Codes and Standards

Food traceability rules for supply chain

The U.S. Food and Drug Administration (FDA) is proposing additional traceability recordkeeping requirements for those who manufacture, process, pack or store foods.

By Rao Kolla March 26, 2021
Courtesy: Chris Vavra, CFE Media and Technology

The U.S. Food and Drug Administration (FDA) is proposing additional traceability recordkeeping requirements for those who manufacture, process, pack or store foods included on the Agency’s new Food Traceability List. The proposed rule is a key component of its New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the Food Safety Modernization Act (FSMA).

The additional recordkeeping requirements would apply not only to foods specifically listed on the Food Traceability List, but also to products that contain these foods as ingredients. Here is what’s included:

Courtesy: Stellar

Courtesy: Stellar

According to the proposal, parties who produce, process, pack and store these foods would need to establish and maintain records containing so-called key data elements (KDEs) associated with different critical tracking events (CTEs).

Records containing KDEs would be required for the following CTEs along the supply chain:

  • Growing
  • Receiving
  • Transforming
  • Creating
  • Shipping

The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs.

Additionally, the proposal would require those subject to the rule to establish and maintain traceability program records. These records are intended to help regulators understand an entity’s traceability program, and include:

  • A description of relevant reference records
  • A list of foods on the Food Traceability List that are shipped
  • A description of how traceability lot codes are assigned
  • Other information needed to understand data provided within the required records

According to the FDA’s proposal, any final rule on the additional traceability requirements would become effective 60 days after being published in the federal register.


Rao Kolla
Author Bio: Senior controls engineer, Stellar