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In 2011, President Barack Obama signed into law the Food Safety Modernization Act, which establishes traceability recordkeeping requirements beyond those in existing regulations, for those who manufacture, process, pack, or hold foods included on a list determined by the United States Department of Agriculture (USDA).
Many grocers will be affected by this rule, and time is ticking — the deadline for being within compliance is 2026. Here’s everything you need to know.
FSMA 204: The food traceability final rule
What is the Food Safety Modernization Act (FSMA)?
The Food Safety Modernization Act (FSMA) is a set of rules that gives the Food and Drug Administration the power to regulate the way foods are grown, harvested, and processed. For grocers who need to follow FSMA, this means key data elements need to be collected on certain food items as far as where the food items originate and the path traveled to the food item’s final destination.
FSMA 204 requirements
When is the compliance date?
Grocers will need to comply with the final rule requirements on or before Tuesday, Jan. 20, 2026.
What kinds of data do grocery operators have to track?
The FDA has identified key data elements grocers must have when receiving food from a distributor. They are:
- Traceability lot code for the food
- Quantity and unit of measure of the food
- Product description for the food
- Location description for the immediate previous source (other than the transporter) for the food
- Location description for where the food was received
- Date grocer received the food
- Location for the traceability lot code source or the traceability lot code source reference
- Reference document type and reference document number
Foods required on the Food Traceability List (FTL)
What is the Food Traceability List (FTL)?
The Food Traceability List identifies the foods that are required to be traced.
How did the FDA determine which foods are included on the FTL?
The FDA created a risk-ranking model for food tracing based on factors Congress identified in the FSMA.
What foods are on the FTL?
Under what circumstances and how often will the FDA revise and update the FTL?
The FDA intends to update the FTL approximately every five years.
Are dried or frozen versions of FTL foods covered by the final rule?
No. Foods altered through freezing or drying are not on the list.
Are foods that contain an FTL food as an ingredient also covered by the final rule?
Yes, if the ingredient remains in the form in which it appears on the list.
Are foods for animals (such as pet food or animal feed) covered by the final rule?
No, these foods are not covered.
Are live-seafood products (e.g., live lobsters, live crabs, live crawfish) covered by the Food Traceability rule?
Live-seafood products do fall under the rule.
Does the rule apply to fresh-cut fruit or vegetables that have been frozen, flash frozen, or individually quick frozen?
Frozen “fresh-cut” fruits and vegetables are not covered by the rule.
If I use ingredients that are not on the FTL to make an FTL food (such as a deli salad), do I need to keep records under the final rule?
Any food on the FTL used as an ingredient needs to be traced.
Are dietary supplements covered by the rule?
Dietary supplements do not have a risk score high enough to be included under the rule.
Are intercompany shipments covered by the rule?
Effective traceability requires that records be kept when a product changes physical location, so intercompany shipments are indeed covered by the rule.
How does FDA identify hazards for each commodity in the Risk-Ranking Model for Food Tracing?
The FDA identifies hazards for each commodity based on associated known or reasonably foreseeable hazards, using outbreak and contamination data and other information, such as foods and hazards associated with outbreaks and illnesses, and detection of hazards in foods (not necessarily implicated in illnesses).
Is “repacking” a transformation event that would require a new Traceability Lot Code (TLC)?
Repacking an FTL food is a transformation event, and it usually requires a new traceability lot code.
Who must follow the FSMA
Are all grocers required to comply with the new rules?
All grocers that carry food on the Food Traceability List need to be in compliance with the FSMA.
Will the FDA be auditing foreign food businesses for compliance with the rule, or is the U.S. importer responsible for demonstrating that the foreign firms are in compliance?
Foreign entities covered by the rule are responsible for complying with the portions of the rule that apply to them based on the critical tracking events they perform.
What are critical tracking events?
Critical Tracking Events (CTEs) are the critical points within the product journey of all foods listed on the Food Traceability List (FTL) where enhanced traceability recordkeeping will be required. For each event, this rule specifies what information must be recorded.
What if products are private label but manufactured and packaged by a third party? Who is responsible for maintaining the records?
The third party would be responsible for maintaining the required records for the CTEs they perform.
Why does the initial packer have to establish a Traceability Lot Code (TLC)?
Because the rule applies to those who initially pack the food.
Are farms covered by the final rule?
Farms are subject to the requirements in the final rule if they manufacture, process, pack or hold foods on the FTL.
What kinds of companies must comply?
All food manufacturers and suppliers that are regulated by the FDA.
Who must maintain a traceability plan?
Those who must follow the rule need to have and maintain a traceability plan.
How does the Food Traceability Rule apply to supermarket distribution centers?
Supermarket distribution centers are required to maintain the key data elements.
Does the final rule apply to importers?
Yes, it applies to food importers.
FSMA enforcement
Upon the rule’s compliance date of Jan. 20, 2026, will the FDA begin conducting routine inspections?
Routine inspections under the Food Traceability Rule will not begin until 2027, so grocers and suppliers have time to make sure the data that is necessary is available and accessible.
Will the FDA issue fines if firms are not in compliance with the rule?
The FDA does not have the authority to impose fines for violations of this rule.
What is the penalty for not complying with the final rule?
That depends on the nature of the violation, but the FDA usually gives violators a chance to make the necessary corrections. If there is still a violation after the grace period, the FDA may issue an advisory action letter. If there is no compliance after the FDA letter, the federal government may bring a civil action in federal court.
Record-keeping requirements
Do the recordkeeping requirements in the final rule apply to foods prior to import into the U.S. or only after import?
The recordkeeping requirements apply to imported FTL foods before and after importation.
When do I need to provide records in an electronic sortable spreadsheet?
Records will only need to be provided on an electronic sortable spreadsheet if the food is involved in the event of a foodborne illness outbreak, recall, or other public-health threat.
Upon the rule’s compliance date of Jan. 20, 2026, are entities expected to have any records from before that date?
Record keeping required under the rule starts on Jan. 20, 2026, not before.
Will the FDA issue a template for the electronic sortable spreadsheet that firms can use to provide requested records?
There will not be an official template.
Will FDA be providing a portal or other way to submit traceability data to the agency?
There will not be a portal provided by the FDA because data does not have to be submitted regularly. The FDA will request data in certain situations, like for a foodborne-illness outbreak investigation.
What are the elements that will be required as part of the electronic sortable spreadsheet?
If the FDA needs an electronic sortable spreadsheet, like if it is doing a foodborne-illness outbreak investigation, it will specify the foods and dates needed.
Should the Traceability Lot Code (TLC) be included on the product label or product packaging?
No, that is not needed.
Does the FDA require a specific application or technology for keeping records?
No, the final rule does not require a specific application or tech for keeping records.
Would traceability records be required if a firm is conducting cross-docking, such as when a pallet of food products is sent from a firm through a distribution center or cross-docker and then sent on to the next point in the supply chain?
Yes, any food involved in transport needs to have traceability records. Records must be kept regarding where transportation begins and where it ends. However, records of the route taken do not need to be kept, including if the food moves from one carrier to another.
What’s next with regard to the Food Safety Modernization Act (FSMA)?
This guide is just the start. Supermarket News will continue to cover FSMA (and how it affects grocers) as we lead up to the Jan. 20, 2026 deadline. Stay tuned for more.