Food Safety

FDA Announces the Final Rule for Food Traceability Under FSMA


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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最終規則の中核を成しているのは、FTLに記載された食品を製造、処理、梱包、貯蔵する業者に対し、重要トラッキングイベント(Critical Tracking Event)に関係する主要データ要素(Key Data Element)といった記録の管理を義務付ける要件です。対象となる企業、農場、小売店、飲食店は、24時間以内またはFDAが合意した合理的な時間内に、FDAに対して情報を提供しなければなりません。





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