In July 2020, the FDA announced a blueprint for the New Era of Smarter Food Safety initiative, which would involve new regulations and processes for an overall goal of creating a more digital and traceable food system. This blueprint was an exciting first step; however, it was more of a general 10-year plan with no specific guidelines in place. Now, as of late September, the FDA has announced its first, proposed rule for standardizing recordkeeping in the food system. The regulation is expected to become effective approximately 60 days from its official publishing. Supply chains will have two years to comply, at which time it is less a question of if your supply chain will be affected, but how it will be affected.
Enhancing tracking and tracing of food and recordkeeping
The FDA’s proposed regulation, Enhancing Tracking and Tracing of Food and Recordkeeping, as part of the Food Safety Modernization Act (FSMA), will place additional tracking requirements onto certain foods that are deemed higher risk for foodborne illness. The FDA has created a Food Traceability List, which includes all foods that will be subject to the new rule. Just a few examples of these foods are certain cheeses, fresh-cut fruits and vegetables, leafy greens and more. The FDA’s goal is to rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks.
This regulation comes after several illness outbreaks and recalls in 2020 alone related to fresh cut lettuce. In June 2020, 90 products, all from the same plant, were recalled in response to an outbreak of Cyclospora infections. The outbreak was traced to one particular production plant, and at least 206 people were affected. With the implementation of the FDA’s new regulation, outbreaks like this will be mitigated, as each step of the supply chain will have in-depth data to track and maintain.
Understanding your part
So, who exactly does this rule apply to? The FDA has designated specific critical tracking events (CTE), which apply to different steps in the supply chain process. The CTEs include growing, receiving, transforming, creating and shipping. Your part of the supply chain will face different changes based on which part of the process you fall under. Regardless of which part of the process you touch, you will be responsible for establishing and maintaining key data elements (KDE) of your specific CTE.
It is crucial to understand which CTE your part of the supply chain manages because your required KDEs will vary based on where the food is in the process when it reaches you. Data points such as location and item information must be tied to the lot code, which is a key commonality for all CTEs. Each CTE also has several designated KDEs to monitor, ranging from growing area coordinates and date of receipt to quantity and units of food items shipped.
Preparing your supply chain
Regardless of the 2-year grace period before compliance becomes mandated, it is critical to overall success that you begin now in understanding how your supply chain practices will need to evolve. In order to be prepared, ensure that you understand where you fit into the supply chain and what your specific responsibilities will be. This will include understanding which CTEs you take part in, as well as which KDEs you will be responsible for – you may already be keeping certain elements, but there will most definitely be new ones to acclimate to. Finally, identify people within your organization who will “own” traceability compliance and can ensure that all KDEs are managed properly.
The future of traceability in the food supply chain
With the FDA beginning to make defined steps forward in its New Era of Smarter Food Safety Initiative, adaptation of supply chains around the country is inevitable. Being aware of the changes to come and preparing in advance of any mandates will be the key to setting yourself up for success.