By Sharon Lindan Mayl 

The Food and Drug Administration has issued many of its foundational rules in the 12 years since the Food Safety Modernization Act (FSMA) was passed, but the agency’s implementation efforts continue. On Nov. 21, 2022, the FDA published the long-awaited final Food Traceability Rule, which establishes additional traceability recordkeeping requirements for those that manufacture, process, pack, or hold certain foods on FDA’s Food Traceability List (FTL).  The final rule identifies key activities or Critical Tracking Events (CTES) along the supply chain where records containing Key Data Elements (KDEs) will have to be created, maintained, and shared for these foods. These KDEs include traceability lot codes that will enable the agency to more quickly and efficiently trace food back and forward in the event of a food safety problem.

While the rule is limited in scope by statute it is still far reaching in a number of different ways.  Unlike other FSMA rules, the Food Traceability Rule applies to entities across the supply chain, from growers to retailers and restaurants, both foreign and domestic. And, while the agency cannot require end-to-end traceability, FDA intends to use the harmonized standards and common terminology established by the rule to achieve voluntary, end-to-end traceability to bring greater transparency to the supply chain.

The ability to track and trace foods across the supply chain is important for a number of reasons.  First and foremost, it can protect public health by identifying recipients of unsafe foods more quickly and efficiently, allowing for more rapid recalls and warnings to consumers. Second, and as a consequence to the first, the ability to being able to identify and remove unsafe food quickly can help to reduce a company’s risk of liability when food safety events occur. Third, being able to quickly identify the source of foodborne illness outbreaks and other contamination events can also help prevent food producers from being unfairly impacted by recalls and advisories about contaminated foods that have nothing to do with them. Recall past outbreaks that wiped all romaine lettuce from store shelves because the problem suppliers could not be identified quickly. Lastly, enhanced food system traceability can help anticipate disruptions in the food supply chain and improve inventory control. This could avoid the kind of problems seen with the recent infant formula crises and during the early days of the Covid-19 pandemic, when foods and other consumer items were not necessarily scarce overall, but in the wrong place at the wrong time (e.g., restaurants and hotels had food that stores were lacking, leading to food waste).  

The FDA’s final Food Traceability Rule is the first step to achieving end-to-end traceability throughout the supply chain. While many companies currently have established tracing systems, the systems are not always interoperable, thus hindering the ability to trace foods from farm-to-table. This final rule creates the foundational components that will allow the food system to speak the same traceability language and can be used by the technology sector to develop software for this rapidly growing market.  

Three years may seem like a long time to prepare for compliance but there is much to be done during that time, both on the part of the agency and industry. This rule is complicated. The agency has posted a great deal of user-friendly materials on its website, including an interactive tool to help determine if and how an exemption applies. However, additional materials from the FDA will be needed to better understand how the rule applies in particular situations. For example, comingled produce will present challenges to initial packers. Retail and restaurants will not only have to figure out which of their tens of thousands of SKUs are on the FTL, but also determine how to deal with food “transformed” at the retail level, some of which may be by separate entities that contract space. The agency has promised to provide further outreach, education, and technical assistance and industry should reach out to the agency to let them know where confusion lies.

Internally, the FDA has additional work to do around its compliance program. While the rule requires entities to furnish records within 24 hours of an agency request during a food safety event, the agency will be doing routine inspections of records to ensure that firms have their traceability programs in place. The agency will need to work with its state and local regulatory partners to determine how to oversee compliance with this rule and train investigators on inspection protocols. As with other FSMA rules, the agency has stated that it will utilize its “educate while we regulate” approach, so we can expect initial inspections to be interactive, focusing on ways to bring firms into compliance rather than initiating enforcement actions. Beyond inspections, the agency will also need to ensure its IT systems can receive the requested data quickly and efficiently when requested during food safety events, and that any new systems are compatible with industry practices.  

The FDA will also continue its work under the agency’s New Era of Smarter Food Safety Initiative, which seeks to utilize this rule as the foundation for encouraging industry to adopt end-to-end traceability. Along these lines, the agency is engaging not only with the traditional food industry, but also with non-traditional stakeholders to create financial models that will enable food firms of all sizes to achieve full traceability in a scalable, cost-effective way, focusing on interoperability across a variety of technology solutions. One noteworthy example is FDA’s “Low- or No-Cost Tech-Enabled Traceability Challenge” in June of 2021, which was intended to encourage participation from new types of stakeholders, including technology providers, entrepreneurs, and innovators, to develop traceability hardware, software, or data analytics platforms that can be adopted by small and medium firms.  

While the agency continues its work, the food industry needs to begin preparing for the 2026 compliance date. First, firms must take the time to fully understand the rule itself, how it applies to their businesses — including whether any full or partial exemptions apply — which critical tracking events they perform, and what KDEs are required. It is important to note that some businesses may conduct more than one critical tracking event. Second, businesses need to look within their companies to determine what data they currently have and/or receive from their supply chain partners and how that data is maintained it (e.g., systems). Third, firms need to begin talking to their supply chain partners to ensure a full understanding of what is needed to comply and how to get there. Will contracts need to be amended to ensure all supply chain partners are keeping and sharing required data?  How will that data be shared?  How will companies assist smaller suppliers, including foreign entities, in meeting their obligations under the rule?  There are countless issues that will need to be worked out and it is not too early to begin those conversations. 

If firms decide that electronic data storing and sharing is desired, they will also want to begin discussions with technology providers well in advance of the compliance date. The rule does not prescribe any particular technology and there are many technology providers out there eager to sell their wares. Firms should engage carefully. Not all technology providers will have the knowledge and experience needed to facilitate compliance with this rule. Be sure the vendor has taken the time to fully understand the rule and the technology offered has the ability to meet needed regulatory requirements. Create a list of questions that will help clarify their capabilities and talk to several before making a decision. 

Lastly, as businesses begin to explore the road to compliance, they may determine that some of the rule’s provisions create unnecessary and/or undue burdens. The rule outlines procedures to request modified requirements or an exemption for a food or type of entity from the requirements of the rule, as well as procedures to request a waiver from one or more requirements due to undue economic hardship on an individual entity or type of entity. The FDA will consider the public health impact of such requests, as well as the impact that any waiver would have on the FDA’s ability to trace products during a food safety event. Notably, the FDA has expressed willingness in the past to reconsider certain provisions in the FSMA final rules in the face of industry hardships, including the agricultural water standards and the “customer provisions” of the supply chain requirements around written assurances that hazards will be controlled before food reaches consumers. Regardless of which pathway is being considered, industry should first engage with the agency to discuss their concerns.  

The bottom line is that industry should begin preparing for compliance now. The road ahead is a long one, even for those that have a head start. And, as you move toward compliance, it is important to keep an eye toward the FDA’s longer-term goal of end-to-end traceability, bearing in mind that expanded transparency in the supply chain can reap additional benefits for industry and consumers.  

About Sharon Lindan Mayl: Sharon is a partner in DLA Piper’s Food & Drug Administration practice. As a prominent and highly experienced former senior FDA official with more than 25 years of experience at the agency, Sharon has a deep wealth of knowledge in the areas of food safety, imports, third-party audits, nutrition, dietary supplements and cannabis products. She applies her high-level experience working within the FDA with companies and businesses within the food, beverage and consumer goods sector.