This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now.  Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, 107 hospitalizations, and one reported death in 41 states.  Reported illnesses began just three days before Thanksgiving in 2017, but due to the unknown source of the turkey at the center of the outbreak, the Centers for Disease Control and Prevention (CDC) did not conclude the outbreak investigation until April 2019.

Two days before Thanksgiving the following year, the CDC warned U.S. consumers not to eat romaine lettuce and destroy any romaine lettuce in their homes due to a potential E. coli contamination.  Concurrently, the U.S. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region.

But as Thanksgiving approaches this year, FDA is setting the table for foodborne illness prevention with a final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule).

Requirements Under the Food Traceability Final Rule

On November 15, as part of the Agency’s implementation of the Food Safety and Modernization Act (FSMA), FDA released the food traceability final rule, which aims to reduce the occurrence of foodborne illnesses by enabling FDA to more efficiently identify and remove potentially contaminated food from the market.

When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.  But as noted above, identifying points in the food supply chain, the source of the product, and where contamination may have occurred can be a long and difficult process.

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S. consumption (absent the applicability of exemptions that are beyond the scope of this summary).  The FTL includes foods like fresh leafy greens, crustaceans, shell eggs, and other foods that FDA designated as requiring additional recordkeeping requirements to protect public health.

Entities covered under the final rule must maintain and provide to their supply chain partners certain Key Data Elements (KDEs) for Critical Tracking Events (CTEs) throughout the supply chain.

CTEs include:

• Harvesting;
• Cooling;
• Initial Packing (other than a food obtained from a fishing vessel);
• First Land-Based Receiver (for food obtained directly from a fishing vessel);
• Shipping;
• Receiving; and
• Transformation (events involving manufacturing, processing, or changing a food, its packaging, or packing, not including initial packing, harvesting, or cooling, listed above).

What information firms must maintain and share under the rule depends on the type of activities they perform in the supply chain with respect to an FTL food.  Some examples of KDEs include:

• Location descriptions (e.g., for the immediate subsequent recipient (other than a transporter) of the food);
• Quantity and unit of measure of the food;
• Product description for the food;
• Relevant dates (e.g., of the applicable CTE(s)); and
• Traceability lot code (TLC).

The TLC is a unique identifier that must be assigned to a food on the FTL.  Once a food has been assigned a TLC, that TLC must be included in the records required at each CTE in the food’s supply chain, and all KDEs must be linked to the relevant TLC.

All persons covered by the final rule must also establish and maintain a traceability plan that includes a description of the procedures used to:

• maintain the required records under the final rule;
• identify handled foods on the FTL; and
• assign TLCs to FTL foods.

In addition, entities that grow or raise an FTL food other than eggs must maintain a farm map showing the area in which the food is grown or raised.  The traceability plan must be updated as needed to ensure that the information reflects current practices.  Following an update, the previous traceability plan must be retained for two years.

All records required under the final rule must be made available to FDA within 24 hours after a request is made.  When necessary to help prevent or mitigate a foodborne illness outbreak or assist in implementing a recall, firms must generally provide an electronic sortable spreadsheet containing information that FDA requests on specified CTEs, FTL foods, date ranges, and TLCs.

The additional records required under the final rule establish a structure for maintaining and providing uniform, data-driven traceability information and coordination.  The new requirements have several aims, including more efficient FDA’s investigations of foodborne illness outbreaks, more targeted recalls, more public trust in the food supply chain, and fewer foodborne illnesses and deaths.

These potential benefits are only on the horizon: because the final rule requires entities across the supply chain to share information with each other, the compliance date for all entities subject to the recordkeeping requirements is set for Jan. 20, 2026.

FDA will hold a webinar to provide an in-depth overview of the final rule and Q&A on Dec. 7, 2022 at 1 p.m. EST.  Attendees can register here or watch the livestream here.