Part of the Food Policy Snapshot Series
Policy name: FSMA (Food Safety Modernization Act) Final Rule: Requirements for Additional Traceability Records for Certain Foods
Overview: The U.S. Food and Drug Administration (FDA) has announced new requirements for tracing contaminated foods in order to reduce the incidence of foodborne illness.
Location: United States
Population: 335.7 million
Food policy category: Food safety
Program goals: To ensure a safe food supply and reduce foodborne illnesses.
How it works: The final food traceability rule is in accordance with the Food Safety Modernization Act (FSMA) of 2011 and is 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 reporting requirements under this rule are those on the Food Traceability List (FTL), and include cheese, eggs, nut butters, certain vegetables and fruits, fish, and ready-to-eat deli salads.
The rule requires that those who manufacture, process, pack, or hold foods on the FTL maintain records containing specific information, depending on what supply chain activities they perform (e.g. harvesting, initial packing, shipping, receiving, etc.). The records must be shared with others along the supply chain and provided to the FDA within 24 hours or another reasonable, agreed-upon time frame.
Progress to date: The FDA first proposed the rule in 2020 as part of the New Era of Smarter Food Safety Blueprint. Through early 2021, stakeholders from the public could provide comments, and, as a result, changes were made to the proposed rule before it was finalized in November 2022.
Why it is important: Foodborne illness occurs when people eat foods contaminated with disease-causing germs. The Centers for Disease Control and Prevention (CDC) estimate that foodborne illnesses infect 48 million people in the United States each year, with 128,000 cases requiring hospitalization and 3,000 leading to death.
The required record-keeping and sharing of information along the food supply chain will make it easier to remove potentially contaminated foods from markets more quickly and efficiently in order to reduce foodborne illnesses and deaths.
Program/Policy initiated: The final rule was announced on November 15, 2022. All entities subject to the requirements of the rule must be in compliance by January 20, 2026.
Point of contact:
Janell Goodwin, Press Officer, FDA
Email: Janell.Goodwin@fda.hhs.gov
Phone: 240-393-3067
Similar practices: This final ruling is part of the New Era of Smarter Food Safety Blueprint and the Food Safety Modernization Act, both of which are designed to reduce food contamination and improve food safety.
Evaluation: The ruling has not yet been evaluated.
Learn more:
- About the CORE Network (U.S. Food and Drug Administration)
- The Economic Burden of Foodborne Illness in the United States (Food Safety Economics)
- Outbreaks of Foodborne Illness (U.S. Food and Drug Administration)
- Surveillance for Foodborne Disease Outbreaks — United States, 2009–2015 (Morbidity and Mortality Weekly Report – Surveillance Summaries)
References:
- FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods (U.S. Food and Drug Administration)
- FDA Announces the Final Rule for Food Traceability Under FSMA (U.S. Food and Drug Administration)
- Foodborne Germs and Illnesses (Centers for Disease Control and Prevention)
- Food Safety Modernization Act (FSMA) (U.S. Food and Drug Administration)
- Food Traceability List (U.S. Food and Drug Administration)
- Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs) (U.S. Food and Drug Administration)
- FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods (U.S. Food and Drug Administration)
- New Era of Smarter Food Safety Blueprint (U.S. Food and Drug Administration)
- Requirements for Additional Traceability Records for Certain Foods (Federal Register)
