FSMA (Food Safety Modernization Act)

A landmark U.S. federal law - signed in 2011 and enforced by the FDA - that shifted food safety regulation from reactive response to preventive controls, with specific rules governing the sanitary transportation of food that directly affect how shippers, carriers, and warehouses handle temperature-sensitive freight.
Glossary
Documentation & Compliance
FSMA (Food Safety Modernization Act)

The Food Safety Modernization Act is the most significant overhaul of U.S. food safety law in over 70 years. While FSMA covers the entire food supply chain from farm to table, the rule most relevant to shippers and carriers is the Sanitary Transportation of Human and Animal Food rule (21 CFR Part 1, Subpart O), finalized in 2016. This rule establishes requirements for vehicles, transportation equipment, transportation operations, records, training, and waivers – and it applies to shippers, carriers, loaders, and receivers of food products transported by motor or rail.

Under FSMA's sanitary transport rule, shippers bear specific responsibilities. They must specify transportation requirements – including temperature, pre-cooling protocols, and cleanliness standards – in writing to the carrier. Carriers must maintain equipment in sanitary condition and operate according to the shipper's written specifications. Loaders must follow procedures that prevent contamination during loading, and receivers must reject shipments that don't meet safety conditions. The rule requires that all parties maintain records of these agreements and compliance for at least 12 months.

For food and beverage shippers – especially those managing cold chain, frozen, or fresh products – FSMA compliance isn't optional and the consequences of violations are severe, ranging from warning letters to recalls to criminal prosecution. Temperature excursions during transit, cross-contamination from unclean trailers, and inadequate documentation of sanitary transport procedures are common compliance gaps. The rule essentially requires shippers to have documented, enforceable processes for how their food moves – which means your TMS, carrier management, and tracking systems are all part of your FSMA compliance infrastructure.

Shippers in food and beverage benefit from platforms that provide continuous temperature monitoring, documented carrier specifications, and complete shipment records – all of which support FSMA's emphasis on preventive controls and traceability throughout the transportation leg.

How Owlery Helps

Owlery is purpose-built for food and beverage shippers, with cold chain carrier integrations, real-time tracking, and comprehensive shipment records that support the documentation requirements of FSMA's sanitary transport rule.

Last Reviewed:
February 16, 2026

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