FSMA Rule 204 Updated: What Restaurants Need to Know Right Now

The Food Safety Modernization Act (FSMA) was signed into law in January of 2011 and expanded the Food and Drug Administration (FDA)’s authority to regulate the way foods are grown, harvested and processed. The FSMA 204 has already been launched, and the final section of the law, FSMA 204, will come into effect in 2023 with a food traceability record compliance date of 2025. This last initiative is perhaps the most urgent for food businesses and requires immediate attention. FSMA Rule 204 allows the FDA to request Critical Tracking Events (CTE) and the business must respond within 24 hours.  The FDA Food Traceability list includes food items such as leafy greens, tomatoes, melons, tomatoes, nut butters, ready-to-eat deli salads, finfish and crustaceans, and all types of fresh-cut fruits and vegetables, among nearly twenty categories of common fresh and processed foods.

Therefore, across the supply chain, food industry leaders need to prepare now – and that includes restaurant executives.

The Roots of FSMA 

Let’s take a step back. The FSMA was prompted after many reported incidents of foodborne illnesses during the first decade of the 2000s and was largely crafted by members of the Grocery Manufacturers Association. Tainted food has cost the food industry billions of dollars in recalls, lost sales, and legal expenses.

The FSMA and associated regulations, is the most sweeping reform of the food safety regulatory system in the USA in more than 70 years. The FSMA confirms the primary role of the producer, processor, transportation, distributor, and retail outlet in assuring food safety, requiring the food industry to conduct risk-based hazard analysis and implement preventive controls to minimize identified hazards, and applies to domestic as well as imported foods.

The actual genesis of this initiative was the Bio-Terrorism Act of 2002 which regulated “1 up 1 down” traceability which is now the de facto standard. Sparked by the death of an individual who died from a tainted spinach E. coli outbreak, it impacted the leafy greens industry by lowering consumer confidence in the spinach supply and led to stricter federal regulations on the industry.

According to the World Health Organization (WHO), currently each year worldwide, unsafe food causes 600 million cases of foodborne diseases and 420 000 deaths. 30 percent of foodborne deaths occur among children under five  years of age. WHO estimated that 33 million years of healthy lives are lost due to eating unsafe food globally each year, and this number is likely an underestimation.  

Compounding this risk, food items have become more complex, along with many new innovations in food, so FSMA was indeed needed. The FSMA enables the FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

The Growth of Digital Traceability

Fast-forward to September of 2020 when the FDA announced FSMA Rule 204, calling it an “important, critical step forward in the U.S. Food and Drug Administration’s efforts to bring about farm-to-table traceability in our food supply. The objective of Rule 204 is to ensure that each member of the food supply chain can respond in an electronic format within 24 hours to FDA requests involving food on the food traceability list.

According to Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response FSMA Rule 204 “lays the foundation for the end-to-end food traceability across the food industry” …as described in the New Era of Smarter Food Safety initiative. The goal is to “create a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.”

Why Restaurants Should Pay Attention

Although the original FSMA was heavily influenced by the grocery lobby, restaurants are clearly included in FSMA Rule 204. This fact is specifically addressed in the FDA’s own FAQs:

“Would restaurants be considered retail food establishments under the proposed rule?

Yes. As stated in the preamble to the proposed rule (see 85 FR 59984, 60002), we regard restaurants as a type of retail food establishment, as that term would be defined in proposed § 1.1310.”

FSMA section 204, Enhancing Tracking and Tracing of Food and Recordkeeping, instructs the FDA to develop additional recordkeeping requirements for certain foods to help establish clear tracing of a food product’s source when needed to address food safety risks. When FDA Commissioner Stephen Hahn and Frank Yiannis announced the New Era of Smarter Food Safety Blueprint in July of 2020, this proposed rule was presented as the bridge to the New Era electronic traceability. 

The Compliance Challenge

Under the new ruling, the FDA is requiring more comprehensive traceability through access to records of key data elements associated with critical tracking events in food production and distribution. This data will be used in both tracebacks and trace forward efforts in case of an outbreak investigation.  

Soon, the FDA will require supply chain actors to provide an electronic record of their internal CTEs (critical tracking event) within 24 hours of being contacted. The FDA is taking an approach that will standardize the data elements and information companies must establish and maintain, along with information they must send to the next entity in the supply chain. The way to achieve this traceability is through RFID technology.

The Restaurant Solution

Clearly a technology that enables accurate and efficient capture of the required Key Data Elements will propel this requirement forward in the food supply chain for all impacted supply chain partners. RFID labels, deployed at the source, facilitate the visibility of all the long list of food items and ingredients on the FDA Food Traceability List. The FDA’s goal for supply chain members is to provide their Critical Tracking Events within 24 hours of request for up to two years after the event has occurred including: originating, transformation, first receiver, transformation events, creation, movement of food within the same organization and Food Retail Establishments.

In fact, Intelligent RFID labels enable efficient First In First Expired food inventory management, recall and waste management, food safety and consumer experience – and most importantly ensures compliance with FSMA Rule 204.

How Restaurants Benefit from FSMA Rule 204 

The FDA’s goal is to “better establish linkages throughout the supply chain during a foodborne illness outbreak investigation and more quickly identify potential sources of contamination and prevent additional illness and death.”

For restaurants, the availability of the traceability records drawing on data obtained through RFID labels can limit the scope of recalls and in some instances, allow the FDA to better target consumer advice, avoiding blanket alerts on whole commodity sectors. This translates to cost-savings. Additionally, gaining speed in recalls effectively mitigates damage to a brand’s reputation when a foodborne illness investigation is in process.  

By enabling traceability these food businesses will by default inherit additional benefits such as inventory visibility, shelf life, improved order management, and other capabilities. The result is a solution that addresses the new FSMA requirement, while meeting many other needs of the industry.

Rather than viewing these demands as a regulatory burden, restaurants should see them as a way to enhance the safety of the food they serve and continue to build consumer trust in their brand.