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FDA Proposes New Rule That Would Expand Traceability Record Keeping Requirements for Certain Foods

On September 21, 2020, the FDA announced a proposed rule that would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain high risk foods designated in a new “Food Traceability List” (FTL) that was published along with the proposed rule. While the proposed requirements would only apply to foods listed on the FTL as well as foods containing FTL foods as ingredients, voluntary industry-wide adoption of the practices is encouraged.  Some examples of the foods on the FTL include: cheeses (other than hard cheeses), shell eggs, nut butter, various fruits and vegetables, finfish (including smoked finfish), Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads.

The proposed traceability requirements would require the establishment and maintenance of records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs). The following CTEs are identified in the proposed rule:


Receiving. There are additional KDEs for “first receivers,” defined as the “first person (other than a farm) who purchases and takes physical possession of a listed food.” Only originated foods (food that are grown, raised, caught, or harvested) have a first receiver.

Creating, defined as the making or producing of a food on the FTL using only ingredient(s) that are not on the FTL (e.g. the making of peanut butter (on the list) from peanuts (not on the list)).

Transformation. Involves changing a food on the FTL, its package, and/or its label, such as by combining ingredients or processing it (e.g. making peanut butter sandwich crackers because one of its ingredients (peanut butter) is a food on the FTL). Transformation does not include the initial packing of a single-ingredient food or creating a food.


A detailed list of KDEs required for each CTE can be found here. In addition to these KDEs, the proposed rule would also require regulated entities to keep various other records of their traceability program to help regulators understand how it is operated, including a description of the relevant reference records, a list of food on the FTL that are shipped, and a description of how traceability lot codes are assigned.

The proposed rule includes a number of exemptions, including for certain types of small originators, farms that sell produce directly to consumers (and certain foods produced and packaged on a farm), foods that are processed in a certain way to destroy microorganisms, produce that is “Rarely Consumed as Raw” (RCR), transporters, non-profit food establishments, persons dealing with food intended for personal consumption, and persons holding food for individual consumers. Partial exemptions would also be available for commingled raw agricultural commodities (RACs), retail food establishments (FDA is considering a full exemption for small retail food establishments), farm-to-school and farm-to-institution programs, and for food from fishing vessels.

The proposed rule will be available for public comment for 120 days from the date of publication, which is scheduled for September 23. Comments should be submitted to docket FDA-2014-N-0053 on regulations.gov

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 266



About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...