What is FSMA 204?
The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).
The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
FSMA 204 requires persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
Central to the proposed requirements is the assignment, recording, and sharing of traceability lot codes (TLCs) for FTL foods, as well as linking these TLCs to other information identifying the foods as they move through the supply chain.
Six FSMA 204 Facts to Know
- The US Food & Drug Administration (FDA) has issued a new food safety regulation.
- The new regulation, the Food Safety Modernization Act (FSMA) Rule 204, was finalized in January 20, 2023.
- FSMA 204 establishes traceability recordkeeping and reporting requirements for certain foods.
4. FSMA 204 applies to all persons who manufacture, process, pack or hold foods.
5. FSMA 204 applies to foreign firms producing food for U.S. consumption.
6. FSMA 204 compliance deadline is January 20, 2026.
- The US Food & Drug Administration (FDA) has issued a new food safety regulation.
- The new regulation, the Food Safety Modernization Act (FSMA) Rule 204, was finalized in January 20, 2023.
- FSMA 204 establishes traceability recordkeeping and reporting requirements for certain foods.
- FSMA 204 applies to all persons who manufacture, process, pack or hold foods.
- FSMA 204 applies to foreign firms producing food for U.S. consumption.
- FSMA 204 compliance deadline is January 20, 2026.
Frank Yiannas
FDA Deputy Commissioner
(Dec 2018 – Feb 2023)
“The New Era of Smarter Food Safety is an approach to bending the curve of foodborne illness through the use of new technologies and approaches.”
“The emergence of blockchain technology, because of its distributed and decentralized nature, that aligns more closely with a decentralized and distributed food system, has enabled food system stakeholders to imaging being able to have full end-to-end traceability.”
“An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.”
What FSMA 204 Does Not Do
In essence, FSMA 204 mandates recordkeeping and reporting of Traceability Lot Codes (TLCs) as food moves through the supply chain.
It does not mandate how those records are kept, but as reporting may have to occur within 24 hours of request, it is essential that those records be quickly and easily obtainable.
It does not mandate the tracking of extensive data beyond TLCs, including:
- certified compliances (e.g., GAP, Halal)
- inventory utilization (e.g., warehouse optimization, storage scheduling)
- costing data (e.g., the cost of each intermediate service)
- collateralized debt obligations (e.g., crop receipts and warehouse receipts)
- positional data (e.g., GPS)
- climate data (e.g., temperature, humidity)
- certified compliances (e.g., GAP, Halal)
- inventory utilization (e.g., warehouse optimization, storage scheduling)
- costing data (e.g., the cost of each intermediate service)
- collateralized debt obligations (e.g., crop receipts and warehouse receipts)
- positional data (e.g., GPS)
- climate data (e.g., temperature, humidity)
FSMA 204 applies to imported foods and requires that foreign suppliers track KTEs and TLCs, but does not provide or specify any means to do this.
The Business Risks Associated with Food Safety
- Customer Safety
- Customer and Reputation Loss
- Financial Losses and Liability
- Regulatory Non-compliance and Penalties
Your Business Priorities Should be Focused on Mitigating Risk
- Safeguard your customers
- Protect your brand
- Reduce financial exposure
- Ensure regulatory compliance
As a Food Producer or Supplier, What You Must Do
- Understand applicability of FSMA 204 to your business
- Decide how you are going to meet applicable requirements
- Determine what additional traceability capabilities are needed to protect your business
- Select an expert implementation partner
