FDA publishes traceability guide for small food firms

The FDA has released a guide that is designed to help smaller organisations comply with the traceability requirements of the Food Safety Modernisation Act (FSMA).

The Small Entity Compliance Guide is aimed at small business and farms, for example, to help them comply with the recordkeeping requirements of the legislation, which come into force on January 20, 2026.

It provides advice on a range of topics, explaining exactly who is subject to the traceability rule and who is exempt, the records that must be kept and for how long, and the consequences of failure to comply. It also covers the procedures to apply for a modification or exemption or waiver.

The Food Traceability Rule requires persons who manufacture, process, pack, or hold foods on a specific list to maintain and provide to their supply chain partners specific information – called key data elements (KDEs) – for critical tracking events (CTEs) in the food's supply chain.

In a nutshell, it involves assignment, recording and sharing of lot codes, and linking those codes to other information that identifies the food as it changes hands in the supply chain from producer to consumer.

The aim is to capture batch/lot and similar shipment level data for a wide variety of fresh produce, seafood and dairy products to make it easier to identify unsafe batches and remove them from the market, protecting the public as well as companies’ risk of liability.

Organisations representing small farms and other producers lobbied hard for exemptions to the requirements, claiming they were unnecessary and onerous for small businesses and could drive some out of business.  

The final rule exempts farms or businesses that sell $25,000 or less of produce annually and egg producers with less than 3,000 hens at a particular farm, as well as charitable organisations like food banks.

While not mandatory, the FDA also hopes to encourage voluntary, even greater end-to-end traceability along with supply chain.