FSMA 204 — Food Traceability Rule
The FDA's final rule on food traceability requires enhanced recordkeeping for high-risk foods across the entire supply chain. Full enforcement begins July 2028.
OriginTrace helps you capture Key Data Elements at every Critical Tracking Event — ensuring audit-ready compliance from farm to fork.
Does FSMA 204 Apply to Your Business?
The Food Traceability Rule applies to all entities that manufacture, process, pack, or hold foods on the FDA's Food Traceability List — from growers and importers to distributors and retailers.
Growers & Harvesters
Farms growing FTL produce must record harvest data, growing area coordinates, and cooling information with traceability lot codes.
Manufacturers & Processors
Entities that transform FTL foods must link input and output lot codes, record transformation data, and maintain supply chain references.
Importers & Distributors
Anyone importing, shipping, or receiving FTL foods must capture receiving/shipping KDEs and maintain electronic traceability records.
FDA's High-Risk Food Categories
The FDA identified these food categories through a risk-ranking model based on foodborne illness outbreak data. If you handle any of these foods, enhanced traceability records are required.
Seafood
- Finfish (fresh/frozen)
- Smoked finfish
- Crustaceans (fresh/frozen)
Produce
- Cucumbers (fresh)
- Herbs (fresh)
- Leafy greens (fresh/fresh-cut)
- Peppers (fresh)
- Sprouts (fresh)
- Tomatoes (fresh)
Fruits
- Tropical tree fruits (fresh)
- Fruits (fresh-cut)
Other
- Shell eggs
- Nut butters
- Vegetables (fresh-cut)
- Ready-to-eat deli salads
- Soft cheeses (certain)
What You Need to Record
FSMA 204 mandates capturing specific Key Data Elements (KDEs) at each Critical Tracking Event (CTE) in the supply chain. Every link must maintain and share this data.
Critical Tracking Event Flow
Growing
Where and when food was grown or raised
Receiving
Receipt of food at a facility
Transformation
When food changes form (processing, packing)
Shipping
Dispatch of food from a facility
Key Data Elements by Stage
Growing / Harvesting
- Growing area coordinates
- Harvest date
- Cooling location
- Quantity and unit of measure
Receiving / Shipping
- Traceability lot code
- Entry / ship date and time
- Origin and destination locations
- Reference document (PO, BOL)
Transformation
- Input and output traceability lot codes
- New quantity and unit of measure
- Transformation date
- Location of transformation
Record-Keeping Requirements
FDA Compliance Essentials
Response Window
Records must be provided within 24 hours of FDA request
Retention Period
Minimum 2-year retention period required
Electronic Format
Electronic records must be sortable and searchable
Traceability Plan
Must include a traceability plan describing your procedures
FSMA 204 Compliance, Built In
OriginTrace maps directly to FSMA 204 requirements — capturing KDEs at every CTE, maintaining audit-ready records, and scoring your compliance in real time.
Lot-Level Traceability
Track every lot from farm origin through each critical tracking event with unique traceability lot codes linked across your entire supply chain.
KDE Capture & Storage
Structured data capture for all required Key Data Elements at each Critical Tracking Event, ensuring no gaps in your recordkeeping.
Sortable, Searchable Records
Maintain electronic records in the format FDA requires — sortable and searchable within 24 hours of a request, with 2-year retention built in.
Supply Chain Link Mapping
Map every supplier, receiver, and processor in your supply chain with their FTL food assignments and traceability protocols.
Compliance Scoring
Real-time compliance scoring highlights gaps in your traceability data before FDA inspectors find them, reducing your audit risk.
Audit-Ready Reports
Generate FDA-ready traceability reports in seconds — complete with lot genealogy, CTE timelines, and KDE verification for rapid response to recalls.
FSMA 204 Compliance Timeline
The FDA finalized the rule in November 2022. Full compliance for all covered entities is required by July 2028.
Proposed Rule published by FDA
Proposed Rule published by FDA
Final Rule published in Federal Register
Final Rule published in Federal Register
Final Rule effective date
Final Rule effective date
Compliance date for large businesses
Compliance date for large businesses
Full enforcement deadline for all covered entities
Full enforcement deadline for all covered entities