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FSMA 204 Detailed Guide

FSMA 204: Your Data Already Complies

The FDA's Food Traceability Rule requires specific data for covered produce. Your product wallet already contains it. This guide shows you exactly how wallet data maps to FDA requirements—and how to generate reports in minutes.

The Regulation

What FSMA 204 Requires

Effective January 2026 for most operations. Here's what you need to know.

Food Traceability List (FTL) - Covered Produce

If you grow these products, FSMA 204 applies to you:

Leafy Greens

  • Lettuce (all types)
  • Spinach
  • Cabbage
  • Kale
  • Arugula
  • Chard

Other Produce

  • Tomatoes
  • Cucumbers
  • Peppers
  • Herbs (fresh)
  • Melons

Exemptions

  • Farm sales under $25K
  • Direct-to-consumer only
  • Produce that's cooked/processed
  • Some farm-to-restaurant
Core Requirements

Key Data Elements (KDEs) = Wallet Messages

FDA specifies exactly what data they need. Your wallet captures it automatically as you work.

The Six Required KDEs for Farm Operations

What FDA Requires:

1. Traceability Lot Code (TLC)

Unique identifier for each batch/harvest

2. Product Description

Type of produce, quantity, packaging

3. Location Description

Growing area (field/plot), GPS if available

4. Harvest Date Range

Start and end dates of harvest

5. Business Name & Address

Your farm, any processors, shippers

6. Reference Records

Link to cold storage, shipping, receiving

What Your Wallet Contains:

Product Wallet ID

TOM-20251009-001 = automatic TLC

Origin Message

Product type, quantity from harvest recording

Field Wallet Reference

Field7.SunriseAcres with GPS coordinates

Timestamp

Blockchain timestamp of harvest event

Farm Wallet Identity

SunriseAcres.farm (your registered identity)

Partner Wallet Messages

Signed messages from cold storage, shipper, lab

100% of FSMA 204 KDEs are already in your wallet. Origin Engine just formats them for FDA submission.

Instant Response

24-Hour Traceback = 5 Minutes of Work

FDA calls Tuesday morning about Saturday's harvest. You have 24 hours to respond. With wallet data, it takes 5 minutes.

Scenario: FDA Traceback Request

The Call:

"We're investigating a potential contamination. We need records for tomatoes harvested Saturday, October 9th, 2025, from your operation. You have 24 hours to provide: harvest location, lot codes, quantities, cold storage details, shipment information, and contact information for all downstream recipients."

❌ Traditional Approach:

  1. Find harvest log (paper or spreadsheet)
  2. Identify which lots were harvested that day
  3. Cross-reference field records
  4. Call cold storage for their records
  5. Get shipping manifests from distributor
  6. Compile everything into FDA format
  7. Double-check accuracy
  8. Submit within 24 hours (maybe)

Time: 4-8 hours of manual work

Risk: Missing records, data gaps, formatting errors

✅ Wallet-Based Approach:

  1. Open mobile app or dashboard
  2. Search: "October 9, 2025, tomatoes"
  3. Select product: TOM-20251009-001
  4. Click: "Generate FDA Traceback Report"
  5. Review auto-populated data (30 seconds)
  6. Click: "Send to FDA" (or download PDF)
  7. Notification sent to you + FDA
  8. Done.

Time: 5 minutes total

Confidence: 100% accurate, blockchain-verified

What the Generated Report Contains:

Product: Tomatoes (Roma variety)

Traceability Lot Code: TOM-20251009-001

Harvest Date: October 9, 2025, 6:30 AM - 2:15 PM

Location: Field 7, Sunrise Acres Farm, Asheville, NC

GPS Coordinates: 35.7796° N, 78.6382° W

Quantity: 500 lbs (42 cases, 12 lbs each)

Initial Receiver: Valley Fresh Cold Storage

Cold Storage Period: Oct 9, 3:45 PM - Oct 12, 8:00 AM

Temperature Logs: 36.2°F avg (full log attached)

Shipment: Fresh Foods Delivery, Oct 12, 9:15 AM

Destination: Whole Foods Distribution, Atlanta, GA

Receiving Time: Oct 12, 2:47 PM

Blockchain Verification: [Hyperlink to immutable record]

All data signed by participants. All timestamps immutable. Complete chain of custody.

Multi-Jurisdictional

State Agriculture Departments + FDA

Different states. Different requirements. Same underlying data. Origin Engine formats for each jurisdiction.

Multi-State Shipment Example

You grow tomatoes in North Carolina. Ship to cold storage in Georgia. Distribute through Florida. Three states, three agriculture departments, one FDA. Each wants different paperwork. Your wallet provides all of it.

North Carolina (Origin)

Wants: GAP certification, harvest records, organic verification (if applicable)

Origin Engine generates NC Ag Dept format

Georgia (Cold Storage)

Wants: Receiving logs, temperature monitoring, facility permits

Origin Engine generates GA Ag Dept format

Florida (Distribution)

Wants: Shipping manifests, arrival times, retail delivery records

Origin Engine generates FL Ag Dept format

How It Works:

Product wallet TOM-20251009-001 contains all the data. Messages from your farm, cold storage partner in GA, distributor in FL. Each state's rules encoded in Origin Engine.

When NC Ag Dept requests data → Origin Engine extracts NC-relevant information, formats per NC requirements.
When GA facility needs verification → Origin Engine generates GA-specific certificate.
When FL distributor ships → Origin Engine auto-generates FL shipping documentation.

One wallet. Multiple outputs. All under your control.

Data Integrity

Immutable Audit Trail

Every access logged. Every change tracked. Complete protection from false data claims.

Cannot Be Altered After Recording

Every message added to a product wallet is timestamped and signed. Cannot be changed after recording. If someone tries to alter data after the fact, the blockchain signature breaks—proof of tampering.

What Gets Logged (Automatically):

  • Who: Which wallet added the data (farm, partner, device)
  • What: Exact data recorded (harvest details, temp logs, test results)
  • When: Blockchain timestamp (can't be backdated)
  • Signature: Cryptographic proof it was that wallet, not someone else
  • Previous Hash: Links to prior message (can't insert fake history)

Example: Temperature Monitoring

Cold storage facility (ValleyFreshStorage.cold) has an IoT sensor authorized to add temperature readings every 15 minutes. Each reading is signed by the sensor's wallet.

If they try to fake data: Signature won't match. Timestamp won't align with blockchain. Hash chain breaks. Tampering is provable.

FDA/buyers/auditors can verify: "Was this data recorded at the time claimed, or added later?" Blockchain proves it.

Access Logging: Who Saw What, When

Every time someone accesses your product data—FDA, state inspector, buyer, partner—it's logged. You can see exactly who's looking at your data and why.

Access Log Example:

[2025-10-15 10:23 AM] WholeFoods.retail requested organic cert for TOM-20251009-001

[2025-10-15 10:24 AM] SunriseAcres.farm authorized access (organic data only)

[2025-10-15 10:24 AM] Origin Engine generated certificate, sent to WholeFoods.retail

[2025-10-15 10:24 AM] Access logged on blockchain (immutable record)

[2025-10-16 2:47 PM] FDA.gov requested traceback report for TOM-20251009-001

[2025-10-16 2:48 PM] SunriseAcres.farm authorized access (full traceability data)

[2025-10-16 2:48 PM] Origin Engine generated FDA report, sent to FDA.gov

[2025-10-16 2:48 PM] Access logged on blockchain (immutable record)

Audit trail for audits. Every access documented. Your protection.

Getting Started

FSMA 204 Implementation Checklist

What you need to do before January 2026 compliance date.

✅ Before You Start:

  • Confirm your produce is on the Food Traceability List (FTL)
  • Verify you're not exempt (sales over $25K, not direct-to-consumer only)
  • Understand your role: grower, packer, initial receiver, or all three

✅ Setting Up Your System:

  1. Create farm wallet (SunriseAcres.farm)
  2. Register field wallets (Field7.SunriseAcres, etc.)
  3. Set up product ID system (TOM-YYYYMMDD-###)
  4. Configure mobile app for harvest recording
  5. Authorize partners (cold storage, labs, distributors)

✅ Daily Operations:

  • Record harvest: date, field, quantity → creates product wallet automatically
  • Partners add their data: cold storage temps, lab results, transit updates
  • All data signed and timestamped automatically
  • No manual spreadsheets. No duplicate entry.

✅ When FDA Calls:

  • Search product by date or lot code
  • Click "Generate FDA Report"
  • Review and authorize (30 seconds)
  • Submit to FDA (or download PDF)
  • Response time: 5 minutes. Within 24-hour requirement.
Test Before You Need It

Compliance Verification Testing Program

Don't wait for a real FDA call to find out if your system works. Test it now with simulated incidents and real data.

Simulate an Incident. Verify Your Response.

We provide a testing program that simulates FDA traceback requests using your actual product data. Find the gaps before they matter. Verify you can respond within 24 hours. Prove your system works.

📋 Tabletop Exercise

Walk through a simulated incident with your team. No real data needed. We provide the scenario, you practice the response process.

What You Practice:

  • Receiving FDA notification
  • Identifying affected products
  • Generating traceback reports
  • Authorizing data access
  • Submitting to FDA portal

Time: 60-90 minutes | Team size: 3-5 people

🔬 Real-World Data Test

Use your actual production data. We simulate an incident with one of your recent harvests. Generate a complete traceback report. Measure your response time.

What You Verify:

  • All required KDEs present
  • Partner data integrated correctly
  • Timestamps and signatures valid
  • Report format FDA-compliant
  • Response time under 24 hours

Time: 15-30 minutes | Output: Full compliance report

Example: Simulated Contamination Incident

We run a test scenario using your last week's tomato harvest. Here's what the verification process looks like:

The Simulated Scenario:

Incident: Potential contamination reported

Product: Roma tomatoes

Date Range: Harvested October 9-11, 2025

Your Task: Provide full traceback within 24 hours

Timer Starts: Now

Your Response (We Time This):

  1. 00:00 - Login to dashboard: Search "tomatoes Oct 9-11 2025"
  2. 00:30 - Identify products: TOM-20251009-001, TOM-20251010-003, TOM-20251011-002 (3 batches)
  3. 01:00 - Generate reports: Click "Generate FDA Traceback" for each batch
  4. 02:00 - Review data: Verify all KDEs present, signatures valid, timestamps correct
  5. 03:30 - Authorize release: Click "Authorize for FDA" (you control this step)
  6. 04:00 - Download/submit: PDF reports generated with blockchain proof links
  7. 05:00 - Complete: All three traceback reports ready for submission

Total response time: 5 minutes. Requirement: 24 hours. You pass.

What We Verify in the Output:

Data Completeness:

  • ✓ Traceability Lot Codes present
  • ✓ Harvest dates and locations
  • ✓ Field identification (GPS coords)
  • ✓ Quantities and packaging
  • ✓ Cold storage records
  • ✓ Shipment information

Data Integrity:

  • ✓ Blockchain signatures valid
  • ✓ Timestamps chronologically consistent
  • ✓ Partner data properly attributed
  • ✓ No gaps in chain of custody
  • ✓ All required parties identified
  • ✓ Format meets FDA specifications

Result: Report certified ready for FDA submission. System verified operational.

Why Test Before You Need It?

Find Problems Early:

  • Missing data fields before FDA asks
  • Partner integration gaps
  • Authorization workflow issues
  • Report format problems
  • Team training needs

Build Confidence:

  • Team knows the process
  • System proven functional
  • Response time verified
  • Data quality confirmed
  • Ready when it matters

Testing Schedule:

We recommend quarterly verification tests using real production data. Ensures your system stays current as operations evolve, partners change, and regulations update.

Think of it like a fire drill. You don't wait for a fire to find out if the exits work.

Ready to Meet FSMA 204 Requirements?

Set up your system before the January 2026 deadline. Your data. Your control. Automatic compliance.

Start Your Setup → FSMA 204 Consultation

Free trial • No credit card • 10 product wallets included
Questions about FSMA 204 requirements? Email our compliance team
or call +1 (561) 789-1139

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