About FSMA 204

FDA FSMA204 and what this means for you

End-to-end traceability across the value chain

Marking a new era for food traceability

FSMA 204

The FDA is proposing to establish additional traceability record keeping requirements (beyond what is already required in existing regulations) for organizations who manufacture, process, pack, or hold foods. The Agency has designated for inclusion on the Food Traceability List. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). Source: FDA The list of food categories ranges from seafoods to fresh produce, and the FTL categories are certain cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks, ready-to-eat deli salads including a list of fresh produce such as cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits.

FDA FSMA 204 and what this means for you

The FDA has established additional traceability record keeping requirements. The rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). Source:FDA

The list of food categories ranges from seafoods to fresh produce, and the FTL categories are certain cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks, ready-to-eat deli salads including a list of fresh produce such as cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits. This list is likely to be expanded in future.

At very high level, the key data elements (KDEs) associated with critical tracking events of data pertains to data from

Growing
Receiving
Creating (manufacturing/processing)
Transformation
Shipping

Final rule effective 60 days after published in the federal register and with 2 years transition for the entities in the supply chain to comply.

In addition, the proposed rule would also require that:

Traceability records be provided to FDA as soon as possible but no later than 24 hours after a request is made.

DNV is a global leading provider of food safety certification, second party supplier audits, assurance & advisory services , we help to assure safety and sustainability compliance for our customers in the food industry. With digital solutions based on verified and assured data, we enhance supply chain operations allowing for higher transparency and compliance, making every product unique, secure, and traceable. Our solutions include setting up traceability solutions for our customers to meet the forthcoming requirements of FDA FSMA 204.