Amid growing concerns over food safety and supply chain resilience, the implementation of the Food Safety Modernization Act Rule 204 marks a pivotal moment in the ongoing evolution of regulatory standards.
As food industry stakeholders brace for the impact of these new guidelines, questions arise about their effectiveness in safeguarding consumer health, streamlining compliance and addressing emerging challenges.
Section 204 of the FDA Food Safety Modernization Act mandates that the Food and Drug Administration identify foods warranting extra recordkeeping measures essential for safeguarding public health. These additional recordkeeping requirements, as delineated in the Food Traceability Final Rule, aim to expedite the detection and swift elimination of potentially tainted food products from circulation.
Ultimately, this initiative seeks to mitigate the incidence of foodborne illnesses and fatalities. The compliance date for all persons subject to the recordkeeping requirements is Jan. 20, 2026.
The Kroger Co. is embarking on a mission to establish an industry benchmark, striving for full compliance with FSMA Section 204.
As part of this endeavor, Kroger has released a Food Traceability Policy and Requirements document that details necessary actions suppliers must undertake to ensure compatibility with Kroger's traceability infrastructure. Kroger aims to use GS1 standards for gathering and documenting traceability data on all food items received at its facilities.
Additionally, the retailer has set a compliance deadline of June 30, 2025, which is six months ahead of the FDA's compliance deadline for FSMA Section 204.
Steps retailers can take to ensure compliance
Kelleher Consultants says it works with large and small food companies throughout the supply chain so they can focus on delivering the best food safety and quality for their customers. This includes working with retailers, manufacturers, processors, primary producers, foodservice, distributors, wholesalers, startups and third-party service providers.
“For me, it's about helping companies build sustainable food safety and quality programs with a focus on prevention,” Gillian Kelleher, CEO and president of Kelleher Consultants, told The Packer.
Kelleher advises retailers and individuals in the produce sector to refer to the recently released PTI FSMA 204 Implementation Guidance document for guidance on produce traceability and compliance within the FSMA Section 204 regulations.
"I would direct retailers to read their part because it breaks down whatever part of the supply chain that you’re in and explains, ‘here is what you should do,'" she said.
When it comes to produce handling, storage and transportation, she recommends reading FMI’s Produce Safety Best Practices Guide for Retailers.
"Within the industry, a lot of us are members of these organizations, and what they are doing is helping their members with tools so they can do a better job protecting the consumer with food safety practices,” Kelleher said.
According to FMI, good agricultural practices and Hazard Analysis Critical Control Point-based food safety principles should form the foundation for a preventive approach to food safety.
“Following the release of the PTI FSMA 204 Implementation Guidance document, we're incorporating pertinent elements into businesses operations," Kelleher said. "Alongside this integration, ongoing awareness training will be imperative, ensuring teams remain abreast of evolving requirements."
FSMA 204 compliance necessitates a proactive role within organizations, he said, and understanding the significance of recordkeeping, scanning, storage and segregation processes is paramount.
"This responsibility commences from the moment goods are received at the back of the store,” Kelleher said.
Best practices for establishing rigorous quality control measures
For a diverse audience including supermarket staff, managers, maintenance personnel and food safety professionals, these produce handling best practices are engineered to seamlessly embed food safety into everyday tasks, Kelleher said.
“Effective training is crucial across all aspects of store operations, particularly in food handling procedures," she said. "From the methods employed to the timing and execution, meticulous attention is required."
This encompasses sanitation practices, including the thorough cleaning and sanitization of store departments, refrigerated cases, shelves and utensils, Kelleher said.
"Such diligence is paramount in preventing cross-contamination, ensuring, for instance, that salad preparation remains distinct from raw chicken handling," she said. "Process flow is meticulously structured to maintain segregation between raw and ready-to-eat items."
Additionally, strict adherence to time-temperature controls is imperative to prevent temperature abuse, particularly for perishable goods requiring refrigeration, Kelleher said.
"Robust record-keeping practices are integral at every stage, from receipt in the department to display on the sales floor, ensuring transparency and accountability in food safety practices," she said. "This commitment ensures that the department consistently upholds the highest standards, prioritizing customer well-being,” Kelleher said.