Contact information: Details of individuals or organizations responsible for managing food safety and responding to emergencies, including their names, roles, and contact numbers.

What Is a Traceability Lot?

A traceability lot refers to a specific quantity of a food product that shares common characteristics and can be traced through the supply chain using designated key data elements (KDEs). Think of a traceability lot as a batch. These lots are tracked from their origin through various critical tracking events (CTEs) until they reach the consumer or endpoint of distribution.

What Is a Traceability Lot Code (TLC)?

A unique code is assigned to raw agricultural commodities when they are initially packed or transformed. For food sourced from a fishing vessel, traceability lot codes are created when given to the first land-based receiver. Note, TLCs remain the same throughout the foods’ supply chain journey, only changing if the food is modified.

Record-Keeping Mandates

Critical elements of traceability record keeping include:

• Preserving records for a minimum duration of two years
• Providing records to the FDA within 24 hours upon request
• Preserving records as original documents in paper or electronic formats, or as accurate reproductions
• Providing electronically sortable records upon request that will help the FDA during outbreaks, recalls, etc. 
• What Comprises a Traceability Plan (Final Rule)?

If your operations fall within the scope of the final rule's mandates, it is imperative to develop and sustain a comprehensive traceability program. This plan ought to delineate procedures for recordkeeping, strategies for pinpointing FTL products, procedures for delegating traceability lot codes when needed, and assigning a primary contact(s) for questions regarding the plan.

For entities engaged in the growing of food (e.g. produce and livestock), creating a detailed farm map that highlights where each food is cultivated is essential. This map should provide information including the geographic layout, names of fields, and precise geographic coordinates. In the case of aquaculture operations, specifics regarding containers should be documented instead of field data.

It is mandatory to periodically review and update the traceability program to ensure it mirrors current operational practices accurately. Organizations must archive former versions of the program for two years following any modification.

The Role of EDI in Food Traceability 

During a CTE, food and beverage manufacturers commonly record KDEs into their ERP or other platforms to comply with the Food Traceability electronic record requirement. Additionally, manufacturers need to obtain and record KDEs from preceding vendors in the supply chain (e.g. farmers, aquaculturists, manufacturers) and pass this information to any subsequent trading partners.

Food Traceability Without EDI

For example, imagine a manufacturer is generating EDI 856 Advance Shipping Notices (ASN) for an order. This normally requires a human to manually enter traceability KDEs for each shipment into each ASN field—a process made even more complex by the varying requirements of different customers.

The drawbacks of manual processing do not end there; not only is it expensive and time-consuming—which impacts your business scalability—but it is also prone to errors in KDEs. KDE errors can be extremely costly. For example, if a food contamination outbreak occurs or is suspected, the food and beverage manufacturer will need to provide the FDA with the required information. If errors are found in the reporting, the FDA may enforce a wider recall of goods which leads to more unusable products and lower sales. Additionally, the FDA may decide to audit a manufacturer to ensure other errors in its operations are not jeopardizing the public’s health—which can lead to further fees and criminal offenses if mistakes are found.

Food Traceability With EDI

By leveraging integrated, cloud-based EDI technology, these risks can be substantially reduced. For manufacturers, an integrated EDI system can automatically extract traceability information from your ERP or WMS and accurately fill in KDEs on crucial documents like ASNs. This technology ensures that your documents meet the necessary standards through proactive monitoring and regular mapping updates. In return, eliminating the need for manual data entry which reduces the potential for costly mistakes and ensures compliance with both trade partners and FDA regulations.

Retailers and other purchasers benefit similarly from integrated EDI technology, which allows for the efficient reception, translation, and dispatch of essential lot information directly to their ERP systems. This same technology also facilitates the acquisition of lot numbers and other crucial KDEs from 3PLs and warehouses involved in handling products on the Food Traceability List. This ensures that all necessary information is readily available when needed, particularly in the face of FDA inquiries.

In summary, EDI integration plays a crucial role in streamlining food traceability within the complex supply chain and recording KDEs by:

• Automating Data Exchanges: EDI automates the exchange of information between businesses, allowing for scalability while eliminating manual data entry and reducing errors. This ensures accurate tracking of food items, including purchase orders, invoices, and advance shipment notices (ASNs) that contain details like lot numbers and expiry dates.
• Improving Visibility: By electronically transmitting data, EDI provides real-time visibility into the movement of food products throughout the supply chain. Businesses can pinpoint the location of their products at any given time, from farm to fork.
• Achieving Regulatory Compliance: EDI helps businesses comply with food safety regulations like the FSMA in the United States. EDI ensures businesses can electronically record and transmit essential data points required for traceability, simplifying the auditing process.

Become FSMA Compliant Today with EDI

Regardless of your position within the food supply chain, adhering to the FDA's requirements for documenting and sharing traceability information is a critical responsibility. Companies that are subject to the Food Traceability Rule must comply by Tuesday, January 20, 2026. Investing in integrated EDI technology now advantageously positions your business for the forthcoming regulation by ensuring your company is running smoothly with the updated technology and processes. Additionally, the benefits of EDI extend beyond regulatory compliance, including cost reduction, enhanced sales, opportunities for new trading partnerships, and more.

EDI integration encourages FSMA compliance by helping with:

1. Traceability and Documentation: FSMA requires enhanced traceability measures to quickly trace the source of contaminated food products in the event of an outbreak. EDI facilitates the electronic exchange of standardized documents, such as electronic traceability records, certificates of analysis, and product specifications, which help in tracking and documenting the movement of food products throughout the supply chain.
2. Recordkeeping and Documentation: FSMA mandates comprehensive recordkeeping to demonstrate compliance with food safety regulations. EDI systems can automate the generation, transmission, and storage of electronic records, including production records, quality control data, and supplier documentation, streamlining recordkeeping processes and ensuring data accuracy and accessibility.
3. Supplier Management: FSMA requires companies to implement supplier verification programs to ensure the safety and integrity of ingredients and raw materials. EDI enables seamless communication with suppliers, allowing for real-time exchange of information regarding product specifications, ingredient lists, allergen information, and supplier certifications, which supports effective supplier management and compliance with FSMA requirements.
4. Risk Assessment and Management: FSMA emphasizes the importance of risk-based preventive controls to identify and mitigate food safety hazards. EDI systems can integrate with other software solutions, such as enterprise resource planning (ERP) systems and supply chain management (SCM) platforms, to enable data-driven risk assessment and management, including monitoring of critical control points, product shelf life, and temperature controls.
5. Audit and Inspection Readiness: FSMA compliance requires companies to be prepared for regulatory audits and inspections by federal agencies, such as the Food and Drug Administration (FDA). EDI facilitates the efficient retrieval and presentation of electronic records and documentation, ensuring companies are audit-ready and can demonstrate compliance with FSMA requirements during regulatory inspections.

These capabilities not only protect your business but also serve a crucial role in preventing the spread of foodborne illnesses among the public.

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Cleo Integration Cloud

Cleo’s flagship solution, Cleo Integration Cloud (CIC) provides best-in-class EDI integration capabilities that help your business become FSMA compliant. CIC also offers innovative features that will help your company succeed in other areas.

With CIC, you can:

• Achieve 10x faster trading partner onboarding by leveraging the Cleo Network and pre-built EDI and API integrations
• Perform rapid error resolution with notifications and alerts
• Automate EDI and API transactions 
• Gain in-depth visibility into any integration or transaction flow

If you’re interested in learning more about these advantages and becoming FSMA compliant using EDI technology—or you have questions about what was covered in this blog—contact us at sales@cleo.com, +1.815.282.7695, or by completing our brief form fill. And be sure to explore some of our educational resources through our content hub.