FDA FSMA 204
Food Safety Modernization Act & Recall Readiness
FSMA 204, enacted in January 2023, requires total
traceability to vessels or farms using the same traceability lot codes. Another requirement is being able to produce a sortable electronic spreadsheet within 24 hours.
Starting now to build your traceability plan is essential. You must be ready—public health depends on it.
Trust TR5 for the solution.
FSMA 204 & Recall Readiness
To protect public health
If you don’t comply
- Risk to people’s health and even death
- Lost customer and consumer confidence resulting in lost sales and severe brand damage
- Lawsuits and litigation – criminal and civil
- Higher insurance rates and the potential to lose coverage
- Multi-million-dollar impacts including compliance penalties, and lost sales
TR5 Solutions & Benefits
- Links single lot number throughout
- Easy to create on-demand digital documents
- Sortable electronic spreadsheets and dashboards to monitor FSMA compliance (coming)
- Less public health risk
- Faster, lower volume, lower cost recalls
- Mitigate brand damage
- Proactive compliance with FDA requirements
Did you know the FSMA 204 Rule is already in effect?
Implemented January 2023,
the final compliance deadline is Tuesday, January 20th, 2026.
But don’t panic!
We’re here to help you get ready.
The FDA developed FSMA to enable faster identification and removal of potentially contaminated food from the market resulting in fewer foodborne illnesses and deaths.
The rule requires the maintenance of additional traceability records for high-risk foods as defined by the FDA.
Food Traceability List or FTL
The FDA’s FTL identifies the categories of foods, but not the individual foods that require additional traceability records.
Does FSMA 204 apply to you?
FSMA applies to the entire food supply chain (domestic and foreign) and companies that manufacture, process, pack, or hold foods on the FTL or foods containing an ingredient on the list unless an exemption applies. There are some complete and partial exemptions for certain entities and foods.
What seafoods are on the FTL?
- Finfish (fresh and frozen), specifically:
- Finfish,histamine-producing species
- Finfish, species potentially contaminated with ciguatoxin
- Finfish, species not associated with histamine or ciguatoxin
- Smoked finfish (refrigerated and frozen)
- Crustaceans (fresh and frozen)
- Molluscan shellfish, bivalves (fresh and frozen)
Companies that must comply with the rule are required to establish and maintain a traceability plan. The traceability plan needs to include traceability procedures and operations. It must:
- Describe the procedures used to maintain the required records.
- Describe the procedures used to identify foods on the FTL that a company manufactures, processes, packs, or holds.
- Describe how traceability lot codes are assigned.
- Include a contact person for questions about your traceability plan and records.
- Show on the farm map for aquaculture farms, the location and name of each container (e.g., pond, pool, tank, cage) in which the seafood on the FTL is raised, including geographic coordinates and any other information needed to identify the location of each container.
Types of traceability records to keep
Traceability records must be maintained and provided for the following CTEs including KDEs and traceability lot codes linked to the product:
- Cooling (before initial packing)
- Initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel)
- First receiving of seafood obtained from a fishing vessel
- Transformation of a food
Traceability lot codes
Traceability lot codes identify products moving through the supply chain, linking them to related records. Records for every CTE must include the traceability lot code and any KDEs linked to the product.
24 hours. Records must be on paper or in electronic format. They must be available to the FDA within 24 hours after the request, along with information needed to understand them.
Two years. Update traceability plans as needed to ensure compliance with the requirements. You must keep your previous traceability plans for two years after a plan update. You must also maintain records for two years from the date they were created or obtained.
Planning for FSMA 204
A Trace Register customer in the gulf of Mexico is fishing, buying, and processing wild-caught gulf shrimp (pink/white/brown). They operate as the first receiver, processor, and distributor. They need a solution for their current buyer requirements and a solid plan to address upcoming FDA FMSA 204 rules.
- Currently, they have records in many places and are missing some of the KDEs they will need for FSMA 204.
- They need a working plan to comply with FSMA 204.
- The company doesn’t have a lot of extra bandwidth to do additional record-keeping and needs time-saving solutions while also managing complex regulatory and buyer requirements.
Threats of Not Complying with FSMA 204
- Risk to people’s health & even death
- Time-consuming, high-cost recalls
- Denial of entry into U.S. commerce
- Compliance penalties
- Severe brand damage
- Advisory action letters
- Criminal or civil action in Federal Court
- Lost customer & consumer confidence
- Lost sales
- Lawsuits & litigation
- Higher insurance rates
- Lost insurance coverage
- Multi-million dollar impacts
TR5 Solutions and Benefits
- With TR5, this company can make solid claims about their traceability to current and potential buyers
- TR5 enables them to look for potential threats before they happen proactively
- They can minimize risk and potential threats to the consumer and their brand
The TR5 Difference
- TR5 provides a way for them to build their individual FSMA 204 plan and to gather/store/organize all of the required documentation in the form(s) required by the FDA
- TR5 will allow them to pull all required KDEs and traceability information within minutes in a sortable digital document (coming soon)
- Because TR5 can be used to model any complexities in the supply chain, it can simplify the record-keeping process and provide time-saving efficiency, even as more KDEs are collected
- Better traceability is the result