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FDA's Traceability Rule: What's Next for the Agency and Industry


by Sharon Lindan Mayl

In the 12 years since the passage of the Food Safety Modernization Act (FSMA), FDA has issued many ground rules, but the agency’s implementation work continues. On November 21, 2022, FDA published its long-awaited final food traceability rule, which establishes additional traceability record keeping requirements. The final rule identifies critical activities in the supply chain, or critical tracking events (CTES), for which records containing key data elements (KDEs) must be created, maintained, and shared. These KDEs include traceability batch codes, enabling the agency to trace food back and forth faster and more efficiently in the event of a food safety issue.

While the scope of the rule is limited by statute it is still far-reaching in many different ways. Unlike other FSMA rules, food traceability rules apply to entities throughout the supply chain, from growers to retailers and restaurants, both domestically and internationally. And, while the agency cannot mandate end-to-end traceability, FDA intends to use rulemaking uniform standards and common terminology to enable voluntary end-to-end traceability, bringing greater transparency to the supply chain.

The ability to track and trace food throughout the supply chain is important for a number of reasons. First, it can protect public health by more quickly and efficiently identifying recipients of unsafe food, allowing for faster recalls and warnings to consumers. Second, and as a result of the first, the ability to quickly identify and remove unsafe food helps reduce a company’s exposure to liability in the event of a food safety incident. Third, the ability to quickly identify the source of foodborne illness outbreaks and other contamination incidents also helps prevent food producers from being unfairly affected by recalls and advisories of contaminated food that have nothing to do with them. Think back to past outbreaks where all the lettuce disappeared from store shelves because the problem supplier couldn’t be quickly identified. Finally, enhanced food system traceability can help predict supply chain disruptions in food supply chains and improve inventory control. This could avoid the kind of problems that arose during the recent baby formula crisis and the early days of the Covid-19 pandemic, when food and other consumer goods were not necessarily scarce overall, but were in the wrong places at the wrong time (e.g., restaurants and The hotel has food that is missing from the store, resulting in food waste).

FDA’s Final Food Traceability Rule is the first step towards end-to-end traceability throughout the supply chain. While many companies currently have tracking systems in place, these systems are not always interoperable, thus hampering the ability to track food from farm to fork. This final rule creates foundational components that enable food systems to speak the same traceability language and that technology departments can use to develop software for this rapidly growing market.

Three years may seem like a long time to prepare for compliance, but during that time there is a lot of work to be done, both by institutions and by industry. This rule is complicated. The agency has posted extensive user-friendly material on its website, including an interactive tool to help determine if and how an exemption applies. However, more material from FDA is needed to better understand how the rule applies in specific circumstances. For example, mixed produce will present challenges for the original packer. 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 handle food “transitions” at the retail level, some of which may be undertaken by independent entities contracting the space. The agency has promised to provide further Outreach, education and technical assistance, industry should reach out to the agency and let them know where the confusion lies.

Internally, FDA has other work to do around its compliance program. While the rule requires entities to provide records upon agency request within 24 hours during a food safety incident, the agency will conduct routine inspections of records to ensure companies have a traceability program in place. The agency will need to work with its state and local regulatory partners to determine how to monitor compliance with the rule and train investigators on inspection protocols. As with other FSMA rules, the agency has said it will use its “educate while we regulate” approach, so we can expect initial inspections to be interactive, focusing on ways to bring companies into compliance, rather than enforcement action. In addition to inspections, the agency also needs to ensure that its IT systems can quickly and efficiently receive requested data when requested during a food safety incident, and that any new systems comply with industry practices.

FDA will also continue its work under the agency’s Smarter Food Safety New Era initiative, which seeks to use the rule as a basis for encouraging industry adoption of end-to-end traceability. Along these lines, the agency is working not only with the traditional food industry, but also with non-traditional stakeholders to create financial models that will enable food companies of all sizes to achieve full traceability in a scalable, cost-effective manner , with a focus on interoperability across various technology solutions. A notable example is the FDA’s June 2021 “Low or No Cost Technology Enabled Traceability Challenge” to encourage new types of stakeholders, including technology providers, entrepreneurs, and innovators, to engage in development Traceability hardware, software, or data analytics platforms that can be adopted by SMEs.

While the agency continues to work, the food industry needs to start preparing for the 2026 compliance date. First, companies must take the time to fully understand the rule itself, how it applies to their business – including whether any full or partial exemptions apply – which key tracking events they enforce, and which KDEs are required. It is important to note that some businesses may have more than one key tracking event. Second, businesses need to look within the company to determine what data they currently have and/or receive from supply chain partners, and how that data is maintained (e.g., systems). Third, companies need to start talking to their supply chain partners to ensure they fully understand what compliance requires and how to achieve it. Will contracts need to be amended to ensure all supply chain partners retain and share required data? How will this data be shared? How will companies assist smaller suppliers, including foreign entities, to meet their obligations under the rules? There are countless issues to be resolved, and it’s not too early to start these conversations.

If companies decide they need electronic data storage and sharing, they also want to start discussions with technology providers well in advance of the compliance date. The rule doesn’t dictate any specific technology, and there are a number of technology vendors eager to sell their wares. Businesses should participate cautiously. Not all technology providers have the knowledge and experience required to facilitate compliance with this rule. Make sure the vendor has taken the time to fully understand the rules and that the technology being offered meets the required regulatory requirements. Create a list of questions that will help clarify their abilities and talk to a few people before making a decision.

Finally, as businesses begin to explore their path to compliance, they may determine that certain provisions of the rule create unnecessary and/or undue burdens. The rule outlines the procedure for requesting a modification of the requirements or for an exemption from the rule requirements for a food or entity type, as well as for an entity requesting an exemption from one or more of the requirements due to undue economic hardship for an individual entity or type of entity. FDA will consider the public health impact of such requests and the impact of any exemptions on FDA’s ability to trace products during food safety incidents. Notably, the FDA has expressed a willingness in the past to reconsider certain provisions of the FSMA final rule in the face of industry difficulties, including agricultural water standards and supply chain requirements around written assurances that hazards will be controlled in the “customer clause” in food before reaching the consumer. Regardless of which avenue is considered, industry should first engage with the agency to discuss their concerns.

The bottom line is that the industry should start preparing for compliance now. The road ahead is long, even for those who are already ahead. And, as you move toward compliance, it’s important to keep an eye on FDA’s long-term goal of end-to-end traceability, while keeping in mind that expanded transparency in the supply chain can bring additional benefits to industry and consumers.

About Sharon Lindan Mayl: Sharon is a partner in Piper Piper’s Food and Drug Administration practice. A distinguished and seasoned former senior FDA official with over 25 years of experience at the agency, Sharon has extensive knowledge in the areas of food safety, importation, third-party audits, nutrition, dietary supplements and cannabis products. She combines her senior experience working at the FDA with companies and businesses in the food, beverage and consumer goods industries.



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