Food Industry Prepares for Phased-in Enforcement of FSMA Rule 204

“This is a key question that will challenge the supply chain,” says Dr. Jennifer McEntire, Founder of the Food Safety Strategy. “The Food Traceability List includes foods that contain FTL ingredients but also exempts FTL foods that have undergone a kill step; a challenge for ingredient suppliers and food processors will be to communicate how a food or ingredient has been processed to determine if the rule applies.”

Advances in testing systems allow food manufacturers to use less staff, and digital records are ready for Rule 204’s 24-hour requirement. Image courtesy of Fortress Technology

“The challenges here are new, but the patterns and frictions are recognizable,” says Wes Frierson, VP of Product Lifecycle Solutions at FoodChain ID. “Technology will play a critical role in compliance, providing platforms that streamline traceability and enhance transparency.”

Automation technology and system software adoption have been accelerating in the food ingredient, formulation and manufacturing segments for years. In the food ingredient and formulator segment, companies have adopted digital technologies in a phased-in approach for years, including data-sharing solutions and ERP platforms.  

“Supply chain partners are already responsible for exchanging a large amount of attribution for ingredients and packaging along with detailed documentation,” adds Frierson. “Ingredient and allergen declarations, chemical and physical specifications, sourcing and sustainability information, and much more must all be exchanged reliably and predictably between these partners and kept up-to-date and accurate.”

FoodChain ID offers consulting on regulatory compliance but also provides a recipe and specifications system that manages current supplier information and allows companies to update nutritional and allergen details as products evolve. More importantly, the system can connect to a company’s product lifecycle management (PLM) software.

“There is extra information with Rule 2024 that must be collected, organized, and made readily accessible, and that becomes a pain point if your business attempts to go about it manually, using pen and paper,” says Payne.

“What we have seen to be the biggest challenge for food manufacturers is attaining electronic records at the source of the raw ingredients and the initial location where the ingredients are being shipped, stored and processed,” says Dave Cirullo, Industrial Key Account Manager at Mettler Toledo.

Food producers rely more on OPC-UA and MQTT protocols to move information to data acquisition platforms and ERP systems. Image courtesy of Mettler Toledo

Flexibility with data formats

The strategy to move data across industrial networks can vary from industry to industry and even from plant to plant in the food industry. Legacy food plants have digital and analog equipment on the plant floor that sends data to historians and data acquisition systems. “Larger food companies want control of all their data, and they’re using our OPC-UA or Ethernet/IP adapters to take the inspection data from our machines at the plant floor and pull this data through to their ERP system,” says Eric Garr, Regional Sales Manager at Fortress Technology.

While food manufacturers standardize industrial networks, data governance is a challenge with many data types created in disparate divisions.

The FDA specifies the type of information or key data elements to be provided in Rule 204 but doesn’t standardize the data format. “The FDA specifies what data needs tracking but not how it should be structured,” says Frierson. “This lack of standard formats adds complexity and creates additional headwinds in collaborating with partners.”  In recent years, regulating bodies have been reluctant to dictate specific standards as they change—see cybersecurity in 2022.

With Rule 204 there are traceability lot codes (TLC) that must be applied to FTL foods and tied to all KDEs for applicable critical tracking events, and traceability plans that must include descriptions of how a company will maintain the established rules. “Additionally, all records must be maintained as originals or true copies, and they must be made available to the FDA within 24 hours of a request in the case of a food emergency,” says Payne.

Supermajors are pushing forward and see “first-mover” advantages in automating the supply chain, including shipping. Tyson recently made news by shutting down legacy food plants and announcing moving new automation investments within its business.

“Food producers also want to automate truck and rail scale transactions,” says Cirullo. “Companies are investing in our PowerCell load cells with advanced technology. This is a key component toward automating vehicle scale transactions and a path toward unattended weigh stations that remove human error, paper transactions, and create a safer truck scale environment.”

In addition, food producers are building greenfield plants to move away from retrofitting plant equipment with updated automation technology. “We’re seeing the combination of new greenfield plants and plant expansions in Virginia, North and South Carolina. The same holds true for a few western states and the Central Valley of California with Cargill, ConAgra, and Nestlé,” says Cirullo.

Walmart meets Rule 204

Walmart prides itself on being a leader in the supply chain, dating back to its introduction of RFID technology in the early 2000s. Now the company is rolling out its own enhanced food traceability requirements, which are also in line with FSMA’s Rule 204.  Walmart’s traceability requirements rely on advance shipping notices (ASNs) or EPCIS as data standards and will also require KDEs and CTEs information by using: 

• Lot and batch codes
• Production and expiration dates
• Gross and net weights
• Location information for shipping and receiving points

Walmart’s requirements and deadline correspond to FSMA’s Rule 204 Jan.20, 2026 date.

Using lot codes is already a practically universal practice, and the rule allows for many common formats (including GS1-128 barcodes and Julian date codes) to be used as the TLC for FTL foods, says Payne. “Traceability features like lot and sublot management are the key modules for tracking products by lot code.”

The truth on enforcement of Rule 204

While Rule 204’s deadline is approaching fast. The FDA has publicly stated that “education while regulating” will be the approach to such comprehensive regulation. Many food companies believe proactive enforcement won’t happen until 2027.

“I’d be surprised if many companies are 100% compliant with the rule come January 2026. For this to happen, all of their FTL foods/ingredients suppliers would have to be providing the traceability lot code and lot code source,” says McEntire. “Many processors currently track ingredients into finished products­­­­­­­­—some still on paper batch logs—but may not provide their customers the lot code and TLC source.”

However, as the technology shows, traceability does provide a first-mover advantage to food producers by growing enterprise efficiencies and removing risk to the brand by avoiding food safety incidents. Says Payne, “The rule demands a considerable amount of time and effort from businesses and their staff to record and maintain additional traceability data, but I see this as an important step forward in our new era of smarter food safety.”