April 7, 2021

Trustworthy Traceability

How to Comply with the Proposed Expansion of the Food Safety Modernization Act to Include Greater Food Traceability

By Kelly Smith

In 2011, the Food Safety Modernization Act (FSMA) was signed into law and became the most sweeping reform of United States food safety law in over 70 years. A primary objective of FSMA was to prevent contamination of the food supply chain, rather than simply respond to it, as was common policy in the past. As a result of FSMA, many food companies needed to enact strategies to ensure greater transparency and traceability across the food supply chain.

Today, the FDA has proposed to expand the requirements under FSMA to include additional traceability recordkeeping requirements for certain foods outlined on the Food Traceability List (FTL). The rule, titled “Requirements for Additional Traceability Records for Certain Foods,” is a key component of the FDA’s New Era of Smarter Food Safety Blueprint, under which the agency is taking a new approach to food safety, leveraging technology to create a safer, more digital and traceable food system.

At the core of the proposed rule is a requirement for organizations that manufacture, process, pack, or hold food on the FTL to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While these requirements only apply to food on the FTL (e.g. cheese, eggs, select fruits and vegetables, certain seafood) as well as any food that contains an ingredient that is on the list, the FDA encourages the voluntary adoption of these practices industry-wide. For many food and beverage companies, however, the requirement for global, ingredient-level traceability will strain existing systems, many of which were not configured for the granular insight the FDA requires.

Let’s take a closer look at the key features of the proposed rule and detail how to comply with it:

Key Feature 1 | Identify Critical Tracking Events

Under the proposal, companies that perform growing, receiving, transforming, creating, and shipping must identify critical tracking events and maintain records containing KDEs. The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs. The proposal also identifies a new role within the receiving CTE: the first receiver. The “first receiver” is the first organization that purchases and takes physical possession of a listed food, and this company would need to establish and maintain additional KDEs. Only foods that are originated—grown, raised, or caught—can have a first receiver. For instance, if a factory purchased a head of lettuce from a farm to create pre-made salad, they would be considered the first receiver and would be accountable for maintaining additional data records.

Key Feature 2 | Establish and Maintain Proper Traceability Program Records

In addition to requiring records of KDEs, the update to the FSMA would require organizations to establish and maintain proper traceability program records. These records are intended to help regulators understand an organization’s traceability program. They include:

• A description of relevant reference records. A company’s traceability program records will need to include a description of the reference records where they maintain the required KDEs. This description should cover where on the reference record the traceability information appears, and an explanation of how reference records for different tracing events for a food are linked.
• A list of foods on the FTL that are shipped. Anyone who ships food on the FTL would need to keep a list of which foods they ship, including the traceability product identifier and traceability product description for each food.
• A description of how traceability lot codes are assigned. Traceability lot codes need to be established when a food on the FTL is originated, transformed, or created. This allows a food to be traced through the supply chain. As part of a company’s traceability program records, they would need to describe how they establish and assign traceability lot codes, which is important because it will enable regulators to better understand the records they review.
• Other information needed to understand data provided within the required records. The traceability program records would need to include any other information required to interpret the data, like glossaries or abbreviations. This will help regulators understand the terminology, methods, and systems a firm uses.

Key Feature 3 | Store Records Properly and Safely

The proposed rule also requires that a company’s records be maintained as either original paper records, electronic records, or true copies. They must all be legible and properly stored to prevent damage or deterioration. For companies that manage their records manually or store data in disparate sources inaccessible to one another, this may prove challenging to execute at scale.

Key Feature 4 | Provide Records to FDA ASAP When Requested

Traceability records must be provided to the FDA as soon as possible, but no later than 24 hours after a request is made. An electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request when necessary to assist the FDA during an outbreak, recall, or other threat. For food companies with multiple farms, factories, and distribution sites, maintaining a digital record of food items may be critical in order to provide a timely response to any agency requests.

Forensic Traceability is a Must to Meet Heightened Food Traceability Standards

As the FDA proposes new requirements under the FSMA, it is critical that food & beverage companies evolve their internal systems to not only meet immediate requirements, but to proactively implement systems that can standup to evolving regulatory standards.

At Ashton Potter, we have nearly a century of experience working with governments to provide global security and traceability down to the unique product. Scalable to the billions, our ProLinc® software is optimized for the food & beverage landscape, enabling you to track individual products and ingredients and generate comprehensive reports on food genealogy at the click of a button. Unlike track and trace software built into ERPs, ProLinc provides traceability at the forensic level, offering the real-time, granular data your company needs to meet evolving regulatory requirements.

Speak with an expert today to learn more about what the FSMA’s new proposal necessitates, and how ProLinc can help fill the traceability gaps in your supply chain.