FSMA 204: Navigating The Food Traceability List

Richard Wilson February 27, 2024

The Food Traceability List, a central aspect of the FDA’s FSMA Section 204, identifies specific high-risk foods requiring enhanced record-keeping to enable rapid tracking and tracing. Understanding and complying with these regulations is paramount for food producers, distributors, and retailers. Our recent webinar, ‘FSMA 204 Explained’, explores insights, tools, and strategies for effectively managing compliance hurdles, providing a comprehensive understanding of the requirements entailed within Section 204. But before you dive into the on-demand session, let’s take a closer look at the Food Traceability List itself.

The Evolution of The Food Traceability List 

Traceability in the food industry has come a long way since its rudimentary beginnings, and the FDA has played a significant role in developing and refining traceability regulations. The introduction of the Food Traceability List (FTL) was a significant development in the FDA’s initiatives towards establishing a safer food supply. Proposed in 2014, the FTL is based on a risk-ranking model that helped the FDA determine which foods would be included on the list based on various factors such as frequency of outbreaks, severity of illnesses, likelihood of contamination, cost of illness, and consumption rate. In September 2020, the FDA announced a proposed FTL, which was finalized with FSMA 204 in November 2022, and the final compliance deadline, January 20th 2026, was confirmed. 

What Food Products Are Included?

The complete Food Traceability List has been published online by the FDA, stating their plans to update the list every five years in the Federal Register. Any proposed changes will be published first in the Federal Register, allowing for public comment before finalization. Once finalized, businesses can avail of a grace period of two years before compliance with the updates and additions required.

Food ItemsDescription
Cheeses, other than hard cheeses, specifically:Cheese (made from pasteurized milk), fresh soft or soft unripened.
Cheese (made from pasteurized milk), soft ripened or semi-soft.
Cheese (made from unpasteurized milk), other than hard cheese.
Shell eggs, specifically:The egg of the domesticated chicken.
Nut butters, specifically:All types of tree nut butter, such as butter from peanuts, almonds, walnuts, hazelnuts, coconuts, etc. 
Fresh Produce, specifically: Cucumbers, Herbs, Leafy Greens, Melons, Peppers, Sprouts, Tomatoes, Tropical Tree Fruits, Fresh-cut fruits, Vegetables other than leafy greens (fresh-cut)
Fish and Seafood, specifically: Fresh and frozen crustaceans, such as shrimp, crab, lobster, and crayfish.

Fresh, frozen, and/or smoked finfish that are histamine-producing and/or ciguatoxin-producing, such as tuna, mahi mahi, grouper, snapper, cod, Alaska pollock, salmon, etc. 

Molluscan shellfish, bivalves (fresh and frozen) such as oysters, clams, and mussels.
Ready-To-Eat Deli Salads, specifically:All types of refrigerated deli salads (excluding egg, potato, pasta, seafood, and meat salads).

Traceability Record-Keeping Requirements

Having identified the products within the FTL, it is required that additional records are kept on these items. FDA audits have been significantly reshaped by FSMA 204, now encapsulating a defined set of metrics called Key Data Elements (KDEs) that correspond with different events in the supply chain known as Critical Tracking Events (CTEs). 

The traceability requirements demand thorough documentation in line with these metrics, enabling the FDA to quickly identify and track down potentially contaminated foods. Records must be maintained for two years and kept as true copies, whether that be electronically or in paper format. 

If the FDA requests documentation, the business must be able to provide those records within 24 hours of the request. Businesses will also need to provide any information that will help the FDA interpret records, such as translations or glossaries. Records can be stored off-site, in a centralized location, or by another entity, as long as they can be delivered to the FDA within the designated time frame.

FSMA 204 Compliance With AuditComply

Customers are increasingly seeking transparency throughout the food supply chain, and regulatory requirements for traceability are accelerating progress in this area. With the deadline for FSMA 204 compliance set for January 20, 2026, food businesses must enhance their traceability strategies and systems to meet these growing expectations.

AuditComply aids in achieving FSMA 204 compliance by documenting and tracking Critical Tracking Events (CTE) information within your organization and among relevant stakeholders. This enables you to monitor your products, maintain records, and swiftly access traceability details upon request. 

AuditComply for FSMA 204 Compliance

Are you prepared to meet the data requirements of FSMA 204? Book a complimentary 30-minute session with the AuditComply team to discuss which foods are affected by the regulation and how you can strategically plan for the January 2026 compliance deadline.

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