FDA publishes final food traceability rule

The FDA has published its Food Traceability Final Rule – due to go into effect on November 21 – designed to reduce the risk of foodborne illnesses and deaths by allowing contaminated foods to be quickly withdrawn from the market.

The final rule – many years in gestation – establishes additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables and ready-to-eat deli salads, said the regulator in a statement.

Along with helping to manage food hazards, the proposed system of lot-level traceability also provides reliable product information that can help to guarantee product authenticity and safety and combat food fraud.

At the core of this rule is a requirement that 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 in a timely manner. The system relies on the use of an alphanumeric code used to identify a lot.

CTEs include: cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.

"This rule lays the foundation for even greater end-to-end food traceability across the food system that we're working on as part of the New Era of Smarter Food Safety initiative," said Frank Yiannas, FDA's deputy commissioner for food policy and response.

"This standardised, data-driven approach to traceability recordkeeping helps create a harmonised, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future."

Earlier this month, the National Grocers Association (NGA) said it had agreed with ReposiTrak to waive a $2,000 setup fee for access to ReposiTrak Traceability Network which is designed to meet the FDA's requirements.