January 27, 2021

Volume XI, Number 27

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FDA Clarifies Food Traceability List Descriptions and Publishes Related FAQ

On January 12, the FDA made the following two updates to its Food Traceability Proposed Rule:

The Agency made clarifying edits to the Food Traceability List (FTL), which lists the foods for which additional traceability recordkeeping requirements in the proposed rule would apply. Edits to certain commodity descriptions were made for clarity, but do not change which foods are on the FTL. For example, the word “fresh” was added to certain fruit and vegetable commodities to clarify the scope. Similarly, the description for “cheeses, other than hard cheeses” was revised to clarify which cheeses apply, and included examples of such cheeses. A description of the edits is available in the memo “Food Traceability List of ‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule – Clarified Language.”

The Agency published an FAQ on the proposed rule to assist stakeholders in providing feedback during the comment period, which was extended until February 22, 2021. Comments can be submitted at https://www.regulations.gov/ Docket ID: FDA-2014-N-0053. Those submitting comments to the proposed rule are encouraged to provide real life examples and details about specific arrangements for consideration.

As previously discussed on this blog here and here, FDA’s proposed rule would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain foods designated on the FTL. The proposed requirements would apply to foods listed on the FTL, including certain cheeses, shell eggs, nut butter, various fruits and vegetables, finfish, Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing FTL foods. At the core of the proposed rule is a requirement for those who manufacture, process, pack or hold foods on the 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 encourages the voluntary adoption of these practices industry-wide.

As mentioned above, the proposed rule is available for public comment until February 22, 2021. 

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© 2020 Keller and Heckman LLPNational Law Review, Volume XI, Number 13
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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...

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