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Food safety has long been one of the issues that keeps retail CEOs awake at night. It’s not only the recalls that worry them, but also the potential for supply chain and in-store mishaps by personnel, routine sanitation, product shelf life and more. While federal, state and local governments have instituted wide-ranging regulations on the handling and transport of food products, companies are left to their own devices to ensure staff members adhere to those and other company requirements designed to reduce risk to both consumers and the corporate reputation.
The landmark Food Safety Modernization Act (FSMA) of 2011 has both increased the regulatory requirements for food handling, transport and sourcing, and refocused the industry’s attention on traumatic events like recalls. The Food and Drug Administration recently expanded its purview to focus on product visibility in the supply chain as a way to ensure compliance by all parties. On September 21, 2020, the FDA released a proposed rule to accomplish traceability in the food system from the farm to the table. The legislation falls under section 204 of FSMA (FSMA 204), and marks a new milestone for the agency’s latest initiative to increase product visibility throughout the supply chain and bolster the health and safety of all Americans.
According to FDA regulations, FSMA 204 establishes “additional traceability record keeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack or hold foods the agency has designated for inclusion on the Food Traceability List [FTL].” The requirements, which are expected to go into effect in November, will help the FDA rapidly mitigate food borne illness outbreaks and other negative health consequences.
At the heart of FSMA 204 is a “requirement for those who manufacture, process, pack or hold foods on the FTL to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).” The regulation goes on to state, “While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”
There is every indication that all fresh foods and much of the rest that’s found in a typical food store will soon have the same requirements. Right now, the FTL includes most cheeses, peanut butter, most fruits and vegetables, finfish, shellfish and ready-to-eat deli salads.
The new rule moves the industry beyond the current “one-forward, one-back” traceability that requires all trading partners to record where product came from and where it was going to. It is a component of the FDA’s New Era of Smarter Food Safety initiative, which covers the range of technologies, analytics, business models, modernization and values that are the building blocks for a safer and more digital, traceable food system.
This approach to traceability, the FDA states, enables trading partners to deploy new digitally enabled technologies and data sharing that greatly reduces the time required to detect and report food safety issues. It also creates the transparency needed to anticipate and help prevent supply chain disruptions in a public health emergency. FSMA 204 doesn’t require electronic records, but the FDA does expect the data to be available within 24 hours of a request. This requirement, coupled with the volume of KDE records created for every product in every step of its journey, makes paper record keeping an improbable task.
Could FSMA 204 compliance increase costs? The quick answer is that it can, but doesn’t have to. There is concern that the requirement for new technologies to capture the lot code, production information, traceability glossary, products shipped to/received from details, and more could impact the cost of doing business for all trading partners. An additional concern, though, is the generation and storage of enormous amounts of data.
There are currently several ways of tracking products through a supply chain. The old way of doing business is manually recording each product transfer into a spreadsheet or similar data collection device. As with most things not automated, this process is laborious and ripe for errors. Newer technologies, including line-of-sight, scan-based and radio frequency identification (RFID) systems, automate the process at a cost level suitable for only the largest companies.
Even though the FDA doesn’t require it, a centralized repository shared by the supply chain network is the responsible approach for retailers and wholesalers and is clearly the most effective path forward.
Supply chain digitization and product tracking have long-lasting business impacts by delivering safe food and reducing costs. They also help with identifying risks, building brand reputation and controlling food safety incidents.
To take advantage of these opportunities, several retailers, wholesalers and suppliers formed the Food Traceability Leadership Consortium (FTLC) to help food retail industry leaders collaborate on the development of a common and scalable food tracing solution. During its inaugural meeting last year, the FTLC established three principles to guide the response to the potential expansion of food traceability requirements:
• Minimal cost that doesn’t impact margins or price to consumer.
• Easy to adopt, use and verify in order to drive universal adoption.
• Meet or exceed FDA-proposed regulations to prepare for the future.
The FTLC is now trialing solutions that meet these goals and expects to support an inexpensive solution for FSMA 204 compliance for suppliers and a free solution for retailers and wholesalers prior to the November deadline set by the FDA for enforcement. Retailers can’t afford to wait until that time to start their journey to meeting the new requirements.
Randy Fields is chairman and CEO of Park City Group Inc., a software and services company based in Salt Lake City. He can be reached at randy@parkcitygroup.com.
