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NewsRegulatorySupply ChainFDAFSMATraceability/Recall

FDA Releases FSMA 204 FAQs, Tools, Resources

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Image credit: mohamed_hassan via Pixabay

June 27, 2023

The U.S. Food and Drug Administration (FDA) has posted answers to frequently asked questions (FAQs) and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Final Rule.

The Food Traceability Final Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule requirements appear on the Food Traceability List (FTL).

The new FAQs address questions to help clarify how the rule applies to specific situations and are largely based on questions received during FDA’s regular interactions with industry and on questions sent via the Technical Assistance Network, a central source of information for questions related to FSMA rules, programs, and implementation strategies.  

Along with FAQs, additional tools developed to help educate and inform industry subject to the Food Traceability Final Rule are accessible from FDA’s traceability website, including:

  • The results for all foods and associated commodity-hazard pairs included in the Risk-Ranking Model for Food Tracing, beyond what appear on the food traceability list
  • Additional description on the Food Traceability List webpage to clarify that “nut butters” include all forms of nut butters: shelf-stable, refrigerated, and frozen products
  • Eight new supply chain examples that illustrate how the rule is applied in different scenarios for different commodities
  • Fact sheets: Recordkeeping Information for Produce Farms and Coverage and Exemption for Produce Farms
  • A “Guide to Getting Started with the Food Traceability Rule”
  • Additional foreign language translations of the Critical Tracking Event and Key Data Elements interactive tool and supply chain examples.

The compliance date for all those subject to the Food Traceability Rule is January 20, 2026.

KEYWORDS: FDA Food Traceability Final Rule

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