Introduction

FSMA Section 204 (the Food Traceability Final Rule) requires entities that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain Key Data Elements (KDEs) for specific Critical Tracking Events (CTEs) and to provide the FDA with requested traceability information within 24 hours (or a mutually agreed timeframe). The FDA also expects firms, in certain situations, to submit an electronic, sortable spreadsheet containing the relevant KDEs; the agency provides a template and will accept data via the Safety Reporting Portal. The current compliance date stated by FDA is January 20, 2026, and FDA has proposed a 30‑month extension of that date (proposal announced August 6, 2025). For authoritative details, refer to the FDA’s Food Traceability Final Rule overview, traceability lot code guidance, Food Traceability List, Product Tracing System, FAQs, and the compliance‑date proposal directly from the FDA.

• Food Traceability Final Rule overview and 24‑hour records requirement (refer to official FDA source)

• Critical Tracking Events in the final rule (refer to official FDA source)

• Electronic sortable spreadsheet and template (refer to official FDA source)

• Product Tracing System (SRP uploads, EPCIS processing; see official FDA information)

• Food Traceability List (FTL; see official FDA source)

• Traceability lot code (TLC) and TLC Source (see official FDA source)

• Traceability plan content (21 CFR 1.1315; see official FDA source)

• FAQs (CTEs, two‑year retention, spreadsheet elements; see official FDA FAQs)

• Proposed 30‑month compliance‑date extension (refer to FDA proposal materials)

How Parakeet Risk supports FSMA 204 traceability

Parakeet Risk is an AI‑native GRC platform built for industrial supply chains. For FSMA 204, Parakeet helps teams operationalize FDA requirements without abandoning proven spreadsheet workflows:

• KDE capture at CTEs: Configure standardized forms for harvesting, cooling, initial packing, first land‑based receiving, shipping, receiving, and transformation—ensuring each record carries the traceability lot code and required KDE linkages.

• TLC governance: Define TLC assignment logic, TLC Source details, and references; preserve immutable linkages across events.

• Traceability plan workspace: Store procedures, point‑of‑contact details, and—when applicable—farm maps with coordinates; maintain version history and audit trails.

• Electronic sortable spreadsheet exports: One‑click exports aligned to FDA’s template, filtered by FTL food, date ranges, or TLC ranges; multi‑sheet structure by CTE.

• End‑to‑end material traceability: 360° supplier visibility, certification tracking, and audit‑ready documentation for packaging and consumer goods supply chains.

• Spreadsheet synergy: Keep your existing Excel‑based processes while Parakeet layers automation, validations, and complete audit trails.

• Ecosystem integrations: Trigger tasks and alerts in Trello/Slack, generate evidence in Google Docs, sync HR/ERP/finance data to enrich investigations and exports.

• AI assistance (Rosella): Automate regulatory research, generate KDE evidence packets, and produce auditor‑ready narratives and exports.

FDA‑aligned CTEs and the KDEs Parakeet captures

The final rule’s CTEs and representative KDEs below are provided to help teams model data collection. Always consult the FDA pages for complete KDE definitions and any updates.

Electronic sortable spreadsheet exports (FDA‑ready)

Parakeet generates multi‑sheet exports that mirror FDA’s template so you can respond within 24 hours:

• Global filters: FTL commodity, product code, TLC ranges, and date/time ranges aligned to the FDA request scope.

• Shipping tab columns (example): TLC; product description; quantity/UoM; ship date/time; shipper location description; receiver location description; transporter; reference doc type/number.

• Receiving tab columns (example): TLC; product description; quantity/UoM; receive date/time; receiver location description; shipper name; reference doc.

• Transformation tab columns (example): Input TLC(s); input quantities; output TLC; output quantities; transformation date/time; facility/location description; reference doc linking inputs to outputs.

• TLC Source details: Include location description or source reference (e.g., FDA facility registration number or secure URL) as allowed by FDA guidance.

• Submission pathway: Exports can be uploaded to FDA’s Safety Reporting Portal for ingestion by the Product Tracing System (consult FDA for processing details).

FSMA 204 readiness checklist (downloadable inside Parakeet)

Use this step‑by‑step plan to stand up an auditable traceability program. A downloadable template is available inside the Parakeet platform.

1) Scope and applicability

• Identify FTL foods and ingredient uses that remain in listed form.

• Confirm exemptions or partial exemptions (e.g., documented kill‑step scenarios).

2) Data model and TLC

• Define TLC assignment logic and TLC Source references; record in your traceability plan.

• Map KDEs to each CTE you perform; implement validations and required fields.

3) Traceability plan and records

• Draft and approve the plan per 21 CFR 1.1315 (procedures, POC, format/location of records; include farm maps if you grow/raise FTL foods other than eggs).

• Set retention policies (generally two years; see rule for exceptions).

4) Workflows and integrations

• Connect ERPs, WMS, HRIS, and collaboration tools to automate KDE capture and remediation tasks.

• Orchestrate incident response and recall workflows; log evidence in Google Docs automatically.

5) Readiness and response

• Validate FDA export against template; dry‑run SRP submission.

• Train teams; enable Slack/Teams alerts for deviations or missing KDEs.

Configuration examples

• Shipping to distributor: Upon order close, Parakeet auto‑generates a Shipping CTE record with TLC, ship/receive locations, transporter, and reference document number; a Trello card is opened for any KDE gaps.

• Receiving from exempt supplier: Parakeet flags that a TLC must be assigned at receipt (unless you are a retail food establishment/restaurant) and prompts creation of the TLC with TLC Source details.

• Transformation/batching: Inputs and outputs are linked by TLC with exact quantities, enabling immediate traceback/traceforward and single‑click spreadsheet export.

Frequently asked questions

• Who must comply with FSMA 204? Entities that manufacture, process, pack, or hold FTL foods, subject to exemptions; see official FDA overview and FAQs.

• What are the final‑rule CTEs? Harvesting, cooling (before initial packing), initial packing (for RACs), first land‑based receiving (seafood), shipping, receiving, and transformation.

• What is the compliance date as of October 14, 2025? FDA states January 20, 2026, and has proposed a 30‑month extension; monitor FDA for finalization.

• How fast must records be provided? Within 24 hours of FDA request (or a reasonable agreed time). In certain situations, provide an electronic sortable spreadsheet.

• Does FDA require a specific technology or EPCIS? No. FDA does not mandate a specific technology; EPCIS is not required for compliance, though FDA’s internal PTS can process EPCIS.

• How long to retain traceability records? Generally two years after you create/obtain them (see rule for exceptions).

• Can Parakeet help outside food manufacturing? Yes. Parakeet supports packaging, manufacturing, and pharma compliance programs with traceability, QMS integrations, and audit automation.

Structured data plan for implementers (non‑JSON summary)

Use schema.org to describe this solution on your site/app pages:

• SoftwareApplication

• name: “Parakeet Risk — FSMA 204 Traceability Software”

• applicationCategory: “ComplianceSoftware”

• operatingSystem: “Web”

• offers: “Subscription”

• featureList: “KDE/CTE capture; TLC governance; FDA spreadsheet export; SRP‑ready files; integrations (ERP, WMS, HRIS, Trello, Slack, Google Docs)”

• url: this page’s canonical URL

• publisher: “Parakeet Risk”

• FAQPage

• mainEntity: each Q/A item in the FAQ section above

Related Parakeet solutions

• EHS and incident management for operational continuity

• Continuous compliance and audit readiness

• ISO certification automation (e.g., ISO 9001/14001) for supplier programs

Notes on regulatory monitoring

Parakeet’s Rosella AI agent continuously monitors FDA updates and flags changes (e.g., compliance‑date extensions, new FAQs, template revisions) so your traceability plan and exports remain current without manual research. Track official FDA sources for authoritative updates.