What is The New Era of Food Safety? (Part 4 of 5)

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by Eric Moore, Director of Food Safety & Industry Outreach, Testo North America

Welcome back food safety friends for part 4 of 5 of my foodservice industry insights on the New Era of Smarter Food Safety. Our conversation today is going to focus on Technology Enabled Traceability, what is it, FDA’s long-term vision, and how this looks to materialize at the retail and foodservice end of the industry.

To start things off let’s define traceability in its simplest form as the ability to follow a product forwards and backwards from start to finish in the supply chain through record keeping at specific stages. In the food industry paper-based documents have been the traditional conduit of this information. A good solution at one point in time and created provided the ability to effectively track product information one step back and one step forward the supply chain process. This kind of process is now outdated in today’s global food supply system that involves multiple stops from multiple suppliers and requires large amounts of labor hours to collect and review paper records if/when a product needs to be tracked for some reason (a recall is one example).

FDA’s ultimate vision is to establish end-to-end traceability throughout the food supply chain system that enables rapid product identification and traceability to protect customers more efficiently and effectively from potentially harmful products in the marketplace. The first step in this process is for FDA to complete section 204 of the Food Safety Modernization Act (FSMA), this section requires that FDA establish enhanced tracking and tracing of food by developing additional recordkeeping requirements for specific high risk food categories. To meet this requirement FDA has published a list of high risk foods called the Food Traceability List (FTL) along with releasing for public comment the FSMA Proposed Rule for Food Traceability. The rule establishes minimum record keeping requirements across the entire supply chain system including retail food establishments for any food product listed on the FTL. This standardization of information will then be required to accompany FTL foods as they travel through the supply chain, with additional information being provided at every stop it makes. It is this standardized information (or data) that will play a key role in facilitating rapid and accurate traceability of products needed to prevent or mitigate foodborne illness outbreaks.

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As outlined on the FDA Food Traceability Proposed Rule At-A-Glance:  “At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). 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 industry-wide.”

A basic example of a Key Data Element (KDE) would be lot numbers, harvest date, time, temperature, etc. KDEs also differ depending on product, as well as where it is in the supply chain defined as a Critical Tracking Event (CTE). There are five basic categories for CTEs outlined in the proposed rule:

In general, the standardization of traceability records will impact the entire global food supply chain system. The current proposed rule will require organizations to establish and maintain traceability program records for entities that manufacture, process, pack or hold FTL foods which by and large covers the entire agriculture, manufacturing, packing and distribution food supply system. It also means that those stakeholders must supply the appropriate traceability information to the business they are shipping their FTL foods.

Receiving then becomes one of the primary impacts to Retail Food Establishments with this rule due to Receiving being classified as a CTE.  This means that Retail Food  Establishments need to ensure that any FTL being delivered must contain all the necessary traceability information, a great reason to ensure you have a good partnership with your suppliers who help develop and support this type of program considering the requirement that FTL product “records must be able to be provided to FDA within 24 hours after a request is made via an electronic sortable spreadsheet that contains all relevant product traceability information”.  Transforming is another CTE that Retail Food Establishments should be sure to have a clear understanding of and how it could impact your business. For example; do you have locations that receive bulk bags of leafy greens which are used to make a grab-go salad? If so, this triggers the Transforming CTE and would require additional record keeping to be added to the product prior to its  sale to consumers.

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As mentioned earlier, the FDA’s new Traceability Rule has not been finalized. Once finalized, the rule will go into effect and industry is provided 2 years to be complying once the rule is finalized, this is currently estimated to be sometime in 2023/4.

Our next and final post in this series will be on the last of the New Era of Food Safety core elements: Smarter Tools and Approaches for Prevention and Outbreak Response. 


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