The ABCs of FDA's Proposed Food Traceability Rule

Columns - Legislative Update

Dr. David Acheson helps untangle some of the alphabet soup behind FDA’s proposed traceability rule.

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February 8, 2021

For the last several years, The Acheson Group (TAG) team has forecast its predictions for the food industry for the upcoming year. This year is no different, with TAG predictions focusing on a number of areas, not the least of which is, as you may expect, the continued impacts of COVID-19. But there was another significant event in 2020 that we see as having a distinct impact on 2021 and onward: the Food and Drug Administration’s (FDA) proposed Food Traceability rule.

As a required aspect of the Food Safety Modernization Act (FSMA), FDA was to propose a rule for traceability requirements for a “high-risk foods” list. Though its finalization will come more than a decade after the enactment of FSMA (on Jan. 4, 2011), we do think that FDA will push to issue the final rule in 2021 with implementation in 2022, and a final compliance date two years after the effective date. Food businesses throughout the supply chain should begin preparations this year.

The key elements of the proposed rule for which the industry needs to be prepared is pretty much an alphabet soup of elements: the FTL, KDEs and CTEs. If you’ve not yet heard of these three acronyms, you can bet that you will by the end of 2021. Here’s a head start.

FTL — The Food Traceability List.

Among the basic statutory authorities granted to FDA with FSMA were its ability to require more complete product tracking records for “high risk foods.” Designating specific foods as high risk is not an easy task, particularly as novel commodity-hazard pairs seem to emerge on a regular basis. Additionally, does designating some foods as high-risk cause industry to reduce their oversight on other (supposedly deemed) lower-risk foods? I would expect both these points were among the reasons for FDA’s nearly decade-long delay in creating the list and the rule.

However, it has abjured from calling it a high-risk foods list. Rather, it has proposed 16 foods for the rule’s Food Traceability List (FTL), mandating additional traceability requirements for both the listed food and any food that contains a listed food as an ingredient. Those listed foods on the FTL include cheeses (other than hard cheeses made with milk), sprouts, shell eggs (of domesticated chicken), tomatoes, nut butter (excludes soy and seed butters), tropical tree fruits, cucumbers, fruits and vegetables (fresh-cut), herbs (fresh), finfish (including smoked finfish), leafy greens (including fresh-cut leafy greens), crustaceans, melons, mollusks, bivalves, peppers and ready-to-eat deli salads.

The FTL foods were determined through FDA’s development of a draft risk-ranking model. Data was collected to populate the model for chemical and microbiological hazards, and the draft risk-ranking model and data were reviewed by independent external experts. It also includes a process to update the list.

KDEs — Key Data Elements/ CTEs — Critical Tracking Events.

It is interesting to note that the foundational elements of the rule are firmly rooted in the recommendations of the 2011-12 pilot tracing projects of the Institute of Food Technologists (IFT) and an oversight panel — on which TAG team members participated. Included in those recommendations was the capture and communication of critical track and trace data (KDEs) at critical points of product transfer and transformation (CTEs).

FDA apparently saw critical point data collection as a valuable traceability concept, as the core components of the rule are requirements to keep records of critical track and trace data associated with specific critical points of transfer and transformation. Thus, the CTEs include new definitions, distinctions and requirements for supply chain processes, including growing (with additional sprout-specific requirements), receiving (establishing a new “first receiver category”), creating (manufacturing/processing), transforming (changing the food, its package and/or label) and shipping (transporting) of an FTL food.

Additionally, the proposed recordkeeping requirements “emphasize the importance of documenting the applicable traceability lot codes and linking these codes to other KDEs at critical points in the supply chain of a food to aid product tracing during an investigation of a foodborne illness outbreak or during a recall,” according to FDA.

We strongly recommend that companies begin to look at the records they keep if they are making foods on the FTL and ask where they have potential compliance gaps. It is not too soon to begin to plan for this regulation and ensure you are working on any gaps.