FDA Subpart S compliance, signed by soil. The 7 KDEs captured automatically. Auditable in 60 seconds.
FarmGuard hardware meets Loess-Lattice entropy. Every Critical Tracking Event attested by earth-borne cryptographic signatures. One bundle. Full chain-of-custody from soil to shelf.
vs. $25,000–$80,000 / yr for comparable FSMA 204 software. 4–8x cost reduction.
21 CFR 1.1455 defines the Key Data Elements required at each Critical Tracking Event. Every KDE below is captured by FarmGuard sensors or Loess-Lattice axis readings and written to a signed receipt at the moment of the event.
KDE definitions per 21 CFR 1.1455. Signed receipts are ML-DSA-65 (NIST FIPS 204). All axis readings written to immutable append-only log.
FDA defines Critical Tracking Events as the moments at which traceability data must be captured. The table below maps each CTE to the Loess-Lattice agent that attests it. Reference: 21 CFR 1.1345.
| No. | CTE | Description | Attesting Agent |
|---|---|---|---|
| CTE-1 | Growing | Produce is grown in an outdoor or indoor environment, or harvested from the wild. | FarmGuard + Axes 17–21 Soil, GPS, chlorophyll, humidity continuous log |
| CTE-2 | Receiving | A person receives a food on the Food Traceability List from another person. | FarmGuard at-receipt scan GLN + timestamp + lot-code cross-reference |
| CTE-3 | Creating | A food on the list is created by combining ingredients, one or more of which is on the list. | Loess-Lattice bundle receipt Input lots linked via cross-axis signature |
| CTE-4 | Transforming | A food on the list undergoes a change — cutting, freezing, cooking — that creates a new item. | Loess-Lattice Axis 24 + bundle sig KDE 07 transformation timestamp and cross-sig |
| CTE-5 | Shipping | A food on the list is shipped to another person. | FarmGuard shipment event Lot code + carrier ID + departure timestamp |
| CTE-6 | Cooling | A raw agricultural commodity on the list is first cooled after harvest. | FarmGuard thermistor + Axis 20 Continuous cold-chain temperature log |
| CTE-7 | Initial Packing | A raw agricultural commodity not obtained from a farm is packed for the first time. | FarmGuard pack event + Loess receipt Weight, count, lot code sealed in signed receipt |
The complete bundle. Hardware, subscription, compliance engine, two-year record retention, and on-demand FDA inspector export — no upsells.
Year 2+ recurring: ($99 + $299) × 12 = $4,776 / yr. Hardware is a one-time cost.
Comparable FSMA 204 traceability software is typically licensed at $25,000–$80,000 per year per facility, before implementation and training costs.
Cost reduction: 3.9× vs. the low end, 7.9× vs. the high end. Year 2+ recurring at $4,776 widens the gap further. Industry figures based on publicly available vendor pricing; actual costs vary by facility size and configuration.
The compliance engine runs continuously on the Hive Civilization edge node co-located with FarmGuard hardware. No operator action is required between events.
/v1/purity/cert/issue and receives a signed Purity Receipt. The compliance engine subscribes to this webhook and processes each receipt within 500 ms of issuance./v1/fsma204/export?lot=TLC-xxx to receive a pre-signed download URL valid for 24 hours. The URL covers all KDE records for the specified lot, across all CTEs, as a single ZIP. The full chain is returned in under 60 seconds.An FDA inspector arrives at a retail store. From QR scan to full chain-of-custody verification takes under 60 seconds, end-to-end, with no operator intervention.
FDA inspector at retail location | | scans QR code on retail packaging v QR → https://thehiveryiq.com/verifier/?lot=TLC-3f9a2c…d814e7 | | /verifier/ resolves to Hive edge node v Verifier lookup (< 300 ms) - Decode TLC: SHA3-256(axis17‖axis18‖harvest_ts) - Pull signed receipt chain from immutable log - Verify ML-DSA-65 signatures at edge | | all signatures valid v 7-KDE chain returned (JSON + FDA CSV) KDE 01 Traceability Lot Code … 3f9a2c…d814e7 KDE 02 Growing Area Coords … 38.847291, -121.094832 KDE 03 Production Date … 2025-11-03T06:14:22Z KDE 04 Cultivar … Romaine 'Parris Island' KDE 05 Receiver Location … GLN 0614141123452 KDE 06 Quantity … 453.2 kg / 1,200 units KDE 07 Transformation Date … 2025-11-04T14:05:10Z | | inspector requests full lot export v /v1/fsma204/export?lot=TLC-3f9a2c…d814e7 | | pre-signed URL returned, valid 24 h v Full CTE chain (ZIP) downloaded - Growing event (CTE-1) signed receipt - Cooling event (CTE-6) signed receipt - Initial pack (CTE-7) signed receipt - Shipping event (CTE-5) signed receipt - Receiving evt (CTE-2) signed receipt | v All signatures verified. Total elapsed time from QR scan to verified export: < 60 seconds.
Signature verification runs at the edge via /verifier/. No round-trip to a central server required for initial KDE lookup. Full chain export routed through US-region object storage. Inspector access is logged and appended to the audit trail.
The FDA Food Traceability List covers high-risk produce categories including leafy greens, herbs, fruits, sprouts, and more. Any entity that grows, packs, ships, transforms, or receives these foods must comply with Subpart S by January 20, 2026.
Hive Civilization, Inc. is not an FDA-registered facility and is not a food business subject to FSMA 204. FSMA 204 in a Box is a data infrastructure product. We provide the sensors, the entropy substrate, the signed-receipt ledger, and the KDE export tooling. We do not file compliance records with FDA on your behalf, nor do we make representations about your regulatory status.
You are the covered entity. You retain compliance responsibility. The data we generate is the substrate from which your compliance records are built. You or your designated compliance officer must verify that the KDE CSV files we produce satisfy the specific requirements of 21 CFR 1.1455 for your facility type and supply chain configuration.
What this means in practice: We capture and sign the data. We store it for two years. We produce the export on demand. You review the export, confirm it covers every CTE applicable to your operations, and maintain it as your official record. If FDA regulations change, we ship mapping-table updates within 30 days, and you review before deploying.
This disclosure does not constitute legal advice. Consult qualified food-safety counsel for a compliance determination specific to your operations.
The first five qualifying facilities receive the complete FSMA 204 in a Box bundle — FarmGuard hardware, Loess-Lattice subscription, and auto-compliance engine — free for 90 days, in exchange for case-study participation rights. You retain full ownership of all data generated during and after the pilot.
Qualifying criteria: a facility on the FDA Food Traceability List with at least one active CTE. Pilot customers must agree to participate in a post-deployment case study (format negotiable — written, video, or technical whitepaper). No minimum commitment after the 90-day period.
Apply for the 5-customer pilotattestation_type: manual flag. Manual entries carry no soil signature and should be supplemented with supplier-provided documentation.
90 days. No charge. Full bundle. Case-study rights in exchange.
Deadline: January 20, 2026 compliance date leaves no margin.
Or email directly: [email protected]. Subject line: FSMA 204 pilot.