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FDA Final Traceability Rule
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FDA Final Traceability Rule
FDA Announces the Final Rule for Food Traceability Under FSMA
Today at 2pm, ET, FDA Deputy for Food Policy and Response Frank Yiannas and the FDA’s Food Traceability Rule Lead Katie Vierk from the Center for Food Safety and Applied Nutrition will brief stakeholders on today’s action.
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November 15, 2022
Today, the U.S. Food and Drug Administration (FDA) issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
Foods subject to the final rule requirements appear on the Food Traceability List (FTL). The FTL includes fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products.
At the core of the final rule is a requirement that persons who manufacture, process, pack or hold food on the FTL maintain records including Key Data Elements (KDEs) related to Critical Tracking Events (CTEs). Covered firms and farms, retail food establishments and restaurants will be required to provide information to the FDA within 24 hours, or some reasonable time to which the FDA agrees.
The final rule provides full and partial exemptions for some entities and foods, such as certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others.
The final rule aligns with current industry best practices and covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for U.S. consumption.
The Food Traceability Final Rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
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3 Replies
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Good morning. I prepared a summary of the Traceability Rule based on the Federal Register Docket and other information published by the FDA. I also created a document with some notes and clarifications from the Docket. I will share it in the chat for those who are interested. It’s produce-focused. I am sharing those if you are interested:
Hope it helps!
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Thank you for this Humberto!
This was the info from a slide that whipped past really fast that I wanted to catch.
In addition to these full exemptions for certain small producers, the final rule also exempts farms whose average annual sum of the monetary value of their sales of RACs and the market value of RACs they manufacture, process, pack, or hold without sale (e.g., held for a fee) during the previous 3-year period is no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year, from the requirement to provide an electronic sortable spreadsheet containing traceability information FDA may request in certain circumstances (§ 1.1455(c)(3)(iii)(A)).
For the Amish and other plain farmers especially this may be very important.
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Thank you for sharing that! I wasn’t able to think of a good example of where the exemption based on religious beliefs would apply. Now it makes more sense.
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