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Are You Ready for the Unspoken Challenges of FSMA 204?

Are you ready for FDA 204

By Norman Alayan, EAS Independent Consultant

“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping 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 FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA)” – (FDA.gov website).

It was said that 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.” FSMA Rule 204 intends to create a more transparent supply chain that ensures safer food for all Americans. The rule also encourages companies in the food value chain to invest in digital traceability technology.

The rule requires: The collection of Key Data Elements (KDEs) and Critical Transformation Events (CTEs); Collection through a Traceability Lot Code (TLC) that remains unchanged with the product throughout the journey through the supply chain (or until a kill-step or relevant transformation event occurs); The delivery of necessary traceability information into an electronically sortable spreadsheet within 24 hours. It is important to note that the rule does not recommend or suggest any particular technology, nor endorse a data format, database, or other known software. FSMA 204 only mentioned what data is to be captured for particular events at specific stage of the food item’s life cycle. This requirement can rapidly scale in complexity with an increase in size, to generate several hundred if not thousands of data points. Source: Kezzler.com/fsma204 and https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-food-traceability-final-rule-12072022.

Rule 204 applies to all the items found on the FDA’s food traceability list (FTL). Some examples of items on the list include nut butters, leafy greens, tomatoes, fresh cut fruits and vegetables, finfish, crustaceans, mollusks, and herbs (see FDA.gov for the complete list). Under the rule, businesses will need to keep detailed traceability records for all foods that fall on this list. There are some exemptions such as certain small farms (Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less. Or a qualified exemption based on two requirements: The farm must have food sales averaging less than $500,000 per year during the previous three years), certain small retail food establishments and restaurants, or foods not listed on the FTL or that have gone through a kill step.

On November 30, 2023, the US Food and Drug Administration (FDA) unveiled new resources and Frequently Asked Questions (FAQs) to further educate stakeholders about the Food Traceability Rule under FSMA 204. These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026.

I also watched and listened some video interviews and webinar for answers – Dr. Benjamin Miller, executive vice president of regulatory and scientific affairs of The Acheson Group (TAG), and Randy Fields, CEO of ReposiTrak as they were interviewed by Kevin Coupe of the Morning News Beat. https://morningnewsbeat.com/2023/11/28/mnb-in-conversation-bringing-clarity-to-fsma-rule-204/. And the widely attended webinar with food industry attorney Shawn Stevens of the Food Industry Counsel, LLC, and ReposiTrak Chief Customer Officer Derek Hannum. Titled “FSMA 204 Food Traceability: We’re Past the Point of Waiting,” the webinar covers the urgency surrounding the regulation and the consequences for companies that aren’t ready in time. https://repositrak.com/webinar-archive/fsma-204-food-traceability-were-past-the-point-of-waiting/. This showed the complexity, challenges, and steps you can take now (e.g. evaluate your labels, standardize to GS1 labels, identify the products and suppliers you need to track/trace, the DC/warehouse, retail stores, human and technology infrastructure, etc.).

Above insights just prove how challenging it is to comply with the FSMA 204 rule. If your products are on the FTL list, start examining what you have and the gaps vs the rule and find the appropriate solution while there is time before the deadline of January 2026.

“FSMA204 have a huge impact on companies’ operations. This is an issue that requires leadership from companies’ highest levels. This is an issue that you can’t ignore or procrastinate.”

The clock is ticking…

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