What You Need to Know About ?FDA's Traceability Rule FSMA 204 | Episode 97
Francine Shaw, CP-FS, FMP
CEO @ Savvy Food Safety l Co-Host @ "Don’t Eat Poop" Podcast ??? l Food Safety Expert ?? l Advisor-Consultant ????♀? l Published Author ?? l Keynote Speaker ?? l ? Goddess of Food Safety ?????
In episode 97 of Don't Eat POOP! A Food Safety Podcast, Matthew Regusci and I are joined by Andrew Kennedy from iFoodDS, straight from the Food Safety Consortium 2024.
Andrew worked in the FDA and was one of the key people involved in writing the FDA's Traceability Rule FSMA 204, and in this episode he is sharing some insights into the process.
He also talks about his time working for the FDA during the COVID pandemic, what he learned about food supply chain management (especially when things go wrong), and his current work facilitating the implementation of the traceability rule through iFoodDS, the leader in food supply chain software.?
LISTEN TO THE EPISODE HERE.
In this episode:
What is the FDA's Traceability Rule FSMA 204?
The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).?
The 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).
The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
The final rule aligns with current industry best practices and covers domestic as well as foreign firms producing food for U.S. consumption along the entire food supply chain in the farm-to-table continuum.
The rule contains certain exemptions and partial exemptions. See FDA’s online exemptions tool for more information.
All key information on the Food Traceability Final Rule can be found here.
Food Traceability List
The recordkeeping requirements in the rule apply to the foods specifically listed on the Food Traceability List and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.
?? Cheese
?? Shell eggs
?? Nut butters
?? Cucumbers (fresh)
?? Herbs (fresh)
?? Leafy greens
?? Melons (fresh)
??? Peppers (fresh)
?? Tomatoes (fresh)
?? Tropical tree fruits (fresh)
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?? Fruits (fresh-cut)
?? Vegetables (fresh-cut)
?? Finfish
?? Crustaceans (fresh, frozen, and previously frozen)
?? Molluscan shellfish, bivalves (fresh, frozen, and previously frozen)
?? Ready-to-eat deli salads (refrigerated)
Requirements of the Rule
The rule identifies Critical Tracking Events (CTEs) along the supply chain where it is necessary to collect traceability information. These are:
Harvesting ?? Cooling (Before Initial Packing) ?? Initial Packing (RAC) ?? First Land-Based Receiver ?? Shipping ?? Receiving ?? Transformation
For each CTE an entity conducts, the rule requires that Key Data Elements (KDEs) are maintained. The KDEs required will vary depending on the CTE that is being performed.
Records must be available within 24 hours after a request by the FDA unless the FDA agrees to a longer timeline.
Compliance Date
Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date.?
?? The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026.
Routine inspections under the Food Traceability Rule will not begin until 2027 to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule.?
While the FDA is not initiating routine inspections until 2027, they may do inspections on a for-cause basis, such as during an outbreak investigation, once the compliance date is reached.
This means that ?the seafood world, the CPG world, the cheese world, and the egg world have one year to implement all the necessary traceability plans to maintain the necessary records. It will be interesting to witness the unbelievable amount of change that will need to happen in a short period of time for a bunch of industries.
??♀? If you fall in the category of people subject to the rule and want help in implementing a FSMA 204-compliant record-keeping system, explore iFoodDS, the leader in food supply chain software.
We'd love to hear from you!
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#FoodSafety #Food #FoodSafetyAndHygiene #FSMA204 #Traceability
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