What led to the Food Safety Modernization Act (FSMA)?

• Frequent and severe foodborne illness outbreaks
• Inadequacies of existing food safety regulations (some nearly a century old)
• Substantial human and economic costs of outbreaks
• High-profile incidents before FSMA:
• Salmonella outbreak linked to peanut products in 2008
• E. coli contamination in spinach in 2006

With the primary goal of preventing foodborne illnesses and ensuring the safety of the nation’s food supply, FSMA introduced a comprehensive set of regulations and standards.

Among its various provisions, Section 204 stands out as a crucial component, especially concerning fresh food retailing and supermarkets.

Section 204: Enhancing tracking and tracing of food and recordkeeping

• What: The final section of FSMA to receive rules from the FDA.
• Goal: Expedite the identification and removal of potentially contaminated food from the market; reduce the risk of widespread outbreaks.
• How: Enhancing traceability in the food supply chain.
• When: Finalized in 2020; to be enforced in 2026.

What is traceability?

The ability to trace the movement of food products through various stages of production, processing, and distribution.

A deep dive into FSMA 204

“The existing FDA requirements were promulgated under the Bioterrorism Act and are referred to as the ‘one at the one back record keeping requirements,’” said Katie Vierk, Director, Division of Public Health Informatics & Analytics, Office of Analytics and Outreach, and Traceability Workgroup Lead, Center for Food Safety and Applied Nutrition at the FDA. “But those regulations don’t cover all the sectors of the food supply chain such as farms or restaurants, there’s no uniform data collection requirements and there’s also no way to adequately link incoming products with outgoing products within a firm or between points in a supply chain. Those shortcomings have limited FDA outbreak investigations by making it difficult to get the right tracing information.” 

How does FSMA 204 help?

By requiring comprehensive record-keeping, Section 204 aims to facilitate rapid and precise traceability in the event of a foodborne illness outbreak or contamination incident.

“The final rule allows for faster identification so that we can rapidly remove potentially contaminated food from the market and can get fewer notices and deaths,” Vierk said. “The rule aims to shorten the time it takes for product to be traced from retailers and distributors back to where it originated.”

Vierk, an epidemiologist, has been at the agency for over 23 years.

“This rule is really trying to get food off the market by identifying key points along the supply chain, those critical tracking events where it’s most important to collect information, and then outlining at each of those points what specific pieces of information we need to know to understand what happened to the product at that point in supply chain and those key data elements,” Vierk said.

Certain entities in the food industry are mandated to establish and maintain records related to:

• Production
• Processing
• Distribution
• Receipt of product

What kind of detailed information is required?

• The origin of ingredients
• The processes involved in production
• The subsequent distribution channels

A group effort: FSMA 204 involves the entire fresh food supply chain

The scope of entities covered by Section 204 is extensive, encompassing not only food retailers but also facilities involved in the processing, packing and storing of food. This broad inclusivity is meant to ensure the entire food supply chain is subject to rigorous record-keeping requirements, reducing the likelihood of information gaps in the event of a food safety concern.

The provision also allows for flexibility, permitting the FDA to identify specific records necessary for different types of food facilities.

“Retailers who operate their own distribution centers and central kitchens have new record keeping requirements for every facility under Section 204,” said Randy Fields, CEO of ReposiTrak, a retail technology company focused on traceability and compliance. “This includes collecting traceability lot codes and related transaction data for every shipment of Food Traceability List products into and out of DCs and central kitchens, and into stores. Also, records must be created and retained at the central kitchens when products from the FTL are transformed into other products on the FTL. This could result in many millions of records to be generated and retained annually for even a regional retail chain.”

“All traceability records containing the required Key Data Elements as prescribed by FSMA 204 must be retained for 24 months, and the data must be sent to the FDA within 24 hours of a request,” Fields said. “Practically no retailers have systems in place to do this today.”

In addition to enhancing traceability, Section 204 emphasizes the importance of interoperable systems for record-keeping. The act encourages the use of technology and standardized formats to ensure that records can be easily accessed, exchanged, and understood by relevant stakeholders. This provision recognizes the role of modern information systems in streamlining record-keeping processes, reducing errors, and expediting response times during food safety incidents.

“The food supply chain needs to generate tens of billions of traceability records for FSMA 204 compliance, and unfortunately most retailers don’t have the technology in place to do this today, at the scale required,” Fields said. “Retailers will need to enhance existing operational systems or look for third party technologies to augment existing systems to capture data, and create and maintain traceability records.”

FDA has new powers

Section 204 also empowers the FDA to access and review these records promptly. This authority enables the FDA to conduct effective investigations and identify the source of a food safety issue efficiently. The provision also outlines specific circumstances under which the FDA may access records, including when there is a reasonable belief that a food product is adulterated and poses a threat to public health. This targeted approach ensures that the FDA’s authority is exercised judiciously while prioritizing public safety.

“Retail stores will need to capture and record certain data for foods on the FSMA 204 Food Traceability List received at the store,” said Andrew Kennedy, principal traceability advisor for iFoodDS, a food safety management solution provider. “These data elements are known as Receiving Key Data Elements and include the original producer or processor’s Traceability Lot Code and Source. Shippers, including retailer-owned distribution centers, are required to share Shipping KDEs with the stores, referred to as Retail Food Establishments in the rule.”

To ensure compliance with Section 204, the FDA is granted the authority to establish record-keeping requirements and issue regulations. This includes specifying the types of records, the appropriate time frames for retention, and the acceptable formats for documentation. The act’s flexibility allows the FDA to adapt these requirements based on the nature of the food product, the size of the facility, and other relevant factors, demonstrating a significantly more nuanced approach to regulatory oversight.

“This rule is trying to help with our prevention efforts because if we can get to the food we’re trying to remove from the shelves, we can prevent additional illnesses,” Vierk said. “We’re able to get to that point of determination and do better root cause analysis to prevent more outbreaks from happening future. Then all of this information that we collect around those points and any investigations do go into part of our risk management and the prioritization of the work that we do.”

Recordkeeping is the focus for traceability

Section 204 of FSMA is a crucial component that addresses the need for robust record-keeping in the food industry to enhance traceability and respond effectively to food safety issues.

By mandating comprehensive and interoperable record-keeping practices, the provision seeks to prevent and mitigate the impact of foodborne illnesses and contamination incidents. Through its careful balance of flexibility and regulatory authority, Section 204 contributes to the overall goal of safeguarding the nation’s food supply and protecting public health.

“Enhanced traceability will enable retailers to more quickly and accurately identify and respond to recalls or safety incidents, potentially limiting the scope of such incidents and reducing public health risks,” said Ben Miller Ph.D., executive vice president of regulatory and scientific affairs at The Acheson Group, a global food safety and public health consulting firm. “A good recent example is the Salmonella Sundsvall outbreak associated with Mexican cantaloupes. Because these cantaloupes are sometimes cut and used in a variety of cut fruit products, the time it took regulators and industry to identify all of the implicated products in the outbreak meant that additional cases of human illnesses were occurring.”

“In the future, and by using the traceability lot code information that would be associated with this type of food, investigators and industry should be able to more quickly trace implicated product forward in the supply chain and more quickly issue recalls and remove contaminated products from sale,” Miller said.

FSMA, with its pivotal Section 204, is ushering in a new era of food safety regulation in the United States. Fresh food retailers and supermarkets play a crucial role in implementing and adapting to the traceability requirements set forth in Section 204. While challenges exist, the benefits in terms of improved consumer confidence, market competitiveness and, most importantly, public health make the efforts to comply worthwhile.

As the industry continues to evolve, a commitment to proactive food safety measures remains paramount to ensuring the well-being of consumers and the sustained success of the fresh food retailing sector. Compliance with FSMA Section 204 will be a critical element of this effort.

Ron Margulis is the managing director of RAM Communications, a full-service public relations and marketing consulting company. He has more than 25 years of experience covering the food, retail, information technology and transportation industries. 

This article is an excerpt from the February 2024 issue of Supermarket Perimeter. You can read the entire Navigating Change feature and more in the digital edition here.