FSMA Rule 204 — lot traceability for LATAM exporters

If you export food to the US and your product is on the Food Traceability List, FSMA Rule 204 requires electronic records of Critical Tracking Events. Rela AI generates them from the PLC + recipe + timestamp, with no QC paperwork.

What is FSMA Rule 204?

FSMA (Food Safety Modernization Act) is the US food safety law — covers all food produced or imported. Rule 204 (published November 2022, officially "Requirements for Additional Traceability Records for Certain Foods") is one of the most demanding traceability regulations.

Enforcement compliance date: January 20, 2026.

It applies to:

• Producers, manufacturers, processors, importers, and distributors handling foods on the Food Traceability List (FTL).
• The FDA requires electronic records of Critical Tracking Events (CTEs) with Key Data Elements (KDEs).
• Records must be available within 24 hours upon FDA request.

Food Traceability List (FTL) — relevant for exporters

Key categories:

• Dairy products — soft cheeses (including feta, mozzarella, brie), creams
• Specific cheeses (queso fresco, soft ricotta, etc.)
• Fish and shellfish raw / refrigerated / smoked / frozen
• Fresh fruits: tomatoes, melons, peppers, leafy greens
• Vegetables: leafy greens, fresh herbs, sprouts
• Nut butters (only when packed ready-to-eat)
• Whole eggs (shell or pasteurized liquid)

For LATAM exporters to the US: dairy + fresh fruits + fish/shellfish are the critical segments.

Critical Tracking Events (CTEs)

The 7 CTEs defined by FSMA Rule 204:

Each CTE requires Key Data Elements (KDEs) — mandatory fields.

Key Data Elements (KDEs) — what to log

For each CTE, FSMA Rule 204 requires:

• Traceability Lot Code (TLC) — unique, assigned to the lot
• Description of food — name, brand, packaging
• Quantity & unit — quantity and unit of measure
• Date — date of event
• Location — physical address
• Reference document — purchase order number, bill of lading, etc.
• Source / Recipient — previous and next entity in the chain

How Rela AI generates CTEs and KDEs automatically

Rela AI already knows, at the moment of each production:

• Lot (cross-referenced with recipe + timestamp)
• Quantity (PLC counters)
• Date (immutable timestamp)
• Location (plant + line + recipe)
• Source (raw material entered via inventory receipt)
• Who executed (operator with WhatsApp credential)

When a lot is transformed (CTE Transformation) or shipped (CTE Shipping), Rela AI generates the record automatically with all required KDEs.

sequenceDiagram
  participant Op as Operator
  participant PLC as Production line
  participant Rela as Rela AI Plant OS
  participant FDA as FSMA report

  Op->>PLC: Start recipe R-104, lot 2026-04-25-001
  PLC->>Rela: Counter +500 units, batch metadata
  Rela->>Rela: Generate CTE-Transformation with KDEs:
  Note right of Rela: TLC 2026-04-25-001<br/>Recipe R-104<br/>Quantity 500 units<br/>Date 2026-04-25 14:32:18<br/>Location Bolonia plant Line A<br/>Source raw material lot MR-882
  Op->>PLC: Close lot
  Rela->>Rela: Generate CTE-Shipping on dispatch
  Rela->>FDA: Export PDF/CSV within 24h

Use case: Italian bakery exporting frozen pastries to the US

COLIP-style (Italian bakery with integrated cheese-making):

1. Receiving — incoming milk with supplier TLC → CTE-Receiving logged in Rela.
2. Transformation — pasteurization + culture → CTE-Transformation with new internal TLC.
3. Cooling — ripening chamber with PLC monitoring → CTE-Cooling with in/out timestamps.
4. Initial packing — automatic packaging → CTE-Initial Packing with quantity unit + reference doc.
5. Shipping — dispatch to US importer → CTE-Shipping with bill of lading.

If the FDA requests records, Rela AI exports the 5 CTEs in PDF/CSV with all KDEs within 24h.

Comparison: paper vs ERP vs Rela AI

Recommended roadmap for LATAM exporters

1. Exported product inventory — check which are on the FTL.
2. Map chain of custody — farm / supplier → plant → US distribution.
3. Design TLC strategy — Traceability Lot Code format (includes country, date, plant, internal lot).
4. Configure CTEs in Rela AI — link PLC events + receipts to CTE generation.
5. FDA audit dry run — simulate request: can you produce records in 24h?
6. Response plan — team + workflow if the FDA requests records of an outbreak.

Honest limitations

• Rela AI does not guarantee FSMA compliance on its own. The FSMA plan must be signed by an FDA regulation specialist.
• Rela AI does not translate the regulation to your country's specific context (e.g. Codex Colombia, INVIMA): requires local legal advice.
• Rela AI logs the events, but the decision to export remains the customer's and their regulatory team's.

Related pages

• Automated HACCP
• BRCGS Issue 9
• FSSC 22000 v6
• Plant OS — what it is and why your plant needs it